Quality Management

Quality Management Requirements (NABH 5th Ed)

Chapter PSQ - Patient Safety and Quality

1. Patient Safety Programme Committee (PSQ 1a):

   • A multidisciplinary committee is responsible for developing, implementing, and maintaining the patient safety programme.

   • The committee should include representatives from administration, facility management, safety officers, clinicians, nurses, paramedical staff, and various clinical and support departments.

   • The committee should meet frequently (e.g., every month).

   • The committee oversees proactive risk assessment tools (Hazard Identification and Risk Analysis - HIRA, Failure Modes and Effect Analysis - FMEA) and is documented as a manual. (PSQ 1a)

2. Programme Scope (PSQ 1b, PSQ 1c):

   • The patient safety programme must be comprehensive and cover all major elements related to patient safety, addressing safety affecting clinical and support services (laboratory, imaging, patient safety). (PSQ 1b)

   • The programme covers incidents ranging from 'no harm' events to 'sentinel events', defining what constitutes these events. (PSQ 1c)

3. Safety Officer Roles (PSQ 1d, PSQ 1e):

   • A designated patient safety officer(s) coordinates implementation of the patient safety programme, with clearly defined roles and responsibilities. (PSQ 1d)

   • Designated clinical safety officer(s) (a doctor or nurse with relevant registration/experience in risk management) coordinates implementation of the clinical aspects of the patient-safety programme. (PSQ 1e)

4. Opportunity Identification (PSQ 1f):

   • The patient-safety programme identifies opportunities for improvement based on review at predefined intervals (at least once in 3 months).

   • Reviews should cover findings from facility rounds, patient safety incidents, risk management, and analysis of key safety indicators. Minutes must be documented. (PSQ 1f)

5. Proactive Risk Analysis (PSQ 1g):

   • The organisation performs proactive analysis of patient safety risks using tools like HIRA, FMEA, Fault tree analysis, and simulations.

   • Improvements are made accordingly. At least one patient safety related risk should undergo proactive analysis every year. (PSQ 1g)

6. Programme Review and Update (PSQ 1h):

   • The patient-safety programme is reviewed and updated at least once a year.

   • Updates should be based on newer literature on patient safety and review findings.

   • If the annual review finds no opportunity for improvement, this should be documented in the safety committee minutes. (PSQ 1h)

7. National/International Safety Goals (PSQ 1i):

   • The organisation adapts and implements national/international patient-safety goals/solutions. (PSQ 1i)

8. Quality Improvement Programme Committee (PSQ 2a):

   • The quality improvement programme is developed, implemented, and maintained by a multi-disciplinary committee.

   • The programme should be integrated across the organisation and provide a network for risk management, ongoing monitoring, and performance improvements based on reviews.

   • The roles and responsibilities of the multidisciplinary committee are defined.

   • The committee should receive inputs on significant deliberations from other committees. (PSQ 2a)

9. Quality Programme Scope (PSQ 2b):

   • The quality improvement programme is comprehensive and covers all major elements related to quality assurance.

   • It should be documented as a manual incorporating programme goals, objectives, activities (data collection, indicators, audits, etc.), committee terms of reference, review policy, and CAPA implementation.

   • It should summarise quality assurance programs for key departments like Lab, Radiology, Emergency, OT, and ICU. (PSQ 2b)

10. Improving Process Efficiency and Effectiveness (PSQ 2c):

    • The quality improvement programme encourages the use of quality tools and novel strategies to improve both clinical and managerial processes.

    • The impact of managerial process innovations should be monitored.

    • Innovations may target improving patient safety, care delivery, reducing costs, or introducing environmentally friendly measures. (PSQ 2c)

11. Quality Programme Coordination (PSQ 2d):

    • There is a designated individual for coordinating and implementing the quality improvement programme.

    • This individual should preferably have good knowledge of accreditation standards, statutory requirements, hospital quality improvement principles, evaluation methodologies, functioning, and operations.

    • The individual should report directly to Top management, and their roles/responsibilities should be defined.

    • Champions should be identified and developed across the organisation. (PSQ 2d)

12. Quality Programme Review (PSQ 2e):

    • The quality improvement programme identifies opportunities for improvement based on review by the quality improvement committee at predefined intervals (at least once in 3 months).

    • Review should include findings of audits, organisational performance, and analysis of key indicators. Minutes must be recorded and maintained. (PSQ 2e)

13. Quality Programme Update (PSQ 2f):

    • The quality improvement programme is reviewed and updated at least once a year.

    • Updates should be based on newer literature on quality improvement and findings from audits, feedbacks, and committee reviews.

    • If the annual review finds no opportunity for improvement, this should be documented in minutes. (PSQ 2f)

14. Audits (PSQ 2g):

    • Audits are conducted at regular intervals as a means of continuous monitoring (at least once in 6 months hospital-wide as per a schedule).

    • Audits should include all applicable standards and OEs.

    • A formal meeting is held after audits to summarise findings and document CAPA. Implementation of changes should be verified and recorded. (PSQ 2g)

15. Monitoring Nursing Quality (PSQ 2h):

    • There is an established process to monitor and improve the quality of nursing care.

    • This can be done through nursing audits or competency evaluations (written questionnaire, witnessed demonstration) focusing on key procedures (medication administration, cannula placement, tracheostomy). KPIs should be identified. (PSQ 2h)

16. Monitoring Clinical Structures, Processes, Outcomes (PSQ 3a):

    • The organisation identifies and monitors key indicators to oversee the management, clinical structures, processes, and outcomes.

    • Indicators mandated by NABH should be monitored. (PSQ 3a) This includes patient assessment, safety/quality control of diagnostic services, medication management, blood/blood component use, surgical services (anaesthesia use, mortality/morbidity). (PSQ 3a interpretation)

17. Monitoring Infection Control (PSQ 3b):

    • The organisation identifies and monitors key indicators to oversee infection control activities (CAUTI, CLABSI, SSI, VAP). (PSQ 3b)

18. Monitoring Managerial Structures, Processes, Outcomes (PSQ 3c):

    • The organisation identifies and monitors key indicators to oversee managerial structures, processes, and outcomes (Medication procurement/utilisation, patient/staff satisfaction rates, waiting times, availability/content of medical records). (PSQ 3c)

19. Monitoring Patient Safety Activities (PSQ 3d):

    • The organisation identifies and monitors key indicators to oversee patient safety activities (Patient safety goals and risk management). (PSQ 3d)

20. Patient Reported Outcome Measures (PROMs) (PSQ 3e):

    • The organisation has a mechanism to capture patient reported outcome measures.

    • PROMs should be used to improve communication and decision making between doctors and patients. (PSQ 3e)

21. Data Verification (PSQ 3f):

    • Verification of data is done regularly by the quality team (through every data or random sampling). (PSQ 3f)

22. Data Analysis and Opportunity Identification (PSQ 3g):

    • There is a mechanism for analysis of data which results in identifying opportunities for improvement. (PSQ 3g)

23. Improvement Implementation and Evaluation (PSQ 3h):

    • The improvements are implemented and evaluated. Improvement activities should have an evaluable outcome, and this should be documented. (PSQ 3h)

24. Communicating Feedback (PSQ 3i):

    • Feedback about care and service is communicated to staff. Feedback should include rates, trends, and opportunities for improvement. (PSQ 3i)

25. Quality Improvement Tools (PSQ 4a, PSQ 4b, PSQ 4c):

    • The organisation uses appropriate analytical tools for its quality improvement activities (Root cause analysis, run chart, stratification diagram, normalisation table, flow chart, pareto analysis, histogram). (PSQ 4a)

    • The organisation uses appropriate statistical tools for its quality improvement activities (Sampling, control chart, ANOVA, six sigma). (PSQ 4b)

    • The organisation uses appropriate managerial tools for its quality improvement activities (Lean, six sigma, PDSA, force field analysis, affinity diagram, matrix diagram, tree diagram). (PSQ 4c)

26. Culture of Safety (PSQ 6a):

    • The management creates a culture of safety.

    • Management needs to measure its safety culture regularly (at least once a year) using validated surveys (MaPSaF, SOPS).

    • Management should act on patient safety culture assessment results. (PSQ 6a)

27. Leadership Awareness (PSQ 6b):

    • The leaders at all levels in the organisation are aware of the intent of the patient safety and quality improvement programme and the approach to its implementation. (PSQ 6b)

28. Departmental Involvement (PSQ 6c):

    • Departmental leaders are involved in patient safety and quality improvement. Each department could have its own objectives/key performance indicators. (PSQ 6c)

29. Resource Availability (PSQ 6d):

    • The management makes available adequate resources required for patient safety and quality improvement programme (Men, material, machine, money, milieu, measurement, and method). (PSQ 6d)

30. Budget Allocation (PSQ 6e):

    • Organisation earmarks adequate funds from its annual budget for quality improvement, possibly based on previous year's spending. (PSQ 6e)

31. Staff Feedback on Quality System (PSQ 6g):

    • The management uses the feedback obtained from the workforce (at least once a year through staff survey) to improve the patient safety and quality improvement programme and systems. (PSQ 6g)

32. Incident Management System (PSQ 7a, PSQ 7b, PSQ 7c, PSQ 7d, PSQ 7e, PSQ 7f):

    • The organisation implements an incident management system.

    • The system includes identification, reporting, review, and action on incidents.

    • A mechanism is required for reporting incidents using a standardised form (simple, clear, confidential, focused on process improvement). (PSQ 7a)

    • A mechanism is in place to identify sentinel events (related to system/process deficiencies, relevant, important, clearly defined, documented). (PSQ 7b)

    • The organisation has established processes for analysis of incidents. Analysis should be completed within seven working days of reporting. Safety committee is responsible for this activity. Corrections should be initiated within 24 hours of occurrence. (PSQ 7c)

    • Corrective and preventive actions are taken based on the findings of incident analysis. Actions should be documented. Findings and recommendations should be communicated to all personnel. Any changes in policies/procedures should be reflected as amendments. (PSQ 7d)

    • The organisation incorporates risks identified in the analysis of incidents into the risk management system (if analysis reveals unidentified risk). (PSQ 7e)

    • The organisation shall have a process for informing various stakeholders in case of a near miss/adverse event/sentinel event (after due analysis). (PSQ 7f)

Chapter AAC - Assessment of Patients (Related Quality Aspects)

1. Care Plan Monitoring Quality (AAC 5c):

   • The care plan is monitored and modified where necessary according to the patient's condition. The dynamic nature should be documented in medical records, showing evidence of changes. (AAC 5c)

2. Documentation Quality (AAC 5d):

   • Staff involved in direct clinical care document reassessments accurately (including vitals, systemic examinations, findings, medication orders). Vague terms like "patient well" are not acceptable, promoting quality in documentation. (AAC 5d)

3. Monitoring Critical Value Response (AAC 12h):

   • A mechanism is in place to monitor whether adequate clinical intervention has taken place in response to critical value alerts. Evidence of the clinical intervention must be documented, ensuring timely and appropriate action for patient safety. (AAC 12h)

4. Predictable Service Timelines (AAC 12g):

   • The organisation ensures predictable service delivery timelines (e.g., Lab/Radiology report turnaround time, waiting time for consultations). Patient/family must be informed if there is any deviation, supporting patient experience and managing expectations. (AAC 12g)

Chapter COP - Care of Patients (Related Quality Aspects)

1. Clinical Pathways (COP 1e):

   • Clinical care pathways are developed, consistently followed across all settings of care, and reviewed periodically (e.g., develop 2 annually, review annually), standardizing and improving care processes. (COP 1e)

2. Procedure Safety Process (COP 7d):

   • Care is taken to prevent adverse events like wrong patient, wrong procedure, and wrong site using documented checklists, identifiers, site marking, and patient/relative involvement, implementing a key safety process. (COP 7d)

3. Rational Use of Blood (COP 8c):

   • Blood and blood components are used rationally, following a SOP addressing indications, inventory, and ordering schedules, promoting appropriate use and safety. (COP 8c)

4. Vulnerable Patient & Risk Management Protocols (COP 16a, COP 16c, COP 16d, COP 16e, COP 16f):

   • The organisation identifies and manages vulnerable patients, defining responsibility for identification, risk management, and monitoring. Care is organised per written guidance. (COP 16a)

   • Patients at risk of fall, pressure ulcers (using validated tools like Morse, Braden, staging systems), and DVT (using validated tool) are identified and managed according to written guidance. (COP 16c, COP 16d, COP 16e)

   • Patients needing restraints are identified and managed per written guidance (SOP). (COP 16f) - These establish systematic processes for identifying and mitigating patient risks.

5. Pain Management Standardization (COP 17b, COP 17c):

   • Patients are screened for pain (5th vital sign) using a yes/no question in initial assessment. (COP 17b)

   • Patients with pain undergo detailed and periodic reassessment using a validated pain rating scale. (COP 17c) - These standardize pain identification and assessment.

Chapter MOM - Management of Medication (Related Quality Aspects)

1. Safe Medication Practices (MOM 4a, MOM 4b, MOM 4c, MOM 4d, MOM 4e, MOM 4h, MOM 6a, MOM 6b, MOM 6c, MOM 7a-h, MOM 7i, MOM 8a, MOM 8b, MOM 8c, MOM 8d, MOM 9a):

   • Prescribing follows good/rational practices (MOM 4a), adheres to minimum requirements (MOM 4b), includes allergy checks (MOM 4c), and utilizes prescribing assistance mechanisms (MOM 4d).

   • Verbal orders follow safe SOPs (MOM 4e).

   • Medication reconciliation is done at transition points (MOM 4h).

   • Dispensing is done safely with checks (MOM 6a). Recalls (MOM 6b) and near-expiry meds (MOM 6c) are handled effectively.

   • Administration follows safe processes (permitted staff, labelling, patient ID, verification including double check for high-risk meds, avoiding misconnections) (MOM 7a-h) and is documented accurately (MOM 7i).

   • Patients are monitored after administration (MOM 8a), and meds are changed based on monitoring (MOM 8b).

   • Near miss/error/ADR events are captured, reported (within specified time), analysed, and acted upon (MOM 8c, MOM 8d).

   • Narcotics/psychotropics/chemo/radioactive agents are used safely following SOPs, prescription by appropriate caregivers, secure storage, and proper record-keeping (MOM 9a-d). - These elements describe a comprehensive system for managing medications safely, which is a critical aspect of quality.

Chapter PRE - Patient and Family Rights (Related Quality Aspects)

1. Complaint and Feedback Mechanism (PRE 2h, PRE 7c):

   • Patient/family right to complain is known (PRE 2h).

   • A mechanism exists to capture patient feedback/satisfaction (PRE 7a) and redress complaints as per a defined process (compiling, analysis, responsible persons, action documentation) (PRE 7c). - These support a system for capturing patient input on quality and addressing concerns.

2. Protecting Rights (PRE 1d, PRE 2c, PRE 2d):

   • A mechanism to report violations of patient/family rights exists (list of instances, staff training). (PRE 1d)

   • Patient/family are protected from neglect/abuse (PRE 2c), and information is confidential (PRE 2d). - These ensure fundamental safety and ethical quality standards.

3. Communication Standards (PRE 8d):

   • The organisation ensures no unacceptable communication occurs, upholding standards of respectful interaction, which is part of service quality. (PRE 8d)

Chapter HIC - Hospital Infection Control (Related Quality Aspects)

1. HIC System (HIC 2c, HIC 2d, HIC 2e, HIC 3a, HIC 3b, HIC 3c, HIC 3d, HIC 4a, HIC 4b, HIC 4c, HIC 4d, HIC 4e, HIC 4f, HIC 5a, HIC 5b, HIC 5c, HIC 5d, HIC 7a, HIC 7b, HIC 7c, HIC 7e, HIC 8b, HIC 8e, HIC 3e):

   • Making HIC resources available (PPE, hand hygiene facilities, isolation) (HIC 2c, HIC 2d, HIC 2e).

   • Adherence to standard practices (standard precautions, hand hygiene guidelines, transmission-based precautions, safe injection practices) (HIC 3a, HIC 3b, HIC 3c, HIC 3d).

   • Managing environmental HIC aspects (engineering controls, construction risk plan, housekeeping, BMW, laundry, kitchen sanitation) (HIC 4a-f).

   • Implementing HAI prevention actions/care bundles (CAUTI, VAP, CLABSI, SSI) (HIC 5a-d).

   • Managing instrument reprocessing for safety (space, guidance, reuse policy, recall procedure) (HIC 7a-c, HIC 7e).

   • Staff health policies (immunisation, post-exposure prophylaxis) (HIC 8b, HIC 8e).

   • Establishing an antimicrobial usage policy (HIC 3e). - The entire HIC chapter describes the management system and processes to ensure safety from infections, a key domain of quality.

Chapter FMS - Facility Management & Safety (Related Quality Aspects)

1. Safety Infrastructure & Management (FMS 1a, FMS 2d, FMS 2e, FMS 3b, FMS 3e, FMS 3f, FMS 4b/d/h, FMS 5b/d, FMS 6a-d, FMS 7a, FMS 7b, FMS 7d):

   • Installing and inspecting patient-safety devices (FMS 1a).

   • Ensuring utility reliability and monitoring quality (FMS 2d, FMS 2e).

   • Planning for security (FMS 3b).

   • Managing hazardous materials safely (identification, handling, storage, disposal, spill plan, staff training) (FMS 3e, FMS 3f).

   • Managing equipment (inventory, inspection, calibration, replacement, disposal) for proper functioning and safety (FMS 4b/d/h, FMS 5b/d).

   • Managing medical gas systems safely and ensuring alternate sources (FMS 6a-d).

   • Planning for and maintaining readiness for fire and non-fire emergencies (plans, personnel, training, mock drills, maintenance of fire equipment) (FMS 7a, FMS 7b, FMS 7d). - These elements describe the system for managing facility-related safety and reliability, contributing to overall quality.

Chapter HRM - Human Resource Management (Related Quality Aspects)

1. Staff Training on Safety and Quality (HRM 6a, HRM 6b, HRM 6c, HRM 6f, HRM 6g):

   • Training staff on the organisation's safety programme, risk management, incident handling, emergency procedures, and the quality improvement programme, ensuring staff competence and awareness for quality and safety. (HRM 6a, HRM 6b, HRM 6c, HRM 6f, HRM 6g)

2. Staff Health for Quality/Safety (HRM 9c):

   • Annual health checks for staff in direct patient care, supporting their fitness and reducing transmission risks. (HRM 9c)

3. Nursing Privilege Audit (HRM 12f):

   • Auditing the use of nursing privileges ensures that care is provided by appropriately qualified and authorized staff, supporting the quality of clinical care. (HRM 12f)

Chapter IMS - Information Management System (Related Quality Aspects)

1. Medical Record Quality (IMS 3c, IMS 3d, IMS 4b):

   • Ensuring medical records are complete, up-to-date, chronological, and use unique identifiers (IMS 3c).

   • Defining authorized staff for making entries and standardizing content (IMS 3d).

   • Ensuring records contain all relevant clinical information (assessments, consultations, investigations, care) (IMS 4b). - These elements contribute to the quality and reliability of patient information, essential for care and management.