APDCH Hospital - Patient Safety & Quality Manual PDF

ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 01 APDH/NABH/PSQ/01 Version: 03 Is...

ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 01 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 1.0 PURPOSE: 1.1 To define the policy and procedure for patient safety and quality improvement programme of APDCH hospital. 1.2 To fix key indicators for the processes. 1.3 To organize the measurement process to assess the performance index on such key indicators. 1.4 Scheduling of periodical measurement of performance index of key indicators explained above. 1.5 Based on periodic measurements data to carry out trend analysis. 1.6 Based on trend analysis to implement corrective action when desired for continual improvement 1.7 To establish a defined system for hospital-wide Nonconformance, incident related events management to improve continuously the performance. 1.8 To provide a confidential mechanism of identification, tracking, analyzing and to pursue and implement corrective/preventive actions of all incidences that poses an actual or potential safety risk to patients, families, visitors and staff. 2.0 SCOPE: 2.1 Outpatient Service 2.2 Applicable to all employees of the hospital 3.0 RESPONSIBILITY: 3.1 Doctors 3.2 All hospital staff 3.3 Internal Quality Assurance Committee 4.0 ABBREVIATION: 4.1 NABH : National Accreditation Board For Hospitals and Healthcare providers 4.2 PSQ : Patient Safety and Quality Improvement PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 02 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 5.0 DEFINITION: 5.1 Non Conformance: Defined as any event or circumstance not consistent with the standard routine operations or not having compliance to defined processes of the hospital in staff functions on support activities to internal/external customers or on care processes to patients. 5.2 Sentinel Events: An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof to a patient, visitor, or an employee. Serious injury specifically includes loss of limb or function. The phrase, “or the risk thereof”, includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. 5.3 Near Miss: Any process variation which did not affect the outcome but for which a recurrence carries a significant chance of a serious adverse outcome. 5.4 Hazardous conditions: Refer to any set of circumstances (exclusive of disease or condition for which the patient is being treated), which significantly increases the likelihood of a serious adverse outcome. 5.5 Lapse in compliance to statutory safety norms resulting in near miss harms the patients/ staff /visitors or to infrastructure. 5.6 Quality improvements: It is an ongoing response to quality assessment data about a service in ways that improve the process by which services are provided to the patients. 5.7 Risk management: Clinical and administrative activities to identify evaluate and reduce the risk of injury. 6.0 REFERENCE: 6.1 NABH: Accreditation for Dental Health Care Service Provider, Third Edition, Apr 2023 / PSQ 6.2 PSQ.1: There is a structured quality assurance and continuous monitoring programme in the DHSP 6.3 PSQ.2: The DHSP identifies key indicators to monitor the structures, processes and outcomes, which are used as tools for continual improvement. 6.4 PSQ.3: The quality improvement program is supported by the management. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 03 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 6.5 PSQ.4: There is an established system for clinical audit 6.6 PSQ.5: Incidents are collected and analysed to ensure continuous patient safety and quality improvement 7.0 POLICY: 1.1 Continuous quality improvement programme shall be implemented by Quality Control Team. 1.2 The quality improvement programme shall be supported by the Hospital management. 1.3 APDCH is committed to provide Quality Services to all the stake holders. 1.4 Hospital has different committees to coordinate and monitor the services provided. Continuous quality improvement programmes are monitored by core committee by regular internal quality audits, physical checks, data analysis, random sample checks etc. 1.5 The internal quality assurance cell meets every month and opportunities for improvement are identified. 1.6 APDCH has identified key performance indicators to monitor the clinical structures, managerial structures, process and outcomes. 1.7 All the key indicators shall be reported every month to the management and on later stage amendments shall be made in discussion with the core committee members. 1.8 Proper awareness to all employees is provided through proper training programmes. 1.9 Hospital conducts Internal Quality Audit once in every six months to ensure that all employees are strictly adhering to policies, procedures and work instructions/SOPs related to them 1.10 The management allocates annual budget for functioning of quality improvement programme 1.11 Quality Policy: 1.11.1 Patient safety shall always be our top priority. 1.12 Quality Objectives: 1.12.1 To maintain high standards of service at all levels. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 04 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 7.1 PROCEDURE: Approach To Designing, Measuring, Assessing And Improving Quality At APDCH Hospital Melmaruvathur. 7.1.1 Planning: Planning for the improvement of patient care and health outcomes includes a hospital-wide approach. The hospital maintains a plan that describes the hospital’s approach, processes, and mechanisms that comprise the hospital’s quality improvement activities. The Team approach serves as a means of collaboration between departments, planning and providing systematic organization-wide improvements. 7.1.2 Designing: Processes, functions or services are designed effectively based on: Mission and vision of APDCH, Melmaruvathur. Baseline quality expectations are utilized to guide measurement and assessment activities. 7.1.3 Measurement: Data is collected for a comprehensive set of Quality measures. To establish a baseline when a process is implemented or redesigned. To describe the dimensions of Quality relevant to functions, processes, and outcomes. To identify areas for improvement. To determine whether changes in a process have met objectives. Data is collected as a part of continuing measurement, in addition to data collected for priority issues. Data collection considers measures of processes and outcomes. Data collection includes at least the following processes or outcomes: 7.1.3.1 Patient assessment 7.1.3.2 Operative and other invasive and noninvasive procedures that place patients at risk 7.1.3.3 Laboratory safety & quality 7.1.3.4 Diagnostic Radiology safety & quality 7.1.3.5 Processes related to medication use 7.1.3.6 Processes related to Local anesthesia 7.1.3.7 Processes related to the use of blood and blood components PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 05 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 7.1.3.8 Processes related to medical records content, availability and use 7.1.3.9 Processes related to timely procurement of supplies 7.1.3.10 Reporting as required by law 7.1.3.11 Risk management activities 7.1.3.12 Needs, expectations, and satisfaction of patients 7.1.3.13 Staff expectations and satisfaction 7.1.3.14 Processes related to patient and staff safety. 7.1.3.15 Utilization of facility. 7.1.4 Assessment: 7.1.4.1 The assessment process involves the relevant departments to draw conclusions about the need for more intensive measurement. 7.1.4.2 A systematic process is used to assess collected data in order to determine whether specifications for newly designed processes were met, priorities for possible improvement of existing processes, actions taken to improve the Quality Improvement processes, and whether changes in the processes resulted in improvement. 7.1.4.3 Collected data is assessed at least quarterly and findings are documented and are forwarded through the proper channels. 7.1.4.4 A pre-determined level of Quality, which would trigger a more in-depth review, is established for each Quality measure to assist in the assessment of the data collected. 7.1.4.5 The reference used may include the following: Internal comparisons in Quality of processes and outcomes are made over time. Quality comparison of data is made about processes with up-to- date information. Quality comparison of data is made about processes and outcomes with other hospitals utilizing reference databases when possible. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 06 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 7.1.4.6 The assessment process includes the use of statistical process control techniques/tools as appropriate. Training for use of statistical process control is provided to the hospital leaders where needed; team members/staff are educated regarding statistical process control techniques on an ‘as needed’ basis. 7.1.4.7 When assessment of data indicates a variation in Quality, more intensive measurement and analysis will be conducted and in addition, the department/service or team will reassess its Quality measurement activities and re-prioritize them as deemed necessary. Intensive assessment is initiated when statistical analysis shows the following: Important single events, levels of Quality, and patterns or trends that vary significantly and undesirably from those expected; Quality that varies significantly from other organizations; Quality that varies significantly and undesirably from recognized standards; Intense assessment is performed on the following: 7.1.4.7.1 Major discrepancies between diagnoses in pathology reports. 7.1.4.7.2 Significant adverse drug reactions. 7.1.4.7.3 Adverse events or patterns of adverse events during anesthesia use. 7.1.4.8 When findings of the assessment process are relevant to an individual’s Quality, the pertinent information will be provided to the director for determining their use in peer review and/or periodic evaluations of a licensed independent practitioner’s competence at reappointment. 7.1.4.9 There is an established Medical Records Committee for audit of patient care services. Committee evaluates medical records for quality, content, format, accuracy, and pertinence of staff compliance with documentation. All audits are documented & required actions to be taken are documented & implemented. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 07 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 7.1.1 Internal Communications: 7.1.1.1 The top management has defined and implemented an effective and efficient process for communicating the Quality Policy, Objectives, Quality management requirements and accomplishments. 7.1.1.2 This helps the hospital to improve the performance and directly involves its people in the achievement of the Quality Objectives. 7.1.1.3 The Management actively encourages feedback and communication from people in the hospital as a means of involving them through the following modes: 7.1.1.3.1 Monthly meets 7.1.1.3.2 Management Review Meetings 7.1.1.3.3 Team briefings and other meetings. 7.1.2 Documentation: 7.1.2.1 Quality Manual: This is an outline of hospital policies of APDCH together with the Mission, Vision and Values of APDCH Quality Policy and Patient Safety priorities. Quality Manual also contains the structure and functions of the continuous quality improvement programme. 7.1.2.2 Department manuals: Every department maintains a manual describing their scope of service, Organogram, staffing patterns, job descriptions of staff. The manual will also contain the specific work instructions, SOPs and policies relevant to the department. Responsibility for keeping the manual updated and current rests with the Head of the Department. The responsibility for implementation, audit and updating of SOPs rests with the NABH coordinator / Correspondent of the hospital. 7.2 NABH Coordinator / Correspondent at APDCH Hospital has the overall authority, responsibility and commitment to communicate, implement, control and supervise the compliance of various PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 08 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 departments with the accreditation standards. The roles and responsibility of the NABH Coordinator include: 7.2.1 Establishing and maintaining the Quality Improvement and Patient Safety Program. 7.2.2 Document control. 7.2.3 Documentation of all Committee Meetings, Agenda and Minutes. 7.2.4 To ensure that Quality Manual and other Quality documents are current. 7.2.5 Schedule and conduct Internal Audits. 7.2.6 Schedule and conduct of Management Review meeting. 7.2.7 Ensuring corrective and preventive action arising from the above 7.3 Document Control: 7.3.1 Documents such as regulations, standards, policies, SOPs, manuals and other normative documents as well as drawings, software form part of the Hospital Quality Management System. 7.3.2 A copy of each of these controlled documents shall be archived for future reference and the documents shall be retained in their respective department the documents are maintained in paper or electronic media as appropriately required. 7.3.3 Documents are identified and established as three levels namely: 7.3.3.1 Quality Manual 7.3.3.2 Hospital Policies & Procedures 7.3.3.3 Departmental Manuals 7.3.4 The Heads of the Departments of the respective departments shall review all documents issued to personnel as a part of management system annually and they shall approve it for the use. The Head of Quality issues the finalized document. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 09 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 7.3.5 The Head of Quality ensures that: 7.3.5.1 Authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the Hospital are performed. 7.3.5.2 Documents are periodically reviewed and revised where necessary to ensure suitability and compliance with applicable requirements. 7.3.5.3 Invalid or obsolete documents are promptly removed from all prints of issue or use or otherwise assured against unintended use. 7.3.5.4 Obsolete documents are retained for either legal and / or knowledge preservation purposes are suitably marked or destroyed or the record and the record of this maintained in a separate register. 7.3.6 Document Changes: 7.3.6.1 Revision of management systems documents is carried out when necessary by the original author and updated at least once in two years. 7.3.6.2 When alternate persons are designated for review, they shall first familiarize themselves with pertinent background information upon which to base their review and approval. 7.3.6.3 Document control system does not follow the amendments by hand unless there is an extreme circumstance. 7.3.6.4 These amendments shall be marked, initiated and dated only by the Head of the Department. 7.3.6.5 The amendment shall be brought to the notice of the NABH coordinator and the same shall be reissued 7.4 Preventive Actions: 7.4.1 The NABH Coordinator shall be perpetually vigilant and identify potential sources of non- compliance and areas that need improvement. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 10 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 7.4.2 These may include trend analysis of specific markers such as turnaround time, risk analysis and introducing proficiency testing for self-assessment. 7.4.3 Where preventive action is required, a plan is prepared and implemented. 7.4.4 All preventive actions must have control mechanisms and monitor for efficacy in reducing any occurrence of non-compliance or producing opportunities for improvement. 7.5 Corrective Action: 7.5.1 The NABH Coordinator takes all necessary corrective action when any deviation is detected in Quality Management System. 7.6 Root Cause Analysis: Deviations are detected by: 7.6.1 Patient complains/feedbacks. 7.6.2 Non-compliance receipt of items/sample. 7.6.3 Non-compliance at Internal/external Quality Audit. Management Reviews. 7.6.4 The NABH coordinator conducts and coordinates the detailed analysis of the nature and root cause of non-compliance along with the responsible persons from the respective sections. 7.7 Selection and Implementation of Corrective Actions: Potential corrective actions are identified and the one that is most likely to eliminate the problem is chosen for implementation. Corrective action is taken into consideration the magnitude and degree of impact of the problem. All changes from corrective action is documented and implemented. 7.8 Monitoring Of Corrective Actions: The NABH Coordinator shall monitor the outcome parameters to ensure that corrective actions taken have been effective in eliminating the problem. 7.9 Procedures for Internal Quality Audit: Internal audit shall be conducted by the internal audit team members once in 6 months. Internal audit team members shall be trained on NABH standards either internally (a trained person who in turn trains the other members of the team) or externally (training conducted by Quality Council of India). Audit starts with the opening meeting. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 11 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 All departmental heads shall be informed about the purpose of audit, audit timings and duration of audit etc. Check list based on standards will be used by the auditor. All minor correction shall be suggested then and there by the auditor to the departmental staff. Audit gets over with the closing meeting, over all observations shall be summarized by the chief auditor. Audit observations shall be handed over to the chairman of the quality assurance committee in a standardized format. All the audit reports shall be discussed with the core committee members and the observations noticed will be presented to the Chairman for improvements. The Audit reports shall be forwarded to the concerned Departmental Heads. Corrective and preventive actions will be done by the department staff based on the audit observations. Reports of the corrective and preventive actions will be submitted to the Quality department by the concerned Head of the department. 7.10 Procedure for collection of data, interpretation and analysis of Quality Indicators: 7.10.1 Collection of Data: Reports of all key indicators as decided by the management will be submitted to the quality coordinator at the end of every month by the Head of each department. All the data will be collected in the standardized format. 7.10.2 Analysis of Data: All the data will be assessed in the form of Structure, process and the outcome. 7.10.3 Structure: Structure includes the facilities provided to the staff. Formula used for calculation. Training or awareness of the set formulas / quality improvement programme. 7.10.4 Process: Strict adherence of developed procedures in the daily work routine. In case of deviations same will be documented in the quality indicator reporting form with proper reasoning. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 12 APDH/NABH/PSQ/01 Version: 03 Issue:01 03/05/2023 of 23 /02/03 7.10.5 Out Come: Based on the reports received trend analysis will be done and the same will be reported to the Correspondent/ Management. 7.11 Trend Analysis:  The outcomes of the Quality Care Indicators are analyzed periodically and a comparative statement is made on the progress for each month.  The progress report is forwarded to the management.  In case of negative progress, if any, corrective action report shall be made by the Core Committee in discussion with the concerned Department Head and the same shall be submitted to the Management. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 13 Version: 03 Issue:01 APDH/NABH/PSQ/04 03/05/2023 of 23 1.0 PURPOSE: 1.1 To establish the guidelines for conducting the audits and their analysis system in the hospital. 2.0 SCOPE: 2.1 Outpatient Services 3.0 RESPONSIBILITY: 3.1 Consultants / Doctors 3.2 All hospital staff 3.3 Internal Quality assurance Committee 4.0 ABBREVIATION: 4.1 NABH : National Accreditation Board For Hospitals and Healthcare providers 4.2 PSQ : Patient Safety & Quality Improvement 5.0 DEFINITION: 5.1 Clinical Audit : Clinical audit is a process that has been defined as "a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change” 6.0 REFERENCE: 6.1 NABH: Accreditation standards for Dental Health Care Service Provider, Third Edition, Apr 2023 / PSQ 6.2 PSQ.4: There is an established system for clinical audit of patient care services. 7.0 POLICY: 7.1 There shall be an established system for the clinical audit of patient care services. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 14 Version: 03 Issue:01 APDH/NABH/PSQ/04 03/05/2023 of 23 7.2 The hospital shall have the responsibility for monitoring every aspect of patient care from the time the patient enters the hospital through diagnosis, treatment, recovery, and discharge, in order to continuously improve the effectiveness of performance. 7.3 There shall be a defined mechanism for ongoing monitoring of performance. 7.4 The quality improvement programme is the subject of all the staff inside the hospital. 7.5 The top management of the hospital has ensured that a mix of staff is organizing the quality control programmers for the hospital. 7.6 Many of them shall have achieved quality assurance training and they are the members of different hospital committees. 7.7 Audit: 7.7.1 Audits shall be carried out regularly for the purpose of improving the quality of patient care. 7.7.2 This is done in a structured manner for every individual clinical department per audit per year. 8.0 PROCEDURE: 8.1 The defined process for clinical audits is as follows: 8.1.1 The topics are chosen for clinical audit to improve the quality of patient care 8.1.2 The audit will be conducted with the pre-defined parameters & objectives. 8.1.3 Sampling, data collection and audit reports are documented 8.1.4 Sample is selected on a periodically 8.1.5 The reports shall be discussed to the correspondent of the institution and Quality committee team for necessary action to be taken. 8.1.6 Implementations and improvements are recorded to complete the clinical audit cycle PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – CONTINUOUS QUALITY IMPROVEMENT Doc No : Issue Date: Page 15 Version: 03 Issue:01 APDH/NABH/PSQ/05 03/05/2023 of 23 1.0 PURPOSE: 1.1 To establish a defined system for hospital-wide Nonconformance, incident related events management to improve continuously the performance. 1.2 To provide a confidential mechanism of identification, tracking, analyzing, and to pursue and implement corrective/preventive actions of all incidences that poses an actual or potential safety risk to patients, families, visitors and staff. 1.3 To establish feedback and complaint mechanism for patient and their relatives. 2.0 SCOPE: 2.1 All hospital employees 3.0 RESPONSIBILITY: 3.1 Correspondent 3.2 Principal 3.3 Quality Manager 3.4 NABH coordinator 3.5 Departmental HODs 4.0 ABBREVIATION: 4.1 NABH : National Accreditation Board For Hospitals and Healthcare providers 4.2 PSQ : Patient Safety & Quality Improvement 4.3 CA : Corrective Action 4.4 PA : Preventive Action 5.0 DEFINITION: 5.1 Non Conformance: defined as any event or circumstance not consistent with the standard routine operations or not having compliance to defined processes of the hospital in staff functions on support activities to internal/external customers or on care processes to patients. PREPARED BY VERIFIED BY APPROVED BY PRINCIPAL CORRESPONDENT NABH COORDINATOR  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – CONTINUOUS QUALITY IMPROVEMENT Doc No : Issue Date: Page 16 Version: 03 Issue:01 APDH/NABH/PSQ/05 03/05/2023 of 23 6.0 REFERENCE: 6.1 NABH: Accreditation standards for Dental Health Care Service Provider, Third Edition, April-2023/ PSQ 6.2 PSQ.5: Incidents are collected and analysed to ensure continuous patient safety and quality improvement 7.0 POLICY: 7.1 APDCH shall have a well-defined system of incidence reporting which shall include: 7.1.1 Identification 7.1.2 Reporting 7.1.3 Review 7.1.4 Action on incidents 7.2 All incidents shall be captured without going into the severity or whether harm was caused. 7.3 APDCH shall have a well-defined process of collecting feedback through patient feedback forms and receiving complaints through the grievance redressal mechanism. 7.4 The Quality Assurance Committee shall be responsible for conducting the Root Cause Analysis of incidents, feedback and complaints received. 7.5 Based on the analysis, the Committee shall formulate the CA / PA for continual improvement of the quality of patient-care services. 7.6 There shall be an internal communication mechanism to convey the patient feedback (negative or positive) and complaints to all hospital staff so that there is improvement in the care delivery. 8.0 PROCEDURE: 8.1 Incident Reporting System: Analysis: Internal Communication mechanism: PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – CONTINUOUS QUALITY IMPROVEMENT Doc No : Issue Date: Page 17 Version: 03 Issue:01 APDH/NABH/PSQ/05 03/05/2023 of 23 PROCEDURE: 8.1 Norms for deciding the necessity for incident reporting system: 8.1.1 When Event falls under the following criteria: 8.1.1.1 The occurrence involves an unanticipated death or major permanent loss of function; 8.1.1.2 The occurrence is associated with significant deviation from the usual processes for providing health care services or managing the organization; 8.1.1.3 The event has undermined or has significant potential for undermining the public’s confidence in the organization. 8.2 Guidelines for incident reporting system: 8.2.1 Shall focus on organizational system and processes. 8.2.2 Direct or “proximate” cause of the Sentinel Event and the processes and systems related to its occurrence shall be determined. 8.2.3 Related systems and processes shall be analyzed. 8.2.4 Special causes in clinical processes and common causes in organization processes shall be considered in the analysis. 8.2.5 Possible risk prevention activities shall be considered. 8.3 Determination of well-defined Corrective/Preventive action plan: 8.3.1 Determination of rationale for constraints if any on the recommended CA/PA. 8.3.2 Defining the responsibility of staff for implementing CA/PA. 8.4 Intense analysis criteria: 8.4.1 When monitoring performance of specific clinical processes, certain events always elicit intense analysis. 8.4.2 Based on the scope of services provided, intense analysis shall also be performed on the following: 8.4.2.1 Significant adverse drug reactions; PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – CONTINUOUS QUALITY IMPROVEMENT Doc No : Issue Date: Page 18 Version: 03 Issue:01 APDH/NABH/PSQ/05 03/05/2023 of 23 8.4.2.2 Significant medication errors and hazardous conditions; 8.4.2.3 Major discrepancies, or patterns of discrepancies, between preoperative and postoperative, including pathologic diagnoses, including those identified during the pathologic review of specimens removed during surgical and invasive procedures; 8.4.2.4 Significant adverse events associated with anesthesia use; 8.4.2.5 Significant infection related issues. 8.5 Analysis shall be done by: 8.5.1 Safety variances involving falls or injuries, material safety handling or damage/lost patient property shall be routed to Safety committee. 8.5.2 Equipment malfunctions reports shall be routed to Biomedical Dept. 8.5.3 Utility outages and pest control issues shall be routed to Hospital Support Services. 8.5.4 All housekeeping related issues shall be referred to Housekeeping. 8.5.5 All other issues shall be categorized departmental accountability wise andshall be referred to HODs concerned accordingly. 8.6 Reports: Consolidated summary report on events with analysis and on concerns if any, shallbe submitted to: 8.6.1 Head of Institution – for Management review and recommendations on Clinical related nonconformance and incidents; 8.6.2 Medication Usage Variances (Adverse Drug Reactions, Medication Errors) shall be by Director 8.6.3 Safety team coordinator for management review and recommendations on safety deficiencies related to Nonconformance/ Incidents. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 19 Version: 03 Issue:01 APDH/NABH/PSQ/05 03/05/2023 of 23 1.0 PURPOSE: 1.1 To define system for hospital-wide sentinel event reporting, analyzing taking corrective and preventive actions to control. 2.0 SCOPE: 2.1 All hospital employees 3.0 RESPONSIBILITY: 3.1 Correspondent 3.2 Principal 3.3 Internal Quality Assurance Committee 3.4 Quality Manager 3.5 NABH Coordinator 4.0 ABBREVIATION: 4.1 NABH : National Accreditation Board For Hospitals and Healthcare providers 4.2 PSQ : Patient safety and Quality Improvement 4.3 CA : Corrective Action 4.4 PA : Preventive Action 5.0 DEFINITION: 5.1 Sentinel Events: An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof to a patient, visitor, or an employee. The phrase, “or the risk there of”, includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. 5.2 Near Miss: Any process variation which did not affect the outcome but for which a recurrence carries a significant chance of a serious adverse outcome. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 20 Version: 03 Issue:01 APDH/NABH/PSQ/05 03/05/2023 of 23 5.3 Hazardous conditions: Refer to any set of circumstances (exclusive of disease or condition for which the patient is being treated), which significantly increases the likelihood of a serious adverse outcome. 5.4 Lapses in compliance to statutory safety norms resulting in sentinel events / near miss which causes harm to the patients / staff / visitors or to infrastructure. 6.0 POLICY: 6.1 Non Conformance/Incident Report process proceedings shall be initiated when an event occurs resulting in: 6.1.1 Process error in service activities; 6.1.2 Patient health care deficiencies; 6.1.3 Noncompliance in preventive processes as per safety norms; 6.1.4 Employee under performance in any of the above. 6.2 The employee/ controlling staff meets an event under one of the above categories shall be responsible for processing incident or Non Conformance Report before the end of their scheduled duty shift. 6.3 If the incident is a potential Sentinel Event, as defined under definition, the individual noting the incident shall notify to their Superior immediately and shall be followed by notification to HOD with parallel notification to Quality coordinator. 6.4 The Quality coordinator shall pursue event processing further by the defined procedure sequence. 6.5 There shall be a defined protocol to determine the necessity for root cause analysis. 6.6 Root cause analysis shall be carried out only on advice from director PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 21 Version: 03 Issue:01 APDH/NABH/PSQ/05 03/05/2023 of 23 6.7 When root cause analysis is initiated, Quality coordinator shall pursue further till corrective action/ preventive action as applicable determined and implemented by HOD concerned with theapproval of Director 6.8 When monitoring performance of specific clinical processes, certain events always elicit intense analysis. 6.9 Based on the scope of services provided, intense analysis shall also be based on defined parameters specific in the process. 6.10 The Quality coordinator shall maintain all records of all Non Conformance /Sentinel Event Reports and their disposition. 7.0 PROCEDURE: 7.1 Norms for deciding the necessity for root cause analysis: 7.1.1 When Event falls under the following criteria: 7.1.1.1 The occurrence involves an unanticipated death or major permanent loss offunction; 7.1.1.2 The occurrence is associated with significant deviation from the usual processesfor providing health care services or managing the organization; 7.1.1.3 The event has undermined or has significant potential for undermining the public’s confidence in the organization. 7.2 Guidelines for root cause analysis: 7.2.1 Shall focus on organizational system and processes. 7.2.2 Direct or “proximate” cause of the Sentinel Event and the processes and systems relatedto its occurrence shall be determined. 7.2.3 Related systems and processes shall be analyzed. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 22 Version: 03 Issue:01 APDH/NABH/PSQ/05 03/05/2023 of 23 7.2.4 Special causes in clinical processes and common causes in organization processes shallbe considered in the analysis. 7.2.5 Possible risk prevention activities shall be considered. 7.3 Determination of well-defined Corrective/Preventive action plan: 7.3.1 Determination of rationale for constraints if any on the recommended CA/PA. 7.3.2 Defining the responsibility of staff for implementing CA/PA. 7.4 Intense analysis criteria: 7.4.1 When monitoring performance of specific clinical processes, certain events always elicitintense analysis. 7.4.2 Based on the scope of services provided, intense analysis shall also be performed on thefollowing: 7.4.2.1 Significant adverse drug reactions; 7.4.2.2 Significant medication errors and hazardous conditions; 7.4.2.3 Major discrepancies, or patterns of discrepancies, between preoperative and postoperative, including pathologic diagnoses, including those identified during the pathologic review of specimens removed during surgical and invasive procedures; 7.4.2.4 Significant adverse events associated with anesthesia use; 7.4.2.5 Significant infection related issues. 7.5 Analysis shall be done by: 7.5.1 Safety variances involving falls or injuries, material safety handling or damage/lostpatient property shall be routed to Safety committee. 7.5.2 Equipment malfunctions reports shall be routed to Biomedical Dept. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT  ADHIPARASAKTHI DENTAL COLLEGE AND HOSPITAL PROCESS MANUAL – PATIENT SAFETY AND QUALITY IMPROVEMENT Doc No : Issue Date: Page 23 Version: 03 Issue:01 APDH/NABH/PSQ/05 03/05/2023 of 23 7.5.3 Utility outages and pest control issues shall be routed to Hospital Support Services. 7.5.4 All housekeeping related issues shall be referred to Housekeeping. 7.5.5 All other issues shall be categorized departmental accountability wise and shall be referred to HODs concerned accordingly. 7.6 Reports : Consolidated summary report on events with analysis and on concerns ifany, shall be submitted to: 7.6.1 Head of Institution – for Management review and recommendations on Clinical related nonconformance and incidents. 7.6.2 Medication Usage Variances (Adverse Drug Reactions, Medication Errors) shall be by Director 7.6.3 Safety coordinator for management review and recommendations on safety deficiencies related to Nonconformance/ Incidents. PREPARED BY VERIFIED BY APPROVED BY NABH COORDINATOR PRINCIPAL CORRESPONDENT