This document provides an agenda and materials for an orientation program on safety standards at GAHAR Hospital. It includes sessions on medication management safety standards, operative and invasive procedure safety standards, and environmental safety standards. The objectives are to help participants identify and implement relevant GAHAR standards to minimize safety risks and harm to patients. The document reviews several specific standards for policies, procedures, labeling, documentation, and checklists to ensure correct patient identification, medication reconciliation, and availability of necessary documents and equipment for procedures.
The document outlines the requirements and agenda for an orientation program on GAHAR Hospital. It discusses the registration requirements for hospitals, including licensure requirements, national safety requirements, operating manual guidelines, leadership requirements, and workforce requirements. The agenda spans 4 days and covers topics such as the GAHAR registration system, national safety standards, operating manual guidelines, leadership manuals and policies, and workforce requirements. Session objectives are provided for each day.
This document outlines the agenda and objectives for Day 3 of the Orientation Program on GAHAR Hospital. The agenda includes sessions on the GAHAR Operating Manual guidelines, the hospital overview, management of the information system, medical records, provision of care and services, quality management and patient safety, infection prevention and control, patient and family education, patient and family rights, social care, anesthesia, operative care, critical care units, labor and delivery, dialysis, emergency room, radiology services, burn unit, and oncology and radiotherapy. The objectives are to identify and implement the GAHAR operating manual guidelines and respect their importance, and by the end of the day for participants to be able to do so.
This document describes a quality improvement project to increase compliance with fall risk precautions for patients at medium to high risk of falling in inpatient units. An audit found that only 33% of patients had all precautions in place. The team identified the most common reasons for non-compliance and addressed them, such as providing more durable signage and repairing broken beds. Re-auditing showed compliance increased to 84%.
Clinical Audits and Process Improvement in HospitalsLallu Joseph
How to conduct a clinical audit, differences between research and clinical audit, medical audit, History of audit, benefits of audit, standard, criteria, benchmarks, compare performance, examples of clinical audit, audit cycle, types of audit, NABH, JCI, QAPI, PDCA, Hospital accreditation,
The document discusses patient safety culture and climate. It defines safety culture as the shared values and behaviors regarding safety in an organization. Safety climate refers to perceptions of safety at a point in time and is measurable. The document outlines tools for assessing safety culture, including the AHRQ Hospital Survey on Patient Safety Culture, which measures 12 dimensions of safety culture. It provides guidance on using the survey results to identify strengths and areas for improvement to enhance patient safety.
This document discusses quality improvement in emergency departments. It outlines the stages of quality improvement as structure, process, and outcome. For structure, it discusses factors like the number of beds, staffing ratios, and available support services. For process, it lists key quality indicators that are measured, such as initial assessment time, medication errors, and times to dispatch ambulances or perform procedures. It emphasizes the importance of documentation, decision making skills, communication, ongoing training, and using tools like Plan-Do-Study-Act cycles to continuously improve quality. Strong leadership, a culture of safety, stakeholder involvement, standardizing care processes, and data analysis are strategies recommended for quality improvement efforts.
The document outlines the requirements and agenda for an orientation program on GAHAR Hospital. It discusses the registration requirements for hospitals, including licensure requirements, national safety requirements, operating manual guidelines, leadership requirements, and workforce requirements. The agenda spans 4 days and covers topics such as the GAHAR registration system, national safety standards, operating manual guidelines, leadership manuals and policies, and workforce requirements. Session objectives are provided for each day.
This document outlines the agenda and objectives for Day 3 of the Orientation Program on GAHAR Hospital. The agenda includes sessions on the GAHAR Operating Manual guidelines, the hospital overview, management of the information system, medical records, provision of care and services, quality management and patient safety, infection prevention and control, patient and family education, patient and family rights, social care, anesthesia, operative care, critical care units, labor and delivery, dialysis, emergency room, radiology services, burn unit, and oncology and radiotherapy. The objectives are to identify and implement the GAHAR operating manual guidelines and respect their importance, and by the end of the day for participants to be able to do so.
This document describes a quality improvement project to increase compliance with fall risk precautions for patients at medium to high risk of falling in inpatient units. An audit found that only 33% of patients had all precautions in place. The team identified the most common reasons for non-compliance and addressed them, such as providing more durable signage and repairing broken beds. Re-auditing showed compliance increased to 84%.
Clinical Audits and Process Improvement in HospitalsLallu Joseph
How to conduct a clinical audit, differences between research and clinical audit, medical audit, History of audit, benefits of audit, standard, criteria, benchmarks, compare performance, examples of clinical audit, audit cycle, types of audit, NABH, JCI, QAPI, PDCA, Hospital accreditation,
The document discusses patient safety culture and climate. It defines safety culture as the shared values and behaviors regarding safety in an organization. Safety climate refers to perceptions of safety at a point in time and is measurable. The document outlines tools for assessing safety culture, including the AHRQ Hospital Survey on Patient Safety Culture, which measures 12 dimensions of safety culture. It provides guidance on using the survey results to identify strengths and areas for improvement to enhance patient safety.
This document discusses quality improvement in emergency departments. It outlines the stages of quality improvement as structure, process, and outcome. For structure, it discusses factors like the number of beds, staffing ratios, and available support services. For process, it lists key quality indicators that are measured, such as initial assessment time, medication errors, and times to dispatch ambulances or perform procedures. It emphasizes the importance of documentation, decision making skills, communication, ongoing training, and using tools like Plan-Do-Study-Act cycles to continuously improve quality. Strong leadership, a culture of safety, stakeholder involvement, standardizing care processes, and data analysis are strategies recommended for quality improvement efforts.
This document outlines the clinical audit process. It defines audit as reviewing, monitoring, and evaluating care against agreed standards to improve patient outcomes, use of resources, education, and staff reflection. Research aims to discover new information rather than evaluate existing care. The audit cycle involves identifying issues, setting criteria, measuring current practice, analyzing data against criteria, implementing changes, and re-auditing. Types of audits include structure, process, and outcome audits. Steps of the audit cycle are also demonstrated through an example audit on postoperative wound infections.
Patient safety goals effective january 1, 2016Hisham Aldabagh
Includes the patient safety goals which must be achieved during the year 2016, focusing on patient identification, proper patient medication, protection patient against infection, and strict per operative patient safety procedures
The National Accreditation Board for Hospitals and Healthcare Providers (NABH) was established to operate an accreditation program for healthcare organizations in India. The NABH has developed entry level certification standards that healthcare organizations can work towards, with the goals of improving patient safety, quality of care, and respect for patient rights. The entry level certification involves meeting standards in 10 areas, including access to care, patient rights, infection control, and management responsibilities. Organizations work with NABH on a stepwise assessment and improvement process towards gaining pre-accreditation certification.
The presentation will last 25 minutes followed by a 5 minute question and answer session. The presentation will discuss establishing a safety culture at the hospital by overseeing various aspects of safety including patient safety, employee safety, radiation safety, environmental safety, and disaster management. It will review incident reports and analyze staff injuries to identify issues and promote a culture of reporting near misses. The presentation will also discuss risk management programs in hospitals and identify common safety issues like patient identification, medication safety, healthcare-associated infections, and falls. [END SUMMARY]
Implementation of quality improvement program in hospitalsLallu Joseph
A quality improvement program in hospitals aims to continuously monitor and improve quality through systematic activities organized by the hospital. The document outlines the steps to implement a quality improvement program which includes selecting a quality improvement project, assembling a team, developing aim and measure statements, identifying change ideas by analyzing current processes, testing changes, and sustaining improvements. The goal is to improve patient outcomes, clinical and managerial processes, and safety through engaging staff and using a systematic approach of planning, testing, and measuring changes.
This document summarizes the key changes between the 4th and 5th editions of the NABH accreditation standards. The 5th edition has reduced the total number of standards from 105 to 100 and objective elements from 683 to 651. It introduces a new graded scoring system of 1 to 5 and defines criteria for accreditation including minimum scores across standards and chapters. Core elements related to patient safety must now be met to achieve accreditation.
This document provides guidelines for various quality and safety practices at a hospital. It discusses proper patient identification procedures, guidelines for verbal and telephone orders, procedures for high alert medications, surgical checklists including site marking and time outs, hand hygiene practices, fall risk assessment and prevention measures, occurrence variance reporting for documenting incidents, and the focus-PDCA methodology for quality improvement. Key areas of focus include correctly identifying patients, improving communication, ensuring surgery and medication safety, reducing healthcare associated infections and patient harm from falls.
This document is a checklist used to assess standards and measurable elements for inpatient care at a healthcare facility. It covers areas like scope of service, patient safety goals, assessment of patients, patient and family education, and patient and family rights. For each standard, staff are asked questions to determine if the element is met, not met, not applicable, or not tested. Remarks can also be included. The goal is to evaluate areas like patient identification, communication, safety of medications, infection control, fall risk reduction, documentation, consent processes, privacy and more.
This document discusses medical audits and provides information on various types of audits including internal and external audits, managerial/organizational audits, medical/clinical audits, and financial audits. It explains the need for audits to maintain safety, quality, reputation and funding. The document outlines the six stages of clinical audits including preparing, selecting criteria, measuring performance, making improvements, sustaining improvements, and re-auditing. Methods used in audits like direct observation, checklists, documentation reviews, questionnaires and interviews are also mentioned.
The document outlines the international patient safety goals established by the Joint Commission International in 2007. The six goals are: 1) Identify patients correctly to prevent medical errors, 2) Improve communication among staff to ensure accurate information exchange, 3) Improve safety practices for high alert medications, 4) Ensure the correct patient, site, and procedure for surgeries, 5) Reduce healthcare associated infections through proper hand hygiene, and 6) Reduce the risk of patient falls through risk assessment and prevention efforts. Details are provided on protocols for each goal around identification, documentation, high risk drugs, surgery verification, and fall prevention.
The document discusses quality improvement in hospitals. It notes that quality improvement (QI) requires sustained leadership, extensive training, robust measurement systems, and a culture receptive to change. It outlines six dimensions of healthcare quality: safety, effectiveness, appropriateness, access, patient satisfaction, and efficiency. Efficiency in healthcare involves deriving maximum benefit from available resources through technical and allocative efficiency. Common causes of medical errors include communication problems, inadequate information flow, human factors, and organizational issues. Many methods can be used to detect adverse events, both passive and active surveillance. Improvement starts with identifying an area for improvement through asking questions. Models for quality improvement include PDCA, Lean, Six Sigma, and change management. Measurement is key to
This document defines key terms related to occurrence variance reporting (OVR) like occurrence, sentinel event, near miss, malpractice, and adverse event. It outlines the objectives, definitions, reporting process, roles and responsibilities, and procedures for completing an OVR form. The goal of the OVR system is to document details of any event that negatively impacts patient care, identify root causes, and implement corrective actions through a non-punitive process. It aims to act as a quality improvement tool for monitoring and preventing future occurrences.
A Key Performance Indicator (KPI) is a measurable value that demonstrates how effectively a company is achieving key business objectives. Organizations use key performance indicators at multiple levels to evaluate their success at reaching targets
Quality in healthcare refers to adhering to predetermined specifications and standards to meet patient needs. Over time, quality practices evolved from craftsmanship to focusing on processes through thinkers like Shewhart and Deming. Donabedian introduced structure-process-outcome measures for assessing quality. National and international organizations like JCAH, ISO, and NABH were formed to standardize healthcare quality. NABH accreditation involves an application process, onsite assessments, and meeting standards in areas like patient care, management, and information systems to certify high quality care.
NABH 5th edition hospital std april 2020anjalatchi
A. National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India (QCI), set up to establish and operate accreditation programme for healthcare organizations.
Case Study on Discharge Process and Turnaround Time-2022.pptxDRTRUPTISONTHALIA
The document analyzes the discharge process at Apollo Hospital in Ahmedabad, finding that the average time for discharge is over 500 minutes which exceeds their 120 minute standard. It identifies delays occurring in the pre-billing, billing, and post-billing phases, and recommends improvements like planning discharges, coordinating staff, and updating bills daily to reduce turnaround times.
The emergency room is staffed 24 hours a day by emergency physicians and nurses to provide urgent medical care outside regular clinic hours. The pre-admission screening process includes a full history, physical exam, nursing assessment, and diagnostic testing. Patients in the emergency room have rights to treatment, informed consent, privacy, confidentiality, involvement in care decisions, and access to protective services.
The document discusses the standards and process for NABH accreditation of hospitals in India. It describes the components that go into developing the standards, which are organized around important hospital functions. The accreditation process involves surveyors conducting interviews, reviewing documents, and visiting patient care areas to assess compliance with over 100 standards across 10 chapters. Surveyors score hospitals on a scale of 0 to 10 for each standard based on the degree of compliance observed. Hospitals must meet minimum average scores in each standard, chapter, and overall to receive NABH accreditation.
This document outlines patient safety goals and standards. It defines key terms like risk and safety. It lists international patient safety goals such as identifying patients correctly and reducing healthcare associated infections. National patient safety goals are discussed in more detail and include accurately identifying patients, improving caregiver communication, safely using medications, reducing anticoagulant therapy harm, maintaining accurate medication information, reducing clinical alarm hazards, and preventing healthcare associated infections. The document provides specific requirements for implementing several of the national goals.
This document outlines the clinical audit process. It defines audit as reviewing, monitoring, and evaluating care against agreed standards to improve patient outcomes, use of resources, education, and staff reflection. Research aims to discover new information rather than evaluate existing care. The audit cycle involves identifying issues, setting criteria, measuring current practice, analyzing data against criteria, implementing changes, and re-auditing. Types of audits include structure, process, and outcome audits. Steps of the audit cycle are also demonstrated through an example audit on postoperative wound infections.
Patient safety goals effective january 1, 2016Hisham Aldabagh
Includes the patient safety goals which must be achieved during the year 2016, focusing on patient identification, proper patient medication, protection patient against infection, and strict per operative patient safety procedures
The National Accreditation Board for Hospitals and Healthcare Providers (NABH) was established to operate an accreditation program for healthcare organizations in India. The NABH has developed entry level certification standards that healthcare organizations can work towards, with the goals of improving patient safety, quality of care, and respect for patient rights. The entry level certification involves meeting standards in 10 areas, including access to care, patient rights, infection control, and management responsibilities. Organizations work with NABH on a stepwise assessment and improvement process towards gaining pre-accreditation certification.
The presentation will last 25 minutes followed by a 5 minute question and answer session. The presentation will discuss establishing a safety culture at the hospital by overseeing various aspects of safety including patient safety, employee safety, radiation safety, environmental safety, and disaster management. It will review incident reports and analyze staff injuries to identify issues and promote a culture of reporting near misses. The presentation will also discuss risk management programs in hospitals and identify common safety issues like patient identification, medication safety, healthcare-associated infections, and falls. [END SUMMARY]
Implementation of quality improvement program in hospitalsLallu Joseph
A quality improvement program in hospitals aims to continuously monitor and improve quality through systematic activities organized by the hospital. The document outlines the steps to implement a quality improvement program which includes selecting a quality improvement project, assembling a team, developing aim and measure statements, identifying change ideas by analyzing current processes, testing changes, and sustaining improvements. The goal is to improve patient outcomes, clinical and managerial processes, and safety through engaging staff and using a systematic approach of planning, testing, and measuring changes.
This document summarizes the key changes between the 4th and 5th editions of the NABH accreditation standards. The 5th edition has reduced the total number of standards from 105 to 100 and objective elements from 683 to 651. It introduces a new graded scoring system of 1 to 5 and defines criteria for accreditation including minimum scores across standards and chapters. Core elements related to patient safety must now be met to achieve accreditation.
This document provides guidelines for various quality and safety practices at a hospital. It discusses proper patient identification procedures, guidelines for verbal and telephone orders, procedures for high alert medications, surgical checklists including site marking and time outs, hand hygiene practices, fall risk assessment and prevention measures, occurrence variance reporting for documenting incidents, and the focus-PDCA methodology for quality improvement. Key areas of focus include correctly identifying patients, improving communication, ensuring surgery and medication safety, reducing healthcare associated infections and patient harm from falls.
This document is a checklist used to assess standards and measurable elements for inpatient care at a healthcare facility. It covers areas like scope of service, patient safety goals, assessment of patients, patient and family education, and patient and family rights. For each standard, staff are asked questions to determine if the element is met, not met, not applicable, or not tested. Remarks can also be included. The goal is to evaluate areas like patient identification, communication, safety of medications, infection control, fall risk reduction, documentation, consent processes, privacy and more.
This document discusses medical audits and provides information on various types of audits including internal and external audits, managerial/organizational audits, medical/clinical audits, and financial audits. It explains the need for audits to maintain safety, quality, reputation and funding. The document outlines the six stages of clinical audits including preparing, selecting criteria, measuring performance, making improvements, sustaining improvements, and re-auditing. Methods used in audits like direct observation, checklists, documentation reviews, questionnaires and interviews are also mentioned.
The document outlines the international patient safety goals established by the Joint Commission International in 2007. The six goals are: 1) Identify patients correctly to prevent medical errors, 2) Improve communication among staff to ensure accurate information exchange, 3) Improve safety practices for high alert medications, 4) Ensure the correct patient, site, and procedure for surgeries, 5) Reduce healthcare associated infections through proper hand hygiene, and 6) Reduce the risk of patient falls through risk assessment and prevention efforts. Details are provided on protocols for each goal around identification, documentation, high risk drugs, surgery verification, and fall prevention.
The document discusses quality improvement in hospitals. It notes that quality improvement (QI) requires sustained leadership, extensive training, robust measurement systems, and a culture receptive to change. It outlines six dimensions of healthcare quality: safety, effectiveness, appropriateness, access, patient satisfaction, and efficiency. Efficiency in healthcare involves deriving maximum benefit from available resources through technical and allocative efficiency. Common causes of medical errors include communication problems, inadequate information flow, human factors, and organizational issues. Many methods can be used to detect adverse events, both passive and active surveillance. Improvement starts with identifying an area for improvement through asking questions. Models for quality improvement include PDCA, Lean, Six Sigma, and change management. Measurement is key to
This document defines key terms related to occurrence variance reporting (OVR) like occurrence, sentinel event, near miss, malpractice, and adverse event. It outlines the objectives, definitions, reporting process, roles and responsibilities, and procedures for completing an OVR form. The goal of the OVR system is to document details of any event that negatively impacts patient care, identify root causes, and implement corrective actions through a non-punitive process. It aims to act as a quality improvement tool for monitoring and preventing future occurrences.
A Key Performance Indicator (KPI) is a measurable value that demonstrates how effectively a company is achieving key business objectives. Organizations use key performance indicators at multiple levels to evaluate their success at reaching targets
Quality in healthcare refers to adhering to predetermined specifications and standards to meet patient needs. Over time, quality practices evolved from craftsmanship to focusing on processes through thinkers like Shewhart and Deming. Donabedian introduced structure-process-outcome measures for assessing quality. National and international organizations like JCAH, ISO, and NABH were formed to standardize healthcare quality. NABH accreditation involves an application process, onsite assessments, and meeting standards in areas like patient care, management, and information systems to certify high quality care.
NABH 5th edition hospital std april 2020anjalatchi
A. National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India (QCI), set up to establish and operate accreditation programme for healthcare organizations.
Case Study on Discharge Process and Turnaround Time-2022.pptxDRTRUPTISONTHALIA
The document analyzes the discharge process at Apollo Hospital in Ahmedabad, finding that the average time for discharge is over 500 minutes which exceeds their 120 minute standard. It identifies delays occurring in the pre-billing, billing, and post-billing phases, and recommends improvements like planning discharges, coordinating staff, and updating bills daily to reduce turnaround times.
The emergency room is staffed 24 hours a day by emergency physicians and nurses to provide urgent medical care outside regular clinic hours. The pre-admission screening process includes a full history, physical exam, nursing assessment, and diagnostic testing. Patients in the emergency room have rights to treatment, informed consent, privacy, confidentiality, involvement in care decisions, and access to protective services.
The document discusses the standards and process for NABH accreditation of hospitals in India. It describes the components that go into developing the standards, which are organized around important hospital functions. The accreditation process involves surveyors conducting interviews, reviewing documents, and visiting patient care areas to assess compliance with over 100 standards across 10 chapters. Surveyors score hospitals on a scale of 0 to 10 for each standard based on the degree of compliance observed. Hospitals must meet minimum average scores in each standard, chapter, and overall to receive NABH accreditation.
This document outlines patient safety goals and standards. It defines key terms like risk and safety. It lists international patient safety goals such as identifying patients correctly and reducing healthcare associated infections. National patient safety goals are discussed in more detail and include accurately identifying patients, improving caregiver communication, safely using medications, reducing anticoagulant therapy harm, maintaining accurate medication information, reducing clinical alarm hazards, and preventing healthcare associated infections. The document provides specific requirements for implementing several of the national goals.
What must i consider to safely anesthetize someoneanvardr
The document discusses considerations for safely anesthetizing patients in an office setting. It covers physical office requirements like adequate space and equipment. It also discusses physician qualifications and certifications. For patient selection, it recommends low-risk ASA 1-2 patients and excluding those with significant comorbidities. Evidence shows office anesthesia can be low-risk when standards are followed. Guidelines published by professional societies provide recommendations.
The document summarizes an audit on surgical antibiotic prophylaxis practices. It found that practices did not fully comply with WHO guidelines. Only 15% of antibiotic choices were guideline-compliant. Performance was best for IV administration but worst for prolonging antibiotics after surgery. The results indicate practice was heterogeneous and did not match evidence-based guidelines. Implementing guidelines through educational materials and reauditing is planned to standardize best practices.
The document discusses the role of pharmacists in pharmacovigilance and adverse drug reaction (ADR) reporting. It provides an overview of pharmacovigilance, including its history, purpose, and processes. Pharmacovigilance aims to improve patient safety by monitoring drug safety and preventing adverse effects. Pharmacists are well-positioned to monitor for drug interactions and report ADRs due to their drug knowledge and patient relationships. The document emphasizes that pharmacist reporting is important for pharmacovigilance programs to reduce drug risks and rationalize medication use.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem.
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
The clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time.
Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to identify new risks, assess known risks, and prevent harm. Pharmacovigilance relies on collecting data on adverse drug reactions (ADRs) through passive and active methods. Data is analyzed to detect safety signals and assess risks and benefits of medicines to optimize safe use. Regulatory authorities use pharmacovigilance data to take actions like updating product information or withdrawing approval if risks outweigh benefits.
The Current Regulatory Thinking in Reprocessing seminar discusses standards and guidance for reprocessing and reusable medical devices as well as insights into the development and validation process.
Goal 1 improve the accuracy of patient identification.npsssuser47f0be
The document discusses patient identification and reducing errors related to misidentification. It focuses on using two patient identifiers, which can help reliably identify individuals and match them to the correct service or treatment. Newborns are at higher risk given their inability to communicate and lack of distinguishing features. The document provides examples of methods to prevent misidentification of newborns such as distinct naming systems and standardized identification banding practices.
The management of a successful microbiological control program involves identifying suitable suppliers, conducting a risk assessment, and establishing an appropriate monitoring system. Environmental monitoring is an important program adjunct but does not control contamination on its own. The microbiological contamination control program should be based on a formal risk assessment to identify critical control points. Consistent contamination control requires an overall process evaluation assessing control elements via risk assessment, which may be coupled with evaluation studies to ensure appropriate prevention measures are in place.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
This document provides information on Risk Evaluation and Mitigation Strategies (REMS) programs required by the FDA for certain prescription drugs. It discusses the history and elements of REMS, including medication guides, communication plans, elements to assure safe use, and implementation systems. The document then examines examples of specific REMS for isotretinoin (Accutane), testosterone topical, chantix, and suboxone, outlining the REMS elements employed for each drug commonly dispensed in community pharmacies.
Objectives
By completing the lesson, the pharmacist will be able to:
• Discuss the history of the REMS program
• Describe the elements of the REMS program
• Identify when a REMS might be used for a particular drug
• Identify REMS elements employed with medications dispensed in community pharmacy
• Discuss selection provision in Ohio law related to REMS requirements
ICH guidelines on impurities in new drug products.pptxDivya Pushp
This document provides a summary of a presentation on ICH guidelines for impurities in new drug products. The guidelines provide guidance for registration applications on reporting and qualifying degradation products and impurities. Key points include: analytical procedures must be validated for detecting degradation products; batches used in development and commercial processes must be compared; degradation products above certain thresholds must be identified, reported, and qualified; and specifications for degradation products should be based on batches from the commercial process. The guidelines do not apply to certain product types like biologics but provide direction on identifying, analyzing, reporting, and qualifying degradation products found in new small molecule drug products.
Clinical investigation and evaluation of medical devices and ivd.pptxreechashah2
This document discusses clinical investigation and evaluation of medical devices and in vitro diagnostics (IVDs). It defines medical devices and IVDs, describes their classification systems, and explains when clinical investigations and evaluations are needed. Clinical investigations generate safety and performance data, while evaluations assess existing data. The document outlines ethical considerations and describes the stages and reports involved in clinical investigations and evaluations.
The document discusses USP 797 compliance for compounding sterile preparations. It explains that USP 797 provides practice standards to ensure high quality compounded sterile preparations by reducing potential for microbial contamination. Compliance requires designated cleanroom facilities, environmental monitoring, personnel training, and standard operating procedures. The guidelines establish low, medium, and high risk levels for sterile preparations based on complexity of compounding and exposure to non-sterile conditions. Ongoing compliance requires updated documentation, training, and environmental monitoring.
An Analysis on the UV-Visible Spectrophotometry MethodAI Publications
In the pharmaceutical industry, quality control is a necessary process. Pharmaceutical medicinal products must be advertised as safe, therapeutically active formulations with predictable qualities and performance. The main aim of the study is an analysis on the UV-Visible Spectrophotometry Method. UV spectroscopy was performed on Shimadzu 1700 uv spectrometer, 1cm cell quartz cuvette. Mode was set as UV mode and Detector wavelength was kept at 231 nm and 276 nm. A simple, rapid, accurate, sensitive and cost economical methodology for simultaneous estimation and precise ultraviolet radiation methodology has been developed and valid as per ICH guidelines for simultaneous Estimation of MET and AGP in Their Combined dose form.
Scale up process and post marketing survilenceKAVITAAGRE
This document discusses scale up process approval changes and post marketing surveillance. It defines scale up as increasing batch size from research to production. It describes SUPAC guidelines which define levels of changes (minor, moderate, major) and required tests and documentation. The guidance provides recommendations for changes to composition, manufacturing site, batch size, and process. It also discusses post marketing surveillance methods like controlled trials, spontaneous reporting, cohort and case control studies to identify adverse drug effects. Manufacturers must establish standard operating procedures for post marketing surveillance.
This document outlines 5 medication management safety standards:
1) Prohibiting dangerous abbreviations
2) Obtaining and documenting a complete list of patient medications upon admission
3) Labeling all medications and containers in procedural settings
4) Removing concentrated electrolytes from patient care areas when possible and labeling those that remain
5) Identifying, storing, and dispensing look-alike and sound-alike medications to minimize risk of error
For each standard, it provides the rationale and outlines a survey process to evaluate compliance which includes reviewing policies and procedures, interviewing staff, and making observations.
multidimensional approach to impulsivity.pptxehab elbaz
understanding impulsivity and its relation to psychiatric disorders. history of the concept and evidence based pharmacological and psychological interventions
The document discusses the history and evolution of case formulation in psychiatry. It originated from Adolf Meyer's holistic approach in the early 1900s and was further developed by George Kelly in the 1950s. Key figures like George Engel promoted biopsychosocial formulations. While important, formulations are still confusing and not uniformly understood. The document outlines core components and functions of formulations, including guiding treatment and integrating diverse clinical information.
depression in intellectual disabilitiy.pptxehab elbaz
1) The document describes a case of a 34-year-old male patient with intellectual disabilities who was referred for treatment of depression. He had a history of cerebral palsy, brain cysts, hydrocephalus, and epilepsy since birth.
2) After his brother traveled abroad for work, the patient became withdrawn, aggressive, and refused to eat, drink, or get out of bed. He was diagnosed with catatonia.
3) Treating the patient's condition proved challenging due to his intellectual disabilities and other medical issues. He did not improve with benzodiazepines or antipsychotics. ECT was considered but he suffered cardiac arrest before it could be administered.
The document discusses addiction replacement therapy (also known as opioid substitution therapy) for treating opioid use disorder. It begins by outlining the objectives and magnitude of the global and Egyptian opioid problems. It then describes medication-assisted treatment using opioid agonists/antagonists like methadone and buprenorphine. The benefits of opioid substitution therapy include reducing illegal opioid use and associated harms while increasing social functioning. Common myths about substitution therapy are addressed. Treatment algorithms are provided to guide patient assessment and selection of optimal replacement therapies like methadone, buprenorphine or naltrexone based on their different pharmacological profiles and patient characteristics.
Focus on long acting opioid substitution therapy.pptxehab elbaz
Long-acting buprenorphine injections like Buvidal can help address some of the limitations of daily-dosed opioid substitution therapies for opioid dependence. Evidence shows that Buvidal provides sustained suppression of withdrawal symptoms and drug cravings from the first dose. It also has favorable retention rates and safety profiles in both short-term and long-term studies compared to sublingual buprenorphine. Buvidal has the potential to improve outcomes for opioid dependence by offering more individualized treatment through less frequent dosing than daily options.
Dissociation is characterized by a disruption in consciousness, memory, identity, emotion, perception, body representation, motor control, and behavior. Dissociative disorders include Dissociative Identity Disorder, Dissociative Amnesia, Depersonalization/Derealization Disorder, Other Specified Dissociative Disorder, and Unspecified Dissociative Disorder. Lifetime prevalence of dissociation and dissociative disorders is around 10% in clinical and community populations. Dissociation exists on a continuum from normal experiences like daydreaming to pathological dissociation as seen in dissociative disorders. Dissociation is often associated with and can be explained as a response to traumatic stress.
Use of smartphone apps in psychotherapy ehab elbaz
The document discusses the use of smartphone apps in psychotherapy. It answers four questions: 1) Barriers to psychotherapy include costs, time, stigma and access issues. 2) Studies show smartphone apps can effectively treat depression, anxiety, and other issues, especially when combined with guidance. 3) Common CBT app features include cognitive restructuring, education on disorders, and suicide risk resources. 4) Few apps are available for Arab populations, most provide general mental health information or alternative treatments like herbal medicine.
This document provides an overview of several somatic symptom and factitious disorders as defined in the DSM-5 including Somatic Symptom Disorder, Illness Anxiety Disorder, Conversion Disorder, Factitious Disorder, and Psychological Factors Affecting Other Medical Conditions. It discusses the diagnostic criteria, epidemiology, etiology, clinical features, differential diagnosis, treatment and prognosis of each disorder. The document is intended to educate medical professionals about these conditions.
Depression commonly occurs in medical settings and can be caused by medical illnesses or their treatments. It is important to thoroughly evaluate depression in medically ill patients, as their symptoms may overlap with medical conditions or be side effects of medications. Treatment of depression in this population requires considering any interactions between antidepressants and other drugs, and utilizing biological, psychological, and educational approaches. Managing both the medical and psychiatric conditions is needed to improve outcomes.
This document describes models and processes in psychosomatic medicine and consultation-liaison psychiatry. It discusses different models including traditional consultation upon request and liaison psychiatry. It outlines the essential tasks of consultation-liaison psychiatrists including assessment, management planning, education, and facilitating understanding between medical teams and patients. The document also reviews the steps in a psychiatric consultation and elements of the written consultation note. Finally, it discusses different methods of integrated mental health care programs within medical settings.
Group psychotherapy versus twelve steps program , similarities and differencesehab elbaz
Both group psychotherapy and 12-step programs aim to help people with addiction issues. They share some similarities, such as relying on group cohesion and participant collaboration, using experiential learning, and encouraging honest self-disclosure. However, they also have some key differences. Group psychotherapy is a therapeutic program run by professionals, while 12-step programs are spiritual programs run by members. Group psychotherapy focuses more on managing conflicts between members during sessions. 12-step programs encourage contact between members outside meetings and restrict boundaries to minimize conflicts. Both approaches ultimately promote learning, growth, and positive change.
Patient safety involves avoiding preventable harm caused by errors in healthcare. There are different types of medical errors from errors to adverse events. A sentinel event is an unexpected occurrence that causes death or serious injury. Near misses refer to errors that could have caused harm but did not. A culture of safety depends on values, attitudes, behaviors and other factors that promote commitment to safety. Proper identification of patients, effective communication, safe practices for high-risk medications, and protocols for surgery are important for quality care and patient safety.
This document summarizes an orientation program at GAHAR Hospital that covers leadership and workforce requirements. The agenda includes reviewing GAHAR's leadership manual, job descriptions, strategic planning policy, and workforce requirements. For leadership, the manual, job descriptions, strategic planning components, and related policies are presented. Workforce topics include staffing plans, recruitment, credentialing, competencies, privileging, employee manuals, bylaws, health programs, and training needs. The objectives are to identify and implement GAHAR's leadership and workforce requirements and adopt their implementation.
This document provides an introduction to the JCI standards for accreditation. It defines key terms like quality and standards. It describes the accreditation process and outlines the chapters covered in the JCI standards, including patient care, health organization management, and academic medical centers. It discusses developing policies and procedures, conducting a baseline assessment, and creating an action plan to prepare for accreditation over an 18-24 month period. The goals are to establish a culture of safety, continually improve quality, and make data-driven decisions.
Relapse is common among addicts, occurring in over 50% of cases according to studies. Relapse can be a process or event, triggered by risk factors in the addict's environment, host factors like cravings, and changes in brain reward pathways. Animal models also show relapse is influenced by environmental factors outside an addict's control. To prevent relapse, modification of an addict's environment is important since relapse is a lifelong risk and cannot always be eliminated, only managed.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
5. 5
Copyright
Reproduction of this material in whole or in part
is totally prohibited without a written permission
from the General Authority for Healthcare
Accreditation & Regulation (GAHAR).
8. GAHAR
AGENDA
3/11/2021 8
GAHAR
Day 2
Session1 Session 2
National Safety
Requirements
(NSR) for Hospitals:
B. Medication Management
Safety Standards
C. Operative & Invasive
Procedure Safety Standards
National Safety
Requirements (NSR) for
Hospitals:
D. Environmental Safety
Standards
9. GAHAR 9
OBJECTIVES
Identify & implement GAHAR medication
management safety standards
Identify & implement GAHAR operative &
invasive procedure safety standards
By the end of this training day each participant will be
able to:
10. GAHAR 10
OBJECTIVES
Identify & apply GAHAR environmental
safety standards
Respect the importance of implementing
GAHAR national safety requirements
(NSR)
By the end of this training day each participant will be
able to:
14. GAHAR 14
NSR.12. 1
Abbreviations not to
be used throughout
the organization
Documentation &
communication of
patient's current
medications & discharge
NSR.12. 2
Labeling of
medications,
medication containers
& other solutions
NSR.12. 3
Prevent errors from
high risk medications
NSR.12. 4
Prevent errors from
look-alike, sound-
alike medications
NSR.12. 5
15. GAHAR
RATIONALE
15
NSR
12
Policies & procedures foster a culture that supports
standardization & documentation, which helps to
create consistency in patient safety practices
minimizing patient harm
16. GAHAR
SURVEY PROCESS
16
NSR
12
Review the relevant medication management
safety policy & check if it includes all the standard’s
items.
Interview staff to check their full awareness of
policies & procedures
17. GAHAR 17
NSR
13
STANDARD
Abbreviations not to be used throughout the
organization are:
o U/ IU
o Q.D., QD, q.d., qd.
o Q.O.D., QOD, q.o.d., qod.
o MS, MSO4
o MgSO4
o Trailing zero (5.0)
o No leading zero ( .5)
o Dose x frequency x duration
19. GAHAR
SURVEY PROCESS
19
NSR
13
Review appropriate number of medical records
(not less than 10) & check for the used abbreviations
with medication orders.
Interview medical staff for awareness of the
prohibited abbreviations
20. GAHAR 20
NSR
14
STANDARD
A process is implemented to obtain and
document a complete list of the patient's
current medications upon admission to
the organization & with the involvement
of the patient.
21. GAHAR
RATIONALE
21
NSR
14
Medication reconciliation at every patient care
transition effectively reduces medication errors
such as; omissions, duplications, dosing errors,
&/or drug interactions. This may result from
unintended medication discrepancies.
22. GAHAR
SURVEY PROCESS
22
NSR
14
Review appropriate number of medical
records (at least 10) & check for the
documentation of current medications upon
admission.
Interview an appropriate number of patients
& ask them if they were asked by doctors
upon admission about their current
medication & if they were educated if any will
interfere with the new prescribed
medications.
23. GAHAR 23
NSR
15
STANDARD
All medications, medication containers
(e.g., syringes, medicine cups, basins),
&/or other solutions on & off the sterile
field in peri-operative & other procedural
settings are labeled.
24. GAHAR
RATIONALE
24
NSR
15
Labeling of medication containers at the point of
care assists health care providers to identify the
correct medicine &/or fluid at all times & reduce
the risk of medication error as well.
26. GAHAR 26
NSR
16
STANDARD
Concentrated electrolytes; including, but
not limited to, potassium chloride
(2 meq/L or greater concentration), potassium
phosphate, sodium chloride (>0.9% concentration),
magnesium sulfate (50% or greater concentration) &
concentrated medications are removed from all patient
care areas, whenever possible.
Concentrated medications, which can not be removed,
are segregated from other medications with additional
warnings to remind staff to dilute before use.
27. GAHAR
RATIONALE
27
NSR
16
The availability of concentrated electrolytes
in areas where there is no immediate need
for them is associated with higher risk on
patient safety.
Accidental administration of concentrated
electrolytes without dilution poses a fatal
threat to patients, therefore, their separation
& differentiation is an error reduction
strategy.
28. GAHAR
SURVEY PROCESS
28
NSR
16
Observe patient care areas & notice if the
concentrated medications are removed whenever
possible.
Observe clinical care areas where concentrated
electrolytes are stored & check for the evidence
based immediate medical necessity allowing for
storing these concentrated electrolytes in these
areas.
29. GAHAR
SURVEY PROCESS
29
NSR
16
Interview nurses at different patient care areas
& check if they understand the preventive
strategies for dealing with concentrated electrolytes.
Observe clinical care areas & notice if there are any
concentrated medications for clinical use & check
whether they are separated in secure areas &
labeled individually, such as, with a visible florescent
warning label that states MUST BE DILUTED or other
effective methods.
32. GAHAR
SURVEY PROCESS
32
NSR
17
Review the updated list of look -alike &
sound -alike medications.
Interview pharmacists & nurses & check if
they understand how to minimize the risk
associated with using look- alike sound -
alike medications.
33. GAHAR
SURVEY PROCESS
33
NSR
17
Observe at the pharmacy & the medication
carts the labeling of LASA medications.
Review the medical records to check if
doctors write the purpose of drug usage, to
avoid confusion due to LASA medication
during dispensing by the pharmacist.
36. GAHAR 36
NSR.18. 1
Preoperative marking
of site of surgery
Process for preoperative
verification of all documents &
equipment needed for surgery
&/or invasive procedures
NSR.18. 2
Accurately documented
patient identification
preoperatively & just
before surgery (time out)
NSR.18. 3
Process for verification of
accurate counting of
sponges, needles &
instruments pre & post
procedure
NSR.18. 4
37. GAHAR
GAHAR 37
RATIONALE
NSR
18
Performing the right surgery on the right
patient & on the right side without any
retained instrument is the mainstay
objective of surgical safety.
Establishing related policies & procedures,
otherwise known as the universal protocol,
is the initial step for offering safe surgery.
38. GAHAR
GAHAR 38
SURVEY PROCESS
NSR
18
Review the operative & invasive procedures
safety policy & procedures & check if it
includes all the standard’s items.
Interview staff to check their awareness
39. GAHAR 39
NSR
19
STANDARD
The precise site where the surgery or
invasive procedure will be performed is
clearly marked by the physician with the
involvement of the patient.
41. GAHAR
SURVEY PROCESS
41
NSR
19
Review surgery/invasive site marking policy &
procedure & check that it specifies situations for
site marking (laterality, multiple structures or
levels), states that organization wide site marking
is done with a recognizable & consistent mark,
which should resist disinfection procedures,
should be visible after draping, should be made
by the authorized person performing the
procedure & should be done when the patient is
awake & fully aware.
42. GAHAR
SURVEY PROCESS
42
NSR
19
Review the checklist & observe whether it is
dedicated to this standard or it is a part of a
wider checklist (surgical safety checklist,
universal protocol checklist).
Review relevant post- operative patients’
medical records & check for documentation
evidence.
43. GAHAR
SURVEY PROCESS
43
NSR
19
Interview surgeons/interventionists & check
their understanding of this process.
Interview relevant post-operative patients &
check their involvement in site marking.
Observe implementation of this process at
the intervention room if possible.
48. GAHAR 48
NSR
20
STANDARD
A process or checklist is developed & used
to verify that all documents & equipment
needed for surgery or invasive procedures
are on hand, correct & functioning properly
before the start of the surgical or invasive
procedure.
49. GAHAR
RATIONALE
49
NSR
20
Ensuring availability of patient data & the
necessary functioning equipment minimizes
the risk of errors.
Implementing regular checkup is a quality
improvement process that should be guided
by well-designed checklists performed by
well-trained staff.
50. GAHAR
SURVEY PROCESS
50
NSR
20
Review document & equipment verification
policy & procedures & ensure that it supports
a documented verification process for:
patient documents (consent, physical
examination, medical assessment, nursing
assessment, pre-anesthetic assessment), as
well as patient laboratory & radiologic test
results, procedure devices &/or blood
products.
51. GAHAR
SURVEY PROCESS
51
NSR
20
Review the checklist & observe whether it is
dedicated to this standard or it is a part of a
wider checklist (surgical safety checklist,
universal protocol checklist).
Review medical records of post-operative patients
& check for checklist utilization.
Interview relevant staff checking their full
understanding of this process
Observe implementation of this process at the
intervention room if possible.
52. GAHAR 52
NSR
21
STANDARD
There is a documented process of
accurate patient identification
preoperatively & just before starting a
surgical or invasive procedure (time out),
to ensure the correct patient, procedure,
& body part.
54. GAHAR
SURVEY PROCESS
54
NSR
21
Review preoperative/pre-intervention policy
& procedure for preventing wrong patient,
wrong site/side, & wrong surgery/invasive
procedure & ensure that it supports patient,
procedure, as well as part of body
verification just before the start of the
procedure, regardless whether the patient is
anesthetized, sedated or awake (Time Out).
55. GAHAR
SURVEY PROCESS
55
NSR
21
Review the checklist & observe whether it is
dedicated to this standard or it is a part of a
wider checklist (such as surgical safety
checklist, universal protocol checklist).
Ensure that the policy states clearly the
responsibilities of each of the
operative/intervention team members in
implementing this standard.
56. GAHAR
SURVEY PROCESS
56
NSR
21
Review medical records of post-operative
patients & check for checklist utilization.
Interview relevant staff to check their
understanding of this process
Observe implementation of this process at
the surgery or intervention room if possible.
57. GAHAR 57
NSR
22
STANDARD
There is a documented process to verify
an accurate counting of sponges, needles
& instruments pre & post procedure.
58. GAHAR
RATIONALE
58
NSR
22
Review retention prevention policy &
procedure & ensure that it covers the role of
nurses & surgeons, pre & postoperative count
double verification, documentation, as well as
steps to be taken in case of discrepancy
between pre & postoperative counts.
Review the checklist & observe whether it is
dedicated to this standard or it is a part of a
wider checklist (surgical safety checklist,
universal protocol checklist).
59. GAHAR
SURVEY PROCESS
59
NSR
22
Review preoperative/pre-intervention policy
& procedure for preventing wrong patient,
wrong site/side, & wrong surgery/invasive
procedure & ensure that it supports patient,
procedure, as well as part of body
verification just before start of the
procedure, regardless whether the patient is
anesthetized, sedated or awake (Time Out).
60. GAHAR
SURVEY PROCESS
60
NSR
22
Review post-operative patient medical
records checking for pre & postoperative
counts documentation of this process.
Interview surgical team & check their
understanding of this process.
Observe implementation of this process at
the operating room if possible.
62. GAHAR 62
NSR
23
STANDARD
There is a well structured & implemented fire &
smoke safety plan that addresses prevention, early
detection, response, & safe exit when required due
to fire or other emergencies & including at least the
following:
63. 63
NSR.23. 1
Frequency of inspecting fire
detection & suppression
systems, including
documentation of the
inspections
Maintenance & testing of fire
protection & abatement systems
in all areas
NSR.23. 2
Documentation
requirements for staff
training on fire response &
evacuation
NSR.23. 3
Assessment of fire risks when
construction is present in or
adjacent to the facility
NSR.23. 4
65. GAHAR
SURVEY PROCESS
65
NSR
23
Review the fire safety plan, facility fire safety
inspections, & fire system maintenance. Fire
alarm should be effectively working. Fire
fighting & smoke containment should
comply with civil defense requirements.
Review plan of testing (drills) & staff training
(all staff should be trained on fire safety).
66. GAHAR 66
NSR
24
STANDARD
Fire drills are conducted at least quarterly in
different clinical areas & during different shifts,
including at least one unannounced fire drill
annually.
68. GAHAR
SURVEY PROCESS
68
NSR
24
Review the documents of fire & evacuation
drills with dates, timings, staff that participated
& the involved areas in the facility.
Review corrective action plan based on the
drill evaluation.
Interview staff to check the awareness of fire
safety plan & basic procedures in such cases
like (Rescue, Alarm, Confine,
Extinguish/Evacuate & Pull, Aim, Squeeze,
Sweep).
69. GAHAR 69
NSR
25
STANDARD
There is a well structured & implemented plan for
hazardous materials (Hazmat) & waste
management for the use, handling, storage, &
disposal of hazardous materials & waste addressing
at least the following:
70. NSR.25. 1
Safety & security
requirements for
handling & storage
Requirements for
personal protective
equipment
NSR.25. 2
Procedures &
interventions to
implement following
spills & accidental
contact or exposures
NSR.25. 3
Disposal in accordance
with applicable laws &
regulation
NSR.25. 4
Labeling of hazardous
materials & waste
NSR.25. 5
Monitoring data on
incidents to allow
corrective action
NSR.25. 5
71. GAHAR
RATIONALE
71
NSR
25
The facility should have a hazmat & waste
management program that addresses different
requirements. The facility environment, staff,
patients, relatives & vendors should be safe from
hazardous material exposure & waste all over the
time.
72. GAHAR
SURVEY PROCESS
72
NSR
25
Review the hazardous material & waste
management program to make sure that it covers
all safety requirements of hazardous materials, safe
storage, handling, spills, required protective
equipment & waste disposal in accordance to local
laws & regulations.
73. GAHAR
SURVEY PROCESS
73
NSR
25
Review the hazardous material & waste disposal
plan, hazardous material & waste inventories, as
well as Material Safety Data Sheet (MSDS), &
inspect hazardous material labeling & storage in
addition to waste collection, segregation storage &
final disposal.
76. GAHAR
SURVEY PROCESS
76
NSR
26
Review safety & security plan/s & make sure
of including suitable risk assessment
surveillance, security high-risk areas &
security requirements, as well as access
control areas.
Review surveillance rounds plan, checklist,
different observations & check for proper
corrective actions when applicable.
77. GAHAR
SURVEY PROCESS
77
NSR
26
Inspect workers in different areas like
workshops & waste to make sure of using
suitable personnel protective equipment
(PPE).
Check for security plan, cameras monitors,
staff ID & access controlled areas.
79. GAHAR
RATIONALE
79
NSR
27
The facility should have documented radiation
safety program according to local laws &
regulations.
The facility environment, staff, patients,
relatives & vendors should be safe from
radiation hazards.
80. GAHAR
SURVEY PROCESS
80
NSR
27
Review the radiation safety program & make
sure of presence of level of exposure
according to local laws & regulations, shielding
methods & safety requirements for staff &
patients.
Review environmental radiation measures,
thermo-luminescent dosimeter (TLD) &/or
badge films of the staff results, CBC results, &
lead aprons inspection & check for staff
awareness.
82. GAHAR
RATIONALE
82
NSR
28
The facility should have a documented
laboratory safety program that covers all
safety requirements specific for the
laboratory. The facility environment, staff,
patients, relatives & venders should be
safe from laboratory hazards.
83. GAHAR
SURVEY PROCESS
83
NSR
28
Review laboratory safety program which
should include at least: list of chemicals &
hazardous materials, dealing with spills, safety
requirements, suitable PPE, maintenance &
calibration of medical equipment & staff
orientation, & proper waste disposal.
Review laboratory safety reports, lab
equipment safety, storage of chemicals,
labeling & waste disposal process.
84. GAHAR 84
NSR
29
STANDARD
There is a well-structured & implemented plan for
selecting, inspecting, maintaining, testing, & safe
usage of medical equipment that addresses at least
the following:
85. NSR.29. 1
Inventory of all
medical
equipment
Schedule for inspection &
preventive maintenance
according to manufacturers
recommendations & frequency
of repair & breakdown.
NSR.29. 2
Testing of all new
equipment before use
& repeat testing, as a
part of the preventive
maintenance.
NSR.29. 3
Testing of alarm
systems including
clinical alarm
NSR.29. 4
Qualified
individuals who
can provide these
services.
NSR.29. 5
Data monitoring
for frequency of
repair or
equipment
failure.
NSR.29. 6
Ensure only that
trained &
competent people
handle specialized
equipment.
NSR.29. 7
86. GAHAR
RATIONALE
86
NSR
29
The facility should have a documented program
for medical equipment that covers all required
standards.
The facility should ensure that all diagnostic
medical equipment are maintained & calibrated to
minimize diagnostic errors.
87. GAHAR
SURVEY PROCESS
87
NSR
29
Review the medical equipment maintenance
program & ensure availability of all required
documents, inventory of medical equipment,
schedule of preventive maintenance, & calibration
& documents of staff training
88. GAHAR 88
NSR
30
STANDARD
There is a well-structured & implemented plan for
regular inspection, maintenance, testing, & repair
of essential utilities addressing at least the
following:
89. NSR.30. 1
Electricity;
including stand-by
generators
Water
NSR.30. 2
Heating, ventilation & air conditioning
including; air flow in negative & positive
pressure rooms, appropriate
temperature, humidity & odors
eliminates
NSR.30. 3
Medical gases
NSR.30. 4
Communicati
on systems
NSR.30. 5
Waste
disposal
NSR.30. 6
Regular
inspections
NSR.30. 7
91. GAHAR
RATIONALE
91
NSR
30
The facility should have a documented program for
utility management that covers all required
standards. The facility should keep safe & effective
key utility system 24 hour 7 days per week.
92. GAHAR
SURVEY PROCESS
92
NSR
30
Review utility management plan & confirm
availability of all required systems, regular inspection,
maintenance & backup utilities.
Review inspection documents & preventive
maintenance schedule, contracts & equipment, as
well as testing results of generators, tanks &/or other
key system to make sure of facility coverage 24/7.