This document provides information about the accreditation requirements and processes for DNV GL and CIHQ. It discusses the key steps in applying for and maintaining accreditation, including submitting applications, undergoing on-site surveys, addressing any deficiencies found, and participating in follow up activities. It also outlines the different types of surveys conducted, how deficiencies are classified and addressed, and consequences for organizations like being put on "accreditation at risk" status.
This document discusses quality control procedures for surgical pathology services. It defines key terms like quality assurance, quality control, and quality improvement. It then outlines the phases of quality control including pre-analytic, analytic, and post-analytic phases. The document provides details on approaches to quality control, including monitoring specimen handling and processing, diagnostic accuracy and turnaround times, pathology reporting standards, and ensuring diagnostic findings are integrated with ancillary study results.
QPS is a contract research organization that provides discovery, preclinical, and clinical development services including bioanalysis, DMPK, biomarkers, and early phase clinical research. It has facilities in Newark, DE, Taipei, Taiwan, and Springfield, MO that are GLP compliant. QPS supports clients through all phases of drug development with specialized services including bioanalysis, PK/PD analysis, ADME studies, and clinical research.
This document summarizes guidelines from the International Conference on Harmonisation (ICH) regarding stability testing of new drug substances and products. It discusses ICH guidelines Q1A(R2) through Q1F, which provide recommendations on conducting stability studies under various storage conditions to determine appropriate re-test periods and shelf lives. The guidelines specify the types of studies, including stress testing, selection of batches, container closure systems, specifications, testing frequency, and evaluation criteria. The document outlines recommended storage conditions and minimum time periods for long-term, intermediate, and accelerated stability studies to support product registrations.
Role of hospital management related to patient safety in hospitals and the active roles played by them to improve patient safety. Details of actionable on part of hospital management pertaining to safety in hospitals.
An introduction on Evidence-Based Clinical Practice Guidelines in Health Care Organizations
Brief on Alexandria Center for EBCPGs in Alexandria University Hospitals, Egypt
By Dr. Yasser Sami Abdel Dayem Amer, MBBCh, MS 2013
Special Thanks to
Prof Dr Mahmoud Elzalabany
Prof Dr Tarek Omar
Prof Dr Nabil Dowidar
Prof Dr Afaf Gaber
Quality assurance scheme for basic composite medical laboratoriesjdyjdo
This document discusses NABL's new Quality Assurance Scheme (QAS) for basic composite medical laboratories at the entry level. The scheme aims to recognize quality practices in small laboratories that perform basic testing, as getting full ISO 15189 accreditation is not feasible for most small labs due to costs, infrastructure requirements, and stringent protocols. The QAS criteria are based on requirements in the Clinical Establishments Rules of 2012. Laboratories that comply with the QAS can switch to ISO 15189 accreditation later if desired. Benefits of the QAS include a certificate of compliance and recognition of quality efforts for small laboratories.
EVIDENCE-BASED CPGs FOR HEMATOLOGY - ONCOLOGY UNIT, KING SAUD UNIVERSITY HOPSITALS
Saudi Arabia, Riyadh
King Saud University Hospitals
CPGs Committee
Quality Management Dept
CPGs Program
By YASSER SAMI AMER
This document provides information about the accreditation requirements and processes for DNV GL and CIHQ. It discusses the key steps in applying for and maintaining accreditation, including submitting applications, undergoing on-site surveys, addressing any deficiencies found, and participating in follow up activities. It also outlines the different types of surveys conducted, how deficiencies are classified and addressed, and consequences for organizations like being put on "accreditation at risk" status.
This document discusses quality control procedures for surgical pathology services. It defines key terms like quality assurance, quality control, and quality improvement. It then outlines the phases of quality control including pre-analytic, analytic, and post-analytic phases. The document provides details on approaches to quality control, including monitoring specimen handling and processing, diagnostic accuracy and turnaround times, pathology reporting standards, and ensuring diagnostic findings are integrated with ancillary study results.
QPS is a contract research organization that provides discovery, preclinical, and clinical development services including bioanalysis, DMPK, biomarkers, and early phase clinical research. It has facilities in Newark, DE, Taipei, Taiwan, and Springfield, MO that are GLP compliant. QPS supports clients through all phases of drug development with specialized services including bioanalysis, PK/PD analysis, ADME studies, and clinical research.
This document summarizes guidelines from the International Conference on Harmonisation (ICH) regarding stability testing of new drug substances and products. It discusses ICH guidelines Q1A(R2) through Q1F, which provide recommendations on conducting stability studies under various storage conditions to determine appropriate re-test periods and shelf lives. The guidelines specify the types of studies, including stress testing, selection of batches, container closure systems, specifications, testing frequency, and evaluation criteria. The document outlines recommended storage conditions and minimum time periods for long-term, intermediate, and accelerated stability studies to support product registrations.
Role of hospital management related to patient safety in hospitals and the active roles played by them to improve patient safety. Details of actionable on part of hospital management pertaining to safety in hospitals.
An introduction on Evidence-Based Clinical Practice Guidelines in Health Care Organizations
Brief on Alexandria Center for EBCPGs in Alexandria University Hospitals, Egypt
By Dr. Yasser Sami Abdel Dayem Amer, MBBCh, MS 2013
Special Thanks to
Prof Dr Mahmoud Elzalabany
Prof Dr Tarek Omar
Prof Dr Nabil Dowidar
Prof Dr Afaf Gaber
Quality assurance scheme for basic composite medical laboratoriesjdyjdo
This document discusses NABL's new Quality Assurance Scheme (QAS) for basic composite medical laboratories at the entry level. The scheme aims to recognize quality practices in small laboratories that perform basic testing, as getting full ISO 15189 accreditation is not feasible for most small labs due to costs, infrastructure requirements, and stringent protocols. The QAS criteria are based on requirements in the Clinical Establishments Rules of 2012. Laboratories that comply with the QAS can switch to ISO 15189 accreditation later if desired. Benefits of the QAS include a certificate of compliance and recognition of quality efforts for small laboratories.
EVIDENCE-BASED CPGs FOR HEMATOLOGY - ONCOLOGY UNIT, KING SAUD UNIVERSITY HOPSITALS
Saudi Arabia, Riyadh
King Saud University Hospitals
CPGs Committee
Quality Management Dept
CPGs Program
By YASSER SAMI AMER
QPS Bio-Kinetic is a clinical research organization located in Springfield, Missouri that specializes in Phase I-IV clinical trials. It has a state-of-the-art facility with 240 beds across 5 study units. QPS Bio-Kinetic has over 15 years of experience conducting over 800 studies and has a dedicated, experienced staff with low turnover. Customers praise QPS Bio-Kinetic for its ability to reliably deliver high quality results on time and on budget.
Standard operating procedures_for_laboratory_servicesFahrudin Yusuf
This document provides standard operating procedures for laboratory services at Coast Provincial General Hospital's antiretroviral therapy program in Kenya. It was prepared in collaboration with the hospital's laboratory department and the Rational Pharmaceutical Management Plus Program with support from USAID. The document includes procedures for processing hematology and clinical chemistry specimens, criteria for rejecting specimens, correcting erroneous reports, identifying critical lab values, specimen collection and handling, blood collection techniques, post-exposure prophylaxis, quality control of equipment and reagents, and handling and disposal of biohazardous waste.
Overview of the progress of the KSUMC Clinical Practice Guidelines Adaptation and Implementation Program in the Department of Pediatrics which is the most active department in the program
Best Quality Practices for Biomedic Research: Rick Calabrese ASQ 2014 NE Conf...akrumenaker
The document outlines best quality practices for biomedical research in drug development. It discusses establishing quality standards for non-regulated research to ensure validity and integrity of data. The technical report specifies general quality requirements covering areas like management systems, documentation, personnel training, facilities, equipment calibration and test methods. The goal is to minimize waste and costs by generating reliable data to support drug development decisions.
Patience Kache Chula is a medical technologist with over 12 years of experience in clinical laboratories. She has a Higher National Diploma in Medical Laboratory Technology from The Kenya Polytechnic and is certified by the Kenya Medical Laboratory Technicians and Technologists Board. Currently she works as a consultant laboratory mentor assisting laboratories in attaining accreditation. Previously she has held positions as a laboratory manager, quality assurance officer, and laboratory technologist.
This document outlines a clinical audit project to prevent ventilator-associated pneumonia (VAP) at KSMC ICU. The audit team is led by Dr. Abdul-Rahman Al-Harthy and includes ICU consultants and fellows. The objectives are to meet guidelines-based criteria to reduce VAP, including elevating patient head, oral chlorhexidine, hand hygiene, ventilator circuit changes only when needed, daily sedation review and weaning assessment, and use of subglottic secretion drainage for long-term patients. Data will be collected from patient charts and observations from March 1 to April 30, 2014 on 88 patients and analyzed to measure compliance with the criteria and standards.
The document discusses the adaptation and implementation of clinical practice guidelines (CPGs) at hospitals of two universities in the Middle East and North Africa region. It provides an overview of the CPG adaptation and implementation program launched at Alexandria University Hospitals in Egypt and King Saud University in Saudi Arabia. It describes how over a dozen CPGs have been adapted through various theses projects at Alexandria University Hospitals, and outlines the current status of the CPG program established at King Saud University Medical City, which has adapted over 30 CPGs across various clinical departments.
This session was conducted as a part of the 6th Resident Professional Development Course titled "Evidence-Based Medicine" in 9th SEPT 2015 at College of Medicine, King Saud University
1) The document discusses guidelines adaptation versus de novo development, outlining the differences in processes and methodologies between the two approaches.
2) It provides an overview of the ADAPTE framework, a systematic approach to adapting existing high-quality clinical practice guidelines to different contexts and organizations. The ADAPTE framework consists of 3 phases and 9 modules over 23 steps.
3) Adaptation offers an alternative to de novo guideline development when high quality guidelines already exist, in order to customize them efficiently for local use while reducing duplication of efforts.
The document discusses the history and purpose of Good Laboratory Practice (GLP). It begins by explaining that GLP originated in the United States in the 1970s when the FDA found many cases of poor laboratory practices. The FDA then created GLP regulations in 1978 to promote quality and validity in non-clinical lab studies. The Organization for Economic Co-operation and Development (OECD) later established widely accepted GLP principles based on the US regulations. GLP aims to minimize mistakes and ensure consistency, documentation, and reproducibility in lab studies submitted to regulatory authorities. The document then goes on to discuss key aspects of GLP such as management responsibilities, quality assurance programs, standard operating procedures, and record keeping.
Evidence-based medicine has evolved from focusing primarily on randomized controlled trials to incorporating a broader range of evidence, including observational studies and evidence generated from practice settings. It aims to integrate the highest quality external evidence with internal organizational data and stakeholder perspectives to improve health outcomes.
Part 1. An overview on implementation of CPGs
Part 2. CPGs & HTAs
Presented during the 2nd Regional Workshop for CPG Adaptation, Tunis, Tunisia May 24-26 2016
A collaborative between INA Sante, WHO-EMRO, KSU
CARTaGENE: Challenges and benefits of a federated biorepository model - Octob...CARTaGENE Biobank
Title: Challenges and benefits of a federated biorepository model
Abstract:Genome-based studies have provided powerful research tools for identifying genetic variants that contribute to chronic diseases. Recognition is growing, however, that chronic diseases are caused by a combination of an individual's genetic predisposition and their exposure to certain environmental risk factors. CARTaGENE was created to support the scientific community in identifying the determinants of chronic diseases of environmental and/or genetic origin. It was also created to accelerate the process of translational medicine through the identification of biomarkers for early diagnosis, disease treatment and prevention. To be competitive with the rest of the world and to increase the statistical power of its data, CARTaGENE has joined forces with four other Canadian cohorts to form the Canadian Partnership for Tomorrow Project (CPTP, http://www.partnershipfortomorrow.ca/). CPTP is the largest population based cohort study in Canada with over 300 000 participants recruited. In 2015 a CPTP Genotyping Project was launched to test drive CPTP’s biosample release procedures to help inform time and resource requirements and to identify challenges that may be present within the federated biorepository model under which the study operates. The project design included specific participant inclusion criteria, sample retrieval, DNA extraction, and genotyping of 5,000 samples. Lessons learned from this project will be shared.
For more information about biosample and data access: access@cartagene.qc.ca
This document discusses how Cochrane reviews are used by Kaiser Permanente Southern California (KPSC) in developing clinical practice guidelines, conducting medical technology assessments, and supporting evidence-based implementation efforts. It provides examples of how Cochrane reviews have influenced guidelines on chronic obstructive pulmonary disease and breast cancer screening. Cochrane reviews are also frequently referenced in KPSC's medical technology assessments and evaluations of implementation strategies for chronic condition education. Overall, Cochrane is considered a primary source of systematic reviews that impact care delivery within the large health system.
This document provides an overview of laboratory quality management and outlines the essential components of a quality management system for laboratories. It discusses that quality management is a continuous journey, not a destination. It then describes the key quality system essentials which include organization, facilities and safety, personnel, equipment, and processes for management, work, and measurement. The relationship between technical and managerial activities is important for ensuring high quality and effective laboratory operations.
Good Laboratory Practices Mubashir MaqboolMUBASHIR WANI
GLP (Good Laboratory Practice) is a quality system for managing non-clinical laboratory studies to ensure reliability and integrity of test data. It outlines requirements for facility organization, personnel responsibilities, quality assurance programs, standard operating procedures, and retention of records and reports. GLP aims to ensure studies are well-designed, conducted and documented according to all principles to allow for traceability and reproducibility of results.
This document outlines test methods for determining the magnitude and rate of consolidation of soils under controlled-stress loading. There are two alternative test methods:
Method A involves constant 24-hour load increments and time-deformation readings on a minimum of two increments. Method B requires time-deformation readings on all increments and successive increments are applied after 100% primary consolidation or at constant time increments as in Method A.
The test determines the relationship between effective stress and void ratio/strain of a laterally restrained soil specimen under axial drainage and incremental loading. Test results are used to estimate settlement magnitudes and rates, but can be affected by sample disturbance so care must be taken in sample selection and preparation. Load increments and durations
Quality Management Systems in Radiotherapy based on ISO 9001 standardVal Antoff
Presentation on the main building blocks of a Quality Management System in Radiotherapy based on the international ISO 9001 standard. The presentation provides internal hyperlinks to bookmarked material for easy navigation.
This document provides an overview of CAP accreditation for laboratories. It defines key terms, outlines the history of CAP, and describes the United Labs Consulting Team. It reviews common laboratory requirements and CAP standards. The steps for accreditation include pre-assessment, assessment, and post-assessment phases. Benefits of CAP accreditation include comprehensive evaluations, expert inspection teams, useful inspection tools, and compliance with regulations. CAP focuses on continuous education to improve laboratory quality and patient safety.
This document discusses quality management in health laboratories. It defines quality and outlines approaches to quality management including planning, organizing, staffing, leading and controlling processes. Key elements of a quality management system are described such as organization, personnel, equipment, purchasing, process control, information management, documents/records, occurrence management and assessment. The document emphasizes that a quality management system involves coordinated activities across all aspects of laboratory operations to ensure quality. External quality assessment through proficiency testing is also discussed as an important tool for evaluating laboratory performance.
QPS Bio-Kinetic is a clinical research organization located in Springfield, Missouri that specializes in Phase I-IV clinical trials. It has a state-of-the-art facility with 240 beds across 5 study units. QPS Bio-Kinetic has over 15 years of experience conducting over 800 studies and has a dedicated, experienced staff with low turnover. Customers praise QPS Bio-Kinetic for its ability to reliably deliver high quality results on time and on budget.
Standard operating procedures_for_laboratory_servicesFahrudin Yusuf
This document provides standard operating procedures for laboratory services at Coast Provincial General Hospital's antiretroviral therapy program in Kenya. It was prepared in collaboration with the hospital's laboratory department and the Rational Pharmaceutical Management Plus Program with support from USAID. The document includes procedures for processing hematology and clinical chemistry specimens, criteria for rejecting specimens, correcting erroneous reports, identifying critical lab values, specimen collection and handling, blood collection techniques, post-exposure prophylaxis, quality control of equipment and reagents, and handling and disposal of biohazardous waste.
Overview of the progress of the KSUMC Clinical Practice Guidelines Adaptation and Implementation Program in the Department of Pediatrics which is the most active department in the program
Best Quality Practices for Biomedic Research: Rick Calabrese ASQ 2014 NE Conf...akrumenaker
The document outlines best quality practices for biomedical research in drug development. It discusses establishing quality standards for non-regulated research to ensure validity and integrity of data. The technical report specifies general quality requirements covering areas like management systems, documentation, personnel training, facilities, equipment calibration and test methods. The goal is to minimize waste and costs by generating reliable data to support drug development decisions.
Patience Kache Chula is a medical technologist with over 12 years of experience in clinical laboratories. She has a Higher National Diploma in Medical Laboratory Technology from The Kenya Polytechnic and is certified by the Kenya Medical Laboratory Technicians and Technologists Board. Currently she works as a consultant laboratory mentor assisting laboratories in attaining accreditation. Previously she has held positions as a laboratory manager, quality assurance officer, and laboratory technologist.
This document outlines a clinical audit project to prevent ventilator-associated pneumonia (VAP) at KSMC ICU. The audit team is led by Dr. Abdul-Rahman Al-Harthy and includes ICU consultants and fellows. The objectives are to meet guidelines-based criteria to reduce VAP, including elevating patient head, oral chlorhexidine, hand hygiene, ventilator circuit changes only when needed, daily sedation review and weaning assessment, and use of subglottic secretion drainage for long-term patients. Data will be collected from patient charts and observations from March 1 to April 30, 2014 on 88 patients and analyzed to measure compliance with the criteria and standards.
The document discusses the adaptation and implementation of clinical practice guidelines (CPGs) at hospitals of two universities in the Middle East and North Africa region. It provides an overview of the CPG adaptation and implementation program launched at Alexandria University Hospitals in Egypt and King Saud University in Saudi Arabia. It describes how over a dozen CPGs have been adapted through various theses projects at Alexandria University Hospitals, and outlines the current status of the CPG program established at King Saud University Medical City, which has adapted over 30 CPGs across various clinical departments.
This session was conducted as a part of the 6th Resident Professional Development Course titled "Evidence-Based Medicine" in 9th SEPT 2015 at College of Medicine, King Saud University
1) The document discusses guidelines adaptation versus de novo development, outlining the differences in processes and methodologies between the two approaches.
2) It provides an overview of the ADAPTE framework, a systematic approach to adapting existing high-quality clinical practice guidelines to different contexts and organizations. The ADAPTE framework consists of 3 phases and 9 modules over 23 steps.
3) Adaptation offers an alternative to de novo guideline development when high quality guidelines already exist, in order to customize them efficiently for local use while reducing duplication of efforts.
The document discusses the history and purpose of Good Laboratory Practice (GLP). It begins by explaining that GLP originated in the United States in the 1970s when the FDA found many cases of poor laboratory practices. The FDA then created GLP regulations in 1978 to promote quality and validity in non-clinical lab studies. The Organization for Economic Co-operation and Development (OECD) later established widely accepted GLP principles based on the US regulations. GLP aims to minimize mistakes and ensure consistency, documentation, and reproducibility in lab studies submitted to regulatory authorities. The document then goes on to discuss key aspects of GLP such as management responsibilities, quality assurance programs, standard operating procedures, and record keeping.
Evidence-based medicine has evolved from focusing primarily on randomized controlled trials to incorporating a broader range of evidence, including observational studies and evidence generated from practice settings. It aims to integrate the highest quality external evidence with internal organizational data and stakeholder perspectives to improve health outcomes.
Part 1. An overview on implementation of CPGs
Part 2. CPGs & HTAs
Presented during the 2nd Regional Workshop for CPG Adaptation, Tunis, Tunisia May 24-26 2016
A collaborative between INA Sante, WHO-EMRO, KSU
CARTaGENE: Challenges and benefits of a federated biorepository model - Octob...CARTaGENE Biobank
Title: Challenges and benefits of a federated biorepository model
Abstract:Genome-based studies have provided powerful research tools for identifying genetic variants that contribute to chronic diseases. Recognition is growing, however, that chronic diseases are caused by a combination of an individual's genetic predisposition and their exposure to certain environmental risk factors. CARTaGENE was created to support the scientific community in identifying the determinants of chronic diseases of environmental and/or genetic origin. It was also created to accelerate the process of translational medicine through the identification of biomarkers for early diagnosis, disease treatment and prevention. To be competitive with the rest of the world and to increase the statistical power of its data, CARTaGENE has joined forces with four other Canadian cohorts to form the Canadian Partnership for Tomorrow Project (CPTP, http://www.partnershipfortomorrow.ca/). CPTP is the largest population based cohort study in Canada with over 300 000 participants recruited. In 2015 a CPTP Genotyping Project was launched to test drive CPTP’s biosample release procedures to help inform time and resource requirements and to identify challenges that may be present within the federated biorepository model under which the study operates. The project design included specific participant inclusion criteria, sample retrieval, DNA extraction, and genotyping of 5,000 samples. Lessons learned from this project will be shared.
For more information about biosample and data access: access@cartagene.qc.ca
This document discusses how Cochrane reviews are used by Kaiser Permanente Southern California (KPSC) in developing clinical practice guidelines, conducting medical technology assessments, and supporting evidence-based implementation efforts. It provides examples of how Cochrane reviews have influenced guidelines on chronic obstructive pulmonary disease and breast cancer screening. Cochrane reviews are also frequently referenced in KPSC's medical technology assessments and evaluations of implementation strategies for chronic condition education. Overall, Cochrane is considered a primary source of systematic reviews that impact care delivery within the large health system.
This document provides an overview of laboratory quality management and outlines the essential components of a quality management system for laboratories. It discusses that quality management is a continuous journey, not a destination. It then describes the key quality system essentials which include organization, facilities and safety, personnel, equipment, and processes for management, work, and measurement. The relationship between technical and managerial activities is important for ensuring high quality and effective laboratory operations.
Good Laboratory Practices Mubashir MaqboolMUBASHIR WANI
GLP (Good Laboratory Practice) is a quality system for managing non-clinical laboratory studies to ensure reliability and integrity of test data. It outlines requirements for facility organization, personnel responsibilities, quality assurance programs, standard operating procedures, and retention of records and reports. GLP aims to ensure studies are well-designed, conducted and documented according to all principles to allow for traceability and reproducibility of results.
This document outlines test methods for determining the magnitude and rate of consolidation of soils under controlled-stress loading. There are two alternative test methods:
Method A involves constant 24-hour load increments and time-deformation readings on a minimum of two increments. Method B requires time-deformation readings on all increments and successive increments are applied after 100% primary consolidation or at constant time increments as in Method A.
The test determines the relationship between effective stress and void ratio/strain of a laterally restrained soil specimen under axial drainage and incremental loading. Test results are used to estimate settlement magnitudes and rates, but can be affected by sample disturbance so care must be taken in sample selection and preparation. Load increments and durations
Quality Management Systems in Radiotherapy based on ISO 9001 standardVal Antoff
Presentation on the main building blocks of a Quality Management System in Radiotherapy based on the international ISO 9001 standard. The presentation provides internal hyperlinks to bookmarked material for easy navigation.
This document provides an overview of CAP accreditation for laboratories. It defines key terms, outlines the history of CAP, and describes the United Labs Consulting Team. It reviews common laboratory requirements and CAP standards. The steps for accreditation include pre-assessment, assessment, and post-assessment phases. Benefits of CAP accreditation include comprehensive evaluations, expert inspection teams, useful inspection tools, and compliance with regulations. CAP focuses on continuous education to improve laboratory quality and patient safety.
This document discusses quality management in health laboratories. It defines quality and outlines approaches to quality management including planning, organizing, staffing, leading and controlling processes. Key elements of a quality management system are described such as organization, personnel, equipment, purchasing, process control, information management, documents/records, occurrence management and assessment. The document emphasizes that a quality management system involves coordinated activities across all aspects of laboratory operations to ensure quality. External quality assessment through proficiency testing is also discussed as an important tool for evaluating laboratory performance.
This document discusses quality indicators, their history, definitions, and examples. It describes how quality indicators can be used to monitor performance, determine quality of services, and identify areas for improvement. The document provides examples of quality indicators collected by various laboratories and organizations. It also outlines best practices for developing, presenting, and using quality indicators effectively.
Breakout 2.2 Commissioning Quality Care: Tools to support the commissioning p...NHS Improvement
Breakout 2.2 Commissioning Quality Care: Tools to support the commissioning process - Stephen Callaghan:
Principal Consultant, EQE Health.
Associate Consultant, Hope Street Centre.
Visiting Lecturer, University of Chester.
ANP, A&E University Hospitals Aintree
Part of a set of presentations from NHS Improvement event: Better value, better outcomes held on Thursday 21 February 2013,
Guoman Tower Hotel, London
How to deliver quality and value in chronic care:sharing the learning from the respiratory programme
The paradigm shift – central lab to point of carejdyjdo
This document discusses the journey of laboratory testing from bedside testing to centralized laboratories to point-of-care testing. It provides a brief history of early diagnostic tests and outlines the benefits of point-of-care testing such as simpler sample collection and faster turnaround time. It discusses quality requirements for point-of-care testing devices and the roles of the manufacturer, laboratory, and point-of-care coordinator in ensuring quality. It also addresses challenges of point-of-care testing and the importance of oversight committees.
Quality indicators for gastrointestinal endoscopy unitsJlioAlmeida21
The document provides guidelines for quality indicators for gastrointestinal endoscopy units. It describes a taskforce convened by the American Society for Gastrointestinal Endoscopy that developed a set of quality indicators through a multi-step process. The taskforce defined 155 potential quality indicators across 5 domains and used a modified Delphi method with two rounds of online voting to reach consensus on the key indicators. Thirty-four percent of invited participants provided responses. The indicators that met consensus thresholds across domains were included in the final guidelines to help endoscopy units measure and improve quality of care.
Quality assurance in pathology is important to minimize errors and ensure accurate diagnoses. External quality assessment programs help laboratories evaluate performance and harmonize results. A quality assurance program involves establishing standards and protocols, monitoring compliance, conducting regular reviews, and participating in proficiency testing. The goal is to maintain accuracy, precision and reliability throughout the pre-analytical, analytical and post-analytical phases to optimize patient care.
This document discusses quality assurance in bioavailability and bioequivalence studies. It outlines key elements of quality management including adherence to standards, prevention of errors, independent assessment of compliance, and having a flexible system. It also discusses Good Clinical Practice, Good Laboratory Practice, and the role of quality assurance in ensuring compliance with regulations and standards. Quality assurance aims to ensure credibility and accuracy of data through audits and monitoring.
This document provides guidelines for conducting and reporting QA audits. It defines key terms like QA, audits and GCP. It outlines the responsibilities of the QA unit and clinical team in audits. The procedures section describes selecting projects for audit, preparing an audit plan, conducting the audit including opening/closing interviews, reporting findings according to severity, responding to audits with corrective actions, and closing the audit after satisfactory responses. The overall purpose is to ensure trials are conducted and data recorded/reported in compliance with GCP and regulations.
The document discusses good practices in the Blood and Marrow Transplant (BMT) Clinical and Marrow Collection Program's annual training. It defines various types of good practices (GxP), including Good Manufacturing Practice (GMP), Good Tissue Practice (GTP), Good Documentation Practice (GDP), and Good Clinical Practice (GCP). It explains that GxP standards guide work to ensure safety. BMT establishments must follow quality standards comparable to pharmaceutical manufacturers. The training covers GxP requirements like personnel qualifications, facilities and equipment, process validation, quality assurance, and auditing.
The document discusses quality assurance in clinical trials. It begins by outlining key frameworks for quality like GCP and ISO standards. It emphasizes that quality assurance requires understanding critical parameters, incorporating quality by design principles, and addressing practical challenges in data collection and documentation. The document then provides examples of risk-based quality management, highlighting the importance of identifying, assessing, and mitigating risks at various stages of a clinical trial's lifecycle. Finally, it presents two case studies, one on a large heart failure trial and another on a global respiratory trial, to demonstrate operationalizing quality assurance practices.
External quality assurance in clinical trace element labs Chris Harrington
Information on how EQA works in clinical trace element laboratories from the perspective of an ISO 17043 accredited EQA provider: UKNEQAS for Trace Elements, Guildford, UK.
2. Delia Geary IDPS lab workshop march 2019PHEScreening
This document discusses the process of incorporating Public Health England's antenatal and newborn screening standards into UKAS accreditation to ISO 15189 for laboratories performing infectious diseases in pregnancy screening. The objectives are to reduce assessment burden, improve communication and patient safety through a coordinated accreditation and quality assurance process. PHE screening requirements have been mapped to ISO 15189. Laboratories must meet both PHE and ISO standards to receive and maintain accreditation, with information sharing between UKAS and PHE's quality assurance program. The process aims to strengthen oversight of screening laboratories while minimizing duplicate efforts.
This document provides information about quality management systems for laboratories. It discusses key aspects of a quality management system including defining quality, the importance of a QMS for ensuring reliable lab operations, and the benefits of implementing a QMS such as improved efficiency and compliance. It also outlines the 12 essential elements of an ISO-compliant lab QMS and provides details on ISO 15189, which provides standards for quality in medical laboratories.
Quality assurance in nursing, (nursing audit).pptxTulsiDhidhi1
This document discusses nursing audit, including its definition, purpose, characteristics, and methods. It defines nursing audit as a process to evaluate nursing care quality by comparing actual practice to agreed standards. The main methods discussed are retrospective review of patient records and concurrent review involving bedside assessment. Retrospective review examines records after discharge while concurrent review evaluates patients still undergoing care. Tools, training, the audit cycle, and uses of nursing audit are also outlined.
This document discusses quality assurance and quality control in clinical research. It defines quality assurance as planned actions to ensure a trial complies with good clinical practice and regulations. Quality control refers to operational techniques that verify quality requirements are fulfilled. Ensuring accurate, reliable data is an ongoing challenge managed through monitoring data collection and management at all study levels. Sponsors are responsible for quality systems with standard operating procedures and allowing monitoring, auditing and inspections. Quality assurance and quality control help ensure successful project completion and credible, compliant research.
Evidence-based practice (EBP) began with Cochrane's encouragement to use randomized controlled trials to determine medical intervention effectiveness. EBP integrates the best research evidence, clinical expertise, and patient values and preferences. The 5 steps of EBP are: formulating a question, locating evidence, critically appraising evidence, applying evidence to a patient, and evaluating outcomes. Challenges to EBP include resistance to change and lack of time and skills, while facilitators include support, resources, and training.
Similar to Does ProVation MD capture colonoscopy KPIs? (20)
The Diabetes Discovery Project at Austin Health aimed to use their Cerner EMR system to routinely test HbA1c levels on inpatients over 54 to identify undiagnosed and poorly controlled diabetes. Testing of over 5,000 patients found 5% had undiagnosed diabetes and 29% had known diabetes. Higher HbA1c levels were associated with increased hospital admissions and longer lengths of stay for surgical patients. The project demonstrated using health IT to identify diabetes management opportunities. Ongoing work includes refining protocols and expanding to other patient populations.
This document summarizes a presentation on using data and informatics to improve allied health services. It discusses the history of allied health and challenges with data collection. Examples are provided of projects in New Zealand that used data to enhance patient and clinician experiences, reduce hospital-acquired infections, and inform staffing needs. The presentation emphasizes standardizing data to facilitate benchmarking and applying knowledge gained from data analysis to drive improvements in allied health.
This document presents a proof of concept for using Twitter data to conduct syndromic surveillance for public health monitoring. It analyzed tweets containing the keyword "measles" between 2014-2015 and found 1,408 relevant tweets. The number of tweets mentioning measles was compared to confirmed measles cases from a national surveillance system, showing potential for Twitter data as an early warning system. However, limitations include using a single keyword and the free Twitter API. Future work proposed improving data collection, applying machine learning techniques, and validating tweets with other health data sources.
The document discusses using surface modelling and mapping techniques to analyze healthcare data. It provides three scenarios as examples: 1) Mapping KPIs regionally to identify opportunities for improvement, 2) Mapping data around a specific pharmacy to examine market penetration, and 3) Comparing the market penetration of two smoking cessation medications. Surface mapping allows easy visualization and comparison of multiple data layers, helps protect patient privacy, and can provide insights into how to optimize outcomes.
The document summarizes how providing laptop computers to clinicians in a community allied health service has enhanced clinical care. Each of the 20 clinicians was provided a laptop with mobile data and remote desktop access to complete administrative and electronic tasks in the community rather than returning to the office. This has increased efficiency by allowing timely and collaborative work, which has decreased stress on clinicians and allowed for more timely information sharing with children and families. Some challenges remain around the weight of laptops and continuing reliance on paper records. Future plans include providing iPads and moving to more paperless systems.
This document describes the development of an electronic workflow system called scope to improve surgical practice at a District Health Board (DHB) hospital. The goals were to seamlessly map the patient journey, accurately collect coded data, and leverage trusted data to inform clinicians. The system streamlines waiting lists, captures accurate operating notes, and facilitates morbidity and mortality meetings. Implementation across surgical specialties has achieved good compliance and uptake. Preliminary results found increased quality of notes, discussion of complications, and potential to change practice through advanced data analysis. In conclusion, scope has replaced a disconnected paper system with a seamless electronic solution that fully captures standardized data to improve surgical outcomes.
1. The document discusses how healthcare has progressed beyond just electronic medical records (EMRs) and is now focused on areas like mobile computing, health collaboration, cloud-based back office systems, health intelligence, and clinical grade communications.
2. It provides examples of how technology is enabling cross-campus collaboration, telehealth, clinical collaboration using medical devices and teleradiology, and clinical communications.
3. The document advocates for sustainable eHealth innovation beyond just EMRs and discusses how areas like health analytics, mobility for care, patient-centered care, and emerging technologies can further improve healthcare.
The document discusses empowering healthcare through technology that is safe, works for everyone, and leaves no one behind. It describes how digital technologies are disrupting traditional healthcare models and outlines opportunities to enhance patient and provider experiences through virtual care, remote monitoring, and analytics. Key goals are mentioned like reducing readmissions, increasing effectiveness, and improving clinical productivity. The future of healthcare is envisioned as personalized, connected, data-driven, and empowering every person and organization to achieve more through technology.
The document discusses using analytics and care coordination to reduce hospitalizations and arrests of mental health patients. It notes that around 10% of patients are readmitted to psychiatric hospitals within 30 days of discharge. Care coordination aims to break this cycle through improved outcomes, treatment adherence, continuity of care, and identifying high-risk patients. Analytics tools can provide predictive modeling, population clustering, and care quality analysis to develop insights. The goal is to engage all stakeholders to deliver an integrated care plan through data-driven insights and coordination between providers.
Dr Nic Woods discusses tools for early recognition and management of sepsis using the electronic medical record (EMR). Sepsis poses a major global health challenge and burden. Tools discussed include a sepsis predictive model built into the EMR that can detect signs of sepsis with sensitivities of 68-91% and specificities of 91-97.6%. Clinical decision support and workflows in the EMR are also used to alert clinicians and guide treatment. Evaluations found these tools helped reduce mortality from sepsis by 4.2-17% and lower length of hospital stays. Key points emphasized that predictive models integrated into clinical workflows can positively impact outcomes, but more progress is still needed.
This document discusses allied health professionals and their role in the healthcare system. It lists various allied health roles and describes how they rehabilitate and enable patients by taking a collaborative and holistic approach focused on patient needs. The document emphasizes that allied health professionals help reduce health service needs by facilitating patients' independence and ability to remain in their communities. It argues that capturing allied health data can help provide visibility into their services, allow for quality improvement, and ultimately benefit patients through a more coordinated system where the "right intervention" is delivered at the "right time". The challenges of engaging stakeholders and integrating passive data extraction are also addressed.
This document discusses changes in clinical data collection and the role of clinical coders. It notes that data now comes from many sources through various mediums and is used for many purposes. Clinical coding translates medical descriptions into codes. While technology has improved coding efficiency, the role of clinical coders may change further as technology advances. In particular, widespread electronic health records could significantly impact current clinical coding practices and roles. The document urges clinical coders and organizations to consider how to prepare for and adapt to technological changes to ensure accurate and consistent health data collection into the future.
This document provides background information on New Zealand's national maternity system called BadgerNet. It discusses the existing national programs and governance structure in place. BadgerNet is being rolled out nationally as an end-to-end maternity information system to record information from conception to six weeks postnatal. It will be used across District Health Boards and in the community. The financial model and implementation process are also outlined.
This document summarizes a presentation given by Dr. Shaun Costello on oncology treatment patterns in the South Island of New Zealand. The presentation discusses the creation of the South Island Cancer Clinical Information System (SICCIS) to capture patient-level oncology data across multiple hospitals in the region. This includes implementation of the MOSAIQ electronic medical record system and a shared data repository called METRIQ. The goal is to analyze the treatment patterns and outcomes of cancer patients in order to improve the quality of care in the South Island. Examples of preliminary analyses of the data are shown, including cancer stages, treatments, and radiation doses for lung cancer patients.
The evaluation identified several unintended consequences of the electronic prescribing pilot including new types of errors related to prescribing workflows and system defaults. Key lessons learned were that ongoing training and engagement are needed as workflows change over time. Regular monitoring is required to identify errors and develop strategies to address them, such as simplifying multi-step processes and minimizing alert fatigue. Overall the evaluation found that electronic prescribing has benefits but also risks, and a focus on how systems are implemented and used is as important as the technology itself.
This document discusses emerging technologies in the pharmacy sector. It begins with an overview of the evolution of pharmacy and a discussion of disruptive technologies. It then examines specific emerging capabilities like online healthcare access in Switzerland, remote patient monitoring in Spain, and ingestible sensors. Exciting retail trends are also explored, such as using customer data to predict behaviors, billboards responding to airplane flights, and the potential of Li-Fi wireless networks. The document suggests several technologies may disrupt pharmacies or remain niche capabilities. Overall, it analyzes new digital innovations and how they could impact pharmacy services and the customer experience.
This document discusses the development of a smartphone app to help patients better manage their rheumatoid arthritis. Interviews with rheumatoid arthritis patients and healthcare professionals revealed key themes. Patients were enthusiastic about an app's potential to record symptoms and communicate with their care team. However, healthcare professionals were apprehensive about increased workloads. Both groups saw value in collecting patient-reported outcomes but acknowledged limitations. Next steps include piloting a new "RAconnect" app and conducting a clinical trial to evaluate its impact on disease management compared to standard care.
This document discusses various self-tracking tools and applications for health, fitness, and well-being. It mentions several companies and products including 23andMe for DNA sequencing, UBiome for microbiome sequencing, Dexcom for continuous blood glucose monitoring, and Jawbone UP and Fitbit for activity tracking. It also discusses ideas around open data, genomic APIs, geo-tracking health data, and future technologies like ingestible sensors. Overall, the document explores the growing field of self-quantification and personalized data collection for improving individual health and wellness.
How to Control Your Asthma Tips by gokuldas hospital.Gokuldas Hospital
Respiratory issues like asthma are the most sensitive issue that is affecting millions worldwide. It hampers the daily activities leaving the body tired and breathless.
The key to a good grip on asthma is proper knowledge and management strategies. Understanding the patient-specific symptoms and carving out an effective treatment likewise is the best way to keep asthma under control.
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
PGx Analysis in VarSeq: A User’s PerspectiveGolden Helix
Since our release of the PGx capabilities in VarSeq, we’ve had a few months to gather some insights from various use cases. Some users approach PGx workflows by means of array genotyping or what seems to be a growing trend of adding the star allele calling to the existing NGS pipeline for whole genome data. Luckily, both approaches are supported with the VarSeq software platform. The genotyping method being used will also dictate what the scope of the tertiary analysis will be. For example, are your PGx reports a standalone pipeline or would your lab’s goal be to handle a dual-purpose workflow and report on PGx + Diagnostic findings.
The purpose of this webcast is to:
Discuss and demonstrate the approaches with array and NGS genotyping methods for star allele calling to prep for downstream analysis.
Following genotyping, explore alternative tertiary workflow concepts in VarSeq to handle PGx reporting.
Moreover, we will include insights users will need to consider when validating their PGx workflow for all possible star alleles and options you have for automating your PGx analysis for large number of samples. Please join us for a session dedicated to the application of star allele genotyping and subsequent PGx workflows in our VarSeq software.
The biomechanics of running involves the study of the mechanical principles underlying running movements. It includes the analysis of the running gait cycle, which consists of the stance phase (foot contact to push-off) and the swing phase (foot lift-off to next contact). Key aspects include kinematics (joint angles and movements, stride length and frequency) and kinetics (forces involved in running, including ground reaction and muscle forces). Understanding these factors helps in improving running performance, optimizing technique, and preventing injuries.
Osvaldo Bernardo Muchanga-GASTROINTESTINAL INFECTIONS AND GASTRITIS-2024.pdfOsvaldo Bernardo Muchanga
GASTROINTESTINAL INFECTIONS AND GASTRITIS
Osvaldo Bernardo Muchanga
Gastrointestinal Infections
GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission.
Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others.
These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others.
The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition).
To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH.
Gastritis and Gastric Health
Gastric Health is one of the most relevant concerns in human health, with gastrointestinal infections being among the main illnesses that affect humans.
Among gastric problems, we have GASTRITIS AND GASTRIC ULCERS as the main public health problems. Gastritis and gastric ulcers normally result from inflammation and corrosion of the walls of the stomach (gastric mucosa) and are generally associated (caused) by the bacterium Helicobacter pylor, which, according to the literature, this bacterium settles on these walls (of the stomach) and starts to release urease that ends up altering the normal pH of the stomach (acid), which leads to inflammation and corrosion of the mucous membranes and consequent gastritis or ulcers, respectively.
In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively.
Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.
“Psychiatry and the Humanities”: An Innovative Course at the University of Mo...Université de Montréal
“Psychiatry and the Humanities”: An Innovative Course at the University of Montreal Expanding the medical model to embrace the humanities. Link: https://www.psychiatrictimes.com/view/-psychiatry-and-the-humanities-an-innovative-course-at-the-university-of-montreal
Pictorial and detailed description of patellar instability with sign and symptoms and how to diagnose , what investigations you should go with and how to approach with treatment options . I have presented this slide in my 2nd year junior residency in orthopedics at LLRM medical college Meerut and got good reviews for it
After getting it read you will definitely understand the topic.
Ageing, the Elderly, Gerontology and Public Health
Does ProVation MD capture colonoscopy KPIs?
1. Does ProVationtm MD
capture colonoscopy KPIs?
David Theobald
Clinical Director
National Endoscopy Quality Improvement Programme
2. National Endoscopy Quality
Improvement Programme
• Catalyst - Bowel Screening Pilot
• Appointment of NCLGIE and wider team
• Colonoscopy
• Widened brief
3. National Endoscopy Quality
Improvement Programme
Goal
The primary aim is to have every
endoscopy unit in the country
providing a patient focused service.
4. The strategy to reach this
goal will be
total service improvement
encompassing individual
performance, unit
performance and training
5. The methodology to reach
this goal will be
change based on evidence
(principles of the ‘Audit
Cycle’)
6. The primary tool to reach
this goal will be
the endoscopy
Global Rating Scale (GRS)
7. What is the Global Rating Scale (GRS)?
The GRS is a web-based self assessment tool
that provides a standard for accreditation and a
quality framework for service improvement
8. GRS Standards
1. Clinical Quality 2. Quality of the Patient Experience
1. Information/consent 1. Equality of access
2. Safety 2. Timeliness
3. Comfort 3. Choose and book
4. Quality 4. Privacy and dignity
5. Appropriateness 5. Aftercare
6. Results to referrer 6. Patient feedback
9. GRS Standards
1. Clinical Quality 2. Quality of the Patient Experience
1. Information/consent 1. Equality of access
2. Safety 2. Timeliness
3. Comfort 3. Choose and book
4. Quality 4. Privacy and dignity
5. Appropriateness 5. Aftercare
6. Results to referrer 6. Patient feedback
3. Workforce
1. Skill mix review and recruitment
2. Orientation and training
3. Assessment and appraisal
4. Staff are cared for
5. Staff are listened to
10. GRS Standards
1. Clinical Quality 2. Quality of the Patient Experience
1. Information/consent 1. Equality of access
2. Safety 2. Timeliness
3. Comfort 3. Choose and book
4. Quality 4. Privacy and dignity
5. Appropriateness 5. Aftercare
6. Results to referrer 6. Patient feedback
3. Workforce 4. Training
1. Skill mix review and recruitment 1. Environment and opportunity
2. Orientation and training 2. Endoscopy trainers
3. Assessment and appraisal 3. Assessment and appraisal
4. Staff are cared for 4. Equipment and materials
5. Staff are listened to
11. GRS achievement levels
• Units score themselves on several items for
each standard
• This gives a level attained and, thus, monitors
progress
• Levels D through A
• These levels can later be used for
accreditation purposes
13. National Endoscopy Quality
Improvement Programme
• Total service improvement
• Approach is that of the audit cycle
• Principal tool is the Global Rating Scale
• Standards
– Quality standards
– Auditable outcomes
14. Auditable Outcomes and Quality
Standards
An auditable outcome refers to an outcome, which is
important to monitor and review, for which it is not
possible to assign a standard. Examples of this might be
use of reversal agents for over sedation, minimum number
of procedures required to maintain competence,
or outcome of endoscopic therapy for variceal bleeding
15. Auditable Outcomes and Quality
Standards
A quality standard is an auditable outcome for which
there is an evidence base that can recommend a minimum
standard, for example completion rates for colonoscopy or
bleeding rates for sphincterotomy. As the evidence base
improves it is expected that it will be possible to convert
auditable outcomes into quality standards.
16. Auditable Outcomes and Quality
Standards
• Both require acquisition of large amounts of
data
• This must be accurate if important decisions
are to be made on it
• Clinical KPIs are part of this data
• Data entry should be as effortless as it is
accurate
17. Audit Cycle
• Standards – initially, for the Development Trial,
most are UK standards
• Reliable Data – various sources
• Schedule of audits - EUG
• Action plans - EUG
18. Clinical data as a KPI
• Choice of data
• Do not collect data because it can be collected
• Using data suggested by British Society of
Gastroenterology (BSG)
20. Requirements of a clinical data
collection solution
• Accurate
• Require minimal extra effort over and above
reporting input
• Collected in a format that is usable
• Is connected to a system that can use it
• Exportable
21. Endoscopy Reporting in NZ
• Mixture
• Dictation
• Hand written
• Legacy standalone electronic reporting
systems
• In some locations more than one method on
the same site
22. Acquisition of ProVationtm MD
• Joint purchase after extensive tender process
by the three Auckland DHBs
• Auckland Installation 2010
• Christchurch installation 2011
• Other DHBs at various stages of engagement
24. How easy is it to get data into
ProVationtmMD?
• Menu structure is regarded as cumbersome by
clinicians
• Leads to more than desirable us of free text
fields
• Structure undeniably US biased with many
redundant fields for a NZ setting
• Changes possible but difficult
25. How easy is it to get data from
ProVationtm MD?
• All keystrokes are recorded
• Theoretically everything entered can be
extracted
• Database queries regarded as cumbersome by
clinicians
• Macros
28. Initial appraisal of Provationtm MD and
clinical KPIs
• Proof of concept investigation to assess
whether standard KPIs could be extracted
from ProVation reports. KPIs were chosen in
line with NHS, ASGE & NZ standards
29. Initial appraisal of Provationtm MD and
clinical KPIs
• Prospective audit across three Auckland DHBs
• Seven KPIs assessed
• Two six-week cycles with a planned preliminary analysis after week six
• Analysis performed using the data export function built into ProVation
(“automated”) and compared to results collated from individual reports
(“manual”).
• Feedback provided after the first round via department meetings or by
email Minor changes made after first round
– Index colonoscopy field added, bowel preparation field made mandatory
– Endoscopists asked to use post-surgical note for appropriate patients
30. EM Johns1, PD Frankish1, RS Walmsley1, DS Rowbotham2, RK Ogra3, DR Theobald1
Departments of Gastroenterology, Waitemata1, Auckland2 & Counties Manukau3 District Health Boards
Introduction Methods
Quality colonoscopy is integral to the success of bowel cancer screening programs. Key
Prospective audit across three Auckland DHBs
performance indicators (KPIs) are well established but require meticulous collection of a
Initial appraisal of Provationtm MD
Seven KPIs assessed
large volume of information. The endoscopy database program ProVation has recently been
Two six-week cycles with a planned preliminary analysis after week six
introduced across the Auckland region. Its potential role as a quality assurance tool was a
Analysis performed using the data export function built into ProVation (“automated”)
key reason for its implementation, and its future use as a nationwide audit tool is under
and compared to results collated from individual reports (“manual”).
consideration.
Feedback provided after the first round via department meetings or by email
Aim and clinical KPIs
Proof of concept investigation to assess whether standard KPIs could be extracted from
Minor changes made after first round
Index colonoscopy field added, bowel preparation field made mandatory
Endoscopists asked to use post-surgical note for appropriate patients
ProVation reports. KPIs were chosen in line with NHS, ASGE & NZ standards1-3.
Results Hospital X Hospital Y Hospital Z
Round 1 Round 2 Round 1 Round 2 Round 1 Round 2
Automated Manual Automated Manual Automated Manual Automated Manual Automated Manual Automated Manual
Caecal intubation rate 208/226 199/209 225/243 216/229 245/264 231/243 268/282 253/263 200/239 202/230 226/257 228/245
92% 95% 93% 94% 93% 95% 95% 96% 84% 88% 88% 93%
Bowel preparation 81% 83% 94% 96% 64% 65% 99% 100% 80% 82% 99% 100%
quality documented
Withdrawal times no 53% 43% 60% 46% 35% 40% 37% 37% 40% 31% 28% 29%
manoeuvre#: proportion
>6minutes
Withdrawal times no 7:41 6:20 7:15 6:02 5:57 6:04 5:46 5:11 5:49 5:11 5:24 4:52
manoeuvre#: mean
Polyp detection rate age Insufficient data Insufficient data 39/86 42/95 Insufficient Insufficient data 37/103 32/101 Insufficient data Insufficient data 45/101 33/98
50-80 (index exams) 45% 44% data 37% 32% 45% 34%
Adenoma detection rate Not supported Insufficient data 26/86* 28/95 Not supported Insufficient data 24/103* 24/101 Not supported Insufficient data 26/101* 24/98
age 50-80 (index exams) 30% 29% 23% 24% 26% 24%
Polyp recovery rate Not supported 165/175 Not supported 190/215 Not supported 150/159 Not supported 159/183 Not supported 243/261 Not supported 191/221
94% 88% 94% 87% 93% 86%
Complications Not supported None Not supported 2 readmissions Not supported None Not supported 2 perforations Not supported 3 perforations Not supported 2 readmissions
1 readmission 1 readmission
*histology manually retrieved
#no polypectomy, biopsy etc
31. Initial appraisal of Provationtm MD
and clinical KPIs
KPI Problem Suggested solution
Caecal Intubation rate Difficulty identifying intact New mandatory field for
colons post surgical patients
Bowel preparation quality Variably reported when not Made mandatory
mandatory
No standardization Need agreement on
definitions of prep quality
32. Initial appraisal of Provationtm MD
and clinical KPIs
KPI Problem Suggested solution
Withdrawal times if no Times overestimated if Should improve with
manouevre manouevres not familiarity
documented
Polyp and adenoma Easily retrieved if Link to a pathology program
detection rates polypectomy documented (currently not possible)
Histology not linked Manual linkage
33. Initial appraisal of Provationtm MD
and clinical KPIs
KPI Problem Suggested solution
Polyp recovery rate Provation records Requires software
qualitatively and not modification
quantitavely
Complications Manual entry by person Needs dedicated audit
with admin privileges personnel
36. Where are we now?
Suggested solution Suggested solution Suggested solution
New mandatory field for Should improve with Requires software
post surgical patients familiarity modification
Made mandatory Link to a pathology program Needs dedicated audit
(currently not possible) personnel
Need agreement on
definitions of prep quality
37. Where are we now?
Suggested solution Suggested solution Suggested solution
New mandatory field for
post surgical patients
Made mandatory
These are done and were easy requiring just
a software tweak within the existing program.
This was done by clinicians
38. Where are we now?
Suggested solution Suggested solution Suggested solution
Should improve with
familiarity
Needs dedicated audit
personnel
Need agreement on
definitions of prep quality These are partly done or partly not done
and require behavioural change from clinicians
39. Where are we now?
Suggested solution Suggested solution Suggested solution
Requires software
modification
Link to a pathology program
(currently not possible)
These are not done and require major software
work and behavoural change from clinicians
40. The way forward
• Progress must be clinician led
• Clinicians must collaborate across the entire
country to formulate an agreed set of clinical
requirements
• This requires strong clinical leadership
• A NZ ProVation Users Group is required for this
• So far abortive attempts to establish this
41. The way forward
• The NZ ProVation Users Group then
approaches company for software updates
(NZ cf US market share)
• The NZ ProVation Users Group needs to have
ongoing close ties with the National
Endoscopy Quality Improvement Programme
42. The way forward
• Should all DHBs purchase ProvationtmMD?
• IT Board of the NHB supports a single software
solution without naming a specific product
• The clinical information required for KPIs is
not very complex……
• …..but it does need to be collected with
something more reliable than a pencil and a
piece of paper