The document discusses the benefits of establishing a Quality Management System (QMS) according to ISO 9001 standards for a fertility center. It outlines that a QMS can help ensure consistency, meet customer needs and requirements, and increase efficiency. It also discusses how to measure these benefits, including through audits, surveys, key performance indicators, and data analysis tools like control charts. The presentation provides examples of how Androfert fertility clinic in Brazil benefited from implementing an ISO 9001 certified QMS.
Quality Management System in ART CentersFabiola Bento
The document summarizes a presentation given by Fabiola C. Bento on establishing a quality management system (QMS) in assisted reproductive technology (ART) centers. It discusses the key components of a QMS, including developing a mission statement, quality policies and objectives, processes and procedures, handling non-conformities, and auditing. It also covers implementing QM specifically in reproductive laboratories, such as defining the laboratory's scope, infrastructure, manuals, and monitoring performance. The goal is to demonstrate how an ART clinic can establish an effective QMS internally and at low cost.
The perfect integration between Lab SOP and clinical strategySandro Esteves
Standard operating procedures (SOPs) are needed in assisted reproductive technology (ART) clinics to standardize complex lab tasks and prevent errors. The document discusses how to develop SOPs that integrate both the clinical and lab perspectives. Key points include determining tests based on clinical needs, writing SOPs that provide information for clinical decisions, and effective communication between clinics and labs to determine the best strategies for patients. Developing SOPs requires considering what information doctors need from lab results and how to handle abnormal values. SOPs must also address specific clinical questions and allow clinicians to make informed decisions.
IVF errors can occur due to clinical, administrative, or embryo lab issues. While rare, mistakes are inevitable. Errors are graded based on their severity from none/minimal to major. Strict systems like double witnessing, barcodes, and electronic tracing can help avoid errors. If errors do occur, clinics should disclose this to patients to promote a culture of transparency and trust.
This document discusses the importance of quality control for blastocyst transfer in IVF clinics. It emphasizes maintaining equipment like CO2 incubators in proper working condition by regularly checking the CO2 concentration, pH, and temperature using tools like a CO2 analyzer, pH meter, and digital thermometer. Strict quality control is critical for fertilization, embryo growth, and blastocyst conversion rates.
There are many IVF centers over the globe, but itis time to make criteria, standards and parameters for establishing an IVF center. This talk may help in this
This document provides information about quality management in embryology laboratories. It discusses how quality standards have evolved from an apprentice-based system with little monitoring to today's highly regulated environment. Key aspects of quality management systems are described, including quality control, document control, audits, risk assessment, and meeting regulatory requirements from bodies like the HFEA. The role of the quality manager is to ensure the quality management system is functional and that quality standards are continuously improved.
Quality Management System in ART CentersFabiola Bento
The document summarizes a presentation given by Fabiola C. Bento on establishing a quality management system (QMS) in assisted reproductive technology (ART) centers. It discusses the key components of a QMS, including developing a mission statement, quality policies and objectives, processes and procedures, handling non-conformities, and auditing. It also covers implementing QM specifically in reproductive laboratories, such as defining the laboratory's scope, infrastructure, manuals, and monitoring performance. The goal is to demonstrate how an ART clinic can establish an effective QMS internally and at low cost.
The perfect integration between Lab SOP and clinical strategySandro Esteves
Standard operating procedures (SOPs) are needed in assisted reproductive technology (ART) clinics to standardize complex lab tasks and prevent errors. The document discusses how to develop SOPs that integrate both the clinical and lab perspectives. Key points include determining tests based on clinical needs, writing SOPs that provide information for clinical decisions, and effective communication between clinics and labs to determine the best strategies for patients. Developing SOPs requires considering what information doctors need from lab results and how to handle abnormal values. SOPs must also address specific clinical questions and allow clinicians to make informed decisions.
IVF errors can occur due to clinical, administrative, or embryo lab issues. While rare, mistakes are inevitable. Errors are graded based on their severity from none/minimal to major. Strict systems like double witnessing, barcodes, and electronic tracing can help avoid errors. If errors do occur, clinics should disclose this to patients to promote a culture of transparency and trust.
This document discusses the importance of quality control for blastocyst transfer in IVF clinics. It emphasizes maintaining equipment like CO2 incubators in proper working condition by regularly checking the CO2 concentration, pH, and temperature using tools like a CO2 analyzer, pH meter, and digital thermometer. Strict quality control is critical for fertilization, embryo growth, and blastocyst conversion rates.
There are many IVF centers over the globe, but itis time to make criteria, standards and parameters for establishing an IVF center. This talk may help in this
This document provides information about quality management in embryology laboratories. It discusses how quality standards have evolved from an apprentice-based system with little monitoring to today's highly regulated environment. Key aspects of quality management systems are described, including quality control, document control, audits, risk assessment, and meeting regulatory requirements from bodies like the HFEA. The role of the quality manager is to ensure the quality management system is functional and that quality standards are continuously improved.
Implementation of air quality control in the IVF laboratory and other critica...Sandro Esteves
This document summarizes Sandro C. Esteves' presentation on the implementation of air quality control in IVF laboratories and critical areas. It discusses the importance of air quality based on evidence from animal, human, and observational studies showing improved IVF outcomes with reduced particle and VOC levels. Regulatory agencies like the FDA, EU, and Brazil require particle and microbial filtration and some recommend VOC filtration. The presentation describes how ANDROFERT implemented air quality control through their facility design and ventilation system to meet ISO 5 cleanroom standards, including HEPA and activated carbon filtration. Monitoring equipment is used to ensure standards are maintained.
What are the benefits of QMS for a fertility centre and how do we measure themSandro Esteves
This document discusses the benefits of implementing a Quality Management System (QMS) for a fertility center. It explains that a QMS helps ensure consistency, meet customer needs, and increase efficiency. Benefits are measured through audits, tracking quality actions, and key performance indicators. Tools like Pareto diagrams, control charts, and the PDCA method are used to analyze data. The presentation then discusses Androfert fertility center's experience implementing ISO 9001 certification in 2006. This helped Androfert improve quality of services, comply with regulations, boost its reputation, increase market share and profitability over time. The QMS created a well-organized workflow and focus on continuous improvement.
The document discusses Total Quality Management (TQM) and how it can be applied to healthcare and IVF clinics. TQM aims to ensure services are standardized, results are analyzed for improvements, and excellence is guaranteed. Key aspects of TQM include defining processes, monitoring quality indicators, registering quality actions, and continuous improvement. When evaluating an IVF clinic's success using TQM, important quality dimensions include safety, effectiveness, patient-centeredness, efficiency, timeliness, and equity which can be measured through consensus quality indicators.
This document discusses setting up IUI and IVF services. It covers the key components needed, including good lab design, infrastructure, equipment, and personnel. For infrastructure, it recommends building from scratch in a pollution-free area for an embryo-friendly environment. It provides details on room classification, air handling units, electricity, and gas supply. Essential and desirable equipment are outlined for IUI and IVF labs. It emphasizes the importance of a cohesive team approach. Startup costs are estimated at 1-1.5 lakhs for IUI and 40 lakhs for IVF, with an ideal setup costing around 100 lakhs plus 40-50 lakhs for infrastructure. Effective service provision focuses
This document discusses individualized controlled ovarian stimulation (I COS) protocols. It notes that conventional approaches use long agonist protocols with standard gonadotropin doses based on age. I COS allows for personalization based on ovarian reserve tests, biomarkers, and other factors to customize stimulation aims at moderate oocyte retrieval while increasing clinical pregnancy rates. Prediction models can be used to determine starting doses, protocols, and adjuvants based on a patient's ovarian response classification as poor, normal, or hyper responders.
This document discusses management strategies for poor responders undergoing assisted reproductive technology. It begins by defining poor responders according to the Bologna criteria. It then reviews biomarkers for predicting poor response, finding AMH and AFC to be similarly accurate. The document outlines an individualized approach to controlled ovarian stimulation for poor responders, discussing adjuvant therapies like growth hormone and testosterone. It reviews evidence that recombinant FSH preparations retrieve more oocytes than urinary FSH or HMG. GnRH antagonists may shorten stimulation duration slightly. LH supplementation, specifically recombinant LH added to FSH, may modestly improve pregnancy rates.
Air quality: is it that important? And if so, how to measure and control it?Sandro Esteves
Quality and Risk Management in the IVF Laboratory; Redlara Brasil, Belo Horizonte, 14-15 September 2016
Content:
1.Air quality: is it that important?
2. How to control?
3. How to measure?
The document discusses future developments in IVF labs in three main areas: 1) Embryo culture techniques aim to better mimic the reproductive tract using microfluidics and dynamic culture systems. 2) Automation seeks to robotically assist processes like ICSI. 3) Non-invasive embryo selection techniques study the chemical fingerprints embryos leave in culture media using spectroscopy and proteomics to predict viability without biopsy. The goal is improving IVF success rates through more physiological culture conditions, precision of techniques, and selecting the highest quality embryos.
The document discusses recommendations for setting up an IUI lab. It recommends that the lab have both a non-sterile and sterile area with adequate space to avoid compromising quality. Key considerations include basic infrastructure like air quality, lighting, temperature control and water supply. The document also recommends proper staffing with an embryologist, andrologist, nurses and counselor. Equipment, disposables, and high quality culture media are also essential to set up the IUI lab. Quality control, assurance and improvement should be prioritized. The lab design should have considerable input from embryologists and specialists to ensure success.
Treatment of poor responders: Review of Systematic reviews 2016 Aboubakr Elnashar
The document summarizes evidence from systematic reviews on treatments for poor responders undergoing IVF. It finds that flare up GnRH agonist protocols, estrogen primed antagonist protocols, DHEA supplementation, and transdermal testosterone are associated with increased clinical pregnancy rates compared to other interventions. The document also reviews interventions such as growth hormone, luteal phase estrogen, corticosteroids, and embryo transfer on day 2 versus day 3. It aims to determine the best evidence on treatments for poor responders based on systematic reviews published between 2003 and 2016.
Optimization of ovarian stimulation to improve success rate in ‘ART’Apollo Hospitals
ART is defined as the technique used where there is a need for in-vitro preparation or manipulation of gametes. The commonest ARTs are intrauterine insemination (IUI) and in-vitro fertilization (IVF). Ovarian stimulation is required with these procedures to increase the pregnancy rate as ART with natural cycle has a very low pregnancy rate. Optimizing pregnancy rates per cycle is the real basis for ovarian stimulation protocols in ART.
PRESENTED AT MASTER CLASS MUMBAI...........THNX TO MANY WHO HAVE CONTRIBUTED TO THIS PRESENTATION.....FEEL FREE TO USE THIS , BUT PLEASE ACKNOWLEDGE THE EFFORTS OF ALL ...........jaideep-narendra
This document discusses monitoring of the ART (assisted reproductive technology) cycle. It describes various methods for monitoring, including ultrasound to measure follicle growth and endometrial thickness, as well as using ultrasound combined with serum estradiol levels. The key objectives of monitoring are outlined, such as predicting ovarian response, monitoring pituitary suppression, evaluating gonadotropin dose, preventing OHSS, determining the optimal time for hCG administration, and avoiding cycle cancellation. Indicators for when to adjust gonadotropin dosage or cancel the cycle are provided. Ultrasound is identified as the most practical monitoring method and combining it with estradiol is particularly useful for high-risk patients.
Recent advances in assisted reproductive technology include:
1. The 1978 birth of Louise Brown, the first "test-tube baby", using in vitro fertilization without ovarian stimulation.
2. Developments like intracytoplasmic sperm injection (ICSI) and preimplantation genetic diagnosis (PGD) that have improved treatment options for male factor infertility and genetic disorders.
3. Continued research on techniques such as cryopreservation of eggs/embryos, stem cell therapy, and cloning that could further advance reproductive medicine if proven successful and safe.
1) Embryo transfer is the final step in IVF where embryos are placed in the uterus. Careful technique is important for success.
2) Factors that can affect the success of embryo transfer include embryo selection, the timing of the transfer, cervical infections, endometrial thickness and pattern, and experience of the provider.
3) During the procedure, gentle technique, ultrasound guidance, and depositing embryos slightly below the uterine fundus can help maximize the chances of implantation and pregnancy. Meticulous attention to factors before, during, and after embryo transfer is crucial.
The Embryology laboratory should been designed to provide an environment that is as close to optimum as possible for the growth of human embryos and to provide the best resulting pregnancy rates for patients undergoing IVF cycles.
Here, we discuss what is the components of IVF laboratory.
This document outlines the protocol for intrauterine insemination (IUI). It describes the indications for IUI including male factor infertility and various types of female infertility. It details the workup that should be done prior to IUI including semen analysis and ultrasound exams. The steps of the IUI process are explained, including ovarian stimulation when needed, follicle monitoring, sperm preparation techniques, timing of insemination, and the insemination procedure. It recommends offering 4 to 6 cycles of IUI.
PPT-Embryo grading and ART Summary.pptxKajal530634
Embryo grading is important in IVF to select good quality embryos for transfer based on developmental rate and morphology. The most followed grading systems are Gardner and Istanbul consensus, which assess embryos daily from fertilization to blastocyst stage based on criteria like cell number, size, and fragmentation. Good quality embryos with early cleavage and cell number on day 2 often develop into good blastocysts. Donor oocyte and sperm criteria and screening are also outlined to follow regulations. Oocyte donors can donate up to 7 oocytes only once in their lifetime from age 23-35.
What the benefits are to implement TQM in ART Units and how to measure themSandro Esteves
Implementing a Total Quality Management (TQM) system like ISO 9001 in assisted reproductive technology (ART) units has several key benefits:
1) It ensures consistency in methods, materials, and equipment used, improving safety and effectiveness.
2) It ensures services meet customers' needs and requirements, improving customer-centeredness.
3) It allows for increased efficiency and profitability by standardizing processes.
Implementing a quality management system provides a framework for ART units to continuously improve performance and satisfy all stakeholders.
How to implement QMS in a Fertility CentreSandro Esteves
The document discusses implementing a Quality Management System (QMS) based on ISO 9001 standards in a fertility center. It describes the key steps to set up a QMS, including defining quality policies and objectives, documenting processes and procedures through standard operating procedures (SOPs), training personnel, registering quality actions, auditing conformity, and using information to support decision making and continual improvement. The goal is to establish coordinated activities to direct and control the organization to continuously improve performance and ensure quality.
Implementation of air quality control in the IVF laboratory and other critica...Sandro Esteves
This document summarizes Sandro C. Esteves' presentation on the implementation of air quality control in IVF laboratories and critical areas. It discusses the importance of air quality based on evidence from animal, human, and observational studies showing improved IVF outcomes with reduced particle and VOC levels. Regulatory agencies like the FDA, EU, and Brazil require particle and microbial filtration and some recommend VOC filtration. The presentation describes how ANDROFERT implemented air quality control through their facility design and ventilation system to meet ISO 5 cleanroom standards, including HEPA and activated carbon filtration. Monitoring equipment is used to ensure standards are maintained.
What are the benefits of QMS for a fertility centre and how do we measure themSandro Esteves
This document discusses the benefits of implementing a Quality Management System (QMS) for a fertility center. It explains that a QMS helps ensure consistency, meet customer needs, and increase efficiency. Benefits are measured through audits, tracking quality actions, and key performance indicators. Tools like Pareto diagrams, control charts, and the PDCA method are used to analyze data. The presentation then discusses Androfert fertility center's experience implementing ISO 9001 certification in 2006. This helped Androfert improve quality of services, comply with regulations, boost its reputation, increase market share and profitability over time. The QMS created a well-organized workflow and focus on continuous improvement.
The document discusses Total Quality Management (TQM) and how it can be applied to healthcare and IVF clinics. TQM aims to ensure services are standardized, results are analyzed for improvements, and excellence is guaranteed. Key aspects of TQM include defining processes, monitoring quality indicators, registering quality actions, and continuous improvement. When evaluating an IVF clinic's success using TQM, important quality dimensions include safety, effectiveness, patient-centeredness, efficiency, timeliness, and equity which can be measured through consensus quality indicators.
This document discusses setting up IUI and IVF services. It covers the key components needed, including good lab design, infrastructure, equipment, and personnel. For infrastructure, it recommends building from scratch in a pollution-free area for an embryo-friendly environment. It provides details on room classification, air handling units, electricity, and gas supply. Essential and desirable equipment are outlined for IUI and IVF labs. It emphasizes the importance of a cohesive team approach. Startup costs are estimated at 1-1.5 lakhs for IUI and 40 lakhs for IVF, with an ideal setup costing around 100 lakhs plus 40-50 lakhs for infrastructure. Effective service provision focuses
This document discusses individualized controlled ovarian stimulation (I COS) protocols. It notes that conventional approaches use long agonist protocols with standard gonadotropin doses based on age. I COS allows for personalization based on ovarian reserve tests, biomarkers, and other factors to customize stimulation aims at moderate oocyte retrieval while increasing clinical pregnancy rates. Prediction models can be used to determine starting doses, protocols, and adjuvants based on a patient's ovarian response classification as poor, normal, or hyper responders.
This document discusses management strategies for poor responders undergoing assisted reproductive technology. It begins by defining poor responders according to the Bologna criteria. It then reviews biomarkers for predicting poor response, finding AMH and AFC to be similarly accurate. The document outlines an individualized approach to controlled ovarian stimulation for poor responders, discussing adjuvant therapies like growth hormone and testosterone. It reviews evidence that recombinant FSH preparations retrieve more oocytes than urinary FSH or HMG. GnRH antagonists may shorten stimulation duration slightly. LH supplementation, specifically recombinant LH added to FSH, may modestly improve pregnancy rates.
Air quality: is it that important? And if so, how to measure and control it?Sandro Esteves
Quality and Risk Management in the IVF Laboratory; Redlara Brasil, Belo Horizonte, 14-15 September 2016
Content:
1.Air quality: is it that important?
2. How to control?
3. How to measure?
The document discusses future developments in IVF labs in three main areas: 1) Embryo culture techniques aim to better mimic the reproductive tract using microfluidics and dynamic culture systems. 2) Automation seeks to robotically assist processes like ICSI. 3) Non-invasive embryo selection techniques study the chemical fingerprints embryos leave in culture media using spectroscopy and proteomics to predict viability without biopsy. The goal is improving IVF success rates through more physiological culture conditions, precision of techniques, and selecting the highest quality embryos.
The document discusses recommendations for setting up an IUI lab. It recommends that the lab have both a non-sterile and sterile area with adequate space to avoid compromising quality. Key considerations include basic infrastructure like air quality, lighting, temperature control and water supply. The document also recommends proper staffing with an embryologist, andrologist, nurses and counselor. Equipment, disposables, and high quality culture media are also essential to set up the IUI lab. Quality control, assurance and improvement should be prioritized. The lab design should have considerable input from embryologists and specialists to ensure success.
Treatment of poor responders: Review of Systematic reviews 2016 Aboubakr Elnashar
The document summarizes evidence from systematic reviews on treatments for poor responders undergoing IVF. It finds that flare up GnRH agonist protocols, estrogen primed antagonist protocols, DHEA supplementation, and transdermal testosterone are associated with increased clinical pregnancy rates compared to other interventions. The document also reviews interventions such as growth hormone, luteal phase estrogen, corticosteroids, and embryo transfer on day 2 versus day 3. It aims to determine the best evidence on treatments for poor responders based on systematic reviews published between 2003 and 2016.
Optimization of ovarian stimulation to improve success rate in ‘ART’Apollo Hospitals
ART is defined as the technique used where there is a need for in-vitro preparation or manipulation of gametes. The commonest ARTs are intrauterine insemination (IUI) and in-vitro fertilization (IVF). Ovarian stimulation is required with these procedures to increase the pregnancy rate as ART with natural cycle has a very low pregnancy rate. Optimizing pregnancy rates per cycle is the real basis for ovarian stimulation protocols in ART.
PRESENTED AT MASTER CLASS MUMBAI...........THNX TO MANY WHO HAVE CONTRIBUTED TO THIS PRESENTATION.....FEEL FREE TO USE THIS , BUT PLEASE ACKNOWLEDGE THE EFFORTS OF ALL ...........jaideep-narendra
This document discusses monitoring of the ART (assisted reproductive technology) cycle. It describes various methods for monitoring, including ultrasound to measure follicle growth and endometrial thickness, as well as using ultrasound combined with serum estradiol levels. The key objectives of monitoring are outlined, such as predicting ovarian response, monitoring pituitary suppression, evaluating gonadotropin dose, preventing OHSS, determining the optimal time for hCG administration, and avoiding cycle cancellation. Indicators for when to adjust gonadotropin dosage or cancel the cycle are provided. Ultrasound is identified as the most practical monitoring method and combining it with estradiol is particularly useful for high-risk patients.
Recent advances in assisted reproductive technology include:
1. The 1978 birth of Louise Brown, the first "test-tube baby", using in vitro fertilization without ovarian stimulation.
2. Developments like intracytoplasmic sperm injection (ICSI) and preimplantation genetic diagnosis (PGD) that have improved treatment options for male factor infertility and genetic disorders.
3. Continued research on techniques such as cryopreservation of eggs/embryos, stem cell therapy, and cloning that could further advance reproductive medicine if proven successful and safe.
1) Embryo transfer is the final step in IVF where embryos are placed in the uterus. Careful technique is important for success.
2) Factors that can affect the success of embryo transfer include embryo selection, the timing of the transfer, cervical infections, endometrial thickness and pattern, and experience of the provider.
3) During the procedure, gentle technique, ultrasound guidance, and depositing embryos slightly below the uterine fundus can help maximize the chances of implantation and pregnancy. Meticulous attention to factors before, during, and after embryo transfer is crucial.
The Embryology laboratory should been designed to provide an environment that is as close to optimum as possible for the growth of human embryos and to provide the best resulting pregnancy rates for patients undergoing IVF cycles.
Here, we discuss what is the components of IVF laboratory.
This document outlines the protocol for intrauterine insemination (IUI). It describes the indications for IUI including male factor infertility and various types of female infertility. It details the workup that should be done prior to IUI including semen analysis and ultrasound exams. The steps of the IUI process are explained, including ovarian stimulation when needed, follicle monitoring, sperm preparation techniques, timing of insemination, and the insemination procedure. It recommends offering 4 to 6 cycles of IUI.
PPT-Embryo grading and ART Summary.pptxKajal530634
Embryo grading is important in IVF to select good quality embryos for transfer based on developmental rate and morphology. The most followed grading systems are Gardner and Istanbul consensus, which assess embryos daily from fertilization to blastocyst stage based on criteria like cell number, size, and fragmentation. Good quality embryos with early cleavage and cell number on day 2 often develop into good blastocysts. Donor oocyte and sperm criteria and screening are also outlined to follow regulations. Oocyte donors can donate up to 7 oocytes only once in their lifetime from age 23-35.
What the benefits are to implement TQM in ART Units and how to measure themSandro Esteves
Implementing a Total Quality Management (TQM) system like ISO 9001 in assisted reproductive technology (ART) units has several key benefits:
1) It ensures consistency in methods, materials, and equipment used, improving safety and effectiveness.
2) It ensures services meet customers' needs and requirements, improving customer-centeredness.
3) It allows for increased efficiency and profitability by standardizing processes.
Implementing a quality management system provides a framework for ART units to continuously improve performance and satisfy all stakeholders.
How to implement QMS in a Fertility CentreSandro Esteves
The document discusses implementing a Quality Management System (QMS) based on ISO 9001 standards in a fertility center. It describes the key steps to set up a QMS, including defining quality policies and objectives, documenting processes and procedures through standard operating procedures (SOPs), training personnel, registering quality actions, auditing conformity, and using information to support decision making and continual improvement. The goal is to establish coordinated activities to direct and control the organization to continuously improve performance and ensure quality.
International Cenario - Where are we today?Fabiola Bento
The document discusses international trends in assisted reproductive technologies (ART) and quality management systems (QMS) for fertility clinics. It provides data showing that the total number of ART cycles and participating clinics has risen worldwide between 2000-2004. However, data is limited as only 52 of 193 countries reported information. There is an increasing focus internationally on establishing guidelines and quality standards to improve safety, effectiveness and patient-centeredness. The document advocates for clinics to implement a QMS to better organize workflows, ensure high quality services, and focus on continuous improvement and meeting patient needs.
Maximizing efficiency and productivity in your ophthalmic practiceDr. Amani Masenya
Standardizing processes, analyzing patient flow, and improving staff training and roles are some ways ophthalmic practices can maximize efficiency. This involves reviewing appointment booking, payment processing, staff schedules, and equipment maintenance. It also means identifying bottlenecks in the patient experience and ensuring staff have the right skills to perform tasks. Increasing the scope of treatments offered and investing in updated technology can further boost profits and patient care.
This document provides an overview of Amatsigroup, a leading European contract development and manufacturing organization (CDMO) for pharmaceutical products. It summarizes Amatsigroup's vision, mission, values, areas of expertise, facilities, accreditations, management team, and approach to providing comprehensive customer service. The document highlights Amatsigroup's flexibility, proximity, quality focus, and project management capabilities from CMC and regulatory support through manufacturing and distribution of clinical trial batches.
Aravind Eye Care System was founded in 1976 in Madurai, India by Dr. G. Venkataswamy to eliminate needless blindness through providing high-quality and affordable eye care. It has since grown to become the largest provider of eye care in the world, conducting over 2 million patient visits and 850,000 surgeries per year across four hospitals and over 1,400 outreach camps. The nonprofit model relies on cross-subsidization between paying and free patients to remain financially sustainable while maximizing its social impact. Key principles include efficient operations, innovative technologies, training programs, and self-sufficiency through revenue generation to fulfill its mission of eliminating needless blindness.
Excellence in Operations For Hospital Operations Group No 4Dr Rahul Deshpande
Rockland Hospitals aim for excellence in operations through quality management. They seek to comply with quality standards, continually improve health and safety, and enhance staff competence. Their vision is to deliver high quality medical services through a team of caring professionals. They measure quality using the five dimensions of service quality: reliability, responsiveness, assurance, empathy, and tangibles. For each dimension, they have identified specific quality standards and targets across different stages of inpatient and outpatient care. This includes standards for patient registration, diagnostics, surgery, post-care, billing, and more. The goal is to achieve excellence by meeting these quality measures.
The presentation outlines the design of sales and distribution channels for a healthcare company. It discusses segmenting customers and services, forecasting demand, and establishing sales channels. Key points covered include segmenting patients by income, visit frequency, and types of medical tests/services. Demand is forecasted using a linear regression model. The sales channel involves doctors, medical representatives, and agents. Compensation, evaluation, and motivating the salesforce are also covered.
The document discusses the healthcare industry in India. It notes that India's healthcare system is undergoing a transformation and growth over the next decade will be closely tied to reforms. The industry is expected to substantially evolve to help India achieve its long-term healthcare vision. It then provides an overview of the healthcare scenario in India including statistics on expenditure and infrastructure. It also discusses St. John's Medical College Hospital including its services, processes, pricing strategies, and quality initiatives to improve service delivery.
Sure Path Labs is a medical laboratory company located in Delhi, India that is committed to providing accurate, reliable test results through innovative technologies and a well-trained staff. The company aims to enhance human life and contribute to a healthy society. It has experienced over 40% annual growth and processes over 30,000 tests annually. Sure Path Labs has obtained NABL certification and provides a range of laboratory and medical services.
Here are the key cost management techniques and accounting principles used in the 1950s and 1960s:
1. Standard costing was widely used to set budgets and measure performance. Standard costs were established for direct materials, labor, and overhead for each product.
2. Actual costs were then compared to standard costs to measure variances from the budget. Major variances were investigated to identify opportunities for improvement.
3. Manufacturing overhead costs were allocated to products using allocation bases like direct labor hours or machine hours. Absorption costing was used to determine unit product costs and value inventory.
4. A heavy focus was placed on plant capacity and utilization through metrics like labor efficiency. Gross margin analysis also helped assess profitability
This document summarizes a national call on October 1st, 2013 about a Canadian MedRec Quality Audit. It includes an overview of the audit tool and experiences using the tool from two organizations. The Winnipeg Regional Health Authority audited admission medication reconciliation processes at Churchill Health Centre and found opportunities for improvement around collecting medication histories and documenting rationales for medication changes. Interior Health in British Columbia also used the audit tool and found that medication histories were usually based on more than one information source but rationales could be documented more consistently. The call promoted a Canadian MedRec Quality Audit Month in October for healthcare organizations to use the audit tool to measure and improve admission medication reconciliation.
Robert Marquis has over 20 years of experience in medical sales, consistently exceeding sales goals. He has held sales roles launching new products for companies like Cardiva Medical and managing territories for Solstice Neurosciences and Valera Pharmaceuticals. Most recently, he was a vascular sales consultant for Cardiva Medical, managing representatives and contracting with hospital systems. He has a proven track record of success in B2B sales within the medical field.
This document provides simple steps for hospitals to achieve NABH accreditation. It begins by explaining what accreditation is and the focus of NABH standards, including patient safety, staff safety, and measuring performance. It then lists 18 specific steps for implementation, including obtaining management commitment, conducting training, establishing policies and procedures, auditing processes, and continuously improving to address any non-compliances found. The overall message is that accreditation is the best tool for quality and patient safety, but it requires commitment, effort, and an ongoing process of assessment and improvement.
Measuring Improvement: Using metrics and data to evaluate seven day servicesNHS England
A supporting document from a webinar run by Rhuari Pike, Programme Lead (Seven Day Services, London) on behalf of the NHS England Sustainable Improvement Team.
Report : Financial analysis of aanjaneya life careSwapnil Chavan
This document provides a financial analysis report on Aanjaneya Lifecare submitted by Swapnil Chavan and Shreyash Pimparkar. It includes an introduction to the company, certificates of work completion, declarations, preface, acknowledgements, contents, and an overview of the company. The document appears to analyze the financial performance and position of Aanjaneya Lifecare through ratios and annual reports from 2012-2013.
The document discusses customer safety in hospitals. It outlines several goals and initiatives to improve safety, including correctly identifying customers, improving communication, safely using medications and alarms, preventing infections, reducing falls and errors, and ensuring the right procedure is done on the right patient. Medical errors are common but preventable. Adverse events increase costs and some safety measures require little funding. Checklists are recommended for surgeries, anesthesia and post-operative care to help avoid mistakes and omissions.
Marketing Plan for Multi Diagnostic CenterSameer Shinde
Hi Tech Diagnostic Center plans to expand its network of diagnostic laboratories in Navi Mumbai. It currently has a main branch in Vashi that offers various testing facilities. The document discusses Hi Tech's mission and services. It then analyzes the demographic data and growth in population in Navi Mumbai zones. The rest of the document outlines Hi Tech's marketing strategy, which includes identifying customer needs, researching competitors, conducting SWOT analysis, and using various promotional techniques. The goal is to provide quality healthcare services and establish a wider presence in Navi Mumbai.
The document summarizes the results of the 2nd annual eyeforpharma Barcelona Awards. It provides details on the winners and finalists in various categories that recognize initiatives put forth by pharmaceutical companies to improve patient outcomes and experiences. In the "Most Valuable Patient Initiative" category, Janssen Healthcare Innovation won for its Care4Today program, an interactive website and printed pack to guide hip and knee replacement patients through their surgical journey and recovery. Key learnings highlighted that providing patients a clear treatment roadmap is valuable when they are physically and emotionally vulnerable, and that two-way communication and empowerment of patients via technology can successfully improve outcomes while adhering to regulations.
Similar to What are the benefits of QMS for a Fertility Centre and how to measure them (20)
Optimize oocyte yield to maximize live birth in ARTSandro Esteves
This document discusses strategies for optimizing ovarian response in ART to maximize live birth rates. It introduces the POSEIDON criteria for stratifying "low prognosis" ART patients based on age, ovarian reserve markers, and number of oocytes retrieved. The target is to retrieve over 15 oocytes to maximize cumulative live birth rates. Personalized gonadotropin protocols and adjuvant therapies can be used to optimize response based on POSEIDON stratification. This includes starting dose, supplementation with LH, and dual stimulation if needed to obtain the estimated number of oocytes for at least one euploid embryo transfer.
Oocyte number, female and male age, and ART outcomes Sandro Esteves
This document summarizes Sandro Esteves' presentation on optimizing ART success through individualizing oocyte retrieval targets based on a patient's age and ovarian reserve. It discusses:
1) The decline in blastocyst euploidy rates with increasing female age and the importance of oocyte quantity and quality for ART success.
2) The Poseidon criteria for stratifying "low prognosis" ART patients based on age and expected oocyte yield.
3) A mathematical model developed to estimate the minimum number of oocytes needed to achieve at least one euploid blastocyst based on a patient's age.
4) How individualizing treatment based on this oocyte target number can maximize ART efficiency
Luteal Phase Support: Key Variables to Achieve Success in ARTSandro Esteves
This document discusses luteal phase support in assisted reproductive technology cycles. It covers:
1. The pathophysiology of the luteal phase defect in stimulated cycles and the role of progesterone supplementation.
2. Different luteal phase support protocols after hCG trigger in fresh embryo transfer cycles, including progesterone alone versus progesterone plus hCG or GnRH agonist.
3. Luteal phase support considerations for frozen embryo transfer cycles, including the type and timing of estrogen and progesterone administration.
Understanding Strategies to Maximize Cumulative Live Birth RateSandro Esteves
1. The document discusses strategies for maximizing success in assisted reproductive technology (ART) treatment by stratifying patients based on factors that influence prognosis, such as age, ovarian reserve markers, and previous response to ovarian stimulation.
2. It introduces the Poseidon criteria for stratifying patients into four groups based on their predicted prognosis: two groups include younger or older patients with a previously suboptimal response, and two groups include those with expected poor ovarian reserve.
3. Stratifying patients according to factors of both oocyte quantity and quality allows for a more individualized treatment approach aimed at obtaining the estimated number of oocytes needed for achieving at least one euploid embryo transfer for each patient.
Role of LH in Controlled Ovarian StimulationSandro Esteves
1) The document discusses the role of LH in controlled ovarian hyperstimulation (COH). It notes that LH plays important roles in folliculogenesis and steroidogenesis.
2) It reviews rationales for LH supplementation in COH, such as lower endogenous LH levels and impaired steroidogenesis in certain patient groups.
3) Studies show LH supplementation can improve outcomes for poor responders and older patients, though effects may depend on the patient subgroup and study design. More research is still needed to determine which specific patient populations benefit most.
Técnicas de Obtencão de Espermatozóides na Azoospermia - Como fazer?Sandro Esteves
This document discusses different techniques for obtaining sperm from men with azoospermia, including:
1) PESA, MESA, TESA, TESE, and Micro-TESE which are used to retrieve sperm from the epididymis or testicles.
2) Micro-TESE has higher sperm retrieval rates compared to conventional TESE, especially for men with non-obstructive azoospermia.
3) Sperm retrieved through Micro-TESE also has higher fertilization rates and live birth rates compared to TESE or techniques for obstructive azoospermia.
O documento discute varicocele e infertilidade masculina. Resume que:
1) Varicocele é causa comum de infertilidade masculina, associada a deterioração dos parâmetros seminais e função testicular;
2) A fisiopatologia envolve hipertermia, hipóxia e estresse oxidativo testicular devido ao refluxo venoso;
3) O tratamento da varicocele, seja cirúrgico ou por embolização, melhora os parâmetros seminais e fertilidade em muitos casos.
1. O documento discute como realizar uma revisão de artigos científicos de forma objetiva e construtiva.
2. São apresentados os objetivos da revisão por pares, as responsabilidades do revisor e dicas sobre como escrever comentários para o editor e autores.
3. O documento fornece diretrizes detalhadas para que os revisores avaliem com qualidade os artigos submetidos prestando um serviço útil aos editores e autores.
Este documento discute conceitos estatísticos importantes para a condução de pesquisas, como poder amostral, escolha do teste estatístico correto, intervalo de confiança e cálculo do tamanho amostral. O documento enfatiza que é crucial escolher o teste estatístico apropriado para o tipo de dados, evitar erros tipo I e II, e justificar o tamanho da amostra utilizada para validar conclusões.
Novel concepts in male factor infertility: clinical and laboratory perspectivesSandro Esteves
Presentation Objectives:
1. Update on the WHO reference values for semen parameters, and understand the role of sperm DNA fragmentation testing to decision-making strategies;
2. Learn how to counsel azoospermic men seeking fertility, and the role of gonadotropin therapy in this infertility condition;
3. Understand the benefits of microsurgery to both sperm retrieval and varicocele treatment;
4. Appraise the role of medical and surgical interventions to infertile men undergoing ART.
Public lecture - Stem Cell and Male InfertilitySandro Esteves
Reproductive Andrology Workshop III
17-21 January 2016 - Kuwait City - KUWAIT
Organized by: Al Jahra Reproductive Medicine Unit - Ministry of Health
Public Lecture - Stem Cell and Male Infertility
Clinical management of men with nonobstructive azoospermia - Role of IVF Labo...Sandro Esteves
Reproductive Andrology Workshop III
17-21 January 2016 - Kuwait City - KUWAIT
Organized by: Al Jahra Reproductive Medicine Unit - Ministry of Health
Lecture 5: Role of IVF Laboratory in Nonobstructive Azoospermia
Clinical management of men with nonobstructive azoospermia - Sperm Retrieval ...Sandro Esteves
Reproductive Andrology Workshop III
17-21 January 2016 - Kuwait City - KUWAIT
Organized by: Al Jahra Reproductive Medicine Unit - Ministry of Health
Lecture 4: Sperm Retrieval Methods in Nonobstructive Azoospermia
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
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The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
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.
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What are the benefits of QMS for a Fertility Centre and how to measure them
1. Sandro Esteves
ANDROFERT, BRAZIL
L9: What are the benefits of
QMS for a fertility center
and how to measure them?
IVF Preceptorship Hamburg, 4-5 July 2014
QMS in the Fertility Centre
ISO 9001:2008
2. Learning objectives
At the completion of this presentation,
participants should be able to:
• Understand how an organization could
benefit from establishing an effective QMS
• Learn how to measure quality as per QMS
perspective
• Learn what we achieved at Androfert after
having implemented ISO 9001:2008
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3. What of the following does
your fertility center have?
Strong customer focus
customer needs/expectations are determined and converted into service requirements
Top managers have leadership
provide unity of purpose by quality policies, ensuring that measurable objectives are
established, and demonstrate that they are fully committed to developing, sustaining
and improving your center
People are involved at all levels
awareness of the importance of meeting customer requirements and responsibilities to
do this, and people are competent on the basis of appropriate training and experience
Process approach
key processes are supported by rigidly-defined procedures determining what is to be
done when undertaking a task
Systems approach
processes are managed so that the most efficient use is made of available resources,
to ensure that the needs of all stakeholders are met
Continual improvement for factual decision-making
attention is given to the voice of the customer and the voice of the processes
(measurement, monitoring, analysis)
4. A set of coordinated activities to
direct and control an
organization to continuously
improve the effectiveness and
efficiency of its performance
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5. Know your customers and define the processes
to meet their expectations
Define goals and objectives, so that procedures
and processes help you achieve them
Offer resources and infrastructure to fulfill
objectives
Systematically correct and prevent non-
conformities
Measure your performance and your customers’
satisfaction periodically
Make changes, adjustments, and improvements
based on measured results and not on
assumptions
Essentials of a successful QMS
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6. ISO 9001: Conceptual Model
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7. Customers are not only our
patients…
• Doctors who use our services
• Our employees
• Suppliers
• People in our community
• Regulatory authorities
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8. Adoption of QMS is a strategic
decision of a fertility center
Influenced by:
Regulatory directives
Concerns about quality of services
Effectiveness & efficiency
Safety
Customer requirements and satisfaction
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9. Worldwide tendency is IVF guidelines
including QMS become mandatory
Australia Code of practice for assisted
reproductive technology units,
Reproductive Technology Accreditation
Committee (RTAC)
Brazil RDC 33 and 23, National Agency of
Sanitary Surveillance (ANVISA)
European
Union
EU directive 2004/23/EG, 2006/17/EG,
2006/86/EG
South Africa National Health Act 61/2003; Human
Tissue Act
USA CLIA for Andrology laboratories; FDA
for cryobiology
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10. What regulatory bodies ask for
Document control system
Personnel training
Periodic audits
Procedures for detection, registration,
correction and prevention of errors and
non-conformities
Compliance with biosafety regulations
System to evaluate and control materials
and equipment
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11. Concerns about quality of services
Dancet et al.
Hum Reprod 2013
0% 50% 100%
Doctors &
embryologists
Nurses
Patients Safety
Effectiveness
Patient-
centeredness
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How stakeholders value the top 3 quality
dimensions of infertility care
12. QM focuses on customer requirements
and satisfaction
Lack of psychological support
and poor quality of service ~60%
treatment discontinuation
22 studies sampling
21,453 patients from
8 countries
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13. A QMS will ensure that two
important requirements are met…
1. Customer’s requirements
confidence in the ability of the center to deliver
the desired service consistently meeting their
needs and expectations
2. Fertility center’s requirements
both internally and externally, and at an
optimum cost with the efficient use of the
available resources (materials, human,
technology and information)
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15. Key points (1)
The benefits are…
1. Enables fertility center to provide
consistency in terms of methods,
materials, equipment, etc.
Safety and effectiveness
2. Ensures that services conform with
customers' needs and requirements
Customer-centeredness
3. Allows an increase in efficiency
Profitability
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16. QMS benefits can only be achieved
if evidence is provided
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17. How to get information
Internal and External Audits
Registration of quality actions
Non-conformities, preventive
actions, improvement actions,
complaints
Satisfaction surveys/questionnaires
Data collection
Key performance indicators
Main
Tools
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18. How to measure & analyze
Pareto diagram
Diagram of cause and effect
Control chart
Histogram
Flowchart
Quality
Tools
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PDCA
Balanced score card (BSC)
Six sigma
Quality
Methods
19. 0
5
10
15
20
25
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Frequency
Andrology Lab - Patients' complaints
Pareto Diagram
Prioritize problems to be solved
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20. Diagram of cause and effect
Prioritize factors that may cause undesired effect
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21. Control chart
Monitor the stability or instability of a process
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24. Flow chart
Visualize a process and identify improvement
opportunities
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25. PDCA
Method to monitor, correct and improve a
process
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26. Category Metric Target Status
Customer
satisfaction
Repeat customer % IVF drop-out <50% 50%
Service % IVF cycles
w/complaints
<5% 2%
Financial
No. IVF cycles % Annual growth >5% 8%
No. tests Andrology lab % Annual growth +/- 10% 8%
Payment rate
sperm/embryo bank
% clients in debt
<35% 40%
Employee
satisfaction
Turnover 2-yr. period <5% 9%
Absenteeism Days year/employee 4 2
Quality
ISO recertification approval
Non-conformities No. year 5 5
Balanced Score Card
Provide a hierarchized view of the organization’s
performance management system
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27. Multiple Perspectives of BSC
How do we look to shareholders?
(Financial)
How do customers see us?
(Customer)
What must we excel at?
(Internal)
Can we continue to improve and create
value?
(Innovation and learning)
Kaplan and Norton
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28. 6 Sigma
Provides a general map that helps to reduce
variability
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29. Key points (2)
Measurement is carried out by…
Getting information
Audits, registration of quality actions, data
collection of (key performance indicators)
Applying quality tools
Pareto diagram, diagram of cause/effect,
histogram, flow chart
Integrating quality tools with quality
methods
PDCA, BSC & 6 Sigma
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30. 1996 – Androfert Foundation
2000 – IVF Program started
2006 – Started QMS implementation
2010 – ISO Certification
2013 – Recertification
ISO 9001:2008
What we achieved…
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31. Organizational Framework of Androfert
Quality and
Administrative
Manager
Clinical Director
Urology
/Andrology
Microsurgery
Gynecology
Endoscopy
Nursing
Complementary
health services
Psychologist
Nutritionist
Acupuncture
Anesthesia Ultrasound
Quality &
Administrative
Manager
General
services
Biomedicine
engineer
Maintenance
IT dept.
Data entry
Website &
Intranet
Administrative
assistant
Secretaries
Legal dept.
Lab Director
Lab Supervisor
Andrology Lab
technicians
Cryopreservation
Lab technicians
IVF Lab
Scientific
Director
Research Training
Associated
services
Endocrine
Laboratory
Genetics Laundry Sterilization Hospital Pathology Immunology Radiology
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32. Main reasons we
implemented QMS
Core reasons
Concerns about quality of services
Regulatory directives
Beyond the core
Image and reputation
Customer satisfaction
Market share (customer retention/acquisition)
Profitability
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33. Core Reasons Achieved
• Quality of services
– Certified and recertified with
“zero” non-conformities
• Compliance with regulatory
authorities
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35. Image and Reputation
Elected Top-quality ART
Center
– Germinative cell and
tissue bank; ANVISA-
Brazil
– Training center for
ANVISA inspectors
(QMS)
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36. 0
5
10
15
20
25
Total number of doctors using Androfert
services after QMS
Market share
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37. 0
2
4
6
8
10
12
14
16
18
20
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Percent
growth
per
year
Year
IVF Program
Profitability
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38. And more…
Set direction & met customers’
expectations
Improved process control & reduced
wastage
Created a proper documentation system
Facilitated training
Involved staff & raised morale
Improved communication & feed-back
with all team members
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39. Key points (3)
What we achieved was …
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o A very well-organized workflow
o Excellence in service provided
o Focus on patient needs and
satisfaction
o Continuous improvement
o Increased operational efficiency
and profitability
Editor's Notes
1. The requirements and expectations of clients are taken into consideration in making decisions and procedures.
2. The quality policies & quality objectives are clearly defined and understood inside the organization.
3. Processes & responsibilities to realize objectives are executed and managed;
4. Resources and infrastructure to fulfill objectives are offered.
5. Ways to measure processes, in addition to services, are defined and implemented.
6. Apply measurements results for improvement (measurement without action is usually a waste and resources).
7. Preventing non-conformities and eliminating reasons for non-conformities are systematic and managed to be a process.
8. Framework for verification of processes and services is clearly defined and understood in the business.
9. Management involvement within the system and thorough management reviews in the system. (This needs to be working meetings and not simply "dog and pony" shows
A QMS enables an organization to achieve the goals and objectives set out in its policy and strategy. It provides consistency and satisfaction in terms of methods, materials, equipment, etc, and interacts with all activities of the organization, beginning with the identification of customer requirements and ending with their satisfaction, at every transaction interface.
Doctors often assume that the patient has to adapt to treatment and not the opposite
TQM is important to infertility care, as new ARTs are frequently introduced without prior safety and effectiveness studies in vulnerable patients burdened emotionally, socially and also physically
TQM is a solution to take into account patients’ perspectives
That both holds the gains achieved through the quality “journey” and prevents good practices from slipping.
Quality indicators are measurable. They are used to quantify and evaluate the organization’s success. They also measure how much progress you’ve made relative to the objectives you wish to achieve.
They are critical to make improvements and support decision making.
Quality indicators are measurable. They are used to quantify and evaluate the organization’s success. They also measure how much progress you’ve made relative to the objectives you wish to achieve.
They are critical to make improvements and support decision making.
Select the problem to be compared
Decide what measurement is appropriate (eg. Frequency, quantitiy, etc)
Select the time period for analysis
Describe the problem clearly
Brainstorm and record data on those involved
Draw diagram with given problem on the right side
Indicate the categories of causes
Group the brainstorm result by category
Elect the most important causes
Define mean values generated by the process
Define the maximum variation the process reaches
Obtain the maximum values allowed by the specification
Prepare chart and record the values obtained in a given period of time
Register the values found in a given process
Accumulate the data
Assemble all information about the process to be studied
Draw the current flowchart
Study the critical points and draw flowchart with the steps that need to be followed
Compare and analyze the differences between what is intended and what is being done
Green: stable process and on target
Yellow: stable but not on target
Red: not stable and not on target
It allows the organisation to benchmark itself against similar organisations.
Accreditation provides evidence to external parties that the organisation has reached the standard required to carry out prescribed functions