The document discusses the economic benefits of transitioning the National Environmental Laboratory Accreditation Program (NELAP) from a system operated by state regulatory agencies to a third-party accreditation model. Budget constraints have negatively impacted states' ability to effectively manage NELAP, reducing assessment frequency and consistency. The proposed third-party system would relieve states of the cost burden while improving program administration, stability, and assessment quality through independent accredited bodies. Laboratories would pay accreditation fees directly to third parties, freeing up state resources for licensing and enforcement. Experts believe this coordinated approach could virtually eliminate costs to states while strengthening the program.
Derivation of Aquatic Life Screening Values | Harmonization of Office of Wate...Loren Larson, CHMM, CPEA
Presentation Slides: This is a technical presentation discussing the harmonization of water quality standards/screening procedures used by the EPA Office of Water for establishing water quality criteria under the Clean Water Action and the EPA Office of Pesticide Programs for evaluation of the potential impacted of pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
2016 LabHIT LRI EHR Test Methods for CLIA ComplianceMegan Sawchuk
1) The document summarizes work to develop test methods for the Laboratory Results Interface certification criteria to ensure electronic health records comply with all Clinical Laboratory Improvement Amendments (CLIA) regulations for laboratory test reports.
2) Existing use cases were evaluated and enhanced to include all required CLIA elements, and new use cases were developed to test corrected laboratory reports.
3) The resulting test methods within the National Institute of Standards and Technology's HL7 validation tool allow EHR vendors to determine if their systems are compliant with CLIA regulations for electronic laboratory test reports.
Supply Chain Pilot Results | Zambia | May 2010ColaLife
A pilot project tested two interventions to improve access to essential medicines in Zambia. System B, where health centers placed direct orders to the Medical Stores Limited (MSL), performed significantly better than System A or comparison districts. Stockout rates were dramatically reduced in System B districts. If scaled nationwide, System B could avert over 27,000 child deaths from malaria annually and reduce child mortality from malaria by up to 37%. The Ministry of Health expressed support for nationwide scale-up of System B to improve availability of lifesaving drugs.
Water Hygiene Survey and Risk Assessment Report for Al Khawarizme Kindergaren...JuliusNeil1
This report refers to the Water Hygiene Survey and Risk Assessment Inspection performed at Al
Khawarizmi Kindergarten school for Girls. The inspection and assessment was commissioned by Process Dynamics Laboratories (PDL) on 10th – 15th February 2020 on behalf of The Maintainers. The report is authored by Julius Neil Buenconsejo, seasoned water professional with 20 years of industry experience. He has worked in across the globe including Japan and Singapore.
This document provides a summary of the qualifications and experience of Manoj Tyagi, Ph.D. He has over 15 years of experience in quality management, regulatory compliance, and laboratory accreditation. Currently he serves as the Chief Scientific Officer and Laboratory Director of Captiva Lab LLC, where he oversees CLIA and accreditation compliance. He has extensive expertise in clinical chemistry, toxicology, and workplace drug testing.
The purpose of this document is to provide a brief summary of the content of the ANPRM in order to present a snapshot of issues that may be under consideration for a revised final rule. An analysis of the information contained in the ANPRM is not included.
http://blog.willbros.com/category/pipeline-integrity/
Despite improvements in drug approval times overall, some therapeutic areas still lag behind others. Oncology, rare diseases, and infectious conditions have received the majority of Breakthrough Therapy designations and seen the fastest approval times, averaging 12 months. While review times have decreased overall since 2009, gastrointestinal, musculoskeletal, endocrine, and central nervous system drugs average longer times of 12-21 months. As the next user fee agreement approaches, there is an opportunity to identify ways to promote more consistent review times across all therapeutic areas.
Derivation of Aquatic Life Screening Values | Harmonization of Office of Wate...Loren Larson, CHMM, CPEA
Presentation Slides: This is a technical presentation discussing the harmonization of water quality standards/screening procedures used by the EPA Office of Water for establishing water quality criteria under the Clean Water Action and the EPA Office of Pesticide Programs for evaluation of the potential impacted of pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
2016 LabHIT LRI EHR Test Methods for CLIA ComplianceMegan Sawchuk
1) The document summarizes work to develop test methods for the Laboratory Results Interface certification criteria to ensure electronic health records comply with all Clinical Laboratory Improvement Amendments (CLIA) regulations for laboratory test reports.
2) Existing use cases were evaluated and enhanced to include all required CLIA elements, and new use cases were developed to test corrected laboratory reports.
3) The resulting test methods within the National Institute of Standards and Technology's HL7 validation tool allow EHR vendors to determine if their systems are compliant with CLIA regulations for electronic laboratory test reports.
Supply Chain Pilot Results | Zambia | May 2010ColaLife
A pilot project tested two interventions to improve access to essential medicines in Zambia. System B, where health centers placed direct orders to the Medical Stores Limited (MSL), performed significantly better than System A or comparison districts. Stockout rates were dramatically reduced in System B districts. If scaled nationwide, System B could avert over 27,000 child deaths from malaria annually and reduce child mortality from malaria by up to 37%. The Ministry of Health expressed support for nationwide scale-up of System B to improve availability of lifesaving drugs.
Water Hygiene Survey and Risk Assessment Report for Al Khawarizme Kindergaren...JuliusNeil1
This report refers to the Water Hygiene Survey and Risk Assessment Inspection performed at Al
Khawarizmi Kindergarten school for Girls. The inspection and assessment was commissioned by Process Dynamics Laboratories (PDL) on 10th – 15th February 2020 on behalf of The Maintainers. The report is authored by Julius Neil Buenconsejo, seasoned water professional with 20 years of industry experience. He has worked in across the globe including Japan and Singapore.
This document provides a summary of the qualifications and experience of Manoj Tyagi, Ph.D. He has over 15 years of experience in quality management, regulatory compliance, and laboratory accreditation. Currently he serves as the Chief Scientific Officer and Laboratory Director of Captiva Lab LLC, where he oversees CLIA and accreditation compliance. He has extensive expertise in clinical chemistry, toxicology, and workplace drug testing.
The purpose of this document is to provide a brief summary of the content of the ANPRM in order to present a snapshot of issues that may be under consideration for a revised final rule. An analysis of the information contained in the ANPRM is not included.
http://blog.willbros.com/category/pipeline-integrity/
Despite improvements in drug approval times overall, some therapeutic areas still lag behind others. Oncology, rare diseases, and infectious conditions have received the majority of Breakthrough Therapy designations and seen the fastest approval times, averaging 12 months. While review times have decreased overall since 2009, gastrointestinal, musculoskeletal, endocrine, and central nervous system drugs average longer times of 12-21 months. As the next user fee agreement approaches, there is an opportunity to identify ways to promote more consistent review times across all therapeutic areas.
The document discusses various classroom distractions and potential IT mechanisms to address them. It describes background noise, use of phones/internet, going off topic in class discussions, not proofreading work thoroughly, speaking in a different language, and writing too much or too little in assignments. The proposed IT mechanisms include using noise cancelling headphones, warnings or confiscating phones, blocking internet access, reminding students to focus, asking students to stay on topic, encouraging thorough proofreading, translating or writing in English, and providing guidelines on assignment length.
This document provides feedback and guidance for a student who completed a quiz on workplace skills. It discusses the student's correct and incorrect answers, and provides justifications and importance for each answer. For the correct answers, it praises the student's performance and explains why their choice was right and important. For the incorrect answers, it politely points out the mistake and offers an explanation of the better answer along with its significance. The overall document serves to both evaluate the student's knowledge and reinforce key concepts to help improve their workplace skills.
David Murrin - Breaking the Code of HistoryChristelH
The document separates history into the past, present, and future sections, with the past and present sections each listing "Book of" multiple times and the future section listing a single "Book of the Future." It concludes by stating that all events will repeat unless humanity consciously changes patterns of empire.
Este documento discute a classe String em Java e seus métodos imutáveis. Ele explica que String representa dados alfanuméricos, e métodos como length(), trim(), replace(), split() e charAt(), dando exemplos de como cada um funciona.
This document provides coding standards for writing robust Java code. It discusses the importance of coding standards for consistency and maintainability. The key points covered include naming conventions, documentation standards, member function standards, and other best practices. The goal is to define a set of standards that lead to code that is easy to understand, maintain, and enhance. Feedback is welcomed to help improve the standards.
This document provides a summary of 9 multiple choice questions about effective communication. For each question, the document provides the correct answer choice and a brief explanation. The overall content covers best practices for formal letters, job interviews, public speaking, listening, note taking, proofreading, and responding during interviews. The key lessons are that emoticons should be avoided in formal letters, maintaining eye contact and asking open questions makes a good impression in interviews, and it's important to listen actively, take relevant notes, check work for errors, and allow the interviewer to finish speaking before answering.
This document discusses predictions for the coming decades based on patterns observed in historical empires. It claims that the Western world is declining as the Asian empire, led by China, rises in economic and military power. Shortages of resources will exacerbate competition and risk of global war. It recommends that Western nations rebuild strong economies, deter Chinese aggression, and elect visionary leaders to change current destructive trajectories. Individuals are urged to educate themselves on these issues and demand better leadership to consciously shape a more positive future course.
The document discusses various distractions that can occur in a classroom setting such as background noise, mobile phone use, going off topic, and talking too much. It then provides potential IT mechanisms to address each distraction, such as using noise cancelling headphones, confiscating phones, reminding students to focus, and asking students to slow down or limit what they are talking about if it is not related to the class topic. The final paragraphs discuss potential issues for students with hearing difficulties and writing or speaking too much, and recommends supplying hearing aids, limiting writing to the required amount, and slowing down speech.
Twitter es una red social rápida basada en mensajes de hasta 140 caracteres llamados tweets. Los usuarios pueden seguir cuentas para ver los tweets publicados y pueden retweetear los tweets de otros para compartirlos con sus propios seguidores. Twitter ofrece ventajas como ampliar el alcance de los mensajes y vincular cuentas con Facebook, pero también tiene desventajas como limitar los mensajes a 140 caracteres y la presencia de spam.
David murrin breaking the code of history - summary presentationChristelH
The document separates history into the past, present, and future sections, with the past and present sections each listing "Book of" multiple times and the future section listing a single "Book of the Future". It concludes by stating that all events will repeat unless humanity consciously changes patterns of empire.
Vee Speers is an Australian artist living in Paris known for her photography portraits. The document discusses two of her portfolios - her "Birthday Party" portraits of children depicting fantasy and childhood escapism, and her "Immortal" nude portraits of youth against natural or post-apocalyptic backgrounds exploring humanity's obsession with defying mortality. Both portfolios confront viewers with themes of vulnerability, isolation, and society's ideals around beauty, aging, and the ephemeral nature of time.
The document discusses growth strategies for businesses using Ansoff's Product Market Expansion Grid. It defines growth strategy and describes the four types: market penetration, market development, product development, and diversification. Case studies of the strategies used by McDonald's and Amul are provided, with details on their product lines, target markets, and how they have employed the different strategies through expanding their offerings or entering new markets. Advantages and disadvantages of using the product market expansion grid for growth planning are also summarized.
This document outlines the clinical audit policy and strategy for Response Med. It discusses statutory requirements that mandate regular clinical audits to assess quality and ensure patient safety. The purposes are to define a framework for clinical audits and clarify roles and responsibilities. The outcomes aim to provide evidence of a robust audit program, improvements based on audit findings, and adherence to best practices. The procedures describe developing an annual audit plan, conducting audits, and monitoring completion of the plan.
Running Head ACCREDITION PROGRAMS1ACCREDITION PROGRAMS2.docxSUBHI7
This document discusses various accreditation programs that can be used by healthcare organizations to improve quality. It analyzes the National Committee for Quality Assurance (NCQA), Accreditation Association for Ambulatory HealthCare (AAAHC), and Underwriter's Laboratories Inc. (UL) programs. NCQA focuses on access, quality of care, and health outcomes. AAAHC aims to improve education, certification, and management systems. UL provides product testing to ensure safety. Based on serving a large population in an urban area, the document ranks NCQA as most important for improving quality and access, followed by AAAHC for standards and education, and UL for product testing.
Clinical Research Org. Intensifies Compliance by Automating Audit & CAPA MetricStream Inc
This document describes a leading clinical research organization that wanted to enhance its compliance and quality management. It was manually conducting audit and corrective action processes using spreadsheets, which led to inefficiencies. It implemented the MetricStream solution to automate audit management and corrective action planning. This streamlined processes, provided better visibility and reporting, and helped ensure compliance with various regulations. The automated solution reduced cycle times and audit costs while improving precision and productivity.
This document provides a summary of the preface to the GAO Cost Estimating and Assessment Guide. It discusses three key points:
1) The guide was developed to establish a consistent cost estimating methodology across the federal government based on best practices. It aims to help generate reliable cost estimates to support budgeting and oversight.
2) Accurate cost estimating is critical given increasing budget pressures as resources become scarce. Reliable estimates are needed to ensure programs can deliver as promised and within budget.
3) The guide compiles best practices from both government and industry to develop and maintain cost estimates throughout a program's lifecycle. It serves as a tool for auditors to evaluate economy, efficiency and effectiveness of government
The document discusses various classroom distractions and potential IT mechanisms to address them. It describes background noise, use of phones/internet, going off topic in class discussions, not proofreading work thoroughly, speaking in a different language, and writing too much or too little in assignments. The proposed IT mechanisms include using noise cancelling headphones, warnings or confiscating phones, blocking internet access, reminding students to focus, asking students to stay on topic, encouraging thorough proofreading, translating or writing in English, and providing guidelines on assignment length.
This document provides feedback and guidance for a student who completed a quiz on workplace skills. It discusses the student's correct and incorrect answers, and provides justifications and importance for each answer. For the correct answers, it praises the student's performance and explains why their choice was right and important. For the incorrect answers, it politely points out the mistake and offers an explanation of the better answer along with its significance. The overall document serves to both evaluate the student's knowledge and reinforce key concepts to help improve their workplace skills.
David Murrin - Breaking the Code of HistoryChristelH
The document separates history into the past, present, and future sections, with the past and present sections each listing "Book of" multiple times and the future section listing a single "Book of the Future." It concludes by stating that all events will repeat unless humanity consciously changes patterns of empire.
Este documento discute a classe String em Java e seus métodos imutáveis. Ele explica que String representa dados alfanuméricos, e métodos como length(), trim(), replace(), split() e charAt(), dando exemplos de como cada um funciona.
This document provides coding standards for writing robust Java code. It discusses the importance of coding standards for consistency and maintainability. The key points covered include naming conventions, documentation standards, member function standards, and other best practices. The goal is to define a set of standards that lead to code that is easy to understand, maintain, and enhance. Feedback is welcomed to help improve the standards.
This document provides a summary of 9 multiple choice questions about effective communication. For each question, the document provides the correct answer choice and a brief explanation. The overall content covers best practices for formal letters, job interviews, public speaking, listening, note taking, proofreading, and responding during interviews. The key lessons are that emoticons should be avoided in formal letters, maintaining eye contact and asking open questions makes a good impression in interviews, and it's important to listen actively, take relevant notes, check work for errors, and allow the interviewer to finish speaking before answering.
This document discusses predictions for the coming decades based on patterns observed in historical empires. It claims that the Western world is declining as the Asian empire, led by China, rises in economic and military power. Shortages of resources will exacerbate competition and risk of global war. It recommends that Western nations rebuild strong economies, deter Chinese aggression, and elect visionary leaders to change current destructive trajectories. Individuals are urged to educate themselves on these issues and demand better leadership to consciously shape a more positive future course.
The document discusses various distractions that can occur in a classroom setting such as background noise, mobile phone use, going off topic, and talking too much. It then provides potential IT mechanisms to address each distraction, such as using noise cancelling headphones, confiscating phones, reminding students to focus, and asking students to slow down or limit what they are talking about if it is not related to the class topic. The final paragraphs discuss potential issues for students with hearing difficulties and writing or speaking too much, and recommends supplying hearing aids, limiting writing to the required amount, and slowing down speech.
Twitter es una red social rápida basada en mensajes de hasta 140 caracteres llamados tweets. Los usuarios pueden seguir cuentas para ver los tweets publicados y pueden retweetear los tweets de otros para compartirlos con sus propios seguidores. Twitter ofrece ventajas como ampliar el alcance de los mensajes y vincular cuentas con Facebook, pero también tiene desventajas como limitar los mensajes a 140 caracteres y la presencia de spam.
David murrin breaking the code of history - summary presentationChristelH
The document separates history into the past, present, and future sections, with the past and present sections each listing "Book of" multiple times and the future section listing a single "Book of the Future". It concludes by stating that all events will repeat unless humanity consciously changes patterns of empire.
Vee Speers is an Australian artist living in Paris known for her photography portraits. The document discusses two of her portfolios - her "Birthday Party" portraits of children depicting fantasy and childhood escapism, and her "Immortal" nude portraits of youth against natural or post-apocalyptic backgrounds exploring humanity's obsession with defying mortality. Both portfolios confront viewers with themes of vulnerability, isolation, and society's ideals around beauty, aging, and the ephemeral nature of time.
The document discusses growth strategies for businesses using Ansoff's Product Market Expansion Grid. It defines growth strategy and describes the four types: market penetration, market development, product development, and diversification. Case studies of the strategies used by McDonald's and Amul are provided, with details on their product lines, target markets, and how they have employed the different strategies through expanding their offerings or entering new markets. Advantages and disadvantages of using the product market expansion grid for growth planning are also summarized.
This document outlines the clinical audit policy and strategy for Response Med. It discusses statutory requirements that mandate regular clinical audits to assess quality and ensure patient safety. The purposes are to define a framework for clinical audits and clarify roles and responsibilities. The outcomes aim to provide evidence of a robust audit program, improvements based on audit findings, and adherence to best practices. The procedures describe developing an annual audit plan, conducting audits, and monitoring completion of the plan.
Running Head ACCREDITION PROGRAMS1ACCREDITION PROGRAMS2.docxSUBHI7
This document discusses various accreditation programs that can be used by healthcare organizations to improve quality. It analyzes the National Committee for Quality Assurance (NCQA), Accreditation Association for Ambulatory HealthCare (AAAHC), and Underwriter's Laboratories Inc. (UL) programs. NCQA focuses on access, quality of care, and health outcomes. AAAHC aims to improve education, certification, and management systems. UL provides product testing to ensure safety. Based on serving a large population in an urban area, the document ranks NCQA as most important for improving quality and access, followed by AAAHC for standards and education, and UL for product testing.
Clinical Research Org. Intensifies Compliance by Automating Audit & CAPA MetricStream Inc
This document describes a leading clinical research organization that wanted to enhance its compliance and quality management. It was manually conducting audit and corrective action processes using spreadsheets, which led to inefficiencies. It implemented the MetricStream solution to automate audit management and corrective action planning. This streamlined processes, provided better visibility and reporting, and helped ensure compliance with various regulations. The automated solution reduced cycle times and audit costs while improving precision and productivity.
This document provides a summary of the preface to the GAO Cost Estimating and Assessment Guide. It discusses three key points:
1) The guide was developed to establish a consistent cost estimating methodology across the federal government based on best practices. It aims to help generate reliable cost estimates to support budgeting and oversight.
2) Accurate cost estimating is critical given increasing budget pressures as resources become scarce. Reliable estimates are needed to ensure programs can deliver as promised and within budget.
3) The guide compiles best practices from both government and industry to develop and maintain cost estimates throughout a program's lifecycle. It serves as a tool for auditors to evaluate economy, efficiency and effectiveness of government
The document describes a year-long pilot program that will select 10 organizations to improve standards of care for people with schizophrenia. Participating organizations will receive tools and expertise to assess treatment outcomes, implement standardized assessments, and identify barriers. They must commit staff time and resources to project goals. In exchange, they receive technical assistance, data management support, and a $3,000 stipend. The goal is to enhance interventions and compare outcomes across diverse clinical settings.
The document describes a pilot program that will provide tools and assistance to 10 community behavioral health organizations to: assess if their treatment regimens are maximizing outcomes, implement a standardized patient assessment, and identify barriers to improving standards of care. Selected organizations will receive year-long technical assistance from experts, use of a web portal for data management, and participation in a learning event. The goal is to help organizations enhance care for people with schizophrenia.
Why is it important to assist your client in the audit process and how can it impact you?
Assisting clients with the audit firm selection process can be an opportunity to add value to your client relationship
Vetting plan audit firms and correspondence may lead to valuable referral relationships
Save clients from the possible risk of fines and penalties
Possible co-fiduciary responsibility in selecting other plan service providers
How to develop a proactive approach for assisting clients with the audit process
APHL Position Statement On nongovernmental Accreditating Bodies for Environme...FSEABOARD
The document discusses the APHL's position that environmental laboratory accreditation should remain a government function and not be privatized. It provides background on why accurate testing is important for environmental laboratories. While third parties can play a role, complete privatization would limit enforcement, consistency, and state authority. Shifting accreditation to the private sector could impact state expertise, laboratory capacity, and a state's ability to maintain regulatory primacy.
Quality Assurance and Improvement Standards for OVC Services in EthiopiaMEASURE Evaluation
The document discusses establishing quality assurance and improvement standards for orphan and vulnerable children services in Ethiopia. It describes the process of developing draft standards through workshops with stakeholders. The draft standards focused on dimensions of quality and minimum activities for areas like food/nutrition, shelter/care, health, education etc. The draft was piloted by NGO programs and reviewed by technical specialists. Revisions were made to make the standards more relevant and feasible. The expected outcomes are creating an enabling environment for vulnerable children, delivering integrated services of good quality, and enhancing capacity for service delivery.
The document summarizes the key findings from a benefits realization study conducted by PwC on the use of electronic medical records (EMRs) in primary care settings in Ontario. Through case studies of six high performing clinics, the study found benefits such as 50% faster lab result turnaround times, nearly immediate access to discharge summaries, and referrals sent to specialists in under 1 day. Provider surveys showed strong agreement that EMRs improve areas like chronic disease management, preventative care, and practice efficiencies. The study modeled potential province-wide benefits if all Ontario providers achieved results similar to the case studies, estimating annual financial benefits of $125 million from improved diabetes management alone.
Depository Trust & Clearing Corporation Shared Assessments Case StudyKen Peterson
DTCC implemented the Shared Assessments Program to streamline its vendor management program and reduce costs. It divided vendors into tiers based on risk and implemented security assessments using Shared Assessments tools. This reduced the time and costs of assessments from $300,000 to $1,400 while improving risk management. DTCC provided vendor training and is enhancing workflow software to make SIG completion more efficient for both DTCC and vendors.
Self-Study Guide for the Evaluation of a Pediatric Dentistry suzi smith
The Self-Study Guide is designed to help an institution succinctly present information about its advanced specialty education program in preparation for an evaluation visit by the Commission on Dental Accreditation. It is suggested that the institution initiate the self-study process approximately 12 months prior to completion of the Self-Study Report. The primary focus of the self-study process should be to assess the effectiveness of the educational program in meeting (1) the program’s stated goals and objectives and (2) the Commission’s Accreditation Standards for Advanced Specialty Education Programs in Pediatric Dentistry.
The Self-Study Report should be a concise, yet thorough, summary of the findings of the self-study process. The Commission hopes that the self-study will be a catalyst for program improvement that continues long after the accreditation process has been completed. In its opinion, this is a more likely outcome if there is thorough planning, as well as involvement of students/residents and administrators in the self-study process. Most programs will concentrate upon questions germane to the Commission’s Accreditation Standards. Nevertheless, the benefits of self-study are directly related to the extent to which programs evaluate their efforts, not simply in light of minimal standards for accreditation, but also in reference to the program’s stated goals and objectives as well as standards for educational excellence. Conclusions of the self-study may include qualitative evaluation of any aspect of the program whether it is covered in the Self-Study Guide or not. Programs must respond to all questions included in the Self-Study Guide. The responses should be succinct, but must in every case provide or cite evidence demonstrating achievement of objectives in compliance with each of the Accreditation Standards.
Strengthening M&E System Among Partners Implementing HIV/AIDS Projects in Tan...MEASURE Evaluation
Tanzania's health system faces challenges with monitoring and evaluation (M&E) systems, including insufficient capacity and limited data use. MEASURE Evaluation was funded to strengthen M&E among organizations providing HIV services in Tanzania. Since 2008, they have conducted data quality assessments (DQAs) and provided training to 28 partner organizations. The DQAs identify gaps which MEASURE Evaluation uses to develop customized capacity building plans with an emphasis on mentoring. Mini-DQAs to track changes have found that 10 of 23 partners assessed multiple times now conduct internal DQAs and 9 of 23 partners exceed the recommended 7% budget allocation for M&E.
CMS Core Measures Compliance: Best Practices for Data Collection, Analysis and Reporting
For many hospitals, the primary challenge with the core measure program is not achieving quality standards, but complying with the complex, time-consuming reporting process and staying current with constantly changing regulations.
The document discusses audit and inspection in the context of local authorities in England. It summarizes the key findings of a 2019 parliamentary report on the topic. The report found that the 2014 Local Audit and Accountability Act fragmented accountability and that the new audit regime is not as effective as the previous Audit Commission in ensuring value for money and fairness. It also discusses limitations of audits and inspections in improving outcomes and ensuring food safety. The document covers the purpose and goals of public audits, inspector independence, the impact of changing regulations, and ways auditing could be improved.
This document discusses best practices for assessing and improving the maturity of a compliance and ethics program. It outlines a framework using five key elements adapted from guidelines like the US Federal Sentencing Guidelines. These elements are risk identification, policies and procedures, training and communication, monitoring and auditing, and evaluation and improvement. The document advises using a maturity curve approach to evaluate where a program's elements fall along a spectrum from basic to best practices. Understanding the current status helps organizations prioritize steps to advance their program.
Control Self-Assessment (CSA) is a technique originally developed in 1987 to allow managers and employees to evaluate their company's risk management and internal controls. CSA involves process owners testing the effectiveness of key controls throughout the year. Benefits of a CSA program include clear accountability for controls, reduced risk of fraud, and lower regulatory costs. Implementing an effective CSA program helps ensure internal controls are operating as intended and provides assurance to stakeholders.
Medical Laboratory Accreditation and its utilization in Japan - Katsuo KubonoMara International
The 3rd GCC Laboratory Proficiency Conference is organized as part of the strategic orientations of the GCC Standardization
Organization (GSO) for the development of the standardization and quality infrastructure, thereby contributing to the development of commerce and industry and to the support of national economy in the GCC member states.
Since the field of proficiency testing is newly introduced in the GCC member states and as the infrastructure of laboratories has not yet taken the shape of national or regional organizations representing the laboratories and reflecting their requirements, GSO is in need of meeting with a considerable group of laboratories to explore and prioritize GCC member states’ requirements in terms of the fields which must top the list of the fields to be developed and upgraded.
Based on the study conducted by GSO during 2011 on the status of proficiency testing activities in the member states which shown that the laboratories operating in the member states are in need of a unified data center on proficiency testing activities, GSO
organized two conferences in 2013 and 2014 on the subject. The conferences scored high rates of success in terms of the selected scientific material, quality of speakers and the targeted audience.
Accordingly, GSO conceptualization of the method of coordinating and upgrading the activity of proficiency tests in the GCC member states included a recommendation on the organization of annual training courses and awareness symposia by the GSO on the fields of proficiency tests.
This year’s Conference will be held in Dubai during two days the 24th and 25th of March 2015, and will coincide with the annual Analytical Industry exhibition ARABLAB which will be held in Dubai during the period 23 – 26 March 2015.
Similar to ACIL White Paper On Third Party Accreditation (20)
Medical Laboratory Accreditation and its utilization in Japan - Katsuo Kubono
ACIL White Paper On Third Party Accreditation
1. American Council of Independent Laboratories (ACIL) White Paper
Economic Benefits of National Environmental Laboratory Accreditation
Using an Alternative Accreditation Process
Executive Summary. The environmental laboratory accreditation process has been traditionally operated
and maintained by State regulatory agencies for all commercial laboratories that produce data for regulatory
purposes. Until 2000, interstate coordination of accreditation programs did not exist, with each State
requiring a diverse range of accreditation requirements for laboratories regardless of their demonstrated
competency in other States. Each State performed individual assessments, evaluated proficiency test sample
data and charged application fees to offset the cost of the program at great expense to the laboratory
community.
At the conclusion of a long development process, several States launched a voluntary National accreditation
program with the assistance of the United States Environmental Protection Agency. This program contains
uniform accreditation standards that are administered by participating States, which, by design, eliminate
divergent State to State requirements, multiple laboratory assessments and proficiency test sample analysis
while establishing rules for interstate accreditation recognition. These changes have resulted in substantial
savings to both the laboratory community and the State agencies. They also established a uniform quality
standard for environmental laboratories that is based on international requirements for laboratory
accreditation. The development of the accreditation standards was eventually migrated to a private sector
consensus standards development organization. Fifteen states actively accredit laboratories using this
program. However, the program is recognized by the majority of states and over 2000 environmental
laboratories are accredited.
Since 2000, the program has matured and is now being managed by an independent 501(c) 3 organization that
has migrated the program to a consensus ISO/IEC standard with the participation of the State environmental
regulatory agencies meeting the requirements for consensus bodies of OMB Circular 119. This process has
had an extremely positive effect on the ability of laboratories to produce environmental data of known and
documented quality while improving the overall usability of the data and has made substantial progress in the
development and establishment of a uniform National Environmental Laboratory Accreditation Program.
The current economic situation is severely impacting State budgets, affecting the viability of the National
accreditation program and other State accreditation programs. Budget constraints have reduced or eliminated
the ability of State agencies to accredit out of State laboratories and meet their obligations for assessing
accredited laboratories on a prescribed schedule, resulting in dramatically increased periods between required
laboratory assessments, which are inconsistent with State and National accreditation programs. Each of these
factors has contributed to a reduction in the effectiveness of the National program with a resulting negative
impact on the ability to verify that laboratories are producing environmental data of known and documented
quality to assure protection of human health and the environment.
The ACIL is proposing a solution using a coordinated State level approach to migrate the accreditation
program to a third party process. This migration would virtually eliminate the accreditation program costs
from State budgets while substantially improving the administration and operation of the program. The
aggregate, nationwide costs for accreditation programs are estimated to be approximately $95MM annually
including overhead. Additional economic benefits to the States will be realized though laboratory licensing
fees authorizing laboratories to operate within an individual State. Further benefit will be achieved by
stimulating the need for professional trained assessors to perform timely assessments of laboratories in the
program. The Department of Defense has employed a similar third party accreditation system for
environmental laboratory accreditation since 2009 which has been successful.
ACIL, Page 1 of 5
2. Introduction. State budget constraints have begun to negatively affect the ability of State environmental
regulatory programs to effectively operate and manage the uniform National Environmental Laboratory
Accreditation Program and other State accreditation programs. Budgetary issues have begun to destabilize
the program, resulting in a reversal of the progress that has been achieved over the past ten years. The
destabilization negatively affects laboratory assessments through an unacceptable decrease in assessment
frequency and an increase in the variability of the caliber of the assessments being performed, primarily
caused by a reduction or absence of adequate training, thus not meeting the requirements of the program or
individual State regulations.
ACIL firmly believes that stability can be returned to the program through the use of existing, third party
accrediting bodies. Using a third party approach would relieve the States of the economic burden of running
the program and fortifying the programs effectiveness through a return to timely consistent assessments
administered by professional assessors. It would also eliminate the majority of the concerns that the USEPA
has had with program administration by State accrediting bodies and the inability of the National program to
gain their compliance with the specifications of the program.
Accredited labs play a key role in generating environmental chemistry data for protection of human health
and the environment. Assuring a uniform, efficient, national accreditation program is in place is the
cornerstone of the protection process.
Background. The National Environmental Laboratory Accreditation Program (NELAP) was initiated over
fifteen years ago to ensure interstate commerce of laboratories that perform environmental testing. The
program was established as a voluntary program implemented at the state level. It was initially administered
by the USEPA, but operated by the States through a mutual recognition agreement. Accreditation
requirements were developed by government and private sector volunteers who collaborated on the
development of the consensus standards.
In 2006, the USEPA converted NELAP to a self sufficient program. The standards development element
was re-engineered into an American National Standards Institute (ANSI) approved consensus standards
development process, meeting the specifications of the US Government’s Office of Management and Budget
circular 119 for consensus standard development organizations. These consensus standards are now used by
States to demonstrate technical competency of laboratories.
The NELAP program relies on uniform implementation by State regulatory agencies such as a department of
health or environment protection. Program costs have traditionally been recovered through accreditation fees
assessed on participating laboratories.
Currently, fifteen States participate in the program with the remaining states relying on NELAP accreditation
for qualification in some form. This system has resulted in multiple accreditation programs that differ in their
complexity. Many state programs operate with a very small staff, qualifying laboratories using minimal
standards. Instead of a centralized program that minimizes infrastructure costs there are fifty small and
inefficient programs that negatively impact State budgets.
The State’s budgets crises have resulted in severe funding restraints on their accreditation programs. Fees
structures do not cover the costs to manage the programs. This results in an inability to run accreditation
programs to their design specifications, resulting in a failure to assure that known quality data is being used
for the protection of human health and the environment.
Solution. The accreditation of individual commercial and State laboratories can be transitioned to an existing
third party framework within a relatively short time period. Internationally Recognized professional third
party accreditation bodies have the resources needed to assimilate this program. The effort can be
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3. coordinated through an existing consensus standards development organization that would serve as the focal
organization for recognizing third party accreditation bodies. All administrative processes beyond assessment
and accreditation would be performed by the consensus standards development organization.
States would no longer be required to maintain the staff or resources needed to operate a full laboratory
accreditation program. A much smaller staff would license accredited laboratories to perform work in their
State and perform enforcement activities as needed.
Accreditation fees would be borne by the laboratory and paid directly to the accreditation body. The
accreditation body would review the laboratories qualifications, perform the assessment, verify corrective
actions from assessment deficiencies, issue accreditation certificates and perform surveillance assessments.
The consensus standards development organization would operate and coordinate all other administrative
functions.
Experts from State accreditation bodies participate extensively in the accreditation standard development and
accreditation oversight processes, which enables them to maintain involvement in the program and participate
in the consensus standards development process. Individual State program needs would be incorporated into
the accreditation process using the existing American National Standards Institute (ANSI) accredited
consensus standards development process.
Benefits
Multiple stakeholders will benefit from the implementation of a third party solution for the accreditation of
environmental laboratories. While the States will primarily benefit from an elimination of accreditation
program costs from their budgets, significant program operational efficiencies will be achieved that will
systematically improve the usability of environmental data. It also promotes a single, internationally
recognized rigorous quality management system standard for all environmental laboratories that produce data
for the protection of human health and the environment.
The primary benefit of the use of third party processes is the elimination of the program cost burden from
State Government budgets. Laboratory accreditation, the most significant expense, would be performed by
International Laboratory Accreditation Cooperation (ILAC) recognized independent, third party
Accreditation Bodies. The accreditation bodies are typically non-profit and non-governmental entities whose
main mission is laboratory accreditation and laboratory-related training. The accreditation bodies are required
to operate to ISO management system requirements, akin to the laboratories they grant accreditation, thereby
resulting in integrity, timely customer service and accountability. The accreditation administration would be
performed by an ANSI recognized consensus standard development organizations. This approach offers an
efficient accreditation solution for the inability of States to perform to the standards specifications caused by
the current economic situation.
Ancillary benefits would include the overall improvement in assessment uniformity. The assessment process
administered by the states was designed for uniformity. However, each State applies the standard differently,
resulting in an unacceptable level of inconsistent, non-uniform assessments, which the program was designed
specifically to eliminate. The assessments would now be performed by professional third party assessors who
are experts in determining if laboratories are complying with the requirements of the accreditation standard.
These assessors are technical experts in the environmental field. This approach eliminates parochial agendas,
further promoting uniformity. An independent consensus standards development organization would
coordinate the program and provide assessor oversight to coordinate standard interpretations. True
assessment coordination increases interstate confidence in the assessment process through assessment
consistency improvements.
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4. Additional ancillary benefits are as follows:
The specific analytical fields of accreditation being offered to laboratories should be standardized.
However, individual states have unique offerings that complicate the accreditation process, frequently
necessitating additional primary accreditations to address missing parameters, greatly increasing the cost
of accreditation to laboratories. The third party approach eliminates interstate restrictions on state
specific accreditation offerings, streamlining interstate recognition.
The frequency of laboratory assessments is specified in the standard. The third party solution eliminates
lengthy delays awaiting required re-assessments, assessment reports and addition to accreditation scopes
while increasing surveillance frequency, resulting in a confidence increase that laboratories are producing
data of known and documented quality.
Proficiency testing (PT), which is a significant accreditation cost to laboratories, is not administered
uniformly by the States. Individual States frequently require additional proficiency testing above the
specified program needs, which is inconsistent with the National program, resulting in increased
individual laboratory costs. Centralizing the PT administration process levels the accreditation playing
field through a uniform approach that eliminates parochial requirements that make accreditation more
costly and difficult to manage.
States would maintain control over laboratory accreditation by issuing fee-based licenses to accredited
laboratories and performing much needed enforcement for non-compliant laboratory operations. State
representatives would continue their strong contribution to the standards development process as
members of the consensus standards development organization.
The use of third parties to accredit or “qualify” laboratories would create an effective barrier to prevent
laboratories that are incapable of performing to the accreditation standard from initial or continued
participation. This eliminates the political bureaucracy encountered by State programs that encounter
difficulties attempting to disqualify or revoke the accreditation of unqualified or non-compliant
organizations and further promotes protection of human health and the environment.
The USEPA regional evaluators have identified problematic operational issues with the States
administration of the National accreditation program. The major issue identified by USEPA is the
absence of assessment uniformity. The third party process resolves the concerns that result from the
operational disparity of the program under State control.
Independent commercial accreditation bodies currently accredit laboratories involved in other types of
testing (food testing, consumer products). They also accredit to other standards required to operate other
laboratory service programs such as the American Industrial Hygiene Association (AIHA) and the
Department of Defense programs. Laboratories performing analyses broader than environmental testing
would be permitted to seek accreditation in these related disciplines. This skill set enables them to
economically combine multiple standard assessments into a single assessment relying on the same
accreditation body and assessment team. This provides additional economic advantages to the
environmental laboratory community, therefore simplifying accreditation for laboratories operating
multiple business lines.
The migration of the program will create employment opportunities in the private sector, stimulating
hiring as additional assessors are needed by commercial accrediting bodies to perform laboratory
assessments. Experienced State assessors would be assimilated by the third parties.
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5. Summary. The ACIL proposal provides a viable solution to the current economic situation that has affected
the State’s ability to effectively operate environmental laboratory accreditation programs. The overall
economic benefit of this proposal to State governments is considerable. The advantages of the third party
approach are numerous without apparent detrimental impact.
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