This document provides suggested documentation for exclusions from various measures related to meaningful use of electronic health records. For each measure, it lists the suggested documentation to provide in order to claim an exclusion. This includes summary reports from certified EHR systems with required details like numerators, denominators, and time periods. It also lists statements or documentation that can demonstrate why a particular exclusion or exception applies in some cases. The documentation suggested aims to prove that exclusions are correctly applied and that meaningful use requirements or objectives are not applicable.
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
Periodic Safety Update Reports: Some commonly asked questionsTGA Australia
This document discusses periodic safety update reports (PSURs), which are required to be submitted regularly to regulatory agencies to evaluate the benefit-risk profile of medicines on the market. It provides answers to commonly asked questions about PSUR requirements, timing of submissions, and what the regulatory agency does with the submitted reports. Key points covered include that PSURs are due annually for 3 years from approval, have a 90 day submission window after the data lock point, and are reviewed for safety changes, new signals, and significant new safety information. Contact information is provided for questions.
Update on new pv legislation plg june2012danisowich
The document provides an overview and update on new European pharmacovigilance legislation coming into effect in July 2012. It discusses timelines for implementation, introduces the new legislation and its aims, outlines Good Pharmacovigilance Practices including 16 new modules, and summarizes some of the key modules covering pharmacovigilance systems, risk management systems, adverse reaction reporting and periodic safety reports.
The document discusses the changes to the format and content of the Periodic Safety Update Report (PSUR) according to the 2012 EU pharmacovigilance legislation and guidelines. Key changes include a new emphasis on evaluating the risk-benefit balance rather than individual case reports. The PSUR format is now modular to allow information to be shared across documents like the Development Safety Update Report and Risk Management Plan. Detailed case listings are replaced by concise summaries, and multiple interim reports are no longer accepted. The submission timelines for PSURs were also amended according to the new guidelines.
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...László Árvai
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Bluefish Pharmaceuticals.
The document discusses the role of the EU Qualified Person for Pharmacovigilance (QPPV). The QPPV must be appropriately qualified, reside in the EEA, and act as a single point of contact for drug safety issues in Europe. The QPPV is responsible for establishing and maintaining the company's pharmacovigilance system, monitoring product safety, submitting regulatory documents, and ensuring compliance with European legislation on safety reporting and risk management. Both the marketing authorization holder and QPPV have overlapping obligations to support pharmacovigilance activities and ensure the safe use of medicinal products in the EU.
PV modules are documents that specify requirements for pharmacovigilance (PV) in the European Union. They cover PV systems, quality systems, inspections, audits, risk management, adverse reaction reporting and management, and periodic safety update reports. Companies with marketing authorization in the EU must comply with these modules to maintain their authorization and avoid financial penalties for noncompliance. The modules are continuously updated to improve patient safety monitoring of medical products in the EU.
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
Periodic Safety Update Reports: Some commonly asked questionsTGA Australia
This document discusses periodic safety update reports (PSURs), which are required to be submitted regularly to regulatory agencies to evaluate the benefit-risk profile of medicines on the market. It provides answers to commonly asked questions about PSUR requirements, timing of submissions, and what the regulatory agency does with the submitted reports. Key points covered include that PSURs are due annually for 3 years from approval, have a 90 day submission window after the data lock point, and are reviewed for safety changes, new signals, and significant new safety information. Contact information is provided for questions.
Update on new pv legislation plg june2012danisowich
The document provides an overview and update on new European pharmacovigilance legislation coming into effect in July 2012. It discusses timelines for implementation, introduces the new legislation and its aims, outlines Good Pharmacovigilance Practices including 16 new modules, and summarizes some of the key modules covering pharmacovigilance systems, risk management systems, adverse reaction reporting and periodic safety reports.
The document discusses the changes to the format and content of the Periodic Safety Update Report (PSUR) according to the 2012 EU pharmacovigilance legislation and guidelines. Key changes include a new emphasis on evaluating the risk-benefit balance rather than individual case reports. The PSUR format is now modular to allow information to be shared across documents like the Development Safety Update Report and Risk Management Plan. Detailed case listings are replaced by concise summaries, and multiple interim reports are no longer accepted. The submission timelines for PSURs were also amended according to the new guidelines.
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...László Árvai
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Bluefish Pharmaceuticals.
The document discusses the role of the EU Qualified Person for Pharmacovigilance (QPPV). The QPPV must be appropriately qualified, reside in the EEA, and act as a single point of contact for drug safety issues in Europe. The QPPV is responsible for establishing and maintaining the company's pharmacovigilance system, monitoring product safety, submitting regulatory documents, and ensuring compliance with European legislation on safety reporting and risk management. Both the marketing authorization holder and QPPV have overlapping obligations to support pharmacovigilance activities and ensure the safe use of medicinal products in the EU.
PV modules are documents that specify requirements for pharmacovigilance (PV) in the European Union. They cover PV systems, quality systems, inspections, audits, risk management, adverse reaction reporting and management, and periodic safety update reports. Companies with marketing authorization in the EU must comply with these modules to maintain their authorization and avoid financial penalties for noncompliance. The modules are continuously updated to improve patient safety monitoring of medical products in the EU.
IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)
Online Clinical Trial Notification (CTN)TGA Australia
1) The document provides an overview of the migration of clinical trial notifications from a paper-based system to an online system through the TGA Business Services (TBS) portal. It discusses the data migration process including re-formatting paper data and posting it to the online system.
2) It addresses frequently asked questions about clinical trials, such as when completion advice should be submitted and labeling requirements.
3) Details are given about paying clinical trial notification fees online through the TBS finance portal or by other means like credit card, and the information that needs to be included for payments. The presentation aims to explain the changes and seek comments on improving the online clinical trial notification system.
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
RMP_14th Annual Conference of Society of Pharmacovigilance and International ...Dr Vineet Shastri
This document discusses risk management plans (RMPs), which are detailed descriptions of risk management systems for pharmaceutical products that are required by the European Union. RMPs identify, characterize, minimize and prevent risks related to medicinal products. They contain modules on safety specifications, pharmacovigilance plans, post-authorization efficacy study plans, and risk minimization measures. RMPs must be submitted with new marketing authorization applications, in response to significant new safety concerns identified by health authorities, or when changes are made to the RMP as a result of data in periodic safety update reports. The goal of RMPs is to ensure patient safety by continuously monitoring pharmaceutical products for adverse drug reactions.
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...TGA Australia
The document summarizes the results of a consultation on proposed reforms to the regulation of software as a medical device in Australia. It discusses key points from international approaches to classifying and regulating software, proposed new classification rules and essential principles for software in Australia, and the results of the consultation which found general agreement with the proposals among respondents.
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
The document provides information on periodic safety update reports (PSURs), including:
- PSURs are intended to evaluate the risk-benefit balance of a drug based on new or changing information during the post-approval phase.
- The objectives of a PSUR are to examine if new safety information aligns with previous knowledge, summarize relevant new safety data that could impact risk-benefit analysis, and provide an integrated risk-benefit evaluation.
- Guidelines for PSURs are provided in the ICH E2C guideline and EU's GVP Module VII, with the format and content changing to focus more on risk-benefit analyses and summary tables rather than individual case reports.
TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides background information on Australia's Therapeutic Goods Advertising legislation and Code. It discusses key aspects of the legislation including:
- The Therapeutic Goods Act and Regulations set advertising requirements for therapeutic goods. Advertising must also comply with the Australian Consumer Law.
- The Act prohibits off-label promotion and requires pre-approval of medicine ads in certain media. It also places restrictions on advertising certain medical conditions.
- The Therapeutic Goods Advertising Code provides the framework for ensuring advertising is conducted properly and does not mislead consumers. It was recently revised to provide more clarity.
- The Code applies broadly to any advertising of therapeutic goods. It exempts genuine news reporting and ads directed to health
ISO: 14971 Quality risk management of medical devicesAtul Bhombe
This document summarizes ISO 14971, the international standard for medical device risk management. It outlines the key aspects of ISO 14971, including the purpose to help manufacturers identify hazards, estimate risks, and implement risk controls. The summary explains the main clauses of ISO 14971 and the overall risk management process of identifying hazards, estimating risks, evaluating and controlling risks, and monitoring risk controls.
Professor Peivand Pirouzi Inc. - Pharmacovigilance Inspections: Representation of Pharmacovigilance System Master File
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
This document summarizes key aspects of clinical evaluation requirements for medical devices in Europe. It discusses the stages of clinical evaluation, including scope definition, identification of pertinent clinical data, appraisal of data, and analysis of clinical data. It notes that clinical evaluation is mandatory for initial CE marking and must be updated. It outlines criteria for determining the quality, relevance and contribution of clinical data sources. Equivalence must be demonstrated when using data from equivalent devices. Clinical investigations are generally required for class III and implantable devices to demonstrate safety and performance.
TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an o...TGA Australia
The document provides an overview of Australia's Good Manufacturing Practice (GMP) Clearance Framework. It discusses the legislative basis for manufacturing requirements, the roles and activities of the Manufacturing Quality Branch, and the two pathways for obtaining a GMP Clearance - a desk-based assessment through a Mutual Recognition Agreement or Compliance Verification, or an on-site TGA inspection. It also outlines the history of GMP Clearance, recognized authorities through agreements like MRAs, and the MRA assessment pathway.
Turacoz Healthcare Solutions - Risk management plan is one of the many documents that come under regulatory writing. It is meant to be submitted to the health authorities during the process of gaining market authorization or at the time of any safety updates to the medicinal product.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
Data Integrity II - Chromatography data system (CDS) in PharmaSathish Vemula
- Introduction
- Functions of CDS
- Validation of CDS
- Regulatory requirements
- Procedures required
- Areas for ensuring CDS Data Integrity
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to CDS
- EU – Non compliance Reports
- WHO - Notice of Concern
- How to avoid observations ?
- Conclusion
Exploring information exchange opportunities between Industry and the TGATGA Australia
The TGA is undertaking a Business Improvement Program to update their systems and processes. As part of this, they are starting an Adverse Event Management project to improve how adverse event reports are collected, processed, and analyzed for medicines, vaccines, and medical devices. They outlined the current reporting systems, volumes and formats, and are seeking industry input on capabilities and needs to help design new reporting formats that meet stakeholder and international standards. Interested parties can register for the project by email.
This document provides an overview of electronic clinical quality measures (eCQMs) and the transition from manual chart abstraction to electronic reporting of quality measures. It discusses upcoming requirements for eCQM reporting to CMS programs like IQR and the vision for a unified set of electronically specified measures. The document reviews the eCQM reporting process including planning, testing, validation and submission. Challenges and opportunities of eCQM reporting are also addressed.
Meaningful Use Workgroup Recommendations Brian Ahier
The document summarizes the recommendations of the Meaningful Use Workgroup to the HIT Policy Committee regarding the objectives for Stage 2 of Meaningful Use. The Workgroup aligned the objectives with national healthcare priorities and recommended raising thresholds or expanding criteria for many Stage 1 objectives. They also proposed maintaining the current timeline but allowing a 90-day reporting period for providers to address concerns about implementation feasibility.
3.J Pharma monitoring of HVAC systems.docxSamehMostafa33
This document discusses pharmaceutical monitoring of HVAC systems. It begins by outlining the purpose of pharma monitoring systems and how they differ from automatic HVAC control systems. Specifically, pharma monitoring systems collect and store quality-relevant data that must be incorporated into batch documentation, while HVAC control systems manage technical data for stable operation. The document then discusses data management requirements for pharma monitoring systems to ensure data integrity and compliance with regulations. Finally, it provides examples of physical parameters that should be monitored, such as temperature, pressure differences, and particle counts, and how alert and action limits can be set to ensure the HVAC system is functioning properly.
IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)
Online Clinical Trial Notification (CTN)TGA Australia
1) The document provides an overview of the migration of clinical trial notifications from a paper-based system to an online system through the TGA Business Services (TBS) portal. It discusses the data migration process including re-formatting paper data and posting it to the online system.
2) It addresses frequently asked questions about clinical trials, such as when completion advice should be submitted and labeling requirements.
3) Details are given about paying clinical trial notification fees online through the TBS finance portal or by other means like credit card, and the information that needs to be included for payments. The presentation aims to explain the changes and seek comments on improving the online clinical trial notification system.
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
RMP_14th Annual Conference of Society of Pharmacovigilance and International ...Dr Vineet Shastri
This document discusses risk management plans (RMPs), which are detailed descriptions of risk management systems for pharmaceutical products that are required by the European Union. RMPs identify, characterize, minimize and prevent risks related to medicinal products. They contain modules on safety specifications, pharmacovigilance plans, post-authorization efficacy study plans, and risk minimization measures. RMPs must be submitted with new marketing authorization applications, in response to significant new safety concerns identified by health authorities, or when changes are made to the RMP as a result of data in periodic safety update reports. The goal of RMPs is to ensure patient safety by continuously monitoring pharmaceutical products for adverse drug reactions.
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...TGA Australia
The document summarizes the results of a consultation on proposed reforms to the regulation of software as a medical device in Australia. It discusses key points from international approaches to classifying and regulating software, proposed new classification rules and essential principles for software in Australia, and the results of the consultation which found general agreement with the proposals among respondents.
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
The document provides information on periodic safety update reports (PSURs), including:
- PSURs are intended to evaluate the risk-benefit balance of a drug based on new or changing information during the post-approval phase.
- The objectives of a PSUR are to examine if new safety information aligns with previous knowledge, summarize relevant new safety data that could impact risk-benefit analysis, and provide an integrated risk-benefit evaluation.
- Guidelines for PSURs are provided in the ICH E2C guideline and EU's GVP Module VII, with the format and content changing to focus more on risk-benefit analyses and summary tables rather than individual case reports.
TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides background information on Australia's Therapeutic Goods Advertising legislation and Code. It discusses key aspects of the legislation including:
- The Therapeutic Goods Act and Regulations set advertising requirements for therapeutic goods. Advertising must also comply with the Australian Consumer Law.
- The Act prohibits off-label promotion and requires pre-approval of medicine ads in certain media. It also places restrictions on advertising certain medical conditions.
- The Therapeutic Goods Advertising Code provides the framework for ensuring advertising is conducted properly and does not mislead consumers. It was recently revised to provide more clarity.
- The Code applies broadly to any advertising of therapeutic goods. It exempts genuine news reporting and ads directed to health
ISO: 14971 Quality risk management of medical devicesAtul Bhombe
This document summarizes ISO 14971, the international standard for medical device risk management. It outlines the key aspects of ISO 14971, including the purpose to help manufacturers identify hazards, estimate risks, and implement risk controls. The summary explains the main clauses of ISO 14971 and the overall risk management process of identifying hazards, estimating risks, evaluating and controlling risks, and monitoring risk controls.
Professor Peivand Pirouzi Inc. - Pharmacovigilance Inspections: Representation of Pharmacovigilance System Master File
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
This document summarizes key aspects of clinical evaluation requirements for medical devices in Europe. It discusses the stages of clinical evaluation, including scope definition, identification of pertinent clinical data, appraisal of data, and analysis of clinical data. It notes that clinical evaluation is mandatory for initial CE marking and must be updated. It outlines criteria for determining the quality, relevance and contribution of clinical data sources. Equivalence must be demonstrated when using data from equivalent devices. Clinical investigations are generally required for class III and implantable devices to demonstrate safety and performance.
TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an o...TGA Australia
The document provides an overview of Australia's Good Manufacturing Practice (GMP) Clearance Framework. It discusses the legislative basis for manufacturing requirements, the roles and activities of the Manufacturing Quality Branch, and the two pathways for obtaining a GMP Clearance - a desk-based assessment through a Mutual Recognition Agreement or Compliance Verification, or an on-site TGA inspection. It also outlines the history of GMP Clearance, recognized authorities through agreements like MRAs, and the MRA assessment pathway.
Turacoz Healthcare Solutions - Risk management plan is one of the many documents that come under regulatory writing. It is meant to be submitted to the health authorities during the process of gaining market authorization or at the time of any safety updates to the medicinal product.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
Data Integrity II - Chromatography data system (CDS) in PharmaSathish Vemula
- Introduction
- Functions of CDS
- Validation of CDS
- Regulatory requirements
- Procedures required
- Areas for ensuring CDS Data Integrity
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to CDS
- EU – Non compliance Reports
- WHO - Notice of Concern
- How to avoid observations ?
- Conclusion
Exploring information exchange opportunities between Industry and the TGATGA Australia
The TGA is undertaking a Business Improvement Program to update their systems and processes. As part of this, they are starting an Adverse Event Management project to improve how adverse event reports are collected, processed, and analyzed for medicines, vaccines, and medical devices. They outlined the current reporting systems, volumes and formats, and are seeking industry input on capabilities and needs to help design new reporting formats that meet stakeholder and international standards. Interested parties can register for the project by email.
This document provides an overview of electronic clinical quality measures (eCQMs) and the transition from manual chart abstraction to electronic reporting of quality measures. It discusses upcoming requirements for eCQM reporting to CMS programs like IQR and the vision for a unified set of electronically specified measures. The document reviews the eCQM reporting process including planning, testing, validation and submission. Challenges and opportunities of eCQM reporting are also addressed.
Meaningful Use Workgroup Recommendations Brian Ahier
The document summarizes the recommendations of the Meaningful Use Workgroup to the HIT Policy Committee regarding the objectives for Stage 2 of Meaningful Use. The Workgroup aligned the objectives with national healthcare priorities and recommended raising thresholds or expanding criteria for many Stage 1 objectives. They also proposed maintaining the current timeline but allowing a 90-day reporting period for providers to address concerns about implementation feasibility.
3.J Pharma monitoring of HVAC systems.docxSamehMostafa33
This document discusses pharmaceutical monitoring of HVAC systems. It begins by outlining the purpose of pharma monitoring systems and how they differ from automatic HVAC control systems. Specifically, pharma monitoring systems collect and store quality-relevant data that must be incorporated into batch documentation, while HVAC control systems manage technical data for stable operation. The document then discusses data management requirements for pharma monitoring systems to ensure data integrity and compliance with regulations. Finally, it provides examples of physical parameters that should be monitored, such as temperature, pressure differences, and particle counts, and how alert and action limits can be set to ensure the HVAC system is functioning properly.
The document provides guidance on the 2007 Physician Quality Reporting Initiative (PQRI) for eligible medical professionals. It describes the goals of the PQRI to focus on quality of care and reward reporting of quality measures with financial incentives. It outlines the eligible professionals, quality measures, reporting requirements, and bonus payments for successful reporting. It also provides details on understanding the quality measures, applicable codes, modifiers, and examples of successful reporting.
Introduction to changes to the TGA's Clinical Trial Notification (CTN) processTGA Australia
This presentation is an overview of the upcoming transition from a paper based Clinical Trial Notification (CTN) process to an online process through the TGA's online portal: eBusiness Services (eBS).
P4-40 (ALL WORK MUST BE ON A EXCEL FILE)Completing the account.docxgerardkortney
P4-40 (ALL WORK MUST BE ON A EXCEL FILE)
Completing the accounting cycle from adjusted trial balance to post-closing trial balance with an optional worksheet
Start from the posted T-accounts and the adjusted trial balance that Daniels Consulting prepared for the company at December 31.
Requirements:
1. Prepare an income statement for the month ended December 31.
2. Prepare a statement of owner’s equity for the month ended December 31.
3. Prepare a classified balance sheet (report form) at December 31.
4. Journalize and post the closing entries at December 31. Denote each closing amount as Clo. and each account balance as Balance.
5. Prepare a post-closing trial balance.
Running head: ACCREDITATION AUDIT 1
ACCREDITATION AUDIT 3
Accreditation Audit Task 1
Compliance status
Nightingale Community hospital is Join commission (JACHO) accredited. The hospital has thirteen month until the Join commission audit. The join commission audits include several areas of compliance. The focus area in this report is communication. After reviewing the join commission standards for communication, Nightingale community hospital is not in compliance of the some of the Joint Commission’s standards of communication. the standards of universal protocols (UP) are UP 01.01.01 conduct pre-procedure verification process, UP 01.02.01 mark the procedure side and UP 01.03.01 perform a time-out before the procedure.
The first Universal protocol UP 01.01.01 conduct pre-procedure verification process has three elements of performance (EPs). Nightingale community hospital is in compliance of the first element of performance to have a policy to identify the correct procedure, for the correct patient, at the correct site. Nightingale community hospital is not in compliance with the second element of performance. The hospital does not have an implemented policy to identify the items that must be accessible for the procedure like documentation of physical, laboratory and radiology results, pathology and biopsy reports and blood products,impalns, devices and special equipments that are required for the procedure. Third element is to match all the previous items to be available to the patient.
The second protocol UP 01.02.01 for preventing the wrong site, wrong procedure and wrong person surgery. 01.02.01 has five elements of performance. Not in compliance with third element of performance to mark the procedure site by a licensed practitioner who is accountable for the procedure and will be present during the procedure. No written alternative policy in place for when it is not possible to mark the procedure site.
The third Universal protocol UP 01.03.01 about conduction time out. It has five elements of performance. The second element of performance is not in compliance. The written policy about conducting time out is lacking all immediate members involved in the procedure should be including in the time out, including the in.
Webinar 4 : Achieve Meaningful Use Core Measures & Menu Measures using DigiDM...Sagar Shah
DigiDMS is an integrated Medical Information Management Company, which offers Electronic Health Records (EHR), Medical Billing, and Transcription Services. Our EHR includes integrated Appointment Scheduling, Billing Modules, Electronic Medical Records, Online Prescriptions and accessibility of information anywhere, anytime. Our services have evolved to a level where we can be deemed a Virtual Secretary targeted for hospitals, clinics, and independent doctors.
2011 CMS Physician Quality Reporting System (PQRS): Teaching Doctors of Chiropractic How to Report on Measures Related to Quality Patient Care by Tony Hamm, American Chiropractic Association
The document discusses changes to the Meaningful Use program requirements for 2015. Key points include:
- All providers will now complete a 90-day reporting period in 2015 instead of full year.
- Providers previously in Stage 1 are now in a "Modified Stage 2."
- Requirements have been simplified into 10 objectives with reduced patient engagement measures.
- Many data entry measures have been eliminated.
- Providers can choose to complete Stage 3 in 2017 or remain in Stage 2, with Stage 3 becoming mandatory in 2018.
Keynote Presentation "Meaningful Use Stage 2 and Meaningful Use Audit Insight"
Think far beyond just threshold increases. The differences between Meaningful Use (MU) Stage 1 and Stage 2, including the 2014 Clinical Quality Measures, are technically and clinically challenging. And just when you thought you could safely look at Stage 1 in the rearview mirror, here come the audits! I will highlight the Stage 1 and Stage 2 differences and talk about the challenges they have initiated at Tenet. I will touch on the impact of Quality measures and will also provide you with insight into the basics of MU Audits and will take you through the actual audit experience at Tenet.
Learning Objectives:
∙ Review the program and measure changes from Stage 1 to Stage 2 and how the changes are being managed at Tenet
∙ Provide insight into the 2014 Clinical Quality Measures chosen by Tenet, the challenges posed, solutions that work and a little about the overall
impact of Quality measures
∙ Discuss Meaningful Use Audits, covering the basics as well as providing the benefit of the Tenet experience
The document summarizes changes to the Meaningful Use Stage 2 rules for electronic health record incentive programs. Key changes include allowing a 90-day reporting period in 2017 for first-time participants and those choosing to implement Stage 3 in 2017. It modifies measures related to patient engagement, public health reporting, and thresholds for Stage 3 objectives like computerized provider order entry and electronic prescribing. The final rule also changes the 2015 reporting period to 90 days and aligns future periods with the calendar year. It streamlines programs by removing redundant measures and modifies several objectives and measures for Stages 1, 2 and 3.
This document provides answers to questions regarding a Japanese guideline on the management of computerized systems used by drug and medical product manufacturers. It clarifies the scope and requirements of the guideline. Key points include:
- The guideline applies to computerized systems that support operations governed by Good Quality Practice and Good Manufacturing Practice regulations, such as systems for production management, quality control, and distribution record-keeping.
- Both in-house systems and those developed by external contractors are within scope. Validation of systems is required, even if they were implemented before the guideline.
- The guideline aims to ensure systems are properly operated, secured, and able to maintain business continuity. It provides requirements for validation, change management, system
Calibration of measuring instruments is required to comply with regulations, improve quality assurance, and increase productivity. A Calibration Master Plan (CMP) defines the requirements for an effective calibration program. It outlines which instruments need calibration, calibration frequencies, how calibration will ensure traceability, and how calibration records will be maintained and labeled. The CMP assigns responsibilities to Quality Assurance, Metrology, and instrument-using personnel. It also describes how calibration standards will be adequate and Standard Operating Procedures for calibration will be prepared. The overall goal of the calibration program is to ensure instruments are calibrated within specifications.
This document provides a software requirements specification for a Hospital ERP System. It describes the purpose, scope, definitions, and overview of the system. The system allows for registration of patients, doctor login, appointment booking, viewing of patient information, pathology testing, prescription of medicine, paramedic services, doctor modules, report generation, billing, and maintenance. It outlines user characteristics, functional requirements including various modules, use cases, and non-functional requirements. Diagrams including sequence, data flow, and state transition diagrams are also included.
This document summarizes the key changes between Meaningful Use Stages 1 and 2, including exemptions. It outlines 17 core objectives that eligible professionals must meet for Stage 2, such as using computerized provider order entry for medication, laboratory, and radiology orders. Other objectives include incorporating lab results as structured data, generating patient lists for quality improvement, and submitting immunization data to registries. The document notes exemptions for some objectives and proposed changes in the 2015 rule, such as allowing Stage 1 providers to report on earlier objectives.
This document provides a guideline for the management of computerized systems used by marketing authorization holders and manufacturers of drugs and quasi-drugs in Japan. It outlines requirements for the development, validation, and operation of computerized systems to ensure compliance with quality standards. The guideline defines a "lifecycle" approach and categorization of computerized systems. It specifies documentation requirements and procedures that must be followed during each stage of the system lifecycle, including development planning, validation activities like design and installation qualification, and change management. The overall aim is to clarify responsibilities and ensure computerized systems function properly and reliably.
OrHIMA Meaningful Use Stage 2 PresentationBrian Ahier
This document discusses changes from Stage 1 to Stage 2 of meaningful use for eligible professionals and hospitals. Key changes include increased objectives for clinical decision support, electronic prescribing, patient engagement and health information exchange. Stage 2 places more emphasis on care coordination through increased objectives for medication reconciliation, patient summaries and electronic transmission of health information between providers. The document also outlines new clinical quality reporting requirements and certification criteria for electronic health records.
Similar to Prepayment Audit Suggested Documentation (20)
Presence Health Resolution Agreement with OCRdata brackets
This resolution agreement between the US Department of Health and Human Services (HHS) and Presence Health Network resolves HHS investigation number 14-176036 regarding Presence Health's violations of the HIPAA Breach Notification Rule. Presence Health failed to provide timely notification of a 2013 breach affecting 836 individuals to those individuals, media outlets, and HHS as required. The agreement requires Presence Health to pay $475,000 and comply with a corrective action plan, which involves revising policies and procedures around breach notification and applying sanctions to employees who fail to follow breach notification policies.
Oregon Health & Science University HIPAA Finesdata brackets
This resolution agreement is between the US Department of Health and Human Services (HHS) and Oregon Health & Science University (OHSU) to resolve HHS investigations of two data breaches at OHSU involving unsecured protected health information. OHSU agrees to pay HHS $2.7 million and comply with the terms of a corrective action plan, which requires OHSU to conduct a risk analysis, develop a risk management plan, implement encryption of mobile and network connected devices, and provide status updates to HHS. The agreement resolves alleged violations of HIPAA privacy and security rules related to the data breaches and ensures OHSU's ongoing compliance during a three year term.
Catholic Health Care Services Resolution Agreement data brackets
This resolution agreement between HHS and CHCS resolves HHS's investigation into CHCS regarding compliance with HIPAA rules. CHCS will pay HHS $650,000 and comply with a corrective action plan to address deficiencies in its risk analysis, security measures, and policies and procedures related to protecting electronic protected health information. The corrective action plan requires CHCS to conduct annual risk analyses, develop and distribute policies to its workforce, report any failures to comply with policies, and provide documentation to HHS. This agreement resolves the issues related to a breach of electronic protected health information at CHCS and its affiliated skilled nursing facilities.
This resolution agreement between the U.S. Department of Health and Human Services (HHS) and New York Presbyterian Hospital (NYP) resolves allegations that NYP impermissibly disclosed patients' protected health information during filming of a television show at the hospital. Under the agreement, NYP will pay $2.2 million and comply with a corrective action plan to strengthen its privacy policies and procedures regarding disclosures to film crews. The agreement includes a release of claims by HHS related to the covered conduct and requires NYP to implement policies addressing uses and disclosures of protected health information, safeguards, authorizations, training, and internal reporting procedures.
This resolution agreement summarizes a settlement between the US Department of Health and Human Services (HHS) and New York Presbyterian Hospital (NYP) regarding an investigation into a potential violation of patient privacy rules. Key points:
- HHS investigated NYP for impermissibly disclosing patient health information to a film crew without authorization.
- NYP agrees to pay $2.2 million and comply with a corrective action plan to resolve the matter.
- The corrective action plan requires NYP to develop comprehensive privacy policies, train staff, investigate potential violations, and report certain incidents to HHS for the next two years.
Raleigh Orthopedic RA and CAP April 2016data brackets
Raleigh Orthopedics's Resolution Agreement and CAP resulting from Raleigh Orthopedic violating the Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules
HIPAA Violation Fines: North memorial Hospistal Settlement data brackets
This resolution agreement resolves a potential violation of HIPAA rules regarding the protection of patient health information. North Memorial Health Care paid $1,550,000 to settle claims that it improperly provided a business associate, Accretive Health, access to patient information without having a signed business associate agreement in place. As part of the settlement, North Memorial agreed to comply with corrective actions to improve its privacy and security practices.
Lincare HIPAA remediated decision by administrative judgedata brackets
The Department of Health and Human Services investigated a complaint that a Lincare manager allowed her estranged husband unauthorized access to protected health information of Lincare patients. Following an investigation, the Office for Civil Rights determined that Lincare violated HIPAA by failing to implement policies to safeguard patient records and failing to protect 278 patients' information from unauthorized disclosure. OCR proposed a $239,800 civil money penalty against Lincare. Lincare appealed and OCR filed a motion for summary judgment, which Lincare opposed.
Lincare HIPAA Notice of Proposed Determination remediateddata brackets
This document from the Department of Health and Human Services notifies Lincare, Inc. that it intends to impose a civil monetary penalty of $239,800 for violations of the HIPAA Privacy Rule. It finds that a Lincare employee impermissibly disclosed protected health information of 278 patients to an unauthorized individual by leaving the PHI in her home and vehicle without safeguards. It also finds that Lincare's policies failed to adequately protect PHI removed from its facilities. Lincare is found liable for impermissible disclosure, failure to safeguard PHI, and inadequate policies regarding off-site PHI protection. Lincare's arguments do not establish affirmative defenses to the violations.
Office of Inspector General Study on OCR's HIPAA audit programdata brackets
Office of Inspector General: OCR should strengthen its oversight of covered entities' compliance with the HIPAA privacy standards.
OIG has recently completed a study of OCR's HIPAA audit program and published the following recommendations:
(1) OCR should fully implement a permanent audit program
(2) OCR should maintain complete documentation of corrective action
(3) OCR should develop an efficient method in its case-tracking system to search for and track covered entities
(4) OCR should develop a policy requiring OCR staff to check whether covered entities have been previously investigated
(5) OCR should continue to expand outreach and education efforts to covered entities. OCR concurred with all five recommendations and described its activities to address them.
OCR's chief Jocelyn Samuels has concurred with all the recommendations of OIG.
For the complete report please visit our slideshare page:
Cancer Care Group HIPAA Settlement Agreementdata brackets
Cancer Care has taken corrective action with regard to the specific requirements of the Privacy and Security Rules that are at the core of this enforcement action, as well as actions to come into compliance with the other provisions of the HIPAA Rules. The Resolution Agreement and Corrective Action Plan (CAP) can be found on the OCR website at: http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/cancercare.html
Parkview Health System, Inc. (Parkview) has agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule with the Department of Health and Human Services (HHS) Office for Civil Rights (OCR). Parkview will pay $800,000 and adopt a corrective action plan to correct deficiencies in its HIPAA compliance program.
HIPAA Settlement New York Presbyterian and Columbia Universtiydata brackets
The resolution agreement summarizes a breach incident involving New York Presbyterian Hospital (NYP) impermissibly disclosing electronic protected health information (ePHI) of 6,800 patients to Google and other internet search engines. It outlines NYP's obligations to pay $3.3 million, implement a corrective action plan, and comply with HIPAA privacy and security rules going forward. The corrective action plan requires NYP to conduct a risk analysis, develop a risk management plan, review and revise access and device policies, implement security awareness training, and report to HHS for three years.
OCR received a breach notice in February 2012 from QCA Health Plan, Inc. of Arkansas reporting that an unencrypted laptop computer containing the ePHI of 148 individuals was stolen from a workforce member’s car. While QCA encrypted their devices following discovery of the breach, OCR’s investigation revealed that QCA failed to comply with multiple requirements of the HIPAA Privacy and Security Rules, beginning from the compliance date of the Security Rule in April 2005 and ending in June 2012. QCA agreed to a $250,000 monetary settlement and is required to provide HHS with an updated risk analysis and corresponding risk management plan that includes specific security measures to reduce the risks to and vulnerabilities of its ePHI. QCA is also required to retrain its workforce and document its ongoing compliance efforts.
OCR opened a compliance review of Concentra Health Services (Concentra) upon receiving a breach report that an unencrypted laptop was stolen from one of its facilities, the Springfield Missouri Physical Therapy Center. OCR’s investigation revealed that Concentra had previously recognized in multiple risk analyses that a lack of encryption on its laptops, desktop computers, medical equipment, tablets and other devices containing electronic protected health information (ePHI) was a critical risk. While steps were taken to begin encryption, Concentra’s efforts were incomplete and inconsistent over time leaving patient PHI vulnerable throughout the organization. OCR’s investigation further found Concentra had insufficient security management processes in place to safeguard patient information. Concentra has agreed to pay OCR $1,725,220 to settle potential violations and will adopt a corrective action plan to evidence their remediation of these findings.
Skagit county- HIPAA violation settlement agreement with HHSdata brackets
Skagit County, Washington, has agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules. Skagit County agreed to a $215,000 monetary settlement and to work closely with the Department of Health and Human Services (HHS) to correct deficiencies in its HIPAA compliance program. Skagit County is located in Northwest Washington, and is home to approximately 118,000 residents. The Skagit County Public Health Department provides essential services to many individuals who would otherwise not be able to afford health care.
OCR opened an investigation of Skagit County upon receiving a breach report that money receipts with electronic protected health information (ePHI) of seven individuals were accessed by unknown parties after the ePHI had been inadvertently moved to a publicly accessible server maintained by the County. OCR's investigation revealed a broader exposure of protected health information involved in the incident, which included the ePHI of 1,581 individuals. Many of the accessible files involved sensitive information, including protected health information concerning the testing and treatment of infectious diseases. OCR's investigation further uncovered general and widespread non-compliance by Skagit County with the HIPAA Privacy, Security, and Breach Notification Rules.
Skagit County continues to cooperate with OCR through a corrective action plan to ensure it has in place written policies and procedures, documentation requirements, training, and other measures to comply with the HIPAA Rules. This corrective action plan also requires Skagit County to provide regular status reports to OCR.
EHR meaningful use security risk assessment sample documentdata brackets
Under the HIPAA Privacy and Security Rule, business associates are required to perform active risk prevention and safeguarding of patient information that are very important to patient privacy. The HITECH act allows only minimum necessary to be disclosed when handling protected health information (PHI).
This security risk assessment exercise has been performed to support the requirements of the Department of Health and Human Services (HHS), Office for the Civil Rights (OCR) and other applicable state data privacy laws and regulations. Upon completion of this risk assessment, a detail risk management plan need to be developed based on the gaps identified from the risk analysis. The gaps identified and recommendations provided are based on the input provided by the staff, budget, scope and other practical considerations
Adult & Pediatric Dermatology, P.C., of Concord, Mass., has agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules with the Department of Health and Human Services, agreeing to a $150,000 payment. The practice will also be required to implement a corrective action plan to correct deficiencies in its HIPAA compliance program. Adult and Pediatric Dermatology is a private practice that delivers dermatology services in four locations in Massachusetts and two in New Hampshire. This case marks the first settlement with a covered entity for not having policies and procedures in place to address the breach notification provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act, passed as part of American Recovery and Reinvestment Act of 2009 (ARRA).
The HHS Office for Civil Rights (OCR) opened an investigation of Adult and Pediatric Dermatology upon receiving a report that an unencrypted thumb drive containing the electronic protected health information (ePHI) of approximately 2,200 individuals was stolen from a vehicle of one its staff members. The thumb drive was never recovered. The investigation revealed that Adult and Pediatric Dermatology had not conducted an accurate and thorough analysis of the potential risks and vulnerabilities to the confidentiality of ePHI as part of its security management process. Further, Adult and Pediatric Dermatology did not fully comply with requirements of the Breach Notification Rule to have in place written policies and procedures and train workforce members.
In addition to a $150,000 resolution amount, the settlement includes a corrective action plan requiring Adult and Pediatric Dermatology to develop a risk analysis and risk management plan to address and mitigate any security risks and vulnerabilities, as well as to provide an implementation report to OCR.
Download the Corrective Action Plan(CAP) here >>
Tips s to providers: Almost all of the HIPAA/HITECH violations identified in the last few years is due to insufficient security risk analysis conducted by the providers or business associates.
This resolution agreement between HHS and Affinity Health Plan resolves an investigation into a breach of protected health information. Affinity will pay $1,215,780 and comply with a corrective action plan. The plan requires Affinity to retrieve photocopier hard drives containing PHI, conduct a security risk analysis, and update policies. If Affinity breaches the agreement or plan, HHS may impose civil money penalties. Both parties aim to resolve the issues without further legal action.
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Final ank Satta Matka Dpbos Final ank Satta Matta Matka 143 Kalyan Matka Guessing Final Matka Final ank Today Matka 420 Satta Batta Satta 143 Kalyan Chart Main Bazar Chart vip Matka Guessing Dpboss 143 Guessing Kalyan night
Dive into this presentation and learn about the ways in which you can buy an engagement ring. This guide will help you choose the perfect engagement rings for women.
IMPACT Silver is a pure silver zinc producer with over $260 million in revenue since 2008 and a large 100% owned 210km Mexico land package - 2024 catalysts includes new 14% grade zinc Plomosas mine and 20,000m of fully funded exploration drilling.
Digital Marketing with a Focus on Sustainabilitysssourabhsharma
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
Best practices for project execution and deliveryCLIVE MINCHIN
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...APCO
The Radar reflects input from APCO’s teams located around the world. It distils a host of interconnected events and trends into insights to inform operational and strategic decisions. Issues covered in this edition include:
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
Frameworks/Models included:
Microsoft’s Digital Transformation Framework
McKinsey’s Ten Guiding Principles of Digital Transformation
Forrester’s Digital Transformation Framework
IDC’s Digital Transformation MaturityScape
MIT’s Digital Transformation Framework
Gartner’s Digital Transformation Framework
Accenture’s Digital Strategy & Enterprise Frameworks
Deloitte’s Digital Industrial Transformation Framework
Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map
Best Competitive Marble Pricing in Dubai - ☎ 9928909666Stone Art Hub
Stone Art Hub offers the best competitive Marble Pricing in Dubai, ensuring affordability without compromising quality. With a wide range of exquisite marble options to choose from, you can enhance your spaces with elegance and sophistication. For inquiries or orders, contact us at ☎ 9928909666. Experience luxury at unbeatable prices.
Presentation by Herman Kienhuis (Curiosity VC) on Investing in AI for ABS Alu...Herman Kienhuis
Presentation by Herman Kienhuis (Curiosity VC) on developments in AI, the venture capital investment landscape and Curiosity VC's approach to investing, at the alumni event of Amsterdam Business School (University of Amsterdam) on June 13, 2024 in Amsterdam.
𝐔𝐧𝐯𝐞𝐢𝐥 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐄𝐧𝐞𝐫𝐠𝐲 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 𝐰𝐢𝐭𝐡 𝐍𝐄𝐖𝐍𝐓𝐈𝐃𝐄’𝐬 𝐋𝐚𝐭𝐞𝐬𝐭 𝐎𝐟𝐟𝐞𝐫𝐢𝐧𝐠𝐬
Explore the details in our newly released product manual, which showcases NEWNTIDE's advanced heat pump technologies. Delve into our energy-efficient and eco-friendly solutions tailored for diverse global markets.
SATTA MATKA SATTA FAST RESULT KALYAN TOP MATKA RESULT KALYAN SATTA MATKA FAST RESULT MILAN RATAN RAJDHANI MAIN BAZAR MATKA FAST TIPS RESULT MATKA CHART JODI CHART PANEL CHART FREE FIX GAME SATTAMATKA ! MATKA MOBI SATTA 143 spboss.in TOP NO1 RESULT FULL RATE MATKA ONLINE GAME PLAY BY APP SPBOSS
Call8328958814 satta matka Kalyan result satta guessing➑➌➋➑➒➎➑➑➊➍
Satta Matka Kalyan Main Mumbai Fastest Results
Satta Matka ❋ Sattamatka ❋ New Mumbai Ratan Satta Matka ❋ Fast Matka ❋ Milan Market ❋ Kalyan Matka Results ❋ Satta Game ❋ Matka Game ❋ Satta Matka ❋ Kalyan Satta Matka ❋ Mumbai Main ❋ Online Matka Results ❋ Satta Matka Tips ❋ Milan Chart ❋ Satta Matka Boss❋ New Star Day ❋ Satta King ❋ Live Satta Matka Results ❋ Satta Matka Company ❋ Indian Matka ❋ Satta Matka 143❋ Kalyan Night Matka..
Cover Story - China's Investment Leader - Dr. Alyce SUmsthrill
In World Expo 2010 Shanghai – the most visited Expo in the World History
https://www.britannica.com/event/Expo-Shanghai-2010
China’s official organizer of the Expo, CCPIT (China Council for the Promotion of International Trade https://en.ccpit.org/) has chosen Dr. Alyce Su as the Cover Person with Cover Story, in the Expo’s official magazine distributed throughout the Expo, showcasing China’s New Generation of Leaders to the World.
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...my Pandit
Explore the fascinating world of the Gemini Zodiac Sign. Discover the unique personality traits, key dates, and horoscope insights of Gemini individuals. Learn how their sociable, communicative nature and boundless curiosity make them the dynamic explorers of the zodiac. Dive into the duality of the Gemini sign and understand their intellectual and adventurous spirit.
Discover timeless style with the 2022 Vintage Roman Numerals Men's Ring. Crafted from premium stainless steel, this 6mm wide ring embodies elegance and durability. Perfect as a gift, it seamlessly blends classic Roman numeral detailing with modern sophistication, making it an ideal accessory for any occasion.
https://rb.gy/usj1a2
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.
Prepayment Audit Suggested Documentation
1. Page 1
Measure Suggested Documentation
Suggested Documentation
For Exclusions
EPOM 01
Protect Patient
Health
Information
A security risk analysis of the EP's Certified Electronic Health Record Technology (CEHRT)
system, which was performed no earlier than the start of the reporting year and no later than the
date of attestation (i.e. a report which documents the procedures performed during the analysis and
the results of the analysis). This analysis must be in accordance with the requirements under 45
CFR 164.308(a) (1), including addressing the encryption/security of data stored in CEHRT in
accordance with requirements under 45 CFR 164.312 (a)(2)(iv) and 45 CFR 164.306(d)(3). The
testing could occur prior to the beginning of the first EHR reporting period. However, a new review
would have to occur for each subsequent reporting period. Documentation should also be supplied
to show that the EP implemented security updates as necessary and corrected identified security
deficiencies.
There is no exclusion for this measure.
EPOM 02
Clinical Decision
Support
For Measure #1- Documentation which proves that five clinical decision support interventions
exist in the EP's CEHRT system (i.e. audit trail, screenshots from the system, letter/e-mail from the
vendor, etc.) and that they remained active throughout the EP's reporting period (i.e. a schedule of
alerts related to clinical decision support interventions that fired during the reporting period or an
indication that the interventions can not be turned off).
For Alternate Measure #1 - Documentation which proves that a clinical decision support rule
exists in the EP's CEHRT system (i.e. audit trail, screenshots from the system, letter/e-mail from
the vendor, etc.) and that it remained active throughout the EP's reporting period (i.e. a schedule of
alerts related to a clinical decision support rule that fired during the reporting period or an
indication that the rule can not be turned off).
For Measure #2- Documentation which proves that this functionality is available in the EP's EHR
system (i.e. audit trail, screenshots from the system, letter/e-mail from the vendor, etc.) and that it
remained active throughout the EP's reporting period (i.e. a schedule of alerts that fired during the
reporting period or an indication that the feature can not be turned off).
There is no exclusion for the first measure.
To meet the exclusion for the second measure, the EP is required to write fewer than 100 medication orders during the EHR reporting
period. To support this exclusion, provide the following:
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology system. This report should
include the following:
● Denominator for Objective Measure #3 (Medication) which should be < 100
● Time period which it covers
● Name of the EP
EPOM 03
CPOE for
Medication,
Laboratory,
and Radiology
Orders
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology
(CEHRT) system. This report should include the following:
● Numerators and denominators for all three CPOEs
● Time period which it covers (must cover the attestation period)
● Name of the EP
If possible, evidence demonstrating that this report was generated by the CEHRT system (i.e. a
screenshot of the report before it has been printed from the system).
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology system. This report should
include the following:
● Denominators for this measure, which should be < 100 (should be 3 sets of numerators & denominators: Medication, Laboratory,
Radiology)
● Time period which it covers (must cover the attestation period)
● Name of the EP
Note- These exclusions are independent of each other. For example, an EP can be excluded from the medication order measure, but
be required to report the laboratory and radiology order measures, based on the threshold of writing 100 orders.
Alternate Exclusion for Measure 2 : Providers scheduled to be in Stage 1 in 2015 may claim an exclusion for measure 2 (laboratory
orders) of the Stage 2 CPOE objective for an EHR reporting period in 2015.
Alternate Exclusion for Measure 3 : Providers scheduled to be in Stage 1 in 2015 may claim an exclusion for measure 3 (radiology
orders) of the Stage 2 CPOE objective for an EHR reporting period in 2015.
Eligible Professionals- Objective Measures
2. Page 2
Measure Suggested Documentation
Suggested Documentation
For Exclusions
Eligible Professionals- Objective Measures
EPOM 04
Electronic
Prescribing
(eRx)
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology
(CEHRT) system. This report should include the following:
● Numerator and denominator for this measure
● Time period which it covers (must cover the attestation period)
● Name of the EP
If possible, evidence demonstrating that this report was generated by the CEHRT system (i.e. a
screenshot of the report before it has been printed from the system).
One of the following exclusions must be documented:
Exclusion #1A- A summary report, preferably generated by the EP's CEHRT system. This report should include the following:
● Denominator, which must be < 100
● Time period which it covers (must cover the attestation period)
● Name of the EP
Exclusion #1B- A statement indicating that at the start of the EHR reporting period, the EP did not have a pharmacy within their
organization or within 10 miles of their practice that accepted electronic prescriptions.
EPOM 05
Health
Information
Exchange
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology
(CEHRT) system. This report should include the following:
● Numerator and denominator for this measure
● Time period which it covers (must cover the attestation period)
● Name of the EP
If possible, evidence demonstrating that this report was generated by the CEHRT system (i.e. a
screenshot of the report before it has been printed from the system).
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology system. This report should
include the following:
● Denominator for this measure which should be < 100
● Time period which it covers
● Name of the EP
Alternate Exclusion : Providers may claim an exclusion for the Stage 2 measure that requires the electronic transmission of a
summary of care document if for an EHR reporting period in 2015, they were scheduled to demonstrate Stage 1, which does not have
an equivalent measure.
EPOM 06
Patient-Specific
Education
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology
(CEHRT) system. This report should include the following:
● Numerator and denominator for this measure
● Time period which it covers (must cover the attestation period)
● Name of the EP
If possible, evidence demonstrating that this report was generated by the CEHRT system (i.e. a
screenshot of the report before it has been printed from the system).
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology system. This report should
include the following:
● Denominator for this measure which should be zero
● Time period which it covers (must cover the attestation period)
● Name of the EP
Alternate Exclusion : Provider may claim an exclusion for the measure of the Stage 2 Patient Specific Education objective if for an
EHR reporting period in 2015 they were scheduled to demonstrate Stage 1 but did not intend to select the Stage 1 Patient Specific
Education menu objective.
EPOM 07
Medication
Reconciliation
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology
(CEHRT) system. This report should include the following:
● Numerator and denominator for this measure
● Time period which it covers (must cover the attestation period)
● Name of the EP
If possible, evidence demonstrating that this report was generated by the CEHRT system (i.e. a
screenshot of the report before it has been printed from the system).
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology system. This report should
include the following:
● Denominator for this measure which should be zero
● Time period which it covers (must cover the attestation period)
● Name of the EP
Alternate Exclusion : Provider may claim an exclusion for the measure of the Stage 2 Medication Reconciliation objective if for an
EHR reporting period in 2015 they were scheduled to demonstrate Stage 1 but did not intend to select the Stage 1 Medication
Reconciliation menu objective.
3. Page 3
Measure Suggested Documentation
Suggested Documentation
For Exclusions
Eligible Professionals- Objective Measures
EPOM 08
Patient
Electronic
Access
A summary report, preferably generated by the EP's Certified Electronic Health Record Technology
(CEHRT) system. This report should include the following:
● Numerator and denominator for this measure (for both measure #1 & 2)
● Time period which it covers (must cover the attestation period)
● Name of the EP
If possible, evidence demonstrating that this report was generated by the CEHRT system (i.e. a
screenshot of the report before it has been printed from the system).
There is no exclusion for the first measure.
Exclusions for the second measure:
Exclusion #1A- A statement indicating why the EP does not order or create any of the information listed for inclusion as part of the
measure (patient name, provider's name and office contact information, current and past problem list, procedures, laboratory test
results, current medication list and medication history, current medication allergy list and medication allergy history, vital signs,
smoking status, demographic information, care plan fields, and any known care team members including the primary care provider
(PCP) of record) except for "Patient name" and "Provider's name and office contact information". (Excludes second measure only)
Exclusion #1B- A statement identifying the county and zip code where the EP conducts ≥ 50% of his/her patient encounters.
(Excludes second measure only)
Alternate Exclusion Measure #2- Providers may claim an exclusion for the second measure if for an EHR reporting period in 2015
they were scheduled to demonstrate Stage 1, which does not have an equivalent measure.
EPOM 09
Secure
Electronic
Messaging
Documentation which proves that this capability was fully enabled in the EP's EHR system (i.e.
audit trail, screenshots from the system, letter/e-mail from the vendor, etc.) and that it remained
active throughout the EP's reporting period (i.e. a schedule of alerts that fired during the reporting
period or an indication that the feature can not be turned off).
One of the following exclusions must be documented:
Exclusion #1A- A summary report, generated by the EP's Certified Electronic Health Record Technology system. This report should
include the following:
● Denominator for Measure #6 (Patient-Specific Education) which should be zero
● Time period which it covers (must cover the attestation period)
● Name of the EP
Exclusion #1B- A statement identifying the county and zip code where the EP conducts ≥ 50% of his/her patient encounters.
Alternate Exclusion- An EP may claim an exclusion for the measure if for an EHR reporting period in 2015 they were scheduled to
demonstrate Stage 1, which does not have an equivalent measure.
4. Page 4
Measure Suggested Documentation
Suggested Documentation
For Exclusions
Eligible Professionals- Objective Measures
EPOM 10
Public Health
Reporting
One of the following criteria must be documented for each attested to measure:
For Active Engagement Option (1), documentation from the EP's public health agency (letter, e-
mail, website screenshot, etc.) demonstrating the EP registered to submit data with the PHA or,
where applicable, the CDR to which the information is being submitted; registration was
completed within 60 days after the start of the EHR reporting period; and the EP is awaiting an
invitation from the PHA or CDR to begin testing and validation. An example of acceptable
documentation would be a letter or e-mail from the public health agency confirming the date the EP
registered to submit data with the PHA or, where applicable, the CDR to which the information is
being submitted and that the EP is awaiting an invitation from the PHA or CDR to begin testing
and validation.
For Active Engagement Option (2), documentation from the EP's public health agency (letter, e-
mail, website screenshot, etc.) demonstrating that the EP is in the process of testing and validation
of the electronic submission of data. Providers must respond to requests from the PHA or, where
applicable, the CDR within 30 days; failure to respond twice within an EHR reporting period
would result in that provider not meeting the measure. An example of acceptable documentation
would be a letter or e-mail from the public health agency confirming that the EP is in the process of
testing and validation of the electronic submission of data.
For Active Engagement Option (3), documentation from the EP's public health agency (letter, e-
mail, website screenshot, etc.) demonstrating that the EP has completed testing and validation of
the electronic submission and is electronically submitting production data to the PHA or CDR. An
example of acceptable documentation would be a letter or e-mail from the public health agency
confirming that the EP has completed testing and validation of the electronic submission and is
electronically submitting production data to the PHA or CDR.
One of the following exclusions must be documented:
Exclusion #1-
Measure #1 - A statement from the EP detailing what types of immunizations, if any, they administered during the reporting period.
If the EP administers immunizations that are not being collected by the registry, obtain confirmation from the registry.
Measure #2 - A statement from the EP indicating why they are not in a category of providers that collects ambulatory syndromic
surveillance information.
Measure #3 - A statement from the EP explaining why they do not diagnose or directly treat any disease associated with a specialized
registry or the public health agencies in their jurisdiction.
Exclusion #2-
Measure #1 - Documentation from the EP's immunization registry or immunization information system (letter, e-mail, website
screenshot, etc.) stating that they were not capable of accepting the specific standards required to meet the CEHRT definition at the
start of the EHR reporting period.
Measure #2 - Documentation from the EP's public health agency (letter, e-mail, website screenshot, etc.) stating that they were not
capable of receiving electronic syndromic surveillance data from EPs in the specific standards required to meet the CEHRT
definition at the start of the EHR reporting period.
Measure #3 - Documentation from the EP's specialized registry (letter, e-mail, website screenshot, etc.) stating that they were not
capable of accepting electronic registry transactions in the specific standards required to meet the CEHRT definition at the start of the
EHR reporting period.
Exclusion #3-
Measure #1 - Documentation from the EP's immunization registry or immunization information system (letter, e-mail, website
screenshot, etc.) which demonstrates that EP operates in a jurisdiction where no immunization registry or immunization information
system has declared readiness to receive immunization data from the EP at the start of the EHR reporting period.
Measure #2 - Documentation from the EP's public health agency (letter, e-mail, website screenshot, etc.) which demonstrates that EP
operates in a jurisdiction where no public health agency has declared readiness to receive syndromic surveillance data from EPs at
the start of the EHR reporting period.
Measure #3 - Documentation from the EP's specialized registry (letter, e-mail, website screenshot, etc.) which demonstrates that EP
operates in a jurisdiction where no specialized registry for which the EP is eligible has declared readiness to receive electronic
registry transactions at the beginning of the EHR reporting period.
Alternate Exclusion - EPs scheduled to be in Stage 1 must attest to at least 1 measure from the Public Health Reporting Objective
Measures 1-3.
• May claim an Alternate Exclusion for Measure 1, Measure 2, or Measure 3.
• An Alternate Exclusion may only be claimed for up to two measures, then the provider must either attest to or meet the exclusion
requirements for the remaining measure described in 495.22 (e)(10)(i).