Social Media : A Recruitment Tool for Clinical Trials

For a successful and efficient completion of Clinical Trial, the poor recruitment is a major obstacle.  A recent survey of corresponding authors of randomized trials found that nearly 60 minutes had either didn't meet their recruitment target or needed an extended recruitment period.  Insufficient recruitment of study participants could result in losing the statistical power of a predictive conclusion, likewise as prolonging the time and increasing the cost related to the study.

The path to recruitment is usually the much story in randomized clinical trials. While even failed results and conclusions of experiments are reported, inefficient recruitment methods often go unreported. Studies assessing effective recruitment methods are far too scarce. The few systematic reviews that have addressed this issue stress the lack of generalization of recruitment methods given the degree of subjectivity with respect to a particular study design, intervention type, and the nature of participation needed by volunteers.

The issue of poor recruitment becomes even more exaggerated when the target of a study is a special population like women in the perceptional period or during pregnancy. Risk perception with a clinical intervention during this period is often skewed from ‘actual risk’ to ‘imagined risk’ given this state of vulnerability and fears of coercion. As a result, there's an excellent want for the assessment of recruitment methods in special populations, like women in the perceptional amount, that aren't only efficient but also cost-effective.

With the arrival of the net and medical info being accessible on the net in recent years, volunteers collaborating in clinical trials have touched far from being “patients” to “informed health-care consumers”.  Many people thoroughly search their symptoms on the internet before they commit to visit a doctor who assigns them a diagnosing.  About one-third of American adult access social media for health matters. A survey conducted by the Opinion analysis Corporation incontestable that fifty nine of adults within the USA use the net to seek health information, creating it the foremost standard possibility over seeking similar information from a health care provider.

The accessibility of medical info on the net has not solely made modern-day patients more aware, however also more involved in their personal healthcare. Thus, social media to expose clinical trialsto a bigger subject population looks like a noticeable next step in making an attempt to optimize recruitment methods. Social media is usually on-line platform which will modify dialogue among people and online communities, serving as a website for info dissemination and discussion.

Clean Air Regulation

There appears to be some stipulations within the new american Power Act which tries to suppress the power of the EPA as clearly outlined in the Clean Air Act. Seen to be a very successful legislation, the Clean Air Act dates back to 1970, however the Supreme Court unrolled its call in 2007, granting full authority to the epa to regulate emissions as part of the said Act.

Critics of legislation passed by the House of Representatives to deal with climate change have created their voices heard during composition of the american Power Act. Specifically, as it seems that the EPA is prepared to introduce regulation to curb stationary sources of carbon emissions, some members of Congress want new legislation to be written to pre-empt it.

It seems that there's some language within the new american Power Act that seeks to dampen the power of the epa as written into the Clean Air Act. The latter is seen as a very successful piece of legislation, dating back to 1970, but in the judgment handed down by the Supreme Court in 2007, the epa was granted powerful authority to regulate carbon emissions as part of that Act.

Provisions at intervals the american Power Act mandate that the epa may not bring the power of the Clean Air Act to bear on major emitters of carbon, specifically power plants and large factories. Critics have cited this regulatory potential to be a "backdoor" way for the Administration to effectively tax energy use and carbon emissions.

Included within the American Power Act may be a cap and rebate provisions that deals with the producers of energy and a few different provisions that take care of threats to climate. whereas the political climate itself is much from appetizing, the damaging events of the Gulf oil spill square measure prompting popular opinion to push for legislation to curb energy usage. several square measure line for vital taxation on fossil fuels and investment in different sources of energy.

Pres. Obama has stated that the U.S. will reduce carbon emissions by 83 in 40 years. The american Power Act grants authority for such in the Environmental Protection Agency. without such legislation it's very unlikely that regulation as part of the Clean Air Act would achieve anywhere near that kind of reduction.

There seems to be a closing window of opportunity in the summer of 2010. Despite the events that happened in the Gulf of mexico, the Congress still doesn't pay that much of an attention to the difficulty. it might appear obvious that the legislation shall need to be addressed  in the near future should the promises made by the Pres. Obama to the listening world are to be unbroken.

In the event that the Congress would not successfully pass the climate bill in 2010, the EPA would currently need to follow through with a regulation that curtails carbon emissions from emitters that are stationary. This could appear to be the least enticing among the choices, tho' it leads to additional premiums on top of the traditional energy which would be shouldered by the other.

Carbon emission realization and ultimate reduction should be the goal of every business in the us. Unrestricted energy use is fast becoming a sore subject and organizations that aren't seen to be proactive risk damage to their reputations, quite apart from additional costs associated with an indirect or direct carbon tax.

Regulations change the way we do business all the time, especially when they involve climate change! For the last 50 years, nuclear energy has been depicted as a carbon free, clean alternative to fossil fuel-fired plants. More recently, wind farms and solar panel fields dominated the landscape. But what are the environmental impacts of these alternative sources? How do the risks of nuclear power play out in the public forum? Why do nuclear projects still encounter such forceful opposition? This program will review the issues that swirl around alternative energy sources as states attempt to comply with the Clean Power Program.

IRS Audits- A Nightmare to all Tax Payers

Though the Internal Revenue Service (IRS) allows taxpayers various means to save on taxes, it is the duty of the payee to keep precise records to the deductions in the audit. Organizing the tax records all through the year will make it easy for you to prepare your tax return and reduce the chances of errors. It will also allow you to build your defense if the IRS seeks to dispute your return. Here are a few best practices that any tax payer must follow to defend themselves against IRS disputes.

1.   Maintain records for at least three years of tax returns
2. Categorize your receipts from all purchases throughout the year
3. Maintain your checkbook stubs
4.  File every bill in organized folders
5. Track the cost basis for all taxable investments
6. Journal deductible items as and when they occur

You may be slapped with penalties depending on your nature of underpayment.

In case of serious under payments resulting from fraud, you may be slapped with 75% penalty.  For tax violations and more serious case of tax evasion, the person could be convicted to prison. In toto audits are unpleasant but you need not dread them if you have kept the financial records organized and up to date.

To learn more on the importance of Pre-planning an anticipated audit, how to analyze an Information Document Request (IDR), and how to solicit a client's cooperation in developing an Audit Plan attend this webinar IRS Audits – Step by Step

What is an EDC system or Electronic Data Capture System?

An EDC system is a software for storing patient data that are collected during clinical trials. Usually the data is first recorded on paper, and then transcribed into the system and stored in an electronic case report form (eCRF). Today almost all clinical trials are using EDC software to replace paper records with electronic records. EDC systems are being adopted by sponsors, contract research organizations (CROs), and sites to carry out both simple and complex trials in all phases of research. Though there are a lot of EDC vendors, a few organizations build their own in-house system. Most EDC systems offer diverse features, but generally EDC software is designed to rationalize data collection.

The advantages of EDC systems over paper records are:

1     Data security
2.   Easy access to the data
3.   Organization
4.    Accuracy
5.    Compliance
6.    Cheaper

How to choose investigators who can be compliant with FDA inspectional requirements for electronic data capture and direct data entry? How to identify study data elements that require hard copy source documentation? How to design your e CRF to address the origination, authorization, and signature inspectional requirements To get answers for all these questions attend the webinar FDA Electronic Data Capture Guidance - What is the impact on Investigator Site Inspectional Source Record Requirements?

Deficits in Telecommuting

Telecommuting is a typical arrangement by which an employee works away from the worksite (such as working from home or library, or business center) for a specific time of period.

The purpose of the Telecommuting concept is to create flexible working conditions to employees to help them integrate their work lives and personal lives more effectively and better manage issues such as care giving, commuting, community service and continuing education. Successful telecommuting arrangements serve the needs both of individual employees and their unit/departments. The focus of the arrangement is on meeting operational needs and job performance.  It is mandatory to have a written agreement clarifying both parties’ expectations for telecommuting purpose. 

To learn more on what are the legal risks involved in "telecommuting" and employees working from home? How do you protect safety sensitive information when employees are working outside the office? How do you keep up with “hours worked” for those who are not exempt under the Fair Labor Standards Act? Attend this webinar Legal Risks & Issues in the Virtual and Telecommuting Working Environment

Customer Centricity in Healthcare Industry

Off late like any other industry the healthcare organizations also started to recognize that a consumer-driven model of care has become the latest norm. As per the consumer psychology, they make the buying decisions based on how they connect with a brand or company, and this is applicable to even the health care industry, for example if a patient is made to wait or he/she do not understand how his/her bill was calculated, they will move to other organization for treatment.

Here are four tips to ensure customer centricity in healthcare industry.

• 1     Provide better access- Patients expect healthcare services to be more accessible from home or wherever they are. Healthcare providers must provide more flexibility, home visits and telemedicine facility.
• 2  No more waiting in queues—It irks a patient to wait to see the doctor in spite of obtaining an appointment. In order to fix this issue the healthcare organization must work robust on scheduling the appointments and treating the patients with courtesy and giving them the privileges of a valued customer.
• 3    Revamping cost- The key objectives of any patient are better service at less cost. To deliver these two an organization must work on a more effective model that brings down the cost and provide value for money services by enhancing the quality for the target patient customers.
• 4   Seek experts help-If the health care personnel do not have ample expertise to lead an organization to such a wide transformation, he must seek the help of an expert to ensure support in delivering a more customer-centric experience on the right path.

To learn more on what and why customer centricity is important to healthcare? Why have we moved from provider-centered focus to patient-centered focus? The impact that a patient-centered focus has on healthcare operations? Attend this Webinar Customer Centricity and Quality Management in Healthcare

Dos and Don’ts in presenting a Property Insurance Claim

You have met with property damage to your home or business. What to do now? How to present an insurance claim? If you already have an insurance policy, then that insurance policy is a contract between you and the insurance company. It defines what are the things to be done and what should not be done after you have had a claim. If you fail to comply with the policy’s terms, it may end up in your claim not being paid. Most people go for a home insurance policy during the closing process, without actually looking at its terms and conditions. You realize many aspects of the policy only when you are forced to make a claim. Here are a few tips for making a successful property insurance claim. 

Dos

1. Read your policy thoroughly before submitting a claim.
2. Secure your property to prevent additional damage
3. Notify your insurance company/agent
4. Find a temporary workplace/housing
5. Get professional help to overcome the red tape
6. Create a detailed inventory of damaged property

Don'ts

1. Do not throw anything away
2. Do not begin repairs until you get the insurance company’s approval
3. Never assume you have to use the insurance company’s vendors
4. Never allow your settlement to be paid to other parties
5. Never respond after replacing/repairing the property

For more info attend this webinar How to Successfully Present a Property Insurance Claim

Date: Friday, 30 October 2015 | Time: 11:30 AM PDT, 02:30 PM EDT | Duration: 90 Minutes. If you cannot make it on the scheduled day, you can always buy our recorded session of the same anytime.

Methods for Financial Statement Analysis

The huge number that appears on the financial statement of a company could be intimidating to the investors. But analyzing the financial statements will open a goldmine of information in front of you. Companies use financial statements to disclose information regarding financial performance. These statements could be used for analyzing whether to make investments in a company or not.

What are the key methods for analyzing financial statements? There are two main methods of analyzing a financial statement the first method is the use of horizontal and vertical methods and the second method is the use of ratios.

Horizontal analysis involves the comparison of financial information over a series of reporting periods, whereas vertical analysis method means the proportional analysis of a financial statement. This means every line term on a financial statement is stated as a percentage of gross sales, each line item on a balance sheet is considered as a percentage of total assets.

The second method for financial statement analysis is the use of many types of ratios. Ratios are used to calculate the relative size of one number in a relation to another. Once the ratio is calculated you can compare it with the same ratio calculated for a prior period or that is based on a certain industry average, to judge if analyzing financial statements is the use of many kinds of ratios. You use ratios to the company is performing in accordance with expectations.

To understand more on the different types of financial statements and what their intended purpose is, how to identify key operating trends and prepare financial ratios on a company's financial statements, the importance of reading the footnotes that accompany financial statements and provide an understanding of how these footnotes often hide important messages attend this webinar How to Analyze Financial Statements and Uncover the Key Trends and Hidden Messages

Identification and Evaluation of Environmental Aspects

http://www.onlinecompliancepanel.com/webinar/RecentUpdates-ISO14001-501077/OCT-2015-SM

Environmental aspect of the product could be anything for example it could be the product packaging or the recyclability of the product at the end of its life cycle. According to ISO 14001, an organization must identify environmental aspects and determine those aspects that can have considerable impact to the environment. Keep a register on general environmental aspects, which is regularly updated.

Environmental aspects could be classified as direct and indirect. In order to identify the environmental aspects, a person must study how the activities and services of an organization are affecting the environment.  While identifying environmental aspects the elements which are usually considered are missions, releases to land and water, raw materials used, natural resources and impacts on the biodiversity.

Other vital techniques that could be used to evaluate environmental aspects are value chain method, materials identification method, value chain method, process flow method and value chain method.

To learn more on Recent updates on ISO 14001 attend this webinar Recent updates on ISO 14001

How to Optimize Excel Charts

Optimizing Excel Charts
Microsoft Excel Charts have evolved over the years. The functionality of the charts in Excel 2007 is almost similar to Excel 2010, while chart functionality in Excel 2013 and 2016 are almost same.
There are a number of techniques that could be used to optimize, automate, and tweak Excel charts. Creating and working with Excel charts-which can convey much more than just a sheet filled with numbers-is easy. Because charts display data in a variety of ways, using the most appropriate chart type and format enables you to display your data in the best meaningful way.

David H. Ringstrom teaches how to streamline creating and managing charts, and explores nuances that often slow Excel users down through the best selling webinar Optimizing Excel Charts

Significance of Food Recall

Plenty of control measures are being taken by food manufacturers to ensure product safety. Sometimes there are some adverse situations wherein a product manufactured and sold in the market is defective and some people fall sick or get injured, or is not in compliance with the legislation. In such a situation when a problem product has left the control of the manufacturer, it must be removed from the market or recalled.

The concern for food safety to your customers and employees must be a constant focus for all operators in the system. Ultimately, how well your company manages the crisis situations will make significant difference in how your company brand is perceived in the public's eyes and how well it succeeds in today's highly competitive marketplace. Most importantly failure to ensure food safety can jeopardize the health of your customers and could be detrimental to your business and reputation.

To understand why your company should have a crisis management plan, why having an effective product recall is critical in your company, FDA Food Safety Modernization Act, how to develop an effective crisis management program for food recall attend this webinar by Angeline Benjamin “Planning and Conducting an Effective Food Recall” Angeline Benjamin is the president of B&B Food Safety Solutions, a food safety consulting firm. She has been in the quality assurance and food safety businesses for over 30 years. Angeline began her quality assurance career at Hunt-Wesson Foods. http://www.onlinecompliancepanel.com/webinar/EffectiveFoodRecall-501024/OCT-2015-SM

Common HMDA Reporting Requirements and Mitigation Steps

The Home Mortgage Disclosure Act (HMDA) demands covered institutions to make loan information readily available to the public. Public, industry leaders and the regulators rely on this data to analyze the performance of mortgage lenders in achieving goals that are achieved under the Equal credit Opportunity Act and the Fair Housing Act and the Community Reinvestment act. Incorrect HMDA data hurdles efforts to track discriminatory patterns that might exist in home mortgage lending and other compliance violations.

The major four errors in HMDA reporting are as follows. Errors in recording any one of these three variables will give incorrect calculations.

• Failure to Capture All HMDA-Reportable Transactions
• Inaccurate Loan Amount
• Incorrect Geocoding
• Wrong Rate Spread Calculation

Some of these mistakes are considered more significant than others. Some are more common than others. If the number of mistakes is high, it can result in rework and even fines. This can lead to loss of trust in your institution by regulators, which is never a good thing.

To learn the significance of HMDA reports, common mistakes in HMDA reports and how to reduce errors attend this webinar http://www.onlinecompliancepanel.com/webinar/HMDA-ReportingMistakes-501070/OCT-2015-SM

Differences between Device and Drug Regulation

Differences between Device and Drug Regulation

http://www.onlinecompliancepanel.com/webinar/DeviceAndDrugResearch-501007/OCT-2015-SM

Here are a few definitions: Clinical investigation is nothing but an investigation involving a test article and one or more than one human subjects.

A Drug is known as a substance recognized by an official pharmacopoeia or formulary. Drug is a substance used in diagnosis, treatments or prevention of a disease.

An investigational Drug means a new drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.

Research Involving Drugs Exempt from IND Requirements: Research Involving Drugs Exempt from IND Requirements means a clinical research of a marketed drug (i.e, an FDA-approved drug) is exempt from the IND requirements if every criteria for exemption are truly met: The drug product is marketed in the United States lawfully; the investigation is not planned to be reported to the FDA as a well-controlled study supporting a new indication and there is no intent to use it to support any other major change in the labeling of the drug. As per the Investigational Device Exemption regulations there are three types of device investigations: Exempt Device Studies, Non-significant Risk (NSR) Device Studies and Significant Risk (SR) Device Studies.

Clinical Investigation: The term Clinical Investigation refers to any research involving one or more than one subjects to determine the safety and effectiveness of a device.

http://www.onlinecompliancepanel.com/webinar/DeviceAndDrugResearch-501007/OCT-2015-SMThis webinar will discuss the differences between device and drug clinical research and the current regulations governing the use of drugs and devices in a clinical study.

Orphan Drug Act

http://bit.ly/ClinicalResearchStudies 

Rare diseases (RDs) are significant public-health issue and they pose a challenge to the medical community. These rare diseases are called ‘health orphans’, because research and developments have neglected them for years due to many RED challenges. Amendments were made to the existing law in the 1960s, mandating that every drug must be proven to be safe and effective through ‘adequate and well-controlled studies’ before getting market approval. Then raising drug development cost ended in drugs for small disease populations being ‘orphaned’ by many top drug companies.

Congressional Findings for the Orphan Drug Act

(1) There are many diseases and conditions, such as Myoclonus, Huntington's disease, ALS (Lou Gehrig's disease), muscular dystrophy and Tourette syndrome, which affect a few individuals residing in the United States that the diseases and conditions are regarded as rare in the United States

(2) Satisfactory number of drugs for treatment of many of such diseases and conditions has not been developed

(3) Drugs for such diseases and conditions are generally referred to as "orphan drugs"

(4) Because very few individuals are affected by such rare diseases or conditions, a pharmaceutical company which develops an orphan drug may expect the drug to generate moderately small sales when compared with the cost of developing the drug and consequently to incur a financial loss

(5) There is reason to believe that some promising orphan drugs will not be developed unless changes are made in the applicable Federal laws to reduce the costs of developing such drugs and to provide financial incentives to develop such drugs; and it is in the public interest to provide such changes and incentives for the development of orphan drugs.

The Orphan Drug Act began many years ago and now, many believe that this is not the best use of resources. Attend the webinar “Orphan Drugs: The Conundrum” by Marybeth Regan, to learn more about the topic.

State-Wise Rules on Mail Order Pharmacy in the USA

http://bit.ly/PharmaRegulatoryCompliance 

Many pharmacies are developing and expanding compounding practices. Based on the uniqueness of the practice, these pharmacies can increase earnings substantially by developing a mail order component and marketing their practice to patients in other states. This program would serve as a guide to enable these pharmacies to expand into mail order. 

Here are the state-wise rules on Mail Order Pharmacy in the USA.

California and Texas

California and Texas require nonresident pharmacies to register with the regulatory board, but do not require them to submit prescription data. 

Georgia and Pennsylvania

Georgia and Pennsylvania neither require nonresident pharmacies to submit prescription data nor dothey require them to be licensed to do business in the state.

Nebraska and Wisconsin

Nebraska and Wisconsin require nonresident pharmacies to be licensed, permitted and/or registered in their state; however, neither Nebraska nor Wisconsin has regulations in place at this time regarding submission of PMP data.

Massachusetts

Massachusetts requires nonresident pharmacies to submit prescription information to the state PMP by rule.  However, there is no corresponding requirement for a nonresident pharmacy to be licensed, registered or permitted by the regulatory board.  Therefore, the Massachusetts PMP has no authority to require nonresident pharmacies to report prescription data.

Alabama

Alabama law requires every mail-order house (also known as a “nonresident pharmacy”)located outside of Alabamathatdispenses drugs or medicines to anywhere inside the state of Alabama obtain a permit from the State Board of Pharmacy.  Alabama regulation requires that every nonresident pharmacy comply with all statutory and regulatory requirements for controlled substances

New Jersey

All pharmacies permitted by the New Jersey Board of Pharmacy are required to submit information about controlled substance prescriptions to the state PMP.  All nonresident pharmacies that ship, mail, distribute or deliver in any manner into the state of New Jersey are required to be registered with the board.

New Mexico

The New Mexico Board of Pharmacy shall monitor the dispensing of all Schedule II, III, IV and V controlled substances by all pharmacies licensed to dispense such substances to patients in the state of New Mexico.  No nonresident pharmacy shall ship, mail or deliver prescription drugs to a patient in New Mexico unless it is first licensed by the Board. 

Washington

Nonresident pharmacies located outside of Washington that ship, mail, or deliver, in any manner, controlled substances, legend drugs, or devices into Washington must be licensed by the department of health and must submit all transactions involving patients with a Washington zip code to the PMP.

http://bit.ly/PharmaRegulatoryCompliance Attend this webinar to know more on the advantages and pitfalls for pharmacy and pharmacist licensure in other states.

Why do you need to use Indemnification Clauses?

Indemnification is a contractual obligation by one party to pay or compensate for the loss or damage example one of your careless consultants leaves certain equipment on the ground causing a visitor to trip over it and injures himself/herself. The visitor sues you because the accident occurred on your office premises. What will you do? If there was an indemnification clause in the contract between you and your consultant, you can seek the consultant to reimburse the amount that you had to pay to the injured. This clearly explains how you can shift the responsibility for payment to the concerned party who caused the injury.

or liability incurred by another party to the contract or by some third person. For

Indemnity is not necessarily limited to personal injuries or property damage. It can also apply to contractual obligations.

Register for the webinar by Kenneth A. Sprang  “IndemnificationClauses: Protecting your Company When Drafting Contracts” to understand significance of the clause deeper.

Health Care Marketing Program

Marketing is one amongst the least understood functions in mainstream health care. This is part as a result of the necessity to vie within the public forum is new to the trade, part as a result of the mediums and technologies have dramatically modified and part as a result of there are so few experienced people with combined trade, technology and marketing experience.

Why is marketing so vital now? 3 reasons: 

Medical technology has created outcomes a lot of consistent and also the internet has created patients a lot of educated; High insurance deductibles drive increasing consumerism wherever eight of 10 people currently choose their suppliers mistreatment search engines, and eight of 10 of them use Google and Service, convenience and perceived value are on par, and will shortly succeed, delivering sensible clinical outcomes, that are currently generically expected.

Competing effectively, and dominating your specialty, is increasingly vital as a result of the current delivery and compensation system is financially unsustainable. those who fail to adapt can possible fail to survive. Size goes to matter because there are crucial efficiencies in scale and volume which will build the distinction.

Marketing is an investment that brings massive returns with the correct partner, and prices dearly with the incorrect one. selling isn't a website, search engine optimization or marketing, advertising, hoarding or pamphlet though plenty of purveyors of these services want you to think thus. Those are simply techniques to support ways that are driven and changed by applied math analysis - which takes experience, deep understanding of the health provision system and knowledge. As Thomas Edison once magnificently aforesaid regarding invention, selling is "99% perspiration and one hundred and twenty fifth inspiration."

Marketing is knowing wherever the competition is vulnerable and wherever you're robust, becoming excellent at the former and higher at the latter - and adapting. it's understanding what the term "patient experience" extremely means and delivering superior service with consistency, competency and a smile. It's hiring people who match your culture, and basing your culture on excellence, clinically, social control and service-wise. it's setting clear goals supported by skilled strategic designing, determinant the simplest combination of techniques and mensuration the results.

It is straightforward for marketers to create claims, thus however does one understand what you're obtaining is working? you cannot fix what you cannot live, and you do not understand what desires fixing while not knowing however it should perform. Our recommendation - follow the money.

When we have a tendency to place during a dollar, expect it to come back ten in revenue at intervals an inexpensive amount of your time. We have a tendency to live output perpetually, calibrate for accuracy and regulate for optimum performance. Once mistreatment solely 2 or 3 techniques without an overall strategy, we have a tendency to expect a come back of 5 to at least one.

Most vendors, particularly advertisers, website developers and search engine optimization professionals, tout their ability to drive traffic, the best metric to attain.

The hard part is to drive quality inquiries, capture and convert them into patients, retain them as patients and earn their referrals. that's what marketers do - and that they count the money, not simply the cars.

Investing during a comprehensive selling program isn't creating a bet; it's stacking the deck, taking part in a full hand and investigation the cards. A comprehensive, expertly managed marketing program can deliver, maintain dominance and secure your future. Check out this link for more knowledge Effective and Compliant Health Care Marketing Program

Hazard Recognition and Assessment

A hazard is a condition, situation, practice or a combination of all these that causes injury or illness to people or damage to property. Hazards that are uncontrolled could cause issues that range from minor illness to hazardous consequences or even death to some individuals.

Business owners must pay serious attention to hazards as it could harm workers. Identifying, assessing and controlling hazards are vital part of a quality safety program. Hazards could be classified into two: Health hazards and safety hazards. Health Hazards could be further classified to 1) Chemical hazards — any form of chemical such as compressed gases, lead, solvents and others. 2) Physical Hazards-- Noise, heat, vibration, radiation and cold. 3) Ergonomic Hazards -- Design of the jobs that involve repetition, force and posture. 4) Biological—Toxins produced by living things that could cause diseases or illness in humans (e.g., viruses, bacteria, fungi, parasites and insects). 

Safety Hazards could be further classified into 1) Machine: Hazards from machines include injury from a moving part of a machine like rotating shafts, pulleys, belts, blades and saws. 2) Energy: energy hazards could include hydraulic pressure, steam, pneumatic, and electricity. 3) Material Handling: Material handling hazard includes mechanical and manual handling like lift trucks, lifting, and conveyors. 4) Work Practices: includes not following the safe work practice guidelines.

The only solution to avoid such mishaps are to follow the hazards recognition techniques. The more hazard recognition techniques that we know, the more are our chances to recognize all hazards that exist in workplaces. A hazard may not be recognized by a certain method, but it could be detected by another method. Principally, we need to ascertain that hazard recognition is performed completely.

Here are a few useful hazard recognition methods:

• Pre-Use Analysis
• Multi-Step Planning Process
• Work Permitting
• Equipment Inspections
• Suggestion Method
• Walk through Safety and Health Audits
• Safety Patrol

Check out http://bit.ly/SafetyAwarenessTraining if you are looking for new ideas to improve safety or are developing a safety program. If you are a manager and want useful, measurable safety activities for your supervisors this http://bit.ly/SafetyAwarenessTraining will help. 

FDA Final Rule on Electronic Medical Device Reporting

The FDA published a final notice on electronic medical device reporting on Feb. 13, 2014, that requires importers and manufacturers to submit medical device reports to the FDA in an electronic format that could be processed, reviewed and archived.

The two choices for submitting an electronic report are:  eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR). Importers and manufacturers Manufacturers and importers will have until Aug. 13, 2015 to begin submitting all MDR reports electronically. In case you fail to meet this date, you must request to obtain an exception from electronic reporting to continue reporting using hardcopy past August 13, 20015.

The two choices for electronic submission of reports are eSubmitter and HL7 ICSR.

E Submitter: The eSubmitter application which is developed by the FDA could be used to send one report at a time. Alternatively an entity can use the HL7 ICSR standard to develop its own application and batch reporting. E Submitter is a free and downloadable application that permits submission of only one MDR at a time. Hence this option best suits for low volume reporters.

HL7 ICSR: The HL7 ICSR submission method allows reporters to submit MDRs either as a batch or individually as XML files from their own complaint handling system.

E-MDR makes use of the FDA Electronic Submissions Gateway, (ESG), which is an agency-wide entry point for all electronic submissions, to receive electronic MDRs.  The requirements to submit MDRs electronically are:  Set up a Web Trader Account and then submit test data that is processed successfully through the FDA’s ESG before receiving a production account for MDR submission. 

The steps you must follow are: First request a Web Trader Account from the ESG. Follow the ESG instructions on compliance submission, submit and then prepare a test eMDR. The scenarios are: Receive an ESG production account, and use the production account to send your real eMDRs to the FDA.

Learn more about FDA final rule on Electronic Medical Device Reporting so your company can be ready through this webinar http://bit.ly/eMedicalDeviceReporting

Sterilization of Health care Products-ISO 11135:2014

Ethylene Oxide Sterilizer

Ethylene oxide (EtO), which was discovered during the late 1850s was first used as a sterilant during EtO sterilization a viable option for numerous moisture, heat, or radiation sensitive medical products.

the 1940s. Its popularity began to fade in the latter years because of the toxicity. Developments in EtO process technology along with improvement in residual limits have kept this sterilization process as the best sterilization choice for manufacturers. The compatibility of EtO with a broad range of material and its property of chemical molecule penetration in a less aggressive sterilization environment compared with alternative techniques make

Manufacturers and healthcare facilities have been provided with an outline for the establishment and validation of an EtO sterilization process for more than two decades by the ISO 11135 standard. In July 2014, ISO 11135:2014 was published to replace ISO 11135-1:2007 and ISO/TS 11135-2:2008 with a 36-month transition period.

Manufacturers need to have control of their sterilization processes; and thus they must take ownership by conducting a gap analysis between the previous version of the standard and the revised standard (2014), and evaluate the current sterilization program’s impact.

Medical device manufacturers interested in ethylene oxide sterilization can learn about the Changes to Ethylene Oxide sterilization in the new ISO 11135:2014 now at onlinecompliancepanel.

How To Prevent Purchase Card Fraud

In order to combat Purchase card fraud or control purchases made with a Purchase Card or P-card, every organization must establish a fraud monitoring policy with regard to use of company P-cards and train all employees with newly issued P-cards and limit purchases to approved merchants. A Purchasing Card is one form of a Commercial Card that permits any organization to make use of the existing credit card infrastructure to create business-to-business (B2B) electronic payments for a variety of business expenses.

1. Tips to combat P-card fraud:
2. Make it clear to all employees that if they are found to have committed fraud, their card will be canceled and they will be subject to disciplinary action or may be prosecuted for criminal activity.
3. There are times when some of your employees might try to produce photocopied receipts of expense reports, in such cases, do not accept. Request employees to ask merchants for a detailed receipt if one is not provided, ask the cardholders to provide a detailed business purpose for each transaction.
4. Whenever you find any suspected split payments by an employee, request the cardholders to review and sign the monthly card statements —if those statements are sent to them rather than to your organization and also request them to produce itemized receipts for all purchases, even if the merchandise was subsequently returned to the vendor.
5. Under circumstances where you find sudden unusual drift in a particular employee's monthly P-Card purchases, the manager in charge of approving and signing employee P-card reimbursement claims or expense reports must carefully review all documentation, prior to signing it. It is also the duty of the managers to review any transactions identified by AP staff as unusual.
6. In order to curb unusual transactions by an employee, an organization must determine whether controls and procedures over purchase and payment for goods and services using purchase cards were adequate to ensure that vendor payments were made according to the policy. 
7. Always determine if all P-cards are issued in accordance with the Policy, verify if changes to existing cards are properly monitored and approved and all cards in circulation are accounted for and used by authorized employees.

Also refer http://bit.ly/Purchasecard-fraud-prevention