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

UPDATED OSHA Regulations-2015

Accurate record keeping plays a very important role in each company. At the least, employers will be more effective managing human resource's policies and it will protect a leader from potential lawsuits, fines and penalties. Here is a quick review of the eight most significant documents - what they're and for a way long they need to be kept.

In general, all records should be maintained for a minimum number of years. The time varies from document to document, and employers ought to ensure that records are secured in a location that's solely accessible to authorized personnel. Once permissible to be discarded, they ought to be destroyed in associate degree in an appropriate manner, like shredding or fully erasing from digital storage.

The following is a quick review of the eight record categories:

Hiring Records

Hiring records embody ads and postings for open positions, resumes, job applications, pre-employment tests and reference checks. Records for employed staff should be filed in their personnel file. Documents for candidates not chosen should still be kept in an human file. 
These documents should be kept for a minimum of two years when the utilization has concluded.

Employee Personnel Files

Employee personnel files usually include the employee's title, classification and job description. It should additionally contain their offer letter, performance reviews, promotion and/or demotion details, attendance and leave-of-absence notices, disciplinary notices, training, testing (including certificates), requests for reasonable accommodations and acknowledgements that they received and reviewed the corporate policies and worker vade mecum.

These documents should be saved in an exceedingly secure location for three years following the tip of the utilization relationship.

Payroll & Wage Records

Payroll records include the employee's name, date of birth, address, Social Security range, job title and outline, terms of employment, pay rates, any union or worker contracts, daily and weekly operating hours, total wages paid every pay-period, internet wages paid, and meal periods.
Employee wage records embody the subsequent info, if applicable: wage rate calculation tables, piece rates, time cards as well as the employee's hours and days worked, and shift schedules. Payroll and wage records should be preserved for a minimum of four years following employment.

I-9 Forms

Employers are needed to finish the Immigration and Naturalization Service's Employment Eligibility Verification kind, otherwise referred to as the I-9 kind. They must include info regarding the identity of all staff and their authorization to figure within the U.S. 
Records should be saved for three years when employment or one year when termination, whichever happens later. I-9s should be kept in an exceedingly common workers file, instead of keeping in every individual's personnel file.

Employee advantages information

Employee advantages information includes ERISA, or the employee Retirement income Security Act, oversees' retirement and other employee benefits. Employers should maintain COBRA notices, any records supporting info found within the benefit summary plan descriptions (SPDs), and records referring to eligibility for advantages below ERISA.

These documents should typically be preserved for 6 years in case of termination of employment. However, records concerning an employee's profit eligibility determination should be kept as long as relevant.

FMLA/CFRA

The Family and Medical Leave Act permits eligible staff to up to twelve weeks of unpaid leave inside a 12-month amount. Request documentation should be kept in the employee's personnel file. However, if there are specific medical necessities or details of requests (such as a medical diagnosis), these should be placed within the employee's medical or health file.

This info should be saved for 4 years.

Employee Health Records

Employee health records include drug and alcohol testing records, pre-employment physicals, medical exams, job injuries, authority records and specific medical files.

In general, worker health records should be saved for5 years. However, any records of a medical exam needed by the authority or ensuing from exposure to cyanogenic or risky materials should be unbroken for 30 years.

Workers Compensation

Any documentation concerning a work-injury should be saved in a separate file. It should embody the employee's name, the claim range, date of injury, a record if the claim is reported  as indemnity or medical-only, and a note if there has been a denial.

Workers comp documentation should be kept for a minimum of five years from the date of injury or one year from the last date the worker received compensation.

This is a brief overview of the most necessary documentation as required by law. Track this link for more details OSHA Training-OSHA Regulations 2015-OSHA Reporting 2015

Saas Applications and Cloud Technology Services

SaaS applications and Cloud services have transformed into major players in the IT marketplace serving life science regulated industries such as Good Practices in Clinical (GCP), Laboratory (GLP), and Manufacturing (GMP) or GXP. Software as a Service (SaaS) uses cloud computing for delivering a single application to multiple users, regardless of their location, rather than the traditional model of one application per desktop. It permits to manage activities from central locations in a one-to-many model, including pricing and management characteristics.

Why should anyone consider Saas? Here are the top 5 reasons to consider SaaS.

• ·         Adopt SaaS for shifting IT budget to operational expense from capital expense.
• ·         Adopt SaaS to lower the expenses in the near term associated with software acquisitions.
• ·       SaaS could be beneficial when you require to re-focus your IT staff from setting up and maintaining high-priority projects.
• ·        Consider Saas when you have only limited IT resources to set up and maintain hardware and software needed.
• ·         Adopt SaaS when you require bringing down consumption of energy and expense.

What are the benefits of the SaaS model? Have a look:

• ·         Saas is easy to administer
• ·         Saas provides simple automatic updates and patch management
• ·         SaaS is compatible; it provides the same version of software to all users.
• ·         SaaS is easy to collaborate
• ·         It is accessible globally.

Are you new to SaaS? If you have just started exploring the concept of SaaS, and you wish to find out what SaaS can do for you, how SaaS is different,  how to learn more about developing SaaS applications? All your questions will be answered by an expert trainer Teri Stokes . Click to learn http://bit.ly/ComputerValidation

How is the California Wage and Hour Law Different from Other States?

A majority of multi state employers often find themselves doing business in one way in forty-nine other states of the USA and entirely different way in California as the compliance obligations enforced by the wage and hour law in California is unique and varies from other states. So a California employer requires to identify and bond with an expert HR professional in order to avoid the many traps posed by state and federal wage and hour law compliance obligations.

As per the California law, an employer can offer "comp" time in lieu of overtime; but Federal law does not. Federal wage and hour law does not "preempt" state law on the same subject; the employers in California are required to follow the applicable legal provision favorable to employees in any situation.

The Federal law and California law, both create a lot of specific "exemptions," but the requirements of Federal and California law often differ from one another in describing the requirements needed for an employee to qualify for a particular exemption. As per California's laws an exempt employee must exercise discretion and independency in judgment in "matters of consequence" of "real and substantial significance to policies or general business operations."

California law provides all employees who are state licensed or certified and primarily engaged in the practice of law, accounting, medicine, teaching, architecture, optometry, dentistry and engineering can be considered exempt professionals. Taking into consideration the modern day Computer Professional exemption, a California employee may be exempt in case he/she is involved in executing duties including application of systems analysis techniques and measures to determine hardware, software, or functional specifications. An exempt computer professional may also be involved in the development, design, documentation, creation, analysis, testing, or modification of computer systems or programs based on user specifications or design specifications. Another aspect of California wage and hour law which differs from Federal law is the requirement that all non-exempt employees and employees classified under limited exemptions such as inside sales, receive daily meal and rest break periods.

FDA PAT-Concept, Regulatory Impact

What is FDA PAT Initiative and how to comply with innovation requirements? Process Analytical PAT approach allows better focus to be placed on relevant multi-factorial relationships. It also serves as a basis for identifying and understanding relationships among critical formulation and process factors and for generating effective risk mitigation strategies (e.g., product specifications, process controls, training). The PAT mechanism for producing product quality & reducing waste presents a good case for utilizing continuous manufacturing technologies. What are the fundamental concepts behind the FDA PAT initiative and how PAT provides a good source of information for anyone involved in risk mitigation and regulatory compliance? Expert speaker Michael Levin provides answers to these queries in his webinar http://bit.ly/ProcessAnalyticalTechnology

How to Use Features in Excel to Minimize Data Integrity Risks

Dashboards empower Excel users to condense large amount of information into easy to read summaries while preserving the ability to dive deep into the details when needed. Dashboard reports provide the managers with high-level overview of the business. Excel is the best tool to create powerful dashboards that can provide analysis and alert managers on a timely manner. Excel dashboards are extremely modular and it is very easy for users to replace a chart or table that requires to be removed or replaced.

 Dashboard reports permits managers to gain high-level overview of the business and help them make quick decisions. Dashboards are often called as information dashboards or management dashboards or dashboard reports.

A Dashboard could be created using many tools. However, Microsoft Excel is the best choice for creating and distributing dashboards because it is easy to use and available universally. Using Microsoft Excel, users can monitor, and visually display vital information for quick response or feedback. Excel is an exceptional tool for data reporting. Excel Reports permits users to resolve the effect predictions using the receiving data. The performance point dashboard platform can cause sophisticated charts, and allow for a common look and feel that users will be comfortable with in the beginning. Register for this Excel crash course to learn indept: http://bit.ly/MSExcel-OnlineTraining

How to protect your organization from penalties and exclusions?

The Civil Money Penalties Law (CMPL) gives the authorization power to the Secretary of Health and Human Services to enforce civil money penalties, an assessment, and program exclusion for different forms of fraud and abuse, which includes the Medicaid and Medicare programs. The monetary sanctions imposed usually exceed the damages sustained by the government.

As a health care executive, physician or other health care provider, one should be very concerned about the potential for liability under the fraud and abuse laws. Under recently enacted health care laws, enforcement activity and health care fraud task forces have been greatly enhanced. This raises the specter of being charged with false and fraudulent activity and being sanctioned and or being excluded from these programs under the Civil Monetary Penalties Law. Learn more on Civil Monetary Penalties Law at  http://bit.ly/CivilMonetaryPenaltiesLaw

Dos and Don’ts while engaging in social Networking: NLRB

Recently the National Labor Relations Board (NLRB) decided that disciplining employees for social media posts that constitute "concerted activity" violates the National Labor Relations Act. This is true even in non-unionized workplaces. The NLRB has also determined many clauses that in employer's social media policies violate the National Labor Relations Act.

Here are a few dos and don’ts that must be adopted by any employee while engaging in social media. Since social media is mostly on engaging people always remember to us a warm and mild language. The tone must be set in such a way that it encourages others to respond to your postings. Be professional while choosing the words. Never make defamatory statements.

An employer can prohibit employee from posting anything on the Internet in the name of the employer without prior written authorization from the president or a designated agent.  The basic enforced requirement is that  employees must be respectful, must be aware of the rules and follow the same, be honest and accurate, not retaliate, and post only appropriate and respectful content. The employer could request the employees to respect financial disclosure laws on social media and to not create a link from their social networking site or blog to an employer website without adequate notice or  identifying himself or herself as an employer associate.

To learn more visit The NLRB and the Social Media .

How to implement an EHS Plant Operating Manual

All elements of managing Environment, Health and Safety (EHS) at the plant level and placing them into an easily understood and usable manual are highly recommended for all organizations. The manual breaks all activities and requirements into various tabs. With the help of these tabs the manager can move from area to area to ensure issues are being addressed and satisfied. The manual is the ideal training document for those entering EHS. It takes the massive amount of paper associated with carrying out the EHS function and provides easy access and understanding. To learn more click Developing-EHS manual- EHS management system.

Fair Hearings from a Hearing Officer's Perspective

Generally, every medical staff member has the right to a fair hearing in case they are accused of technical incompetence or unprofessional behavior, but ensuring a truly fair process can be difficult. There are certain key dos and don’ts to help make your fair hearing process just.

Too often, organizations fail to follow their own procedures, leading to sometimes catastrophic
circumstances. There is no excuse for failing to provide the affected practitioner due process because clear directions were not followed.

In order to apply for a fair hearing, you need to understand how to develop the application process to take into account what information is required to support the application with regard to education and training, references prior practice, and prior adverse actions and liability settlements. Other vital information to be aware of are: what information should be solicited from other hospitals where the applicant claims to have privileges. It is important that the information solicited be specific, leaving no room for gaps. What are the elements of good, clear and concise bylaws, fair hearing plans and other policies. The importance of not only having these documents but following them to the letter will be emphasized. Click to learn everything about Medical Staff Fair Hearings from a Hearing Officer's Perspective.