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An Introduction to CLIA Regulations and Facilitation Software for CLIA Regulated Industries

By: Marci Lynn Crane

The CLIA regulations (Clinical Laboratory Improvement Amendments), like many regulations, were a response to less than desirable situations. Like Upton Sinclair?s The Jungle (and other manifestations of a heightened awareness of unsafe food handling environments and techniques) resulted in the passing of the Food, Drug and Cosmetic Act of 1906, it was the incidents regarding erroneous clinical laboratory procedures that brought about the CLIA regulations in the 1980s.

CLIA and Technology

In conjunction with increasing regulations and process recommendations for handling those regulations, it?s no wonder that software developers are busily creating the ?soft? technology that can manage rote regulatory procedures for doctors, laboratories and other life science organizations or individuals. However, finding the software that will effectively mange and streamline documentation and processes associated with CLIA regulations isn?t always an easy task. In fact, when searching online for quality software solutions, a life science professional might find that many software solutions are designed with the manufacturing environment in mind, which is fine as long as the software solution can also provide the following features and benefits:

Look for Software that Provides Document Control

CLIA regulations require (see section 493.1200) documentation, and documentation is always easier to control electronically. Look for a software solution that streamlines processes electronically. In addition, search for a solution that is web-based and easy to access from virtually anywhere. Document control features should also include automation capabilities. For example, document routing and approval should be able to be automated during the implementation of the software. Escalation capabilities should also be automated for best results—on time.

Look for Software that Manages CLIA related Training

Whether in regards to compliance or quality, in a laboratory, employees are going to require continuous training. The CLIA regulations require (see section 493.1445) that training policies and procedural documentation be created and adhered to. So, in addition to the software solution that manages document control, search for a software solution that also provides training management. The solution should include the control of training documentation, and should also provide customized automation for tasks associated with training, scheduling and escalations. Look for a solution that requires trainees to actively participate and ?pass off? certain requirements within the training system. Once they have completed their training, electronic signing will occur, the documentation will be tracked, secured, and readily available when it?s time for internal or external audits.

Look for Software that Makes the Approval of CLIA-Related Documentation Simple

In a laboratory, the lab director, or lab manager, is required by CLIA regulation (see section 493.1251) to date, sign and approve any revisions or changes to laboratory policies and procedures. These director tasks become tedious quickly since it isn?t always convenient for a manager or director to be in his or her office or to manually sign required paper work. However, with the right GxP software solution, all revised policies and procedures can be approved electronically and the lab director can approve the electronic documents from virtually anywhere.

Look for a Software Solution that Will Manage Customer Complaints Documentation and Processes

Customer complaints come to every life science company. The complaints arrive in a variety of fashions. They may come by mail, by Internet, by fax, via phone, etc. According to CLIA regulations (see section 493.1233) customer complaints handling processes must be systemized.

With the right software solution ((http://mastercontrol.com/solutions/complaints_fb.html), these customer complaints forms can be streamlined electronically.

How does it work?

Well, a customer service professional will enter a complaint (regardless of how it was received) into the software system and then the information will be transferred to the applicable investigation personnel. The right software solution can even be customized to help determine priority levels.

Conclusion: The Ideal Software to Help Manage CLIA Regulations

Ideally, CLIA regulations should be managed effectively with software that controls documentation, automates processes and simultaneously connects departments and procedures.

Article Source:
http://www.articlecity.com/articles/business_and_finance/article_8985.shtml

7 Common Overlooked Tax Areas & Savings

By: Kent Irwin

The Ernst and Young Tax Guide for 2007 listed 50 of the most easily overlooked deductions. You may want to purchase this large book as well as to see publication 529 at IRS.gov http://www.irs.gov/publications/p529/index.html. Also see IRS.gov for a list of highlights and what’s new and what’s hot at http://www.irs.gov/taxtopics/tc302.html.

Some of these items you are able to deduct as un-reimbursed employee expenses. Remember ‘ some of these deductions are phased out due to income, circumstance or “floor” limits required. Check with your tax professional to see if these are applicable to you.

1. Be aware of AMT - the Alternative Minimum Tax

The AMT affects more people now than ever, and sneaks up and surprises many people with large tax bills. The alternative minimum tax (AMT) attempts to prevent some who benefit from tax savings (deductions and credits) by making sure they pay a minimum tax.

For middle Americans, the most typical cause of AMT tax is the level or amount of State, Local and Property Tax combined with miscellaneous deductions like unreimbursed employee costs; especially if your household income is over $100,000. According to studies, it’s only going to get worse if Congress doesn’t intervene! This is the one part of the code not adjusted for inflation since its inception in the 60’s. So that’s why more and more people are affected to this tax each year!

You can see if the AMT affects you by consulting the AMT worksheet in the Form 1040 instructions entitled “Worksheet to See if You Should Fill in Form 6251 ‘ Line 45.” People with more complex financial situations should probably consult a good accountant to help them calculate what they might owe. For more information go to http://www.irs.gov/taxtopics/tc556.html.

2. Higher Education Expense Deductions and Credits

You may be able deduct $2,000 or $4,000 of qualifying tuition expenses, depending on your income. It applies to expenses for post-high school education for you, your spouse, or your dependents regardless if you had to take out loans to pay for the cost. It even counts for Grandma to pay for grandson’s college! Grandma can get the deduction.

The Hope Credit or the Lifetime Learning Credit have stricter income limits than higher education deductions to qualify, but provide greater tax savings because they reduce your taxes dollar for dollar. Because both of these types of educational deductions and credits are dependent upon income levels, year in school, and many other factors, it’s not an easy choice which one is right for your case. Run all the scenarios or consult your tax advisor for the best treatment.

3. Medical expense deductions

To be able to deduct medical expenses you must itemize and expenses are deductible only to the extent they exceed 7.5% of your adjusted gross income (AGI). Given the high rate of health care inflation, more people are eligible for this than in years past. Be sure to keep records of all medical expenses to see if you qualify each year.

4. Reinvested stock dividends

This is a tip to avoid double taxation. When mutual fund and qualified stocks pay dividends to investors they are taxed in that year, whether or not those dividend monies were paid out to you in cash or reinvested. Most investors automatically re-invest them in additional shares. When you own investments, keep all of your statements.

When an investor subsequently sells qualified shares of stock or the mutual fund, they are taxed on their gain. Meaning if you invested $9,500 and it grew to $12,000, $2,500 could be subject to tax in that year. However let’s assume that $9,500 generated $500 worth of dividends that were reinvested only $2,000 would be subject to tax. Many people do not keep good records and end up paying unnecessary tax. Many mutual fund companies will provide you with records if you do not have them. Each year when your broker “sells” stocks, a 1099-Div will be generated. You will need to compare the cost basis of these stocks against their sale price less commission in order to truly know how much gain to include in your taxable income.

5. Out-of-pocket expenses for charities and not for profits

You can write off out-of-pocket costs you incur while doing good works for nonprofit organizations such as churches, food pantries and schools. Keep records of items purchased and costs incurred, such as miles driven (14 cents per mile 2007).

6. Child care credit

You may be eligible for the child care tax credit up to 35% of your qualifying expenses (depending upon your income) you paid someone to care for your child (under age 13) or dependents unable to care for themselves (because of physical or mental reasons) while you work or look for work.

For 2007, you may use up to $3,000 of the expenses paid in a year for one qualifying individual, or $6,000 for two or more qualifying individuals. If you have a tax-favored reimbursement plan at work, you can pay up to $5,000 of work related child care expenses. If you max-out the $5,000 through work but spend more, you may be eligible for an additional $1,000.

7. Estate tax on income in respect of a decedent

Did you inherit an IRA or other ‘income in respect of a decedent,’ or IRD? Secondly, was their estate large enough that it was subject to federal estate tax? If so, you may be eligible for a deduction for the amount of estate tax paid on the IRD assets.

Article Source:
http://www.articlecity.com/articles/business_and_finance/article_8949.shtml