NNAAP-NA test - NNAAP Nurse Aide Updated: 2023

Northern Marianas College nursing assistant graduates Lerica Primo, Karena Torres, Cindy Yang, and Antoinnette Hernaez have added their names to the growing list of successful NMC graduates who have passed the National Nurse Aide Assessment Program Competency Exam, becoming certified nursing assistants.

The NNAAP test is an industry certification developed by the National Council of State Boards of Nursing to assess competency in nurse aide skills. To prepare for the NNAAP, the four students underwent a rigorous 10-week nursing assistant training course hosted by the college’s Nursing Department last summer 2022.

NMC Nursing Department chair Rosa Aldan congratulated the four on their achievements. “We are extremely proud of our graduates who are certified nursing assistants and are excited for them to start their careers as certified nursing assistants,” she said.

Lerica Primo, a current NMC Pre-Nursing student, chose the nursing profession out of a desire to care for others. “I am aware that the job can be demanding, but I have personally witnessed the positive impact CNAs can have on their patients’ lives. I’ve always had a passion for helping others and want to make a difference by caring for those who are incapable of caring for themselves. I also sought to gain as much experience as possible to boost my confidence and strengthen my abilities in preparation for the nursing program,” she said.

According to Primo, her children serve as her greatest inspiration. She is now working at Marianas Health Services as a CNA.

Karena Torres entered the medical field with the goal of making a meaningful impact in people’s lives through healthcare. Torres said, “I’ve always been drawn to the healthcare field and felt that becoming a certified nursing assistant would be a great way to start my career. The program at NMC had an excellent reputation for providing comprehensive training and support, which further motivated me to choose it as my educational path.”

Torres described her experience in the NMC CNA program as incredibly rewarding. She gained not only essential clinical skills but also learned the importance of compassion, empathy, and effective communication in providing high-quality care to patients. Torres plans to work in a healthcare facility on Saipan and continue her education in Occupational Therapy.

Torres has applied at the Commonwealth Healthcare Corp. to work as a certified nursing assistant.

Cindy Yang enrolled in NMC’s summer 2022 CNA program with the passion of joining the healthcare sector and aspirations of becoming a registered nurse in the future. “This programexceeded my expectations and had a reputation for providing complete training and support, reinforcing my desire to become a nurse to serve more people on this island,” Yang said.

She found the NNAAP test challenging but worthwhile.

Yang has applied at CHCC to work as a certified nursing assistant.

From a young age, Antoinnette Hernaez knew she wanted to work in the medical field, and the CNA program served as an important stepping stone toward achieving her goal. “Being a CNA is a great opportunity for me to be part of people’s lives, especially when they need someone to care for them the most,” she said.

Influenced by a close friend, Hernaez enrolled in NMC’s summer 2022 CNA program, leading her to learn more about CNAs. After researching the profession and its responsibilities, she decided that it was the right path for her. Hernaez is now eager to apply her skills, abilities, and knowledge by working in a healthcare center.

Hernaez has applied at CHCC to work as a certified nursing assistant.

For more information about NMC’s CNA program, email Aldan at rosa.aldan@marianas.edu or call (670) 237-6744. (NMC)

A life insurance medical test is part of the life insurance company’s underwriting process to determine your eligibility and premium. The life insurance test can occur in your home, office, or the paramedical company’s lab. It’s done by a trained medical professional who will ask basic health and lifestyle questions. There are also tests that typically require a urine sample, blood sample, height and weight measurements, and blood pressure readings.

Why life insurance companies require a medical exam

Insurance companies use personal information to determine your risk of filing a claim. In the case of a life insurance policy, the closer you are to your life expectancy, the riskier you are to insure since your beneficiary is more likely to file a death benefit claim while the policy is active. Besides a physical test and medical records, life insurers also use other factors to determine your mortality risk, like your:

• Hobbies.
• Occupation.
• Driving record.
• Family medical history.
• Tobacco and drug use.

The less risk you pose to the insurance company – like being in good health with a low-risk lifestyle – the better rates you’ll receive. But if you’re not in the best of health, for example if you have a medical condition like high blood pressure or a family history of cancer, you’ll likely get approved at higher rates.

Can I get life insurance without a medical exam?

You can get life insurance without a medical examination, though it’s usually more expensive, especially if you’re in good health. Three types of policies offer coverage without a paramedical exam: simplified issue, final expense, and guaranteed issue life insurance. You may also be eligible for employer-sponsored life insurance through your job.

Simplified issue life insurance

Simplified issue life insurance is popular for applicants who want a policy fast and may not qualify through the traditional underwriting process. Rather than use test results from the medical exam, life insurers use the applicant’s answers to health questions and third-party data to determine ratings.

You can get term or whole life insurance through the simplified issue application process. After completing the entire application, you could receive an instant approval or denial, depending on your responses. If you don’t get an immediate decision, the life insurance company may need more information to complete their assessment.

Final expense life insurance

Final expense insurance is a type of whole life insurance geared towards older adults with medical conditions. The application process is similar to the simplified issue process, but there is no option for term life coverage. Available coverage amounts are usually smaller, topping at $25,000 or $50,000.

This type of policy is best for seniors with good overall health but may not be the ideal life insurance candidate. Maybe you’re overweight and have high blood pressure readings or cholesterol levels. If you don’t need a lot of coverage, you could get better rates through the final expense application process and not have to worry about the added step of a life insurance physical.

Guaranteed issue life insurance

A guaranteed issue policy is the easiest to qualify for but is also the most expensive. Approval is guaranteed with a simple application process that doesn’t have medical questions or a health exam. Since you’re guaranteed to be approved, you also get instant coverage. However, the death benefit isn’t fully available for two or three years. 

Guaranteed issue is only available as a whole life insurance policy and is mainly for older adults. If you or a loved one needs a small amount of coverage but has severe health issues, guaranteed issue is the best way to get it.

Employer-sponsored life insurance

Also called group life insurance, employer-sponsored life insurance is available through some employers as part of your employee benefits package. This policy has a fixed rate based on your age and coverage amount. There is no medical exam, though you may have to answer health questions on the application. 

This option is usually the most affordable but typically comes in smaller death benefit amounts and may not be portable, meaning you can’t take it with you if you leave your current employer. 

What a life insurance medical test entails

A life insurance medical test usually includes asking questions about your medical history and health conditions, if you have any, plus the exam. The process can take up to an hour but usually lasts around 30 minutes. 

The amount and type of tests can vary by your age, life insurance company, type of policy you’re applying for, and the requested coverage amount. The paramedical company examiner may:

• Take samples to complete a urine and blood test.
• Measure your height and weight to check your body mass index (BMI).
• Check your pulse and blood pressure readings.
• Administer an electrocardiogram (EKG) or treadmill stress test.

After collecting the necessary samples and health information, your part of the application process is complete. The life insurance company underwriters will evaluate your application answers, medical history and test results to determine your policy cost and eligibility.

What do life insurance companies test for?

Life insurance companies test blood and urine samples to confirm the information you provided in the application process and get a good idea of your general health. Any health conditions or drug use that could shorten your life expectancy can also increase your premium.

Generally, life insurance companies test for:

• Blood sugar levels.
• Cholesterol levels.
• Prescription and recreational drug use.
• AIDS or HIV.
• Sexually transmitted diseases.
• Tobacco usage.
• Enzyme levels.
• Red and white blood cell counts.
• Health issues such as diabetes, infections, liver problems, or kidney disease.

How to prepare for a medical exam

Here are some ways you can prepare for your medical test appointment to get the best results:

• Focus on lean meats, fresh fruits, and vegetables a few days leading up to your appointment.
• Avoid high cholesterol and salty foods for at least 24 hours prior to your test time.
• Use a clear liquid diet for six to 12 hours before your exam.
• Avoid strenuous activity and alcoholic beverages for at least 12 hours before your appointment.
• Limit caffeine or nicotine for at least an hour before your exam.
• Drink one or two glasses of water an hour before.
• Get a full night’s rest the night before your examination.
• Wear something light and loose on test day for comfort and to ensure an accurate weight reading.
• Bring a government-issued picture ID and any other paperwork with you as instructed by the insurance company.

How to get a life insurance medical exam

Getting a life insurance medical test is simple. After completing the application, you’ll be contacted by phone or email to schedule your test with the insurer’s paramedical test partner. The examiner can complete the test at your home or office or the paramedical laboratory. If you must complete an EKG or treadmill stress test, you may be required to visit the facility. 

How to get life insurance without a medical exam

The good news is getting a life insurance policy without a medical test is easy. Many life insurers offer this option, though some still require fully underwritten applications. There are also brokers offering this option, like Ladder Life and Ethos. Both companies offer term no medical test life insurance. Ethos also offers simplified issue whole life insurance for adults 66 and older. 

There is usually a cap on the insurance coverage you can get without a paramedical exam. Ladder, for example, only offers term life insurance without a medical test if you apply for $3 million or less in coverage. Ethos's maximum term life option is $2 million and for seniors needing whole life coverage, $30,000.

Whether searching for fully underwritten life insurance to get the best rate as a healthy individual or prefer to skip the medical exam, shopping for quotes can help you find the most coverage at the lowest price. Evaluating your coverage needs and assessing your health risk and budget can help you determine which policy type and underwriting process is best for you.

Frequently asked questions (FAQs)

What is the catch with no medical test life insurance?

The catch with no medical test life insurance is higher rates. Since there is no medical test to assess your current health and predict your future health, life insurance companies rely instead on third-party data and your health question responses. While accelerated underwriting can get you approved faster, you might pay more if you’re in good health with a low-key lifestyle and low-risk occupation.

Does life insurance medical test include drug test?

The life insurance medical test typically includes a drug test. You can test positive for prescribed, recreational and illegal drugs, plus non-prescribed and over-the-counter medications. Depending on your results, answers to application questions and the insurer’s underwriting guidelines, you could be denied, approved, or approved with a higher risk class and premium.

Will no-exam life insurance cost more?

No-exam life insurance will usually cost more than completing the medical exam. Insurance companies take on more risk by insuring applicants without a medical exam. The higher the risk they take on, the higher the premium you pay to offset the insurer’s risk. Even if you have a medical condition, getting a traditional life insurance policy may be cheaper than no-exam life insurance if your condition is well managed.

Can I “fail” a life insurance medical exam?

You can’t “pass” or “fail” a life insurance medical exam. The insurer collects the information you provide during the paramedical test to determine your risk class. The lower your risk class, the better your premiums will be. The higher your risk class, the more you’ll pay for the same coverage. If you have serious health issues, the insurance company may not be willing to take on the risk, in which case the insurer can decline to offer you coverage.

What if I don’t feel well on the day of my exam?

If you don’t feel well on the day of your exam, you should call the paramedical company to reschedule. An illness could affect your blood pressure readings and other results, which can also impact the rate the insurance company offers you.

The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country.

The marketing approval was granted to LetsGetChecked’s Simple 2 Test, which allows individuals to collect a demo at home that is then submitted to a laboratory for processing. Prior to this, the only approved tests for these two STIs required samples to be collected at medical facilities such as doctors’ offices.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”

The Simple 2 Test will be available over the counter and is intended for use by people aged 18 and older. The only other STI test that allows for home demo collection is for HIV.

Jodie Dionne, an STI expert at the University of Alabama at Birmingham, welcomed the news, saying experts in the field have been advocating for this approach for some time.

“It is exciting to see the FDA recognize the value of this type of testing by granting marketing authorization through the premarket review pathway,” Dionne, an associate professor of infectious diseases, said in an email.

“There are many people who would like to be tested for STIs who may not know where to go or who have barriers to accessing medical care. If we are going to do a better job of reaching more sexually active people for STI testing as recommended … we need to be creative about how to get them tested and treated in a way that is highly effective and works for them.”

Alan Katz, an STI expert at the University of Hawaii, said the test deploys the same assay clinicians use to diagnose chlamydia and gonorrhea, an assay that has an excellent accuracy record. And Katz, who is a medical consultant at the Hawaii State Department of Health’s Diamond Head STI/HIV Clinic, said this approach also has other advantages.

“This option is exceptionally useful for individuals who live in rural areas or are geographically distanced from a clinic where STI testing can be done and there is no telehealth option available,” he said via email. “If a person screens positive, they can then contact a healthcare provider for further evaluation and treatment.”

Rates of new infections of chlamydia and gonorrhea have been soaring in the U.S. The Centers for Disease Control and Prevention estimates there were more than 1.6 million cases of chlamydia in 2021, and over 710,000 cases of gonorrhea the same year. Both infections are curable, but if left untreated can trigger serious long-term effects, including infertility.

Home samples are taken either using vaginal swabs or urine samples, which are then submitted to a designated laboratory. Results are delivered online, with follow-up care provided when a diagnosis is positive or ambiguous.

Unapproved home tests for chlamydia and gonorrhea have existed for some time, but until now none has gone through the FDA’s approval process. This approval may make it easier for future such tests to clear the FDA’s regulatory pathway.

Originally Published MDDI January 2002

TEST SYSTEMS

Test System Engineering for Medical Devices: A Guide

Developing test systems for R&D through production requires a combination of preparedness and ongoing evaluation.

Tore Johnsen

A large number of medical device manufacturers use automated test and measurement systems during each stage of the product cycle, from R&D to production testing. These systems play an important role in improving the quality of products and helping speed them to market. Purchasing the test equipment is often less expensive than putting it into use; it can cost more to develop the software to run a system than to purchase the instrumentation. Many companies choose to outsource all or a portion of their test system development. Whether it's done internally or by an outside vendor, the critical factors for success remain the same: maintaining good communication between developer and client, following an efficient development process, selecting appropriate development tools, and recruiting people with the skills to do the job correctly.

This article provides a broad overview of test and measurement system development for the medical device industry. Included is a discussion of commonly used instrumentation and tools and an overview of the skills and practices necessary for successful test system development.

HOW AND WHY TEST SYSTEMS ARE USED

In the medical device manufacturing industry, test and measurement systems are used for a wide range of purposes. Some examples include those developed to:

• Demonstrate proof-of-concept prototypes for new equipment used to cauterize heart tissue.
• Research the shrinkage of new dental filling materials as they cure.
• Verify that such implantable devices as pacemakers and neurostimulators function according to specifications.
• Condition and test batteries for implantable devices.
• Simulate the pressing of buttons, turning of knobs, collecting of patient data, and other functions while monitoring and recording a blood-treatment machine's operation.

In order to carry out these tasks, the required systems must be capable of performing such functions as automatically controlling switches and relays, setting and practicing temperatures, measuring or generating pulse widths and frequencies, setting and measuring voltages and currents, moving objects with motion control systems, using vision systems to detect misshaped or missing parts, and others. The medical device industry's need for test equipment and related sensors and technologies is as varied as the industry itself. No matter what the specific need, however, compliance with the quality system regulation is mandatory.

TEST SYSTEM TRENDS

Some trends have emerged as the popularity of automating test systems has grown. For instance, integrating test systems with a corporate database is becoming more common. A number of test stations can be networked, and data can be stored in the corporate database. From that database, important statistical process data can be gathered and analyzed.

Additionally, manufacturers are growing more interested in using standard Web browsers to view data and in remotely controlling their test systems. Data are routinely passed between test applications and standard office applications such as Microsoft Excel and Word. Both the complexity and number of technologies being incorporated into the systems are growing, and, consequently, so are the demands on systems developers and project managers. Test system developers are using more-efficient software development and project management methodologies to meet these increased demands.

Standardizing specific test system development tools and instrumentation is another increasingly popular way to keep costs relatively low. Using the same development tools from R&D to production has obvious benefits: it reduces training costs, allows for technology reuse, and makes it easier to shift employees from one area to another, depending on demand. If executed with diligence, maintaining consistency also facilitates the creation of a library of reusable code. Standardizing makes compliance with quality systems requirements easier, too.

TEST SYSTEM INSTRUMENTATION

A typical test system is created in one of two ways. It can be built around a PC using a plug-in data acquisition board (DAQ), serial port instruments, or general-purpose interface bus (GPIB). Alternatively, it may be built around a chassis with an embedded computer and various plug-in modules such as switches, multimeters, and oscilloscopes (see Figure 1).

The existing member of the latter family of instrumentation systems is the PXI chassis, which uses the standard PCI-bus to pass data between the plug-in modules and the embedded computer. This technology offers high data acquisition speeds at a relatively low cost. Originally invented by National Instruments (Austin, TX), it is now an open standard supported by a large number of instrument vendors. (For additonal information on this system, visit http://www.pxisa.org).

Manufacturers should keep in mind the several variations that exist on these schemes. To select the optimal instrumentation for any given project, a company must consider both the cost and performance requirements of the project, and the need for compliance with internal and external standards.

An important system-selection criterion is the availability of standardized ready-made software modules (i.e., instrument drivers) that can communicate with the instruments. Because the major instrument vendors are currently involved in a significant instrument-driver standardization effort, it makes sense for companies to check the availability of compliant instrument drivers before purchasing an instrument. The Interchangeable Virtual Instruments Foundation (http://www.ivifoundation.org) works on defining software standards for instrument interchangeability. The foundation's goal is to facilitate swapping of instruments with similar capabilities without requiring software changes. Creating a custom instrument driver can take from days to weeks depending on the complexity of the instrument; if it's not done correctly, future maintenance and replacement of instruments might be more difficult than need be.

DEVELOPMENT TOOLS

Development tools designed specifically for PC-based test system development have been in existence for more than a decade. Specialized graphical languages for drawing, rather than writing, programs are useful. One such product from a major instrumentation vendor is LabVIEW (National Instruments). Developing everything from scratch in C is probably not a good idea—unless there is plenty of time and money to spare.

As alternatives to specialized graphical languages, several add-on packages exist that can make a text-based programming language more productive for test system development. For example, one can buy add-ons for both Visual Basics and Microsoft Visual C++. If one's preference is C, for instance, but the benefits of a large library of ready-made code for instrumentation, analysis, and presentation are desired, LabWindows/CVI from National Instruments is a tool to consider.

If what's needed is development of an advanced system to make automated logical decisions about what test to run next and to perform loops and iterations of tests—and store the results in a database—a test executive that can work with the test code is a wise option. Figure 2 shows an example of test-executive architecture. The test system developer writes the test modules and then uses the test executive's built-in functionality to sequence the tests, pass data in and out of databases, generate reports, and make sure all test code and related documentation is placed under revision control (i.e., configuration management).

Although this option still requires significant effort to develop the test modules and define the test sequences, using a standard test executive is, in many cases, far more cost-effective than making one from scratch. This is especially true for such large, ongoing projects as design verification testing and production testing, which require regular modifications of tests and test sequences.

THE NECESSARY SKILLS

A test system development project requires a multitude of skills to achieve success, including project management skills and good communication to keep the project on track and to ensure that all stakeholders' needs and expectations are addressed. Understanding and practicing good software development methodologies are also needed to ensure that the software that is built will actually meet the user's requirements. Test system development also requires that engineers have a thorough understanding of software design techniques to ensure that the software is both functional and maintainable, and an understanding of hardware and electronics to design the instrumentation and data acquisition portions of the system.

Before a test system can be put into production, it needs to be tested and validated. This means that the development team also needs the expertise to put together a test plan and to execute and document the results in a report. The engineers who built the system are not necessarily the best people to test it, so additional human resources are often needed for testing. Finally, because documents are created during the development process, documentation skills are also necessary.

When one considers that the typical project team for a midsize test system consists of two to four developers, one realizes there are more major skills required than there are team members; therefore, one of the challenges is to locate individuals with sufficiently broad skills and abilities to supply both technical and managerial leadership. To ease this burden, make the tasks less daunting, and increase the chances of project success, defining a development process is key. If the test system is used for regulated activities, such as production testing of medical devices, then the test system itself is subject to the quality system regulation and a defined development process is not only desirable, it's mandatory.

THE BENEFITS OF COLLABORATION

Outsourced projects are most successful when the developers and the clients collaborate. Keeping the client involved is the most efficient way of making sure that the system meets the client's needs. It also helps avert surprises—at either end—down the road. Collaboration requires honest and direct communication of issues, successes, and problems as they occur.

Miscommunication sometimes happens even with good collaboration. While it is important to keep the communication channels open so the developers and their clients can discuss issues without too much bureaucracy, it can be hard to keep track of who said what if too many parallel communication channels exist. And when engineers on both sides have ideas of features they would like to add to a particular system, controlling feature creep can become difficult.

Designating a single point of contact for discussing both a project's scope and its content is recommended, and making sure new solutions are reviewed before being accepted can also prevent problems. Instituting a change-control procedure is yet another important step to minimizing unnecessary changes.

THE PROJECT PROCESS

The goal for any project is to add only as much process overhead as is absolutely necessary to satisfy the objectives. When a process must be added because regulations mandate it, the involved parties should keep in mind that the process isn't being instituted merely to satisfy FDA or other agencies; it's being done to build better and safer products. Structure and process improvements can have a significant positive impact on the quality of the finished test system.

The Software Engineering Institute has defined the following key process areas for level 2 ("Repeatable") of the capability maturity model: requirements management, project planning, project tracking and oversight, configuration management, quality assurance, and subcontractor management.¹ The foundations for a project's success are good requirements development and good project planning; if the requirements aren't right, or if a company can't determine how to get the project done, then the project is essentially doomed. What follows is a description of the progression of a few types of test system development projects as well as a discussion of requirements development.

Phases of Test System Development. Whether a formal documented development process is followed or not, there are a few major tasks (i.e., project phases) that must be addressed: requirements development, project planning, design, construction, testing, and release. Should this particular order of tasks always be followed? Probably not. During the 1980s the software industry saw a number of large projects go significantly over budget, become significantly delayed, or be cancelled because they were inherently flawed. One cause of these problems was companies' strict adherence to the waterfall life-cycle model (see Figure 3). In this type of life cycle, the project goes through each phase in sequence, and the phases are completed one at a time. The waterfall model presumes that the requirements development phase results in nearly perfect requirements, the design phase results in a nearly perfect design, and so forth.

Unfortunately, projects are normally less predictable and run less smoothly than the waterfall model assumes. For example, a company doesn't always know enough at the beginning of a project to write a complete software requirements document. The sequence of actions necessary for project success depends to a large extent on the nature of the project. Because every project is unique, those involved must analyze the project throughout its phases and adapt the process accordingly.

Keeping that in mind, software companies have done much to Excellerate software development methods since the 1980s. Today, one can find descriptions of a number of life-cycle models useful for different project characteristics. Choosing the appropriate life-cycle model depends on the nature of the project, how much is known at the start of the project, and whether the project will be developed and installed in stages or all at once. Of course, mixing and matching ideas from different life-cycle models can be an effective strategy as well. Even if a company has decided upon and made standard a particular life-cycle model, small modifications should be made to that model when a particular project necessitates it. The trick is to identify high-risk items and perform risk-reducing activities at the start of the project.

Test System Characteristics. The test systems used in the three device development stages—R&D, design verification, and production—each have their own characteristics.

R&D Systems. R&D test systems range in development time from a few days to many months. Scientists use the systems to explore new ideas; R&D test systems are also used to perform measurements and analyses not possible with off-the-shelf equipment and to build proof-of-concept medical equipment. Others are used by physicians for medical research. Vastly varied in both scope and technologies, most R&D test systems have one thing in common: the need for continuous modification and development. As the research progresses, the scientist learns more, generates more ideas, and might decide to incorporate a new functionality or new algorithms, or even try a different approach. Clearly the waterfall life-cycle model doesn't fit such developments. With R&D test systems, one doesn't know what the final product will look like at the start of the project. In fact, there might not be a final product at all, just a series of development cycles that terminate when that particular research project is over and the system is no longer needed.

Assuming that a reasonable idea of the scope of the R&D project is known at the start, one possible life-cycle model to follow is the evolutionary-delivery model (see Figure 4). This model includes the following steps: defining the overall concept, performing a preliminary requirements analysis, designing the architecture and system core, and developing the system core. Then the project progresses through a series of iterations during which a preliminary version is developed and delivered, the client (i.e., the researcher) requests modifications, a new version is developed and delivered, et cetera, until revisions are no longer needed.

Of course, it's wise to try to pinpoint potential changes at the beginning of the test system development project so that the software architecture can be designed to handle the changes that might come later on.

Design Verification Test Systems. There often is a blurry line between R&D and design verification test (DVT) systems. In the final stage of DVT system usage, the output is verification and a report stating that the medical device performs according to its specifications. Before that stage is reached, however, it is not uncommon to encounter several DVT cycles, each delivering valuable performance data back to the device's designers, and each resulting in modifications either to the device's design or to its manufacturing process.

It may be desirable to use the DVT system to test parts of the device or portions of its functionality as soon as preliminary prototypes are available, but it may not always be possible to have the complete test system ready for such applications. In these cases, the staged-delivery life-cycle model (see Figure 5) may be the best choice. According to this model, test system development progresses through requirements analysis and architectural design, and then is followed by several stages. These subsequent stages include detailed design, construction, debugging, testing, and release. The test system can be delivered in stages, with critical tests made available early.

Production Test Systems. A production test system needs to be validated according to an established protocol.² Such a test system is therefore developed and validated using a well-defined process, and the system can normally be well-defined in a requirements specification early on. There is still, however, a long list of possible risk factors that, if realized, can have a serious negative impact on the project if a strict waterfall development life cycle is followed. Research has shown that it costs much more to correct a faulty or missing requirement after the system is complete than it does to correct a problem during the requirements development stage.

A risk-reduced waterfall life cycle might be an appropriate model to follow when developing a production test system. In this life-cycle model, main system development is preceded by an analysis of risks and a performance of risk-reducing activities, such as prototyping user interfaces, verifying that unfamiliar test instruments perform correctly, prototyping a tricky software architecture, and so forth. Iterations are then performed on these activities until risk is reduced to an acceptable level. Thereafter, the standard waterfall life cycle is followed for the rest of the project—unless it is discovered that some new risks need attention.

Requirements Development. As the aforementioned life-cycle models show, requirements development directly influences all subsequent activities. It's important to remember that the requirements document also directly influences the testing effort. Writing and executing a good test plan are only possible when a requirements document exists that clearly explains what the system is supposed to do.

Developing a software or system requirements document is important, but there is no one perfect way to do it. Depending on the nature of the project, the life-cycle model selected, and how well the project is defined at its early stages, the requirements document might use a standardized template and be fairly complete, it might be a preliminary requirements document, or it might simply take the form of an e-mail sent to the client for review. No matter how it's done, putting the requirements in writing improves the probability that both parties have the same understanding of the project.

Test system developers also are well advised to create a user-interface prototype and prototypes of tangible outputs (e.g., printed reports, files, Web pages) from the system. These might take the form of simple sketches on paper or actual software prototypes. The purpose of the user-interface prototype is to make sure the software maintains the correct functionality. Often, the first time clients see a user interface, they remember features they forgot to tell the developer were needed, and they realize that the system would be far more valuable if greater functionality were added. Creating a user-interface prototype is perhaps the most efficient method for discovering flawed or missing functional requirements. Both parties will want this discovery made during the requirements development phase, not upon demonstration of the final product.

To the greatest extent possible, developers should identify any items that are potential showstoppers, such as requirements that push technology limits or the limits of the team's abilities. Identifying such problems might require some preliminary hardware design to ensure the system actually can be built as specified. High-risk items should be prototyped and developers should try to identify ways to eliminate the need for requirements that push the limits. Waiting until the final testing stage to find out that some requirements cannot be met is not a good idea. Even waiting until after the requirements are signed off to find that some cannot be met is unpleasant—especially if all it would have taken to prevent the problem was a few hours' research.

For outsourced development projects it is essential that the test system developer get feedback from the client and iterate as needed until an agreement is reached and, in some cases, the requirements are signed off. While performing the activities described above, the developer also should review any solutions suggested or mandated by the client. For instance, if the client says it already has the hardware and only wants the test developer to provide the software, the first thing the developer should do is request a complete circuit diagram of that client's hardware solution and carefully explain why it's necessary to fully understand the client's hardware in order to build a good software system. Flaws in the test instrumentation design are very costly to fix after the test system is built, yet it costs comparably very little to review the design ahead of time. Of course, an in-house test system developer also should evaluate the hardware design carefully before starting the software design.

Project Review Timing. It's likely that outside developers who get this far have dealt solely with the client's project team. If the project is large, however, it is not uncommon for the client to bring more people into the picture and conduct a project review after the system is complete. Some of the newcomers will have insights and desires that would result in changes—sometimes expensive ones.

If possible, this type of situation should be avoided. The system developer should insist on a project review by all affected parties before the requirements stage is concluded. It is not enough to just send around the software requirements specifications; people are often too busy with other projects to really go through them as meticulously as they should. A better strategy is to bring everybody together and show them the user-interface prototypes, the report prototypes, and any other important components of the project. Representatives of the end-users should be present as well. Although they should have been consulted during the requirements development process, the end-users are still likely to contribute valuable insights during the review.

By now it should be evident that there is more to requirements gathering than just writing a requirements document and getting it signed off. If the system doesn't work to the client's satisfaction at delivery, then it doesn't matter who is to blame. The project will be remembered by both parties as a painful experience with no winners.

PROJECT PLANNING

Every project needs a plan. The first step in project planning is to define the deliverables, then to create a work breakdown structure (WBS) hierarchy of all the project's required tasks. The WBS is then used to develop a timeline, assign resources, and develop a task list with milestones. A good project plan will also clearly define roles, responsibilities, communication channels, and progress-report mechanisms. It certainly helps to have some background or training in project management in order to plan and control the execution of the project. Some basic project management training is recommended for anyone in charge of a test system development effort. Seminars and classes in project management based on the Project Management Institute's standards are offered worldwide.

CONCLUSION

Successful test system development requires attention to both process and technology. Both clients and developers need to understand and appreciate good software engineering practices. Collaboration and communication are critical for success. Clearly defining roles and responsibilities, using efficient development processes and tools, and handling project risks early on permits problems to be handled at a stage when their effect on cost and schedule will be minimal.

REFERENCES

1. Capability Maturity Model for Software, Version 1.1, Technical Report CMU/SEI-93-TR-024-ESC-TR-93-177 (Carnegie Mellon University, Pittsburg, PA: The Software Engineering Institute/February 1993).

2. Medical Device Quality Systems Manual: A Small Entity Compliance Guide, (Rockville, MD: FDA, 1997).

BIBLIOGRAPHY

A Guide to the Project Management Body of Knowledge. Newton Square, PA: Project Management Institute Standards Committee, 2000.

McConnell, Steve. Rapid Development. Redmond, WA: Microsoft Press, 1996.

McConnell, Steve. Software Project Survival Guide. Redmond, WA: Microsoft Press, 1998.

Wiegers, Karl E. Software Requirements. Redmond, WA: Microsoft Press, 1999.

Tore Johnsen is technical director and en-gineering manager at Computer Solutions Integrators & Products in Woodbury, MN.

Figures 3 and 4 adapted from Rapid Development, with permission of the author, Steven C. McConnell.
Figure 5 adapted from Rapid Development, with permission of the author.

Copyright ©2002 Medical Device & Diagnostic Industry

Most of us can say that we have taken an obsolete hard drive out of a computer and felt it was a waste to toss it in the e-waste pile. Some of us have children’s drawings hung on the fridge with actuator magnets, or maybe a vast spreadsheet suspended on a steel filing cabinet. Let us not forget that there is also a high-speed, low-noise motor in there. On some models it is separate from the PCB, so grab an Electronic Speed Controller (ESC), your microcontroller of choice, and make yourself a salvaged HDD centrifuge like [Cave Man] has. His build uses the tray as a chassis, but he modeled and printed a new face in the same style as the original.

On top, he has an OLED screen for displaying the requested speed, measured speed, and runtime. Next to the display is a four-button pad with a customized legend for setting parameters. The video after the break shows the machine running through its paces. This version accommodates the tiny capillary tubes, microhematocrit tubes, for processing raw blood. This test can calculate the packed cell volume, which professionals use to determine things from dehydration to anemia.

There are other builds out there where people have modified an old drive into the kind of centrifuge that accepts larger diameter tubes, but this was a shining example of what is possible. One good turn deserves another, so we recommend a desktop bio-lab companion, or enlist some LEGO Mindstorms to help out.

Our experts answer readers' insurance questions and write unbiased product reviews (here's how we assess insurance products). In some cases, we receive a commission from our partners; however, our opinions are our own.

Medical exams are among the top reasons people hesitate to buy life insurance. You imagine sitting in a doctor's waiting room, doing blood draws, standing on a scale, and many other things that make us uncomfortable. But it's easy to understand why life insurance medical exams remain an industry stap — an insurer must gauge its risk before it grants you a policy. Ironically, medical exams lower insurance premiums for the average life insurance customer.

Of course, medical exams may sound overwhelming, especially if you've abandoned a life insurance application or been denied. This is where no medical test life insurance comes in. The stereotypical no medical test policy includes no medical data of any kind. Many buyers also expect coverage in days, or at least that's the idea. Despite what you might hear, it isn't quite that simple.

Who should buy a no medical test life insurance policy?

Many shoppers are misinformed about the target audience for no medical test life insurance. "Who should buy a no medical test life insurance" should be rephrased as "who will qualify for no medical test life insurance coverage?" These policies eliminate the inconvenience of a medical test for healthy buyers who don't use tobacco in most cases. However, it comes with higher premiums, and underwriting can be extended as insurers gather medical data from other sources.

Some small funeral cost policies are more flexible, especially if you invest in workplace life insurance. However, more sizable policies not connected to your workplace can only accept limited risk. Seniors, buyers with preexisting health conditions, tobacco users, and other high-risk buyers may not qualify.

How do insurance companies know who presents a more considerable risk? First, no medical test doesn't mean medical records-free. Applications still include basic medical questions, and companies can rescind life insurance policies if you get caught lying on your application. More importantly, life insurance companies may still order a copy of your medical records. So, companies would go off your last blood tests or appointment notes if you have a history of high cholesterol, heart disease, diabetes, etc.

College students and young working adults with no significant medical issues may be ideal candidates for a no medical test life insurance policy. Another thing to note is companies will only issue small life insurance policies without an exam, and premiums are higher. So if you're looking for a $1 million policy or retirement planning options, you should make time for a short medical exam.

What if I don't qualify for a no medical test life insurance policy?

Some companies only offer small life insurance policies with no medical test required. However, most insurers offer a range of permanent and term life insurance policies. If you don't qualify for a no medical test policy, licensed insurance agents can help you apply for a medical test life insurance policy.

While many companies are going online, we recommend working with a licensed insurance agent, especially for no medical test policies. Any time your application is denied, it creates an alert for other life insurance companies you might try to buy from, reducing your chance of getting a policy elsewhere. An agent can help you avoid this by stopping short of denial if you need to switch to a medical test plan.

Types of no medical test life insurance

Life insurance companies sell four life insurance policies without a medical exam. Coverage, pricing, and the application process are a few of the things that vary widely. So what are your no medical test life insurance options?

Simplified issue life insurance

Simplified issue life insurance looks to streamline the approval process. No blood tests or medical exams are required, but applicants answer basic health questions. If the answers given meet underwriting guidelines (the company uses electronic medical records to verify), you may qualify for a policy. Generally, these policies cover non-smokers with minimal known risk factors. However, premiums are higher, and benefits tend to be lower to account for the elevated risk.

Guaranteed issue life insurance

Guaranteed issue is also commonly referred to as guaranteed acceptance. These whole life insurance plans require no medical test or health surveys. Age limits are imposed, with most policies issued to seniors. But if you're within the stated age range, you are guaranteed a life insurance policy. Guaranteed issue life insurance offers death benefit policies topping out around $20,000 to $30,000, depending on the company. The company does not certain the death benefit or premiums, only the policy. So the same policy may or may not be budget-friendly.

The company may also utilize a waiting period, during which beneficiaries would get a refund of premiums. However, the full benefit would only apply once the waiting period passes.

Accelerated underwriting life insurance

Accelerated underwriting uses everything except the medical exam. Underwriters access applicants' public medical records and credit data. Typically, companies take applicants between the ages of 18 and 60. Regular life insurance underwriting could take weeks or even months. Simplified underwriting life insurance policies can be issued the same day with some online insurance providers. It is not guaranteed issuance, and licensed agents may refer some customers for a medical test life insurance policy. However, death benefits could be higher than other no-medical test policies.

Group life insurance

Group life insurance is part of many employer benefit packages. No medical test is required, and death benefits are typically small. More importantly, it's tied to your employment. So if you separate from your employer, the policy will lapse. You can invest in higher death benefits by increasing your monthly deductions, but this is not required.

Pros and cons of no medical test life insurance

Pros:

• No blood tests or other medical exams required
• Quick approval, sometimes even the same day
• Guaranteed issue available within set age limits

Cons:

• More expensive than a medical exam-based life insurance policy
• Death benefits are lower, and waiting periods may apply
• Insurance companies may base your approval on health questionnaires and medical records
• Underwriting may be less tolerant of prior health issues, including things that would otherwise be non-problematic

No medical test life insurance is sometimes mistaken for a fast and easy solution for older adults or those with preexisting health conditions. In reality, it's just the opposite in many cases. Guaranteed issue policies may only be sold through life insurance companies for seniors. You also pay more to get less coverage across the board.

Life insurance companies can still access medical records. So applicants aren't hiding a history of heart disease, diabetes, or other chronic conditions. The only difference is you don't have to meet with a medical professional for a formal exam. If in doubt, non-guaranteed policies may be harder to get.

How to shop for a no medical test life insurance policy

A workplace policy will be issued based on your employment and yearly benefit elections. If you want the best life insurance companies for no medical life insurance that's all yours, remember a few key things:

• Work with a qualified life insurance agent
• Choose a company or brokerage with medical test options
• Compare quotes and coverage to ensure you understand what you're getting
• Be prepared for higher prices with limited death benefits
• Be honest on any health questionnaires

A no medical test life insurance policy's simplicity may be deceiving. It takes one element out of the application process, but underwriters may pull medical records and be stricter about smoking, preexisting conditions, age, and other common risk factors. Unfortunately, being denied by a life insurance company could make it harder to get life insurance coverage in the future.

Your agent can get a soft underwrite if you're working with a broker or company offering medical test policies. If it looks like your application can be denied, your agent could run a medical test life insurance application instead. A great thing about no medical test policies is that many companies offer online estimates. So you can compare pricing based on age, smoking status, desired coverage amount, etc., before you start the application process.

The most important thing to remember is underwriters still consider medical history. So if answering medical questions, answer honestly. If discrepancies come up later, leaving out details about your health may cause significant problems.

FAQs

Any parent or guardian who brings their child to receive medical care may have to sign a consent form, especially if a procedure or medical test is involved. Consent to undergo care is usually signed even before a child is seen by a doctor, evaluated in an emergency department, or is being admitted to a hospital. When it comes to teen minors (ages 13 through 17), the areas of consent, dissent and assent become remarkably gray, especially when it comes to undergoing any type of medical or surgical intervention. For example, what is the law (versus the ethics) when it comes to forcing a teen (or a child, for that matter) to undergo a medically indicated, albeit elective, surgical procedure?  Can the parents and treatment team physically or pharmacologically (sedating them with drugs) restrain a developmentally appropriate teen refusing surgery, regardless of the teen's reason to hold off? The answer is, it depends. It partially depends on the medical indication for the procedure, but more specifically it depends on the state in which the procedure is performed.

There are no federal guidelines regarding a minor teen's rights when it comes to medical care, and each state medical board has different regulations.  In many treatment facilities across the country, a pre-procedure pregnancy test is performed on all females of  menstruating age, even if the individual is pre-menstrual or menopausal. The only indication to forego this test is absence of a uterus.  In my institution, pre-procedure urine pregnancy testing is performed in females between ages 10 and 53 years.  While the likelihood of pregnancy in a 10-year-old or a 53-year-old is quite low, it is not zero.  The tricky part ensues when a minor's urine pregnancy test is positive.  In the state of California, by law, the treatment team is not permitted to disclose the positive pregnancy results to the patient's family without permission of the pregnant minor. And simultaneously, the treatment team cannot proceed with any intervention, as the parent or guardian is not able to deliver informed consent, given the treatment team's newly recognized additional risks of anesthesia and surgery on a pregnant individual and fetus.  One of the most bizarre medical treatment conundrums: medical professionals cannot, by law, inform the parents of the pregnancy test results. And they cannot, by law, provide informed consent for an intervention without informing the added risks to the pregnant patient or the fetus of undergoing an intervention. Therein lies the rub.  The treatment team has to cancel the procedure, but they cannot tell the pregnant teen's parents why.

The latest issue regarding minor teen consent (as opposed to assent or dissent) is the hot button issue of vaccines. There are currently 17 states, including those with active measles outbreaks, which allow parents to opt out of vaccinations for their children based on personal beliefs. The state of California requires medical exemptions to opt out.  But even these became inordinately widespread, whereby some doctors would essentially 'sell' medical exemptions to families who, in reality, did not have a medical indication to opt out.

A recent story of an 18-year-old un-vaccinated young man deciding to receive vaccinations against his parents wishes made headlines.  The fact that he was 18, the age considered to be a legal adult in the world of health care and medical consent forms, made his decision easier to carry out.  But what about teens ages 17 years and younger?  As the laws regarding teen consent for medical procedures varies from state to state, so do the laws for a teen requesting a vaccine when parents have refused.  With new cases of measles popping up in multiple communities with high rates of un-vaccinated children, the issue of taking one's health into one's own hands has been raised in the teen population. It turns out that not only does the age a teen can make this decision vary from state to state, the specific vaccine in question also varies.

In California, minors ages 12 years and older can independently receive treatment for sexually transmitted infections (STI's) as well as receive the HPV vaccine, which prevents human papilloma virus (HPV)-induced lesions of the genital tract in both females and males, as well as cervical cancer, throat cancers, and sinus cancers.  California minors can also receive the Hepatitis B vaccine without parental consent. In Oregon, where a public health emergency has been declared due to measles outbreaks, teens ages 15 and up may receive hospital care, dental and vision services, and any immunization without parental consent. In Washington state, teen minors may receive vaccines without parental consent if the treating physician deems the teen "mature," which seems a bit up for grabs regarding a true legal descriptor. Almost every state enables teen minors to make medical decisions regarding reproductive health, drug and alcohol dependence issues, and mental health support without need for parental permission.  And, while in the past, parents would readily want to protect their children from infectious diseases by immunizing, teens are now being faced with having a say in protecting themselves against illnesses they've never seen. Until now.