The Clinical Laboratory Improvement Amendments (CLIA) specified that the requirements of laboratories were depended upon the difficulties in performing the tests and classifying a test as a waived. The waived tests are defined as the simple laboratory screening and the home testing methodologies, which are to be cleared by the FDA. These testing devices are accurate and easy to detect the drug.
The status of CLIA waived indicates that drug testing kits are easy enough to use at home, schools, laboratories, workplace and other test sites. These devices are stored at room temperature and have 18 months of durability after manufacture. It doesn’t need any instruction and available to buy immediately. They are even capable of providing results within five minute or even less. Its main objective is to provide a qualitative test result. As all the laboratories are certified to receive the payments for Medicare or Medicaid, CLIA doesn’t have responsibilities for direct Medicare or Medicaid program.
You may be asked to test for drugs at any place such as, school, sports, workplace, or at any testing site. The efficient way to qualify your drug testing is to know the result previously for sure. They are easy to use in the comfort of your home and are also accurate in resulting. It helps you in taking the required precautions to qualify the drug test. They will also qualify the requirements and tests of the CLIA regulations.
The CLIA waived drug testing kits are also approved by FDA. There are different devices available for different specimens of blood, urine, hair, or any other specimens. These drug testing devices are in the form of reliable dip cards and integrated plastic cup tests. These devices are easy to use and fast in giving the results. Moreover, it enables privacy to you, as they can be tested in your home.
Applying for a CLIA Certificate of Waiver
All the entities that test the drug usage for the individuals have to apply for the CLIA certificate. To get a waiver certificate from CLIA, you have to implement the following 3 simple steps. They are:
1. Call your local CMS (Centers for Medicare &Medicaid Services) office and request for Form-116, or any other form for obtaining a CLIA certificate.
2. Fill the form Completely and verify the “certificate of Waiver” in the section-2.
3. Once you submit the form to CMS, you can start testing. When the payment is made to CMS, your account will be receiving the CLIA identification number. They are to be renewed for every 2 years.
CMS regulates CLIA Program
CMS is a government body that ensures an effective health care and promotes qualitative care for recipients. It regulates all laboratory testing that are performed through CLIA. Altogether CLIA covers about 175,000 laboratory entities. Under the CMS, the division of laboratory services has the responsibility for regulating the CLIA Program.
The above information helps you in obtaining awareness about the CLIA waived program.
Archive for the ‘drug test kit’ Category
Clia Waived Drug Testing
Home Test Kits 101 – How to Choose a Reliable Test Kit
Home test kits are becoming increasingly popular because they offer some advantages over traditional laboratory testing, but before choosing a kit is important to make sure that the one you select yields accurate and reliable test results.
A variety of CLIA-waived, FDA cleared and FDA approved tests kits are available including those that test for illegal drug use, pregnancy, fertility, the diagnosis of sexually-transmitted diseases including AIDS, paternity, wellness, early disease detection and exposure to various environmental toxins such as heavy metals.
CLIA, which is an acronym for Clinical Laboratory Improvement Amendments, was established in 1988 and implemented in 1992 to develop quality control standards for the entire laboratory industry to ensure the accuracy, reliability and consistency of test results regardless of where the test is performed. The Food and Drug Administration (FDA), which is responsible for assigning testing devices to one of three categories based on the complexity of the test methodology and the potential risk to public health by the devices. It designates the simplest category of home test kits as CLIA-waived tests, which means that the methodologies employed in conducting the tests are so simple and accurate so as to render the likelihood of erroneous results negligible and to pose no reasonable risk of harm to a consumer if the test is performed incorrectly. Many of the home test kits and even some of the kits for professional use are CLIA-waived, but to ensure accuracy of test result it is always advisable to check the certification of any test kit before purchasing it to determine if it is CLIA-waived and manufactured by a reputable company. The most popular CLIA-waived devices are some of the home drug test kits.
If the kit is not CLIA-waived and involves more complex methodology, it is important to make sure that it is FDA cleared or FDA approved. FDA clearance is different from FDA approval in the sense that for a device to obtain FDA clearance the manufacturer must demonstrate to the FDA prior to marketing that the device is substantially equivalent to a similar device already on the market and that it does not require pre-market FDA approval. If the submission is successful FDA clearance is granted for marketing of the product. FDA approval on the other hand applies to a new device which requires that prior to marketing evidence including clinical data be submitted to the FDA constituting reasonable evidence that new device is safe and effective. If the submission is successful FDA approval status is granted, but the process for obtaining FDA approval is much more stringent than that for obtaining FDA clearance. Since FDA approval applies primarily to devices that are life-sustaining and that can carry significant risks, the FDA approval label for home testing kits is a misnomer, and the FDA cleared label is a more appropriate one. An exception however is The Home Access HIV-One Test System and The Home Access Expressed HIV-1 Test System. These are the only HIV home test kits which are FDA approved.
Depending on the complexity of the methodology of the testing process and the immediacy of test results, there basically two types of test kits. The first type which is oftentimes CLIA-waived is that which provides immediate test results in the home or other setting in which the specimen was obtained. The other type is that which requires shipment of the collected specimen(s) to a reference laboratory for analysis and interpretation of the test result which is then reported to the consumer, usually by mail. In the case of the latter type of kit an additional variable that affects the accuracy and quality of the test device is the reference lab that analyzes sample and interprets the test result. Therefore, in doing your due diligence before choosing a home test kit it is advisable to make sure that the reference laboratory is CLIA-certified or has other certification and accreditation vouching for its proficiency as a testing center.
It should be noted that many testing kits are bogusly marketed and sold as FDA approved when in fact they have not even been FDA cleared. Although these products may have a certain degree of appeal to the consumer because they are sold at a cheaper price than those that are not FDA unapproved, it stands to reason that they should be afforded.
In summary, in selecting a kit for home testing it is of utmost importance to make sure that the kit you choose is an accurate one which produces proven reliable results. This can be best accomplished making sure that it meets the CLIA and FDA standards as they apply and that if a reference laboratory is involved in analyzing a sample and interpreting the test result it has the proper accreditation and certification credentials. It is also important that the test is manufactured by a reputable company.
Common Drugs That are Detected Through Drug Testing
There is a wide range of drugs that are abused by the people for non-therapeutic effects and there are different testing kits that are used to detect the presence of these drugs. The drug addictive effectiveness differs from the drug ingested from person to person.
Common Drugs That Are Detected Through Drug Testing
The following are some of the common drugs that are abused by the individuals, which can be detected with different testing devices.
· Amphetamines (AMP): This is a schedule II forbidden drug used according to the prescription, which is also accessible in the illicit market. These drugs are the stimulants that affect the brain and body rapidly. These are psychologically addictive and if the addicted person stops using them will face various problems like, assault, anger and anxiety. Usually this drug effects for 24 hours and will exist in the body for 2 to 6 days.
· Barbiturates (BAR): These drugs are central nervous system depressants that are used to heal the tranquilizers, mesmerizing and anticonvulsants. Its effects are similar to that of alcohol intoxication effects. The detection period of Barbiturates is about 3-8 days. Continuous abuse of barbiturate can lead to clinically considerable level of tolerance and physical dependence.
· Benzodiazepines (BZO): It is usually stipulated for indicative treatment of aggression and insomnia. Benzodiazepines are also used for tranquilizers in surgeries and medical practices. It exists in the system for about 3 to 7 days. Frequent consumption these drugs can lead to raise the risk of physical dependency. Valium and Versed are examples of Benzodiazepines.
· Cocaine (COC): It is a sedative and a forceful stimulant for central nervous system, which brings intense strength and restiveness. This drug results into hypnotics, over-sensitivity and convulsions. Cocaine stays in the system for about 24 to 40 hours after use. Huge consumption of cocaine causes fever, insensitivity, inhalation problem and unconsciousness.
· Marijuana (THC): This drug produces exhilarated effects, which mainly contains Tetrahydrocannabinol (THC). If they are used continuously for longtime it causes impairment of short-term memory loss, behavioral disorder and slowed learning. This drug lasts in the body for 3 to 10 days after smoking.
· Methamphetamine (mAMP): It is an addictive energizer drug, which stimulates certain systems in the brain. This drug is closely related to the amphetamine and has higher effects than that. Consuming mAMP can have effects such as anxiety, psychotic behavior, tiredness and paranoia. The detection period of this drug in urine is about 3 to 5 days.
· Methylenedioxymethamphetamine (MDMA): It is an exclusive drug, which was first produced for healing obesity. The unsympathetic effects of MDMA are potency tension and sweating, it can also increase blood pressure and heart rate.
The above information makes you aware of various drugs that can be detected through different drug testing.
Know About Laboratory Urine Drug Test
Many types of drug testing techniques are available for detecting drug abuse. Urinalysis is one of the most commonly used urine based drug testing as it is a simple technique, and less expensive. Urine drug testing has been popular and employed successfully for testing drugs across the organizations, schools, at home etc.
Drugs tested
Laboratory urine drug testing detects the presence of many drugs with accurate results. This drug testing can detect maximum of 10 most commonly used drugs at once. It detects the parent drug or its metabolites by demonstrating recent use of prescription medications like opioids, benzodiazepines, amphetamines, barbiturates and illegal substances like heroin, illicit cocaine, marijuana, phencyclidine (PCP). This test is used as a screening tool to determine the prior use and concentrations of drugs present in the body.
Procedure followed
For laboratory urine drug test, collection and testing urine specimen is done under the presence of an authorized person. After this, tests are conducted on collected specimen for detection of drug tests by immunoassay screen followed by GS-MS confirmation test. Chemical highlighted test strip is used for this test. The test strip should be examined carefully with the help of lab testing devices depending upon the types of substances to be detected.
For each drug the detection periods and cut off levels depend on the nature and usage of the drug. The detection period of any drug through laboratory urine drug testing is from 6 hours to 3 days from the time of consumption. All screening tests are performed by the immunoassay based on the technology of the testing kit. Confirmatory tests are performed using either gas chromatography/mass spectrometry (GC/MS) or any other superior technique. The samples are treated with either the technical or all of these methods to verify the results. Confirmation results are reported as positive or negative based on SAMSHA cut off levels and all non-negative results are confirmed prior to any disclosure.
Laboratory urine drug test is used as standard test for drug detection. Reliable results are possible with this laboratory drug testing and they can be used as a proof drug abuse. The above information gives you a helpful insight about the laboratory urine drug test, drugs detected through this and the procedure followed.
Know How the Swab Drug Test is Conducted
Swab drug test is conducted to check for the drug abuse or the presence of alcohol in a sample. It is very easy to perform and it gives out accurate results almost at any place. It is so accurate that it reduces the risk of repeating the test. This test is just a single step process, which is very simple and any one can perform this test at any place according to the convenience.
• Prior to the test:
One has to be very carefull in conducting the swap drug test. In order to attain the accurate test result, the person who is about to undergo test is advised not to eat, smoke or drink for at least 10 minutes before performing the test. If the donor has had something, he has to wait for 10 minutes to give the sample for the test for accurate results.
• Sample collection:
In swab drug test collecting the sample is very easy. The cotton swabs are used for collecting the saliva samples from the donor. The donor has to place this cotton swab below the tongue for about 10 to 15 minutes. The strip will absorb saliva from the donor, which is further used as the sample to test drug abuse or the level of alcohol presence in the sample.
• Lab testing:
The next process after sample collection is laboratory testing. The saliva sample collected in swab is put into a small specimen vial and is sealed. The specimen is tested through an appropriate testing strip in the laboratory, to test the drug abuse and the level of alcohol present in the sample.
The swab drug test is just a process of few minutes, but gives out accurate results. This test helps in detecting active drugs present in the saliva. This test is very helpful to an individual because it is accurate and instant result oriented. More over this test can be performed at any place and at any time according to the convenience. An individual can perform the test independently without others assistance even for the first time as it is a single step process.
Know About One Step Multi-Drug Screen Test
Drug abuse is a major issue as many people irrespective of age and gender are getting addicted to illicit drugs. According to NSDUH 2007, 114 million Americans of 12 years and above, accounting 46% of the population reported drug abuse at least once in their entire life time. This fact alone states the severity of drug abuse in the United States. To check the drug abuse, instant drug testing kits are playing an important role. Of them, one step multi-drug screen test is unique, as it screens 12 most commonly abused drugs at a time with single device and a single sample.
The twelve drugs:
The one step multi-drug screen test provides quick and quality results of multiple drugs and drug metabolites in urine specimen. This test card tests for combination of Cocaine, Amphetamine, Methamphemine, Marijuana(THC), Methadone, Opiates, Phencyclidine, Barbiturate, Benzodiazepine, Propoxyphene, Tricyclics, and Oxycodone. This drug test is FDA approved.
How to take the test:
The one step multi-drug screen test is simple to administer, designed in the dip-and-read model to check most commonly abused drugs. Make sure that the test card and urine specimen reach the room temperature before testing. Remove the test card from the pouch and discard the moisture absorbent packet. Immerse the test strip in urine with arrows pointing towards the urine specimen, for 10-15 seconds. Do not cross the maximum (MAX) line while immersing the test strip in the urine sample. Put the test card on non-absorbent flat surface, start the timer and wait for red lines to appear. Take the results at five minutes and do not measure after ten minutes.
Interpretation of the test:
With a one step multi-drug screen test, results are available within 5 to 10 minutes, which are 95% to 98% accurate. For a positive result, a red line appears in control region and no line appears in test region. For a negative result, one red appears in control region and another red or pink line in the test region. For an invalid result, a line in control region fails to appear, which generally is caused due to insufficient specimen volume or incorrect procedural techniques. The cut-off levels in one step multi-drug screen test are set to the SAMHSA cut-off levels.
A considerable number of people are abusing illicit drugs causing a major threat to their health and safety. In order to detect and avoid drug abuse in your near ones, one step multi-drug screen test can be helpful to you either at your home or workplace with instant and accurate results.
Detecting Cocaine Abuse with Drug Test Kits
Cocaine is one of the most powerful addictive drugs of abuse. According to a recent survey from NIDA, around one in six Americans (15% in 2007), by the age of 30, have tried cocaine. Cocaine can directly affect brain and has serious impact on health of the abused. Detecting cocaine abuse with drug testing kits is easy, quick, and provides sensibly accurate results. Frequent screening helps to monitor people from cocaine abuse, effectively.
About Cocaine
Cocaine is extracted from the plant Erythroxylon coca. It is stimulant of the central nervous system and suppressant of appetite. Cocaine is a popular as recreational or club drug in many countries all over the world. Chewing, smoking, snorting, inhaling, and injecting are general methods of cocaine consumption. Cocaine consumption results in increased stamina, alertness, heart rate, body temperature, blood pressure, and euphoria in the abused.
Cocaine inside human system
The time taken for cocaine to enter into the human system depends upon the method of consumption. Cocaine takes 30 minutes to enter the blood stream of the abused when it is consumed orally. It is around 20 minutes in case of inhaling and 3.1 minutes in case of injecting. Cocaine melts effortlessly into the fat of the abused and thus stays for around 2 to 4 days inside a human system.
Cocaine drug testing kits
Cocaine can be detected for up to 3 days in urine drug testing. It can be detected for up to 90 days in hair drug testing. Cocaine drug testing kits provide quick results with reasonable accuracy.
Hazards of cocaine abuse
The regular usage of cocaine develops a tolerance to the drug, thus possessing high risks of developing into drug dependence or addiction. Inhalation of cocaine destroys nose membranes. Smoking of cocaine may damage the lungs. Consuming cocaine through injections possess high risks of acquiring transmittable diseases like HIV and Hepatitis. Chronic cocaine users have high risks of strokes, seizures, and heart attacks.
Cocaine drug tests help people to monitor their friends or family members and help to stay away from cocaine abuse. Even people, who have applied for a job where drug screening is a part of the interview process, use drug testing kits to check traces of previous cocaine dosage in their body.
Types of Corporate Drug Testing
Corporate drug testing: The drug testing is made mandatory at many corporations. The main reasons for drug testing at corporations is to
· Prevent any harmful effect that may occur to the employees.
· To prevent the harms this could happen to other employees due to the person consuming the drug.
· In the view of corporate social responsibility, most of the corporations are conducting drug testing.
Types of corporate Drug testing: There are different types of drug tests available that are been done at various levels and various circumstances. They are
Pre-Employment Drug testing: The most common type of drug test that can be found at most of the corporations is the Pre-employment drug testing. This type of test is been done to the person at the time of recruitment. Most employers use the standard five-panel test that detects the drugs like marijuana, cocaine, PCP, opiates and amphetamines.
Post Accident Drug Testing: This type of drug testing is conducted after any accident occurs to the employee during the job timings. This post accident drug test is not meant to fire the employee but to protect the company from the liability in the event that the individual is under the influence of the drug that caused the accident. If the drug content is detected in the body, then the company is not obligated to pay for the employee or it is neither obligated to any sort of cases which may effect the company’s goodwill.
Random drug testing: Random drug testing is the procedure where the employees do not know when the tests would be conducted. The frequent and unpredictable random drug testing acts as a deterrent on the employees as they will think twice before taking drugs.
Return to duty/ Follow-up testing: If any employee could not pass the drug test then that person should once again undergo the test with in forty-five days from the test. In that test, the person should get a clearance from the EAP and then he can rejoin the job. After joining, the person will be again tested unannounced and periodically the employee will be tested for six times in the next one year.
Request to retest: The person who has been tested positive for the drugs can apply for the retest, but he should apply only after seventy-two hours after the previous test is been done.
· Reasonable Suspicion Test: If the employee’s behavior or any other observational characters suggests that the person may be impaired due to drugs or alcohol, then both the drug test and the alcohol test would be conducted. If an employee is identified for reasonable suspicion testing, he will be suspended but when the results for the test are negative then he will be again taken in the job and will be paid for the time he has been suspended.
Choosing Drug Test Kits in Canada
The alarming statistics of substance abuse among children and teens has prompted many parents to take a more aggressive approach to monitoring the activities of their young ones. This can mean that the parent is keeping an eye on any new or unusual behavior, asking more questions about what their kids are doing every day, and looking for signs of drug or alcohol use.
Although many of the indications of substance abuse are rather obvious, like slurred speech or bloodshot eyes, there are ways that a resourceful child can cover up certain telltale signs that they are using drugs or alcohol. For this reason, drug test kits in Canada are becoming more popular every day as an aid to parents who want to protect their children from the dangers of substance abuse.
The problem that many parents will face when embarking on a drug detection program is the intrusion into their privacy that a child may feel. That is why home drug tests have been designed to be as unobtrusive as possible. A small sample is all that is required for test purposes, and the test itself is conducted in the privacy of the home. This can help to reduce the invasive nature of any drug or alcohol testing program.
Saliva and urine tests are the fastest way to determine the presence of drugs in a person’s system. The results of these types of tests can be obtained in a matter of minutes, and can detect the presence of many different types of drugs. The time frame that can be determined by these tests can go back as far as 72 hours or more.
It should be noted that of all the drug test kits in Canada, only one can be considered as being positively 99.9% accurate according to mandated guidelines for substance levels in the body. The hair follicle test is the only test that can screen for drug use in the past 90 days. The sample is tested in a CLIA certified laboratory which tests samples using gas chromatography and mass spectrometry which is very accurate and can provide amounts and a timeline of drug use.
The other types of drug test kits in Canada mentioned above do contain pre-set cutoff levels that adhere to SAMHSA guidelines to provide a cut-off level of the substance. This allows for use of some prescription drug use at low, monitored levels.
The best deterrent to substance abuse is to spend time with your family and be involved in their lives. Sometimes though, you just won’t know. In that case, especially in situations where drug or alcohol use is suspected, drug test kits in Canada can be the extra step that is needed in order to reassure everyone that the dangers of substance abuse are not taking hold in the home.
8 Tips on How Home Test Kits Can Benefit You
Home test kits should not be totally relied upon as a substitute for a CLIA approved laboratory, but in certain settings they provide advantages over traditional laboratory testing. These advantages can reduce healthcare costs, provide peace of mind and be instrumental in improving health and improving healthcare.
One of the major advantages of the kits is the convenience they provide particularly for individuals who are homebound for various reasons including illness, limited funds, or lack of transportation. Home test kits can be ordered online and are shipped to your home. The test results are obtained within minutes after following directions that come with the kit or in the case of a test requiring interpretation by reference lab, the results are mailed to you in a few days in most cases. Tests traditionally performed by laboratories usually require a needle stick and the removal of a modest to moderate amount of blood from a vein which might be painful depending on the technique and proficiency of the phlebotomist. With the use of a home kit however, only a small amount of blood from a finger puncture is needed and is generally much better tolerated than the puncture of a vein. Many of the home tests don’t require collection of blood at all, but the collection of urine, hair or saliva instead.
The safety of the specimen collection hinges not only upon the technique and the proficiency of the person that collects it, but also on the environment in which the specimen is collected. It is a well-known fact that environments frequented by sick people generally harbor more germs (primarily viruses and bacteria), particularly during the height of flu season and which will certainly be the case in the event of a flu pandemic. Not having to go to a laboratory or doctor’s office to have a test specimen collected substantially reduces exposure to infectious disease producing viruses and bacteria which might be of major importance if you have a condition which lowers your immunity.
Home test kits also provide privacy and confidentiality of test results which is particularly important for individual who live in small communities where discussions in doctor’s offices sometimes become community knowledge. This is especially true with respect to tests for sexually transmitted diseases, illegal drug use and paternity. Many are also concerned about test results ending up in a national databank which does not happen in the case of home testing.
With the burgeoning illegal drug epidemic that is plaguing our society today, a home drug testing program might be the only way of ensuring a drug free home and the linchpin of family stability, particularly if you have teenagers. Drug test kits enable you to implement and enforce a Parent and Teen Drug Free Home Agreement which could prove priceless in terms of the future direction of your family.
Home testing might also be a good initial step in helping you decide on the type of group health insurance plan you select if you have not recently been to a doctor and are concerned that you might have a particular illness which has not been diagnosed. This is important because many of the PPO and other non-HMO insurance plans have pre-existing illness exclusions which are not covered for a specified period of time or are not covered at all once the policy goes into effect. If you discover that you do probably have a particular condition based on home test result that could very well be the deciding factor in whether or not you select an HMO or PPO insurance plan. If you are planning to purchase your own insurance home testing prior to the application might be of value in validating your answers to questions on the insurance application questionnaire, and might spare you the unexpected pre-existing illness exclusions(s) if your application is approved.
The use of a home testing kit can provide peace of mind regarding environment concerns and can be instrumental in diagnosing disease related to home environment hazards such as exposure to radon gas, lead and other heavy metals. Routine screening for these health hazards is not a part of traditional medical practice because environmental safety is not emphasized in medical training and screening tests to diagnose illnesses related to them are not routinely covered by insurance companies. The health-insurance industry reimburses based on a coding system. Services, including doctor visits and laboratory testing have specified service codes or CPT codes. When a claim for re-imbursement is submitted to an insurance company by your doctor, laboratory or other healthcare provider the insurance company is informed of the reason(s) the service was provided via diagnosis codes known as ICD-9-CM codes. If a carrier processes a claim in which a listed service code is not justified by an appropriate ICD-9-CM diagnosis code, the claim is denied and the recipient of the service (the patient) is billed. Given customary laboratory fees, that charge most likely will be significantly greater than the cost of a test kit to perform a comparable test. If a diagnosis is made by use of a test kit and additional future testing for that same problem is required the relevant ICD-9-CM code can then be submitted with futures claims to the insurance carrier and who should then pay the claim. A negative environmental safety home test on the other hand can provide peace of mind that you don’t the home environmental hazard test for.
Finally, home testing can be a bridge between not having health insurance and obtaining healthcare. An example is participation in clinical research trials which afford great opportunities for individuals to receive medical care who otherwise would not be able to afford the care. All clinical trials have what are known as inclusion criteria which include the diagnosis among other variables that have to be met in order to be a participant in the trial. A condition which is diagnosable via home test kit might be the necessary data for screening and eventual enrollment in a clinical trial. Social Security disability benefits are also an avenue for individuals without health insurance coverage to obtain coverage if deemed disabled following a disability determination evaluation. Many of the evaluations are performed however without applicants having established diagnoses because their inability to afford to see a doctor and have tests performed. It stands to reason that, if for example an applicant filing for disability due to fatigue has an accompanying diagnosis of AIDS or hepatitis C, whether the diagnosis was made via traditional laboratory testing or from the use of a home kit, the likelihood of obtaining disability benefits would be greater.
In summary, home test kits provide convenience and safety of the testing process, confidentiality of the test results, increased likelihood of a drug free home, and peace of mind with respect to concerns about possible home environmental hazards. Additionally the kits might diagnose problems that would otherwise go undiagnosed and can be of benefit in obtaining medical care, whether it is in the form participation in a clinical trial or the acquisition of health insurance.
RSS Feed
Twitter
Posted in
Tags: 