FAQs | Medical Diagnostic Laboratories

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<strong>Office:</strong> <p>609-570-1000</p> </li> <li class="group"> <strong>Fax:</strong> <p>609-570-1050</p> </li> <li class="hours group"> <strong>Hours:</strong> <p><strong>Mon-Fri:</strong> 8:00am - 10:00pm EST<br> <strong>Sat:</strong> 9:00am – 5:30pm EST </p> </li> <li class="email"> <a href="mailto:customerservice@mdlab.com" class="email_cs"><icon class="icon">e</icon></a> </li> </ul> <ul id="billing" class="tab"> <li class="group"> <strong>Toll Free:</strong> <p>877-333-9233</p> </li> <li class="hours group"> <strong>Hours:</strong> <p><strong>Mon-Fri:</strong> 8:00am - 10:00pm EST<br> <strong>Sat:</strong> 9:00am – 5:30pm EST </p> </li> <li class="email"> <a href="mailto:BCS@mdlab.com" class="email_cs"><icon class="icon">e</icon></a> </li> </ul> </div> <div id="gbs"> <h2><strong>GBS</strong> Hotline</h2> <div> 877.635.4277 <span>Physician's Only</span> </div> </div> </section> <section class="f_col"> <div class="flex_wrap"> <div id="location" class="iconP" href="" 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class='rField'> <input type='radio' id='fc_2' name='forms_cats' value='' data-show='#faq_cystic_fibrosis_testing' > <label for='fc_2'>Cystic Fibrosis Testing</label> </div> <div class='rField'> <input type='radio' id='fc_3' name='forms_cats' value='' data-show='#faq_h1n1_testing' > <label for='fc_3'>H1N1 Testing</label> </div> <div class='rField'> <input type='radio' id='fc_4' name='forms_cats' value='' data-show='#faq_mrsa_testing' > <label for='fc_4'>MRSA Testing</label> </div> <div class='rField'> <input type='radio' id='fc_5' name='forms_cats' value='' data-show='#faq_general_information' > <label for='fc_5'>General Information</label> </div> </fieldset> <select class="toggler" data-target=".m_col"> <option value='Patients' data-show='#faq_patients'>Patients</option> <option value='Physcicians and Other Order Clinicians' data-show='#faq_physcicians_and_other_order_clinicians'>Physcicians and Other Order Clinicians</option> <option value='Cystic Fibrosis Testing' data-show='#faq_cystic_fibrosis_testing'>Cystic Fibrosis Testing</option> <option value='H1N1 Testing' data-show='#faq_h1n1_testing'>H1N1 Testing</option> <option value='MRSA Testing' data-show='#faq_mrsa_testing'>MRSA Testing</option> <option value='General Information' data-show='#faq_general_information'>General Information</option> </select> </aside> <div class="m_col"> <section id="faq_patients" class="category"> <h2 class="expand"> <strong>What method of payment do you accept?</strong> <p class="scb">MDL accepts check, money order, Visa, MasterCard, American Express and Discover.</p> </h2> <h2 class="expand"> <strong>Does MDL accept Medicare?</strong> <p class="scb">Yes. MDL is a CLIA approved laboratory and can file Medicare claims throughout the United States.</p> </h2> <h2 class="expand"> <strong>Does MDL accept Medicaid?</strong> <p class="scb">MDL is able to file Medicaid in most states. Please contact us toll free at 609-570-1000 to find out if we accept Medicaid in your state.</p> </h2> <h2 class="expand"> <strong>What is the billing policy for International patients?</strong> <p class="scb">Any patient residing outside the United States must pre-pay for testing with a major credit card or a United States money order.</p> </h2> <h2 class="expand"> <strong>How much do MDL’s tests cost?</strong> <p class="scb">To obtain pricing information on testing performed by MDL, please contact us toll free at 609-570-1000.</p> </h2> <h2 class="expand"> <strong>What is a “deductible”?</strong> <p class="scb">A deductible is the amount a patient must pay before his or her insurance carrier will begin paying for a covered service. This amount will depend on each patient’s health insurance plan. Questions should be directed to your insurance company.</p> </h2> <h2 class="expand"> <strong>What is “co-insurance”?</strong> <p class="scb">Co-insurance is the amount a patient must pay for a service based on the percentage that his or her insurance carrier’s has agreed to pay for that particular service. This amount will depend on each patient’s health insurance plan. Questions should be directed to your insurance company.</p> </h2> <h2 class="expand"> <strong>What is “co-payment”?</strong> <p class="scb">A co-payment is the amount a patient must pay up front for a service based on the patient’s insurance policy with their insurance carrier.</p> </h2> <h2 class="expand"> <strong>What is “patient responsibility” on my invoice?</strong> <p class="scb">Patient responsibility is the amount a patient must pay for a service according to his or her insurance plan. The patient may need to satisfy his or her deductible, pay for services not covered under his or her insurance plan or pay for amounts that exceed the patient’s annual maximum benefit.</p> </h2> <h2 class="expand"> <strong>Why do I owe MDL if my insurance has already paid?</strong> <p class="scb">Your insurance carrier and policy states the benefits that are paid for laboratory services. Whether you use an in-network or an out-of-network provider, you could still be responsible for a portion of the services depending on the benefits of your policy. After MDL has received payment from your insurance carrier, if there is a deductible, co-pay, co-insurance, or patient responsibility, you will be billed for that portion. This is the amount you owe to MDL.</p> </h2> <h2 class="expand"> <strong>Can MDL give me an interpretation of my laboratory results?</strong> <p class="scb">You may obtain test results from your ordering physician who will provide an interpretation of your results based on your specific clinical information contained in your medical charts.</p> </h2> <h2 class="expand"> <strong>Are my results kept confidential?</strong> <p class="scb">MDL is HIPAA compliant and adheres to strict confidentiality of test result information disclosure laws. Please click to view MDL’s privacy policy.</p> </h2> <h2 class="expand"> <strong>Why have I received a bill from MDL?</strong> <p class="scb">MDL has received information from your ordering physician or from your insurance carrier indicating patient responsibility for testing services. For further information on the specific nature of the bill, please contact us toll free at 609-570-1000.</p> </h2> <h2 class="expand"> <strong>I have received a bill from MDL, but I have insurance. Can MDL file my claim directly with my insurance company?</strong> <p class="scb">MDL received information from your ordering physician which may have included incomplete insurance information. Simply attach a copy of your insurance card to your MDL bill and return it. MDL will then file the claim with your insurance company.</p> </h2> <h2 class="expand"> <strong>As a patient, can I order my own testing by requesting a specimen collection kit?</strong> <p class="scb">We cannot perform testing without the written order of a physician or other medical practitioner authorized by law to order such testing.</p> </h2> </section> <section id="faq_physcicians_and_other_order_clinicians" class="category hide"> <h2 class="expand"> <strong>What information must be included on MDL’s test requisition form?</strong> <p class="scb">The following information must be included on MDL’s test requisition form: the patient’s name and demographic information, ICD-10 diagnosis code(s), specimen collection date, specimen source, and the test(s) being ordered. Do not forget to include a signature of the ordering physician or other person authorized to order laboratory tests on the test requisition form.</p> </h2> <h2 class="expand"> <strong>Must insurance information be included with MDL’s test requisition form?</strong> <p class="scb">Physicians are encouraged to attach insurance information to MDL’s test requisition so that MDL can submit the patient’s claim to his or her insurance carrier.</p> </h2> <h2 class="expand"> <strong>Do I have to provide diagnosis information codes for ordered laboratory tests?</strong> <p class="scb">Diagnosis information is required to be included on each test requisition. The best practice is to choose an ICD-10 diagnosis codes, however the physician or other authorized ordering clinician may include a clear description of the diagnosis information for the patient, as long as it follows the type of description used by the World Health Organization (WHO) when it establishes diagnosis codes.</p> </h2> <h2 class="expand"> <strong>How do I choose a correct ICD-10 code for MDL’s testing?</strong> <p class="scb">Physicians or other persons authorized to order laboratory tests must submit diagnosis codes that reflect signs, symptoms, complaints, and reasons for the encounter of your patient. Such information should also be documented in the patient’s medical records for the date of service in which the testing was ordered. If symptoms are present, but a definitive diagnosis has not yet been determined, choose diagnosis codes that reflect the symptoms the patient presents at his or her office visit. It is the ordering clinician’s responsibility to choose ICD-10 diagnosis codes and MDL does not choose diagnosis codes under any circumstances.</p> </h2> <h2 class="expand"> <strong>Can a physician order additional tests after the patient specimen has already been sent to MDL?</strong> <p class="scb">Testing can be added to a request if the specimen volume permits and it is within an allowable time period from specimen collection. All test additions must be received in writing and faxed to MDL’s QA/QC Department at 609.570.1020. Written test addition requests may be submitted on office stationary, a test requisition form, or a script.</p> </h2> <h2 class="expand"> <strong>What if the physician needs to cancel a test that was ordered in error?</strong> <p class="scb">If MDL has not begun testing of the specimen, please fax your written cancellation request to MDL’s QA/QC Department at 609.570.1020. All requests must be in writing. Written test cancellation requests may be submitted on office stationary, a test requisition form, or a script. If testing has already begun, unfortunately we are unable to cancel the test.</p> </h2> <h2 class="expand"> <strong>How long does a physician have to add a test?</strong> <p class="scb">Generally, a physician has thirty (30) days from the date the specimen is collected to order additional tests from MDL. However, depending on the specimen type, it may be viable for a shorter period of time. If you have questions regarding the viability of a specimen, you may call MDL’s QA/QC Department toll free at 866.814.4751.</p> </h2> <h2 class="expand"> <strong>What type of specimens does MDL accept?</strong> <p class="scb">The specimen type varies depending on the actual tests ordered. To view the specific acceptable specimen sources for specific tests, please refer to our test list page. If you have questions regarding the types of specimens MDL accepts, please contact MDL’s Call Center toll free at 877.269.0090.</p> </h2> <h2 class="expand"> <strong>How do physicians receive results of laboratory tests?</strong> <p class="scb">MDL can release test results by fax, mail, and web-based result retrieval system, LifePoint Informatics directly to the ordering physician’s office. Additional copies of the test reports can be forwarded to another physician if the ordering physician makes a written request in the designated area of the test requisition form.</p> </h2> <h2 class="expand"> <strong>Can MDL send a laboratory test result directly to the patient?</strong> <p class="scb">Patients should contact their ordering physician directly for test results so that the physician can provide the necessary result interpretation. If for some reason a patient is unable to obtain test results through the ordering physician, please contact our Call Center toll free at 877.269.0090 to request a records release form. The patient will need to complete this form with all pertinent information and have it notarized to ensure his or her identity in attempt to maintain patient confidentiality in accordance with HIPAA requirements.</p> </h2> <h2 class="expand"> <strong>How many tubes of blood does a physician need to collect to perform laboratory tests?</strong> <p class="scb">The number of tubes of blood needed depends on the type of test being requested.</p> </h2> <h2 class="expand"> <strong>How do I set up an account with MDL?</strong> <p class="scb">Contact MDL’s Call Center toll free at 877.269.0090. They will forward your information to the appropriate MDL representative for your area.</p> </h2> <h2 class="expand"> <strong>How do I get specimen collection supplies?</strong> <p class="scb">Contact your MDL Representative or call MDL’s Call Center toll free at 877.269.0090 and they can send you the necessary specimen collection supplies. If you are a current client of MDL, you can fax your supply request form to 609.570.1050.</p> </h2> <h2 class="expand"> <strong>Can MDL assist with an interpretation of my patient’s laboratory results?</strong> <p class="scb">Contact MDL’s Call Center toll free at 877.269.0090. Your request can then be forwarded to the appropriate member of our staff to address your questions.</p> </h2> <h2 class="expand"> <strong>How do I get my specimens to your laboratory?</strong> <p class="scb">If you are located in certain parts of the United States we are able to offer specimen pick-ups via a local courier. Outside of these zones, we utilize FedEx. For local courier pickups or to obtain prepaid, preprinted FedEx Lab Packs, please call 877.269.0090. Please visit our Specimen Transport Arrangements page to view the listing of courier zones.</p> </h2> <h2 class="expand"> <strong>Can I attach a print out of patient demographics and/or insurance information generated from our Electronic Medical Record (EMR) system to the MDL Test Requisition form?</strong> <div class="scb"> <p>As long as the following information is included on the print out, you may attach it to MDL’s Test Requisition form:</p> <ul> <li>Patient name</li> <li>Patient Date Of Birth</li> <li>Ordering physician information and signature</li> <li>Date of collection</li> <li>Specimen Source</li> <li>Tests ordered</li> </ul> </div> </h2> </section> <section id="faq_cystic_fibrosis_testing" class="category hide"> <h2 class="expand"> <strong>What is Cystic Fibrosis (CF)?</strong> <p class="scb">Cystic Fibrosis, usually diagnosed in the first few years of life, is an inherited, life-long illness that is characterized by problems with the lungs and digestive tract of its sufferers.</p> </h2> <h2 class="expand"> <strong>What is the purpose of Cystic Fibrosis Carrier Screening?</strong> <div class="scb"> <p>The purpose of CF carrier testing is to see if a couple is at increased risk for giving birth to a child who will have CF prior to conception through prenatal screening. The American Congress of Obstetricians and Gynecologists (ACOG) recommends carrier screening be offered to the following populations prior to conception or within the first or early second trimester of pregnancy:</p> <ul> <li>Individuals with a family history of CF</li> <li>Reproductive partners of individuals with CF</li> <li>Couples in whom one or both partners are Caucasian of Ashkenazi Jewish or European decent and are planning pregnancy or seeking prenatal care</li> </ul> <p>While these groups constitute those at highest risk of CF transmission, individuals at lower-risk should also be provided with counseling and screening information.</p> </div> </h2> <h2 class="expand"> <strong>Why do you need the patient’s ethnicity for Cystic Fibrosis Testing?</strong> <div class="scb"> <p>The incidence and carrier risk for CF varies greatly based upon race or ethnicity. This information is required to complete the result interpretation process.</p> <article id="cf_table"> <p><strong>Table 1.</strong>Incidence and Carrier Risk for Cystic Fibrosis Based on Race or Ethnicity (American College of Obstetritions and Gynecologists and American College of Medical Genetics Preconception and prenatal carrier screening for cystic fibrosis. Clicnical and laboratory guidelines. American College of Obstetricians and Gynecologists, Washington, DC 2001)</p> <table> <tbody><tr> <td>Racial or Ethnic Group</td> <td>Incidence of CF</td> <td>Carrier Risk</td> </tr> <tr> <td>Ashkenazi Jewish</td> <td>1/3,300</td> <td>1/29</td> </tr> <tr> <td>European Caucasian</td> <td>1/3,300</td> <td>1/29</td> </tr> <tr> <td>Hispanic American</td> <td>1/8,000-9,000</td> <td>1/46</td> </tr> <tr> <td>African American</td> <td>1/15,300</td> <td>1/62</td> </tr> <tr> <td>Asian American</td> <td>1/32,100</td> <td>1/90</td> </tr> </tbody></table> </article> </div> </h2> <h2 class="expand"> <strong>What is the clinical significance of the six 6 reflexed mutations? If the patient is positive for one of the 32 mutations they are a carrier, why do we do the reflexes?</strong> <p class="scb">The American Congress of Obstetricians & Gynecologists (ACOG) recommends that testing offered include these six mutations.</p> </h2> <h2 class="expand"> <strong>Why does MDL require two swabs when collecting genetic tests?</strong> <p class="scb">Two swabs are requested for all genetic based assays to ensure adequate amounts of human genomic DNA are obtained for analysis.</p> </h2> </section> <section id="faq_h1n1_testing" class="category hide"> <h2 class="expand"> <strong>What type of testing do you have available for Swine Flu?</strong> <p class="scb">MDL currently performs Test 1125 2009 H1N1 Influenza Virus (Swine Flu) with tamiflu resistance by Pyrosequencing.</p> </h2> <h2 class="expand"> <strong>Is MDL’s testing methodology the same as the Centers for Disease Control and Prevention (CDC) methodology?</strong> <p class="scb">Yes. Both the genetic region and methodology parallel the CDC’s approach with slight variation.</p> </h2> <h2 class="expand"> <strong>What type of specimens do you accept for H1N1 testing?</strong> <p class="scb">We accept a swab of nasopharyngeal surfaces collected with a NasoSwab<sup>™</sup></p> </h2> <h2 class="expand"> <strong>What is tamiflu resistance?</strong> <p class="scb">Tamiflu (oseltamivir), is an antiviral drug often used to treat influenza. According to the CDC in the 2007-08 flu season, reports indicated that worldwide there was a significant increase in the incidence of oseltamivir, or Tamiflu, resistance among H1N1 viruses and that in the U.S. 10.9% of H1N1 viruses tested were resistant to Tamiflu, which presents a problem for treatment.</p> </h2> <h2 class="expand"> <strong>Does MDL report positive H1N1’s to the state health departments?</strong> <p class="scb">Each state has their own reporting requirements for laboratories. We forward positive H1N1 results to the states that require such reporting.</p> </h2> </section> <section id="faq_mrsa_testing" class="category hide"> <h2 class="expand"> <strong>What type of testing do you have available for MRSA?</strong> <p class="scb">There are two assays currently available from MDL for MRSA testing. Test 1118: Methicillin resistant Staphylococcus aureus (MRSA) by conventional PCR and Test 1119 Panton-Valentine Leukocidin (PVL) DNA by Real-Time PCR.</p> </h2> <h2 class="expand"> <strong>What is the difference between the two tests available for MRSA?</strong> <div class="scb"> <p>Test 1118 will determine if MRSA or Methicillin Susceptible Staphylococcus aureus (MSSA) is present in a sample. If Test 1118 returns a positive result, then 1119 can differentiate hospital and community associated MRSA.</p> <p>Test 1118 also has the ability to determine the type of a mobile genetic element or transposon within MRSA called the Staphylococcal Cassette Chromosome (SCC) which carries the genes that cause methicillin resistance such as mecA. There are 4 main types of SCCs named type I, type II, type III, and type IV. SCC type I, II, and III are typically found in Hospital Associated MRSA (HA-MRSA) strains, while Type IV in conjunction with a positive PVL gene, test 1119, are typically found in Community Associated MRSA (CA-MRSA) strains. The SCC types within HA-MRSA strains also typically have other antibiotic resistance genes associated with them that could limit the number of alternative antibiotics used to treat MRSA. The CA-MRSA is typically a more virulent MRSA strain that can cause more aggressive infections, however the SCC type IV does not typically contain other antibiotic resistance genes, therefore when detected early can be easily treated with a number of alternative antibiotics.</p> </div> </h2> <h2 class="expand"> <strong>What type of specimens do you accept for MRSA testing?</strong> <p class="scb">We accept a swab of nasopharyngeal surfaces collected with a NasoSwab<sup>™</sup> or swabs of skin surfaces, boils, vaginal and anal tracts using the OneSwab<sup>®</sup>.</p> </h2> </section> <section id="faq_general_information" class="category hide"> <h2 class="expand"> <strong>How long has MDL been providing laboratory services?</strong> <p class="scb">MDL was founded in 1997 and serves primarily as a reference laboratory for Polymerase Chain Reaction (PCR) based testing to physicians, laboratories and hospitals worldwide.</p> </h2> <h2 class="expand"> <strong>Does MDL have a Research & Development Department?</strong> <p class="scb">At MDL, we believe that life science research is constantly evolving to improve human health and longevity. Our curiosity and resources are directed toward these challenges. Our research is focused on the creation and fostering of research excellence centers that define the relationship and interactions between host cells, disease causing agents and Pharmacogenomics. The Research and Development at MDL is intellectual property driven, and serves to create an accelerated bridge between basic research, product development and clinical implementation. Through its multiple discipline integrated division-based scientific strategy, our Research and Development Department encourages and supports the creation of innovative projects in the fields of Microbiology, Women’s Health and Gynecology, Pediatric Infectious Diseases, Cancer, Genetic Immunology, and Pharmacogenomics. This state-of-the-art research program promotes and fosters research collaborations and strategic partnerships with local, national and international Universities, Research Institutes and Biopharma companies.</p> </h2> <h2 class="expand"> <strong>Can I buy shares of MDL?</strong> <p class="scb">MDL and its affiliated companies are privately owned.</p> </h2> <h2 class="expand"> <strong>What licenses does MDL hold?</strong> <p class="scb">MDL is certified by the federal government under laws and regulations applicable to laboratories (Clinical Laboratory Improvement Amendments, also known as CLIA) that perform high complexity testing. It is also licensed in its home state of New Jersey and other states where licensing is required for out-of-state laboratories. 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