99 Erie Street, Cambridge, MA 02139
Client Services Hours of Operation: 8:30 to 5 ET
Q: Where do I send a specimen?
A: Claritas Genomics Attn: Specimen Processing 99 Erie Street Cambridge, MA 02139
Q: How do I send a specimen?
A: All specimens should be packed and shipped according to US Department of Transportation (DOT) and International Air Transportation Association (IATA) regulations. Please consult the shipping guidelines before packing specimens. Shipments should include a completed requisition form. Additional forms may be required for specific tests and are outlined on the test page. We do not accept prenatal samples.
Q: Can I ship specimens by regular postal mail?
A: DNA may be shipped by regular mail. All other types of samples should be sent by overnight or second-day delivery. If a sample is collected on a Friday or Saturday, it should be kept in the refrigerator and shipped on the next business day for overnight delivery. Keeping the specimen refrigerated over the weekend will not compromise the quality of the specimen.
Q: Does Claritas Genomics accept deliveries on Saturdays?
A: No. If a specimen is collected on Friday or Saturday and cannot be shipped overnight, please keep it in the refrigerator and ship it on the next business day for overnight delivery. Please consult the shipping guidelines before packing specimens.
Q: Does Claritas pay for shipping?
A: If a specimen is sent using a Claritas specimen collection kit, shipping is paid (domestic shipping only). If a Claritas collection kit is not used, or if specimens are shipped internationally, shipping is the responsibility of the sender. Order kits here.
Q: Can I request that DNA be shipped from your laboratory to another laboratory/institution?
A: If there is DNA available, the original ordering provider can request that it be sent to another facility. The laboratory is not responsible for the cost of shipping. Additionally, a consent form giving permission to release the sample is required from the patient or the patient’s parent/ guardian.
Q: What paperwork do I need to include?
A: All orders require completion of the test-appropriate requisition form. The required requisition form is listed on the test-specific webpage. Additional forms, including clinical features checklists or consent forms, may be required. Please see the individual test description for details. Specimens without appropriate paperwork will be held for five business days. If the paperwork is not received within that time period, the sample will be rejected.
Q: Is a consent document required?
A: Claritas does not require consent on many tests. However, it is required for samples sent for the Claritas Clinical Exome and Region of Interest tests. Additionally, ordering physicians from New York must sign the Statement of Medical Necessity on the first page of the requisition form.
Q: What types of samples are accepted at Claritas?
A: Please see Sample requirements and shipping page
Q: Do you accept buccal samples?
A: Not at this time.
Q: I am drawing a specimen from an infant. What is the minimum amount of blood required?
A: Please send at least 2cc of whole blood in lavender top (EDTA).
Q: If more than one test is being ordered on the same patient, is it better to provide a tube of blood for each test?
A: No. Claritas obtains enough DNA from one specimen to complete a number of tests.
Q: Do you offer prenatal testing?
A: No. We are happy to assist you with identifying a facility that is able to test prenatal samples for variants identified in our laboratory.
Requesting Raw Data
Q: How do I order raw data?
A: More information about how to order raw data is available at http://www.claritasgenomics.com/data-return-program. Note that this is a free service unless the provider requests that data is returned on a hard drive. Contact client services for more information about the fees associated with requesting data on a hard drive.
Ordering Tiered Testing
Q: May I order tiered/ sequential testing?
A: Yes. We encourage you to order tests sequentially when possible to avoid unnecessary testing and cost for your patient. Document your request on the requisition form or contact our Client Services team to discuss it in detail.
Q: How do I know when tiered/ sequential testing would be applicable or appropriate?
A: Ordering guidance is available for mosts tests; this can be found on the test-specific webpage. This advice is supplied by our staff of board-certified genetic counselors and medical directors. If you have further questions about test selection in general or related to a specific patient, call 617-553-5880 and ask to speak with a genetic counselor.
Q: What types of payment from patients does Claritas accept?
A: Claritas accepts the following as forms of payment from patients: Money order, bank transfer, credit card, and PayPal. Contact Claritas Client Services (Toll Free: (855) 373-9003, [email protected]) for more information.
Q: Does Claritas bill insurance?
A: Yes. Claritas attempts to bill all commercial insurances. See our Billing and Financial Assistance page for more information.
Q: May I receive a discount or possibly have testing at no charge?
A: Claritas offers a Financial Assistance Program which provides support to each patient or family to help mitigate out-of-pocket expenses based on their needs. Patients or their families may contact Claritas at 617-553-5880 or (toll-free) 855-373-9003 to discuss qualifying or pre-qualifying for this program. Claritas also offers an Economic Hardship Program; Providers must apply for this on behalf of their patient. More information is available on our Billing and Financial Assistance page.
Results and Analysis
Q: Why are the results of testing sent directly to the referring provider rather than the patient or parent of a patient?
A: Genetic testing is usually performed as a tool to help the healthcare provider make a diagnosis or to help a healthcare provider manage a patient’s health care. Because the results of genetic testing may lead to additional testing, it is best for the provider to receive the results so that an appropriate plan for the care of the patient can be determined. In addition, the results of genetic testing may be complicated and difficult to understand. In most cases it is best to report the results to a healthcare professional who has both a relationship with and the time to explain such results to the patient or patient’s parents.
Q: Is my test finished yet?
A: Our goal is to provide you with an accurate result in a reasonable time period. The time it takes to complete a test varies depending on a number of factors including the size of the gene, the complexity of the interpretation, the occasional need to redesign or repeat a test, and other events that may extend the amount of time it takes for results. Turnaround time is specific for each test. These estimates are based on the average amount of time it has taken us to complete the test in the past. As soon as a test is completed, the results are transmitted to the referring provider or ordering facility.
Q: The test result has been lost or was never received, can you resend it?
A: Claritas can provide you with a duplicate copy of the test result if you are the ordering provider or are from the ordering facility. We cannot send results to the patient or other providers involved in the care of the patient without a signed release from the patient authorizing us to do so. When calling for a report, please let us know the first and last name of the patient, date of birth, and when the specimen was sent.
Q: I received an invoice, but not the result.
A: Billing occurs separately from the laboratory analysis. We understand that many laboratory policies require the results before a payment is made.
Q: Is it possible to receive reports electronically?
A: If tests are ordered through NextGxDx, reports are returned electronically. Generally, however, reports are returned by fax. Additional mechanisms for online ordering and electronic results return are in development, so stay tuned.
Q: I am a patient who has had testing performed at Claritas Genomics. How do I get a copy of my report?
A: To obtain a copy of your report, please call our Client Services team at 855-373-9003. We will be happy to assist you.
Adding on Tests
Q: I would like to order another test on a patient who was tested previously. Do I need to submit another specimen?
A: Generally, Claritas obtains enough DNA from one specimen to allow completion of a number of tests, in which case a second specimen is not necessary. If you have previously ordered a number of tests on the same sample, we suggest contacting us to confirm that we have adequate DNA available.
Q: What is the procedure for adding on further testing to a sample already at Claritas?
A: To add on a test please fax a new requisiton form to Claritas Genomics Client Services at (617) 553 – 5842 or email [email protected]. Be sure to include the patient’s name, date of birth, and the institutional billing information. We will contact you if there is insufficient DNA to fulfill your request.
Q: How can I contact you?
Certifications and Important Numbers
Q: What is your CLIA identification number?
A: Our CLIA identification number is 22D0950490. Also, in 2015, we gained ISO 15189 accreditation, which is an accreditation that has been granted to only 7 other clinical laboratories in the US for quality and competence in medical laboratories.
Q: What state licenses do you have?
A: Massachusetts state license 3338
Rhode Island state license LCO00843
California state license #00800509
Pennsylvania state license #033760
Maryland state license 2147
Florida state license 800027665
Note that some expiration dates may not be current. This is usually due to delays by the federal, state or private agency responsible for inspection, application review and issuance of these licenses or certificates. All licenses or certificates remain current while license renewal applications, inspections, and/or other review process are taking place toward the issuance of a new license.
Q: Do you have a New York state license?
A: We are currently in the “Applied” stage of obtaining New York state licensure.
Until we receive full licensure, providers based in New York state must obtain special consent for testing samples at Claritas. Please contact Client Services at (617) 553-5880 if you require additional guidance.
Q: Are your tests FDA-approved?
A: No. Our tests are developed and validated in-house and the FDA has determined that such clearance or approval is not necessary.
A: Claritas is committed to protecting the privacy of our patients and families and complies with the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security rules. Visit http://www.hhs.gov/ocr/privacy/ for more information on HIPAA.