FAQ

Shipping

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.

Required Paperwork

Q: What paperwork do I need to include?

A: All orders require completion of the requisition form. 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 documentation. However, your state or institution may have such a requirement. A generic consent form is available here for your records.

Specimen Requirements

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: We would like at least 2 mL of whole blood in lavender top (EDTA) tube to perform any test.

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.

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. Our requisition form allows you to order up to three tests sequentially on a single form.

Q: How do I order tiered/ sequential testing?

A: On the requisition form, please indicate in the numbered tests code boxes the codes for the tests you would like performed. Please list them in the sequence in which you would like them to be run (i.e. the test to be performed should be listed in the box with the “1” in front of it) and check the box labelled “Check for Tiered Testing.”

Q: How do I know when tiered/ sequential testing would be applicable or appropriate?

A: Ordering guidance is available for mosts tests at the bottom of the test information page. 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: How do I know if the second test I request will be performed?

A: We will automatically proceed with the next test requested if the results of the prior test are negative. If a variant is identified, whether pathogenic or uncertain, one of our genetic counselors will contact you to discuss the result and determine whether or not you would like to proceed with further testing.

Billing

Q: Does Claritas bill insurance?

A: Not at this time, though we will in the future. We bill via institutional billing only. Please contact your home institution about insurance coverage.

Q: May I receive a discount on the testing or possibly at no charge?

A: This request is considered on a case by case basis. Please contact Client Services at (617) 553 – 5880 or (855) 373 – 9003 for such requests.

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: Can a test be expedited?

A: If the result is needed as quickly as possible due to various circumstances, a note indicating this is a RUSH should be included on the requisition form. The laboratory will do its best to turn the test around as soon as possible.

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. Additionally mechanisms for online ordering and electronic results return are in development, so stay tuned.

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 requisition form to Claritas Genomics Client Services at (617) 553 – 5842 or email clientservices@claritasgenomics.com. Be sure to include the patient’s name, date of birth, and the institutional billing information. We will be in touch if there is not enough DNA available.

Contact Information

Q: What is your phone number?

A:  General Inquiries: info@claritasgenomics.com
Client Services: clientservices@claritasgenomics.com, (617) 553 – 5880, or toll-free (855) 373-9003.

Certifications and Important Numbers

Q: What is your CLIA identification number?

A: Our CLIA identification number is 22D0950490

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

We are currently working to obtain other state licenses. Contact Client Services at (617) 553-5880 to ask about the progress of our application for your state.

Q: Do you have a New York state license?

A: We do not have a New York state license.
Providers based in New York state must obtain special consent for testing samples at laboratories without a New York state license. Please contact Client Services at (617) 553-5880 if you require additional guidance.

Q: Are you CAP certified?

A: No.

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.