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Home > Laboratory for Molecular Medicine > FAQs

Laboratory for Molecular Medicine

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FAQ

Please click on the category or any individual question below for more information. Still have questions? Please contact us at 617-768-8500 or lmm@partners.org.


Test Ordering Payment Certification and Licenses 
Shipping Results and Analysis Downloadable Forms
Sample Requirements Contact Information  

 

Test Ordering

Q: What paperwork do I need to include?

A: Minimally, you will need to complete the entire test-specific requisition form, including the payment option, informed consent, and clinical information, and include these with the specimen. All specimens without proper required ordering components or payment information will be held until the appropriate information is provided.

New York Residents only: In addition to the test requisition form, an informed test consent must also be reviewed with the ordering provider and signed by the patient. 

Q: Where can I find test prices, turn-around-times, and CPT codes?

A: All information regarding test prices, turn-around-times, and CPT codes can be found by going on the specific test ordering page or by going to the Price List & CPT Codes section under ordering.

Q: Are consent forms required?

A: Yes, consent forms are required and may be signed by the referring physician in cases, where testing is being preformed for diagnostic purposes. In all other cases, the patient or parent/legal guardian must sign the consent form. For additional information on this requirement, please refer to our policies.

New York Residents only: In addition to the test requisition form, an informed test consent must also be reviewed with the ordering provider and signed by the patient. 

Q: When should I order familial variant testing instead of full Gene, panel testing?

A: If someone in your family already has been tested and we found a variant, in most cases, we only need to look for that variant, which is what is done with familial known variant testing. Full gene sequencing, Next Generation sequencing panels, Genome testing are performed when specific pathogenic variants have not been identified in a family.

Q: How do I order reflex, as opposed to concurrent testing?

A: You are able to order testing by a reflexive order or concurrently on the requisition form. If you choose to have the test run in a reflexive order, please indicate the order (i.e., 1, 2, 3…) in which you would like testing to proceed on the requisition form, next to the respective gene/test. This order communicates that you wish only to run testing, in the numerical order provided, until a positive result has been found. If you would like multiple tests to be run at the same time, please mark the appropriate check box next to the test with an “X.”

Q: I would like to order another test on a patient who was tested previously. Do I need to submit another specimen?

A: If enough DNA remains from the original testing, an additional specimen is not required. Because the original amount of DNA received depends on several factors, please contact us at 617-768-8500 or lmm@partners.org to determine if a second sample would be required.

Q: What is the procedure for adding on additional testing to a sample already at the LMM?

A: An additional test can be added on to a sample we previously received by submitting a written request for the new test to be performed. Please reference the LMM Accession # (PM#), the patient's name and his/her date of birth. Unless specified otherwise, payment will be processed in the same manner as the original test request. This request can be faxed at 617-768-8513 or emailed to us at lmm@partners.org.

Q: How can I order Genome Sequencing?

A: To learn more about how to order Genome Sequencing, requirements, report content and interpretation, please visit our Genome Sequencing Frequently Asked Question page.

Q: What is copy number variant (CNV) analysis, and how can it be ordered?

A: To learn more about how to order CNV analysis, requirements, and technology, please visit our Copy Number Variant analysis Frequently Asked Questions page.

Shipping

Q: Where do I send a specimen?

A: Specimens should be shipped, along with the completed requisition form, to

Laboratory for Molecular Medicine
65 Landsdowne Street
Cambridge, MA 02139

Q: How do I send a specimen?

A: Labeled samples should be sent overnight at room temperature and accompanied by a completed requisition form with signed consent.

Please ship samples to:

Laboratory for Molecular Medicine
Attention: Clinical Laboratory
65 Landsdowne Street
Cambridge, MA 02139

The LMM DOES NOT accept samples on Saturdays, Sundays, or holidays. For blood samples drawn on Fridays or that cannot immediately ship, please keep samples refrigerated overnight and ship on the next business day.

Please follow specific regulations set, depending on courier service utilized. For questions regarding shipping of samples, please see our FAQ or contact the lab at 617-768-8500 or lmm@partners.org.

Q: Can I ship specimens by regular postal mail?

A: Cheek buccal swabs and saliva specimens can be sent through the regular postal mail using the return envelope addressed to the LMM that is included with the kit. All blood, DNA, prenatal, and other specimens should NOT be shipped to using regular postal mail and should be shipped by an overnight delivery service.

Q: Does the Laboratory for Molecular Medicine accept deliveries on Saturdays?

A: No, the LMM cannot receive deliveries on Saturdays or Sundays. If a sample is collected on a Friday or over a weekend, 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 the Laboratory for Molecular Medicine pay for shipping?

A: No, the referring institution or send-out lab is responsible for coordinating and paying for the shipment of samples. The LMM will cover return shipping for specimen collection kits (buccal swab or saliva) sent directly to patients.

Q: When will the Laboratory for Molecular Medicine accept shipments?

A: Our regular business hours are 8:30 a.m. - 5:00 p.m. EST, Monday through Friday. The LMM is NOT open for deliveries on weekends or holidays. If you have additional questions about when shipments can be received, please contact us at 617-768-8500 or lmm@partners.org.

Q: What is the Laboratory for Molecular Medicine's holiday schedule?

A: The LMM is closed on:

  • New Year's Day
  • Martin Luther King Day
  • Presidents Day
  • Memorial Day
  • Independence Day
  • Labor Day
  • Columbus Day
  • Thanksgiving
  • Christmas

*Please note, if the holiday falls on a Saturday, the laboratory will be closed the previous Friday. Holidays which fall on a Sunday are observed the following Monday.

Sample Requirements

Q: Do you prefer a blood specimen over a buccal swab or saliva specimen? Is there any difference?

A: The accuracy and turn-around time of the testing is the same between a blood specimen and a buccal swab or saliva specimen. However, since the amount and quality of DNA that can be obtained from buccal swab or saliva sample can differ, they are only accepted for our familial known variant testing.

Q: What buccal swab kits or saliva kits does the LMM accept?

A: The LMM accepts any brand of buccal swab kit, but will only accept Oragene® DNA kits for saliva samples.  If you have any questions regarding kit brands or would like to request a cheek brush or saliva kit, please contact us at 617-768-8500 or lmm@partners.org.

Q: I am drawing a specimen from an infant. What is the minimum amount of blood required?

A: We would like at least 1–2cc of whole blood in a K2EDTA or K3EDTA (purple top tube) to perform any test. If testing is for a familial known variant(s), a buccal swab can be used.

Q: Can buccal brush specimens be collected on infants?

A: For Familial Known Variant testing, we can generally obtain adequate DNA from buccal swab specimens on infants. For all other testing, we request blood specimens (minimum 1–2 cc of whole blood in a K2EDTA or K3EDTA purple top tube) on small babies.

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. The laboratory generally obtains enough DNA from one specimen of 7ml of blood to complete a number of tests. Please call for specifics.

Q: Do you offer prenatal testing?

A: We  can not  accept cultured/direct amniotic fluid or CVS specimens. The laboratory does not offer maternal cell contamination (MCC) studies; therefore, we can only accept DNA derived from prenatal specimens (amnio, CVS, cord blood) if MCC has previously been run and results are provided with the specimen at the time of submission. The laboratory must be contacted prior to sending any DNA derived from prenatal specimens.

Q: Can I order more buccal swab or saliva kits?

A: Yes, please contact us at lmm@partners.org or 617-768-8500.

Q: Can I send DNA?

A: Yes. We are able to accept isolated DNA for all tests EXCEPT deletion/duplication testing (MLPA). Please see sample requirements for specifics.

Q: Why are formalin-fixed autopsy tissues not accepted for genetic testing?

A: Formalin fixation causes degradation of DNA. Although testing can often be successfully performed on biopsy material that undergoes brief fixation, autopsy specimens are fixed for much longer periods of time causing too much degradation to the DNA. Please refer to our post-mortem specimen requirements for additional information.

Payment

Q: Does the Laboratory for Molecular Medicine accept insurance or state Medicaid or Medicare?

A: No, the Laboratory for Molecular Medicine is not able to bill insurance companies (exceptions occur for some tests performed on Brigham and Women's Hospital patients). We can either bill the referring institution or accept personal payment. If a patient plans to pay directly, payment must be received prior to the start of testing.

Q: How can I find out if I will get reimbursed by my insurance company?

A: This depends on your particular plan and whether your deductible has been met. Facts you can give your insurance company about the test itself and the LMM are as follows:

  1. The CPT codes, a series of several 5-digit numbers that, taken together, describe the test procedure for analyzing any gene. The CPT codes differ for each test.  Please go to the Price List and CPT Codes page to find the CPT codes listed by test.
  2. If the CPT codes are accepted, note that some codes have multipliers such as "x 5." This number varies depending on how many genes are analyzed in the test panel. Ask how many times a code can be used per date of service. Explain that ONE test does, indeed, call for the full number of codes and multipliers stated.
  3. Make sure the insurance company covers those CPT codes for the diagnosis or symptoms you or your child has. Your doctor may need to provide a letter of medical necessity. The symptoms or reasons for needing the test may be described with code numbers called ICD codes. 
  4. For additional information, please see our page about seeking reimbursement from insurance companies. [LINK: 3.2.13.1]

Q: Can I set up an institutional billing account?

A: There is generally no need to set up an account with us if you are shipping specimens from a hospital laboratory or physician's office. Simply provide the name and contact information of where we can mail the invoice and CPT codes for the services rendered.

Results and Analysis

Q: Why are the results of testing sent directly to the referring physician rather than the patient or parent of a patient?

A: Massachusetts state law requires genetic tests to be ordered by health care providers, and the results of those tests can only be returned to the ordering provider, unless we receive permission from the health care provider to release the results directly to the patient. Genetic testing is usually performed as a tool to help the physician make a diagnosis or to help a physician manage a patient's health care. The results of genetic testing may lead to additional testing, and therefore, it is best for the physician 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 can sometimes be complicated and difficult to understand. In most cases, it is best to report the results to a health care professional, who has both a relationship with and the time to explain such results to the patient or patient's parents. However, once the results of testing have been discussed with the patient, through a health care provider, a copy of the report may be provided to the patient or guardian directly.

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 type of test, the size of the gene(s) being tested, the complexity of the interpretation, the occasional need to repeat a test, along with other factors. The estimated turn-around times for each test can be found under Price Lists and CPT Codes. These estimates are based on the typical turn-around time for test. As soon as a test is completed, the results are faxed to the referring physician or ordering facility. For positive results or prenatal testing, the referring physician or a genetic counselor is contacted by phone or email, if this contact information is provided to us.

Q: The test result has been lost or was never received, can you resend it?

A: The Laboratory for Molecular Medicine can provide a duplicate copy of the test result to the ordering physician, the ordering facility, or anyone else listed on the requisition form. We cannot send results to other physicians 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 and patient’s date of birth.

Q: Can a test be expedited?

A: All prenatal specimens for which the pathogenic variant in the family is known are expedited. If there are other medical indications for expediting a test, please let us know, and we will do our best to get a result out as quickly as possible. The most common indications for expediting a test in the lab are a scheduled or necessary procedure (e.g., surgery, bone marrow transplant) and testing on a pregnancy or family member of a pregnant woman.

Contact Information

Q: What is your phone number?

A: Our main phone number is 617-768-8500. Additional contact information can be found on our contact us page.

Q: Can I speak to the person in charge of ordering supplies, marketing, etc., at the Laboratory for Molecular Medicine?

A: The easiest way to reach us is by email. Please send your question to lmm@partners.org, and it will be delivered to the appropriate person.

Certifications and Licenses

Q: What is your CLIA identification number?

A: For information about our CLIA (Clinical Laboratory Improvement Act)  certificate or other certificates, please visit: http://www.massgeneral.org/pathology/clinical/regulatory_compliance.aspx

Q: Are you CAP certified?

A: No. Like many laboratories within hospitals, we are CLIA-accredited through The Joint Commission.

Q: Are your tests FDA-approved?

A: No. Our tests are developed and validated in-house and regulated by both CLIA  and The Joint Commission. The FDA has determined that such clearance or approval is not necessary.

Q: What out-of-state licenses/permits does the laboratory hold?

A: MD State License #1200
     PA State License # 033982

Downloadable Forms

Q: How can I open the downloadable forms from your site?

A: To view documents in PDF format, you need to install Adobe Acrobat Reader, a free application distributed by Adobe Systems.

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