Policy for Informed Consent and Clinical Information

Below is a list of the Laboratory for Molecular Medicine (LMM) policies regarding the informed consent and the collection of clinical information.  For additional information or to discuss any of our policies in further detail, please contact us at 617-768-8500 or lmm@partners.org.

Ordering Provider Signature

By requesting testing from the LMM, the ordering provider indicates that he/she understands AND accepts the policies of the LMM, as noted below, and has communicated these policies to the patient.

• Our testing process includes highly skilled technicians and advanced technology. As in any laboratory, there is a small possibility that the test will not work properly or an error may occur.
• Listed turn-around times (TATs) represent the typical TAT for a test but are not guaranteed.
• If the requisition form is incomplete, and the health care provider cannot provide the required information, lab staff may need to contact patients directly to obtain or verify the information needed to complete the form.
• Test results, as well as any updates to those results, may become part of a patient’s permanent medical record (electronically or otherwise) or be made available (electronically or otherwise) to the ordering health care institution and its health care team.
• Results will only be released to the ordering provider and other providers listed on the requisition form. The ordering provider assumes the responsibility to disclose the test results and direct care as appropriate.

Blood or other samples sent to the LMM may be used by Partners Healthcare System (PHS), by medical organizations connected to PHS, or by educational or business organizations approved by PHS, for research, education, and other activities that support PHS’s mission, without your/the patient’s specific consent. Other types of research performed in association with the LMM require that we obtain consent from the patient (see requisition form).

Requisition forms can be found on our website, navigate to the Ordering section and find the specific disease area of interest.

Massachusetts State Law

Each requisition form must contain an ordering provider signature.

Massachusetts State Law [http://www.mass.gov/legis/laws/mgl/111-70g.htm] requires that:

“A laboratory receiving a request to conduct a genetic test from a facility … may conduct the requested test only when the request is accompanied by a signed statement of the medical practitioner ordering the test warranting that the appropriate prior written consent has been obtained from the patient.”

Please note: a patient consent form is available on our website for your convenience and DOES NOT need to be returned to the LMM. Click here for a pdf copy.

Clinical Information

The Laboratory for Molecular Medicine (LMM) requests at least a minimal amount of clinical information to define an indication for testing on all patients for which testing is ordered. The LMM requests clinical information to:

• Provide accurate test result interpretations
• Determine if familial variant test results are consistent with variant interpretations
• Provide the best clinical sensitivity data for our tests

If clinical information is not included on the requisition form or provided previously, LMM may contact you to provide this information prior to the reporting of test results.