Clinical trial research fluid/serum samples process via the procedures described below. A study-specific UAMS Clinical Lab Research Sample Submission form and EPIC billing account are established upon completion of this process.
Research samples involving biopsied/excised tissue should initiate through the UAMS Experimental Pathology Core Lab. Current rate and service information is available via the Tissue Work Order Form / IDT which can be accessed through this web link.
- For lab test pricing information on research fluid/serum samples (based on provided CPT codes received from the Pathology Lab – see below for contacts), please contact the Clinical Trials Innovations Unit (CTIU) Financial Revenue Unit Manager (Contact Cynthia Spinks via email at SpinksCynthiaD@uams.edu, or by phone at 501-526-4619). CTIU’s?? Financial Unit? w?ill ass??ist?? res??ea?rch st??aff w?it?h en?ter?ing ???study? bu?dget? information into CLARA.
- To create a study-specific, EPIC Institutional & Study Guarantor account and receive a UAMS Clinical Lab Research Sample Submission form, please contact the following Laboratory and Pathology Service Line (LPS) staff: Patty Gminski (firstname.lastname@example.org, phone number 501-686-6519) or Jim Marshall (JSMarshall@uams.edu, phone number 501-296-1247). The following information is required to initiate EPIC account(s) and submission form(s):
Name of Study:
Name of Responsible Person for Study billing:
Study Contact Information
- Phone Number:
- Fax Number:
- UAMS Account Number to be billed:
Upon receipt of this information, LPS staff will submit a request to UAMS IT Patient Systems to create the study-specific EPIC Institutional & Guarantor account numbers which are used during lab registration.
- Once the EPIC Institutional & Guarantor account numbers are created, UAMS IT Patient Systems informs UAMS Beaker Laboratory Information System (LIS) of the account creation. UAMS Beaker LIS then creates the submitter record within EPIC which allows for the registration of the submitted research sample.
- Upon completion of the submitter record, UAMS Beaker LIS notifies LPS staff who will issue a UAMS Clinical Lab Research Sample Submission form to the requestor. This form must accompany all specimens sent to the UAMS Clinical Lab.
- At the time of consent, study research staff are responsible for entering study participant information into the Research Participant Registration System (RPRS). (Deidentified Patient samples do not require RPRS entries. However, identifiable, Patient samples for Study participants must be entered into RPRS prior to delivery of lab specimen for accurate linking of lab results to the study record in RPRS.) Please label specimens appropriately. Labels may be handwritten or printed. Specimen label must include:
- Study participant ID number (i.e. Subject 2016-001)
- Study IRB number
- Deliver specimens with the completed Clinical Lab Research Sample Submission form to the Lab’s receiving?? ?window which is located in the hospital, Room B095. This? s?amp?le d?rop?-off location is manned 24/7.
- Clinical Lab staff uses specimen labeling and Research Sample Submission form to register the study participant’s assigned ID number and IRB number in the EPIC/Beaker System.
- The Clinical Lab system sends lab results to research staff via fax or to AR-CRIS using HL7 message channel. Study participant ID and IRB number must be included in the HL7 message. Registered study participant’s lab results can be viewed in RPRS under the study’s record.
- Study is aut?omat?ically? billed by? UAMS? Pat?ient? Billing Services and statements issued to the responsible person identified above (see step 2).
- Critical Values: Please note, critical values will not be reported for de-identified samples. LPS will follow critical value policy if research sample is properly labeled and received for patient care.