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Client Services
Our customer service representatives are available live via telephone around the clock (24/7) to answer your questions about test result information, test menu, test add-ons, specimen requirements, stability, supply orders, Subject information, corrections and complaints, as well as to assist you in obtaining laboratory testing services and supplies. 1-844-LAB-2031 (1-844-522-2031).
Labpharma Contact Information:
Shipping Information:
Labpharma, LLC
Attn: Receiving Department
Protocol ID: XXXXX
2324 SW 8 Street
Miami, FL 33135
24 hour Customer Service Line: 844-522-2031
Alternate numbers: 305-547-9394 / 1-844-LAB-2031 (1-844-522-2031)
Email: clinical.trials@labpharmacorp.com
Real-Time Secure Result Portal: https://labpharma.labnexus.net/
Project Manager: Oliver Miguel, direct number: 786-426-3205, email: omiguel@labpharmacorp.com
Technical Supervisor: Roman Miguel, BS, MT, direct number: 844-522-2031, email: rmiguel@labpharmacorp.com
Customer Service Manager: Patricia Jardines, direct number: 844-522-2031, email: patriciaj@labpharmacorp.com
Test Additions After Submission of Specimen
Client Services can arrange for additional testing if the specimen is stable and the volume sufficient after initial tests have been completed. We are required by Federal Regulations 42 CFR 493.1291 to request written authorization for every test we perform. Our clients will receive a request for written confirmation for verbal test requests via hard copy reporting or by facsimile, which will contain the same information as the original requisition form. The Principal Investigator or authorized employee must sign and return written confirmation prior to any additional testing being performed. Note: All additional testing must be approved by Sponsor or Site manager prior to performance of the test.
STAT Services
Selected tests are available on a STAT (emergency) basis for an additional fee. Specimens requiring STAT services should be called in to our STAT department 1-844-LAB-2031 (1-844-522-2031). Please consult your local Labpharma for more information.
Note: Additional testing must be approved in advance by the Principal Investigator, Sponsor or Site Manager.
Quality Assurance: An Overview
As part of an extensive set of activities focused on quality, we have a formal Quality Assurance Program that monitors and evaluates the quality of the testing process (pre-analytic, analytic and post-analytic). In our Quality Assurance Program, Labpharma rigorously monitors, precision, reproducibility and proficiency as an ongoing process of constant improvement.
Reporting
Test result reporting times vary, depending upon the nature of the test, the analytical time required for the procedure, and the method of reporting. The primary method of report delivery will be electronically, distributed by Labpharma:
· Real-Time secure web portal (https://labpharma.labnexus.net/),
However, if results cannot be accessed in this manner for any reason, sites can request results using the following methods:
· by email,
· by facsimile (Auto-fax), or
· By hard-copy mail or courier delivery.
Communicating Urgent Results (STAT)
The Principal Investigator, physician or authorized employee who requests a testing procedure is responsible for providing 24-hour reliable contact information for STAT and priority reporting. Notification will provided to the Principal Investigator, physician, or his/her authorized representative, as permitted or required by state and federal law, and these authorized personnel will have the responsibility of interpreting the result(s) in the context of the Subject’s clinical condition. The authorized personnel will be responsible to take immediate action, if needed. If the authorized personnel is not qualified to make these decisions, he/she has the responsibility to communicate the information to a qualified person immediately.
STAT test results will be reported for tests that have been ordered as STAT by the client and are offered as a STAT test by Labpharma receiving the specimen. We will use reasonable efforts to promptly communicate STAT test results within 4 hours, 7 days/week.
Critical Result Reporting
Our Critical Result Reporting Policy includes special notification for results that may require immediate attention by authorized personnel prior to regular delivery of results. Critical result reporting is in addition to the regular reporting procedures for all test results. Sites may review our Critical Values on the Labpharma website: www.labpharma.us
Critical-1 test results include, but are not limited to, results considered “critical” according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA; CFR 493.1109F) and the College of American Pathologists (CAP) Laboratory Accreditation Program and so designated by the Laboratory Medical Director.
Because test results cannot be fully interpreted without knowledge of the Subject’s current clinical condition and treatment, we will use reasonable efforts to promptly communicate Critical -1 results with a high degree of urgency, 7days/week so that the authorized personnel can determine the clinical implications and possible need for immediate attention.
Critical-2 test results are those that may require attention prior to the receipt of routine laboratory reports. We will use reasonable efforts to promptly communicate these results the same day (up to 5pm), 7 days/week.
Critical-3 reporting applies only to clients whose sole means of obtaining Labpharma results is the printed report (i.e. receiving only mailed or courier-delivered reports). These are test results that may require attention before receipt of the printed report and will be communicated in the same day reported during weekday working hours 6:00 a.m.– 6:30 p.m. EST.
Reissued Reports
These are Subject lab reports with changes or additions made to previous reports. After the change, amendment or addition is made, these reports will be reissued.
Revised: Any change in test result(s)
Amended:
▪ A change in the age/DOB or gender that affects the reference range of previously reported test results or how the results are flagged (e.g., abnormal)
▪ A change in client provided information (e.g., clinical information from the requisition form) previously reported, with no change in actual test result values
Addendum: New or additional information added to a previously reported result
Confirmatory: Indication that a repeat test request was performed, and the previously reported results are confirmed
Confidentiality
We are committed to protecting the confidentiality of individual Subject and client information such as private laboratory test results and other personal information in compliance with all applicable federal, state and local laws and regulations, 45 CFR § 164.524. For more information about our privacy practices, please visit our website at www.labpharma.us, or send a written request for information to Data Privacy & Security Officer, Labpharma, LLC, 2324 SW 8 Street, Miami, FL 33135.
Supplies
To order supplies, study kits and test requisition forms, call Client Services at 1-844-LAB-2031 (1-844-522-2031) or email clinical.trials@labpharmacorp.com.
Special study-specific sample collection supplies include the following materials:
(2) Alcohol Pads
(1) Tourniquet
(1) BD® Eclipse® Needle Collection System (22GA)
(1) Vacutainer® Holder
(2) BD® Serum Separator Tubes (SST)
(1) BD® Lavender Top Tube (EDTA)
(1) Band-Aid® spot bandage
(1) Specimen Transport Bag
(2) Additional Labels
(1) Clinical Trial Requisition Form
Cancellations
Tests may be cancelled without charge while specimens are in transit. A nominal fee will be charged for cancellations after specimens have been accessioned but not yet assayed. For cancellation requests, please call Client Services as soon as possible after it is discovered that tests require cancellation.
Reference Ranges
We establish our reference ranges for analytes in compliance with standard operating procedures, manufacturer specifications as suggested by the reagent manufacturers or reported literature and CAP guidance. Many of our reference ranges have been developed in conjunction with major healthcare institutions and industry standards to the methodology and assay tested. For a listing of study specific rages please contact customer support or email clinical.trials@labpharmacorp.com.
Human Specimen Acceptability
Requests for uncommon specimen type testing will be rejected, and the order cancelled, unless validation information is available.
Repeat Determinations
We will repeat a test without charge whenever, in the opinion of the Principal Investigator, the result does not correlate with the Subject’s clinical profile. Please call the laboratory as soon as possible after the original result is reported. When requesting a repeat determination on a new specimen, include the prior laboratory specimen number and explain the circumstances for the request on the test requisition accompanying the new specimen.
Follow-up or confirmatory testing is not considered a repeat determination. These specimens will be processed and billed as new requests. Note: these tests must be approved by Sponsor.
Specimen Retention
At Labpharma, samples are refrigerated for 14 days to allow repeat testing if necessary and then discarded. The retention time for all samples will vary and is based upon criteria such as:
▪ Study protocol specifications
▪ State and federal regulations
▪ Test manufacturer’s recommendations
▪ Deterioration of the analyte
▪ CAP requirements and CLSI guidelines
▪ Acute/convalescent testing requirements
▪ Pending litigation
Appropriateness of testing is ultimately a technical decision and is made by the technical staff using test-specific criteria. Our Sample Storage Policy assures availability of adequate and reliable specimens. Please call Client Services at 1-844-522-2031 for more details.
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