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CT/GC Testing Specimen Collection Submission and Ordering. Objectives. Learn about specimen collections Learn about specimen submissions Learn about specimen ordering. 2. CT/GC Testing. Gen-Probe/ Hologic APTIMA Combo 2 Assay
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CT/GC Testing Specimen Collection Submission and Ordering
Objectives • Learn about specimen collections • Learn about specimen submissions • Learn about specimen ordering 2
CT/GC Testing • Gen-Probe/Hologic APTIMA Combo 2 Assay • A target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseriagonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcalurogenital disease. • FDA-cleared for male urethral and endocervical swab specimens, plus male and female first-catch urine (FCU) specimens, and in patient-and clinician-collected vaginal swab specimens. • Turnaround Time: 2-5 days
Specimen Collection • Acceptable Specimen Types • Urine (Male & Female) • Vaginal Swab • Unisex Swab • Endocervical • Male Urethral • Rectal • Must be collected using only APTIMA Specimen Collection Kits (see package insert for instructions)
CT/GC Testing: Specimen Transport • Specimen Transport • Store specimens in their collection systems and keep at 15-30°C until shipped to ISDH • Specimens must be transported to the ISDH Lab at 2‐30°C in Gen-Probe/Hologic urine, vaginal or unisex swab APTIMA Collection Kits. • Specimens MUST be received at the ISDH Lab in a timely manner: • Urine: within 30 days of collection • Swabs: within 60 days of collection
Common Causes of Specimen Rejection • Mismatch of patient name/ID • Name on specimen tube and LimsNet entry don’t match • Lack of patient identifier on specimen tube • Specimen tube is completely blank • Specimen tube is leaking or broken • Specimen received in Lab after: • 30 days for urine specimens • 60 days for swab specimens • Improper specimen type • Expired transport tube • Multiple swabs in specimen tube
Packaging and Shipping • Package all specimens as UN3373 Category B, • “Biological Substance” following federal guidelines. • ISDH Labs will provide the UN3373 mailing labels, inner and outer mailing containers and small/large Tyvek mailing evelope. • Ordering of these supplies will be done by each submitter • via LimsNet.
ISDH Shipping Containers • 3 Components to Container • Urine/Swab collection tube (primary container) • Watertight, metal secondary container (absorbent material NOT provided by ISDH Labs) • Rigid (cardboard) outer container • All shipping containers are provided by ISDH Labs 8
Specimen Packaging • Must package and ship using UN3373 Biological • Substances, Category B • LimsNet coversheet should be wrapped around the secondary container • Must be separated from specimen to avoid contamination • UN3373 mailing label should be placed on the rigid outer container and the mailing envelope • Place outer container(s) inside the Tyvek mailing envelope • Specimens may also be shipped using just the rigid outer container as long as it contains the UN3373 mailing label
CT/GC Testing: Specimen Shipping • Options • UPS *best option* • FedEx • U.S. Postal Service • Courier Service • Ship specimens to arrive at ISDH Labs on Monday-Friday, excluding holidays
LimsNet Submissions • What is LimsNet? • ISDH Lab’s electronic specimen submission system that allows submitters to submit lab testing requests electronically rather than with paper form • Benefits • No need to fill out paper submission forms • Reduced turnaround time-results are available sooner-no need to rely on faxing or mailing • Delays in testing due to incomplete patient/submitter information are virtually eliminated • Submitters are able to view, print and save laboratory reports as PDF files at their convenience. • Currently, 100% of CT/GC specimens submitted to ISDH labs are via LimsNet
LimsNet Submissions • How to obtain a LimsNet account? • Call the ISDH Lims Help Desk at 317-921-5506 or 888-535-0011 • E-mail the ISDH Lims Help Desk at LimsAppSupport@isdh.IN.gov • Support is available Monday – Friday from 8:15 to 4:45 • http://limsnet.isdh.in.gov/
LimsNet Submissions • Be sure that “CT/GC” is the test selected on the Log new test dropdown. • Type in patient’s demographic • information. • Be sure to complete items marked in red. • Click “Save” at the bottom of the page • Repeat for additional specimens. 13
LimsNet Submissions • Be sure to fill out the Insurance Type! • Specimens with complete billing info will NOT be counted against your allotment! • Select the appropriate “Reason for Test” • MSM (urine & rectal swabs only) • Anal Risk (Female rectal swabs only) • Routine testing • Priority Age, Signs/Symptoms, Contact to confirmed STD, IUD, Prenatal, WIN-UPT, Test of Cure, Positive CT/GC within past 6 months. 14
Submit Tests Screen • Click “Submit Tests” at the top of the page. • Check the box next to the specimens to be shipped. • Enter the UPS Tracking #, if applicable. • Click “Mark as Shipped” at the bottom of the page. • Print LimsNet coversheet to send in with specimens.
Test Results Screen • Click on “Test Results” at the top of the page to view the status of specimens submitted. • Enter patient search data, or use collection data to search. • Click “Search” at the bottom of the page.
LimsNet Reports Screen • See the “Status” column to see if lab results are available • Unshipped • Not yet sent to ISDH Labs • In Transit • Sent but not yet received by ISDH Labs • Released • Lab report released by ISDH Labs • Click “View” to see a PDF of the lab report.
LimsNet: Ordering Collection & Shipping Supplies • Log into LIMSNET. • On the CT/GC Request Form, click the Order Supply button. • A new window will open displaying the Order Form . 18
The top fields (red asterisks) will be pre-populated but are editable. • Enter the quantity of each item needed. • Enter a contact name, phone #, fax # and email address at your facility. • Click the Save button. **ISDH will automatically receive your order via email and you’ll receive a “completed” message** • ALL ORDERS MUST BE SUBMITTED BY THE 10TH OF THE MONTH!
Billing For Services When you provide the patient’s insurance information and the clinic’s NPI # to ISDH through LIMSNET, the specimen submission will not be subtracted from your allotted amount of annual clinical tests provided in the STD Grant.
Questions? Virology/Preparedness & CT/GC Supervisor Phone: 317-921-5843 Fax: 317-927-7804