Post on 15-Dec-2015
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CT/GC TestingSpecimen Collection
Submission and Ordering
Objectives
• Learn about specimen collections
• Learn about specimen submissions
• Learn about specimen ordering
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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 Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital 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
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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)4
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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
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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
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• 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
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Specimen Packaging
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• 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
• Options– UPS *best option*
– FedEx
– U.S. Postal Service
– Courier Service
• Ship specimens to arrive at ISDH Labs on Monday-Friday, excluding holidays
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CT/GC Testing: Specimen Shipping
LimsNet Submissions
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• 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
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• 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.
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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.
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• 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.
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Submit Tests 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.
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Test Results 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 Reports Screen
LimsNet: Ordering Collection & Shipping Supplies
1. Log into LIMSNET.2. On the CT/GC Request Form, click the Order Supply button.3. A new window will open displaying the Order Form .
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1. The top fields (red asterisks) will be pre-populated but are editable.2. Enter the quantity of each item needed.3. Enter a contact name, phone #, fax # and email address at your facility.4. Click the Save button. **ISDH will automatically receive your order via
email and you’ll receive a “completed” message**5. ALL ORDERS MUST BE SUBMITTED BY THE 10TH OF THE MONTH!
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Billing For Services
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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.
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Questions?
Virology/Preparedness & CT/GC Supervisor
Phone: 317-921-5843
Fax: 317-927-7804