Study Coordinators Guide to Laboratory Testing

1. Study Coordinators Guide to Laboratory Testing March 2013 Anita Patel apatel90@uic.edu 312-996-4294

2. Introduction The topics covered will be: • What testing is included in the “laboratory”? (pg. 3) • What services the laboratory can and cannot provide? (pg. 4) • How do I get stated? (pg. 5) • What is the deal with the pricing for grants/studies? (pg. 6) • How do I get approval for the study? (pg. 8) • How long does the process take? (pg.12) • Sample Requisitions. (pg. 13) • Special instructions for “anonymous” subjects. (pg. 14) • Instructions for testing done on In Patient participants (pg. 15) • How do I get the results? (pg. 16) • Where can I find test reference ranges and specimen requirements? (pg. 17) • What happens if there is a problem with the bill? (pg. 24)

3. What testing is included in the “laboratory”? • All Anatomic Pathology testing • Surgical Pathology • Cytology • All Clinical Pathology tests: • Chemistry • Hematology • Coagulation • Blood Bank • Microbiology • Molecular Genetics • Flow Cytometry • Cytogenetics • Tests that are sent to our approved reference labs

4. What are the services the laboratory can and cannot provide? Can: • The laboratory will provide a custom requisition for the study. Please use only the custom requisition. • The laboratory phlebotomists (in the OCC) can draw the blood for testing or for processing by the study (there is a fee for this service). • The Laboratory can process tests that are supported by our laboratory. • The Laboratory can provide results in Cerner or a printed copy. • The Laboratory can provide copies of Accreditations and certifications. Can not: • The laboratory can NOT process specimens unless the results go into the lab system - we won’t spin, pack, or send. • The laboratory will NOT allow the use of centrifuges for processing non-laboratory resulted specimens. • The phlebotomists can NOT come to the patients. Note: if you need to be trained in the art of phlebotomy, the CRC may be able to help you. Contact them at 996-3937.

5. How do I get started? • If this is a preliminary inquiry to determine feasibility – just send the list of specific tests you are interested in to Sally Opel (sopel@uic.edu) • Note: be as specific as possible – Don’t ask for “Chemistries” – there are probably 100+ tests we consider “chemistry”. • If you are already approved, more specific information will be needed. (More on that later – slide #11.)

6. What is the deal with pricing for grants/studies? • The prices provided by the lab are the list (non-discounted) prices. Depending on the sponsor, the study receives a discount. (see next slide) • The price of all laboratory tests typically increases July 1st. The increases in the past have been 5%, however that may not always be the case. • Prices for some tests (send outs or tests where methods change) may be subject to change without notice. • Always recheck the actual prices or % adjustment if a new fiscal year has begun since you were given the prices.

7. Discounts for Clinical Laboratory testing:

8. How do I get approval for the study? The place to start is at The University of Illinois Medical Center Clinical PAF Processing Office (PAF) web site. That web page is found on either of the UIC web sites http://intranet.uimcc.uic.edu/SitePages/Home.aspx (requires log-in and password) or http://tigger.uic.edu/depts/ovcr/research/proposals/forms/index.shtml These sites give you all the forms, the names of the departmental contacts, how the process works.

9. PAFWebsite: Intranet

10. PAF Website: Internet

11. Specific information needed If after the funding has been approved and the services of the UIC Pathology Laboratory are required, you will need to have this information: • The account number – the account number we need must end in 9517 • The name of the study or a suitable acronym (of 4-8 letters) • The tests to be done or if the “lab” will only draw blood and your study will process the specimens. • Whether the patient(s) are to be registered (have an MRN) or will the patient be “anonymous”, use only a study ID. • Do you want the results to go into Powerchart (EMR)? • If the results will not go into Powerchart (patients with only a study ID can not go into Powerchart) – how will you get the results – pick them up or have them mailed? More about this later. • Who the contact person is in the event of problem with the specimens, critical results that need to be called, or other information?

12. How long does the set-up process take? After the funding has been approved – and the account number set up through Patient Accounts. • The laboratory computer set up can take from 1day to a week. • The custom requisition can take from 1 day to 2 weeks - depending on the complexity of the requisition and the availability of the LIS staff.

13. Requisition Example Here are examples of what the requisitions look like:

14. Special Instructions for “Anonymous” patients: • Anonymous patients are those that are not registered in Cerner or because they are not people (monkeys, rats, etc.). • When determining the study ID that will be used in place of the MRN – please don’t start your numbering at 1. We have dozens of studies and if everyone started with 1 – well, you can see the problem! • If these patients will be drawn in the OCC, a coordinator must accompany the patient or an actual name must be supplied to assure proper patient identification (this can be part of the requisition and will never be entered into the system)

15. IP and ED Patient participants • Sometimes IP or ED patients will have some of the testing covered by the Grant/Study. (If all services are covered, the specific admission may be “linked” to the study and no special procedures are required.) • All requests for the Grant/Study covered testing must be submitted using a custom requisition. • Orders for these test can NOT be entered through Cerner (PowerChart). • Blood can be drawn by the laboratory phlebotomists, however, they must be contacted (call 3-3799 or 6-8048) and arrangements made for the draw. Scheduled IP draws will take priority. • Specifically timed draws must be done by staff other than the phlebotomist. • Results can post to Cerner or print out for pick-up in the laboratory. (Coordinator’s choice.) • Billing will function like all other Grant/Study billing

16. How do I get results? • For patients with an actual MRN – the results can go into Cerner. • For those patients or subjects whose results should or can NOT go into the EMR(Cerner), printed reports are available. These reports print in the evening and, for testing completed by 5pm, are available the next morning to be picked up in Room 214 CSB. The reports can be sent through campus mail if pick-up is inconvenient. • If printed reports are “misplaced”, lost, or eaten by those pesky office gremlins – contact the lab for a reprint. You will need to provide the MRN or Research Subject Study ID to get another copy.

17. Where can I get test reference ranges and specimen requirements? You can access the specimen requirements and reference ranges from the hospital’s home page. http://www.employee.hospital.uic.edu or http://intranet.uimcc.uic.edu/SitePages/Home.aspx or If you are outside of the University and do not have access to the UIC home page, paste this link into your browser. www.testmenu.com/uic

18. Where can I get test reference ranges and specimen requirements? • Through UIC home page • Home page > Departments > Pathology Laboratory Services (slide 19) • Laboratory User’s Guide (slide 20) • Search: enter test name (slide 21) • Test specific information (slide 22 and 23) Note: Access through other websites may go directly to slide 21 view.

19. Home page > Departments > Pathology Laboratory Services

20. Laboratory User’s Guide

21. Lexicomp Search: enter test name Click on the letter or enter the test name in the Search box.

22. Test specific information • Search view: all tests that meet the search criteria will display

23. Test specific information • Test info layout: scroll to bottom to get reference ranges.

24. What happens if there is a billing problem? • Bills print monthly and should be reviewed ASAP. • If there are charges or patients that don’t belong to your study, contact Curtis Goss, Grant Administrator, 312-413-2979, Patient Accounts.

25. Study Coordinators Guide to Laboratory Testing Let the studies begin! The End!