1. Doctors Orders

2. Why Utilize Accurate Doctors Orders? Doctors Orders are: Legal documents for completion of study visits by GCRC staff. The responsibility of the investigator. Signed (not stamped) by the investigator. Written in a specified format. Implementation guidelines for GCRC staff for study completion. A reflection of the protocol design and study question(s). Ready for implementation upon approval by the GCRC. A guide to the development of templates used for scheduling study visits.

3. When to Submit Doctors Orders Submit a complete set of the most current (Microsoft Word version) of Doctors Orders with the Protocol Application. Refer to Doctors Order sheet template for format (found at MyNetworkPlaces\GCRCM_DO). Electronically submit to the GCRC Administrative Coordinator at ffortune@partners.org.ffortune@partners.org Draft (pending) orders will be posted in the GCRC online doctors orders found on Partners desktop at: MyNetwork places\GCRCM_DO

4. Review of Doctors Orders Draft (pending) Doctors Orders are reviewed and approved by the protocol nurse, protocol bionutritionist and administration. Points considered during the review process: Consistency with the study proposal and procedures. Clarity of study procedures for implementation by GCRC staff. Once reviewed & approved, the Doctors Orders are converted to PDF Files, marked with the Approval Date and stamped with the GCRC watermark and placed in the SPIDs approved folder.

5. Approved Doctors Orders The GCRC Approval Date must match the date the orders were last approved. This ensures we are using the most recent orders revision. All orders must have the GCRC watermark. This ensures they have been printed from the approved folder on the Doctors Orders drive.

6. Access to Approved Doctors Orders To obtain access to the GCRC online Doctors Orders, please contact the GCRC Administrative Coordinator ffortune@partners.org.ffortune@partners.org The GCRC online doctors orders are found (on Partners desktop) at: MyNetwork places\GCRCM_DO For study visits, only approved, water-marked and dated Doctors Orders will be accepted.

7. When are Revised Doctors Orders Needed Changes in the conduct of a study visit must be reflected in revised Doctors Orders. Revisions may include changes in study staff, addition/deletion of a test, increase or decrease of medication dose, etc. Changes in Doctors Orders often require an IRB amendment and approval. In the email to the GCRC Administrative Coordinator ffortune@partners.org, describe the change(s), including the IRB amendment number, when applicable. This will speed review and approval. ffortune@partners.org

8. Revised Doctors Orders When changes are needed in approved Doctors Orders, submit (Microsoft Word version) revisions as a complete set of revised (pending) Doctors Orders) to the GCRC Administrative Coordinator ffortune@partners.org. ffortune@partners.org These revised Doctors Orders will be placed in the pending folder and cannot be used for study visits until approved. Prior to submitting revised Doctors Orders, review revisions with the Principal Investigator, protocol nurse, protocol bionutritionist and administrator. Revised Doctors Orders are reviewed and approved by GCRC staff within 3 days of receipt. The orders are then placed in the Approved Folder at (MyNetwork Places\GCRCM_DO) and may now be used for subject visits.

9. Scheduling Templates and Doctors Orders Study visit templates reflect approved Doctors Orders. These study visit templates are developed by the scheduler in consultation with the protocol nurse, protocol bionutritionist and study team. Keeping the number of study visit templates to a minimum will facilitate scheduling.

10. Scheduled Subject and Doctor Orders Complete the Doctors Orders as soon as the visit is scheduled and confirmed with the patient. Make sure randomization/enrollment numbers are correct so that all samples will be accurately labeled at the time of the visit. Bring completed Doctors Orders to the GCRC reception desk. Log all orders in the Red Book. The GCRC prepares the trays/labels so incorrect/illegible info on the Doctors Orders may result in lab errors! When bringing up Doctors Orders for a last minute visit, always alert the front desk, in addition to logging them in the Red Book. If it is last minute, the GCRC needs the orders right away so they can prepare the tray. Remember to never cross out any part of the doctors orders. If a change is needed, the study investigator should write a note on a separate progress note and attach it to the doctors orders.

11. Dropping Off Orders Once a visit is scheduled, please drop off the most current signed, dated and timed approved doctors orders to the GCRC front desk. Doctors Orders should be placed in the black Orders bin on the desk. Please use the red book to sign in the date/time orders were dropped off along with your name.

12. How do I use the red book? When dropping off orders, fill out the columns as shown below. Leave the last three columns blank for OA use.

13. When is the deadline for dropping off orders? Signed Doctors Orders must be received NO LATER than the morning of two business days before the visit. Two days allows sufficient time for study visit preparation. Trays and Labels Food Equipment Remember, earlier is better!

14. Order Deadline Examples Patient VisitOrders Due 4:00pm WednesdayMonday morning 11:00am SundayThursday morning 8:00am, Tuesday after Columbus Day Thursday morning

15. What about add-on visits? If you add a visit less than two days before the visit, you must drop off the Doctors Orders as soon as the visit is scheduled.

16. What is Required for the OA to Accept the Orders? The GCRC Approval Date must match the date the Doctors Orders were last approved. This ensures we are using the most recent revision. All Doctors Orders must have the GCRC watermark. This ensures they are unaltered.

17. Why are orders rejected? When there is no watermark When the date on the orders is before the most recent revision When the orders are unsigned When the pre-printed Doctors Orders have been altered. Changes must be made on a separate Doctors Order sheet.

18. Signed Orders All orders must be signed by a study MD, NP or PA. It is against federal law for us to use orders that have not been signed by an MD,NP or PA, or that have been altered by somebody other than an MD, NP or PA on the study team.

19. What happens if orders I dropped off are rejected? The Operations Associate at the GCRC front desk will notify you immediately, and tell you what to do in order for the orders to be accepted.

20. What if the Doctors Orders need to be altered? Alterations to the orders, even those made by a study MD, NP, or PA must be first approved by the protocol RN or RD, depending upon which section is altered. The RN or RD will make sure the alterations fall within the HRC-approved protocol. Altered Doctors Orders will not be accepted unless they are approved.

21. Identifying Orders Neatly write the subjects name and medical record number on the orders. Make sure to leave space for the blue card stamp! Claus, Santa 000-00-00 Claus, Santa 0000000 YES NO

22. Trays and Labels

23. Introduction Study staff provide Doctors Orders and materials needed for the visit. Materials for your subjects visit are set up in advance by GCRC staff, in accordance with the Doctors Orders.

24. Background Trays and Labels Technicians are GCRC support staff who set up the visit materials. Trays and Labels Technicians are not the same as Laboratory Technicians. Techs are non-clinical staff. For the benefit of all, Doctors Orders must be clear and specific.

25. Responsibilities The responsibilities of Trays and Labels Technicians include: Printing out labels and lab slips for each visit Accurately labeling specimen tubes Setting up trays of specimen tubes per the Doctors Orders

26. Effective Doctors Orders for Trays and Labels Doctors Orders must be written with clarity and specificity to ensure that specimens are processed according to study requirements. For example, for a 24-hour urine collection, specify whether this should be collected in a plain, acid, or split container.

27. Effective Doctors Orders for Trays and Labels Keep orders separate. For example, separate 24hr urine orders from others. INCORRECT: Discharge patient with teaching sheet, plain 24hr urine collection, and 2 weeks of medication. CORRECT: Discharge patient home with plain 24hr urine collection. Discharge patient with teaching sheet Discharge with 2 weeks of study medication.

28. Effective Doctors Orders for Trays and Labels Orders should include a list of every tube needed, with color and size. Make sure to specify how each tube should be labeled.

29. Writing Clear Orders Some color tubes come in more than one size. Specify which size you will need. Double-check that this is the correct size for the tests that need to be done, and that this is a size carried by the GCRC.

30. Tubes The following slide lists the tubes that are carried by the GCRC, along with their types and the tests they are commonly used for. All other tubes must be supplied by the coordinator.

31. GCRC Tube List TubeType(s) Common Test(s) Green 3mL, 10mL STAT electrolytes, chemistries Green/Gray 4mL electrolytes, chemistries Red 5mL, 10mL chemistries, blood bank, serology Lavender 3mL, 6mL, 10mL hematology, 3mL: CBC, HbA1c Light Blue 4mL coagulation Gray 4mL glucose Yellow 8.5mL blood bank Black 10mL urine Falcon Cloudy, Clear for investigator

32. Study Supplies All study-provided supplies must be delivered to the Trays and Labels Techs. If a tech is not available, supplies can be left with Front Desk personnel at the same time as the Doctors Orders. Supplies must be delivered during business hours. Examples of supplies include aliquot tubes, other special tubes, kits, and special lab requisitions.

33. Study Supplies (continued) Study staff should restock supplies before they run out. Study-specific supplies not needed for Trays and Labels must be brought up 24hrs in advance of the visit may result in cancellation of the visit. Clean supplies are to be kept in designated bins in the Clean Utility Room. Cardboard, coolers, and study-specific bulk supplies can not be stored on the GCRC. Feel free to contact a tech if you are unsure if you have sufficient supplies for your study.

34. Subject Information Double-check that the following information is correct on the Doctors Orders: Provider number Medical Record Number Spelling of the subjects name Randomization Number Please stamp with an addressograph, type, or print neatly.

35. Subject Information The information on the Doctors Orders will go on tubes, processing slips, lab requisitions and more. If this information is incorrect, test results may not be recorded for the correct subject.

36. Subject Information Some Doctors Orders have check boxes that change the setup depending upon various factors (i.e., weight of the subject). Please check off the correct box and complete all information before you submit the Doctors Orders.

37. Setting up a Tray Doctors Orders must be brought to the floor the morning of two business days before the visit. (see Facilitating the Visit) Doctors Orders for add-on visits must be brought to the floor as soon as possible.

38. Supplies and Late Orders If Doctors Orders are not brought to the unit in a timely manner, the supplies may not be ready in time for the visit. For longer visits, the visit may need to be delayed or rescheduled. For shorter visits, the coordinator may be required to assist setting up the tray.

39. Go Back to GCRC Orientation Go Back to GCRC Orientation Please click here to Doctors Orders SOPhere