Doctor’s Orders preparation.

Specifics:

·  Font on orders should be Comic Sans; 10 pt-black ink only. No color font, no bolding, no highlighting, no underlining, no italics of information on orders will be accepted. Orders should be formatted as a singled space document.

·  Orders are used by several disciplines as communication of patient needs to implement the protocol. They should be clear and leave no room for assumptions.

·  Contact sheet: It is used by the CRC staff to locate study staff with questions or concerns about subject issues. Name of PI, study coordinators must be listed with complete and accurate contact information. Use the “contact sheet” template to assist you. All study staff that have access to the scheduling program, must be added to the contact page.

·  The orders: Each order set must be labeled with a “visit specific name”. Additional visits require additional order sets. Identical visits may use one set of orders. Use the “doctor’s order sheet” template to assist you.

·  Naming/Saving order files: The electronic name should match the visit name. This unique visit name will be used to create visit/booking name and the unique file for lab slips and labels. The name of the protocol (in full) and SPID number must be placed in the header on every page of the orders, the contact sheet and the processing instructions.

·  Each protocol has a specific “start time”. The PI sets “time 0” and all activities follow around that time. There should be only ONE start time for each protocol, all time points for sampling and study related activities will evolve from that start point.

As an example: Is the start time when you give the drug, after you give the drug, after the drug is given and the line is flushed? Based on the research protocol the orders must be specific for the study start time so that ALL those involved with the CRC visit understand and will consistently keep the SAME start time!

The Orders:

Visit Number:

Unless identical, each visit on the CRC requires a unique set of orders be submitted. Each set of orders sent must include the contact page as well. (Each visit name on the order sheet is used to ensure the visit scheduled matches the orders and the associated lab and label set up.)

If orders are identical, then one order set can be completed for each identical visit, but the specific visit must be noted or “circled” on the orders so that the correct visit may be booked on our scheduling system.

Charges:

Administrative Director reviews charges on Doctor’s Orders and communicates with study staff as needed. “C” charges denote those that are covered by the CRC. “I” charges denote those covered by the investigator. “I” charges require the investigator obtain and then document a special fund number. The special find number must be listed on the orders if there are any items that will require billing to the investigator.

Special Study identification numbers: Please document use of HRES/Study ID/Randomization numbers in this field. If no special study identification numbers required: N/A should be placed in this field.

·  If samples are being sent “de-indentified” this must be documented in this area.

Example: Study ID number:___77644______

All samples to be sent de-identified. Do not use name or MRN number on lab slips or labels.

·  All fields on the doctor’s order sheets must remain as outlined. If you are not using a field/resource please note this is “not applicable” to your study by using N/A in the required field.

1. Admit to CRC: Inpatient/Outpatient Scatter:______

Date: Time:

·  This is required field-choose type of visit, Date and time of visit to be completed prior to patient admission. If this is a scatter visit please note if in or outpatient and complete the location of the scatter on the orders.

2.  Appointments/Tests: Specific appointments/tests (CT scan/Biopsy) that will take place during the CRC visit will be documented in this field.

3.  Diagnosis: Required: Healthy volunteer versus study population. To be specified prior to patient admission.

4.  Code status: Required field: to be completed prior to patient admission.

5.  Allergies: Required fields: Drugs, Latex, Food. To be completed prior to patient admission.

6.  Diet: Required field: Dietary restrictions, NPO status etc, to be completed prior to patient admission. All requests for food should be specific in the timing. For example: “during visit” or “at discharge”. If subject will be on a “special diet” or “research diet” please list specifics on orders. Example: “low sodium” or “dysphasia”

7.  Nutrition: Required field: Any Nutrition requirements during the CRC visit must be ordered under this field this can include only those approved by nutrition team, please use CRC nutrition approved names of testing. Please use bullet format. See approved RD request list.

8.  Activity: Required field: Activity (ad lib, bed rest, bathroom privileges) must be documented on the orders.

9.  Nursing: Required field: Nursing activities-vital signs, blood draws, assessments should be requested in this field. Specifics of nursing activities should be documented on flow sheets and NOT in orders.

Bullet each nursing request; do not include space in the orders for documentation of request.

10.  Urine Sampling: Completed if urine collected. Type of collection, amount, tubes and tests should be clearly documented in this space. Test names and test codes (if Labcorp used) must be clearly identified.

11.  Blood Sampling: Completed if blood collected. Type of collection, amount, tubes and tests should be clearly documented in this space. Test names and test codes (if Labcorp used) must be clearly identified. The specific amounts of blood and timing of draw must be clear. Sampling instructions such as “place tube on ice” should be placed in this area. Very clear instructions should be provided as to when sampling should start and end.

12.  Protocol Specific orders: This section must be completed if additional orders are requested. NP visit, use of specific testing or monitoring should be identified in this area.

13.  Discharge: Is a required field. It must be clear when discharge from the CRC is expected. Any associated care needs-such as discharge with study medication or study supplies should be documented in this field. If patient is to follow for additional testing at discharge please write these instructions in this area

14.  Labeling and Processing Instructions: Required field for protocols that request any sampling while visits are conducted. These instructions are completed as PART of the orders, but will be considered instructions after protocol approval. CRC labeling is standard! Protocol specific labels must be provided by study staff.

NOTE: Time of draw will be noted on flow sheet or on outpatient flow sheets.

Processing:

Processing instructions must be consistent with the lab recommendations. Study staff must review recommendation of lab where samples will be sent.

·  Processing instructions: Must be submitted as part of the orders. Processing instructions are instructions and not orders. Each investigator must ensure that processing instructions for each visit are submitted with orders.

·  Use Processing Template: This will be attached to orders.

Example:

Tube (s) Include C or I: / Test (s): / Processing instruction: / Special instruction: / Storage/Send To:
3.5ml Gold Gel Barrier tube / Albumin, Total Cholesterol
Code:
001081, 001065 / Clot: Spin within 15 minutes
Spin: 2800 RPM for 10 minutes
Aliquot: NO
Temp: Ambient / N/A / Label with Labcorp labels and send entire tube to labcorp.
Send at room temperature up to 24 hours.

Final Edits: To remove pink and blue notes/highlights please do the following:

1.  Go to View

2.  Toolbars

3.  Check off Formatting

4.  Go to the Red X on the toolbar

5.  Go to Delete all Comments in Document

1