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Seattle Cancer Care Alliance

General Guidelines for Creating Blood and Marrow Transplant (BMT) Protocol Specific Preprinted Orders

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Table of Contents

I. Introduction …………………………………………………………………... Pg. 3

a. Protocol Specific Orders and BMT Standard Orders Pg. 3

b. Laboratory Order, Testing and Requisitioning Resources Pg. 3

c. Contact Information Pg. 4

II. Components of an Order …………………………………………………… Pg. 4

a. Page Set-up Pg. 4

b. Header Pg. 5

c. Important Items Pg. 5

d. Order Sections Pg. 7

e. Signature Lines Pg. 12

f. Note: DO NOT THIN/LEAVE IN CHART Pg. 12

g. Study Contact Information Pg. 12

h. Routing Information Pg. 13

i. Footers Pg. 13

III. Using Templates …………………………………………………………… Pg. 14

a. Template Options Pg. 14

b. Document Naming and Saving Pg. 15

c. Template Instructions Pg. 16

IV. Template Specific Information …………………………………………….. Pg. 17

a. Pre Transplant Additional Evaluation Ambulatory Order Guidelines Pg. 17

b. Pre Transplant Additional Evaluation Inpatient Guidelines Pg. 21

c. Post Transplant Evaluation Ambulatory Order Guidelines Pg. 25

d. Post Transplant Evaluation Inpatient Order Guidelines Pg. 31

e. Outpatient Prescription Guidelines Pg. 37



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V.

Appendices

1. Laboratory Test Ordering and Requisitioning Overview Pg. 39

2. BMT Lab Testing Decision Flows a) Grouped Clinical Labs b) Other Clinical Labs and Research Labs

Pg. 43 Pg. 44

VI. Template Options

1. Pre Transplant Additional Evaluation Ambulatory Order

2. Pre Transplant Additional Evaluation Inpatient Order

3. Post Transplant Evaluation Ambulatory Order

4. Post Transplant Evaluation Inpatient Order

5. Ambulatory Prescription

6. Pediatric Prescription



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NOTE: Standard/Generic Orders should always be used instead of protocol specific orders if

not in conflict with protocol requirements. (Refer to Clinical FYI for an alphabetical list of BMT Standard Pre-Printed Orders and examples of orders).

I. INTRODUCTION: These guidelines have been developed as a resource for research staff

and should be referred to during creation or revision of protocol specific preprinted orders. Procedures differ between outpatient and inpatient. Differences are called out within the applicable guideline and/or template.

A. Protocol specific preprinted orders and the relationship with existing

BMT Standard Orders: BMT Standard Pre-Printed Orders exist to confirm that standards are met per current BMT Standard Practice Guidelines.

1. Protocol specific orders may be used in conjunction with standard orders:

When portions of protocol specific requirements are in addition to standard items; When only those non-standard items/requests are included in the protocol specific

order, and; When the protocol specific order includes text to refer the end user to the standard

orders with which they will be used.

OR

2. Protocol specific orders may be used in lieu of standard orders when the protocol specific requirements are extensively and significantly different than existing standard orders; If a protocol specific order is replacing a standard order, the PI should confirm that

basic transplant requirements (per Standard Practice Guidelines for that time point) are still covered in the protocol specific order.

B. Laboratory Ordering, Requisitioning and Testing Resources: Understanding the dynamics between a physician order, a lab requisition and the testing that is to be performed can be difficult. Resources are available to help understand the process and are available as appendices to the guidelines. The specific resources include:

Laboratory Test Ordering and Requisitioning Overview (Appendix 1); BMT Lab Testing decision flows to aid in determining how a particular test should be

ordered and requisitioned, and who is responsible for ordering and/or requisitioning the test (Appendix 2);

SCCA Specimen Collection and Handling Manual http://www.seattlecca.org/clinical-departments-and-labs.cfm.



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C. Contact Information: All questions related to protocol specific preprinted order guidelines and templates should be directed to the following people in the SCCA Research Implementation Office (RIO):

Kelli Cline at [email protected] 288-7025 Molly Clawson at [email protected] 288-1048

II. COMPONENTS OF AN ORDER

A. PAGE SET-UP:

All orders need to be created with a specific page set-up to fit on SCCA order paper stock. (Margins: Top 0.5”, Bottom 2.25”, Left 1.00”, Right 0.5”, Gutter 0, Header 1.0”, Footer 0.5”);

Ex: II.A

Ex: II.A

Ambulatory order font type: Times New Roman; Inpatient order font type: Arial Narrow; Header font size: 11, Bold; Protocol title font size: 8-9; General content font size: 10; Ambulatory orders need to contain a “star” symbol at the top of the page,

which differentiates them from Inpatient orders. Note: Proper formatting allows for content to print correctly onto non-carbon copy, 3 ply paper stock which contains a stock header, logo and stock footer, which includes space for patient information and institutional information.

mailto:[email protected]

mailto:[email protected]



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B. HEADER:

All orders need a header containing the protocol title and type of order; Headers are set up in Word to repeat automatically on each page; Always note in the header any Standard Orders that the protocols specific orders

are to be used in conjunction with (ex: standard arrival orders, standard pre-transplant (generic) evaluation orders, standard disease specific orders, SCCA Blood and Other Samples Physician’s Order/Multiple Lab Requisition, SCCA Bone Marrow Physician’s Order/Multiple Lab Requisition, or conversely:

Always note in the header any Standard Orders that the protocol specific orders are being used in lieu of, so that the order pathway for that protocol patient is cued for the patient care staff.

C. IMPORTANT ITEMS:

1. Protocol number: Include only if order will be used by multiple protocols.

Insert a blank for provider to fill in to indicate which study the order applies to.

2. Diagnosis: Include if the protocol covers more than one diagnosis, especially if distinctions are made in patient care based on diagnosis. Insert a blank for provider to fill in to indicate diagnosis.

3. Allergies and Drug reaction information: Required if order includes medications.

4. Weights table:

a. Include only if drugs, infusions, or other care in the order are based on weights;

b. Use complete standard weight bar for chemotherapy or medications orders that require all weight types; otherwise, use only headings required to calculate dosages or to determine blood draw amounts as required on the applicable order;

c. For chemotherapy orders include date blank to indicate when weight was obtained and add standard note “weight must be obtained within 4 weeks of administration”.



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5. Check Boxes “[ ]” in body of order:

a. Include “Check appropriate boxes” wording if check box options are given; b. Always use brackets to create check boxes. Do not insert symbols; c. May need to appear throughout orders in various sections where choices

must be indicated, including headers; d. Check boxes can be used to indicate options, for items that will be done

differently based on patient demographics, clinical situation or by protocol number (if order is being used for multiple protocols);

e. When an order uses check boxes to indicate options, a parenthetical phrase should follow the check box to indicate for what purpose or demographic it should be checked;

f. Check boxes may be used to indicate items in a series where each instance of use of that order may not cover the whole series. An example is when admits and discharges might be anticipated during the series of care and some components of the series are covered by ambulatory clinic orders and other components are covered by inpatient orders.



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D. ORDER SECTIONS: Pre-printed orders must be separated by sections with headings. Items inside each section may be further divided, and organized categorically. Repeat section headings for content that carries to following pages.

1. Medications:

a. Include “supply from IDS pharmacy” next to medication header or next to the specific drug order, as applicable;

b. Include dose, duration and/or frequency of drug such that the pharmacy knows exactly how much to provide to the patient;

c. Include sequence of administration, route and time medication is to be given; d. Include all dosing options as based on weight or age, etc. Use “[ ]” as check

box in front of options and criteria in parenthesis following check box; e. Specify which weight should be used for dosing: if dosing per kg, note which

weight to use or note that standard adjustments can be made; f. If calculations to obtain weight value are different than standard, protocol

specific order must include protocol specific calculations; g. Standard weight adjustments for chemotherapy or other medications: Refer

to standard practice guidelines and ensure protocol specific orders meet requirements.



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h. Include the following standard wording for non-formulary drugs:

i. “Non-formulary request paperwork to accompany order. Contact UW Pharmacy to ensure (insert drug name) is in stock”.

i. Include the following standard wording for non-formulary drugs for which there is a Pain & Toxicity (P&T) Authorized automatic substitution policy in place (ex: famotidine) but the protocol does not allow substitution:

i. “NO SUBSTITUTION ALLOWED. Non-formulary request paperwork to accompany order. Contact UW Pharmacy to ensure (insert drug name) is in stock”.

Note: Medications to be taken outside the clinic require an ambulatory clinic prescription page in conjunction with this order. Refer to the Outpatient Prescription Order guideline for more information and instructions. [Link to Outpatient Prescription Order guideline]



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2. Chemotherapy: Use appropriate table formatting for administration components.

Refer to templates for more information. 3. Laboratory work: (Refer to Appendix 1 & 2)

a. Must be separated into “Clinical” and “Research” sub-sections; b. Stipulate if bloods can be drawn with AM labs (inpatient orders); c. Simple date specific lab testing can be in a numbered list; d. List more complex specific or repeat testing first; e. Day specific testing: Break down tests by date and day designation pre or

post transplant; f. If dates are not scheduled per transplant day, note per study day or date; g. If protocol specific research requisitions are supplied by the research staff,

the following language should be noted in the lab section of the order when applicable:

i. For in-patient orders: “Send with research requisition supplied by research staff”

ii. For out-patient orders: “Send with research requisition”



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4. Procedures: a. Must be separated into “Clinical” and “Research” sub-sections; b. Simple date specific procedures can appear in a numbered list; c. List more complex specific or repeat procedures first; d. Day specific procedures: Breakdown procedures by date and day

designation pre or post transplant; e. If dates are not scheduled per transplant day, note per study day or date; f. On ambulatory clinic orders, begin item with “Schedule for…” so that team

coordinators (aka schedulers) are alerted to appropriate items according to their responsibilities;

g. Procedure sample collection, processing and billing: There are multiple scenarios depending on where the testing will occur and who is responsible for the cost of the testing. Determine the scenario that best matches the protocol requirements and follow the guidelines. More detailed instructions are included in the evaluation guidelines and templates.

i. Procedure sample going to a clinical lab and to be billed to patient/pt's

insurance. Item or cue should appear under clinical procedure section on the appropriate protocol-specific evaluation order.

a) If sample will be sent to one of the labs listed below, sample collection,

processing and testing information is included on the protocol-specific pre-printed order as a cue for the provider that will be completing the appropriate order/multiple lab requisition (i.e, Bone Marrow Procedure Order/Multiple Lab Requisition or Blood and Other Specimens Physician Order/Multiple Lab Requisition).

SCCA Pathology Lab SCCA Cytogenetics Lab SCCA CIL UW Hematopathology Lab UW Cytogenetics Lab UW Molecular Virology Lab

b) If a sample will be sent to any other clinical lab than those listed above,

it may simply be ordered via your protocol specific order and standard procedures for collection, processing and requisitioning will be followed.

c) No special billing information is necessary. Costs will be billed to

patient/pt's insurance.



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ii. Procedure sample going to a clinical lab and to be billed to study budget via a Research Study account. (Item or reference should appear under research procedure section on the appropriate protocol-specific evaluation order).

a) If sample is going to one of the labs called out in section g.i.a above,

create protocol-specific order/multiple lab requisition depending on the type of procedure and/or sample to be collected and tested. Contact RIO for templates and instructions. Research Study account billing information will be included on the protocol-specific order/multiple lab requisition.

b) Refer to protocol-specific order/multiple lab requisition on appropriate protocol-specific evaluation order.

c) If a sample will be sent to any other clinical lab than those listed above, the test is ordered via the appropriate protocol specific evaluation order, with details needed to identify appropriate clinical test, reference to specialized “research” requisition to charge testing to the Research Study Code, and the requisition going with the sample to the lab must be specialized to include the EPIC Research Study Code and RRR Research Study Name

RS Study Codes are for all SCCA research billable activity; include this on all Ambulatory Orders

RU Study Codes are for all UWMC research billable activity; include this on all UWMC Orders and Ambulatory Orders with ECGs that will be read by UW staff

d) Billing will be done by the destination lab to the Research Study Code provided.

iii. Procedure sample going to a research lab and to be billed to the study

budget. (Item should appear under research procedure section on the appropriate protocol-specific evaluation order). Use a purple Research Lab Request form in conjunction with the physician’s order and include Research Study Code and RRR Research Study Name, as applicable.

a) Order must include collection, processing and routing information to

include:

Type of sample and the research lab where it is to be sent Size of sample including any allowable pediatric smaller amounts

or pediatric maximums Tube additive or media type Special instructions for labeling tube Special instructions for pick-up, shipping, light exposure, or

temperature control of sample



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b) Billing arrangements should be made directly with specific research lab and will not need to be indicated on the orders.

5. Nursing: If requesting vital signs to meet protocol requirements, specify what is needed and any timing restrictions or postural restrictions.

6. Scheduling: Any specific scheduling that must be communicated to team

coordinators (aka schedulers) should be noted. Primarily applicable for ambulatory clinic if patient must arrive at a certain time for treatment.

7. Monitoring & Other: Rarely required for protocol specific orders. Protocol should

specify all needs.

E. SIGNATURE LINES: (Refer to appropriate template for example)

1. Prescriber: Each page of the protocol specific order has to have at least the basic “prescriber” signature line at the bottom of the page.

2. Attending Physician: Certain items also require the “Attending Physician”

signature line at the bottom of the page. These items include: a. Chemotherapy, biotherapy, and radioimmunotherapy treatments; b. Infusion order pages with cell goals identified.

Note: Whenever possible it is best to limit items needing the attending physician signature to one page, so the attending physician only needs to sign once.

3. Nursing and pharmacy verification: Needed at the bottom of any page with

Chemotherapy, biotherapy and radioimmunotherapy treatments; an additional unique nursing signature is required for ambulatory clinic PO Busulfan orders only.

F. Note if order must be kept in active chart (i.e. not thinned)



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G. Include study contact information

H. ROUTING INFORMATION: 1. Routing information is required on all ambulatory orders.

2. Routing locations are based upon the order type and who will need a copy of the order. Transplant personnel assist in determining the necessary routing locations, which include the following areas: Requisition Team, Scheduler, Pharmacy, Team RN, Cellular Therapy Laboratory and Apheresis.

I. FOOTERS: Footers are always “right aligned” and include three lines with information about

the specific order: 1. Line 1: Page x of x

2. Line 2: File name:

a. Protocol file names always begin with the protocol number, followed by the

type of order and location where orders will be used (if UWMC) (e.g. 1234_treatment.uwmc.doc).

b. File names should not include spaces or characters (i.e., +, -, parentheses, etc) that may cause the file to become unstable. Use an underscore to separate the protocol number from the file name and in between words within the file name (e.g., 1234_pre_treatment_evaluation.doc)

c. File names should be as brief as possible while still distinguishing from other protocol file names.



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d. Refer to Section III B for more details on saving and naming documents.

3. Line 3: Date of current draft, final draft or latest revision.

III. USING TEMPLATES

A. Protocol Specific Preprinted Order Template Options: Note: To be used along with associated guidelines. Options include both Ambulatory and Inpatient versions which must be requested separately.

1. Chemotherapy Orders: (Guidelines are embedded into each template)

a. Cyclophosphamide containing regimens (option with TBI) b. Busulfan containing regimen (option with TBI)

PO in Ambulatory Clinic PO Inpatient UWMC

IV Inpatient UWMC c. Multiple chemotherapy containing regimens (option with TBI) d. Multi chemo with cyclophosphamide (option with TBI) e. Fludarabine containing regimens (option with TBI): Ambulatory version of this

order is for the first dose of Fludarabine administered in the clinic followed by the rest of treatment on an inpatient basis.



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2. Pre & Post Transplant Additional Evaluation Orders: a. May include medications, laboratory work, procedures, imaging, etc. b. May be used both pre and post transplant for clinical or research sampling for

eligibility, baseline screening, monitoring, etc. c. If the patient was admitted or discharged during the time span of coverage,

the order would need to be re-written on the appropriate version, inpatient or ambulatory clinic.

3. Prescriptions:

a. Adult b. Pediatric

Note: If your protocol specific order requirements do not fit the options above contact: Kelli Cline 288-7025.

B. SAVE AND NAME THE DOCUMENT After obtaining the correct template: 1. Save: Go to “File”, “Save As”, to save the template with the proper file name for your

protocol. 2. Select a file name: Protocol file names should start with the protocol number and

include the minimum amount of words to differentiate them from any other orders for the same protocol. If the file name is too long instability can occur. Example: “5555_NM_treatment.doc

3. Match electronic file and document file names: Make sure electronic file name

matches document file name in footer of the order.



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C. TEMPLATE INSTRUCTIONS: Each template includes instructions and references to specific information contained in this guidelines document. Use instructions, as applicable, to create protocol specific orders. Make sure all items are consistent with protocol requirements.

1. Refer to Legend: Templates include a color coded legend as follows:

a. Non-highlighted text = Standard requirements which should be on the finished

order draft with appropriate specifics for your protocol. b. Yellow = Instructions, follow and then delete from protocol specific draft. c. Blue/Turquoise = Examples and/or options, replace with the protocol specific

requirements. Delete the examples that do not apply to your protocol.



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IV. TEMPLATE SPECIFIC INFORMATION A. Pre Transplant Additional Evaluation Ambulatory Order

1. List in the header the type of orders in the standard pre transplant series this order

will be used in conjunction with (standard arrival orders and standard (generic) pre-transplant evaluation orders) or in lieu of. Below are examples of orders that can be used in conjunction with the pre transplant additional evaluation order (b & c) or in lieu of (a);

a. Standard disease specific pre-transplant orders; b. SCCA Bone Marrow Procedure Order/Multiple Lab Requisition; c. SCCA Blood and Other Samples Physician’s Order/Multiple Lab Requisition.

Note: For studies involving sample collection prior to signing the main consent, a Consent R is required. In this situation a special prompt alerting nursing staff to confirm that the patient has signed a Consent R must be included at the top of the Pre Transplant Evaluation Order. Ex: FOR EVERY RESEARCH SAMPLE IDENTIFIED IN THIS ORDER: NURSING: Protocol specific research consent R has been signed. Research samples CANNOT be obtained until this confirmation occurs! Confirmation by (RN) _____________________________ (RN Signature)

2. Components: (If multiple time-point testing is required repeat component headings “b

& c below” for each time point as needed per protocol.)

a. Diagnosis: Needed if protocol covers more than one disease and that disease is not in the name of the protocol, except if there is no difference in sampling or treatment by disease;

b. Laboratory Work

Specify date to draw or collect; Include check boxes and criteria language if lab is based on particular

protocol criteria, e.g., o For women of childbearing potential; o If not done within 30 days; o For patients >40 kg;

If blood draw volume is based on weight, must add weight line to order ex: “Actual weight:__________kg”

Separate clinical samples from research samples;

1) Clinical samples section: (Refer to Section I.B)



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a) List any clinical samples going to the Alliance Lab;

b) The next part of this clinical samples section is to be used as a cue for the

provider to order protocol requirements by adding them to an appropriate SCCA order/multiple lab requisition. Insert the following language: “Also see separate SCCA “Blood and Other Samples Physician’s Order/Multiple Lab Requisition, The following tests would be ordered on that form” for protocol required clinical blood (or other non-bone marrow samples) being sent to the following clinical labs:

SCCA Pathology Lab SCCA Cytogenetics Lab SCCA CIL UW Hematopathology Lab UW Cytogenetics Lab *UW Molecular Virology Lab

*Exception: If item is only going to Molecular Virology the item may be ordered with the items in section a) without the reference to the SCCA order, and a regular virology requisition will be used.

List tests separately (size 9 font) and in the same sequence as they should

appear on the SCCA Blood and Other Samples Physician’s Order/ Multiple Lab Requisition;

To keep references distinct from items ordered on the protocol specific order do not number the items acting as a cue.

2) Research samples section: Must include all protocol required specifics related to the sampling, such as:

a) Type of sample; b) Size of sample including any allowable pediatric smaller amounts or

pediatric maximums; c) Tube additive or media type; d) Special instructions for labeling tube; e) Special instructions for pick up, shipping, light exposure, or temperature

control of sample;

f) Reference to a Research Lab Request form, for samples going to a research lab. If applicable, note if this form will be supplied by study staff



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(refer to section I.B and II.D.3 of the General Guidelines for additional information related to laboratory ordering, requisitioning and testing);

g) If protocol requires research blood samples to be sent to a clinical lab

listed in item 1b above and charged to the study, insert the following language “See protocol specific Blood or Other Samples Physician’s Order/Multiple Lab Requisition”. This will prompt the provider to complete the order necessary to obtain and process these protocol required samples. If applicable, note if this form will be supplied by study staff (refer to section I.B and II.D.3 of the General Guidelines for additional information related to laboratory ordering, requisitioning and testing);

h) If research staff is supplying tubes or other sampling kits, note this on

order.

c. Procedures

Separate clinical procedures from research procedures; Include the word “Schedule” in front of each item; List time point necessary by, or, if just one list of procedures, specify any

required date or time ranges required per protocol; Include clarification wording if being done with clinical procedures (e.g.

“being done with clinically scheduled marrow procedure”); Include cue for provider to see separate order/form for procedure, if

applicable. Refer to the Section II.D.4 for more details.

1) Clinical procedure section:

a) List any non-bone marrow procedures in a separate section from the bone marrow items;

b) The next part of the clinical procedure section is used as a cue for the

provider to order clinical protocol requirements going to a lab listed below by adding them to an appropriate SCCA order/multiple lab requisition. Insert the following language “Also see separate SCCA “Bone Marrow Procedure Order/Multiple Lab Requisition. The following tests would be ordered on that form:” for protocol required clinical bone marrow samples being sent to the following clinical labs:

SCCA Pathology Lab SCCA Cytogenetics Lab SCCA CIL UW Hematopathology Lab



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UW Cytogenetics Lab UW Molecular Virology Lab

List tests separately (size 9 font) and in sequence as on the SCCA order/requisition;


For samples sent to Pathology: Indicate whether sample(s) should be unilateral or bilateral.

For samples sent to any other clinical lab (excluding Pathology): Indicate whether sample(s) should be unilateral, bilateral pooled or bilateral non-pooled based on protocol requirements and/or disease type.

Note: If more than one lab performs specified test (e.g. SCCA versus UW cytogenetics) specify destination lab in cue.

2) Research procedure section:

a) List any research required non-bone marrow procedures (if procedure

results in specimens refer to research samples section); b) Under a “Bone Marrow” header, list research required bone marrow

sampling being sent to labs other than the clinical labs listed above (see research samples section IV.A.2.b.2) for specifics required). Indicate whether sample should be unilateral, bilateral pooled or bilateral non-pooled;

c) If protocol requires research bone marrow samples to be sent to a clinical

lab listed in item 1b above, insert the following language “Refer to protocol specific Bone Marrow Physician’s Order/Multiple Lab Requisition”, (refer to section I.B and II.D.3 of the General Guidelines for more information).

For samples sent to Pathology: Indicate whether sample(s) should be

unilateral or bilateral. For samples sent to any other clinical lab (excluding Pathology): Indicate

whether sample(s) should be unilateral, bilateral pooled or bilateral non-pooled based on protocol requirements and/or disease type.

d. Signature Line: A signature line is required at the bottom of each page. Refer to

Section II item E: “Components of an order” for details. e. Contact Information: A contact name and pager number should be included on the

last page of the protocol specific order.



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IV. TEMPLATE SPECIFIC INFORMATION B. Pre Transplant Additional Evaluation Inpatient Order

1. List in the header the type of orders in the standard pre transplant series this order will be

used in conjunction with (standard arrival orders and standard (generic) pre-transplant evaluation orders) or in lieu of. Below are examples of orders that can be used in conjunction with the pre transplant additional evaluation order (b & c) or in lieu of (a):

a. Standard disease specific pre-transplant orders; b. SCCA Bone Marrow Procedure Order/Multiple Lab Requisition; c. SCCA Blood and Other Samples Physician’s Order/Multiple Lab Requisition.

Note: For studies involving sample collection prior to signing the main consent, a Consent R is required. In this situation a special prompt alerting nursing staff to confirm that the patient has signed a Consent R must be included at the top of the Pre Transplant Evaluation Order. Ex:

PLEASE NOTE: FOR EVERY RESEARCH SAMPLE IDENTIFIED IN THIS ORDER:

RESEARCH ITEMS SHOULD NOT BE DONE UNLESS/UNTIL PROTOCOL SPECIFIC RESEARCH CONSENT R HAS BEEN SIGNED!

2. Components: (If multiple time-point testing is required repeat component headings “b and c

below” for each time point as needed per protocol) a. Diagnosis: Needed if protocol covers more than one disease and that disease is not in

the name of the protocol, except if there is no difference in sampling or treatment by disease.

b. Laboratory Work:

Specify date to draw or collect; Include check boxes and criteria language if lab is based on particular

protocol criteria e.g., o For women of childbearing potential; o If not done within 30 days; o For patients >40 kg;


Separate clinical samples from research samples; Note next to header or next to specific dates or items which labs are drawn

between 0100 to 0400 (e.g. may be drawn with a.m. labs). 1) Clinical samples section: (Refer to Section I.B)



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a). List any clinical samples going to UWMC Lab Medicine; b). The next part of this clinical samples section is to be used as a cue for the

provider to order protocol requirements by adding them to an appropriate SCCA order/multiple lab requisition. Insert the following language: “Also see separate SCCA “Blood and Other Samples Physician’s Order/Multiple Lab Requisition. The following tests would be ordered on that form:” for protocol required clinical blood (or other non-bone marrow samples) being sent to the following clinical labs:


* Exception: If item is only going to Molecular Virology the item may be ordered with the items in section a) without the reference to the SCCA order, and a regular virology requisition will be used.

List tests separately (size 9 font) and in the same sequence as they

should appear on the SCCA Blood and Other Samples Physician’s Order/ Multiple Lab Requisition;


2) Research samples section: Must include all protocol required specifics related to the sampling, such as:

a). Type of sample; b). Size of sample including any allowable pediatric smaller amounts or pediatric

maximums; c). Tube additive or media type; d). Special instructions for labeling tube; e). Special instructions for pick up, shipping, light exposure, or temperature control

of sample; f). Reference to a Research Lab Request form, for samples to be to a research lab.

If applicable, note if this form will be supplied by study staff (refer to section I.B



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and II.D.3 of the General Guidelines for additional information related to laboratory ordering, requisitioning and testing);

g). If protocol requires research blood samples to be sent to a clinical lab listed in

item 1b above and charged to the study, insert the following language “See protocol specific Blood or Other Samples Physician’s Order/Multiple Lab Requisition”. This will prompt the provider to complete the order necessary to obtain and process these protocol required samples. If applicable, note if this form will be supplied by study staff (refer to section I.B and II.D.3 of the General Guidelines for additional information related to laboratory ordering, requisitioning and testing);

h). If research staff is supplying tubes or other sampling kits, note this on order.

c. Procedures:

Separate clinical procedures from research procedures; List time point necessary by, or, if just one list of procedures, specify any required

date or time ranges required per protocol; Include clarification wording if being done with clinical procedures (e.g. “being

done with clinically scheduled marrow procedure”); Include cue for provider to see separate order/form for procedure, if applicable.

Refer to the Section II.D.4 for more details. 1) Clinical procedure section:

a). List any non-bone marrow procedures in a separate section from the bone

marrow items; b). The next part of the clinical procedure section is used as a cue for the provider to

order clinical protocol requirements going to a lab listed below by adding them to an appropriate SCCA order/multiple lab requisition. Insert the following language “Also see separate SCCA “Bone Marrow Procedure Order/Multiple Lab Requisition, The following tests would be ordered on that form” for protocol required clinical bone marrow samples being sent to the following clinical labs;

SCCA Pathology Lab SCCA Cytogenetics Lab SCCA CIL UW Hematopathology Lab UW Cytogenetics Lab UW Molecular Virology lab



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List tests separately (size 9 font) and in sequence as on the SCCA order/requisition;


For samples sent to Pathology: Indicate whether sample(s) should be unilateral or bilateral.

For samples sent to any other clinical lab (excluding Pathology): Indicate whether sample(s) should be unilateral, bilateral pooled or bilateral non-pooled based on protocol requirements and/or disease type.



a). List any research required non-bone marrow procedures (if procedure results

in specimens refer to research samples section);

b). Under a “Bone Marrow” header, list research required bone marrow sampling being sent to labs other than the clinical labs listed above (see research samples section IV.B.2.b.2 for specifics required). Indicate whether sample should be unilateral, bilateral pooled or bilateral non-pooled

c) If protocol requires research bone marrow samples to be sent to a clinical lab

listed in item 1b above, insert the following language “Refer to protocol specific Bone Marrow Physician’s Order/Multiple Lab Requisition”, (refer to section I.B and II.D.3 of the General Guidelines for more information).









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IV. TEMPLATE SPECIFIC INFORMATION

C. Post Transplant Evaluation Ambulatory Order

1. Time Point Order Configurations (depending on protocol requirements post transplant):

a. Create an order covering a range of dates with more than one time point and include check boxes for each time point so that the order could be pulled to cover all or only a portion of the dates listed. When initially generated, check boxes for all dates would be checked. When there is a change in patient site of care, the order must be re-written (refer to Section III A.2.c) and only the dates still needed would be checked. See example of the template for configuration example.

Use this configuration if: There are multiple time points, with varying requirements at each time point. It can’t be predicted if patient will change sites of care during time range covered

by the order.

b. Create a single order which can be pulled and used at each evaluation time point indicated by check boxes, ex:

Protocol xxxx Post Transplant orders

Check appropriate boxes: [ ] day +28 [ ] day +56 [ ] day +84

Use this configuration if: There are a limited number of time points for testing required by the protocol. Sampling and testing at each time point is identical or nearly identical (if an item is

required at only one of the time points represented, it can be indicated as a check box item with the criteria in parenthesis ex: Day +28 only).

c. Create a series of separate orders with each order covering only one time point

(avoid this option if there are many time points required) ex:

Protocol xxxx Post Transplant Orders Day +28

Use this configuration if: Sampling is lengthy and/or unique to each time point. There is a high likelihood that patients may change sites of care between time

point evaluations.

2. List in the header the type of orders in the standard post transplant series this order will be used in conjunction with, ex:

a. SCCA Bone Marrow Procedure Order/Multiple Lab Requisition;



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b. SCCA Blood and Other Samples Physician’s Order/Multiple Lab Requisition;

3. Components (If multiple time-point testing is required repeat component headings “b and c below” for each time point as needed per protocol):

a. Diagnosis: Needed if protocol covers more than one disease and that disease is not in


b. Laboratory Work:

Specify date to draw or collect; Include day # post transplant or range of dates tests are required, if applicable; Include check boxes and criteria language if lab is based on particular protocol

criteria e.g., o For women of childbearing potential; o If not done within 30 days; o For patients >40 kg;


Separate clinical samples from research samples;

1) Clinical samples section: (Refer to Section I.B)

a. List any clinical samples going to the Alliance Lab;

b. The next part of this clinical samples section is to be used as a cue for the provider to order protocol requirements by adding them to an appropriate SCCA order/multiple lab requisition. Insert the following language: “Also see separate SCCA “Blood and Other Samples Physician’s Order/Multiple Lab Requisition. The following tests would be ordered on that form:” for protocol required clinical blood (or other non-bone marrow samples) being sent to the following clinical labs:


* Exception: If item is only going to Molecular Virology, the item may be ordered with

the items in section a) without the reference to the SCCA order, and a regular virology requisition will be used.



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List tests separately (size 9 font) and in the same sequence as they should appear on the SCCA Blood and Other Samples Physician’s Order/ Multiple Lab Requisition;


2) Research samples section: Must include all protocol required specifics related to the

sampling, such as:

a) Type of sample;

b) Size of sample including any allowable pediatric smaller amounts or pediatric maximums;

c) Tube additive or media type;

d) Special instructions for labeling tube;

e) Special instructions for pick up, shipping, light exposure, or temperature control

of sample;

f) Reference to a Research Lab Request form, for samples going to a research lab. If applicable, note if this form will be supplied by study staff (refer to section I.B and II.D.3 of the General Guidelines for additional information related to laboratory ordering, requisitioning and testing);

g) If protocol requires research blood samples to be sent to a clinical lab listed in


h) If research staff is supplying tubes or other sampling kits, note this on order.

c. Procedures:

Separate clinical procedures from research procedures; Include the word “Schedule” in front of each item; List time point necessary by, or, if just one list of procedures, specify any

required date or time ranges required per protocol;



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Include clarification wording if being done with clinical procedures (e.g. “being done with clinically scheduled marrow procedure”);

Include cue for provider to see separate order/form for procedure, if applicable. Refer to the Section II.D.4 for more details.


a) List any non-bone marrow procedures in a separate section from the bone

marrow items.

b) The next part of the clinical procedure section is used as a cue for the provider to order clinical protocol requirements going to a lab listed below by adding them to an appropriate SCCA order/multiple lab requisition. Insert the following language “Also see separate SCCA “Bone Marrow Procedure Order/Multiple Lab Requisition. The following tests would be ordered on that form:” for protocol required clinical bone marrow samples being sent to the following clinical labs:


List tests separately (size 9 font) and in sequence as on the SCCA

order/requisition. To keep references distinct from items ordered on the protocol specific order do

not number the items acting as a cue. For samples sent to Pathology: Indicate whether sample(s) should be unilateral

or bilateral. For samples sent to any other clinical lab (excluding Pathology): Indicate whether

sample(s) should be unilateral, bilateral pooled or bilateral non-pooled based on protocol requirements and/or disease type.


2) Research procedure section: a) List any research required non-bone marrow procedures (if procedure results in

specimens refer to research samples section); b) Under a “Bone Marrow” header, list research required bone marrow sampling

being sent to labs other than the clinical labs listed above (see research samples



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section IV.C.3.b.2 for specifics required). Indicate whether sample should be unilateral, bilateral pooled or bilateral non-pooled;


listed in item 1b above, insert the following language “Refer to protocol specific Bone Marrow Physician’s Order/Multiple Lab Requisition”, (refer to section I.B and II.D.3 of the General Guidelines for more information).









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Addendum

Protocol requirements and the departure evaluations: Some research protocols require procedures or activities to occur around the same time as or during the patient departure work-up, which typically begins at day 75 post-transplant for an allogeneic transplant patient. If this situation applies, there are two options available:

1. Create a protocol-specific post-transplant evaluation order to be used in addition to the standard departure evaluation order;

2. Create a protocol-specific departure evaluation order to be used in lieu of the standard

departure evaluation order. Option 1 is the preferred option. For this option, refer to the appropriate post-transplant evaluation order guidelines and templates noting the following differences: Order header:

1. List the time-point that this order should be used (e.g., “Post Transplant Protocol Specific Additional Evaluation Orders (day +80 to day +100)”)

2. List the types of orders this order will be used with (e.g., “To be used in conjunction with standard departure evaluation order”

Option 2 is not encouraged. However, if this option is chosen for a research protocol due to significant differences from standard departure evaluation, contact the Research Implementation Office to obtain the current version of the standard departure evaluation order. For this option, the following changes are needed to the order: Order header:

1. Change the title from “Post Allogeneic Transplantation Departure Evaluation Orders” to the appropriate number and title for your protocol.

2. List the time-point that this order should be used (e.g., “Post Transplant Protocol Specific Additional Evaluation Orders (day +80 to day +100)”).

3. List the types of orders this order will be used in lieu of, and possibly in conjunction with (e.g. “Use in conjunction with SCCA Blood and Other Samples Physician’s Order/Multiple Lab Requisition and SCCA Bone Marrow Procedure Order/Multiple Lab Requisition and use in lieu of the Standard Post Allogeneic Transplantation Departure Evaluation Orders”).

4. Change the items that are significantly different from your protocol. 5. Add items that are in addition to standard for your protocol. 6. Leave all standard items in place which do not conflict with your protocol.



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IV. TEMPLATE SPECIFIC INFORMATION

D. Post Transplant Evaluation Inpatient Order

1. Time Point Order Configurations (depending on protocol requirements post transplant):

a. Create an order covering a range of dates with more than one time point and include check boxes for each time point so that the order could be pulled to cover all or only a portion of the dates listed. When initially generated, check boxes for all dates would be checked. When there is a change in patient site of care, the order must be re-written (refer to Section III A.2.c) and only the dates still needed would be checked. See example of the template for configuration example.

Use this configuration if: There are multiple time points, with varying requirements at each time point. It can’t be predicted if patient will change sites of care during time range covered

by the order.

b. Create a single order which can be pulled and used at each evaluation time point indicated by check boxes, example:

Protocol xxxx Post Transplant orders

Check appropriate boxes: [ ] day +28 [ ] day +56 [ ] day +84

Use this configuration if: There are a limited number of time points for testing required by the protocol. Sampling and testing at each time point is identical or nearly identical (if an item is

required at only one of the time points represented, it can be indicated as a check box item with the criteria in parenthesis ex: Day +28 only).

c. Create a series of separate orders with each order covering only one time point

(avoid this option if there are many time points required) example:

Protocol xxxx Post Transplant Orders Day +28

Use this configuration if: Sampling is lengthy and/or unique to each time point. There is a high likelihood that patients may change sites of care between time

point evaluations.

2. List the type of orders in the standard post transplant series this order will be used in conjunction with, ex:

a. SCCA Bone Marrow Procedure Order/Multiple Lab Requisition;



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b. SCCA Blood and Other Samples Physician’s Order/Multiple Lab Requisition;

3. Components (If multiple time-point testing is required repeat component headings “b and c” below for each time point as needed per protocol):

a. Diagnosis: Needed if protocol covers more than one disease and that disease is not in


b. Laboratory Work:

Specify date to draw or collect Include day # post transplant or range of dates tests are required, if applicable Note next to header or next to specific dates or items which labs are drawn

between 0100 to 0400 (e.g. may be drawn with a.m. labs) Include check boxes and criteria language if lab is based on particular protocol

criteria e.g. o For women of childbearing potential; o If not done within 30 days; o For patients >40 kg;


Separate clinical samples from research samples

1) Clinical samples section: (Refer to Section I.B) a) List any clinical samples going to the UWMC Lab Medicine

b) The next part of this clinical samples section is to be used as a cue for the

provider to order protocol requirements by adding them to an appropriate SCCA order/multiple lab requisition. Insert the following language: “Also see separate SCCA “Blood and Other Samples Physician’s Order/Multiple Lab Requisition, The following tests would be ordered on that form” for protocol required clinical blood (or other non-bone marrow samples) being sent to the following clinical labs:




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* Exception: If item is only going to Molecular Virology the item may be ordered with the items in section a) without the reference to the SCCA order, and a regular virology requisition will be used.

List tests separately (size 9 font) and in the same sequence as they

should appear on the SCCA Blood and Other Samples Physician’s Order/ Multiple Lab Requisition;


2) Research samples section: Must include all protocol required specifics related to the

sampling, such as:

a) Type of sample; b) Size of sample including any allowable pediatric smaller amounts or pediatric

maximums; c) Tube additive or media type; d) Special instructions for labeling tube; e) Special instructions for pick up, shipping, light exposure, or temperature control

of sample; f) Reference to a Research Lab Request form, for samples going to a research lab.

If applicable, note if this form will be supplied by study staff (refer to section I.B and II.D.3 of the General Guidelines for additional information related to laboratory ordering, requisitioning and testing);

g) If protocol requires research blood samples to be sent to a clinical lab listed in


h) If research staff is supplying tubes or other sampling kits, note this on order.



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c. Procedures:

Separate clinical procedures from research procedures List time point necessary by, or, if just one list of procedures, specify any

required date or time ranges required per protocol Include clarification wording if being done with clinical procedures (e.g. “being

done with clinically scheduled marrow procedure”) Include cue for provider to see separate order/form for procedure, if applicable

Refer to the Section II.D.4 for more details.


a) List any non-bone marrow procedures in a separate section from the bone marrow items

b) The next part of the clinical procedure section is used as a cue for the provider to

order clinical protocol requirements going to a lab listed below by adding them to an appropriate SCCA order/multiple lab requisition. Insert the following language “Also see separate SCCA “Bone Marrow Procedure Order/Multiple Lab Requisition. The following tests would be ordered on that form:” for protocol required clinical bone marrow samples being sent to the following clinical labs:


List tests separately (size 9 font) and in sequence as on the SCCA

order/requisition To keep references distinct from items ordered on the protocol specific

order do not number the items acting as a cue. For samples sent to Pathology: Indicate whether sample(s) should be






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a) List any research required non-bone marrow procedures (if procedure results in

specimens refer to research samples section); b) Under a “Bone Marrow” header, list research required bone marrow sampling

being sent to labs other than the clinical labs listed above (see research samples section IV.D.3.b.2 for specifics required). Indicate whether sample should be unilateral, bilateral pooled or bilateral non-pooled;


listed in item 1b above, insert the following language “Refer to protocol specific Bone Marrow Physician’s Order/Multiple Lab Requisition”, (refer to section I.B and II.D.3 of the General Guidelines for more information):





Section II item E: “Components of an order” for details.

e. Contact Information: A contact name and pager number should be included on the last page of the protocol specific order.



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Addendum

Protocol requirements and the departure evaluations: Some research protocols require procedures or activities to occur around the same time as or during the patient departure work-up, which typically begins at day 75 post-transplant for an allogeneic transplant patient. If this situation applies, there are two options available:

1. Create a protocol-specific post-transplant evaluation order to be used in addition to the standard departure evaluation order;

2. Create a protocol-specific departure evaluation order to be used in lieu of the standard

departure evaluation order. Option 1 is the preferred option. For this option, refer to the appropriate post-transplant evaluation order guidelines and templates noting the following differences: Order header:

1. List the time-point that this order should be used [e.g., “Post Transplant Protocol Specific Additional Evaluation Orders (day +80 to day +100)”]

2. List the types of orders this order will be used with (e.g., “To be used in conjunction with standard departure evaluation order”

Option 2 is not encouraged. However, if this option is chosen for a research protocol due to significant differences from standard departure evaluation, contact the Research Implementation Office to obtain the current version of the standard departure evaluation order. For this option, the following changes are needed to the order: Order header:

1. Change the title from “Post Allogeneic Transplantation Departure Evaluation Orders” to the appropriate number and title for your protocol.

2. List the time-point that this order should be used [e.g., “Post Transplant Protocol Specific Additional Evaluation Orders (day +80 to day +100)”]

3. List the types of orders this order will be used in lieu of, and possibly in conjunction with (e.g. “Use in conjunction with SCCA Blood and Other Samples Physician’s Order/Multiple Lab Requisition and SCCA Bone Marrow Procedure Order/Multiple Lab Requisition and use in lieu of the Standard Post Allogeneic Transplantation Departure Evaluation Orders”).

4. Change items that are significantly different from your protocol. 5. Add the items that are in addition to standard for your protocol. 6. Leave all standard items in place which do not conflict with your protocol.



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IV. TEMPLATE SPECIFIC INFORMATION E. Outpatient Prescription Order: An ambulatory clinic prescription (i.e., half sheet RX page) must be created to be used in

conjunction with a physician order for medication(s) that will be dispensed to the patient to take outside of the clinic (e.g. non-IV medications).

Separate prescriptions need to be prepared for the regular pharmacy and/or the Investigational

Drug Services (IDS) pharmacy depending on from where the medication will be dispensed. Ambulatory clinic prescriptions need to be created in adult and/or pediatric format depending on protocol inclusion and time point requirements.

Include all of the information that is contained on the physician order for the medication on the

prescription (i.e., drug name, dose, start and stop dates).

1. Page set-up requirements: Use the outpatient prescription template when creating protocol specific outpatient prescriptions to ensure that the unique page set-up requirements are met. Paper (8.5” x 5.5”) Margins (top 0.5”, bottom 0.3”, left 0.8”, right 0.5”).

2. Components:

a. Header: Include protocol number and the protocol title. Note: For pediatric

prescriptions a special symbol is included in the upper right hand corner of the document.

b. Pediatric prescriptions: Include table for recording Height (cm), weight (kg) and BSA

(m2).

c. Drug name: Include the generic name only. If trade name denotes a required formulation include both the generic name and trade name ex: “Trimethoprim/Sulfamethoxazole [Bactrim]”. Include “supplied by IDS pharmacy” next to medication name if medication will be dispensed by IDS pharmacy.

d. Check box [ ]: Use a check box before the drug name if not all patients will receive

the medication listed and there are multiple drugs and/or if there is special criteria for prescribing the drug ex: “for female patients > age 10 and < age 65”.

e. Dose: Include dose of the prescribed drug ex: “10 mg”. For pediatric patients note if

dosing is a calculated dose and include method for calculation ex: “1 mg/kg =________mg (dose)”.

f. Special instructions: Include details such as when to start medication “start

___________ date” as well as a stop date, when clinically indicated. Reiterating a physician’s order to discontinue a medication (i.e., stop date) is allowable on an order



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document. However, that medication discontinuation should not be reiterated on a prescription.

g. Dispense: Quantity of drug to dispense ex: “30 pills”, 6 doses or 2 day supply”.

h. Refills: Refill options to be selected by provider ex: “0 1 2 3 PRN”.



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Appendix 1

Laboratory Test Ordering and Requisitioning Overview Background: Two things are necessary for specimen testing to occur:

1. A physician order to collect the specimen for the testing 2. A laboratory requisition to instruct the lab what to do with the specimen and how to bill the

testing Both of these are required to ensure that the specimen is collected and tested accordingly. Lab testing is divided into two categories: “clinical” and “research.” These are broad, loosely-defined terms of art. Typically, “clinical” refers to testing that is being done at a time point that is usual or standard for a patient with that disease or treatment plan. “Research” refers to testing that is being done at a time point that is not usual or standard for a patient with their disease or treatment. In addition, “research” can refer to testing that is not occurring in a clinical laboratory. For example, a blood sample that is to be collected and sent to the PI’s lab is referred to as a “research” specimen. Clinical versus Research Testing: In order to determine if a particular lab test required by a protocol is a “clinical” or “research” test, consider the following:

1. When is the test occurring? 2. Why is the test occurring? 3. Where will the testing occur?

When is the test occurring? If the testing is occurring at a time point that would be considered routine or usual for a patient with that disease or undergoing that treatment, the testing might be considered “clinical.” If the testing is happening at a time point that would not be considered routine or usual, or that is more frequent than usual, that testing might be considered “research.” Why is the testing occurring? The reason for the testing and the use of the test results is also important in assessing whether a test is “clinical” or “research” related. In general, if the results of the test could or will be used to monitor the patient or adjust the patient’s treatment that test would be considered “clinical.” If the test results are only to collect data for end-of-study analysis, then the test should be considered “research.” For example, if a study requires that the patient have 3 CBC’s at 1 hour, 2 hours and 4 hours after receiving the study drug to look at the effects of the study drug on the patient’s hematocrit and platelet count, those 3 lab tests would probably be considered “research.” Where will the testing occur? The location where the testing will occur can also be an indicator of whether the testing is of a “clinical” or “research” nature. Laboratory testing that will be occurring in a non-SCCA or non-clinical lab is considered “research” testing. This would include testing that occur at the PI’s or a co-PI’s



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laboratory or at a centralized laboratory arranged by the study sponsor. Typically, these research labs lack the required certification to be able to report test results to be used for patient care and management. However, it cannot be assumed that testing that will occur at a SCCA or other clinical laboratory is therefore a “clinical” test. The example in the “Why is the testing occurring?” section above illustrates why this isn’t the case. Financial responsibility for the testing: Determining whether a test is “clinical” or “research” will clarify who is financially responsible for the cost of the specimen collection and/or lab testing. In most cases, “clinical” testing is billed to the patient or the patient’s insurance. Likewise, “research” testing is billed to the study. In order for testing to bill to the patient, orders and requisitions are completed as usual. For testing to be billed to the study, a Research Study account with study codes is needed. A Research Study account must be created to ensure that the charges associated with the “research” testing will not be billed to the patient’s account. If you think your study has “research” testing and will require a Research Study account, please contact the Research Implementation Office (RIO) at 288-6607 to discuss. Who orders the specimen and/or test? The specimen and testing must be ordered by a provider with privileges to do so. Common examples include physicians and mid-level providers. The provider orders the testing by completing a physician order. Within the hematopoietic cell transplant (BMT) program, numerous pre-printed physician orders exist to assist the providers in ordering and communicating their instructions to other clinical staff. However, a provider can also handwrite the order to collect and test a specimen. Many PIs and study teams choose to create and use protocol-specific pre-printed orders to assist clinical providers in ordering protocol-required services, which can include both “clinical” and “research” specimens and/or lab testing. For more information on creating protocol-specific pre-printed orders, refer to the General Guidelines for Creating BMT Protocol Specific Protocol Specific Orders. Who completes the lab requisition? The lab requisition form is important to ensure that the requested testing is performed, reported and billed as stipulated. However, the party responsible for completing the lab request can vary depending on the type of lab test and collection location. At the SCCA clinic, there is a Requisitioning Team (aka the Req’ing Crew) that can assist clinical care teams and research groups in completing laboratory requisitions. The Requisitioning Team is responsible for completing lab requisitions for all “clinical” tests. In addition, research groups can work with the Requisitioning Team to arrange for the team to complete requisitions for “research” tests that are ordered on protocol-specific pre-printed orders. If no arrangement is made with the Requisitioning Team then the research group is responsible for completing the lab requisition for the “research” tests.



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At the UWMC inpatient units, there is no Requisitioning Team. The unit staff will complete lab requisitions for all “clinical” tests but the research group is responsible for completing the lab requisition for the “research” tests. For pediatric inpatient units, contact Lauren Depue at 987-1548 to discuss who completes lab requisitions. For additional assistance in determining who is responsible for completing the lab requisitions, refer to Appendix 2 for decision tree diagrams. What type of requisition must be completed? There are many types of requisitions that can be used depending on the laboratory that will be performing the testing and who is financially responsible for the cost of the test. In general, the laboratory’s standard lab requisition can be used for either a “clinical” test or a “research” test assuming that the request for the “research” test includes additional information to ensure that the patient is not billed for the testing (i.e., a reference to the research protocol’s research study code and account name). Several labs that serve the BMT program have developed a combined dual-use physician order and lab request form. If the testing will be performed at one of the following labs, the specimen collection and lab testing must be ordered using this dual-use order/form: SCCA Pathology SCCA Cytogenetics SCCA Clinical Immunogenetics Lab (CIL) SCCA Molecular Virology UW Hematopathology UW Cytogenetics There are two types of these dual-use forms. One is for collection and testing of bone marrow and the other is for collection and testing of blood or other specimens. Typically, the clinical care team provider is responsible for completing the appropriate physician order/multiple lab requisition form based on the specimen type. Many research groups include reminder information (or cues) on the study’s protocol-specific pre-printed orders to prompt the clinical care team provider to complete the physician order/multiple lab requisition form in accordance with the protocol requirements. If the protocol requires testing at one of the above referenced labs and the specimen is determined not to be of a “clinical” nature, the research group must create a protocol-specific physician order/multiple lab requisition form for the appropriate specimen type. By completing a study-specific version, this will ensure that the appropriate specimen and testing is ordered and performed, and that the patient is not billed for testing that is not relevant to their care or treatment. To create a protocol-specific physician order/multiple lab requisition form, contact the RIO at 288-7025. At the SCCA Clinic, research groups can use the SCCA Research Lab Request for specimens or testing that will occur at a “research” lab (e.g., testing that occurs at the PI’s or fellow researcher’s



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laboratory or at a centralized laboratory arranged by the study sponsor). The Research Lab Request is easily identified because it is on purple paper. This form contains details regarding sample size, handling instructions, destination, contact information and the research study code and account name. This form does not indicate the specific testing required. The PI and study team will need to discuss testing requirements with the research lab prior to the start of the study and ensure that appropriate communication mechanisms between study staff and research lab staff are in place once protocol accrual begins. What about study kits? Some studies have specific requirements about the type of specimen collection container, media or labeling. In these situations, the study team provides research specimen “kits” that may include these materials as well as packaging and mailing materials if the specimen is to be mailed to an off-site testing facility. At the SCCA Clinic, research groups should work with the Requisitioning Team on a process for ensuring that study participant’s specimens are collected appropriately using the kit provided materials. The Requisitioning Team can be reached at 288-2057. If the study kit-related specimen is to be collected while the patient as on the inpatient unit, research staff are responsible for getting the study kit to the inpatient unit and coordinating the collection and pick-up of the kit.



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FRED HUTCHINSON CANCER RESEARCH CENTER/SEATTLE CANCER CARE ALLIANCE Protocol # xxxxx: xxxxx

Pre Transplant Protocol Specific Additional Evaluation Orders (to be in used in conjunction with standard Arrival orders, standard Pre-transplant (generic) Evaluation orders, Blood and Other Samples

Physician’s Order/Multiple Lab Requisition, Bone Marrow Procedure Physician’s Order/Multiple Lab Requisition) Refer to Guidelines Section II.A-B for Header and page set-up requirements.

Refer to Guidelines Section II.I for footer requirements Page 1 of 2

File name.doc Date of creation

Pre Transplant Additional Evaluation Ambulatory Order Template

★Non-highlighted text = Standard requirements which should be on your finished order draft along with specifics for your protocol. Yellow highlighting = Instructions, read and delete from protocol specific draft. Blue highlighting = Examples and/or options, replace with your protocol specific requirements, if applicable. Delete examples or options that do not apply to your protocol.

DIAGNOSIS: Refer to Guidelines Section IV.A.2.a CHECK APPROPRIATE BOXES: (Delete if no check box options)

FOR EVERY RESEARCH SAMPLE IDENTIFIED IN THIS ORDER: NURSING: Protocol specific research consent R has been signed. Research samples CANNOT be obtained until this confirmation occurs!

Confirmation by (RN) ___________________________________(RN signature) Delete Table and Text if not applicable to Protocol (i.e., no Consent R)

LABORATORY WORK: Refer to Guidelines Section IV.A.2.b On ________________________ (date) (must be within 28 days prior to stem cell mobilization)

Clinical samples: Refer to Guidelines Section IV.A.2.b.1

1. xxxxx [ ] 2. Quantitative Immunoglobulin levels [IgG, IgM, IgA] (if not already done within 28 days prior to stem cell

mobilization)

Also see separate SCCA “Blood and Other Samples Physician’s Order/Multiple Lab Requisition”. The following tests would be ordered on that form: (Delete if not applicable)

Blood for inventory for future chimerism studies to SCCA CIL laboratory Blood for PCR/molecular studies, for Ph + A.L.L. and CML to UW Hematopathology lab. FLOW cytometry: (all patients except Hodgkins lymphoma) - blood for disease specific immunophenotyping to UW Hematopathology laboratory CLL patients ONLY- blood to UW Hematopathology Lab for ZAP-70 analysis.

Research samples: Send with appropriate Lab Request form Refer to Guidelines Section IV.A.2.b.2

1. Blood in 7 ml Na Heparin (green top) tube. Draw blood and send at room temperature to XXXXX lab

2. Blood in [ ] Children 5-10 ml [ ] Adults 7 ml EDTA (purple top) tube. Put immediately on ice and page XXXXX for pick up

3. Reticulocyte count (SARET) Bill to Research Study Code: RS# xxxxxxx, RRR, xxxxxxxxxxxxxxxxxxx

Also see separate protocol xxxxx specific Blood and Other Samples Physician’s Order/Multiple Lab Requisition for: Blood for protocol specific xxxxxx testing, 7 ml EDTA (lavender top) tube to xxxxx.

____________________________ _____________________________, MD/PA-C/ARNP ____________ __________ _______ Prescriber (signature) (printed name) prescriber # date time

FRED HUTCHINSON CANCER RESEARCH CENTER/SEATTLE CANCER CARE ALLIANCE Protocol # xxxxx: xxxxx

Pre Transplant Protocol Specific Additional Evaluation Orders (to be in used in conjunction with standard Arrival orders, standard Pre-transplant (generic) Evaluation orders, Blood and Other Samples

Physician’s Order/Multiple Lab Requisition, Bone Marrow Procedure Physician’s Order/Multiple Lab Requisition) Refer to Guidelines Section II.A-B for Header and page set-up requirements.



Pre Transplant Additional Evaluation Ambulatory Order Template

★Non-highlighted text = Standard requirements which should be on your finished order draft along with specifics for your protocol. Yellow highlighting = Instructions, read and delete from protocol specific draft. Blue highlighting = Examples and/or options, replace with your protocol specific requirements, if applicable. Delete examples or options that do not apply to your protocol.

Refer to Guidelines Section II.E PROCEDURES: Refer to Guidelines Section IV.A.2.c

Clinical procedures: Refer to Guidelines Section IV.A.2.c.1

1. Schedule for CT scan – chest, abdomen, pelvis (See separate Radiology Order Form)

Bone marrow:

Also see separate SCCA “Bone Marrow Procedure Physician’s Order/Multiple Lab Requisition”. The following tests would be ordered on that form: (Delete if not applicable).

A. Morphology: Bone Marrow aspirate and bone marrow slides (to the Pathology Lab). a. Unilateral bone marrow biopsy for CML, solid tumors, & MDS (or for patients with other

diseases, only if unable to obtain adequate aspirate sample) (to SCCA Pathology Lab). b. Bilateral bone marrow biopsy, for NHL, HD, CLL, & multiple myeloma (to SCCA Pathology Lab).

B. Unilateral bone marrow aspirate for immunophenotyping by flow cytometry. C. Unilateral bone marrow aspirate for cytogenetics; If clinically indicated (to SCCA Cytogenetics Lab).

Research procedures Refer to Guidelines Section IV.A.2.c.2

Charge to Research Study Code: RS# xxxxxxx/RU# xxxxxxx, RRR, xxxxxxxxxxxxxx Include RU# for CT scans

1. Schedule for ECG, 12 lead 2. Schedule for clinic visit with MA for weight and vital signs including xxxxx, xxxxx, and xxxxx

On day -7, __________________(date) ( + 2 days) (Repeat sections below for each time point, as needed, per protocol requirements)

LABORATORY WORK: Clinical samples: Research samples:

PROCEDURES: Clinical procedures: Research procedures:


Refer to Guidelines Section II.E For protocol questions, please contact xxxxx at xxxxx (pager) Route a copy of this order to: xxxxxxx ______, xxxxxxxx _____, xxxxxxxxxxx ______, xxxxxxxx ______ (Operational use only)

Non-highlighted text = Standard requirements which should be on your finished order draft along with specifics for your protocol. Yellow highlighting = Instructions, read and delete from protocol specific draft. Blue highlighting = Examples and/or options, replace with your protocol specific requirements, if applicable. Delete examples or options that do not apply to your protocol.

SCCA/FRED HUTCHINSON CANCER RESEARCH CENTER Protocol # xxxxx: xxxxx

Pre Transplant Protocol Specific Additional Evaluation Orders To be used in conjunction with standard Arrival orders, standard Pre-transplant (generic) Evaluation orders, Blood and Other Samples Physician’s

Order/Multiple Lab Requisition, Bone Marrow Procedure Physician’s Order/Multiple Lab Requisition. Refer to Guidelines Section II A & B for Header and page set-up requirements.

DIAGNOSIS: Refer to Guidelines Section IV.B.2.a CHECK APPROPRIATE BOXES: (Delete if no check box options)

PLEASE NOTE: FOR EVERY RESEARCH SAMPLE IDENTIFIED IN THIS ORDER: RESEARCH ITEMS SHOULD NOT BE DONE UNLESS/UNTIL PROTOCOL SPECIFIC RESEARCH CONSENT R HAS BEEN SIGNED! Delete table and text if not applicable to protocol (i.e., no Consent R)

LABORATORY WORK: Refer to Guidelines Section IV.B.2.b On ________________________ (date) (must be within 28 days prior to stem cell mobilization)

Clinical samples: (may be drawn with a.m. blood draws) Refer to Guidelines Section IV.B.2.b.1

1. xxxxx 2. EBV PCR. to Molecular Virology via Alliance Lab

[ ] 3. Quantitative Immunoglobulin levels [IgG, IgM, IgA] (if not already done within 28 days prior to stem cell mobilization)

Also see separate SCCA “Blood and Other Samples Physician’s Order/Multiple Lab Requisition”. The following tests would be ordered on that form: (Delete if not applicable)

Blood for inventory for future chimerism studies to SCCA CIL laboratory Blood for PCR/molecular studies, for Ph + A.L.L. and CML to UW Hematopathology lab. FLOW cytometry: (all patients except Hodgkins lymphoma) - blood for disease specific immunophenotyping to UW Hematopathology laboratory CLL patients ONLY- blood to UW Hematopathology Lab for ZAP-70 analysis.

Research samples: Send with appropriate Lab Request form Refer to Guidelines Section IV.B.2.b.2

1. Blood in 7 ml Na Heparin (green top) tube. Draw blood and send at room temperature to XXXXX lab

2. Blood in 7 ml EDTA (purple top) tube. Put immediately on ice and page XXXXX for pick up

3. Reticulocyte count (SARET) Bill to Research Study Code: RU# xxxxxxx, RRR, xxxxxxxxxxx

Also see separate protocol xxxxx specific Blood and Other Samples Physician’s Order/Multiple Lab Requisition for: Blood for protocol specific Cytogenetic xxxxxx testing, 7 ml EDTA (lavender top) tube to UW Hematopathology and then forwarded to SCCA CIL

__________________________ ________________________________, MD/PA-C/ARNP ____________ __________ _________ Prescriber (signature) (printed name) prescriber # date time

Refer to Guidelines Section II.E



Pre Transplant Additional Evaluation Inpatient Order Template

SCCA/FRED HUTCHINSON CANCER RESEARCH CENTER Protocol # xxxxx: xxxxx

Pre Transplant Protocol Specific Additional Evaluation Orders To be used in conjunction with standard Arrival orders, standard Pre-transplant (generic) Evaluation orders, Blood and Other Samples Physician’s

Order/Multiple Lab Requisition, Bone Marrow Procedure Physician’s Order/Multiple Lab Requisition. Refer to Guidelines Section II A & B for Header and page set-up requirements.



Pre Transplant Additional Evaluation Inpatient Order Template

PROCEDURES: Refer to Guidelines Section IV.B.2.c

Clinical procedures: Refer to Guidelines Section IV.B.2.c.1

Schedule for CT scan – chest, abdomen, pelvis (See separate Radiology Order Form)

Bone marrow: Also see separate SCCA “Bone Marrow Procedure Order/Multiple Lab Requisition”. The following tests would be ordered on that form: (Delete if not applicable) A. Morphology: Bone Marrow aspirate and bone marrow slides (to the Pathology Lab).

a. Unilateral bone marrow biopsy for CML, solid tumors, & MDS (or for patients with other diseases, only if unable to obtain adequate aspirate sample) (to SCCA Pathology Lab).

b. Bilateral bone marrow biopsy, for NHL, HD, CLL, & multiple myeloma (to SCCA Pathology Lab). B. Unilateral bone marrow aspirate for immunophenotyping by flow cytometry. C. Unilateral bone marrow aspirate for cytogenetics; If clinically indicated (to SCCA Cytogenetics Lab).

Research procedures: Refer to Guidelines Section IV.B.2.c.2 Charge to Research Study Code: RU# xxxxxxx, RRR, xxxxxxxxxxxxxxxx

1. ECG, 12 lead

On day -7, __________________(date) ( + 2 days) (Repeat sections below for each time point, as needed, per protocol requirements)

LABORATORY WORK: Clinical samples: (may be drawn with a.m. blood draws) Research samples:

PROCEDURES: Clinical procedures: Research procedures:


Refer to Guidelines Section II.E (Add contact information on last page) For protocol questions, please contact xxxxx at xxxxx (pager)

Non-highlighted text = Standard requirements which should be on your finished order draft along with specifics for your protocol.Yellow highlighting = Instructions, read and delete from protocol specific draft. Blue highlighting = Examples and/or options, replace with your protocol specific requirements, if applicable. Delete examples or options that do not apply to your protocol.

★FRED HUTCHINSON CANCER RESEARCH CENTER/Seattle Cancer Care Alliance

Protocol # xxxxx : xxxxx Post Transplant Protocol Specific Evaluation Orders Day XX through Day ZZ

(To be used in conjunction with Blood & Other Samples Physician’s Order/Multiple Lab Requisition) Refer to Guidelines Section II. A-B for Header and page set-up requirements

Refer to Guidelines Section IV.C.1 CHECK APPROPRIATE BOXES: (Delete if no check box options) DIAGNOSIS: Refer to Guidelines Section IV.C.3.a [ ] On Day +XX ______________ (date) (Use checkbox even if date is not optional to allow for rewriting of order if site of care changes).

LABORATORY WORK: Refer to Guidelines Section IV.C.3.b

Clinical samples Refer to Guidelines Section IV.C.3.b.1 (List on-going testing first) Blood for xxxxx weekly for three weeks starting ________________(date) (Day +XX) (Draw Monday through Thursday only) (Include qualifiers: days of the week to draw, time ranges, etc.) ( + 2 days)(Include date range, if applicable)

(Followed by day +XX clinical samples) Clinical samples

1. PTT daily for xxxxx days, starting ____________(date) (Day +5) 2. CBC [CBD] (includes HCT, HGB, WBC, RBC, indices, PLATELET, DIFF/SMEAR EVAL) 3. xxxxx

[ ] 4. (for patients > 10 years and < 65 years) xxxxx [ ] 5. (if not already done within previous 2 days) Quantitative Immunoglobulin levels [IgG, IgM, IgA]

Also see separate SCCA “Blood and Other Samples Physician’s Order/Multiple Lab Requisition”. The following tests would be ordered on that form: (Delete if not applicable) Refer to Guidelines Section IV.C.3.b.1.b Blood for inventory for future chimerism studies to SCCA CIL laboratory Blood for PCR/molecular studies, for Ph + A.L.L. and CML to UW Hematopathology lab. (for all patients except Hodgkins lymphoma) – FLOW cytometry: Blood for disease specific

immunophenotyping to UW Hematopathology laboratory CLL patients ONLY – Blood to UW Hematopathology Lab for ZAP-70 analysis.





Post Transplant Additional Evaluation Ambulatory Order Template

FRED HUTCHINSON CANCER RESEARCH CENTER/Seattle Cancer Care Alliance Protocol # xxxxx : xxxxx

Post Transplant Protocol Specific Evaluation Orders Day XX through Day ZZ (To be used in conjunction with Blood & Other Samples Physician’s Order/Multiple Lab Requisition)

Refer to Guidelines Section II. A-B for Header and page set-up requirements Refer to Guidelines Section IV.C.1




Day + XX LABORATORY WORK (continued) Research samples: Send with Research Lab Request form Refer to Guidelines Section IV.C.3.b.2

1. Blood in 7 ml Na Heparin (green top) tube. Draw blood and send at room temperature to Dr XXXXX lab 2. Blood in [ ]children 5-10 ml [ ]adults 7 ml EDTA (purple top) tube. Put immediately on ice and send

STAT to XXXXX lab 3. Reticulocyte count (SARET) Bill to Research Study Code: RS # xxxxxxx, RRR, xxxxxxxxxxxxxxxxxxx

Also see separate protocol xxxxx specific Blood or Other Samples Physician’s Order/Multiple Lab

Requisition: Refer to Guidelines Section IV.C.3.b.2.g Blood for chimerism studies, protocol specific sorting of xx, xx, and xx cells, 7 ml EDTA (lavender top) tube to UW Hematopathology and then forwarded to SCCA CIL

PROCEDURES: Refer to Guidelines Section IV.C.3.c Clinical procedures: Refer to Guidelines Section IV.C.3.c.1

1. Schedule for CT scan – chest, abdomen, pelvis (See separate Radiology Order Form)

Bone marrow: Also see separate SCCA “Bone Marrow Procedure Physician’s Order/Multiple Lab Requisition”. The following tests would be ordered on that form: (Delete if not applicable) Refer to Guidelines Section IV.C.3.c.1.b

A. Morphology: Bone Marrow aspirate and bone marrow slides (to the Pathology Lab). a. Unilateral bone marrow biopsy for CML, solid tumors, & MDS (or for patients with other

diseases, only if unable to obtain adequate aspirate sample) (to SCCA Pathology Lab). b. Bilateral bone marrow biopsy, for NHL, HD, CLL, & multiple myeloma (to SCCA Pathology

Lab). B. Unilateral Bone marrow aspirate for immunophenotyping by flow cytometry.



FRED HUTCHINSON CANCER RESEARCH CENTER/Seattle Cancer Care Alliance Protocol # xxxxx : xxxxx

Post Transplant Protocol Specific Evaluation Orders Day XX through Day ZZ (To be used in conjunction with Blood & Other Samples Physician’s Order/Multiple Lab Requisition)

Refer to Guidelines Section II. A-B for Header and page set-up requirements Refer to Guidelines Section IV.C.1




Day +XX PROCEDURES (continued) C. Unilateral Bone marrow aspirate for cytogenetics; If clinically indicated (to SCCA Cytogenetics Lab).

Add FISH probes (as appropriate for disease)

D. PCR studies: (as appropriate for disease)

Research procedures: Refer to Guidelines Section IV.C.3.c.2

Charge to Research Study Code: RS# xxxxxxx/RU# xxxxxxx RRR, xxxxxxxxxxxxxxxxxx (include RU code for CT scans)

1. Schedule for ECG, 12 lead [ ] On day YY, __________________(date) ( + 2 days) (Use checkbox even if date is not optional to allow for rewriting of order if site of care changes. Repeat sections below for each time point, as needed per protocol requirements.)


PROCEDURES:

Clinical procedures: Research procedures:

[ ] On day ZZ, __________________(date) ( + 2 days) (Use checkbox even if date is not optional to allow for rewriting of order if site of care changes. Repeat sections below for each time point, as needed per protocol requirements.)


PROCEDURES:




Route a copy of this order to: xxxxxxx ______, xxxxxxxx _____, xxxxxxxxxxx ______, xxxxxxxx ______(Operational use only)

SCCA/FRED HUTCHINSON CANCER RESEARCH CENTER


Protocol # xxxxx : xxxxx Post Transplant Protocol Specific Evaluation Orders Day +XX through Day +ZZ

To be used in conjunction with Blood & Other Samples Physician’s Order/Multiple Lab Requisition Refer to Guidelines Section II.A-B for Header and page set-up requirements

Refer to Guidelines Section IV.D.1 for information regarding configuration options. CHECK APPROPRIATE BOXES: (Delete if no check box options) DIAGNOSIS: Refer to Guidelines Section IV.D.3.a [ ] On Day +XX ______________ (date) (Use checkbox even if date is not optional to allow for rewriting of order if site of care changes).

LABORATORY WORK: Refer to Guidelines Section IV.D.3.b

Clinical samples (may be drawn with a.m. blood draws) Refer to Guidelines Section IV.D.3.b.1 (List on-going testing first) Blood for xxxxx weekly for three weeks starting ________________(date)(Day +XX) (Draw Monday through Thursday only)(Include qualifiers: days of the week to draw, time ranges, etc.) ( + 2 days)(Include date range, if applicable)

(Followed by day +XX clinical samples processed during routine labs) Clinical samples 1. PTT daily for xxxxx days, starting _____________(date) (Day +5) 2. CBC [CBD] (includes HCT, HGB, WBC, RBC, indices, PLATELET, DIFF/SMEAR EVAL) 3. xxxxx

[ ] 4. (for patients > 10 years and < 65 years) xxxxx [ ] 5. (if not already done within previous 2 days) Quantitative Immunoglobulin levels [IgG, IgM, IgA]

Also see separate SCCA “Blood and Other Samples Physician’s Order/Multiple Lab Requisition”. The following tests would be ordered on that form: (Delete if not applicable) Refer to Guidelines Section IV.D.3.b.1.b Blood for inventory for future chimerism studies to SCCA CIL laboratory Blood for PCR/molecular studies, for Ph + A.L.L. and CML to UW Hematopathology lab. (for all patients except Hodgkins lymphoma) - FLOW cytometry: Blood for disease specific immunophenotyping to UW

Hematopathology laboratory CLL patients ONLY - Blood to UW Hematopathology Lab for ZAP-70 analysis.





Post Transplant Additional Evaluation Inpatient Order Template

SCCA/FRED HUTCHINSON CANCER RESEARCH CENTER Protocol # xxxxx : xxxxx

Post Transplant Protocol Specific Evaluation Orders Day +XX through Day +ZZ To be used in conjunction with Blood & Other Samples Physician’s Order/Multiple Lab Requisition

Refer to Guidelines Section II.A-B for Header and page set-up requirements Refer to Guidelines Section IV.D.1 for information regarding configuration options.




Day +XX LABORATORY WORK (continued)

Research samples: Send with Research Lab Request form Refer to Guidelines Section IV.D.3.b.2.f

1. Blood in 7 ml Na Heparin (green top) tube. Draw blood and send at room temperature to Dr XXXXX lab 2. Blood in 7 ml EDTA (purple top) tube. Put immediately on ice and send STAT to XXXXX lab 3. Reticulocyte count (SARET) Bill to Research Study Code: RU# xxxxxxx, RRR, xxxxxxxxxxxxxxxxx

Also see separate protocol xxxxx specific Blood or Other Samples Physician’s Order/Multiple Lab Requisition:

Refer to Guidelines Section IV.D.3.b.2.g Blood for chimerism studies, protocol specific sorting of xx, xx, and xx cells, 7 ml EDTA (lavender top) tube to UW Hematopathology and then forwarded to SCCA CIL

PROCEDURES: Refer to Guidelines Section IV.D.3.c.

Clinical procedures Refer to Guidelines Section IV.D.3.c.1 1. CT scan – chest, abdomen, pelvis (See separate Radiology Order Form)

Bone marrow: Also see separate SCCA “Bone Marrow Procedure Physician’s Order/Multiple Lab Requisition”. The following tests would be ordered on that form: (Delete if not applicable) Refer to Guidelines Section IV.D.3.c.1.b

A. Morphology: Bone Marrow aspirate and bone marrow slides (to the Pathology Lab). a. Unilateral bone marrow biopsy for CML, solid tumors, & MDS (or for patients with other diseases, only

if unable to obtain adequate aspirate sample) (to SCCA Pathology Lab). b. Bilateral bone marrow biopsy, for NHL, HD, CLL, & multiple myeloma (to SCCA Pathology Lab).

B. Unilateral Bone marrow aspirate for immunophenotyping by flow cytometry.









Day +XX PROCEDURES (continued)

C. Unilateral Bone marrow aspirate for cytogenetics; If clinically indicated (to SCCA Cytogenetics Lab). Add FISH probes: (as appropriate for disease) D. PCR studies:(as appropriate for disease)

Research procedures Refer to Guidelines Section IV.D.3.c.2

Charge to Research Study Code: RU# xxxxxxx, RRR, xxxxxxxxxxxxxxxxxxxx

1. ECG, 12 lead

[ ] On day +YY, __________________(date) ( + 2 days) (Use checkbox even if date is not optional to allow for rewriting of order if site of care changes. Repeat sections below for each time point, as needed per protocol requirements.)

LABORATORY WORK:

Clinical samples: (may be drawn with a.m. blood draws) Research samples:

PROCEDURES:










[ ] On day +ZZ, __________________(date) ( + 2 days) (Use checkbox even if date is not optional to allow for rewriting of order if site of care changes. Repeat sections below for each time point, as needed per protocol requirements.)

LABORATORY WORK:

Clinical samples: (may be drawn with a.m. blood draws) Research samples:

PROCEDURES:





ADULT PRESCRIPTION PAGE: OUTPATIENT PRESCRIPTION ORDER Page 1 of 1 Protocol #1234 xxxxx xxxxx xxxxxx (match number and name of associated order)

DATE

PHYSICIAN NO CLINIC

RX INDICATE WHICH MEDICATIONS TO FILL BY CHECKING BOX TO LEFT OF DRUG NAME [ ] Trimethoprim/Sulfamethoxazole DS 1 tablet PO BID

D/C on ___________(date) after am dose (48 hours before stem cell infusion) Dispense: xxx REFILLS:

0 1 2 3 PRN [ ] (for female patients > age 10 and < age 65) (put specific criteria for check box as in order)

Xxxxxxxx(generic name) xx mg PO every 12 hours start __________________date and continue for 90 days.

Dispense: xxx REFILLS: 0 1 2 3 PRN

Xxxxxxxx(generic name) xx mg PO every xxxxxx(no checkbox needed if all patients get med), start __________________date.

Dispense: xxx REFILLS: 0 1 2 3 PRN

PRINT PRESCRIBER NAME HERE

DEA NO

PRESCRIBER SIGNATURE (substitution permitted)

PRESCRIBER SIGNATURE (dispense as written)

IMPRINT BELOW THIS LINE

PT NO

NAME

DOB

ALLERGIES: [ ] NKDA

______________________________

_______________________ _______________________ _______________________

SEATTLE CANCER CARE ALLIANCE

825 Eastlake Avenue East

Seattle, WA 98109

(206) 288-6500

(match number amd name of associated order)1234_xxxxxxx.rx.peds.doc 10-05-10

PEDIATRIC PRESCRIPTION PAGE: OUTPATIENT PRESCRIPTION ORDE Page 1 of 1 R Protocol #1234 xxxxx xxxxx xxxxxx (match number and name of associated order)

DATE

PHYSICIAN NO CLINIC


HEIGHT: cm WEIGHT kg BSA: m2 RX INDICATE WHICH MEDICATIONS TO FILL BY CHECKING BOX TO LEFT OF DRUG NAME

[ ] (for patients 20 kg) (put specific criteria for check box as in order)trimethoprim/sulfamethoxazole = 5 mg/kg/day (trimethoprim component) divided as _________ mg PO every 12 hours

Dispense: QS (suspension)

REFILLS: 0 1 2 3 PRN

[ ] (for patients 20-40 kg) trimethoprim /sulfamethoxazole: = 1 SS tablet PO BID. Dispense: QS REFILLS: 0 1 2 3 PRN [ ] (for patients > 40 kg) trimethoprim /sulfamethoxazole: = 1 DS tablet PO BID. Dispense: QS REFILLS: 0 1 2 3 PRN

Start ____/___/____(date) and D/C after am dose ____/___/____(date) (48h prior to stem cell infusion)

Xxxxxxxx(generic name) xx mg PO every 12 hours(no checkbox needed if all pediatric patients get med), start __________________date

Dispense: 60 REFILLS: 0 1 2 3 PRN

PRINT PRESCRIBER NAME HERE

DEA NO

PRESCRIBER SIGNATURE (substitution permitted)

PRESCRIBER SIGNATURE (dispense as written)

IMPRINT BELOW THIS LINE

PT NO

NAME

DOB

ALLERGIES: [ ] NKDA

______________________________

_______________________ _______________________ _______________________

SEATTLE CANCER CARE ALLIANCE

825 Eastlake Avenue East

Seattle, WA 98109

(206) 288-6500

(match number amd name of associated order)1234_xxxxxxx.rx.peds.doc 10-05-10

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