Seattle Cancer Care Alliance. Table of Contents

Transcription

1 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 Page 1 of 44

2 V. Appendices 1. Laboratory Test Ordering and Requisitioning Overview Pg 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 Page 2 of 44

3 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 Page 3 of 44

4 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 Molly Clawson at 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. Page 4 of 44

5 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 pretransplant (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. Page 5 of 44

6 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. Page 6 of 44

7 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. Page 7 of 44

8 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] Page 8 of 44

9 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 Page 9 of 44

10 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. Page 10 of 44

11 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 Page 11 of 44

12 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) Page 12 of 44

13 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. Page 13 of 44

14 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. Page 14 of 44

15 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 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. Page 15 of 44

16 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. Page 16 of 44

17 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) pretransplant 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) Page 17 of 44

18 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 Page 18 of 44

19 (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 Page 19 of 44

20 UW Cytogenetics Lab UW Molecular Virology Lab 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 nonpooled 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 nonpooled; 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 nonpooled 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. Page 20 of 44

21 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; If blood draw volume is based on weight, must add weight line to order ex: Actual weight: 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) Page 21 of 44

22 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: 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 to be to a research lab. If applicable, note if this form will be supplied by study staff (refer to section I.B Page 22 of 44

23 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 Page 23 of 44

24 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 nonpooled 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.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). 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 nonpooled 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. Page 24 of 44

25 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 rewritten (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; Page 25 of 44

26 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 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 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; 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) 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. Page 26 of 44

27 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: c. Procedures: 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 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. 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; Page 27 of 44

28 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 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. 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 Page 28 of 44

29 section IV.C.3.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 nonpooled 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. Page 29 of 44

30 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. Page 30 of 44

31 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 rewritten (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; Page 31 of 44

32 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 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 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; 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) 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: SCCA Pathology Lab SCCA Cytogenetics Lab SCCA CIL UW Hematopathology Lab UW Cytogenetics Lab *UW Molecular Virology Lab Page 32 of 44

33 * 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 (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. Page 33 of 44