Protocol Index	

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OP RESEARCH CTL H-43516 CARMEN	

Types:      Research Oncology Treatment
Synonyms:  H43516, 43516

Pre Day 0	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH OK TO USE	Interval: --	Occurrences: --		  	ACCESS PORTACATH	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For females of child bearing age
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Day 0	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vitals (Include breath sounds) Pre-infusion, During Infusion, and Post Infusion 

Following Post Infusion: Monitor Every 30 minutes x2, Then Every 1 hour x2. 

(Total monitoring period Post Infusion is 3 hours.)
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Continuous Pulse Oximetry for Oxygen Saturation levels GREATER than 90% Before, During, and at least 30 minutes Post-Infusion.
		  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --	Comments:	Start peripheral IV, if no central line. Use 3-way stopcock and tubing.
		  	RESEARCH - SUPPLIES/KIT TO BEDSIDE	Interval: --	Occurrences: --	Comments:	Must be at bedside prior to infusion: Oxygen and suction set up, normal saline flushes, sterile gloves, red caps, and syringes with needles (1mL and 3 mL).
		  	RESEARCH - ASSESS	Interval: --	Occurrences: --	Comments:	Patient for immediate reactions: 1) Allergic reactions (anaphylaxis) 2) Decreased oxygenation (due to migration of lymphocytes to lungs).
			Provider Communication
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	History and Physical: *** (date)
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Calculate BSA.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Please order pre-meds as soon as labs are sent.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Hydration
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Give 30 minutes prior to product administration.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose			Offset: 0 Hours	Instructions:	Give 30 minutes prior to product administration.			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Cell infusion to be administered MORE than 24 hours after Fludarabine and Cytarabine
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Cells to be administered by physician (generally by syringe injection with 0.9% Normal Saline flush)

Verify cell dose and patient information on Component Infusion Form. Record infusion start and stop time on form and place in patient's medical record.

Clinic nurse to remain at bedside during the entire infusion

Ensure informed consent is obtained
			Emergency Medications
  	TRANSFUSION REACTION EVALUATION	Interval: Once	Occurrences: --	Comments:	Emergency Medications: Anaphylactic precautions: Keep medications at the bedside to administer per physician's orders.
		  	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once PRN	Start: S			Instructions:	Keep at the bedside to administer per physician's orders.		  	hydrocortisone sodium succinate (Solu-CORTEF) injection 250 mg	Dose: 250 mg	Route: intravenous	once PRN	Start: S			Instructions:	Keep at the bedside to administer per physician's orders.		  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S			Instructions:	Keep at the bedside to administer per physician's orders.			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Post Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Week 1	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH OK TO USE	Interval: --	Occurrences: --		  	ACCESS PORTACATH	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Week 2	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH OK TO USE	Interval: --	Occurrences: --		  	ACCESS PORTACATH	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Week 3	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Week 4	Repeat 1 time	Cycle length: 14 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH OK TO USE	Interval: --	Occurrences: --		  	ACCESS PORTACATH	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Week 6	Repeat 1 time	Cycle length: 14 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH OK TO USE	Interval: --	Occurrences: --		  	ACCESS PORTACATH	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Week 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH OK TO USE	Interval: --	Occurrences: --		  	ACCESS PORTACATH	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 3	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 6	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 9	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Month 12	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	History & physical with PS
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --