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OP / IP PRO00043706 NVC001-PT-CL-001 TRACHTENBERG	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 19 days	Day -14	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Verify Hep B / C panel status prior to treatment initiation. Date *** of panel. Result positive/negative/pending/unknown:22867

Results Required prior to administration of Rituximab.  
The required components for the hepatitis B panel includes: Hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (anti-HBc), and hepatitis B surface antibody (anti-HBs). 
The required hepatitis C results include:  Hepatitis C Antibody with Reflex to PCR
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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
  	INV-Acetaminophen (NVC001-PT-CL-001/Pro00043706/Trachtenberg) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes prior to rituximab or NVC001. Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	INV-Diphenhydramine (NVC001-PT-CL-001/Pro00043706/Trachtenberg) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes prior to rituximab or NVC001. Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-RiTUXimab (NVC001-PT-CL-001/Pro00043706/Trachtenberg) 750 mg/m2 in sodium chloride 0.9% 250 mL IVPB	Dose: 750 mg/m2	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Initiate rituximab 750 mg/m2 at 50 mg/hr. In absence of toxicity, increase by 50 mg/hr every 30 minutes to a max of 400 mg/hr.  For the second infusion, rituximab 750 mg/m2 IV may be initiated at 100 mg/hr, and in the absence of infusion toxicity may be increased in increments of 100 mg/hr every 30 minutes to a max infusion rate of 400 mg/hr. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-RITUXIMAB 10 MG/ML CONC, INTRAVENOUS (NVC001-PT-CL-001/PRO00043706/TRACHTENBERG)	Medications	750 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Rituximab Instructions
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	1) During Rituximab infusion:
-Vitals every 15 minutes during 1st hour of infusion, THEN
-Every 30 minutes for 1 hour, THEN
-Every hour until end of infusion
-Call MD if SBP less than 90, pulse less than 60 or greater than 120, temperature greater than 38.5 degrees C
		  	ONC NURSING COMMUNICATION 26	Interval: --	Occurrences: --	Comments:	2) Infuse antibody via pump
3) If any of the following occurs: FEVER (T greater than 38.5 degrees C), RIGORS, HYPOTENSION (30mm Hg decrease from baseline), and / or MUCOSAL CONGESTION / EDEMA, HOLD infusion until improvement of symptoms (When symptoms improve, resume infusion at HALF the previous rate)

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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
  	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				Day -7	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Patient will start sirolimus on this day (Day -7). This drug will be provided through IDS via a paper order.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Patient will start sulfamethoxazole/trimethoprim (BACTRIM) single strength once a day starting on this day (Day -7) and will remain on this while on steroids. This drug will be provided through IDS via a paper order.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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
  	INV-Acetaminophen (NVC001-PT-CL-001/Pro00043706/Trachtenberg) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes prior to rituximab or NVC001. Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	INV-Diphenhydramine (NVC001-PT-CL-001/Pro00043706/Trachtenberg) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes prior to rituximab or NVC001. Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-RiTUXimab (NVC001-PT-CL-001/Pro00043706/Trachtenberg) 750 mg/m2 in sodium chloride 0.9% 250 mL IVPB	Dose: 750 mg/m2	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Initiate rituximab 750 mg/m2 at 50 mg/hr. In absence of toxicity, increase by 50 mg/hr every 30 minutes to a max of 400 mg/hr.  For the second infusion, rituximab 750 mg/m2 IV may be initiated at 100 mg/hr, and in the absence of infusion toxicity may be increased in increments of 100 mg/hr every 30 minutes to a max infusion rate of 400 mg/hr. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-RITUXIMAB 10 MG/ML CONC, INTRAVENOUS (NVC001-PT-CL-001/PRO00043706/TRACHTENBERG)	Medications	750 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Rituximab Instructions
  	VITAL SIGNS - T/P/R/BP PER UNIT PROTOCOL	Interval: --	Occurrences: --	Comments:	1) During Rituximab infusion:
-Vitals every 15 minutes during 1st hour of infusion, THEN
-Every 30 minutes for 1 hour, THEN
-Every hour until end of infusion
-Call MD if SBP less than 90, pulse less than 60 or greater than 120, temperature greater than 38.5 degrees C
		  	ONC NURSING COMMUNICATION 26	Interval: --	Occurrences: --	Comments:	2) Infuse antibody via pump
3) If any of the following occurs: FEVER (T greater than 38.5 degrees C), RIGORS, HYPOTENSION (30mm Hg decrease from baseline), and / or MUCOSAL CONGESTION / EDEMA, HOLD infusion until improvement of symptoms (When symptoms improve, resume infusion at HALF the previous rate)

			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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
  	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				Day -1	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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
  	INV-Methylprednisolone sod succinate (NVC001-PT-CL-001/Pro00043706/Trachtenberg) injection 0.8 mg/kg (Treatment Plan)	Dose: 0.8 mg/kg	Route: intravenous	every 24 hours over 5 Minutes for 3 doses	Start: S			Instructions:	Administer IV over 5 minutes. Draw up prescribed dose and discard remainder. Caution: New Drug-Limited by Federal (USA) Law to Investigational use.				Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	ONC NURSING COMMUNICATION 12	Interval: Once	Occurrences: --	Comments:	Please issue paper order on the following lab orders:
1. SC5b-9 
2. MCP-1
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	SIROLIMUS LEVEL, TROUGH	Interval: Once	Occurrences: --		  	SIROLIMUS LEVEL, PEAK	Interval: Once	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: Once	Occurrences: --		  	COVID-19, INFLUENZA A&B, AND RSV QUALITATIVE RT-PCR	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --		  	HAPTOGLOBIN	Interval: Once	Occurrences: --		  	TROPONIN T	Interval: Once	Occurrences: --		  	GGT	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	CK-MB	Interval: Once	Occurrences: --	Comments:	To be performed at Quest
		  	LDH	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: Once	Occurrences: --		  	C3 COMPLEMENT COMPONENT	Interval: Once	Occurrences: --		  	COMPLEMENT C3A	Interval: Once	Occurrences: --	Comments:	To be performed at LabCorp
		  	C4 COMPLEMENT COMPONENT	Interval: Once	Occurrences: --		  	COMPLEMENT C4A	Interval: Once	Occurrences: --	Comments:	To be performed at LabCorp
		  	ANTIBODY TITER	Interval: Once	Occurrences: --		  	INTERLEUKIN 1 BETA	Interval: Once	Occurrences: --	Comments:	To be performed at Quest
		  	INTERLEUKIN 6	Interval: Once	Occurrences: --		  	INTERFERON GAMMA	Interval: Once	Occurrences: --		  	TUMOR NECROSIS FACTOR - ALPHA	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	PHYSICAL EXAM - TO BE PERFROMED BY PI
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	To be done prior to pre-medications.   
Patient must be rested for at least 10 minutes in a supine position.
		  	ONC NURSING COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Review Inclusion/Exclusion Criteria.
		  	MEASURE WEIGHT	Interval: Once	Occurrences: --	Comments:	Current weight must be documented in Epic for IDS Pharmacy.
		  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	NYHA FUNCTIONAL CLASS TO BE DOCUMENTED IN PI'S NOTE.
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	NURSE TO PERFORM ALL QUESTOINNAIRES.
		  	ONC NURSING COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Oral prednisone (or equivalent) of 60 mg orally (up to a maximum dose of 60 mg regardless of body weight) will start on Day 3 and will continued daily until approximately 8 weeks of corticosteroid treatment have been completed. This drug will be provided through IDS via a paper order.
			Line Care
  	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
  	INV-Acetaminophen (NVC001-PT-CL-001/Pro00043706/Trachtenberg) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes prior to rituximab or NVC001. Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	INV-Diphenhydramine (NVC001-PT-CL-001/Pro00043706/Trachtenberg) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes prior to rituximab or NVC001. Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		  	INV-Famotidine (NVC001-PT-CL-001/Pro00043706/Trachtenberg) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer prior to NVC-001. Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Medications
  	INV-NVC-001 (NVC001-PT-CL-001/Pro00043706/Trachtenberg) infusion	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Administer IV at a rate of 1 mL/min via peripheral vein. Flush the line with at least 30 mL NS at 1 mL/min to ensure complete infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					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.				Day 2	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	ONC NURSING COMMUNICATION 14	Interval: Once	Occurrences: --	Comments:	Please issue paper order on the following lab order: SC5b-9
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	GGT	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	CK-MB	Interval: Once	Occurrences: --	Comments:	To be performed at Quest
		  	LDH	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TROPONIN T	Interval: Once	Occurrences: --		  	C3 COMPLEMENT COMPONENT	Interval: Once	Occurrences: --		  	COMPLEMENT C3A	Interval: Once	Occurrences: --	Comments:	To be performed at LabCorp
		  	C4 COMPLEMENT COMPONENT	Interval: Once	Occurrences: --		  	COMPLEMENT C4A	Interval: Once	Occurrences: --	Comments:	To be performed at LabCorp
		  	ANTIBODY TITER	Interval: Once	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	PHYSICAL EXAM - TO BE PERFROMED BY PI
				Day 3	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	ONC NURSING COMMUNICATION 14	Interval: Once	Occurrences: --	Comments:	Please issue paper order on the following lab order: SC5b-9
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	C3 COMPLEMENT COMPONENT	Interval: Once	Occurrences: --		  	COMPLEMENT C3A	Interval: Once	Occurrences: --	Comments:	To be performed at LabCorp
		  	C4 COMPLEMENT COMPONENT	Interval: Once	Occurrences: --		  	COMPLEMENT C4A	Interval: Once	Occurrences: --	Comments:	To be performed at LabCorp
		  	ANTIBODY TITER	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	CK-MB	Interval: Once	Occurrences: --	Comments:	To be performed at Quest
		  	GGT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TROPONIN T	Interval: Once	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	PHYSICAL EXAM - TO BE PERFROMED BY PI
				Day 4	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	ONC NURSING COMMUNICATION 12	Interval: Once	Occurrences: --	Comments:	Please issue paper order on the following lab orders:
1. SC5b-9 
2. MCP-1
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	C3 COMPLEMENT COMPONENT	Interval: Once	Occurrences: --		  	COMPLEMENT C3A	Interval: Once	Occurrences: --	Comments:	To be performed at LabCorp
		  	C4 COMPLEMENT COMPONENT	Interval: Once	Occurrences: --		  	COMPLEMENT C4A	Interval: Once	Occurrences: --	Comments:	To be performed at LabCorp
		  	ANTIBODY TITER	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	CK-MB	Interval: Once	Occurrences: --	Comments:	To be performed at Quest
		  	GGT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TROPONIN T	Interval: Once	Occurrences: --		  	INTERLEUKIN 1 BETA	Interval: Once	Occurrences: --	Comments:	To be performed at Quest
		  	INTERLEUKIN 6	Interval: Once	Occurrences: --		  	INTERFERON GAMMA	Interval: Once	Occurrences: --		  	TUMOR NECROSIS FACTOR - ALPHA	Interval: Once	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	PHYSICAL EXAM - TO BE PERFROMED BY PI