Download Budget Request Application

CLINICAL RESEARCH SERVICES
BUDGET ESTIMATE REQUEST FORM
Revised May 2, 2017
Email completed form to [email protected]
INVESTIGATIVE TEAM PERSONNEL
Protocol Title:
Principal Investigator (Financially Responsible PI):
Title (Professor, Associate Professor, etc.):
Department :
Financial Contact Name :
Other Study Personnel Name(s) :
Email:
Phone:
Financial Contact Email :
Other Study Personnel Email(s) :
FUNDING INFORMATION
Funded
Grant Proposal
Anticipated Start Date:
Anticipated End Date:
FUNDING SOURCE
Please check the appropriate box and specify the agency/sponsor name
Federal (NIH, NSF, DOD, etc.) :
Non-profit Organization :
Industry (Investigator-initiated) :
SFVAMC :
University (non-UCSF) :
Cooperative Group :
Industry (Sponsor-initiated) :
Investigator-initiated (non-sponsored) :
NCIRE :
External Entity :
STUDY TYPE (CHECK ALL THAT APPLY)
Clinical Trial
Translational Science
Behavioral Science
Basic Science
SITES REQUESTED
Please indicate your preferred site(s) for this work; use numbers to prioritize your preference (if applicable):
Adult Outpatient Units
Parnassus Outpatient (Monday-Friday, 08:00-18:00;
Visits >8hrs Tu & Th only; Closed campus holidays)
SFGH Outpatient
(Monday-Friday, 07:00-15:00)
San Francisco Veterans Affairs Medical Center
(Monday-Friday, 08:00-17:00)
Mt. Zion – Sample processing only
(Monday-Friday, 08:00-17:00)
Adult Inpatient Units
Moffitt Hospital
Inpatient
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SFGH Inpatient
Pediatric Outpatient Units
Benioff Children’s Hospital Mission Bay –
Pediatrics (Monday-Friday, 08:00-18:30)
Benioff Children’s Hospital Mission Bay - NCRC/
Critical Care Unit
Pediatric Inpatient Units
Benioff Children’s Hospital Mission Bay –
Inpatient Pediatrics
Phlebotomy Only
Mission Bay Clinical Lab
(Monday-Friday, 07:00-17:30)
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PROJECTED PARTICIPANTS & SPACE UTILIZATION
PARTICIPANT AGE RANGE (CHECK ALL THAT APPLY)
Prenatal
> 10 - 17 years
Birth - 1 month
> 18 - 64 years
> 1 month - 2 years
> 64 years
> 2 - 10 years
Specify Major Eligibility Criteria:
Study Arm
# Participants
# Inpatient Days
# Outpatient Visits
# Mobile Visits
(e.g. Screening, Arm A, etc.)
SPECIALITY ROOMS REQUIRED FOR STUDY
Smoking isolation (SFGH only)
# hrs:
Private consult / Interview
# hrs:
Negative pressure isolation
# hrs:
Monitored sleep room (SFGH and Moffitt Adult only)
# hrs:
Lead-lined room (UCSF Benioff Children’s Hospital) # hrs:
Applicant Comments:
EQUIPMENT REQUIRED FOR STUDY
Indicate CRS equipment needed for the study (e.g. infusion pumps, hand-warming box, glucose analyzers, cardiac
monitor, blood pressure machines, SP02 monitors):
List study-team provided equipment that will be used for this study:
REQUESTED CRS RESOURCES
NCRC COORDINATOR
COORDINATOR SERVICES
☐Screening
☐Procedure scheduling
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☐Family follow-up
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BODY COMPOSITION, EXERCISE PHYSIOLOGY, AND ENERGY METABOLISM
In addition to testing services, the core offers consultation in protocol development and data interpretation, training, and
assistance with referrals for other types of testing available at UCSF (e.g. heavy water analysis).
Core Director and Contact – John Shepherd, PhD, 415-476-8814, [email protected]
Select all that apply:
# Tests/
Participant
DEXA
Exercise, Functional Testing
DXA 1 scan per visit
Location of Scan
DXA 2 scans per visit
Location of Scans
DXA 3 scans per visit
Location of Scans
DXA >3 scans per visit
Location of Scans
DXA Infant 1 scan per visit
Location of Scan
DXA Infant 2 scans per visit
Location of Scans
Treadmill w/ ECG (no VO2)
DXA Infant >3 scans per visit
Location of Scans
Biodex: number of positions?
Other Body Composition Tests
Treadmill w/ VO2 (no ECG)
Treadmill w/ ECG and VO2
Cycle ergometer test w/ ECG (no VO2)
Cycle ergometer test w/ VO2 (no ECG)
Cycle ergometer test w/ ECG and VO2
6-minute walk test
Bioimpedance (single or
multifrequency) including
calibration, data analysis & report
4M gait speed
Anthropometry: waist/hip
circumference only
Stair climb (routine)
Anthropometry: full set of skinfolds
and circumferences
Grip strength
Anthropometry: Fit 3D scan
Short Physical Performance Battery
(SPPB)
BodPod (air displacement
plethysmography)
Spirometry (routine)
Other (specify)
Spirometry (complex)
Other Metabolic Measurements
# Tests/
Participant
Other (specify)
Resting energy expenditure(indirect
calorimetry)
Use of lab space/equipment (by
special arrangement)
Applicant Comments:
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3
OUTPATIENT NURSING
If your study is complex in nature, contact the nurse manager at the site where you plan to conduct the majority of your
research prior to submitting this application.
Parnassus
Mission Bay Benioff Children’s Hospital
SFGH
VAMC
Lourdes Moldre, RN, MSN, 415-218-4927, [email protected]
Michele Downing, RN, 415-502-2683, [email protected]
Bernadette Tobin, RN, 415-206-8239, [email protected]
Wesley Falatoonzadeh, RN, [email protected]
On your Schedule of Events, please highlight/indicate which services you are requesting from the CRS
Requesting CRS mobile nurse services. (If requesting mobile services, please contact the appropriate Nurse Manager to
ensure the CRS can accommodate your needs)
COMMON PROCEDURES
*Note: Parnassus OP visits lasting >8hrs only on Tues/Thurs
Vitals Signs: Single position
Vital Signs : Multiple positions
Height / Weight / BSA
POCT: HCG, Blood Glucose, HbA1C (PCRC), Hgb (SFGH)
Direct Venipuncture ≤ 4 tubes (single lab)
Direct Venipuncture ≥ 5 tubes and/or multiple lab sendouts
Medication Administration: PO, SQ, IM, ID
Medication Administration: IV and/or High-risk meds
Have you coordinated with Pharmacy to ensure
Have you coordinated with Pharmacy to ensure drug is
drug is available in a timely manner?
available in a timely manner?
ECG (12 lead):per time point, no interpretation,
Specimen Collection
# of time points =
PK Serial Blood Testing*: # of time points =
Facility Use:
Duration (min) =
List time points :
METABOLIC TESTING
Oral Glucose Tolerance (2 hr Test)
IVGTT
Oral Glucose Tolerance (3 hr Test)
Frequent Sample IV Glucose Tolerance Test
Glomerular Filtration Rate (3hr Test)
Mixed Meal Tolerance (2 hr Test)
Hyperinsulinemic-Euglycemic Clamp
PROCEDURAL ASSISTANCE
Moderate Sedation Administration by RN*
Bone Biopsy Assistance
Glomerular Filtration Rate (4hr Test)
Mixed Meal Tolerance (4 hr Test)
Steady State Plasma Glucose
*NOT available in Parnassus OP clinic
Liver Biopsy Assistance*
Lumbar Puncture Assistance
Bronchoscopy Assistance*
Fat Biopsy Assistance
PATIENT MONITORING
Patient Monitoring Post Treatment (standard)
Muscle Biopsy Assistance
Node Biopsy Assistance
Cardiac Monitoring & Lead Placement
Patient Monitoring Post Treatment: Pediatric, High Risk
or procedural assistance beyond standard
Holter Monitor
Central Line Access
Hydration Pre and Post infusion
IV Access (Pediatric or Dialysis)/Mediport
PICC Line Access
PPD Placement and Reading
Pre Medications for Infusions
IV Access (Standard)
Large Volume Blood Collection up to 500cc
Patient Teaching
Questionnaires (administered by CRS staff)
Skin Testing
Strict I / O
OTHER
Applicant Comments:
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4
INPATIENT NURSING
If your study is complex in nature, contact the nurse manager at the site where you plan to conduct the majority of your
research prior to submitting this application.
Parnassus
Mission Bay Benioff Children’s Hospital
SFGH
VAMC
Lourdes Moldre, RN, MSN, 415-218-4927, [email protected]
Michele Downing, RN, 415-502-2683, [email protected]
Bernadette Tobin, RN, 415-206-8239, [email protected]
Wesley Falatoonzadeh, RN, [email protected]
On your Schedule of Events, please highlight/indicate which services you are requesting from the CRS
Requesting CRS mobile nurse services. (If requesting mobile services, please contact the appropriate Nurse Manager to
ensure the CRS can accommodate your needs)
COMMON PROCEDURES
*Note: Parnassus OP visits lasting >8hrs only on Tues/Thurs
Vitals Signs: Single position
Vital Signs : Multiple positions
Height / Weight / BSA
POCT: HCG, Blood Glucose, HbA1C (PCRC), Hgb (SFGH)
Direct Venipuncture ≤ 4 tubes (single lab)
Direct Venipuncture ≥ 5 tubes and/or multiple lab sendouts
Medication Administration: PO, SQ, IM, ID
Medication Administration: IV and/or High-risk meds
Have you coordinated with Pharmacy to ensure
Have you coordinated with Pharmacy to ensure drug is
drug is available in a timely manner?
available in a timely manner?
ECG (12 lead):per time point, no interpretation,
Specimen Collection
# of time points =
PK Serial Blood Testing*: # of time points =
Facility Use:
Duration (min) =
List time points :
METABOLIC TESTING
Oral Glucose Tolerance (2 hr Test)
Oral Glucose Tolerance (3 hr Test)
IVGTT
Glomerular Filtration Rate (3hr Test)
Mixed Meal Tolerance (2 hr Test)
Hyperinsulinemic-Euglycemic Clamp
PROCEDURAL ASSISTANCE
Moderate Sedation Administration by RN*
Frequent Sample IV Glucose Tolerance Test
Glomerular Filtration Rate (4hr Test)
Mixed Meal Tolerance (4 hr Test)
Steady State Plasma Glucose
*NOT available in Parnassus OP clinic
Liver Biopsy Assistance*
Bone Biopsy Assistance
Bronchoscopy Assistance*
Fat Biopsy Assistance
PATIENT MONITORING
Patient Monitoring Post Treatment (standard)
Lumbar Puncture Assistance
Muscle Biopsy Assistance
Node Biopsy Assistance
Cardiac Monitoring & Lead Placement
Patient Monitoring Post Treatment: Pediatric, High Risk
or procedural assistance beyond standard
Holter Monitor
Central Line Access
Hydration Pre and Post infusion
PICC Line Access
PPD Placement and Reading
IV Access (Pediatric or Dialysis)/Mediport
IV Access (Standard)
Large Volume Blood Collection up to 500cc
Patient Teaching
Pre Medications for Infusions
Questionnaires (administered by CRS staff)
Skin Testing
Strict I / O
OTHER
Applicant Comments:
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5
MOBILE NURSING
If your study is complex in nature, contact the nurse manager at the site where you plan to conduct the majority of your
research prior to submitting this application.
Parnassus
Mission Bay Benioff Children’s Hospital
SFGH
VAMC
Lourdes Moldre, RN, MSN, 415-218-4927, [email protected]
Michele Downing, RN, 415-502-2683, [email protected]
Bernadette Tobin, RN, 415-206-8239, [email protected]
Wesley Falatoonzadeh, RN, [email protected]
On your Schedule of Events, please highlight/indicate which services you are requesting from the CRS
Requesting CRS mobile nurse services. (If requesting mobile services, please contact the appropriate Nurse Manager to
ensure the CRS can accommodate your needs)
COMMON PROCEDURES
*Note: Parnassus OP visits lasting >8hrs only on Tues/Thurs
Vitals Signs: Single position
Vital Signs : Multiple positions
Height / Weight / BSA
POCT: HCG, Blood Glucose, HbA1C (PCRC), Hgb (SFGH)
Direct Venipuncture ≤ 4 tubes (single lab)
Medication Administration: PO, SQ, IM, ID
Have you coordinated with Pharmacy to ensure
drug is available in a timely manner?
ECG (12 lead):per timepoint, no interpretation,
# of timepoints =
PK Serial Blood Testing*: # of timepoints =
List timepoints :
METABOLIC TESTING
Hyperinsulinemic-Euglycemic Clamp
PROCEDURAL ASSISTANCE
Moderate Sedation Administration by RN*
Bone Biopsy Assistance
Bronchoscopy Assistance*
PATIENT MONITORING
Patient Monitoring Post Treatment (standard)
Direct Venipuncture ≥ 5 tubes and/or multiple lab sendouts
Medication Administration: IV and/or High-risk meds
Have you coordinated with Pharmacy to ensure drug is
available in a timely manner?
Specimen Collection
Steady State Plasma Glucose
*NOT available in Parnassus OP clinic
Muscle Biopsy Assistance
Node Biopsy Assistance
Cardiac Monitoring & Lead Placement
Patient Monitoring Post Treatment: Pediatric, High Risk
or Biopsy – over 4 hours
Holter Monitor
Central Line Access
Hydration Pre and Post infusion
IV Access (Pediatric or Dialysis)/Mediport
IV Access (Standard)
PICC Line Access
PPD Placement and Reading
Pre Medications for Infusions
Strict I / O
OTHER
Applicant Comments:
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6
SAMPLE PROCESSING SERVICES
If your study is complex in nature, contact the sample processing manager at the site where you plan to conduct
the majority of your research prior to submitting this application.
Lab Operating Hours: Monday-Friday, 08:00-17:00; closed on campus holidays
Sample Processing Director and Contact:
Nick Larocque, MS, 415-218-3698, [email protected]
Veterans Affairs Medical Center Contact:
Wesley Falatoonzadeh, RN, [email protected]
Select all that apply:
Sample Processing
# tubes per
participant
Sample Storage
Temperature
Serum, Plasma, or Whole Blood processing and aliquoting (1-10
aliquots)
+4°C Storage
Yes
No
Whole Blood without processing (DNA Bank, etc.)
-20°C Storage
Yes
No
Urine processing and aliquoting (1-10 aliquots)
-80°C Storage
Yes
No
Saliva processing and aliquoting (1-10 aliquots)
Liquid Nitrogen
storage
Yes
No
Sample Storage
CSF processing and aliquoting (1-10 aliquots)
Non-Routine processing - fluid with 11 or more aliquots, special
additives, or extra centrifugation step
1 Month Storage
PBMC isolation (up to 40mL)
2 Month Storage
Amniotic Fluid
3 Month Storage
Stool
4 Month Storage
Buccal
7 Month Storage
Biopsy
8 Month Storage
Data Management, please provide details:
9 Month Storage
Estimated # of
vials (aliquots)
10 Month Storage
Other processing, please provide details:
11 Month Storage
Packaging and Shipping (all shipping costs paid by the
investigator)
# of Shipments
12 Month Storage
(Max)
Shipment: ambient, cold packs or dry ice
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7
SPECIAL BUDGETARY REQUESTS
Enter special requests here:
DOCUMENTS CHECKLIST
Please provide the following documents when applicable:




Protocol / Proposal
Schedule of Events
Coverage Analysis Determinations* (for nursing service requests at UCSF Medical Centers)
Lab Manual (for sample processing requests)
*Note that a budget estimate cannot be finalized without a record of the coverage analysis determinations
Email completed form to [email protected]
5/2/17 11:54 PM
8
Appendix 1: CRS Most Common nursing service procedures
Procedure
Unit
Description
Direct Venipuncture ≤ 4
tubes (single lab send-out)
Procedure
• Draw through single access, peripheral /central line or PICC up to 4 tubes of blood and
send out to a single lab for assay or processing
Direct Venipuncture ≥ 5
tubes and/or multiple lab
send-outs
ECG (12 lead): per time
point, no interpretation
Procedure
• Draw through single access, peripheral /central line or PICC5 or more tubes of blood
Time-point
Medication
Administration: PO, SQ,
IM, ID
Procedure
• Obtain supplies, complete requisition, explain procedure to patient
• Apply leads, perform 12 lead EKG
• Make appropriate copies and complete documentation
• Review, prepare and administer oral, subcutaneous, intramuscular, or intradermal
meds
• May include up to four medications for one patient in a single protocol up through a
24-hour period
• Includes only routine medications provided by UC pharmacy without high risk checks
 One predose/baseline blood draw
• 30 mins of patient monitoring after the end of medication administration
Medication
Administration: IV and/or
High-risk meds
Procedure
Patient Monitoring Post
Treatment (standard)
Hour
PK / Serial Blood Testing
(per time-point)
Time-point
Specimen Collection
Procedure
Vitals Signs / Height /
Weight
Procedure
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• Prep for administration (VS, Height/Weight, peripheral /central line or PICC access)
• Administer medications per MD orders
• May include > 8 separate medications (including IV/PO/SQ/IM/ID/Inhale meds, premeds, hydration, and flush)
• One baseline blood draw
• One hour of patient monitoring after the end of medication administration
• All VS and pain management throughout administration & 1hr monitoring period
• Emergency Meds
• Assess patient (VS, pain management) & monitor for side effects for one hour
• Complete necessary documentation on forms (including Toxicity Assessment)
• Prep for medication administration (peripheral/central line or PICC access)
• Draw specimens on time-points per MD orders
• One hour of patient monitoring following the time-point
• All VS and pain management throughout 1hr monitoring period
• Obtain a specimen: urine, stool, blood (finger stick), sputum, breath
• Does not include blood samples drawn by direct venipuncture or specimens collected
during pharmacokinetic study initiation
• VS in one position only, taken at a designated time
• Obtain measured height and weight
• Could include BSA calculations for drug administration
9
Appendix 2: AIC Most Common nursing service procedures
Procedure
Unit
Description
Patient Monitoring Post
Treatment (standard)
Hour
• Assess patient (VS, pain management) & monitor for side effects for one hour
• Complete necessary documentation on forms (including Toxicity Assessment)
PK / Serial Blood Testing
(per time-point)
Time-point
Direct Venipuncture ≤ 4
tubes (single lab send-out)
Procedure
• Prep for medication administration (peripheral/central line or PICC access)
• Draw specimens on time-points per MD orders
• One hour of patient monitoring following the time-point
• All VS and pain management throughout 1hr monitoring period
• Draw through single access, peripheral /central line or PICC up to 4 tubes of blood and
send out to a single lab for assay or processing
Direct Venipuncture ≥ 5
tubes and/or multiple lab
send-outs
Specimen Collection
Procedure
• Draw through single access, peripheral /central line or PICC up to 5 or more tubes of
blood
Procedure
• Obtain a specimen: urine, stool, blood (finger stick), sputum, breath
• Does not include blood samples drawn by direct venipuncture or specimens collected
during pharmacokinetic study initiation
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Appendix 3: Full Procedure List
Single Procedure
Procedure
Cardiac Monitoring & Lead
Placement
Unit
Procedure
Description
• Prep skin, apply cardiac leads, instruct patient regarding procedure
• Cardiac monitoring of patient during exercise testing and training procedures
• Setup of emergency equipment and medications for intervention if required
Central Line/PICC Line
Access
*(SOC in AIC)
Procedure
Direct Venipuncture ≤ 4
tubes (single lab send-out)
Procedure
• Access a central line including ports, peripherally inserted central catheters, and
central line catheters
• Assemble all supplies for dressing care and access (sterile)
• Prepare catheter flush, prepare patient, access site, connect tubing
• Infusion and/or draw all baseline lab specimens
• Flush (Saline) line at end of procedure and complete catheter/site care
• Draw through single access, peripheral /central line or PICC up to 4 tubes of blood and
send out to a single lab for assay or processing
Direct Venipuncture ≥ 5
tubes and/or multiple lab
send-outs
ECG (12 lead): per time
point, no interpretation
Procedure
• Draw through single access, peripheral /central line or PICC5 or more tubes of blood
AND/OR send out to two or more labs for assay or processing
Time-point
Facility Use (15min
increments)
15 mins
• Obtain supplies, complete requisition, explain procedure to patient
• Apply leads, perform 12 lead EKG
• Make appropriate copies and complete documentation
• Closed room to ensure privacy for consenting /screening
• No RN or phlebotomy services provided
Holter Monitor
Procedure
•
•
•
•
IV Access (Pediatric or
Dialysis)/Mediport
Procedure
• Assemble supplies
• Instruct pediatric/dialysis patient
• Start and secure IV line
IV Access (standard)
*(SOC in AIC)
Procedure
• Assemble supplies
• Instruct patient
• Start and secure IV line
Patient Teaching
Procedure
Instruct and reinforce instructions for a patient in a single protocol
PPD Placement and
Reading
Procedure
•
•
•
•
•
POCT (HCG, Blood Glucose,
Hemoglobin (Hgb),
HgbA1C, Pulmonary
Functioning Test)
Procedure
• Explain procedure to research participant
• Assure quality control testing is completed on testing materials prior to using
• Perform point of care testing for urine pregnancy, glucose levels, drugs of abuse,
Hemoglobin (Hgb), HbA1C, or Pulmonary Functioning Test.
• Document results and notify responsible MD if any out of range or positive results
obtained
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Order equipment from EKG Department
Schedule application times for entire protocol period
Change electrodes and complete skin care on patient at 48- hour intervals
Ensure patient completion of daily diary and complete nursing documentation
Scan MD order to pharmacy and obtain supplies
Explain procedure to research participant
Perform injection and document administration
Make appointment for patient to return for reading within 48 to 72 hours
Result of PPD read and documented in medical record
11
Questionnaires /
Assessments
(by CRS staff)
questionnaire
/ assessment
Administer one structured interview, written questionnaire, or other study assessment
(up to 15 minutes in duration) at one designated time point.
Strict I / O
Procedure
• All oral intake must be measured and/or counted and recorded
• All output must be measured and/or counted and recorded
Vital Signs : Multiple
positions
Specimen Collection
Procedure
• VS taken in multiple positions at designated times
Procedure
• Obtain a specimen: urine, stool, blood (fingerstick), sputum, breath
• Does not include blood samples drawn by direct venipuncture or specimens collected
during pharmacokinetic study initiation
Vitals Signs / Height /
Weight/Waist
Measurements
Procedure
• VS in one position only, taken at a designated time
• Obtain measured height , weight , and/or waist
• Could include BSA calculations for drug administration
Testing Service
Procedure
Frequent Sample IV
Glucose Tolerance Test
Unit
Test
Description
• Preparation (set up supplies, verify MD orders and consent)
• Obtain vital signs and weight
• Insert IV
• Draw baseline bloods
• Monitor multiple infusions
• Blood draw time points (2,3,4,5,6,8,10,12,14,1nd 19 min then
22,25,30,40,50,70,100,140,and 180 min)
• Monitor for AE’s
Glomerular Filtration Rate
(3hr Test)
Test
• Obtain supplies, including Omnipaque 350 & emergency meds (epinephrine, Benadryl,
and atropine)
• Set up tubes with labeled time point blood draws
• Verify no consumption of drugs that effect kidney function
• Inform participant of expected procedures during test period
• Insert peripheral IV and administer omnipaque
• Draw blood specimens to and send to lab
Glomerular Filtration Rate
(4hr Test)
Test
•
Obtain supplies, including Omnipaque 350 & emergency meds (epinephrine,
Benadryl, and atropine)
• Set up tubes with labeled time point blood draws
• Vital Signs
• Verify no consumption of drugs that effect kidney function
• Inform participant of expected procedures during test period
• Insert peripheral IV and administer omnipaque
• Draw blood specimens to and send to lab
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12
IVGTT
Test
• Obtain supplies, fax MD orders to obtain medications
• Set up equipment for two peripheral IV lines
• Label all tubes, complete all lab requisitions and document all required information on
flow sheets and in UCare (if inpatient)
• Establish base level of glucose (determined by finger stick or venous sample to meet
required blood level start of 80-120mg/dl)
• May include setting up an insulin drip to meet this baseline glucose level range
• Start test by drawing -10 minute sample of glucose, insulin and C-peptide blood levels
• Administer IV glucose and insulin at specified time points
• Draw blood at specified time points
• Discontinue IV lines at end of test
• Continue to monitor blood sugar until returns less 250mg/dl
• Provide patient with meal
• Provide adjusted normal insulin dose per MD orders
Mixed Meal Tolerance
(2 hr Test)
Test
Mixed Meal Tolerance
(4 hr Test)
Test
Oral Glucose Tolerance
Test (2 hrs.)
Test
• Obtain supplies, including Boost
• Set up labeled tubes for blood draw procedures at specified time points
• Complete baseline patient assessment and teaching to include confirmation patient
has followed pre-admission instructions on insulin and NPO except for water
• Place peripheral IV line and obtain baseline glucose level to meet range of 80120mg/dl for start of procedure
• Run IV one half normal saline during procedure, calculate dose of Boost for oral
administration
• Draw blood samples at specified time points
• Administer Boost after -5 minute blood draw to be consumed within 5 minute time
frame
• Following MMTT, check finger stick glucose, if <250mg/dl patient may eat with
adjusted insulin dose per MD order (if not, contact MD for Insulin after Metabolic testing
orders)
• Discharge once blood sugar returns to <200mg/dl
• Obtain supplies, including Boost
• Set up labeled tubes for blood draw procedures at specified time points
• Complete baseline patient assessment and teaching to include confirmation patient
has followed pre-admission instructions on insulin and NPO except for water
• Place peripheral IV line and obtain baseline glucose level to meet range of 80120mg/dl for start of procedure
• Run IV one half normal saline during procedure, calculate dose of Boost for oral
administration
• Draw blood samples at specified time points
• Administer Boost after -5 minute blood draw to be consumed within 5 minute time
frame
• Following MMTT, check finger stick glucose, if <250mg/dl patient may eat with
adjusted insulin dose per MD order (if not, contact MD for Insulin after Metabolic testing
orders)
• Discharge once blood sugar returns to <200mg/dl
• Obtain supplies including oral glucose solution
• Teach procedure components to participant and confirm NPO since midnight except
for water and medications
• Place one peripheral line for sequential IV draws or to draw each specimen
peripherally at specified time points
• Oral administration of glucose solution
• Discontinue IV if applicable and provide meal upon completion of OGTT
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13
Oral Glucose Tolerance
Test (3 hrs)
Test
Skin Testing or
PST Testing (Peds)
Procedure
• Obtain supplies including oral glucose solution
• Teach procedure components to participant and confirm NPO since midnight except
for water and medications
• Place one peripheral line for sequential IV draws or to draw each specimen
peripherally at specified time points
• Oral administration of glucose solution
• Discontinue IV if applicable and provide meal upon completion of OGTT
• Preparation (set up supplies, verify MD orders and consent)
• Apply allergens to skin
• Measure and record reactions
• Monitor for AE’s
Nursing Service Procedure
Procedure
Hydration Pre and Post
Unit
Procedure
Description
• Preparation (set up supplies, verify MD orders and consent)
• Insert IV
• NS Infusion
HyperinsulinemicEuglycemic Clamp
procedure
bundle
• Preparation (set up supplies, verify MD orders and consent)
• Obtain vital signs and weight
• Monitor Multiple Infusions
• Insert retrograde IV
• Provide hand warming box
• Insert second IV
• Draw baseline bloods and then bloods every 5 min
• Glucose analyzer
• Requires 1:1 nursing
Large Volume Blood
Collection up to 500cc
procedure
• Preparation (set up supplies, verify MD orders and consent)
• Check vital signs pre and post collection
• Monitor for AE’s
• Record blood volume and flow rate
• Provide post donation instructions to the patient
*(SOC in AIC)
Medication
Administration: PO, SQ,
IM, ID
Procedure
• Review, prepare and administer oral, subcutaneous, intramuscular, or intradermal
meds
• May include up to four medications for one patient in a single protocol up through a
24-hour period
• Includes only routine medications provided by UC pharmacy without high risk checks
 One predose/baseline blood draw
• 30 mins of patient monitoring after the end of medication administration
Medication
Administration: IV and/or
High-risk meds
Procedure
• Prep for administration (VS, Height/Weight, peripheral /central line or PICC access)
• Administer medications per MD orders
• May include > 8 separate medications (including IV/PO/SQ/IM/ID/Inhale meds, premeds, hydration, and flush)
• One baseline blood draw
• One hour of patient monitoring after the end of medication administration
• All VS and pain management throughout administration & 1hr monitoring period
• Emergency Meds
5/2/17 11:54 PM
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Moderate Sedation
Administration by RN
Procedure
• Provide 1:1 nursing for monitoring and documentation of respiratory rate,
oxygenation status and hemodynamic status before, during and post drug
administration
• Continuous pulse oximetry, cardiac monitoring, blood pressure, pulse, respiratory rate
• Continuous assessment of level of sedation and/or responsiveness to verbal and
tactile stimuli by titrating drug to the patient’s response using small incremental doses of
drugs
• Estimated time of drug administration is 15-30 minutes
• Total procedure time 60 to 120 minutes
• Patient must return to baseline aldrete score and all documentation of monitoring
parameters, documentation of meds administered and patient assessment scores must
be completed
PK / Serial Blood Testing
(per time-point)
Time-point
Patient Monitoring Post
Treatment (standard)
Hour
Patient Monitoring Post
Treatment -Pediatric, High
Risk, or Biopsy-over 4hrs
Hour
• Prep for medication administration (peripheral/central line or PICC access)
• Draw specimens on time-points per MD orders
• One hour of patient monitoring following the time-point
• All VS and pain management throughout 1hr monitoring period
• Assess patient (All timed VS, pain management) & monitor for side effects for one
hour
• Complete necessary documentation on forms (including Toxicity Assessment)
• Assess patient & monitor for side effects or reaction to medications
• Complete necessary documentation on forms (including Toxicity Assessment)
• All timed VS and management throughout 1hr monitoring period
• Subjects with high acuity due to medications or procedure requiring acute monitoring
Pre Medications for
Infusions
*(SOC in AIC)
Procedure
• Preparation (set up supplies, verify MD orders and consent)
• Insert IV
• Administer IV Infusion or IV push medication
Steady State Plasma
Glucose
procedure
bundle
• Preparation (set up supplies, verify MD orders and consent)
• Blood glucose analyzer
• Monitor Multiple IV Infusions
• Obtain vital signs weight
• Insert two IV’s
• Draw blood every 30 min
• Monitor for AE’s
Nursing Assistance Service
Procedure
Bone Biopsy Assistance
Unit
Procedure
Bronchoscopy Assistance
Procedure
5/2/17 11:54 PM
Description
• Order and set up equipment
• Administer medications
• Assist physicians with procedures
• Complete unit based procedure forms and transport specimens
• Includes patient preparation, teaching, and monitoring post procedure
• Set up room with equipment
• Prepare and teach patient
• Administer medications
• Complete unit based procedure forms
• Provide continuous nursing monitoring presence during actual bronchoscopy and
post-procedural recovery
• Recording of procedural data and discharge teaching
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Fat Biopsy Assistance
Procedure
•
•
•
•
Order and set up equipment
Assist physicians with procedures
Complete unit based procedure forms and transport specimens
Includes patient preparation, teaching, and monitoring post procedure
Liver Biopsy Assistance
Procedure
Lumbar Puncture
Assistance
Procedure
• Order and set up equipment
• Administer medications
• Assist physicians with procedures
• Complete unit based procedure forms and transport specimens
• Includes patient preparation, teaching, safety lab draw for hematocrit and monitoring
post procedure
• Order and set up equipment
• Pre/Post Vital Signs
• Assist physicians with procedures
• Complete unit based procedure forms collect and transport specimens
Muscle Biopsy Assistance
Procedure
•
•
•
•
Order and set up equipment
Assist physicians with procedures
Complete unit based procedure forms and transport specimens
Includes patient preparation, teaching, and monitoring post procedure
Node Biopsy Assistance
Procedure
•
•
•
•
Order and set up equipment
Assist physicians with procedures
Complete unit based procedure forms and transport specimens
Includes patient preparation, teaching, and monitoring post procedure
Inpatient Nursing Service
Procedure
Daily Inpatient Nursing:
Low Intensity (1-6 nurse
hours per patient day)
Unit
Description
Day
• Nurse/subject ratio 1:4
• Data/specimen collection or a collection not less than every two hours with periodic
monitoring not more than every two hours
• Subject is healthy volunteer or with minor dependent needs
• Independent with ADLs or with minor cognitive, emotional, physical dependent needs
requiring teaching or discharge planning support
• Periodic monitoring not more than every two hours
Daily Inpatient Nursing:
Moderate Intensity (6-10
nurse hours per patient
day)
Day
• Nurse/subject ratio 1:3
• Data specimen collection and documentation every 1-2 hours
• Subject moderately dependent; may require minor assistance with ADLs, emotional
support, extensive teaching or discharge planning
• Pediatric patients
Daily Inpatient Nursing:
High Intensity (>10 nurse
hours per patient day)
Day
•
•
•
•
5/2/17 11:54 PM
Nurse/subject ratio 1:1 or 1:2
Data/specimen collection & documentation at 1 minute to 1 hour intervals
Subject maybe totally dependent
Intensive nursing assistance required
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