Biomedical Sciences Institutional Review Board

1

Baselice, Holly

From: OR IRB Info <[email protected]>Sent: Friday, March 5, 2021 7:54 AMTo: Santry, Heena P.Cc: Baselice, HollySubject: Initial Submission Approved for #2021H0077

Biomedical Sciences Institutional Review Board

300 Research Administration building 1960 Kenny Road

Columbus, OH 43210-1063

orrp.osu.edu

03/05/2021

Study Number: 2021H0077 Study Title: Social Determinants of Acute Abdomen Outcomes

Type of Review: Initial Submission

Review Method: Expedited

Date of IRB Approval: 03/05/2021 Date of IRB Approval Expiration: 03/05/2022

Expedited category: #5

Dear Heena Santry,

The Ohio State Biomedical Sciences IRB APPROVED the above referenced research.

In addition, the following were also approved for this study:

Waiver of Consent Process Full Waiver of HIPAA Research Authorization

Administrative Note:

As the university moves to a staged approach to restarting research activities, refer to Human Subjects Guidance and FAQs. If after reviewing this information and working through your college you have additional questions, please direct emails to [email protected].

As Principal Investigator, you are responsible for ensuring that all individuals assisting in the conduct of the study are informed of their obligations for following the IRB-approved protocol and applicable regulations, laws, and policies, including the obligation to report any problems or potential noncompliance with the requirements or determinations of the IRB. Changes to the research (e.g., recruitment procedures, advertisements, enrollment numbers, etc.) or informed consent process must be approved by the IRB before implemented, except where necessary to eliminate apparent immediate hazards to subjects.

This approval is issued under The Ohio State University's OHRP Federalwide Assurance #00006378 and is valid until the expiration date listed above. Without further review, IRB approval will no longer be in effect on the expiration date. To continue the study, a continuing review application must be approved before the expiration date to avoid a lapse in IRB approval and the need to stop all research activities. A final study report must be provided to the IRB once all research activities involving human subjects have ended.

Records relating to the research (including signed consent forms) must be retained and available for audit for at least 5 years after the study is closed. For more information, see university policies, Institutional Data and Research Data.

2

Human research protection program policies, procedures, and guidance can be found on the ORRP website.

Karla Zadnik, OD, PhD, Chair Ohio State Biomedical Sciences IRB

02/03/2021 8:48pm projectredcap.org

ConfidentialP1631 - Social Determinants of Acute Abdomen Outcomes

Page 1

Institution Information

Database ID__________________________________

Study ID__________________________________(Ex. XX-XXX)

Type of Institution DomesticInternational

Site Ohio State

HOSPITAL LEVELOwnership Non-Governmental

GovernmentalInvestor-owned

ACS Trauma Certified Center YesNo

Medical School Affiliation YesNo

Teaching Status MajorMinorNon-teaching

Location UrbanRural

Bed size < 100100-199200-299300-399400-499> 500

https://projectredcap.org



Page 1

Basic ID

Database ID__________________________________

Was this patient a re-admission from a prior admit for NoEGS? Yes

DO NOT create a new record for a readmission from a prior admit for EGS; add the readmission using the "90-dayReadmission(s)" page.

Was this patient admitted during the COVID-19 Yespandemic? No

Year of Admission 2017201820192020

DEMOGRAPHICSAge at time of admission:

__________________________________

Gender MaleFemaleOtherUnknown

If 'Other' please explain:__________________________________

Race WhiteBlack/ African AmericanAsianNative American/Alaskan NativeNative Hawaiian/Other Pacific IslanderBi/MultiracialOtherMissing/Unknown


Hispanic Ethnicity YesNo

Zip__________________________________(5-digit (+4) if available)

County__________________________________

State Abbreviation__________________________________



ConfidentialPage 2

Level of Education Less than high school degreeHigh School degree or equivalent (e.g., GED)Some College but no degreeAssociates degreeBachelor degreeGraduate degreeUnknownOther

Does this patient have a primary care provider (PCP)? YesNo

When was the last time this patient had an annual Less than a yearcheck-up with their PCP? 1-2 years

2-3 years3-5 years5-7 years7-10 yearsMore than 10 years

AREA DEPRIVATION INDEX: use the link below, select your state, and enter the patient'saddress in the search box.https://www.neighborhoodatlas.medicine.wisc.edu/mappingADI State Decile (1-10)

__________________________________

ADI National Percentile (1-100)__________________________________

ADMISSION DATAHow Surgery Was Made Aware of Patient Emergency department consult/admission

Direct admit ("transfer") from acute carehospital, rehab, SNF, or LTACDirect admit from homeInpatient consult (overrides ED consult)OtherUnknown

(If patient was admitted to a different servicefrom the ED and surgery was later consulted, thisis considered an inpatient consult and not an EDadmission.)


Was the patient admitted through the Emergency YesDepartment (to any service)? No

(If patient was admitted to a different servicefrom the ED and surgery was later consulted, theanswer to this should be "yes" (in contrast toprevious question).)

How did the patient come through the ED? HomeTransfer from acute care hospital, rehab, SNF, orLTACOther



ConfidentialPage 3

Was the patient admitted as a transfer from another Yesfacility (to any service)? No

Was one of the patient's primary diagnoses sepsis or Noseptic shock? Sepsis

Septic shock

Admission Diagnosis Text__________________________________(DO NOT include sepsis/septic shock)

Admission Diagnosis ICD-10 Code__________________________________(DO NOT include sepsis/septic shock; OMIT PERIODS)

Was the primary diagnosis non-EGS? YesNo

Primary EGS Diagnosis Text__________________________________

Primary EGS Diagnosis ICD-10 Code__________________________________(OMIT PERIODS)

Did the patient have any complications? NoYesUnknown

Which kind? SystemicOperative/Surgical

Were there any unplanned abdominal reoperation(s) Yesduring the index hospitalization? No

CARE TIMELINELength of stay (days)

__________________________________(NOTE: DATE OF ADMISSION IS DAY 0)

Did the patient die while inpatient? YesNo

Was the patient admitted to hospice at time of death? YesNo

Where did patient go upon discharge? HomeHome with ServicesRehabSNFLTACHospiceTransferred to another acute care hospitalOtherUnknown



ConfidentialPage 4


MISC. DATA (NOTES)Mode of Transportation to Hospital Own Transportation

AmbulanceHelicopterLaw EnforcementPrison/Jail EscortOtherUnknown

If 'Other' please explain__________________________________

Did the patient have any pre-existing co-morbidities? NoYesUnknown

INSURANCEType of Primary Insurance No Insurance

MedicareMedicaidPrivateMilitaryOtherUnknown





Page 1

Acute Severity Measures

Database ID__________________________________

ACUTE DISEASES: findings/symptoms/acute co-occurring diagnoses at time of admission orinitial consultation to the surgery service.

These differ from chronic comorbidities in that they may be secondary to theirprimary/underlying diagnosis and show how severe their condition is at time of presentation.Acute Renal Failure Yes

No

Acute Renal Failure - Dialysis requirement DOES NOT require dialysisDOES require dialysis

Acute Renal Failure - Intermittent Dialysis YesNo

Acute Renal Failure - Continuous Hemofiltration YesNo

Only choose one dialysis requirement between none, intermittent, and continuous.

Acute Psychosis YesNo

(Delusions, hallucinations, etc.)

Altered Sensorium (CAM positive) YesNo

(Requires: (acute onset OR fluctuating course) ANDinattention AND (disorganized thinking OR alteredlevel of consciousness))

Cardiac Arrest with ROSC YesNo

(Only applicable if the patient has a documentedcode during their admission but prior to consult.)

Coma YesNo

Dyspnea/shortness of breath YesNo

Ventilated YesNo

(Note that "spontaneous ventilation" does notnecessarily mean a patient is on a ventilator.)

Active Pneumonia on Treatment YesNo



ConfidentialPage 2

Ascites YesNo

(Found in either CTAB results or laparotomy data)

Open Abdominal Wound YesNo

Stress Dose Steroids YesNo

(Ex. Cortisone, prednisolone, prednisone,methylprednisolone, dexamethasone, etc.; Consultpatient's "scheduled medications" list)

Medication Induced Coagulopathy YesNo

(Ex. Factor X inhibitors (-xabans, Eliquis,Lovenox, others), heparin, tPA, etc.)

Name of medication inducing coagulopathy__________________________________

Physiologic Coagulopathy YesNo

(Ex. DIC)

Sepsis or Septic Shock YesNo

Recent (72 hours) Blood Transfusion YesNo

(Consult "Other Orders" for "TRANSFUSE RED BLOODCELLS" within 72 hours BEFORE consult/admission)

Describe any other acute conditions that the patientpresents with if not listed elsewhere:

__________________________________________

Acute Severity Measure Count (Max: 15)__________________________________

PRESENTING VITALS (Surgical H&P or consult note)Systolic Blood Pressure (mmHg)

__________________________________

Diastolic Blood Pressure (mmHg)__________________________________

Diastolic BP should be less than systolic BP

Temperature (F)__________________________________

Heart Rate (BPM)__________________________________



ConfidentialPage 3

Respiratory Rate (breaths/min)__________________________________

Height (inches)__________________________________

Weight (lbs)__________________________________(If not with other vitals, check the top ofanesthesiology report.)

BMI__________________________________

Oxygen Saturation (%)__________________________________

Oxygen Source Room AirNasal CanulaHigh Flow NCMaskNon Re-BreatherNon-Invasive VentilationMechanical VentilationOtherUnknown/Missing


Amount of Supplemental Oxygen (L/min)__________________________________(Report amount of supplemental oxygen in L/min orFiO2 (below) and enter "999" for value notreported.)

FiO2 (%)__________________________________(Report amount of supplemental oxygen in L/min(above) or FiO2 and enter "999" for value notreported.)

PEEP__________________________________

LAB VALUES AT TIME OF ADMISSION (only use labs from within the 24 hours prior to surgery)

NOTE: If missing then enter 999 as value. If repeated, use the last value reported prior tosurgery.White Blood Cell (WBC) Count

__________________________________

Hemoglobin (Hg)__________________________________



ConfidentialPage 4

Hematocrit (HCT)__________________________________

Platelet count__________________________________

% Neutrophils__________________________________(Note that "band neutrophils" are NOT the same.)

% Lymphocytes__________________________________

% Eosinophils__________________________________

% Monocytes__________________________________

Serum Blood Urea Nitrogen (BUN)__________________________________

Serum Sodium (Na)__________________________________

Serum Potassium (K)__________________________________

Serum Chloride (Cl)__________________________________

Serum Creatinine (Cr)__________________________________

Serum Glucose__________________________________

Serum Albumin__________________________________

Serum Pre-Albumin__________________________________

Bilirubin (Direct)__________________________________

Bilirubin (Total)__________________________________

Alkaline phosphatase (Alk Phos)__________________________________

Aminotransferase, alanine (ALT)__________________________________



ConfidentialPage 5

Aminotransferase, aspartate (AST)__________________________________

pH__________________________________(From arterial blood gas (ABG) ONLY.)

PaO2__________________________________(From arterial blood gas (ABG) ONLY.)

PaCO2__________________________________(From arterial blood gas (ABG) ONLY.)

Serum Bicarbonate (HCO3)__________________________________

Base Excess__________________________________

Lactate__________________________________

Prothrombin Time (PT)__________________________________

Activated Partial Time (PTT)__________________________________

International Normalized Ratio (INR)__________________________________

Serum Calcium (Ca)__________________________________(Note that "ionized calcium" is NOT the same.)

Serum Magnesium (Mg)__________________________________

Serum Phosphate__________________________________

Serum Ethanol (EtOH)__________________________________

Serum Lipase__________________________________

Serum Amylase__________________________________

HgA1C__________________________________



ConfidentialPage 6

Troponin__________________________________

PRESENTING IMAGINGWas a chest x-ray (CXR) done? Yes

No

Was a CXR completed on date of admission? YesNo

If not, what day was it completed on?__________________________________

What time?__________________________________

CXR Results __________________________________________

Was an abdominal x-ray (AXR) done? YesNo

Was an AXR completed on date of admission? YesNo


What time?__________________________________

AXR Results __________________________________________

Was an abdominal ultrasound (US) done? YesNo

Was an US completed on date of admission? YesNo


What time?__________________________________

US Results __________________________________________

Was an abdominal/pelvis CT (CTAP) done? YesNo



ConfidentialPage 7

Was a CTAP completed on date of admission? YesNo


What time?__________________________________

CTAP Impression __________________________________________(If ascites noted, make sure to go back to acutediseases and answer "yes" to ascites.)

Was a chest CT done? YesNo

Was a Chest CT completed on the date of admission? YesNo


What time?__________________________________

Chest CT Results __________________________________________

Plain Film Site__________________________________

Plain Film Results__________________________________

CODE STATUSCode Status at Admission Full Code

DNRCCADNRCCA/DNIDNRCC (CMO)OtherMissing/Unknown


02/04/2021 10:20am projectredcap.org


Page 1

Chronic Risk Factors

Database ID__________________________________

Only record conditions that were diagnosed prior to admission.This form will only populate if you indicated that the patient had comorbidities and that the patient is not a 90-dayreadmission.

Co-morbidities: RespiratoryNo Yes

AsthmaCOPDCOPD with oxygen requirement

Co-morbidities: ThromboembolicNo Not currently but has a

history ofCurrent/active thrombosis

Deep vein thrombosis (DVT)Pulmonary embolism (PE)

Co-morbidities: RenalNo Yes

Chronic kidney diseaseChronic kidney disease requiringdialysis (Hemodialysis orperitoneal dialysis)

Co-morbidities: CardiovascularNo Yes

Coronary artery diseaseCoronary artery disease withangina

Previous PTCA/PCI (coronarystents)

ArrhythmiaArrhythmia not requiringimplantable device

Arrhythmia requiring pacemaker(in place)

Arrhythmia requiring AICD (inplace)



ConfidentialPage 2

Pulmonary circulation disorderValvular disease (stenosis orregurgitation of any of the heartvalves)

History of myocardial infarction(MI) (confirmed or probable)

Congestive heart failure (CHF)Peripheral vascular disease(PVD)Hypertension (HTN)

Only choose one arrhythmia severity between no device, pacemaker, and AICD.

Co-morbidities: MalignancyNo Yes

Active cancerLocalized solid tumor (nometastatic spread)

Metastatic/stage IV solid tumor(Metastatic disease (lymphnodes, regional or distantmetastasis)

LeukemiaLymphomaHistory of cancerChemotherapy within 30 days ofadmission

Radiotherapy within 30 days ofadmission

Only select one cancer type between localized solid tumor, metastatic solid tumor, leukemia, and lymphoma.

Co-morbidities: NeurologicalNo Yes

History of cerebrovascularaccident (CVA)

History of CVA with deficitHistory of CVA withoutdeficit/transient ischemic attack(TIA)

Cerebrovascular disease



ConfidentialPage 3

Neurodegenerative disorder (Ex.Alzheimer's disease, dementia,Huntington's disease, SCA, SMA,etc.)

Alzheimer's diseaseDementiaHemiplegia/hemiparesisParaplegia/paraparesisQuadriplegiaPersistent vegetative state

Only choose one type of paralysis between hemiplegia/hemiparesis, paraplegia/paraparesis, and quadriplegia.

Co-morbidities: EndocrineNo Yes

Type 1 diabetes mellitusType 2 diabetes mellitusType 2 diabetes mellitus, dietcontrolled

Type 2 diabetes mellitus, oralmedication controlled

Type 2 diabetes mellitus, insulincontrolled

Diabetes with end organdamage (Ex. retinopathy,neuropathy, nephropathy)

Hypothryoid disease (includingHashimoto's thyroiditis)

Hyperthyroid disease (includingGraves disease)

Only choose one form of diabetes mellitus between type 1 and type 2.

Only choose one degree of T2DM severity between diet-controlled, oral medication-controlled, and insulin-controlled.

Co-morbidities: HepaticNo Yes

CirrhosisLiver diseaseMild liver disease (chronichepatitis or cirrhosis withoutportal hypertension)



ConfidentialPage 4

Moderate liver disease (cirrhosisand portal hypertension withoutvariceal bleeding)

Severe liver disease (cirrhosisand portal hypertension withvariceal bleeding)

Esophageal varices

Only choose one degree of severity between mild, moderate, and severe liver disease.

Co-morbidities: HematologicNo Yes

Clotting disorder(hypercoagulable states such asfactor V Leiden, protein S or Cdeficiencies, etc.)

Bleeding disorder(coagulopathies such ashemophilia, von Willdebrand,etc.)AnemiaChronic blood loss anemiaDeficiency anemia

Co-morbidities: GastrointestinalNo Yes

Gastroesophageal reflux disease(GERD)

Peptic ulcer disease (PUD)(history of or current)

Inflammatory bowel disease (IBD= UC, Crohn's)

Ulcerative colitisCrohn's diseaseHistory of GI/abdominal surgery(NOT WITHIN 90 DAYS)

What was this previous abdominal surgery?__________________________________

What year?__________________________________



ConfidentialPage 5

Co-morbidities: PsychiatricNo Yes

Major depressive disorder(requiring pharmacotherapy tocontrol)

Major anxiety disorder (requiringpharmacotherapy to control)

SchizophreniaObsessive compulsive disorder(OCD)

Co-morbidities: MiscellaneousNo Yes

Chronic steroid use (onprednisone or equivalent; have ahigh index of suspicion if +connective tissue/autoimmunedisease or adrenal insufficiency)

Raynaud's syndromeConnective tissue disease (ex.rheumatoid arthritis, lupus,scleroderma, etc.)

Rheumatoid arthritis/rheumaticdisease

Other autoimmune disorder (notspecified elsewhere)

Chronic pain syndromeFluid/electrolyte disorder (ex.diabetes insipidus)

HIV/AIDSCongenital abnormalities (ex.spina bifida, cerebral palsy, cleftlip/palate, congenital heartdefects)

>10% body weight loss over last6 months

MalnutritionObesity (BMI >/= 30.0)



ConfidentialPage 6

Surgical historyNo Yes

Previous cardiac surgeryHistory of organ transplant

Social historyNever History of Active

Tobacco abuseOpiate abuseExcessive alcohol use (> 7/weekwomen, > 14/week men)

CALCULATIONSCharlson Comorbidity Index: Age Points ([age])

__________________________________

cci_ckd__________________________________

cci_liverdisease__________________________________

cci_hemiplegia__________________________________

cci_cancercll__________________________________

cci_cancerdis__________________________________

cci_hivaids__________________________________

Deyo-Charlson Comorbidity Score__________________________________

eci_chf__________________________________

eci_rhythm__________________________________

eci_valvular__________________________________

eci_pulmcircdo__________________________________

eci_pvd__________________________________



ConfidentialPage 7

eci_paralysis__________________________________

eci_neurodegen__________________________________

chronicresp__________________________________

eci_respiratory__________________________________

eci_ckd__________________________________

eci_liverdisease__________________________________

eci_lymph__________________________________

eci_dissem__________________________________

eci_ctrl__________________________________

eci_bleedingdo__________________________________

eci_obesity__________________________________

eci_weightloss__________________________________

eci_lytedo__________________________________

eci_anemia__________________________________

etohabuse__________________________________

drugabuse__________________________________

eci_opiates__________________________________

eci_depression__________________________________



ConfidentialPage 8

Elixhauser-van Walraven Comorbidity Score__________________________________(Rough estimate as actual value is based on ICDcodes.)

ahrq_chf__________________________________

ahrq_pulmcircdo__________________________________

ahrq_pvd__________________________________

ahrq_htn__________________________________

ahrq_paralysis__________________________________

ahrq_neurodegen__________________________________

ahrq_respiratory__________________________________

ahrq_diabetes__________________________________

ahrq_ckd__________________________________

ahrq_liverdisease__________________________________

ahrq_lymph__________________________________

ahrq_dissem__________________________________

ahrq_ctrl__________________________________

ahrq_bleedingdo__________________________________

ahrq_obesity__________________________________

ahrq_weightloss__________________________________

ahrq_lytedo__________________________________



ConfidentialPage 9

ahrq_anemiacbl__________________________________

ahrq_anemiadef__________________________________

ahrq_etoh__________________________________

ahrq_opiates__________________________________

ahrq_psychosis__________________________________

ahrq_depression__________________________________

AHRQ Elixhauser Comorbidity Scale__________________________________

Other chronic conditions if not listed elsewhere: __________________________________________




Page 1

Social Variables

Database ID__________________________________

CASE MANAGEMENT NOTESource of information Patient

FamilyFriendElectronic medical record

Who does the patient live with? AlonePartner/adultChildrenParentsExtended familyFacilityGrandchild(ren)OtherMissing/Unknown


Living Arrangement Extended Care FacilityApartmentHouseHomelessMobile HomeOtherMissing/Unknown


Primary Care is Provided by: SelfAgencyPartnerChild(ren)Sibling(s)Parent(s)Extended FamilyFriend(s)OtherMissing/Unknown




ConfidentialPage 2

Primary Care is Provided for: NonePartnerSibling(s)Child(ren)Parent(s)Friend(s)Pet(s)Grandchild(ren)OtherUnknown/Missing


Quality of Relationships UnsupportiveSupportiveVery SupportiveUnknown/Missing

(Take this verbatim from the case managementnotes.)

Types of Support Systems: Immediate FamilyExtended FamilyFriendsReligious OrganizationCommunityOtherMissing/Unknown

Describe 'Religious Organization':__________________________________

Describe 'Community':__________________________________


Employment Status: Not EmployedEmployedRetiredDisabledMissing/Unknown

Employment Concern: YesNoMissing/Unknown

Source of Income: NoneDisabilitySalary/WagesRetirement/PensionSocial SecurityOtherMissing/Unknown




ConfidentialPage 3

Financial Concern: YesNoMissing/Unknown

Transportation at Time of Discharge Family will provideFriend will provideFriend or family (not specified) will provideOtherMissing/Unknown


Subjective Quality of Social Support UnsupportiveSupportiveVery supportiveUnknown

(Make a subjective judgment based on informationincluded in case management notes.)




Page 1

Emergency Department Data

Database ID__________________________________

This form will only populate if you indicated that the patient was admitted to an abdominal surgical service from theED on the Basic ID page.

ED Encounter Note > Care TimelineED Arrival Time

__________________________________

ED Departure Time__________________________________(May or may not be the same as the time ofadmission (depending on if beds were available))

ED Disposition Operating RoomFloorStep downICUOtherUnknown/Missing


ED NotesPre-hospital Location Home

Acute Care Hospital EDRehabSkilled Nursing FacilityLong Term Acute Care FacilityOtherUnknown/Missing

(Most likely the same as address/residence typeunless otherwise stated in ED notes.)





Page 1

Referring Facility Data

Database ID__________________________________

This form will only populate if you indicated that the patient was a transfer on the Basic ID page.

Name of Transferring Facility__________________________________

Address__________________________________

City__________________________________

State Abbreviation__________________________________

Zip Code__________________________________

Transferring Facility Type Acute Care HospitalRehabSkilled Nursing FacilityLong Term Acute Care FacilityOtherUnknown/Missing


Transferring Service SurgeryGeneral MedicineEmergency MedicineOtherUnknown/Missing


Location prior to Transfer ORFloorStepdownICUEDOtherUnknown/Missing


Was the date of admission to referring facility the Yessame calendar day as the admission to the new Nohealthcare facility?



ConfidentialPage 2

If not, how many days did the patient spend at thereferring facility? __________________________________

Urgency of Original Admission Elective/PlannedUrgent/Emergent/Unplanned

Primary Diagnosis__________________________________

Primary Diagnosis ICD-10 Code__________________________________(OMIT PERIODS)

Reason for Transfer__________________________________(E.g. Anesthesia needs, critical care needs,complications, etc.)




Page 1

Consult Data

Database ID__________________________________

This form will only populate if you indicated that the patient was an inpatient consult to an abdominal surgicalservice on the Basic ID page.

Service of physician who consulted surgical service Hospital MedicineMICUOther ICUVascular SurgeryCardiac SurgeryOrthopedic SurgeryPlastic SurgeryOB/GYNOtherUnknown/Missing


Primary Service at Time of Consult Hospital MedicineMICUOther ICUVascular SurgeryCardiac SurgeryOrthopedic SurgeryPlastic SurgeryOB/GYNOtherUnknown/Missing


Patient Location at Time of Consult Operating RoomFloorStepdownICUOtherUnknown/Missing


What day of this admission was a consult requested?__________________________________

Consult Request Time__________________________________

What day of this admission was the consult completed?__________________________________

Consult Seen Time__________________________________



ConfidentialPage 2

Consult Disposition Patient to ORFollowed patient as consultTransferred patient to ACS servicePatient stayed in OR with consulting surgeonOtherUnknown/Missing





Page 1

Laparotomy Data

Database ID__________________________________

Did the patient have an operation? YesNo

Brief Op Note & Operative ReportWas the operation completed within one calendar day? Yes

No

Day of surgery during admission__________________________________

Attending Surgeon__________________________________(Only include the first and last name of thesurgeon.)

Pre-procedure diagnosis text__________________________________

Pre-procedure ICD-10 diagnosis code__________________________________(OMIT PERIODS)

Post-procedure diagnosis text__________________________________

Post-procedure ICD-10 diagnosis code__________________________________(OMIT PERIODS)

How many procedures were performed?__________________________________

Primary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)

Primary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)

Primary surgical procedure text__________________________________

Secondary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)



ConfidentialPage 2

Secondary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)

Secondary surgical procedure text__________________________________

Tertiary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)

Tertiary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)

Tertiary surgical procedure text__________________________________

Quaternary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)

Quaternary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)

Quaternary surgical procedure text__________________________________

Quintary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)

Quintary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)

Quintary surgical procedure text__________________________________

Intraoperative findings __________________________________________



ConfidentialPage 3

First Assistant Attending AlonePGY-1PGY-2PGY-3PGY-4PGY-5PGY-6Other AttendingOtherMedical Student(s)Unknown/Missing


Degree of contamination NonePhlegmonFree airPurulent contaminationFeculent contaminationGangrenous visceraOther


Were there any intraoperative complications? YesNo

Complication text__________________________________

Was the fascia closed? YesNo

How? Running SutureInterrupted SutureUnknown/Missing

Retention sutures used: Running SutureInterrupted SutureUnknown/Missing

If fascia left open, what was the temporary closure Abtheratype? Bogota Bag

Whitmann PatchVicyrl MeshGortex MeshOtherUnknown/Missing




ConfidentialPage 4

How was the skin closed? Closed with staplesClosed with subcuticular stitchClosed with wicksClosed with Provena/Topical NPWTOpen with wet to dryOpen with antibiotic soaked gauzeOpen with NPWTOtherUnknown/Missing


Were any packs/laps left in abdomen during temporary Yesclosure? No

How many?__________________________________

Were any drains placed in the abdomen? YesNo

How many?__________________________________

Were there any drains placed in the sub-q? YesNo

How many?__________________________________

If ascites was a finding that was noted within the operative report, make sure to go back to acute severity measuresto answer "yes" to ascites.

Anesthesia RecordAnesthesia Type General

EpiduralGeneral + EpiduralLocalMACSpinalRegionalOtherUnknown/Missing


ASA Classification Normal (I)Mild Systemic Disease (II)Severe Systemic Disease (III)Severe Systemic Disease w/ Constant Threat to Life(IV)Moribund, Not Expected to Survive (V)Unknown/Missing



ConfidentialPage 5

Did the patient receive a perioperative antibiotic? NoAmpicillin-sulbactam (Unasyn)CefazolinCefotetanCefoxitinErtapenem (Invanz)Fluoroquinolone (any drug ending in "-floxacin")Fluoroquinolone-metronidazole (ex. Cipro-Flagyl)GentamicinMetronidazolePiperacillin-tazobactam (Zosyn)VancomycinOther

(Medications)

If "Other", please describe__________________________________

Drug Given Time__________________________________

Was the first antibiotic given within 1 hour of Yesincision? No

(Will need to determine incision time (nextsection) first)

Did the patient receive another perioperative Noantibiotic? Ampicillin-sulbactam (Unasyn)

CefazolinCefotetanCefoxitinErtapenem (Invanz)Fluoroquinolone (any drug ending in "-floxacin")Fluoroquinolone-metronidazole (ex. Cipro-Flagyl)GentamicinMetronidazolePiperacillin-tazobactam (Zosyn)VancomycinOther


Drug Given Time__________________________________

Was the second antibiotic given within 1 hour of Yesincision? No




ConfidentialPage 6

Was a beta blocker administered? NoAtenololBisoprololEsmololLabetalolLandiololMetoprololNadololOxprenololPindololPropranololSotalolOther

(Medications)


IV fluids given (crystalloid) (mL)__________________________________(Medications)

Colloid given (mL)__________________________________(Medications)

Starting Temperature (F)__________________________________(Intraprocedure grid)

Ending Temperature (F)__________________________________(Intraprocedure grid)

Lowest Temperature (F)__________________________________(Intraprocedure grid)

Lowest Mean Arterial Pressure < 40 mmHg40-54 mmHg55-69 mmHg>= 70 mmHg

(Intraprocedure graph)

Lowest Heart Rate >85 bpm76-85 bpm

"Pathologic bradycardia" includes sinus arrest, AV 66-75 bpmblock or dissociation, junctional or ventricular 56-65 bpmescape rhythm < = 55 bpm

Pathologic bradycardia or asystole(Intraprocedure graph)

Estimated Blood Loss > 1000 mL601-1000 mL101-600 mL< = 100 mL

(Intraprocedure grid)



ConfidentialPage 7

Urine Output (mL)__________________________________(Intraprocedure grid)

Was a urinary catheter placed? YesNo

(Lines, drains, and airways)

Was a central venous line (CVL, may only be listed as Yes"Central Line") placed? No


Was an arterial line placed? YesNo


Note that 1 unit is ~300 mL.Packed Red Blood Cells (# of units transfused)

__________________________________(Blood products; if not listed, assume 0)

Fresh Frozen Plasma (# of units transfused)__________________________________(Blood products; if not listed, assume 0)

Whole Blood (# of units transfused)__________________________________(Blood products; if not listed, assume 0)

Cryoprecipitate (# of units transfused)__________________________________(Blood products; if not listed, assume 0)

Cell-Saver (mL)__________________________________(Blood products; if not listed, assume 0)

Did the patient leave the OR intubated? YesNo

(Handoff report or operative notes/report)

Did the patient go to the PACU? YesNo

(Handoff report)

PACU Arrival Time__________________________________(Handoff report)

PACU Discharge Time__________________________________(Events)



ConfidentialPage 8

Linked SurgeryCase Booking Status (Case Classification) Status A - Emergent (60 min)

Status B - Urgent ( < 6 hours)Status C - Regular CaseMissing

(Log report)

NSQIP Wound Classification CleanClean/contaiminatedContaminatedDirty infectionUnknown/Missing

(Procedure(s))

OR Start Time (Patient In-Room)__________________________________(Case tracking events)

Incision Time (Incision/Procedure Start)__________________________________(Case tracking events)

End of Operation Time (Incision Close/Procedure End)__________________________________(Case tracking events)

OR End Time (Patient Out-Room)__________________________________(Case tracking events)

Type of prep used: Chlorhexidine (ChloraPrep)BetadineOtherUnknown/Missing

(Patient preparation)


How was hair removed? Not removedClippedShavedNot applicableOtherUnknown/Missing



What kind of DVT prophylaxis was used? NoneSCDsHSQLovenoxOtherUnknown/Missing

(Sequential compression devices (Or Anesthesia >Medications if heparin or Lovenox))



ConfidentialPage 9


Encounter > Additional Orders and Documentation > Detailed Report > ADT EventsWhere did the patient go after index operation, not Floorincluding PACU? Stepdown

ICUOtherUnknown/Missing

If 'Other' please describe:__________________________________

Procedures: CASE REQUEST - SURGERYWas the case request submitted on the same calendar Yesday as the operation? No

If not, what day of admission was the case requestedcompleted? __________________________________

OR Case Request Submitted Time__________________________________

CALCULATED VALUESCalculated incision-to-antibiotic time is > 60 minutes and you answered 'yes' to 'Was the first/second antibiotic givenwithin 1 hour of incision?'.

Surgical Apgar Score__________________________________




Page 1

Index Hospital Complications

Database ID__________________________________

UNPLANNED REOPERATION(S)# of Unplanned Reoperations During IndexHospitalization __________________________________

This complications fields will only populate if you indicated that the patient had systemic or surgical complications onthe Basic ID page.

SYSTEMIC COMPLICATIONS: only include those not present on admission# of Systemic Complications

__________________________________

Day of systemic complication #1__________________________________

Category of Systemic Complication #1 ShockCardiacPulmonaryNeurologicalGenitourinaryThromboembolicOther

Was this complication a healthcare-acquired infection? YesNo

Microbe name AcinetobacterBurkholderia cepaciaClostridioides difficile (C diff)Enterobacteriaceae with carbapenem resistanceKlebsiellaMethicillin-resistant staphylococcus aureus (MRSA)NorovirusPseudomonas aeruginosaStaphylococcus aureusTuberculosis (TB)Vancomycin-resistant Staphylococcus aureus orenterococciVancomycin-intermediate Staphylococcus aureus

Text of Systemic Complication #1__________________________________

ICD-10 code for complication #1__________________________________(OMIT PERIODS)




ConfidentialPage 2












ConfidentialPage 3














ConfidentialPage 4













ConfidentialPage 5












ConfidentialPage 6




Category of Systemic Complication #9 ShockCardiacPulmonaryNeurologicalGenitourinaryThromboembolicHealthcare Acquired Infection (HAI)Other










ConfidentialPage 7




SURGICAL COMPLICATIONS# of Surgical Complications

__________________________________

Day of surgical complication #1__________________________________

Category of Surgical Complication #1 WoundHemorrhageDeep SpaceAnastomotic LeakIntestinalOther

Text of Surgical Complication #1__________________________________







ConfidentialPage 8

















ConfidentialPage 9
















ConfidentialPage 10







CODE STATUSYou stated that the patient's code status at time of Yesadmission was [code_status] (Basic ID). No

Did the patient have a change in code status?

Day changed:__________________________________

What did it change to? Full codeDNRCCADNRCCA/DNIDNRCC (CMO)




Page 1

Index Unplanned Reoperations

Database ID__________________________________

This form will only populate if you indicated that the patient had at least 1 unplanned reoperation in the IndexHospital Complications and Events page.

Index unplanned reoperation # (out of[unplanned_reop_num]) __________________________________

Brief Op Note & Operative ReportWas the operation completed within one calendar day? Yes

No

Day of Unplanned Reoperation during admission:__________________________________

Attending Surgeon__________________________________(Only include the first and last name of thesurgeon.)

Post-procedure diagnosis text__________________________________

Post-procedure ICD-10 diagnosis code__________________________________(OMIT PERIODS)

How many procedures were performed?__________________________________

Primary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)

Primary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)

Primary surgical procedure text__________________________________

Secondary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)

Secondary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)



ConfidentialPage 2

Secondary surgical procedure text__________________________________

Tertiary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)

Tertiary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)

Tertiary surgical procedure text__________________________________

Quaternary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)

Quaternary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)

Quaternary surgical procedure text__________________________________

Quintary surgical ICD-10 procedure code__________________________________(OMIT PERIODS)

Quintary surgical CPT code__________________________________(Refer to "Procedures" > "Case Request - Surgery"for this)

Quintary surgical procedure text__________________________________

First Assistant Attending AlonePGY-1PGY-2PGY-3PGY-4PGY-5PGY-6Other AttendingOtherUnknown/Missing


Were there any intraoperative complications? YesNo

Complications text__________________________________



ConfidentialPage 3

Was the fascia closed? YesNo

How? Running SutureInterrupted Suture

Retention sutures used: Running SutureInterrupted Suture

If fascia left open, what was the temporary closure Abtheratype? Bogota Bag

Whitmann PatchVicyrl MeshGortex MeshOtherUnknown/Missing


How was the skin closed? Closed with staplesClosed with subcuticular stitchClosed with wicksClosed with Provena/Topical NPWTOpen with wet to dryOpen with antibiotic soaked gauzeOpen with NPWTOtherUnknown/Missing


Were any packs/laps left in abdomen during temporary Yesclosure? No

How many?__________________________________

Were any drains placed in the abdomen? YesNo

How many?__________________________________

Were there any drains placed in the sub-q? YesNo

How many?__________________________________



ConfidentialPage 4

Anesthesia RecordAnesthesia Type General

EpiduralGeneral + EpiduralLocalMACSpinalRegionalOtherUnknown/Missing


ASA Classification Normal (I)Mild Systemic Disease (II)Severe Systemic Disease (III)Severe Systemic Disease w/ Constant Threat to Life(IV)Moribund, Not Expected to Survive (V)Unknown/Missing

Did the patient receive a perioperative antibiotic? NoAmpicillin-sulbactam (Unasyn)CefazolinCefotetanCefoxitinErtapenem (Invanz)Fluoroquinolone (any drug ending in "-floxacin")Fluoroquinolone-metronidazole (ex. Cipro-Flagyl)GentamicinMetronidazolePiperacillin-tazobactam (Zosyn)VancomycinOther

(Medications)


Drug Given Time__________________________________

Was the first antibiotic given within 1 hour of Yesincision? No




ConfidentialPage 5

Did the patient receive another perioperative Noantibiotic? Ampicillin-sulbactam (Unasyn)

CefazolinCefotetanCefoxitinErtapenem (Invanz)Fluoroquinolone (any drug ending in "-floxacin")Fluoroquinolone-metronidazole (ex. Cipro-Flagyl)GentamicinMetronidazolePiperacillin-tazobactam (Zosyn)VancomycinOther


Drug Given Time__________________________________

Was the second antibiotic given within 1 hour of Yesincision? No


Was a beta blocker administered? NoAtenololBisoprololEsmololLabetalolLandiololMetoprololNadololOxprenololPindololPropranololSotalolOther

(Medications)


IV fluids given (crystalloid) (mL)__________________________________(Medications)

Colloid given (mL)__________________________________(Medications)

Starting Temperature (F)__________________________________(Intraprocedure grid)

Ending Temperature (F)__________________________________(Intraprocedure grid)



ConfidentialPage 6

Lowest Temperature (F)__________________________________(Intraprocedure grid)

Lowest Mean Arterial Pressure < 40 mmHg40-54 mmHg55-69 mmHg>= 70 mmHg

(Intraprocedure graph)

Lowest Heart Rate >85 bpm76-85 bpm

"Pathologic bradycardia" includes sinus arrest, AV 66-75 bpmblock or dissociation, junctional or ventricular 56-65 bpmescape rhythm < = 55 bpm

Pathologic bradycardia or asystole(Intraprocedure graph)

Estimated Blood Loss > 1000 mL601-1000 mL101-600 mL< = 100 mL

(Intraprocedure grid)

Urine Output (mL)__________________________________(Intraprocedure grid)

Was a urinary catheter placed? YesNo


Was a central venous line (CVL) placed? YesNo


Was an arterial line placed? YesNo


Note that 1 unit is ~300 mL.Packed Red Blood Cells (# of units transfused)

__________________________________(Blood products)

Fresh Frozen Plasma (# of units transfused)__________________________________(Blood products)

Whole Blood (# of units transfused)__________________________________(Blood products)

Cryoprecipitate (# of units transfused)__________________________________(Blood products)



ConfidentialPage 7

Cell-Saver (mL)__________________________________

Did the patient leave the OR intubated? YesNo

(Handoff report or operative notes/report)

Did the patient go to the PACU? YesNo

(Handoff report)

PACU Arrival Time__________________________________(Handoff report)

PACU Discharge Date & Time__________________________________(Events)

Where did the patient go after index operation, not Floorincluding PACU? Stepdown

ICUOtherUnknown/Missing

If 'Other' please describe:__________________________________

Linked SurgeryCase Booking Status (Case Classification) Status A - Emergent (60 min)

Status B - Urgent ( < 6 hours)Status C - Regular CaseMissing/unknown

(Log report)

NSQIP Wound Classification CleanClean/contaiminatedContaminatedDirty infectionUnknown/Missing

(Procedure(s))

OR Start Time (Patient In-Room)__________________________________(Case tracking events)

Incision Time (Incision/Procedure Start)__________________________________(Case tracking events)

End of Operation Time (Incision Close/Procedure End)__________________________________(Case tracking events)



ConfidentialPage 8

OR End Time (Patient Out-Room)__________________________________(Case tracking events)

Type of prep used: Chlorhexidine (ChloraPrep)BetadineOtherUnknown/Missing



How was hair removed? Not removedClippedShavedNot applicableOtherUnknown/Missing



What kind of DVT prophylaxis was used? NoneSCDsHSQLovenoxOtherUnknown/Missing

(Sequential compression devices (Or Anesthesia >Medications if heparin or Lovenox))


Procedures: CASE REQUEST - SURGERYWas the case request submitted on the same calendar Yesday as the operation? No

If not, what day of admission was the case requestedcompleted? __________________________________

OR Case Request Submitted Time__________________________________



ConfidentialPage 9

CALCULATED VALUESCalculated incision-to-antibiotic time is > 60 minutes and you answered 'yes' to 'Was the first/second antibiotic givenwithin 1 hour of incision?'.

Surgical Apgar Score__________________________________




Page 1

30-Day Complications

Database ID__________________________________

Was there an unplanned readmission within 30 days of Yesindex surgery? No

How many of these unplanned readmissions were there intotal? __________________________________

Was there an unplanned reoperation within 30 days of Yesindex surgery? No

How many of these unplanned reoperations were there intotal? __________________________________

Did the patient have any 30-day complications? YesNo


Has the patient died within 30 days of index surgery? YesNo

(Regardless of whether the patient wasreadmitted/inpatient at the time of death.)

If so, how many days since their discharge from thehospital? __________________________________

SYSTEMIC COMPLICATIONS# of Systemic Complications

__________________________________

How many days post hospital discharge did systemiccomplication #1 happen? __________________________________

(Day of discharge is Day 0)





ConfidentialPage 2













ConfidentialPage 3














ConfidentialPage 4













ConfidentialPage 5














ConfidentialPage 6













ConfidentialPage 7














ConfidentialPage 8





__________________________________

How many days post hospital discharge did surgicalcomplication #1 happen? __________________________________











ConfidentialPage 9



















ConfidentialPage 10




















ConfidentialPage 11












Page 1

30-Day Readmissions

Database ID__________________________________

This form will only populate if you indicated that the patient had at least 1 unplanned readmission in the 30-daycomplications page.

Unplanned 30-day readmission # (out of[read_30day_num]) __________________________________

Was the patient readmitted to an outside hospital Yes(records cannot be viewed in EMR)? No

Fill out the data below with as much information as is available.

30-DAY READMISSION DATAHow many days from index hospital discharge was thepatient readmitted? __________________________________


Readmission Time__________________________________

Readmission Source Emergency DepartmentDirect admit ("transfer") from acute carehospital, rehab, SNF, or LTACDirect admit from homeInpatient consult (overrides ED)OtherUnknown



Was the patient admitted through the Emergency YesDepartment? No


Admission Diagnosis Text__________________________________

Admission Diagnosis ICD-10 Code__________________________________




ConfidentialPage 2

How many days post index hospital discharge did thepatient die? __________________________________






Page 1

90-Day Complications

Database ID__________________________________

Was there an unplanned readmission within 90 days of Yesindex surgery? No

How many of these unplanned readmissions were there intotal? __________________________________

Was there an unplanned reoperation within 90 days of Yesindex surgery? No

How many of these unplanned reoperations were there intotal? __________________________________

Did the patient have any 90-day complications? YesNo


Has the patient died within 90 days of index surgery? YesNo

(Regardless of whether the patient wasreadmitted/inpatient at the time of death.)

SYSTEMIC COMPLICATIONS# of Systemic Complications

__________________________________







ConfidentialPage 2













ConfidentialPage 3














ConfidentialPage 4













ConfidentialPage 5














ConfidentialPage 6













ConfidentialPage 7














ConfidentialPage 8





__________________________________












ConfidentialPage 9



















ConfidentialPage 10




















ConfidentialPage 11




Date of surgical complication #10__________________________________(Day of discharge is Day 0)







Page 1

90-Day Readmissions

Database ID__________________________________

This form will only populate if you indicated that the patient had at least 1 unplanned readmission in the 90-daycomplications page.

Unplanned 90-day readmission # (out of[read_90day_num]) __________________________________

Was the patient readmitted to an outside hospital Yes(records cannot be viewed in EMR)? No

Fill out the data below with as much information as is available.

90-DAY READMISSION DATAHow many days from index hospital discharge was thepatient readmitted? __________________________________


Readmission Time__________________________________

Readmission Source Emergency DepartmentDirect admit ("transfer") from acute carehospital, rehab, SNF, or LTACDirect admit from homeInpatient consult (overrides ED)OtherUnknown



Was the patient admitted through the Emergency YesDepartment? No


Admission Diagnosis Text__________________________________

Admission Diagnosis ICD-10 Code__________________________________




ConfidentialPage 2

How many days post index hospital discharge did thepatient die? __________________________________






Page 1

Followup

Database ID__________________________________

This form will not populate if you indicated that the patient died during their index admission (Basic ID).

How many follow-up appointments did the patient have?__________________________________(Max is 12)

How many days post index hospital discharge did thepatient have follow-up appointment #1? __________________________________


Did the patient show up for their appointment? YesNo

What was the primary purpose of this follow-up visit? Routine Follow-upConcern for wound infectionOngoing wound careOngoing painGI symptomsOtherUnknown












ConfidentialPage 2


















ConfidentialPage 3


















ConfidentialPage 4

















ConfidentialPage 5




Documents

Biomedical Sciences Institutional Review Board