1. PURPOSE: 3. RESPONSIBLE INDIVIDUALS: 4. DEFINITIONS ...

STANDARD OPERATING PROCEDURE (SOP) FOR CLINICAL RESEARCH

TITLE: Research Documentation

Last Revised:

5/2017

Prior Version: None

SOP NUMBER: SC- 403 Page 1 of 9

Developed by the UH Clinical Research Center SOP Committee 1

1. PURPOSE:

To establish documentation standards for clinical research projects to ensure applicable

safety, compliance, and billing requirements are met.

2. SCOPE:

All entities conducting clinical research within the University Hospitals Health System.

3. RESPONSIBLE INDIVIDUALS:

Clinical and research personnel who interact or care for clinical research participants.

4. DEFINITIONS/ACRONYMS:

DOS - Date of Service

EMR – Electronic Medical Record

Enrollment/enrolled - generally means a research subject has been consented and screened,

with eligibility verified

GCP - Good Clinical Practice. Good Clinical Practice (GCP) is an international ethical and

scientific quality standard for the design, conduct, performance, monitoring, auditing,

recording, analyses and reporting of clinical trials. It also serves to protect the rights,

integrity and confidentiality of trial subjects

HIPAA - Health Insurance Portability and Accountability Act

ICF - Informed Consent Form

ICH - International Conference on Harmonization. Launched in 1990, ICH is a unique

undertaking that brings together the drug regulatory authorities and the pharmaceutical

industry of Europe, Japan and the United States.

Licensed Medical Provider – An individual, such as a, physicians, nurse practitioners, or

other health care professional with documented qualifications and/or licensure to perform

medical related tasks (i.e. medical exam, review safety reporting, writing orders for

procedures, prescribing medications, etc.)

Medical Record - Paper or electronic source document repository of care provided to and

patient status. Includes, but not exclusive of, the following: Allscripts Sunshine

Enterprises [UHCare Ambulatory –Ambulatory Electronic Medical Record (aEMR)] &

UHCare Acute– In Patient Electronic Medical Record; Community Record; Ensite;

Mosaic (Radiology); Physician Portal

Research - A systematic investigation, including research development, testing, and

evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.102



Last Revised:

5/2017

Prior Version: None



Source Data - All information in original records and certified copies of original records of

findings, observations, or other activities in a clinical trial necessary for the

reconstruction and evaluation of the trial. Source data are contained in source documents

(original records or certified copies)

Source Document - Original documents, data, and records (e.g., hospital records, clinical

and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists,

pharmacy dispensing records, recorded data from automated instruments, copies or

transcriptions certified after verification as being accurate and complete, microfiches,

photographic negatives, microfilm or magnetic media, x-rays, subject files, and records

kept at the pharmacy, at the laboratories, and at medico-technical departments involved in

the clinical trial)

5. POLICY STATEMENT:

Accurate and complete documentation is the cornerstone of Good Clinical Practice (GCP)

and permits an observer to recreate a subject’s participation in a research study and to

account for the use of any investigational products.

Source documentation must be kept in accordance with FDA regulations (21 CFR 11, 21

CFR50.25, 21 CFR 312.62 (b), 21 CFR 812.140 (a) (3) guidelines), Guidance for Industry:

Electronic Source Data in Clinical Investigations, FDA BIMO Chapter 48-Biomedical

Monitoring Program 7348.811, and ICH GCP E6.

6. PROCEDURES:

A. Medical Record Access

1. Access to the medical record is based on job function.

2. If your entity utilizes an EMR, access to the medical record is granted when

an employee’s UH Manager submits an e-security request. The type of access

granted is dependent on the employee’s job function, UH Policy CP-44 -

UHCare Training for Clinical Staff.

3. Training must be completed prior to accessing or documenting in the medical

record. See Training and Job Aids UHCare Home Page

4. Orders can only be written by medically qualified and authorized study

personnel, in accordance with UH Research SOP GA – 104 Scope of Practice.

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCare/default.aspx

STANDARD OPERATING PROCEDURE (SOP) FOR CLINICAL RESEARCH TITLE: Research Documentation

Last Revised: 5/2017 Prior Version: None



B. Research Registration/Scheduling 1. All research subjects seen onsite at UH facilities must be registered and given

a medical record number if they don’t already have one. “Research insurance” must be placed in the primary insurance position for any clinical study-related DOS, in accordance with UH Policy R-2 Patient Billing under Research Grants.

i. The registration process for a new UH patient assigns them a singleunique medical record number in accordance with UH Policy GM-71 – Patient Access Service (PAS).

2. Research related appointments must be scheduled in the hospital or entityscheduling system.

i. Scheduling at University Hospitals Cleveland Medical Center(UHCMC) must occur in Athena and/or Soarian, depending uponwhether technical or professional patient care services will beprovided.

ii. Registration and scheduling instructions are located in Appendix C –“Registration Workflow: Athena/ Soarian Research Documentation”.

C. HIPAA and Research 1. Parts of the Health Insurance Portability and Accountability Act (HIPAA)

regulations are designed to ensure research patients’ privacy and the security of the information we use and retain within UHCMC and regional offices.

2. Researchers accessing, using or retaining protected health information (PHI) ofUHCMC patients must abide by the UHCMC’s HIPAA-related policies.

3. Restricted/Confidential Records follow organizational guidelines for restrictedrecords (i.e., Browns players, public figures, infectious disease and psychiatricpatients).

In accordance with UH Policy GM-61 Accessing Medical Records (Section 12.3 research records), PH-3 - Permitted Uses/ Disclosures of PHI (Section 2.11 – for research), PH-4 Authorizations for Use and Disclosure of PHI (Section 7.1 – Research), PH-23 – Psychotherapy Notes, R-3 Uses & Disclosures of PHI for Research.

E. Research Documents 1. All original source and essential research documents must be retained.

Measures should be taken to prevent any premature or accidental destruction.



Last Revised:

5/2017

Prior Version: None



2. A copy of research records should be maintained in the EMR if applicable per

institutional policy or at the discretion of the investigator to ensure adequate

subject safety.

3. When original observations are entered directly into a computerized system, the

electronic record is the source document. This requirement applies to the

retention of the original source document, or a copy of the source document.

In accordance with UH Policy GM-1 Records Management, ICH E6 4.9.4.b,

21CFR312.62 Investigator Record Keeping and Record Retention – Case histories, FDA

Guidance for Industry - Computerized Systems Used in Clinical Investigations: Source

Documentation and Retention.

D. Required Medical Record Documentation

In accordance with UH Policy CP50 – Worklist Documentation (including eMAR),

UH Policy EMR-1 Integrated Interdisciplinary Documentation and Charting in the

EMR, UH Policy GM-49 Medical Records Completion and UH Policy GM-93 –

Timely Completion of Transactions in the Ambulatory EMR.

1. All clinical study related tasks must be documented on a timely basis by the

clinician and/or delegate who performed the task.

2. Include secondary diagnosis code Z00.6 (research) on billing charge capture

documents for all care provided as documented below.

3. Assure that the following elements are documented in the patient medical

record:

i. Informed consent (IC).

In accordance with FDA 21 CFR 50.27: “Documentation of Informed

Consent”, and UH IRB Policy “Informed Consent”.

The IC process must be documented in the subject’s medical

record.

Refer to Appendix E: UH Clinical Research Tools and Templates

Informed Consent Documentation Checklist Informed Consent

Documentation Checklist for suggested IC process documentation

content.

http://www.uhhospitals.org/~/media/UH/documents/research/research-tools-checklist-informed-consent-documentation.doc?la=en

http://www.uhhospitals.org/~/media/UH/documents/research/research-tools-checklist-informed-consent-documentation.doc?la=en



Last Revised:

5/2017

Prior Version: None


Developed by the UH Clinical Research Center SOP Committee

5

Original fully executed (signed) IC forms must be maintained in

the research records.

A copy of the fully executed (signed) IC document must be added

to a paper medical record or scanned into an EMR.

Refer to UH Policy GM68 - “Medical Record Content”. For

instructions on how to scan see Appendix D: Ambulatory Scan

Job Aid. See EMR Standard Filing Guide Master (The table

provides a roadmap for placement of scanned documents into

folders within the patient’s EMR) and Guide to Clinical Data

Location (Clinical Data Matrix-The ability to connect with patient

data across the UH system and affiliated hospitals is vital to

continuity of care and patient safety. The table provides a roadmap

for patient data by source, type and location.

Any subsequent changes to the IC form must be discussed with the

study subject and the study subject re-consented. This process

must also be documented as a narrative note in the subject’s

medical record, indicating that the subject has been re-consented

and wishes to continue in the study.

Additional versions of the IC document must be maintained as is

the original versions.

ii. Enrollment* note source documentation must contain the following:

Date

Narrative of visit

Phraseology must include the following: “patient has been

enrolled/participating in the (insert IRB approved short study

name) research study” (or “research database” or “research

registry” if applicable) written by or signed by PI or designee.

* “Enrollment/Enrolled" generally means "consented and screened,

with eligibility verified."

iii. Orders

Research study related clinical procedures and tests must be

ordered by a licensed medical provider and documented as a

written order in the study subject’s medical record. In accordance

https://intranet.uhhospitals.org/ClinicalProfessional/PhysicianServices/docs/UHCare_Policies/Standard_Filing_Guide.xlsx

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCareAmbulatory/docs/Document_Matrix/Clinical_Data_Matrix.pdf#search=clinical%20data%20matrix



Last Revised:

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Prior Version: None



6

with UH Policies: EMR-2 – Master UHCare Order Management

and MM-2 – Medication Orders.

iv. Administration or Implant of Investigational Product

Drug or biologic administration should be documented by the

person administering item, according to their scope of practice.

Implant of an investigational product must be documented in the

procedure note by a physician.

a. Phraseology must include the following: “Patient met

eligibility requirements and has been enrolled in the (insert

IRB approved short study name) research study and

received (insert investigational device product name).

b. Must include IDE number

When applicable, investigational study medications must be

managed by Investigational Drug Services (IDS) in accordance

with UH Policy: MM-4 - Investigational Drugs.

v. Visit Progress Notes (Initial and follow-up visits)

The Investigator and/or delegate will document progress notes for

each visit the participant makes to the clinic or hospital.

Documentation should include but not limited to the following:

purpose of visit, any ICF changes information, subjects status of

study involvement (i.e. still receiving study medication, not

receiving study medication, terminated from study, etc.), whether

or not the research subject had an adverse event or any health

changes since last study visit, date of next study visit, any other

important information or conversations, and the identity of person

completing the note.

Update any medication changes, enter new vitals, and add/update

any new medical conditions, as necessary.

vi. Telephone Encounter Note

The Investigator or delegate will be expected to document

telephone contact notes for relevant research study related calls to

the participant.

Documentation should include: the purpose of call, information on

whether or not the research subject had an adverse event or any

changes in health since last study visit/telephone call, date of next

study visit, any other important information or conversations, and

the identity of person completing the note.



Last Revised:

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Prior Version: None



7

Update any medication changes, and add or update any new

medical information, as necessary.

vii. Investigational Medication or Product Reconciliation

If required by the research protocol, document use, return and

destruction of investigational product in accordance with UH

Policy EMR-3 UHCare Medication Administration Record.

viii. Withdrawal / Early Termination / Study Completion

The Investigator or delegate must document in the subject’s

medical record when a research subject terminates participation in

a research study.

Include all pertinent information for the continuation of care.

Enter a progress note of study termination, document the date and

purpose of the study termination and identify person completing

the note. The EMR must be updated to indicate the research

subject is no longer participating in the research

In accordance with Ohio Code 4731-23-02 - Delegation of Medical

Tasks, UH Policy EMR-2 Master UH Care Order Management

and EMR-3 UHCare Medication Administration Record.

Refer to Appendix A: UHCare Inpatient EMR Workflow and/or Appendix B: UHCare

Ambulatory EMR Workflow on how to complete required steps outlined in section 6D.

7. APPENDICES:

Appendix A: UHCare Inpatient EMR Workflow

Appendix B: UHCare Ambulatory EMR Workflow

Appendix C: Registration Workflow (Athena/Soarian Research Documentation)

Appendix D: Scanning Workflow

Appendix E: UH Informed Consent Documentation Checklist

8. REFERENCES:

DHHS 45 CFR 46: Protection of Human Subjects

EMR Standard Filing Guide Master (Where to file scanned documents in the subjects’ EMR) https://intranet.uhhospitals.org/ClinicalProfessional/PhysicianServices/docs/UHCare_Policies/Sta

ndard_Filing_Guide.xlsx FDA Guidance for Industry: Electronic Source Data in Clinical Investigations

FDA 21 CFR 11: Electronic Records and Electronic Signatures



http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf



Last Revised:

5/2017

Prior Version: None



8

FDA 21 CFR 50.25: Elements of Informed Consent

FDA 21 CFR 50.27: Documentation of Informed Consent

FDA 21 CFR 312.62: Investigator Record Keeping and Record Retention

FDA 21 CFR 812.140: General Responsibilities of Sponsors

GCP ICH E6: 1.51: Source Data

GCP ICH E6: 1.52: Source Documents

Guide to Clinical Data Location (Clinical Data Matrix) (How to connect with patient data across

UH systems and affiliated hospitals for continuity of care and patient safety)

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCareAmbulatory/docs/Document_

Matrix/ Clinical_Data_Matrix.pdf#search=clinical%20data%20matrix FDA BIMO Chapter 48: Biomedical Monitoring Program 7348.811

Ohio Code 4731-23-02 - Delegation of Medical Tasks

UHCare Link (Information for UHCare training manuals and job aids): https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCare/Training2_Home.aspx

UH IRB Policy: Informed Consent

UH IRB Policy: Records

UH Policy CP-44: UHCare Training for Clinical Staff

UH Policy CP-50: Worklist Documentation (including eMAR)

UH Policy EMR-1: Integrated Interdisciplinary Documentation and Charting in UHCare

UH Policy EMR-2: Master UH Care Order Management

UH Policy EMR-3: UHCare Medication Administration Record

UH Policy GM-49: Medical Records Completion

UH Policy GM-61: Accessing Medical Records (Section 12.3 Research Records)

UH Policy GM-68: Medical Record Content

UH Policy GM-71: Patient Access Service (PAS).

UH Policy GM-93: Timely Completion of Transactions in the Ambulatory EMR

UH Policy MM-2: Medication order

UH Policy MM-4: Investigational Drugs

UH Policy PH-3: Permitted Uses and Disclosures of PHI (Section 2.11 – For Research)

UH Policy PH-4: Authorizations for Use and Disclosure of PHI (Section 7.1 – Research)

UH Policy PH-23: Psychotherapy Notes

UH Policy R-2: Patient Billing Under Research Grants

UH Policy R-3: Uses and Disclosures of PHI in Research

UH Research SOP GA-104: Scope of Practice

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCareAmbulatory/docs/Document_Matrix/%20Clinical_Data_Matrix.pdf#search=clinical%20data%20matrix

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCareAmbulatory/docs/Document_Matrix/%20Clinical_Data_Matrix.pdf#search=clinical%20data%20matrix

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCare/Training2_Home.aspx

STANDARD OPERATING PROCEDURE (SOP) FOR CLINICAL RESEARCH TITLE: Research Documentation

Last Revised: 5/2017 Prior Version: None



9

APPROVALS

Approved by Dr. Grace McComsey, Associate Chief Scientific Officer, University

Hospitals Health System, Director, UH Clinical Research Center– June 16, 2017

1

EMR Research Work Flow –Inpatient

Version 05/23/2017

Appendix A

Electronic Medical Record

Research Workflow - Inpatient EMR

Patient List Display_____________________________________________________________

Research staff will not see new patient lists. Lists will need to be created via finding a patient, or

via a Criteria List.

Finding a Patient_______________________________________________________________

1. Click the Find Patient icon located on the icon toolbar.

2. Click the Name, Identification, Provider or Other tab.

3. Type your search request. (e.g., Last Name>Smith.)

4. Click Search.

5. Select the patient from the Search Results.

6. Click the Show visit.

7. Highlight the correct visit.

8. Click Save Selected Patients to save to a Personal List.

OR

9. Click OK to save to a Temporary List

Flag a Patient as Research (Adding Research Participant to the Header)______________________

1. Click on the Patient info Tab.

2. Under Data Entry click on Comment.

3. Under the Type choose HEADER 1.

4. Under Comments, type in, Research Participant.

5. Click OK (Research Participant will show up on the Header).

If the patient is no longer in a research study than this will need to be removed from the

Header

2


Version 05/23/2017

Adding a Care Provider_________________________________________________________

1. Highlight the Patient’s Name for the Patient List.

2. Click the Add Care Provider icon

3. Choose a Type and Role in the Adding New Care Providers Dialog Box.

Types and Roles available are:

Type Role

Nurse Research Coordinator

Monitoring Population Tracking

4. Click OK.

Entering Health Issues__________________________________________________________

Health issues are entered via the Patients info tab based on Consent and Eligibility.

1. Select Patient Name from the Patient List

2. Click the Patient Info tab.

3. Click Health Issues in the Data Entry Section of the Patient info tab.

4. Select Research in the selection a type section.

5. Search for Research Protocol Name or IRB Number

NOTE: If searching for and IRB code, click the

Search Code box before entering an IRB number.

6. Click Add.

7. Double click the added Health Issue located at the top.

3


Version 05/23/2017

8. Select the Research Type from the status drop down box.

9. Type any notes that you will need for this s in the Description box.

10. Click Close.

Research Order Entry__________________________________________________________

DCRU Order Set (Only the DCRU nurses can/should document in the DCRU Research section)

Research Workflow

Role Work Flow

DCRU Nurses

Sign into the EMR

Find a Patient

Create patient lists by finding a patient, or by creating Criteria Lists.

Add a Care Provider to each patient.

Add Health Issue to each patient.

Be sure to mark each Health Issue as it is related to the Research Status

Admission Checklist

General Information

Health and Illness

Home Medications/Allergies

Additional information

Vital Signs

Pediatric Assessment

Pediatric Screens

Narrative Notes

All other DCRU Research documentation (physician order, study flow sheets) are

still hard copy source documents

Investigational Medicines

Role WorkFlow

Inpatient

Fax Order to Investigational Pharmacy

Investigational Drug Services (IDS) enters into the system

eMAR – sign off medications

Outpatient Fax Order to Investigational Drug Services (IDS)

eMAR – sign off medications

Other Areas Remains on paper

4


Version 05/23/2017

eMAR________________________________________________________________________

The Worklist Manager displays a list of your selected patient(s) tasks and medications for the

displayed period.

Anything currently documented an inpatient medication administration, continue that in EMR.

Outpatients will remain the same for now.

The standard eMAR view timeframes are:

12 hour shift (+2 hours before and 2 hours after)

24 hour shift

8 hour shift (+2 hours before and 2 hours after)

The filters at the top of the window allow you to change the worklist view in a number of ways

to display the information you wish to see. Click the drop-down arrow for the files you wish to

filter and select the appropriate options(s).

Update patient Information______________________________________________________

Research staff will enter or update the following patient information as appropriate:

Allergies

Significant Events

Home Medications

Worklist Manager_______________________________________________________

The Worklist Manager is used to view tasks that have been done and those that need to be done

for patients. This is also where tasks are documented against, such as “marked as done” or “not

done”.

Colors Used in the Worklist Manger

Color Description

Cyan background indicates a continuous task.

Magenta background indicates a PRN task.

Yellow background indicates a scheduled task

Red background indicates an overdue task.

Green background indicates it is an unscheduled task.

Blue background indicates a manual scheduled task.

5


Version 05/23/2017

Purple background indicates a conditional order/task.

√ White background and a check mark indicate all occurrences are recorded.

White background without a check mark indicates no occurrence within the designated time frame.

Green trough indicates unscheduled tasks.

Yellow trough indicates provisional tasks where the order was placed after the last scheduled time for

today. The trough enables you to perform the task sometime within the trough time frame if desired.

Magenta trough indicates scheduled or non-scheduled PRN tasks.

White task description cell with a single line through it indicates a discontinued / canceled task.

References____________________________________________________________________

UHCare Training including Job Aids

Training and Job Aid information on UHCARE Acute and Ambulatory settings for allied health,

nurses and physicians/providers.



1

EMR Research Work Flow – Ambulatory

Version 05/23//2017

Appendix B

Electronic Medical Record

Research Workflow – Ambulatory EMR

Finding a Patient______________________________________________________________________

Application opens to daily schedule, select patient. If patient is not on the schedule, “select patient”, “last

name” or “MRN #” or “DOB”. The clinical desktop = home page for patient chart.

Flag a Patient as Research______________________________________________________________

There are two ways to flag a research subject (please use both ways), from the clinical toolbar:

1. Select the “FYI” icon in the patient banner; enter free text regarding research study. The

FYI button will turn from white to yellow when a comment has been added.

2. Select the “i” icon in the patient banner to “Add an Alert”, select “Research Study Patient”

this will mark an alert in the patient banner in a very noticeable red font. Alerts can be removed

when patient has completed study.

Add Care Provider/Assigning Research Care Provider(s)____________________________________

From the clinical toolbar, select the “i” icon in the patient header, in the demographic section, select

“Patient Care Team” tab. Enter the following: names of the research team caring for the patient (e.g. PI,

Co-I, study coordinator, study nurse…), role, relationship (e.g. research coordinator). Select “Comment”

section to enter additional data or free text (e.g. research study name, IRB number), and contact numbers.

Entering a Health Issues/Research Diagnosis ______________________________________________

From the clinical toolbar, select the “Problem” icon, select “Research” diagnosis code Z00.6. Select

“Comments” section to enter additional data or free text (e.g. study start and stop dates).

Creating a Research Visit and/or Research Telephone Note(s)________________________________

1. For a generic Visit Notes: from the clinical toolbar, select the style as “note authorizing” icon, and

then select a “visit type as “office note” and complete requested details.

2. For a Nursing Visit Note: Select “visit type” as “nursing visit”, and then select the following:

“Nurse Note” - REQUIRES MD/Licensed Medical Provider sign off.

“Nurse Note - Per Protocol” - No need for MD/Licensed Medical Provider signs off but can

forward to doctor, will appear on task list.

Some fields (current medications list, date of birth, allergies) will auto populate.

2


Version 05/23//2017

3. For a Telephone Note – Select “communication” than select “telephone note”.

Research Order Entry________________________________________________________

1. Order Entry: from the clinical toolbar, access the “Add Clinical Item” icon and select the

appropriate tab based on the type of order you wish to enter (i.e. Rx, lab, Proc, Rad, etc.) and

complete requested information.

For research orders, complete the following “Select the order detail tab, scroll down past the

details section to the question section, select “yes” to Research and enter the grant number and

the IRB number of the research study.

3. Resulting Orders: can be documented by selecting the clinical desktop and select the “HMP or

Orders tab" and enter result details.

4. Authorizing Orders – based on your workscope, orders may need to be signed off by the

provider.

5. Orders Completion - may occur automatically or may need to be done manually.

Documentation and Sign Off on Investigational Drugs_______________________________________

There are two places to add medications to the chart, from the clinical toolbar, select:

1. “Rx” tab – Not recommended. This choice sends a message to the physician to approve the

medication

2. “Medical History” tab – Free text box – can add anything, unspecified medication,

investigational product

Select “Unspecified Research Medication” from the medication dictionary. Comments can be added

(e.g. study drug name/placebo).

*Please note, the system cannot check for drug to drug interactions when using medications listed as

“Unspecified Research Medication”.

Scanning of Research Informed Consent and Other Research Document______________________

Scanning documents is a separate application but makes documents available in UHCare. Once

documents are scanned they can be put into patient specific folders. Documents can be filed in the

“Research” or other folders.

Ambulatory Scan Job aid Job aid for scanning documents into the EMR.

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCareAmbulatory/docs/Provider/ScanGuide

FINAL.pdf

EMR Standard Filling Guide Master The table provides a roadmap for placement of scanned documents into folders within the patient’s EMR.

https://intranet.uhhospitals.org/ClinicalProfessional/PhysicianServices/docs/UHCare_Policies/Standard_F

iling_Guide.xlsx

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCareAmbulatory/docs/Provider/ScanGuideFINAL.pdf

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCareAmbulatory/docs/Provider/ScanGuideFINAL.pdf



3


Version 05/23//2017

Guide to Clinical Data Location (Clinical Data Matrix) The ability to connect with patient data across the UH system and affiliated hospitals is vital to continuity of care and patient

safety. The table provides a roadmap for patient data by source, type and location.

https://intranet.uhhospitals.org/ApplicationsPortal/System/UHCareAmbulatory/docs/Document_Matrix/C

linical_Data_Matrix.pdf#search=clinical%20data%20matrix

References___________________________________________________________________________

UHCare Training including Job Aids Training and Job Aid information on UHCARE Acute and Ambulatory settings for allied health, nurses and

physicians/providers.





Appendix C

Registration for Athena and Soarian

Registration v Scheduling

• Corporate Compliance mandate: all clinical

research participants must be registered with a

MRN

• Outpatient departments register own patients

• At CMC, Patient Access Services (PAS) registers:

– Radiology

– Seidman

– Dahms Clinical Research Unit (DCRU) visits for

both RB&C and Coleman Clinical Research Suite

• Patients must be scheduled for billable

research services

– Hospital/technical (UHC, PMC, SJMC etc)

– Professional (UHMG)

– Not necessary to formally schedule

research personnel time only visits (e.g.

Study Coordinator or research nurse)

Registration v Scheduling – cont.

Research Registration - Athena

Registration team adds research “insurance”

Research Registration - Soarian

9/2014

February 7, 2012

Be the Difference.

Scan 1

UHCare Ambulatory Scan

UHCare Ambulatory Scan Overview

The Scan module is an electronic imaging and chart management application. It is used to transfer written documents such as consults, some test results, journal articles (for reference), and other pertinent chart information into an electronic format.

Scanned documents are indexed to the appropriate patient for the appropriate visit and under the correct document type.

Scanned documents may then be viewed from the Clinical Desktop.


Job Aid UHCare Ambulatory 2

Logging In to Scan

1. From the desktop, double-click the UHCare Ambulatory Scan icon.

The UHCare Ambulatory Scan Sign On page displays.

2. Enter your User Name and Password.

Your User Name is your UH Network User ID.

Your initial password is welcome01.

Note ► You must change your password manually the first time you access UHCare Ambulatory Scan by clicking Configure and Change Password.

3. Click Login.

4. Accept the Licensing Agreement, if necessary.

Note ► The User (or User Group) rights govern what is available to the Scan user. Certain buttons or pages may be grayed out or unavailable based on these rights.


UHCare Ambulatory Job Aid 3

Searching for Patients in UHCare Ambulatory Scan

1. From the Scan toolbar, select the Search Menu.

2. Select Patient Charts from the drop-down menu.

3. Complete the Patient and Type fields in the Patient Search page.

4. Click Search.

Tip ► Users may search for patients by Name, MRN, DOB, Phone, Other, or Bar Code.

5. On the Pick Patient page, select a patient name.

6. Click Select.

The Patient Chart displays with the Chart Group in the middle of the page.

7. To view a document in a chart, select the appropriate folder from the Chart Group.

8. Double-click the folder to open it.

Notes Regarding Folders

Empty Folders are gray.

Parent folders with content are gray/yellow.

Sub-folders with content are yellow.

System folders have a blue diamond.



Batch Scan with Tasking

The Batch Basket workflow is the preferred method when scanning similar document types for multiple patients.

Similar documents may be placed in a pile upon receipt and scanned in as a Batch Basket by anyone at the end of the day. Once all documents are scanned, they must be sorted to the appropriate patient chart.

Recommended batch size is less than 50 pages.

1. From the Scan toolbar, click Batch.

2. Select Scan.

3. From the Batch Scan Documents page, enter a name for the batch.

Note ► Batch names should be intuitive to the document type and contain your 4 letter code for your practice. (This is the same code as entered into ImpactMD and Athena).

Tip ► The Default Document Name and Default Document Date are default values and may be changed while sorting to a patient’s Chart Group folder.

4. Set the Access Group to limit access to this batch to specific groups of users, if necessary.

5. Click Scan to begin scanning the batch.

6. Click Sort to Chart to sort images to patient charts.

7. Manipulate the image as necessary to identify the document type and identify the patient.

8. Enter Name of the Patient (Last Name first) in Patient field.

9. Click Search.

10. Select the patient.

11. Click on ellipsis next to the Current Folder field to display the Folder Tree Window.

12. Click the appropriate folder to file this document.

13. Click OK.

14. Enter the Document Date, if not, enter today’s date.

15. Verify that the owner of the document is the Provider.



16. If the owner is incorrect, then click the ellipsis (three dots) button next to the Encounter field and choose the correct encounter.

Note ► By choosing the correct encounter, the correct owner will automatically fill in.

17. To task this document to the Provider for electronic signature, choose the Send Review Task to Owner in TouchWorks button, if necessary

18. Click File Document.

19. Click [Page 2] if the current document is an additional page to the last document that was filed.

20. If all remaining pages belong to the same document, click File Remaining Pages to include the remaining images as additional pages.

21. Repeat steps 9-19 to complete the batch scanning.

22. Close (door) when completing batch scanning and close again to get to initial screen.

Filer Scan with Tasking

The Filer workflow is the preferred method when scanning multiple documents of different types for a single patient.

The Filer workflow may also be used when scanning a single document type for a single patient. Using this method images are scanned into the specific folder, thus eliminating the need for the filer to indicate document type.

1. Place the document in the scanner.

2. Log in to Scan.

3. Click Search.

4. Select the patient.

5. Count your pages before you begin.

Tip ► While the scanner can scan up to 50 pages at a time, it is recommended that you don’t scan more than 30 at a time to avoid jamming.

6. From the Scan toolbar, click the Scan button .

Tip ► The patient information displays in the Chart#, SSN, and Name fields.



Note ► All documents will be scanned into the To be filed folder. The Document Name and Date fields default to the system date and folder.

7. Select the Duplex option if scanning double-sided documents.

Note ► If using a flatbed scanner, the user is prompted to continue scanning after each page.

8. Click Scan.

Note ► When scanning is complete, the application returns to the patient chart and the To Be Filed folder contains the scan job.

9. Click Filer to file documents to the Chart Group folders for the patient.

10. Manipulate the image as necessary to identify the document type and identify the patient.

11. Confirm that the document type and date are correct.

12. Change the date to match the date of the document being scanned.

Note ► The document date defaults to the scan date.

13. If the document needs to be electronically tasked to the Provider for an electronic signature, complete the following steps:

a. Click New Task (icon with the circular arrow) on the Scan Toolbar

The Create New Task window displays.

b. From the Category drop-down, select Verify or Sign.

c. Click To .

d. In the Type Name field, enter the Provider’s name.

e. Click once on the Provider’s name.

f. Click To-> in the middle.

Note ► The Provider’s name should show on the right side.



g. Click OK.

h. In the Reply To drop-down, verify that the sender’s name displays.

i. Enter a short description of the document or message being sent, if desired.

j. Click Send to send the task and return to the Document Viewer.

Note ► Once the task is sent, it displays on the Task List in UHCare Ambulatory for follow-up.

k. Set the status of the task using the buttons at the top of the window:

The default is set to Normal, no icon required.

The red exclamation point denotes Urgent.

The blue arrow means Low Priority.

14. Click the sub-folder button to file the scanned image as the selected document type.

15. Click [Page 2] if the current document is an additional page to the last document that was filed.

16. If all remaining pages belong to the same document, click File Remaining Pages to include the remaining images as additional pages.

Note ► The association between the image and selected document type is not finalized until the page is closed.

Tip ► Any images not filed will remain in the To Be Filed folder.

Searching for a Document in UHCare Ambulatory Scan

1. From the Scan toolbar, select the Search Menu.

2. Select Documents from the drop-down menu.

3. In the Document Search window, enter your search criteria.

The Document tab enables a user to enter document specific search criteria by: Document Number, Document Date, Document Name, Acquire (Scan) Date, Last Change, Chart Group, and Folder.

The Chart tab enables a user to enter patient specific search criteria by: Site, Patient, and Type.

4. Click Search.

5. Click Clear to clear the search tabs and search again.

Tip ► To re-access recent patient charts, from the top toolbar select Chart Lists and then Recent from the drop-down menu.



Viewing a Document in UHCare Ambulatory Scan

1. To work with a document in Scan, bring a patient into context.

2. Select the appropriate folder from the Chart Group.

3. Double-click a document to open it in the Document Viewer.

4. To manipulate the scanned image, use the toolbar at the top of the Document Viewer.

Document Viewer Toolbar Options

Informed Consent Documentation Checklist

Protocol Title:

IRB Number: Principal Investigator:

Version 5/2017

Study ID: _______________________ Study Visit Date: _____________________________ (Month /Day/Year)

Date of first contact with participant regarding study: __________________________________

Informed Consent (ICF) Obtained by: ______________________________________________

Date Signed: _____________________ Time Signed: _________________________ (Month/Day/Year) (Military time format)

Individuals present during the informed consent process: ________________________________________

Date and Time research activities began: _____________________________________________________

Did the participant verbalize an understanding of the main purpose Yes No

of the study, procedures, follow-up, risks, etc.)

*If no, what additional procedures were used to ensure understanding? (Please list): ______________________________

The participant was consented in a private location, e.g. exam room, private office. Yes No

*If no, what additional procedures were used to ensure privacy? (Please list): _____________________________________

Were the participant’s questions answered to his/her satisfaction? Yes No

Were others involved in the decision making? Yes No

If yes, who? / Relationship: __________________________________________________________

Was the participant given a current, stamped copy of the ICF? Yes No

Version Date/Number ___________________________ Expiration Date: ________________________________

ADDITIONAL DOCUMENTATION

The participant signed and dated the ICF before any study procedures were performed. Yes No

The participant was given adequate time to review the ICF and ask questions. Yes No

The participant was entered on the Enrollment Log. Yes No

A copy of the consent form is filed in the UH medical record. Yes No

The current UHCMC IRB consent template version is being used and appropriate signature Yes No

blocks are present (i.e., LAR, next of kin, one parent, two parents, etc.)

FORM COMPLETED BY: __________________________________________ DATE: ____________

Master Master

To Be Filed To Be Filed Documents in this folder are not viewable in the EMR

Scanned documents that have not yet been filed

Clipboard Clipboard System folder. Please do not scan

Imported Documents Imported Documents System folder. Please do not scan

HITECH RESTRICTIONS HITECH RESTRICTIONS PHI Restriction Request form

PATIENT NOTES Office Notes Office Notes

ACOG ACOG documentation

Psych Clinical Documents Beck Depression Inventory - pre and post score

Psychological evaluations and documentation

History & Physicals EPSDT form

Growth Chart

History and Physical Exam documentation

Medicare Initial Physical form

Physical Exam form

Well Child Care form

Past Medical History ASQ Information summary

Athena Physical History Form

Gap Survey

Past Medical Information Sheet

Patient Questionnaire

Problem List

Phone Messages Parent Communication Log

Phone message sheet

Phone Messages

Rainbow Advice Center messages

Triage Call Documentation Report/Nurse Triage

Backfill Information Storage area for UHCare Ambulatory backfill forms

Procedure Notes Documentation related to procedures

Urodynamics

Hospital Notes Hospital Notes

Devices Devices other than Cardiac and Hearing Aid

OP Reports OP reports and documentation

H&P (Hospital) H&P documentation

Discharge Summary Patient Discharge Summaries documentation

ED Report ED Visit documentation

Health Maintenance CONNERS/ ADHD Assessment Form

Diabetic Flow SheetHealth Maintenance documentation, such as Logs and wellness documents

NICHQ Vanderbilt Assessment Scale

Vaccine and Immunization forms

Medication Refills Medication Refill requests

Ritalin Summary

Notes/Alerts - Impact MD Notes/Alerts - Impact MD

Chart Notes - ImpactMDChart Notes brought over during ImpactMD conversion. Do not scan

Alerts - ImpactMD Alerts brought over during ImpactMD conversion. Do not scan

Referral/Consult Professional correspondence

Prenatal Do Not Scan into this folder ‐ use ACOG folder

LABORATORY Blood Work Blood Work documentation and results

PT/INR Anticoagulation/Protime Flowsheet

Blood Work documentation and results

Pathology Pathology documentation and results

PAP Pap results

Other Lab ResultsLaboratory documentation and results other than blood work and pathology

Urine Urine results

RADIOLOGY/IMAGING Breast Imaging Breast Imaging images and impressions

CT + CTA CT and CTA images and impressions

Intervential Radiology Interventional Radiology images and impressions

MRA + MRI MRA and MRI images and impressions

Nuclear Medicine Nuclear Medicine images and impressions

Radiography + Fluoroscopy Radiography and Fluoroscopy images and impressions

Ultrasound Aortic or Venous Duplex scans.

Carotid or Vascular reports/studies

PVR – Pulse Volume Recordings

US, Sonograms

Other Radiology *

Drawings/Diagrams Drawings/Diagrams

Tumor Map Tumor Map

DIAGNOSTIC TESTING Cardiovascular Testing Cardiology

Angiogram Angiogram documentation and results

Catheterization Catheterization documentation and results

Doppler Doppler documentation and results

Echo Echo documentation and results

EKG EKG documentation and results

Monitors Cardiovascular Monitoring data and documentation

Stress Test Stress Test documentation and results

CV Devices Cardiovascular device documentation

Initial Interrogation Report

Mechanical Assist Device and Lead Information sheet

PST Meter Training

Pulse Width Threshold Test

Other CardiovascularCardiovascular Testing documentation and results other than those categorized above

Gastro Testing Gastro Testing

Colonoscopy Colonoscopy documentation and results

Endoscopy Endoscopy documentation and results

Barium Swallow Barium Swallow documentation and results

EGD EGD device documentation

Other GastroGastro Testing documentation and results other than those categorized above

Neurology Neurology

EEG EEG documentation and results

EMG EMG documentation and results

Other NeurologyNeurology documentation and results other than those categorized above

Pulmonary Testing Pulmonary Testing

Bronch Bronch documentation and results

Sleep Study Epworth Sleepiness Scale/ ESS

Sleep Questionnaire

Sleep Study documentation and results

PFT/Spirometry PFT and Spirometry documentation and results

Other Pulmonary Pulmonary Testing documentation and results other than those categorized above

Other Testing Speech Therapy

Testing information that doesn't go into any other folder listed.

Voice evaluations

Vision Vision testing documentation and results

Advanced Diagnostic tests Advanced Diagnostic testing information

Audiology Hearing test documentation and results

Hearing Aid/Spec Devices Hearing aid and device information

Cochlear Implant Cochlear Impact information

Allergy Allergy

Skin Testing Skin Testing documentation

Patient Formula Immunotherapy form RX

Patient Formula sheet

Shot Chart Antigen Shot Record

Immuno-Progress sheet

Shot Reaction Record

Venum Shot record

Xolair/ IVIG Xolair/ IVIG forms

PATIENT INFORMATION ABN Patient ABN Consent Forms

Consent Forms Contract for Controlled Substance Prescriptions

Other Patient Consent Forms

DNR/DNI/Directives Advanced Directives

HIPAA HIPAA-related documentation

Living Will Patient's living will

POA Power of Attorney

Registration Forms Patient Registration Forms

ROI Release of Information Forms

Other Patient Information Other patient forms that do not match any of the above folders

CORRESPONDENCE Patient Patient

FMLA FMLA case documentation

Physical Forms Patient Physical documentation

Disability Disability Claim forms and documentation

Insurance Patient insurance documentation

Medical Records/Record ReleasMedical Record Release Forms and requests

Legal Legal forms and documentation

BWC Miscellaneous BWC documents not listed below

C9 C9 Forms

First Report of Injury First Report of Injury Forms

Medco 14 Work Ability Frm Medco 14 Forms

C23 Change Phys of Record C23 Forms

Medco 31 Prior Auth Meds Medco 31 Forms

DOT Forms DOT Forms

BWC Clinical Notes BWC Visit Notes/documentation

MRO Verification MRO Verification Forms

Incident Report BWC Incident Reports

Miscellaneous Miscellaneous Correspondence

Surgery Reservation Request

Rehab/Home Health Home Health Visit Notes

PT/OT

DME Certification DME Certification forms

Multidisciplinary Notes Craniofacial notes

Social Work Social Work

Dietary Dietary

OLD RECORDS OLD RECORDSTransfer records sent from a different practice. Usually proceeded by an Authorization to release information

MISFILED MISFILEDDocuments in the wrong patient's chart that have been electronically signed by the physician

DATA SOURCE DATA TYPEPhysicianPortal

Community Record*

State HealthInformationExchange (HIE)

UHCare Acute EMR

UHCare Ambulatory

EMR

UH PersonalHealth

Record (PHR) OTTR

Demographics (ADT) ‐ Downtime Only x x xAllergies x x x

History & Physical x x xProgress Notes x

Consults x x xDischarge Summary x x x

Oncology Notes (Ambulatory) x x xCoordinated Care Notes x x xMedication Reconciliation x x

C‐CDA x x

CCD x x xOffice Visit,

Health Maintenance,Dietitian, Medicare, PharmD,

PPD Result, Procedure Notes

x x x

Athena Registrations (ADT) x x x x x xCardioLab (PRUKA) Adult Electrophysiology x x x x

CoPath Pathology x x x x x xSyngo Peds ECHO x x x X xEmbla Sleep Lab Studies x xHeartlab Adult Cath/Vascular/Stress x xSyngo Adult ECHO X X X X XIDX Rad Radiology Reports (textual) x x x x x x xMedgis Genetics Reports x x

MedQuist Transcriptions (unsigned) x x x xMeta Demographics, Dx, Px x x x

Meta (eSig) Transcriptions (signed) x x xMuse EKG wave reports x x

Provation GI Documents x x x (select results) x x xSoarian Demographics (ADT) x x x x xSoftlab Lab Results x x x x x x xSoftlab Microbiology x x x x xSpheris Transcriptions x x x x

Viewpoint Ultrasounds x x x

The ability to connect with patient data across the UH system and affiliated hospitals is vital to continuity of care and patient safety. The table below provides a roadmap for patient data by source, type and location. If you have any questions, please contact the Clinical Portals team at [email protected].

DATA RESIDES IN:

UHCare Acute EMR

UHCare Ambulatory EMR

Revised: 10‐15‐15

UHCare Acute EMR

UHCare Ambulatory EMR

UH Ancillary Systems


Community Record*


UHCare Acute EMR

UHCare Ambulatory

EMR

UH PersonalHealth

Record (PHR) OTTR

DATA RESIDES IN:Revised: 10‐15‐15

Orchard Harvest Lab Results x

McKesson Demographics (ADT) xCerner Lab Results and Microbiology xSeris RIS Radiology Reports X

Dictaphone/Horizon Transcribed Notes X

Demographics (ADT) xRadiology Reports xTranscriptions x

Lab Results and Microbiology x

Soarian Demographics (ADT) xDictaphone Radiology Notes xSiemens EDM Transcriptions x

SoftLab Lab Results and Microbiology x

Demographics (ADT) xRadiology Notes xTranscriptions x

Lab Results and Microbiology x

Demographics (ADT) xLab Results x

Transcribed Notes xMedications x




Portage Medical Center

Data from Other FacilitiesUniversity Suburban Health Center (Green Rd.)

Parma Medical Center

Mercy Medical Center

Meditech

Meditech

Meditech

Elyria Medical Center

Southwest General Health Center

Cerner

St. Vincent Charity Hospital

St. John Medical Center

Meditech


Community Record*


UHCare Acute EMR

UHCare Ambulatory

EMR

UH PersonalHealth

Record (PHR) OTTR

DATA RESIDES IN:Revised: 10‐15‐15


* In the UHCare Ambulatory EMR, access Community Record by selecting the “Community” button at the bottom on the Clinical Desktop. In the UHCare Acute EMR, select the “Community Record” tab.

Meditech

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