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THE POWER OFADVANCED MEDICINE

Daoping Zhang, MT(ASCP)SBBcm, Blood Bank

University of Kentucky Chandler Hospital

daoping.zhang@uky.edu

August 16, 2019

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DisclosureI have no conflicts of interest to declare in

relation to this presentation.

Blood Bank is full of paper records, we are barely keeping ahead everyday!

• QC and temperature forms

• Antibody panels

• SOPs and form document

• Staff review and training document

• QA and testing reports

• Blood Bank orders and pick up forms

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• Tech time: finding, recording and filing the paper forms are time consuming

• Consistency of record: paper records are hard to keep up and difficult to ensure accuracy and completion

• Document control: is challenging to ensure every staff is correcting a record following document correction policy; or not to use an outdated document (eg. old copies or did not replace old document with updated one promptly)

• Document access: taking time to access document due to different storage locations, such as binders, folders, cabinets, drawers or warehouse, etc

• Storage and space needs: most of the records have to be kept for at least 5 years, some are kept permanently, there are limited space to keep all the records; packing and shipping to warehouse cost manpower and money

• Save manpower and reduce time searching for document

• Increase completion, accuracy and consistency

• Easy access, maintenance and customization

• Improve compliance on document control

• Secured documents

• Reduce costs and storage needs

• Save environment

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• Analyze the problems

• Select an improvement

• Organize a team

• Identify an issue

Plan Do

StudyAct

• Electronic documentation of QC, PM, and critical supply

• Electronic document control system of SOPs/forms

• Electronic documentation of temperatures

• Electronic document and storage of antibody panels

• Electronic documentation system for CAP checklist

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Went live on 7/1/16

Create e-forms using Excel or Microsoft Word

Store e-forms in designated UKBB Sharesitewith authorized Read/Write access for BB users

Assign form control number for each e-form correlated to its paper form with password protection

Follow routine document control process and document correction policy

Perform record review per routine process

Archive and lock the e-forms monthly once review is completed

• UK SharePoint system to store Blood Bank SOPs and forms - went live on 11/1/16- Authorized user with Read only access- Easy access to SOPs and forms on PC- Designee to upload new/updated SOPs/Forms inSharepoint, maintain document control log, andensure both e-record and paper copy are current and matched

- A great improvement

However, approval and staff sign off process were still on paper trial.

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MediaLab is a cloud based software solution for laboratory document control , InspectionProof and continue education.

Like: SOPs document control went live on 5/1/19 Streamlined and standardized a paperfree secured document

control system for SOPs and forms Collaboration workflow to share edits among reviewers Signature workflow to approve document Automatic email notification to inform review, approve, sign off or

task status To-Do-List displaying incomplete tasks Print controlled copy of document Tracking record of signature and edit history View/Print task reports and sign off reports Automatic weekly backup of all information A designee will download the backups weekly Work in progress: forms control go-live in September

Dislike: • Too many email notifications! Need to customize the email

notifications properly.

Sample: MediaLab Email Notification

Sample: MediaLab To-Do-List

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MediaLab could download current CAP inspection checklist

Link SOPs to checklist items

Attach supporting documents to checklist items and freetextresponses

Easily update checklist to new edition and copy responses accordingly

Work in progress: go-live in October 2019

Like: Paperless-no more thick stack of paper checklists and paper

documents

Simple, easy and organize

Make inspector happy!

• SensoScientific system went live on 8/21/17• Continually record equipment temperature, cloud based,

centralized monitoring system, no more chart recorder• High/Low alarm• Email/phone notification if alarm goes off• Daily/monthly temp graph reports• View/Print reports including temp and corrective action

reports• We use an e-form to document daily and monthly temp

review

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Helmer iC3 equipment temperature recording device

Continually record temperature

High/Low alarm

Daily/Weekly temp graphs

Display alert detail for each alarm event

We use additional e-form to document daily and monthly temp review

Cons: • Store only one month’s temp data in device which requires monthly

download and store temp data

• When the device is down or broken, might lost previous temp records

• Require installation of additional remote alarm system if the equipment is located at a remote area

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Problems:• Lot of paper panels accumulated throughout the

years

• Long retention period

• Need to be kept on site for immediate access

• Taking out storage space

• Tech time to file and refile records

• Time wasted to search panel records especially there is a misfile

• Environmental harm

Solutions:• Electronic storage of antibody panels

• Paperless system to document and store antibody workup

Organize a project team consist with BB staff members Distribute tasks to each member

- Create electronic Ab panel folder in restricted UK Sharesite for each patient- Scan each panel and save it to the related e-folder for each patient - Review and audit process to check completeness and accuracy of scannedpanels

- Organize and separate scanned vs unscanned panels- Separate and transport the panels on expired patient to ware house

Spreadsheet to keep up with progress status of each task

Time line: > 2 years, very challenging!- Massive workload and continuous new add on panels - Lack of manpower to keep up with on-going work (Helper: college students from hospital volunteer program to help scan the panels, a huge success!)

Finally completed in Nov 2018 (project started in 2014)

Unresolved issue: Paper Documentation

Current Panels Progress SheetORDER OF

OPERATIONS-> Folders Staples Scanned Merged Sorted Uploaded CheckedBackup to

USB

AHPY 5-10-18 X

X 06/18/18

AE

06/19/18 AE

10/26/18 AE

07/11/18 AE

7/11/2018

08/06/18 AE

08/31/18 AE

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Antigen-Plus software: the antibody identification system

Option of hosting in Cloud or on local server Download available commercial Ab screen and

panel antigrams Combine Ab screen, panels and selected cells on

one Ab work sheet Customize the Ab work sheet to allow entering

results under diff. testing methods, eg. gel, elution, tube, absorption, etc

Display antibodies that are ruled in/out Ab ID evaluation system to assist Ab interpretation Could print out completed panels, or store on line

for review and record retention We create a coversheet to document patient info

and history Ab worksheet and coversheet are saved in restricted

UK Sharesite Work in progress: will go-live in Sep/Oct 2019

Looking forward to this paperless system!

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Moving from paper to electronic significantly improve documentation

management!

Project Reminder:

Organize a project team

Set timeline and follow up on progress

Validation

SOPs

Staff training