OTIS-Blood Bank vs. OTIS-Laboratory

Nouvation’s OTIS®-Blood Bank (“BB”) and OTIS®-Laboratory (“Lab”) are “sibling” incident management or CAPA software solutions designed to drive process improvement and compliance in the blood bank (or hospital transfusion service) and laboratory, respectively. As such, these deviation tracking-and-trending systems share nearly identical functionality (return to OTIS Overview to review these commonalities). They primarily differ in the data elements they track and trend, which the table below delineates. The “C” indicates elements coming in next upgrade.)

Data Element or Feature
BB Lab
Capture supporting documents (SOP pages, emails, etc.) via scanner attached to workstation, OTIS’ unique virtual scanner (e.g., click on Word or PDF doc) or Windows Clipboard; view all data and supporting documents on one screen

Yes

Yes

Individual (staff or QA) initiating incident
Automatically fill in individual, date and time per login

Yes

Yes

Location of event (incident)
Customizable drop-down list

Yes

Medical record number
Free-form field

Yes

Date discovered
Pop-up calendar

Yes

Yes

Time discovered
Drop-down hour & minute lists

Yes

Date occurred
Pop-up calendar

Yes

Yes

Time occurred
Drop-down hour and minute lists

Yes

Person who discovered incident
Drop-down list

Yes

Yes

Non-physician(s) involved (optional)
Free-form; minimum entry is last name

Yes

Physician(s) involved (optional)
Free-form; minimum entry is last name

Yes

Immediate corrective actions taken (optional)
Free-form with spell-check

Yes

Yes

Supervisor(s) notified (optional)
Free-form with comment and spell-check; customizable drop-down list of means of notification

Yes

Description of the incident
Free-form with spell-check

Yes

Yes

Customizable incident description library (optional)
“Standard” library description may be modified/augmented; spell-check available

Yes

   C
Person responsible for investigating incident
Customizable checklist or drop-down list

Yes

Yes

Employees involved
Checklist

Yes

Yes

Employee statements (optional)
Free-form with spell-check

Yes

SOPs involved (optional)
Listed by SOP ID

Yes

Yes

Process improvement suggestions (optional)
Free-form with spell check

Yes

Staff notice(s) (optional)
Free-form with spell-check

Yes

Units involved (scannable ID with component codes and disposition)
With customizable, drop-down lists for component code and immediate disposition

Yes

 N/A
Deviation code(s)
Fully customizable; multiple code sets may be defined; any incident may be assigned two deviation codes, one from each of two code sets.

Yes

Yes

Customizable flags (optional)
Drop-down list (cf. tagging manila folders with vari-colored tags to signify different conditions)

Yes

   C
Group review required indicator (may be implemented in BB via flags)
Check box and date completed

Yes

Medical director review required indicator (may be implemented in BB via flags)
Check box and date completed

Yes

Preloaded and customizable list of root causes
Customizable checklist

Yes

 Yes
FDA-reportable indicator
Date due, date reported, FDA confirmation number; nag screen on launch until incident is reported

Yes

 N/A
Corrective actions taken as a result of the investigation (optional)
Customizable checklist

Yes

Yes

SOPs revised as a result of the investigation (optional)
Listed by SOP ID

Yes

Yes

Other related reports (e.g., MIDAS) (optional)
Customizable

Yes

 

17639 Beech St., Fountain Valley, CA 92708 | (714) 963-7099