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 |
