Blood Bank Conversion Validation Guide

Blood Bank Conversion Validation Guide

Version 3.0

December 14, 2004

MEDITECH Circle, Westwood, Massachusetts 02090

(781) 821-3000

THIS INFORMATION IS PROPRIETARY AND SHOULD BE TREATED ACCORDINGLY

Introduction

The exercises in this guide are designed to assist you with validating the data converted from the Blood Bank Historical Conversion. Please note that these exercises will use only a sampling of patients and that it is the hospital’s responsibility to validate all records in accordance with its policies and procedures and any regulatory requirements for Blood Bank validation.

1.1: Validation of Medical Records

This section will validate the medical records of the patients who are included in the conversion. The validation process should begin with the start of the conversion in ZCONV (C/S) or MRI.CNV (Magic).

Functions to be validated::

Medical Records linked during the AUTOLINK

Medical records linked manually during the PROCESS MEDICAL RECORDS

Medical records created during the PROCESS MEDICAL RECORDS

Reports to print:

PRINT PATIENT (in Medical Records)

LIST FINALIZED MEDICAL RECORDS

Exercise 1:

From the List Finalized Medical Records report, select a patient that was auto-linked. Using the Print Patient routine in Medical Records, print this report and verify that this patient has only one medical record number. Print this report and attach it to this validation exercise.

Patient name: ______Unit #: ______

THIS ROUTINE VALIDATED BY: ______DATE: ______

ACCEPTABLE:NOT ACCEPTABLE:

Exercise 2:

From the List Finalized Medical Records report, select a patient that was manually linked. Using the Print Patient routine in Medical Records, print this report and verify that this patient has only one medical record. Print this report and attach it to this validation exercise.

Patient name: ______Unit #: ______

THIS ROUTINE VALIDATED BY: ______DATE: ______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 3:

From the List Finalized Medical Records report, select a patient that had a new medical record created. Using the Print Patient routine in Medical Records, print this report and verify that this medical record was created in the correct facility, as defined in the conversion parameters. Print this report and attach it to this validation exercise.

Patient name: ______Unit #: ______

New Medical Record Facility defined in BBK Conversion Parameters: ______

THIS ROUTINE VALIDATED BY: ______DATE: ______

ACCEPTABLE: NOT ACCEPTABLE:

1.2: Visual Validation of the Blood Bank Conversion

The converted histories should be compared with the data in your current system for accuracy. This step in the conversion is critical for the conversion to proceed as scheduled. It is to the hospital’s benefit to identify and correct field-formatting errors, missing demographic data, etc at this point.

Functions to be validated:

BBK HISTORY INQUIRY

BBK HISTORY TRANSFUSION INQUIRY

VIEW BBK HISTORY from E/E REQUISITION

VIEW BBK HISTORY from RESULT ENTRY

VIEW BBK HISTORY from ISSUE UNITS

VIEW BBK HISTORY from ISSUE UNITS BY PATIENT

VIEW BBK HISTORY from E/E TRANSFUSION DATA

VIEW BBK HISTORY from TRANSFUSE UNITS BY PATIENT

Reports to print:

LIST CONVERTED HISTORIES

PRINT BBK HISTORY

PRINT ONE MEDICAL RECORD CARD

Exercise 1:

Print the List Converted Histories report. Keep this report for reference.

Choose a patient from the List Converted Histories report. Perform a BBK History Inquiry. Verify that the correct information is appearing on the report. This report should be compared to a report or card printed from your other vendor or to a card from your card file. Attach the other vendor report or card and the MEDITECH History inquiry to this validation exercise. Verify that the following information is correct:

Note: only compare items that are applicable to the patient selected

Patient Name: ______Unit #: ______

Field / Value
Blood Type:
Blood Type Date/Time/User:
Antigens:
Antigen Reaction:
Antigen Date/Time/User:
Antibodies:
Antibodies Date/Time/User:
Markers:
Markers Date/Time/User:
Comments:
Transfused Unit Number:
Transfused Unit Source:
Transfused Unit Product:
Transfused Unit Volume
Transfused Unit Blood Type:
Transfused Unit Date/Time:
Transfused By:
Transfusion Date:
Transfusion Start Time:
Transfusion End Time:
Unit Entered User:

THIS ROUTINE VALIDATED BY:______DATE:______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 2:

Choose a patient from the List Converted Histories report that you know has a converted transfusion. Print a BBK Transfusion Inquiry. Attach this report to the validation exercise. Verify that the correct information is appearing on the report. This report should be compared to a report or card printed from your other vendor or to a card from your card file. Attach the other vendor report or card and the MEDITECH Transfusion Inquiry to this validation exercise. Verify the following:

Is the transfusion data accurate? ______

Patient Name: ______Unit #: ______

THIS ROUTINE VALIDATED BY: ______DATE:______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 3:

1. Choose a patient from the List Converted Histories report. Create a new account

number for this patient and enter a requisition for packed cells. Verify that the correct

Blood Bank history information is appearing on the requisition screen. This

information should be compared to a report or blood bank history card printed from

your other vendor or to a card from your card file. Attach the other vendor report or

card to this exercise. Verify the following:

Note: only compare items that are applicable to the patient selected

Patient Name: ______Unit #: ______

Field / Display Correctly? Y/N
Blood Type
Antigens (AG)
Antibodies (AB)
Markers (MK)
Comments (CM)
Transfusions (TX)

2. File this requisition and record the specimen number: ______

THIS ROUTINE VALIDATED BY: ______DATE:______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 4:

Enter results for the specimen ordered in Exercise 3. Verify that the correct information is appearing on the screen. Verify the following:

Note: only compare items that are applicable to the patient selected

Field / Display Correctly? Y/N
Blood Type
Antigens (AG)
Antibodies (AB)
Markers (MK)
Comments (CM)
Transfusions (TX)

2. Verify the results.

THIS ROUTINE VALIDATED BY: ______DATE:______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 5:

Identify the patient, from exercise 3, in the Issue Units Routine. Verify that the correct information is appearing on the screen. Verify the following:

Note: only compare items that are applicable to the patient selected

Field / Display Correctly? Y/N
Blood Type
Antigens (AG)
Antibodies (AB)
Markers (MK)
Comments (CM)
Transfusions (TX)

Do not issue the units.

THIS ROUTINE VALIDATED BY: ______DATE: ______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 6:

Identify the patient, from exercise 3, in the Issue Units by Patient Routine . Verify that the correct information is appearing on the screen. Verify the following:

Note: only compare items that are applicable to the patient selected

Field / Display Correctly? Y/N
Blood Type
Antigens (AG)
Antibodies (AB)
Markers (MK)
Comments (CM)
Transfusions (TX)

Issue the units.

THIS ROUTINE VALIDATED BY: ______DATE:______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 7:

Identify the patient from exercise 3, in the E/E Transfusion Data Routine. Verify that the correct information is appearing on the screen. Verify the following:

Note: only compare items that are applicable to the patient selected

Field / Display Correctly? Y/N
Blood Type
Antigens (AG)
Antibodies (AB)
Markers (MK)
Comments (CM)
Transfusions (TX)

Do not transfuse these units.

THIS ROUTINE VALIDATED BY: ______DATE:______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 8:

Identify the patient from exercise 3, in the Transfuse Units by Patient Routine. Verify that the correct information is appearing on the screen. Verify the following:

Note: only compare items that are applicable to the patient selected

Field / Display Correctly? Y/N
Blood Type
Antigens (AG)
Antibodies (AB)
Markers (MK)
Comments (CM)
Transfusions (TX)

Transfuse the units.

3. Print the BBK History Inquiry for this patient. Verify that the history data is accurate.

THIS ROUTINE VALIDATED BY: ______DATE: ______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 9:

Choose a patient from the List Converted Histories report. Identify the patient in the Print BBK History Routine. Print this report and attach it to the validation exercise. Verify that the correct information is appearing on the report. This report should be compared to a report or cards printed from your other vendor or to a card from your card file. Attach the other vendor report or card to this validation exercise. Verify the following:

Note: only compare items that are applicable to the patient selected

Patient Name: ______Unit #: ______

Field / Display Correctly? Y/N
Blood Type
Antigens (AG)
Antibodies (AB)
Markers (MK)
Comments (CM)
Transfusions (TX)

THIS ROUTINE VALIDATED BY: ______DATE: ______

ACCEPTABLE: NOT ACCEPTABLE:

Exercise 10:

Choose a patient from the List Converted Histories report. Identify the patient in the Print One Medical Record Card Routine. Print this report and attach it to the validation exercise. Verify that the correct information is appearing on the report. This report should be compared to a report or card printed from your other vendor or to a card from your card file. Attach the other vendor report or card to this validation exercise. Verify the following:

Note: only compare items that are applicable to the patient selected

Patient Name: ______Unit #: ______

Field / Display Correctly? Y/N
Blood Type
Antigens (AG)
Antibodies (AB)
Markers (MK)
Comments (CM)
Transfusions (TX)

THIS ROUTINE VALIDATED BY: ______DATE: ______

ACCEPTABLE: NOT ACCEPTABLE:

1.3: Entering Histories Not Converted

Print the List Histories Not Converted reports. This includes both the Linked but Discrepancies Exist and the Not Linked or History Locked reports.

Although the histories for these patients will not convert as part of the BBK conversion, you will be allowed to manually enter these patients’ histories into the BBK History routines within Meditech.

Functions to be validated:

E/E HISTORICAL DATA

Reports to print:

BBK HISTORY INQUIRY

Exercise 1:

In BBK E/E Historical Data routine:

1. At the History Record field, enter the patient’s name in the Lastname,Firstname format.

Expected Result: The system prompts the user to enter the patient’s sex and date of birth.

2. File the sex and DOB information.

Expected result: The system will search the MPI for the patient.

3. If the patient exists in the MPI, select that patient. Otherwise, continue through the MPI search until you are brought back to the BBK E/E Historical Data routine.

Expected Result: No History Record exists for [patient name] – create one?”

4. Select Yes to create a new history number.

5. The following data can be entered:

Note: only enter data that is applicable to the patient selected.

Patient Name: ______

Field / Value
Blood Type:
Blood Type Date/Time/User:
Antigens:
Antigen Reaction:
Antigen Date/Time/User:
Antibodies:
Antibodies Date/Time/User:
Markers:
Markers Date/Time/User:
Comments:
Transfused Unit Number: *
Transfused Unit Source:
Transfused Unit Product:
Transfused Unit Volume
Transfused Unit Blood Type
Transfused Unit Date/Time
Transfused By:
Transfusion Date:
Transfusion Start Time:
Transfusion End Time:
Unit Entered User:

* Note: The Transfused Unit Number field will accept a free text entry. Once the number is entered, the user will be prompted to enter additional unit information (i.e. source, product, volume, blood type, etc) in order to save to the BBK History file for the patient.

6. Upon filing the data, a history number will be created for this patient. Print the BBK History Inquiry and verify that the data appears correctly for this patient’s history. Attach the report to this validation exercise.

BBK History Number: ______

THIS ROUTINE VALIDATED BY: ______DATE: ______

ACCEPTABLE: NOT ACCEPTABLE:

1.4: Compare Histories Pre and Post Conversion

The comparison report compares the information in TEST and the pre-conversion LIVE backup file(created by the conversion) with the post-conversion LIVE data.

Note: This routine is run in LIVE after the conversion has been run in LIVE.

This is the last step in the conversion process. In order to get an accurate report this should be run in LIVE immediately following the conversion. Otherwise, discrepancies in the history could most likely come from recent edits made to the existing history file in the LIVE database. Keep in mind that any edits made to a history in LIVE can possibly make the comparison show errors. Each error on the comparison report should be checked thoroughly to rule out edits to the LIVE history after the conversion.

Functions to be validated:

COMPARE HISTORIES PRE AND POST CONVERSION

Reports to print:

BBK HISTORY INQUIRY

Exercise 1:

1. Run the Compare Histories Pre and Post Conversion report in LIVE.

Did discrepancies exist? _____

2. Attach the comparison report to this validation exercise.

3. Print the BBK History Inquiry for the histories that were on this report and verify that the discrepancies are valid.

THIS ROUTINE VALIDATED BY: ______DATE: ______

ACCEPTABLE: NOT ACCEPTABLE: