The document outlines the requirements for ensuring compatibility in blood transfusions through a computer crossmatch system, involving serologic tests and rule-based software interpretation. It highlights data entry processes, decision-making protocols, and the handling of potential issues, including warnings for incompatibility and procedures during computer downtime. Additionally, it emphasizes quality control and record-keeping for a minimum of 10 years.

2. Basic
requirements
Determines the compatibility using data
entered and stored in the computer.
Data are obtained by performing serologic
tests on separate blood samples of the donor
and recipient.
Software interprets the data using a set of
precisely defined rules.
If the rule-based criteria for compatibility are
not met, or if essential data are missing -
displays a warning message.

3. Elements of a computer crossmatch system
DATA ENTRY
REVIEW AND
ACCEPTANCE
RECIPIENT
DATA
ELEMENTS
DONOR DATA
ELEMENTS
DONOR RBC
ANTIBODY
ASSESSMENT
DECISION
TABLES
WARNING
MESSAGES
COMPUTER
DOWNTIME

4. Data Entry
Review and
Acceptance
Method for a user to review and verify data
before it can be used in the decision process.
• or
User enters data, reviews it on screen and
then accepts the entry
• or
User enters data twice and the system
accepts the entry

7. either perform or maintain a record of a second test
• Repeating ABO & Rh (D) tests on the same specimen is not recommended
in emergencies
• Cannot use Electronic Xm if

11. decision rules used to determine

12. • software-generated message
obtrusive
logging with parameters

13. written procedures how to perform compatibility
during computer downtime.

14. new equipment or a new process in the environment
reliably produce a product

15. • Routine functions
• At-risk functions
• Unexpected outcomes and events
• Security and authority

17. change that
might affect

18. documentation of all significant activities
• Quality control records
no less than 10 years