The Road to Auto-Verification at MWMC enhanced by IM

1. The Road to Auto-Verificationat MWMC enhanced by IM Bina Mepani, MS CCChemistry Lab Managerbina.mepani@mwmc.com

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4. Laboratory Profile at MWMC 2 hospital-based laboratories serving Framingham and Natick area 13 blood collection centers in surrounding region Framingham Hospital Dual-Cobas 6000s in a cluster Urisys 2400 connected via Instrument Manager to LIS approx. 2,000,000 tests per year Natick Hospital Two Integra 400s not connected to IM LIS: Meditech Common database

5. Why Create Rules on IM? Standardized reporting Minimal operator intervention Prompts operator on manual tasks Decreased turnaround time Auto-verification

6. Rule Writing on IM: Preparation Organizational needs Evaluate LIS capabilities Study test application Define test limits on analyzer (possible on C-module tests only) Define repeat limits on analyzer Turn on auto-rerun if repeat is desired for each test and on the system Order serum indices on each serum/plasma specimen with IM Examine alarm codes Evaluate audit trail reports on IM

7. Rule Types Request rules Limit rules Serum indices Operator prompts Suppression Result status Numerical translation rules

8. Numerical Translation: Error Mapping Attach description to all alarm codes �Advantages: Reduces operator error Saves time Easier to troubleshoot

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10. Request and Suppression: An Example Suppress requested test based on another result CKMB needed only if ordered and when CK >=135 CKMB suppressed by creating request rule If ( Test Ordered "SCK" ) AND ( Test Ordered "SCK-MB" ) Then Suppress Test "SCK-MB" AND Set Specimen Comment = Specimen Comment Concatenated With "CKMB" Specimen held in rerun buffer till CK is resulted. If ( Test Result of "SCK" Is Numeric ) AND ( Test Result of "SCK" >= "135" ) AND ( Specimen Comment Contains "CKMB" ) Then Order Test "SCK-MB� Advantage: No operator intervention needed

11. Further Customization Problem: Angioplasty - CKMB even if CK <135 Resolution: Created another download code SPCK instead of SCK CKMB is not suppressed Advantages CKMB and CK done simultaneously Reduce turnaround time for critical patients

12. Operator Prompts: An Example� Problem: physician wants call even if results are normal Technologist responsible for calling results Resolution: Create a test named �CALL� in LIS If test �CALL� is downloaded set specimen comment =�CALL RESULTS� If specimen comment �CALL RESULTS� add test error flag display name of CALL Error flag CALL displayed in red to alert operator to call . �Advantage Operator alert to call Auto-verification halted Note: Meditech requires creation of different prefixes (for instance, �SCCALL� or �CMCALL�)

13. LIS Rules Examples Delta results Reflex requests specific to physician Reflex request approved by Medical Executive Committee QC failure stops auto-verification

14. LIS, Analyzer, and IM Combination Rules Critical Results Critical Results repeated by analyzer (parameters set on analyzer) Repeated results available for operator to review (rule created on IM) �Auto-verification blocked by LIS for all critical results Allows operator to comment (�result checked and called�) Problem: Cannot repeat E module critical results by setting repeat parameters if outside test limits (encoded on reagent barcode) Resolution: Write a rule on IM to repeat

15. C Module: Index Failure Create rule on IM to comment when H, I, or L index affect a test result Instrument creates an �> index� error when H, I, or L are high but not specific IM rule can add comment to note which index is out of limits If Test Resulted "SCRE" AND ( Test Result of "SCRE" Is Numeric ) AND ( Test Result of "I" Is Numeric ) AND ( Test Result of "I" > "20" ) AND ( Test Result of "I" < "60" ) Then Hold all Tests for Verification AND Set Test Comment of "SCRE" = Test Comment of "SCRE" Concatenated With "Specimen Icteric, Creat result affected Advantages Test comment goes to LIS attached to the result Operator does not have to type the comment in LIS Result is released by LIS if it does not violate critical or delta rule. Rule saves time and standardizes protocol

16. Index failure on K

17. E Module: Index Failure Problem: No �>index� error when H, I, or L out of limit Resolution: When H, I, or L out of limit, add comment, then use that comment to note E Module test affected. If ( Test Result of "H" Is Numeric ) AND ( Test Result of "H" > "20" ) AND ( Test Result of "H" < "80" ) Then Set Test Comment of "H" = "Specimen Slightly Hemolysed" AND Set Specimen Comment = Specimen Comment Concatenated With �SLH� Troponin when reported on hemolysed specimen If ( Test Result of "STN-T" = "<0.01" ) AND ( Test Error Flags of "STN-T" = "27" ) AND ( Specimen Comment Contains "SLH" ) Then Set Test Comment of "STN-T" = Test Comment of "STN-T" Concatenated With "Slight Hemolysis, Depressed Troponin values are seen with hemolysis" AND Hold all Tests for Verification

18. Case: H Index Failure Non-Critical Result Problem: Test result for K is abnormal but not critical Result is between 3.0 and 3.5 Provider needs to be notified Resolution: Rule created to alert operator to call provider If ( Test Result of "SK" Is Numeric ) AND ( Test Result of "SK" < "3.5" ) AND ( Test Result of "H" Is Numeric ) AND ( Test Result of "H" > "20" ) Then Hold all Tests for Verification AND Set Test Comment of "SK" = Test Comment of "SK" Concatenated With "@CALL RESULTS"

19. Limit Rules: Low Results outside test limit get repeated if Auto-rerun is selected Low test limit Can be set up on the analyzer according to needs (only on C module) Alcohol less than 10 � no repeat Lower test limit for alcohol is set as -5 Rule is set up on IM to report alcohol values as less than 10 if result is less than 10 mg/dl If - ( Test Result of "SALC" Is Numeric ) AND ( Test Result Status of "SALC" = "F" ) AND ( Test Result of "SALC" < = "10" ) Then - Set Test Result of "SALC" = "<10" �

20. Limit Rules: High High Test Limit� set up as test�s analytical High range� Based on the test application if auto-rerun is selected a dilution is made by the analyzer and test resulted Rule is set up to report the highest reportable test value CK is reported as >20000 U/L if result is >= to 20000

21. Limit Rules for Repeat A low and a high limit for repeat can be set up K < 2.5 or > 6.5 is repeated E Module tests can have limit rules as well

22. Result Status Rules First time a test is run result status is F� Repeated test result�s status is C� Example First result for AST is 4 with error code < test Second result for AST is 5 resulted by increasing sample volume No error code� Rules are written to hold the test when result status is C Advantage Gives operator a chance to compare the first and second result

23. Result Status and Limit Rules Combined Error-free auto-verification by using both Example: First result for Lipase is 2700 with error code > test Second result for Lipase is 3025 resulted by dilution and error code > test� Rule created capturing result status and test limits (>test error code) to report Lipase as >3000

24. Error Code: Reactivity Seen in enzymatic tests with very high values Limit rules to report enzyme activity do not work here� Error code fires before > test error code� Rules created to capture > reactivity and report result allowed based on reportable range If ( Test Result of "SLIPC" Is Numeric ) AND ( Test Result Status of "SLIPC" = "C" ) AND ( Test Error Flags of "SLIPC" = "7" ) AND ( Test Result of "SLIPC" > = "3000" ) Then Hold all Tests for Verification AND Set Test Result of "SLIPC" = ">3000"

25. Operator Prompt Rules Manual dilution required for TSH (Diluent not on board).� If ( Test Result of "STSH" Is Numeric ) AND ( Test Result Status of "STSH" = "F" ) AND ( Test Error Flags of "STSH" = "26" ) Then Hold all Tests for Verification AND Set Test Comment of "STSH" = Test Comment of "STSH" Concatenated With "@ Manually dilute with Multiassay diluent � Cortisol manually diluted > 630 for cortisol stimulation studies If - ( Test Result of "SCORT" Is Numeric ) AND ( Test Result Status of "SCORT" = "C" ) AND ( Test Error Flags of "SCORT" = "26" ) Then - Hold all Tests for Verification AND Set Test Comment of "SCORT" = Test Comment of "SCORT" Concatenated With "@ manually program 1:50 dilution on instrument @ before the prompt stops comment from going to LIS

26. Result Rule: Rerun Test on Abnormal Calculation Abnormal gap causing rerun of Na, Cl, CO2 If ( Test Result of "GAP" Is Numeric ) AND ( ( Test Result of "GAP" < = "2" ) OR ( Test Result of "GAP" > = "20" ) ) Then - Hold all Tests for Verification AND Rerun Test "SNA" AND Rerun Test "SCL" AND Rerun Test "SCO2�

27. Conversion: Numeric to Text Drugs of abuse: result converted to �positive� or �negative� If ( Test Result of "U-THC" Is Numeric ) AND ( Test Result of "U-THC" < "0" )Then - Set Test Result of "U-THC" = "NEGATIVE�� If - ( Test Result of "U-THC" Is Numeric ) AND ( Test Result of "U-THC" > = "0" ) Then - Set Test Result of "U-THC" = "POSITIVE" AND Hold all Tests for Verification Note: Could not use LIS since Natick Laboratory on the same test dictionary Conversion in Meditech based on test and not by method.

28. Urisys 2400 and Instrument Manager Needed to hold results only if backup tests like Ictotest for bilirubin or Sulfosal for protein needed� Rule created to add test Ictotest if bilirubin is positive and test result of Ictotest set to �?�� Operator is prompted to perform Ictotest and result it Once resulted and released from IM results get autoverified� If �?� is released from IM, test is not autoverified Meditech is looking for Positive or Negative as test result

29. Hierarchy of Rules Rules run from left to right, top to bottom Proper sequencing of rules is important Error codes fire in ascending order Example: �> Reactivity� runs before �> test� (7 vs 26)

30. Audit Trail Report Why is it important? Audit trail report helps building rules Tells you what LIS is sending to IM Request rules can be created from these parameters Results sent from analyzer with/without error code Result rules can be created by analyzing this data

31. Check rules Test rules using sample data Study report to figure out if accepted result was achieved Process actual specimens through LIS Keep audit trail reports for documentation

32. Summary Create rules based on your needs any error or situation Write rules to: Free operator Avoid errors Ease operation Improve turnaround time