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Quality Control of Hematology Critical Values:

What to do and What NOT to do

Joshua Hayden, PhD DABCC FACB Assistant Director, Central Lab

Su-Chieh (Pam) Sun MPA, MT(ASCP) Supervisor, Hematology

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Welcome to your new job…

Plt of 5x103/μL?!? I better…

That Plt was wrong!!! I just transfused a

patient for no reason!

My patient needs Plts!Why did it take you so long

to report that value!!!

…report this as fast as possible …make sure this result is correct

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• Pre-analytic errors (and how to detect them?)

• When to perform manual intervention

• Whether or not to repeat critical values?

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• Pre-analytic errors (and how to detect them?)

• When to perform manual intervention

• Whether or not to repeat critical values?

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Do pre-analytical errors ever happen?

Doc didn’t believe the patient was

hyperkalemic so I am double checking

these QC recordsI need new co-workers

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Pre-analytic errors

• Account for highest errors in testing process

• Common Errors Misidentification

Clotted / Incorrect volume

Lipemic / Hemolysis / Contamination

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Example 1

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What to do?

• Instrument flags?

• Spurious results?

• Delta check pass?

• Sample Integrity?

• Specimen ID?

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Sample Mixups

Patient AHct 9% CF

Patient BHct 49%

Wrong blood in tube 1/1300 – 1/2700↑ rate with non-phlebotomy/lab collect

Br J Haematol. 2015 Jan;168(1):3-13

EHRPatient APrior Hct 50%

Patient BPrior Hct 11%

Pt

AP

t B

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Delta ChecksEHRPatient A

Prior Hct 50%

Patient BPrior Hct 11%

Pt

AP

t B

Delta Check|Prior Hct – Current HCT |

< 9% Report> 9% STOP

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Delta Checks (might be) AWESOME!EHRPatient A

Prior Hct 50%

Patient BPrior Hct 11%

Pt

AP

t B

Patient APrior: 50%Current: 9%|50% - 9% | > 9%

Patient BPrior: 11%Current: 50%|11% - 50% | > 9%

Middleware

Hold results, notifytechnologist

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Delta Checks (might be) not awesomeEHRPatient A

Prior Hct 50%

Patient BPrior Hct 11%

Patient APrior: 50%Current: 39%|50% - 39% | > 9%

Patient BPrior: 11%Current: 21%|11% - 21% | > 9%

Middleware

Hold results, notifytechnologist

Patient A

Patient B

Pt

AP

t B

X3

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Delta Checks (might be) not awesome

No More Delta Checks!!!!!!

Hold results, notifytechnologist

Hold results, notifytechnologist

Hold results, notifytechnologist

Hold results, notifytechnologist

Hold results, notifytechnologist

Hold results, notifytechnologist

Hold results, notifytechnologist

Hold results, notifytechnologist

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Utility of Delta Checks varies by analyte

and Medical Center (M.C.)

Del

ta C

hec

k C

alcu

lati

on

Clinica Chimica Acta. 2011;21:1973–1977

MC #1 (AUC)

MC #2(AUC)

MCV 0.93 0.93

HCT 0.85 0.79

GLU 0.66 0.65

K 0.66 0.67

AUC = 0.5

MC#1: trauma and critical careMC#2: cancer and transplant hospital

(frequent transfusions)

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How to make Delta Checks useless

Hold results, notify

technologist

Verify inEHR

Act

ion

fo

llow

ing

Del

ta C

he

cks

Rate of False Positive Delta Check0%

100%

Hayden et al, unpublished

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Example 2

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What to do?

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What is the most common reason for

specimen rejection in the clinical laboratory?

Mislabel?

Wrong tube?

Inadequate volume?

Hemolysis?

Icterus?

Lipemia?

Clotted sample?

Specimen stability?

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And the winner is…..

Clinical Chemistry and Laboratory

Medicine. Volume 46, Issue 6, Pages

764–772

Hemolysis

Clin Biochem. 2014 Aug;47(12):1002-5.

Clotted sample

Biochem Med (Zagreb). 2015 Oct 15; 25(3): 377–

385.

Clotted sample

Clin Chem Lab Med. 2011 Oct 14;49(12):2047-

50

Clotted sample

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How can you check for clotted samples?

CAP Standard HEM. 22150CBC specimens are checked for clots (visual, applicator, or automated analyzer histogram inspection/flags) before reporting results.

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Clotted Specimen Example 1

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Clotted Specimen Example 2

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Clotted Specimen Example 3

?

?

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Delta Check fails indicates further investigation

• Sample mix up? (MCV, HGB, PLT)• Clotted specimen?• Contaminated specimen?• Check for spurious results?• True change in patient status?

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Recognize instrument flag and histogram • Check for sample integrity• Check for spurious results

Specimen Integrity should be confirmed prior to reporting any critical values

• false negative instrument flags• Insensitive delta check rule

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• Pre-analytic errors (and how to detect them?)

• When to perform manual intervention

• Whether or not to repeat critical values?

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Example 2

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Example 2Post-warm

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Example 2Before and After

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Example 3

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When to perform manual microscopy

I don’t trust you

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Would you report a critically low PLT on

this patient?

http://www.sun.ac.za/english/faculty/healthsciences/haematological_pathology/Pages/Platelet-morphology.aspx

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Would you report a critically low PLT on

this patient?

Leukemia Practical Clinical Hematology. Cytochemical Reactions in Acute Leukemia Blasts Identified Cellular Element Stained Cytochemical Reaction Myeloblasts.

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Know the analyzer!Sysmex Coulter Advia

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When to perform manual microscopy

• New patient

• Flagged result

• Failed delta

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• Pre-analytic errors (and how to detect them?)

• When to perform manual intervention

• Whether or not to repeat critical values?

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To repeat or not to repeat…that is the

question?

IncreasedAccuracy (?)

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How to investigate the utility of repeating

critical values

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Analytical repeats are not necessary on

the Beckman DxH

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Repeating critical values wastes

resources

Workflow analysis by Juan David Garcia, MBA

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Repeating Critical values delays TAT

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Repeating critical values delays

necessary clinical action

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Hematology Critical Value Workflow at

NYPH - WC

Hgb, Hct, WBC Plt

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Juan David Garcia, MBA (Manager, Clinical Laboratory Services)

Hematology Technologists, NYPH-WC

Stephen Master, MD PhD (Medical Director, Central Laboratory)

Acknowledgements

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Questions?

Hgb, Hct, WBC Plt