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8/9/2019 #29 LEAN in the Lab 1
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Auto-Release
David Plaut
Beth Friedt
&
Tammy Taylor
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Auto-release in Daily
Life My car wont let me turn it offuntil its in park.
I cannot get out of the car withoutit beeping unless I take the key out.
Thank goodness there is auto-release (autoverify)
with the delete key on my computer!
And then theres the toaster. I tell it howbrown I want my toast. It releases it on time!
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Patient Safety (some interesting findings)
In 2000, the U.S National Institute of Medicine
issued an important report: to err is human:
building a safer health system.
The report highlighted that preventable
medical errors cause up to 98,000 deaths and
770,000 adverse drug events.
Industry efforts to address patient safety and
patient misidentification are mainly focused
on error reduction at the point-of-care.
3
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Common Errors in SpecimenCollection
A 2005 study of identification errors by CAP Q-Probes completed by 120 laboratories over a five-week period:
Total error rate was 86.7 errors per 10 000
billable tests 56% of the errors were primary specimen label
errors
345 of the errors resulted in reported adverseevents, out of the total of 6 705 reported errors
On average, adverse events resulted from 1 outof 18 identification errors
Extrapolating the adverse event rate from this studyto all US hospital-based laboratories suggests that160 900 adverse events per
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Process
Carl Rogers the process of becoming a
person
Auto-release is a process of .
becoming more efficient saving money improving patient care
the rocess is
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What is Auto-release?
The process in which a computer systemautomatically reviews and releases ONLY those resultsthat meet YOUR criterion.
YOU determine the criterion for accepting or rejectingdata.
Also known as auto-validation, auto-result
Other words to keep in mind: middleware, LIS/HIS
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What is Auto-release?
A process or system that reduces
time spent looking at data, releasing gooddata and flagging questioned data, thus
allowing the staff to do more useful work.
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Auto-validation
|||ID,Tube
Analysis
Instrument
checks
QC rules
Normal vs. AbDelta (change)
etc, etc
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What Was it Like Before
Auto-release?In microbiology we looked then said
No growth, report it.
Before computers we looked at the worksheet
ID HemoglobinJ S 12.3
M J 11.8 They look normal; send them out.M C 10.5K W B 13.2Etc.
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What are the potential impactsof auto release
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What are the potentialimpacts of autovalidation?
Saves money
Allows technologists to spend time onother meaningful tasks
Increases physician, patient andlaboratory satisfaction
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How do we do so much with sofew?
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Auto-Verification!
No brainerNecessary for OUR sanity
Optimistic, but cautious
Team effort
Customized
Start with basics, increase whencomfortable and at YOUR own pace.
Technologist is the best judge
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The important people
The laboratory staff
Medical director
Your LIS/HIS point person
The instrument,
middleware or LIS/HISvendor technical specialist
Adapted fromJohnsonand Stelmach
Clin. Lab News Sept, 2007
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The Process
First step is to acknowledge what data
you are sending out currently without any
intervention
Identify things that the techs like toreview, check specimen integrity, rerun.
Current policies in place that require tech
interventionrerunning critical results,calling critical results, documentation
of indices or comments.
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Sample Collection -Venipuncture
Proper patient identification
Length of time tourniquet is applied
Proper antiseptic to cleanse site Proper tube;
Proper amount of blood
Proper order of draw Proper mixing of blood with
anticoagulant
16
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APPLICATIONFLOW
Orders Sent from LIS to Server
Orders distributed to Handhelds
View Collection List / Select Patient-Review
Inventory (tubes/tests), Patient History, & Open
vs. Collected Draws
Scan Bracelet - Positive Patient ID
Collect Specimens
Print Barcode Specimen Labels at Bedside
Route Specimens to Lab
Collection Data Transferred to LIS
Received-In Specimens are Scanned
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Print Label at the Patients
Bedside After specimen is collected, user isprompted to SCAN CONTAINER Specimen label prints when correct
container bar code is scannedusing the BD Vacutainers.
Label applied by aligning notcheswhen using BD Vacutainers
Stron
g,O
s c ar
Strong, Oscar
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Reviewing Patients
with Open OrdersW-440-A (Allen, Angelo)
W-442-A (Rodriguez, Carlos)
W-444-B (Johnson, Kimberly)
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Viewing Patients
with Open OrdersW-444-B (Johnson, Kimberly)
Blue PT, PTT
Red BMP
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Some (not all) of the Icons
These icons merely indicate a specimen
This icon indicates an incomplete order
This icon indicates a missed order could
not be completed at this time.
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Some (more, not all) ofthe Icons
This icon indicates a completedorder
This icon indicates a stat request
This icon indicates a timed samplethat is incomplete at this time
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Scanning thePatients Wrist Band
Please ID the Patient by scanning
the correct field
Johnson, Kimberly
DOB Age Sex Bed
4.24.32 79 F W444B
MRN MHC3579B
FIN Incorrect PT ID !
The PT bar codeon the wrist isscanned to givethe MedicalRecordNumber.
The bar codedid notmatchthe patientsfinancial ID
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Collecting Screen
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Order of Draw
1. Blood culture tube
2. Sodium citrate (light. blue)
3. Serum tubes (w/ or w/o clot activator, w/ or w/o gel
separator)
4. Heparin tubes (green)
5. EDTA tubes (lavender)6. Glycolytic inhibitor (gray)
7. Revision reflects increased use of plastic tubes
8. Plastic red top tubes (serum) contain a clot
activator that may interfere with coag. testing9. Glass non-additive red top tubes may still be drawn
before the coagulation tube
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Checking ForHemolysis
In whole blood sample, hemolysiscannot be observed oin serum only ifHgb > 50 ug/dL
Recommended to check when results
outside designated limits, e.g. HGB andHCT do not match; Potassium >5.5 mmol/L
Centrifuge and inspect plasma
Always note on the requisition or report
if hemolysis is observed
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Analytes Affected byHemolysis
Seriously affected (all increased) LD -- Potassium AST -- Plasma hemoglobin
Noticeably affected Iron (increased) -- T4 (decreased)
ALT (increased)
Slightly affected (all increased)
Phosphorus -- MagnesiumTotal protein -- Calcium Albumin -- Acid phosphatase
Source: Laessig RH et al.Am J Clin Path. 1976; 66:639-64428
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Types of accept/rejectcriterion
Normal SeverityTechnologist decides what results to stop
QC Severity If Quality control is out, then patient results
will be held for release/rerun at thetechnologists discretion.
Instrument Severity Can hold patient results due to all or any
instrument flagging.29
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Analyzer Flags Error Code Suppress Result Error Interpretation
1 NO Temperature out of range
2 NO Calibration expired
3 NO Assay out of range
4 NO Absorbance
5 NO Measurement system (noise, cuvette, etc.)
6 NO Reagent QC
7 YES Arithmetic error
8 YES Never calibrated
9 YES No reagent
10 YES Aborted test
11 YES Processing error
12 YES Software error
13 NO "Hemoglobin" 14 NO Abnormal reaction
15 NO Diluted
16 YES Below assay range
17 YES Above assay range
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The Process, contd
Instrument flags that are related to
questionable results
Delta failures- pre-analytical errors or
changes in the patients condition
Quality Control issues
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Types of accept/rejectcriterion
Delta Severity Current result will be compared to previous
results and if the results significantly varythen the result will hold for technologistreview.
Average of Normals
32
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Average of Normals
At the end of a run (or day)calculate the average of those
patients within a given range (e.g.normal).
Treat this like a Levey-JenningsChartUse a 1 3s flag.
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Average of Normals
Control
Patient
Cannot be used on all tests (e.g. drugs)
May not work on clinic days
Is less sensitive than the controls (sometimes)
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Delta Checks
Absolute DeltaHemoglobin 11/10/07 12.1
11/11/07
9.2 ?% DeltaCreatinine 08/12/07 0.9
11/13/07 1.2% 33%
Johnson and Stelmach Clin. Lab News September, 200
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Delta Checks
Absolute or % Delta
BUN If < 19.9 mg/dL 10mg/dL
>20 40%
Consider the time between samples,e.g. 7 d for BUN
Johnson and Stelmach Clin. Lab News September,
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Delta Checks
Anion gap:
Na + K (Cl + CO2)
Johnson and Stelmach Clin. Lab News September,
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When You ShouldNOT VerifyResults?
Critical values are immediately called,then are documented in the computeras called.
Abnormal, Technical, Dilution orLinearity results that need torepeated / reviewed
Any specimen integrity flags orinstrument flagging that alerts thetechnologist of questionable results.
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Follow up of rejected data
Once a value is NOT auto-released,
it must be verified.
Repeated?
Discussed with clinician?Compared with other data
Same patient different time
Same patient different tests
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Critical Values
Regulations:
National Patient Safety Goals
Proper Documentation
Validate results
Get a chance to rerun to check results
Get a chance to question specimenintegrity
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After Questions are Considered
Write the Protocol & Develop the
Procedure
Be as Detailed as Possible Develop Workflow Diagram
Consider Resulting Possibilities
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Testing Once AutovalidationCriteria are set
1. Pick a rapid TAT analyte (i.e. cTnI).
2. Test normal result, with no flags.
3. Test normal result with all analyzer
flags.4. Test high and low results without
flags.
5. Test critical results without flags.
6. Test normal results with delta checkfailures.
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Once Autovalidation is Turned on
As technologists become morecomfortable with autovalidation,
increase the number of teststhat are auto-validated
Add more criterion.
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Some AutoverificationConsiderations
Rules Can be Difficult toChange/Implement/Maintain
Complex Algorithms Usually Difficult toImplement
Special Testing Laboratories
Molecular Biology
Microbiology Anatomic Pathology
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The introduction ofauto-verification was keyto improving our
productivity anddecreasing human error.
Stephanie McFaddenCore Laboratory Manager,Grant/Riverside Methodist Hospital
Some comments from folks like you
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Before Auto-release, review and releasetimes averaged 22 seconds per sample.
After Auto-release, normal samples wereauto-validated, saving the laboratoryalmost three hours in technologist timedaily,
and increasing the number of billableprocedures per technologist.
For laboratorians, the technologysignificantly reduces the number ofspecimens that require manualintervention.
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Autorelease is able to auto-verifyapproximately 80 percent of the morethan 1,000 complete blood counts(CBCs) each day.This allows technologists to focus on
the 20 percent ofsamples thatrequire their critical analysis.The detailed follow-up procedures
provided by the analyzer makes theprocess even more efficient.
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Auto-verification has allowed us to
provide the highest quality results,even in the face of a significantincrease in work,Without the burden of manually
checkingCBCs, technologists can focus onabnormal test results, specialty testsand bone marrow results. For
patients, this means a high qualityresult delivered as quickly aspossible.
Susan Fuhrman, MD director of pathology and laboratory services.
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Advantages
Increases physician confidence
Ability to Increase Volume without IncreasingStaff
Enables Further Technologist Development inManual Areas
Provides for Consistent Release of Results
Reduces TAT and costs
Reduces frustration
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Readings
http://www.aacc.org/NR/rdonlyres/0055EF3C-48D5-4AED-8EEA-14AC0F626D6B/0/AACCAutoverificationPresentationRev4.pdf
www.aacc.org/AACC/pub./cln/2007/sept/series
http://press.siemens.us/index.php?s=43&item=139http:// laboratory-manager.advanceweb.
com/editorial/search/aviewer.aspx?an=al_06nov1_alp64.html&ad=11-01-2006
www.westgard.com/essay57.htm
CLSI AUTO10-A-Autoverification of Clinical Laboratory Tests;
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Thank you !