#29 LEAN in the Lab 1

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.

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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

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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

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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 !

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#29 LEAN in the Lab 1