1 ARCs Journey Toward EP23 Compliance David Martin BS MT(HEW)

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ARC’s Journey Toward EP23 Compliance

David Martin BS MT(HEW)

Austin Regional Clinic (ARC)

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1,000,000 patient visits380,000 active patients1,500 employees320 physicians18 locations16 specialties6 cities3 counties1,000 square miles

TQMP Development

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ARC’s journey toward an EP23 IQCP from my perspective as a Lab Director• Patient Safety is my #1 priority• My Patient Safety Plan is the TQMP • In the late 90s I found a promising Total Quality Management

Plan• Key to Quality from CLSI in 1998• Lucia Berte• 3rd party QC material• Bio-Rad’s Unity RealTime & Westgard Advisor• Lean• Standardized policies, processes, & procedures• Document Management System• Balanced Scorecard• EP23P – 2010 • Discussion with Lab Support Group• Quality Control Designs using data from Unity Real Time

Bio-Rad’s Quality Group to the Rescue

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The Bio-Rad Discovery Group had been working with us on quality control design strategies.

During one of our meetings I expressed an interest in the newly released EP23-A guideline.

Dr. Parvin asked us if we would be interested in trying to “tackle” an EP23 effort and share the experience – we agreed.

This is our story to date.

Project Participants

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ARCDavid Martin, Administrative Director for Laboratory

ServicesJane Morgan, Clinical Laboratory SupervisorLeah Murphy, Laboratory Quality TechnologistTina Lam, Project SpecialistMary Tsourmas, Medical Director Clinical Risk

Assessment

Bio-RadCurtis Parvin, Manager of Advanced Statistical ResearchJohn Yundt-Pacheco, Scientific FellowLakshmi Kuchipudi, Senior Scientist

What is EP23?

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Laboratory Quality Control Based on Risk Management

EP23-A; Approved Oct 2011

Clinical and Laboratory Standards Institute (CLSI)

Consensus produced guidelineLaboratory Professionals, Govt, &

Industry

Project: Risk Assessment for a Vista 1500

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Start with the EP23-A document & workbookWhere necessary fill in gaps or modify to fit needDivide analytes by methodology

PhotometricIntegrated Multisensor Technology (IMT)LOCI-chemiluminessenceNephelometric

Begin with one analyte from each methodologyCalciumSodiumTSHC-Reactive Protein

EP23-A: Risk Assessment (Figure 5)

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7.1 Hazard Identification Create a process map Identify potential failures in each process step Determine mechanisms in place to prevent or detect a failure

7.2 Risk Estimation Assess the likelihood or probability of harm for each failure Assess the severity of harm to a patient from each failure

7.3 Risk Estimation Is the residual risk

of harm clinicallyacceptable

7.5 The Laboratory’s QCP Compile set of QC process into QCP Review QCP for conformance to regulatory and accreditation requirements Document and implement the set of control processes as the laboratory’s QCP

No

Yes

7.4 Risk Control Determine what control processes are needed to lower the risk to an acceptable level

F ar W est Lab A ccession ing

Harvest/ R SO

Value S tream M ap for Specim en and O rder Processing for V ista Specim en

F ar W est/ F W A H

S pecim en

V is tas

R eports to

sa te llite c lin ics

D um b W aite r

C opia

O rders

S pecim en

H arvest

CO P IA

A rch ive / R efrige ration

Specim en

Van/C ourier C opia

P A D

S ate llite Labs

Harvest EP IC

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Identify Potential Failures

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Identify potential stages in the process where failures could occur (fishbone diagram)

List all potential failure modes at each stage

Characterize the consequences of each failure mode

11Austin Regional Clinic Laboratory

=v

Potential Errors in the Lab

Patient ID

Samples Measuring System

Operators Reagents/QC Lab Environment

Specimen Collection

Incorrect Patient ID

Collection Technique

Wrong Tube Contamination

Site Selection

Improper use of tourniquet

Labeling specimen incorrectly

Specimen Processing Improperly mixing

the specimen Not allowing SST to clot completely

Not centrifuging specimen within 2 hrs for the correct

time and RPM

Pouring over into incorrect container

Improper storage of the specimen

Specimen Transport

Incorrect Temperature

Centrifuging tubes

Specimen Receiving

Specimen Integrity

Manifest RSO

Hemolysis, Icteric

Lipemia

Capacity

Training

Competency Proficiency (API) Staffing

Short staffing

Shipping

Storage

Preparation

Expiration Date

Temperature

Humidity

Power Failure

Software Failure

Hardware Failure

Reagent fails specs

Sample analysis failure

Reagent Failure

Bubbles in reagent Short

sample Clot

HIL

Bubbles in sample

Water purification system failure

Consequences of a Failure

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The consequences of a failure which lead to a hazardous situation for a patient

• Incorrect result• Delayed result

What is an incorrect result?• Define an allowable total error for each analyte, TEa

• If the difference between the correct result for a patient’s specimen and what the lab measures exceeds TEa then the result is incorrect.

What is the “extent” of a failure?• A failure that adversely effects only a single patient

specimen• A failure that can adversely effect many patient

specimens

• No result• Other

EP23-A: Probability of Harm (Figure 6)

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Sequence of Events Creating Risk of Harm for a Patient (Example)

Initiatingcause

Testingprocessfailure

Incorrectresult

generated

Incorrectresult

reportedMisdiagnosis

Hazardousmedicalaction

Patientharmed

P1 P2 P3 P4 P5 P6

Hazardous Situation

Probability of harm given a delayed or incorrect patient result

Probability of a failure

Lab prevention/detection

of failureNumber of delayed

patient results, incorrect patient results not

detected

• Frequent = once per week• Probable = once per month• Occasional = once per year• Remote = once every few years• Improbable = once in the lifetime of the

measuring system

EP23-A: Probability of Harm (Figure 6)

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Sequence of Events Creating Risk of Harm for a Patient (Example)

Initiatingcause

Patientharmed

Probability of harm given a delayed or incorrect patient result

Probability of a failure

Lab prevention/detection

of failureNumber of delayed

patient results, incorrect patient results not

detected

Severity of Harm

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Severity of harm is described in terms of the severity of the consequence to a patient

• Severity of harm will differ for different analytes• For a given analyte, severity of harm could differ

for• An incorrect result• A delayed result• No result

• For a given analyte, severity of harm could differ for different patient care situations• Consider the most common patient care situation

for the patient population served by the laboratory• For a given analyte, can the severity of harm

from an incorrect result differ based on the failure mode that produced the incorrect result?

EP23-A: Severity of Harm Categories

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Negligible = inconvenience or temporary discomfort

Minor = temporary injury or impairment not requiringprofessional medical intervention

Serious = injury or impairment requiring professional medical intervention

Critical = permanent impairment or life-threatening injury

Catastrophic = patient death

EP23-A Risk Acceptability Matrix

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Probability of Harm

Negligible Minor Serious Critical Catastrophic

Frequent Unacceptable Unacceptable Unacceptable Unacceptable Unacceptable

Probable Acceptable Unacceptable Unacceptable Unacceptable Unacceptable

Occasional Acceptable Acceptable Acceptable Unacceptable Unacceptable

Remote Acceptable Acceptable Acceptable Acceptable Unacceptable

Improbable Acceptable Acceptable Acceptable Acceptable Acceptable

Severity of Harm

EP23-A Risk Assessment Table

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Probability of harm and severity of harm are assessed for each targeted failure modeAcceptability of residual risk based on risk acceptability matrix

Targeted Failure Mode

(Hazard)

Measuring System

Feature or Recommend

ed Action

Known Limitations of

Feature or Recommended

Action

Control Process

Effective?

Actions Required to Address Known

Limitations(the QCP)

Residual Risk

Acceptable?(Yes/No)

Fault condition

caused by maintenance procedure

Recalibrate after major

maintenance.

Recalibration may not correct

all possible conditions that

could be introduced

during maintenance.

N/A - No automated

control process.

Manufacturer recommendations: - Recalibrate following major maintenance.

Laboratory-implemented control process: - Analyze QC samples before and after major maintenance

procedures.

Yes.

ARC Experience

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Struggled to make effective use of the EP23-A risk assessment table in its original formReplaced 4 columns

Measuring system feature or recommended actionKnown limitations of feature or recommended actionControl process effective?QCP actions required to address known limitations

With 2 columnsEngineering controls/Internal QC – manufacturerLab implemented monitors/External QC – ARC TQMP

Added 3 additional columnsCauses of failureMethodology effectedExtent of failure

EP23 Workshop in Houston, TX

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Tools for Tackling EP23TM:Laboratory Quality

Control Based on Risk Management;

Approved Guideline

September 29, 2012Presented by the

Clinical and Laboratory Standards Institute

ARC Progress

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Decided to include additional columns in our risk assessment worksheet for

FrequencySeverityDetectabilityCriticality

Easier to think in terms of probability of occurrence of a failure

andthe ability to detect the failure

Rather than probability of occurrence of patient

harm

EP23 Workshop Risk Assessment Worksheet

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New columns added to the worksheetFrequencySeverityDetectabilityCriticality

-------- New Columns --------

Targeted Failure Mode

(Hazard)

Measuring System


Action

Known Limitations of


Action

Frequency(1 - 5 Scale)

Severity(1 - 5 Scale)

Detectability(1 - 5 Scale)

Criticality(Frequency X Severity X Detectablity)

Control Process

Effective?

Actions Required to

Address Known

Limitations(the QCP)

Residual Risk Acceptable?

(Yes/No)

Risk Assessment Worksheet: Frequency

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Common Terms

RatingExample

(ISO 14971)Practical Example

Frequent 5 ≥1/1,000More than once/week

Probable 4<1/1,000 and

≥1/10,000Once every few months

Occasional 3<1/10,000 and

≥1/100,000Once a year

Remote 2<1/100,000 and

≥1/1,000,000Once every few years

Improbable 1 <1/1,000,000Unlikely to

ever happen

Frequency (or probability) of occurrence of a failure

Note, “probability of occurrence of harm” (EP23-A) is not the same as “probability of occurrence of a failure” (above)

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Common Terms

RatingPossible Description

(ISO 14971)

Catastrophic 5 Results in patient death

Critical 4Results in permanent injury or life-

threatening injury

Serious 3Results in injury or impairment requiring professional medical

invervention

Minor 2Results in temporary injury or

impairment not requiring professional medical intervention

Negligible 1Inconvenience or termporary

discomfort

Severity of patient harm

Risk Assessment Worksheet: Severity

Risk Assessment Worksheet: Detection

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Common Terms

Rating Example

Low 5 Control is ineffective

4 Control less likely to detect the failure

3 Control may or may not detect the failure

2 Control almost always detects the failure

High 1 Control can detect the failure

Probability of detecting a failure mode that has occurred

Not explicitly addressed in EP23-A

Risk Assessment Worksheet: Criticality

Criticality = Frequency X Severity X Detectability

Criticality ResultLow <10Mid 10-20High >20

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ARC Final Worksheet Design

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TEST SYSTEM: SIEMENS VISTA 1500 ASSAY: Calcium Methodology: Photometric

TEa: 1.0 mg/dL Average volume: 475 daily M-F, 10,800/month; 130,00/year

Shipping All ME Yes, abnormal assay will flag if result monitor detects problem with reagent quality or delivery

Integrity of reagents verified upon receipt. Lot to lot correlations performed with new lots. External QC run at beginning and end of each shift to verfy reagent integrity

1 3 2 6 Yes

Storage All ME same as above Temps monitored at beginning and end of day

1 3 2 6 Yes

Lot to lot changes All ME No Lot to lot correlations run when new reagent lot # received. Results must be within TEa

1 3 1 3 Yes

Calibrator degradation

Shipping All ME Calibration will fail if slope and intercept exceed ranges

Calibrations have auto acceptance criteria but are also reviewed b operator for acceptablility. External QC is run with every calibration.

1 3 2. Operator review of calibration combined with external QC is effective in deteting calibration shifts

6 Yes

Reagent degradation

Stage or aspect of test system process under investigation

List all manners in which failure could occur in this step

REAGENTS

List all causes of the failure mode that have the potential to produce incorrect results

Which instrument methodologies can be affected by the failure?1. Photometric2. Nephelometric3. IMT4. Loci

Amount of residual risk and priorty to address failure:< 10 low10-20 mid> 20 high

Does the failure affect a single specimen or have the potential to affect multiple specimens?1E: single erroneous result1D:single delayed resultME: multiple erroneousMD: multiple delayed

Are there manufacturer checks, including internal controls, that reduce the probablity of failure?

What external controls, laboratory monitors, and/or operator training are in effect to increase the probability to detect failure?

What is the potential severity of harm to the patient?1. Negligible2. M inor3. Serious4. Critical5. Catastrophic

What is the likelihood that the QCP will prevent or detect the failure?1. failure detected2. almost always detected3. may or may not be detected4. not likely to be detected5. not detected by QCP

Severity of harm(S)

Detectability(D)

Criticality(F x S x D)

Residual risk

acceptable? Yes/No

If no, how will QCP address?

How often does the failure occur?1. Improbable2. remote3. occasional4. probably5. frequent

Steps:Failure mode:

Causes:Methodology

affectedExtent:

Engineering controls including

internal QC

Laboratory implemented

monitors including

external QC

Frequency of Occurrence

(F)

ARC Final Worksheet Design: Left Columns

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Shipping All ME Yes, abnormal assay will flag if result monitor detects problem with reagent quality or delivery

Integrity of reagents verified upon receipt. Lot to lot correlations performed with new lots. External QC run at beginning and end of each shift to verfy reagent integrity

Storage All ME same as above Temps monitored at beginning and end of day

Reagent degradation

Stage or aspect of test system process under investigation

List all manners in which failure could occur in this step

REAGENTS

Extent:

Engineering controls including

internal QC

Laboratory implemented

monitors including

external QC

List all causes of the failure mode that have the potential to produce incorrect results

Which instrument methodologies can be affected by the failure?1. Photometric2. Nephelometric3. IMT4. Loci

Does the failure affect a single specimen or have the potential to affect multiple specimens?1E: single erroneous result1D:single delayed resultME: multiple erroneousMD: multiple delayed

Are there manufacturer checks, including internal controls, that reduce the probablity of failure?

What external controls, laboratory monitors, and/or operator training are in effect to increase the probability to detect failure?

Steps:Failure mode:

Causes:Methodology

affected

ARC Final Worksheet Design: Right Columns

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1 3 2 6 Yes

1 3 2 6 Yes


How often does the failure occur?1. Improbable2. remote3. occasional4. probably5. frequent

Frequency of Occurrence

(F)

Severity of harm(S)

Detectability(D)

Criticality(F x S x D)

Residual risk

acceptable? Yes/No

Amount of residual risk and priorty to address failure:< 10 low10-20 mid> 20 high

What is the potential severity of harm to the patient?1. Negligible2. M inor3. Serious4. Critical5. Catastrophic

What is the likelihood that the QCP will prevent or detect the failure?1. failure detected2. almost always detected3. may or may not be detected4. not likely to be detected5. not detected by QCP

Shipping

Storage

Quality Control Plan for Siemens Vista Chemistry Analyzer

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1. External QC: Liquid Unassayed QC:a. Multiqual QC is run at the beginning and end of each shift (3x/day)

b. Immunoassay, Cardiac, and Immunology QC are run at the beginning of each shift only due to lower patient volume for those tests

c. TDM and Direct LDL QC is run once per day that patient is run due to extremely low volumes

d. QC is run following each assay calibration, or when recommended by service

e. Refer to QC - 2 level procedures for interpretation of results including Westgard rules

2. Proficiency/Competency testing:a. Participate in API proficiency testing 3x per year. PT is rotated among personnel

b. Annual competency reviewed and documented by technical supervisor

c. Techs are required to complete 10 hours of Continuing Education credits per year, 2-3 hours mandatory specific to ARC

d. Lab Assistants are required to complete 2-3 hours of Continuing Education per year depending upon position

3. Traininga. Lab Assistants: all laboratory assistants must complete phlebotomy and specimen

process training. Refer to specimen collection procedures/manuals

b. Techs: Operators must complete online training for Vista chemistry analyzer combined with hands on training before operating instrument without supervision

c. Materials Manager: Follows all procedures for receipt and storage of reagents

Quality Control Plan for Siemens Vista Chemistry Analyzer

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4. Environmental Controla. Reagent storage refrigerators/freezers monitored 2x per day

b. Room temperature and humidity monitored and recorded daily

5. Instrument Maintenance/Verificationa. Instrument maintenance is performed as required by manufacturer

b. Calibration/Verification of all assays with less than 3 point calibration is performed every 6 months.

c. Instrument to instrument correlations are run on all Vista assays every 6 months

6. Monitor the IQCP on an ongoing basis for effectiveness

a. NCEs are submitted and monitored by Lab Supervisor to document failures

b. Review any complaints the laboratory may receive from providers

c. LJ graphs are reviewed at least weekly to detect possible trends and shifts

d. Balanced Scorecard prepared quarterly to monitor quality indicators

Laboratory Environment

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Steps Failure Mode Causes Extent Operator Training/External Control Engineering Control

General Comments of other Laboratory-Implemented

MonitorFrequency (F) Severity (S) Detectability (D) Criticality (FxSxD) Residual Risk

Acceptable? Yes/No

List the stage or aspect of the

test system’s process under

investigation.

List all manners in which failure could occur in this

step.

List all causes of the failure mode that have the potential

to produce incorrect test results.

Does the failure affect a single patient or have the potential to

affect multiple patients?

Can external controls and/or operator training increase the probablility to detect failure?

Are there manufacturer checks to reduce the probability of failure?

What other processes can the laboratory implement to

detect failure?

1- Improbable 2- Remote

3- Occasional

4- Probable

5-Frequent

1-Negligible 2-Minor 3-Serious 4-

Critical 5-Catastrophic

What is the likelihood that the

control process detects or prevents the failure? (1-5)*

<10 Low 10-20 Mid >20 High


Laboratory Environment

TemperatureTemperature out of range (too

high or too low)

A temperature failure can affect multiple patients. Whether it be

in a freezer, refrigerator, ambient air, or if the analyzer's

temperature goes out of range.

The techs are trained to monitor the temperatures of ambient air as

well as the refrigerators and freezers around the lab. There is a

24 hour temperature monitor in the walk-in regrigerator.

The Vista is programmed to alarm if the temperature falls out

of acceptable range.

24 hour monitoring system for walk-in refrigerator and each zone of the Laboratory. Techs record the temperatures for the

freezers/refrigerators and ambient air at the beginning and end of work day. Velcro closures

placed on the freezer doors. Installed a monitor in the walk-in

refrigerator which records the temperature every 15 minutes,

this information will be reviewed every Monday.

Occasional Negligible 2 <10 Low Yes

Humidity Humidity (too high or too low)A humidity failure can affect multiple tests and therefore

multiple patients.

Techs are trained to record humidity on a daily basis

No Procedures/logs Remote Negligible 2 <10 Low Yes

Power Source Power Failure

A power failure can affect multiple patients. Multiple

specimens can be lost due to a power failure changing the

temperature in the refrigerators, freezers, incubators. Tests can also be lost due to the power source of the analyzer being

compromised.

NoThere is a power source backup on the vista that will last for 20

minutes.Possibly a back up generator. Ocassional Negligible 2 <10 Low Yes

* Where 1 represents the control can detect the failure and 5 represents the control is ineffective.

Specimen Ordering

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Steps Failure Mode Causes ExtentOperator

Training/External Control

Engineering ControlGeneral Comments of other Laboratory-

Implemented Monitor

Frequency (F) Severity (S) Detectability (D)

Criticality (FxSxD)


Yes/No



investigation.

List all manners in which

failure could occur in this step.

List all causes of the failure

mode that have the potential


Does the failure affect a single patient or have the

potential to affect multiple patients?

Can external controls and/or operator

training increase the probablility to detect

failure?


What other processes can

the laboratory implement to

detect failure?

1- Improbable 2- Remote 3- Occasional

4- Probable

5-Frequent

1-Negligible 2-Minor 3-

Serious 4-Critical

5-Catastrophic



<10 Low 10-20 Mid

>20 High


Specimen Ordering

Ordered by provider

Test entered incorrectly

Single

Yes, training the providers to

correctly order lab tests.

NoTraining not done with laboratory

procedures. NCEs are written up and discussed with the

center managers and providers

Frequent Negligible 1 <10 Low

Yes, but this can result in a

delay in testing.

Dx code incorrect or missing

Single No Frequent Negligible 1 <10 Low

No orders Single No Frequent Negligible 1 <10 Low

Ordered by lab staff

Transcription errors Single

Yes, training the providers to

correctly order lab tests.

NoRefer to procedures:

Processing Lab Orders in Copia,

Processing Add-on Lab Tests,

Processing CPL Specimens and Reports, DSHS

Specimen Processing

Probable Negligible 1 <10 Low

§Epic àCopia Single No Probable Negligible 1 <10 Low

§paper ordersàCopia Single No Probable Negligible 1 <10 Low


Specimen Collection

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Engineering Control

General Comments of

other Laboratory-Implemented

Monitor

Frequency (F) Severity (S) Detectability

(D)Criticality (FxSxD)


Yes/No

List the stage or aspect of the test system’s process under

investigation.

List all manners in which failure could occur in this step.



Does the failure affect a single patient or

have the potential to affect multiple

patients?


training increase the probablility to detect

failure?

Are there manufacturer

checks to reduce the probability of failure?



detect failure?

1- Improbable 2-

Remote 3- Occasional

4- Probable 5-Frequent

1-Negligible 2-Minor

3-Serious 4-Critical 5-Catastrophic

What is the likelihood that

the control process detects or

prevents the failure? (1-5)*

<10 Low 10-20 Mid

>20 High


Specimen Collection

Patient ID Incorrect Patient IDCan affect two

patients

Yes, training all staff collecting specimens with proper specimen

processing criteria.

No

Refer to Blood Specimen Collection

procedure and NCE Management

Program.

OccasionalSerious or

Critical2 Mid to High

Collection Technique

Wrong Tube Single No Probable Negligible 1 <10 Low

Yes, all of these can result

in a delay in testing.

Contamination: Incorrect Order of Draw, Improper

cleansing of draw siteSingle No Occasional Negligible 1 <10 Low

Site Selection Single No Occasional Negligible 1 <10 Low

Improper use of tourniquet Single No Occasional Negligible 1 <10 Low

Improperly labeling specimen (provider)

Single No Occasional Negligible 1 <10 Low

Improperly labeling specimen (lab)


Improperly mixing the specimen

Single

Yes, training all lab staff with

proper specimen processing criteria.

No

Refer to procedures: Blood

Specimen Collection, Criteria

for Specimen Rejection, Centrifuge

Instructions, and NCE

Probable Negligible 1 <10 Low

Specimen Processing

Not allowing SST to clot completely

Single No Probable Negligible 1 <10 Low

Not centrifuging specimen within allotted 2 hour

period or not centrifuging at the correct RPM for the correct amount of time


Pouring over specimen into the incorrect container


Improper storage of the specimen.



Specimen Transport and Receiving

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Engineering ControlGeneral Comments of other Laboratory-

Implemented Monitor

Frequency (F) Severity (S) Detectability

(D)Criticality (FxSxD)


Yes/No


test system’s process under investigation.

List all manners in which failure could occur in this

step.



Does the failure affect a single patient or have the

potential to affect multiple patients?

Can external controls and/or operator training

increase the probablility to detect failure?




detect failure?


3- Occasional

4- Probable

5-Frequent

1-Negligible 2-Minor 3-

Serious 4-Critical

5-Catastrophic


control process detects or

prevents the failure? (1-5)*

<10 Low 10-20 Mid

>20 High


Specimen Transport

Incorrect TemperatureSpecimen shipped under incorrect conditions ex. No ice pack in cooler

Potential for multiple since samples are shipped in batches

Training staff to properly prepare

coolers for transport. Some analytes can

give clues as to whether tubes were centrifuged within 2 hours. Ex. Glucose

No

Currently there are procedures for

Criteria for Specimen Rejection, Centrifuge

Instructions, and Processing

Specimens in Copia LIS.

Occasional Negligible 1 <10 Low Yes

Centrifuging Tubes

Specimens not centrifuged w/in 2 hours

can yield incorrect results

Potential for multiple if samples are batched

before centrifugingNo Occasional Negligible 1 <10 Low Yes

Specimen Receiving

Manifest Incomplete/Incorrect Single

Properly training staff to check-in coolers that arriving at the FW lab.

No Probable Negligible 1 <10 Low Yes

RSO (Release Stored Orders)

Orders released in RSO but no sample received

in labSingle No Probable Negligible 1 <10 Low Yes

Specimen received in lab but orders not released in RSO

Single

Vistas will give a "No Test Ordered" alarm for specimens that

have not been released in the RSO.

Probable Negligible 1 <10 Low Yes

Sample Integrity

Lipemia Single Staff are instructed to let the Vista determine

whether the sample can(not) be run based on it's measurements of the severity of HIL

Vista will measure HIL and reject specimens not suitable to run.

Probable Negligible 1 <10 Low Yes

Hemolysis Single Frequent Negligible 1 <10 Low Yes

Icteric Single Probable Negligible 1 <10 Low Yes


Operator Training and Competency

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Steps Failure Mode Causes Extent Operator Training/External Control Engineering Control

General Comments of other Laboratory-

Implemented MonitorFrequency (F) Severity (S) Detectability (D) Criticality

(FxSxD)


Yes/No



investigation.





Does the failure affect a single patient or have the potential to

affect multiple patients?

Can external controls and/or operator training increase the probability to detect failure?



detect failure?


3- Occasional 4- Probable

5-Frequent

1-Negligible 2-Minor 3-Serious 4-

Critical 5-Catastrophic



<10 Low 10-20 Mid >20

High


Operator Training and Competency

Capacity

TrainingA tech has the potential to

affect many patients if they are not properly trained. Training by

staff/supervisors, staff must be signed off before

operating the Vista on their own.They are not given a log-in to approve results

until they are signed off by a supervisor. Making sure maintenance is completed

on the Vista at the appropriate times.

Competencies are given on a yearly basis. Controls can

also detect correct preparation of

controls/reagents.

No, there is an option to enter individual user IDs on the Vista. ARC does not utilize this because

results are approved in the LIS and tech ID can be tracked through the LIS system. The controls are approved in Unity Real

Time which also requires a unique log-in for each

user.

Ensure that only staff that have been adequately

trained and signed off are the sole operators of the Analyzer. If API surveys come back unsatisfactory,

council the staff and figure out why the test

was inaccurate, whether it be machine failure or staff

incompetency.

Remote Serious 1 <10 Low Yes

Competency

A tech has the potential to affect many patients if they

do not have the knoweledge/competency to

perform testing and interpret the results.

Remote Serious 1 <10 Low Yes

API Proficiency

Since API testing mimics patient testing in the

laboratory, any false results reported to API can mirror false results that are being reported on patients, and

could affect multiple patients

API Samples are run 3x per year and rotated among all

Vista operators and between both analyzers to test the competency of laboratory

personnel and the proficiency of the Vista

Analyzer

No Remote Negligible 1 <10 Low Yes

Staffing Short Staffing

A tech who is overly stressed out has a greater

chance of making a mistake and reporting inaccurate results which can affect

multiple patients.

Even the best trained staff can make mistakes when

under stress or when rushed.

Limited, the vista will detect a QNS control, but

only review of the QC values will determine if a

control/reagent was prepared improperly.

Ensure that there is as much staffing as is

required for the lab to run efficiently. Understand the

limitations of staff, different staff members

have different work capacities.

Probable Serious 1 10-20 Mid Yes


Specimen Storage and Archiving

37



Engineering Control

General Comments of

other Laboratory-Implemented

Monitor

Frequency (F) Severity (S) Detectability (D)

Criticality (FxSxD)


Yes/No



investigation.



List all causes of the failure

mode that have the potential

to produce incorrect test

results.

Does the failure affect a single patient or have the potential to affect

multiple patients?


training increase the probability to detect

failure?

Are there manufacturer

checks to reduce the

probability of failure?


detect failure?

1- Improbable 2-

Remote 3-

Occasional 4-

Probable 5-

Frequent

1-Negligible 2-Minor 3-Serious 4-Critical

5-Catastrophic

What is the likelihood that

the control process detects or prevents the failure? (1-5)*

<10 Low 10-20 Mid

>20 High


Storage and Archiving

Specimen Storage

Specimen stored improperly after

testingMultiple

Yes, training of techs to properly store

specimens that have already been tested and to adhere to a disposal schedule for specimens

that are stored in the clinical laboratory

refrigerator

No

Write a procedure pertaining to the

storage and disposal of chemistry specimens.

Remote Negligible 1 <10 Low Yes

Specimen disposed of too soon

Multiple No Remote Negligible 1 <10 Low Yes

Archiving

Archiving too soon MultipleYes, lab staff are

trained to properly archive documents.

No Refer to "Archiving Laboratory

Reports" procedure

Remote Negligible 1 <10 Low Yes

Archiving the wrong reports

Multiple No Remote Negligible 1 <10 Low Yes


What Did We Change/Learn

38

QC Frequency From 2x/day to 3x/day – added QC at end

of day runType and number of QC samples

2 levels of 3rd party QC unassayedStatistical QC limits used to evaluate the

result – added the 10x ruleCompared our QC results with target

results weeklyFrequency of periodic review for trending

shifts and trendsWeekly or more often if we have a failure

What Did We Change/Learn (cont’d)

39

Actions taken when results exceed acceptable limitsEducation of operatorsStop repeating QC – perform RCA

Controls built into the measuring systemIMT self calibrates every 2 hoursPhotometer checkChecks reagent specs before adding

samplePerforms HIL interference

• TEa needs scrutiny and should be easier to find for each analyte

Lessons Learned

40

Challenges in performing a risk assessment for QCDaunting and Tedious – make templatesResources – internal, e.g. HR and external, e.g. vendors and seminarsSupport Staff – motivation & knowledgeFront Line Staff – how to push down the info – educate and trainEstablish Allowable total error (TEa) for each analyte – CLIA, API, CAP, etc.

Methods to minimize the challengesStaff Education and Training

Start before you begin the journeyCLSI EP23 workbook - imperativeBio-Rad Quality series - Dr. Westgard’s web site - CLSI Docs on quality GP26-A4

Utilize Industry periodicals, gurus, manufacturers, Involve front line staff in developmentAttend seminarsRead instrument manuals

Lessons Learned cont.

41

Which test methods might be prioritized for risk assessment

High volume quantitative tests Chemistry tests with high probability of harm

Tests with most problematic historySodium, Potassium, Glucose, Calcium, TSH

EP23 IQCP can be modified or scaled for quantitative, semi-quantitative and qualitative tests

Does risk assessment approach align with institutional quality goals

ARC has a mature Patient Centered Medical Home and is part of a Pioneer Accountable Care OrganizationQuality & Value and demonstrating Quality & Value are priorities

The Journey Continues

42

ARC implemented their new EMR in July at the

first clinic.

The lab’s resources are supporting this endeavor

I know the new Lab director will continue to refine and implement the IQCP

1 ARCs Journey Toward EP23 Compliance David Martin BS MT(HEW)

Documents

Transcript of 1 ARCs Journey Toward EP23 Compliance David Martin BS MT(HEW)