Rose Romeo, PhD, DABCC, FACB

Redwood City, CA 94065

 Identify key components of pre-analytic
testing

 Provide examples how pre-analytic issues

evolve with changes in technology

 Compare and contrast pre-analytical aspects

of sample management
Patient (Biologic Blood/Urine/Other Sample
Sample Transport Sample Processing
Status) Collection Process Storage/Stability

Don’t Forget changes in

technology: Tube
treatments, automation
tube requirements, etc
 Wians Cites Carraro P, Plebani M. Errors in a stat laboratory: Types and frequencies 10 years later. Clin
Chem. 2007;53:1338–1342. Abstract/FREE Full Text:

Top 5 Causes of pre-analytical

errors in a Stat Lab:

Collection tubes not filled

properly

Patient ID error

Inappropriate tubes/container

Test Request Error

Empty tube
 Pre-Analytic Analytic Post-Analytic

 V
? p(Quality)

 Image retreived from: www.actasifblog.com

 Tests offered
◦ Patient prep besides standard blood draw?
◦ Examples
 GTT
 24 hr urine
 Supply chain management
 Tube type
 Venipuncture requirements
◦ Patient requirements
 Traceability
◦ Tube requirements
 Draw order
 Filling
 Anticoagulant
 Storage/transport requirements
◦ Within hospital
◦ From draw center
◦ Other
 Patient Patient
Personal Disease
Practices States

Sample Sample
Processing Collection &
and Storage Transport
 Patient Patient
Personal Disease
Practices States

Sample Sample
Processing Collection &
and Storage Transport
Diurnal Considerations  External Variables
Exercise Caffeine
Total CK (albeit a bit Cheeseburgers
historic )
Tobacco
Diet Prescription drugs
Too Many cheeseburgers “Other”
Too many tomatoes for
someone with Renal Failure
Stress  Personal Variation
Multiple undetectable
Age TSH’s
Posture
Different Nationalities-
Gender CD4/CD8 levels
“Low T”-Male & Female
 Over the Counter Treatments

 Others
◦ Historic: Heavy Metal Poisoning
◦ Current: Longevity Treatments, Allergies (Latex)
 Concierge Medicine
 Compounding Pharmacies/New Mixtures
◦ Future: ?????
 Patient Patient
Personal Disease
Practices States

Sample Sample
Processing Collection &
and Storage Transport
 Clinical Scenarios
 Metabolic Disease(s)
 Inherited
 Organic

 Coagulopathies

 Heart Disease

 Cancers

 Impaired Renal Function

 Alcoholism
 Patient Patient
Personal Disease
Practices States

Sample Sample
Processing Collection &
and Storage Transport
 Minimum-phlebotomy training
◦ Certification required in some states

◦ Technical knowledge of entire process helpful

◦ Technique-approach for difficult veins, where to draw the

line

 Soft Skills
◦ Management of patient anxiety

◦ Comprehension of applicable languages

◦ Ability to manage unexpected diversions

 Hemolysis

 Cross contamination between tubes

 In adequate mixing

 Short Samples

 Hematoma’s
 Heparins
Attempts to “mix and
 Chelators match” usually
detectable
 Inhibitors

 One other point

◦ Size

◦ Not only for the patient, but also your particular automation
system

 Is your decapper et al compatible with desire to “downsize” to

smaller tube
 Clear Patient Instructions

◦ Venipuncture
◦ Urine/Swab/Other Collections

 Collection Process

◦ Phlebotomist Competency
 Tourniquet application
 Mixing
 Final application of cotton ball and tape

◦ Test/tube order

◦ Other collection supplies

 Swabs
 Culture tubes
 Urine/other containers

◦ Time of Collection

◦ Phlebotomist Competency

◦ Laboratory Policy (e.g. CO2 collection policy)

 Patient Patient
Personal Disease
Practices States

Sample Sample
Processing Collection &
and Storage Transport
 In house carriers

 Coolers

 Ice Packs

 Temperature Tapes and/or studies defining the minimum # of ice

packs/dry ice
◦ Shipping studies
◦ Tracking of Temperature
 Direct
 Indirect

 Trays

 Hand off of samples to processing location which is typically near/at

point of analysis
 Labeling Quality
◦ Individual Tests
◦ Timed samples
◦ Management in busy scenarios
 Avoidance of patient mix ups

 Established procedures for packaging

◦ Shipping studies to define (defined either internally
or by Reference Laboratory)
 Upright?
 Bagged?
 Boxed?
 Proper storage/transport

 Robust LIS
◦ Usability/User Friendly

◦ Change Management, Change Management, Change

Management

 Management of Problem samples

◦ Via LIS or Offline

 Organization for streamlined analysis

 Maintenance of temperature requirements
◦ How to record for rapid assessment
 Electronic

 Manual

 Mixing & Aliquotting

◦ Mixing (not shaking)

◦ No Mixing (e.g. Urine Samples Transported and not in solution upon

arrival

◦ Clots

◦ Volume

◦ Other
 Standard Strategies for:

◦ Sample Examination/Testing

◦ Storage

◦ Stability

◦ Retention
 Wrap Up:
◦ Hamerling (2012):

◦ 5 interrelated steps to reduce pre-analytic errors:

 Develop/Implement clear written procedures

 Enhance health care professional training

 Automate functions, both for support operations and for

executive operations

 Monitoring quality indicators

 Improving communication/fostering interdepartmental

cooperation
 Small BioTech Company that offers an LDT via their CLIA
Lab provides Customers with a sample processing kit

 Kit was shipped and was reported by one site as showing

up “wet”. This is the first time you’ve heard this

◦ You investigate and realize this is a new customer, who when

asked about the kit, is not very clear on the use (even though
there is documented training.

 What do you do?

 Two weeks later, additional customers report the same

issue

◦ What happens now??

 Physician concerned re: Patient Compliance for
prescribed Morphine sulfate.

 Urine sample sent to local laboratory

 Urine Screen=Positive (Assay=EIA)

 LCMS Confirmation (at a different Lab)=Negative

Both samples retrieved at Original Lab and verified on EIA

Was the patient non compliant?
If so, what might be the cause(s) of the +EIA?
 You are validating an assay (might be serum,
urine or other) and verifying a reference interval

 A large difference is observed between the

manufacturer’s claim and the data obtained

 What might be the outcome of such a study if

your patient populations is skewed by
◦ Age??
◦ Health Status??
◦ Diet??
◦ Nationality??
 A Large Reference Laboratory has received a
complaint regarding elevated CO2’s. The
patient population is largely young adults
undergoing specialized training.

 NOTE: The Laboratories upper end of the

reference interval was 31 mmol/L and the
client had just joined after using another
laboratory for years?

◦ What might be the root cause of the complaint?

 An observation was made regarding
increased hemolysis in several samples
received from several draw locations

 What are the steps typically involved in such

an investigation?

 What might be the root cause if the hiring of

phlebotomists had recently expanded to
increase the number of per diem hires?
 Key Components of pre analytic testing include (but may not be limited
to):
◦ A. Patient Clinical Presentation & Sample Transport
◦ B. Sample analysis and Reporting
◦ C. Patient Personal Practices and Sample Collection
◦ D. All of the Above
◦ E. A&C

 Consideration of a change of part number of an existing tube by a

vendor (that still might look like the same tube) should be investigated
to ensure:
◦ A. No change in analytical performance (e.g. contents within the tube do not differ
from the original verification/validation
◦ B. The tube still functions when placed on the automation system
◦ C. The tube does not create any issues with existing phlebotomy practices
◦ D. All of the Above

 LIS traceability for Pre analytic processes should include the ability to
◦ A. Retrieve verification and validation data for interfaces
◦ B. Have a dynamic change management process with sign off by all key stakeholders
◦ C. Test the entire cradle to grave process anytime there is a change
◦ D. A&B
◦ E. All of the Above
 McPherson, RA and MR Pincus (2011) Henry’s Clinical Diagnosis and Management
by Laboratory Methods, 22nd Edition; Elsevier, Philadelphia.

 Fink, DJ (2005); Pre-Analytical Issues in Laboratory Medicine; Retrieved

from:http://www.columbia.edu/itc/hs/medical/selective/AdvClinicalPathology/20
05/lecture/PreAnalyticalLectureBW_Fink.pdf on January 28, 2013.

 Jui, T (2010); The Importance of Pre-Analytical Phase in Laboratory Testing and

Diagnosis; Retrieved from:
Rehttp://www.centrallab.synevo.eu/FileOpenCache/1116-The-importance-of-
preanalytical-phase-in-laboratory-testing-tryb-zgodnosci-.pdf on January 28,
2013.

 Guirl, T Pre-analytical Errors, Retrieved from: facweb.northseattle.edu/.../Pre-

analytical%20Laboratory%20Errors.p...File Format: Microsoft Powerpoint - Quick
View on January 28, 2013

 Hamerling J, (2012) A Review of Medical Errors in Laboratory Diagnostics and

Where We Are Today, Lab Med.;43(2):41-44.
THANK YOU!!