The document discusses using the scientific method (TSM) as an operational tool to reduce laboratory errors. It describes TSM as a knowledge acquisition tool that imposes rigorous standards to establish facts before taking action. TSM provides a structured process and feedback loops to integrate elements critical for successful laboratory practice, including validating instruments and investigating errors. Implementing TSM principles through an integrated validation system would allow flexible configuration of verification steps to ensure all information is evaluated and necessary actions are taken.

1. THE SCIENTIFIC METHOD
AS THE OPERATIONAL TOOL FOR
EFFECTIVE REDUCTION OF LABORTORY ERROR
Mark Gusack, M.D., Staff Pathologist
VA Medical Center, Huntington, WV
Adjunct Clinical Professor
Marshall University School of Medicine
NORTHEAST LABORATORY CONFERENCE
15 OCT 2013
RISK

2. Mark Gusack, M.D., OCD [Overly Concerned Doctor]
Staff Pathologist,
Pathology and Laboratory
Medicine Service
VA Medical Center
Huntington, WV 25704
mark.gusack2@va.gov
SPEAKER
Dr. Gusack has almost 40 years experience in the Laboratory field starting as a Nuclear Medicine
Technologist in the early 1970’s, then working as a clinical engineer, and then becoming a
physician and pathologist. He is AP/CP boarded, has held positions in a variety of hospital and
reference based laboratories as a medical director and as staff pathologist. During this time he
has also been a consultant and practiced as a Licensed Health Care Risk Manager in Florida. Dr.
Gusack has been involved with all aspects of laboratory development and management including
startup, licensing, as well as designing integrated management systems for clinical laboratories.
The opinions expressed in this presentation are those of the author and do not necessarily
represent those of the Department of Veterans Affairs

3. SPECIAL THANKS ACCORDED TO:
Anita Bickford
Ninth Grade Laboratory Science Teacher
for having taught me
The Scientific Method

4. THE ULTIMATE PURPOSE OF THIS PRESENTATION
“Our object, then, in reviewing these researchers,
and in adding to them such observations as our own sphere of action
supplies, should be to deduce from them rules of practice,
to gather from the tree of knowledge fruit for the
solace and refreshment of mankind”
Thomas King Chambers
Goulstonian Lecture 1850

5. SITUATION
WHAT TOOL IS AVAILABLE TO DO THE JOB?
The purpose of healthcare is to direct professional activities toward
the most favorable outcome for the patient.
 Technological advances have resulted in increased capability AND
 Increased complexity of running a laboratory AND, therefore,
 Potential for and actuality of error.
A critical Systemic Failure leading to this situation is the absence of
an effective Operational Management Tool to organize, direct, and
document the laboratory effort so as to assure optimal patient
outcomes.
This applies in particular to how we implement and monitor
laboratory tests in our laboratories.

6. PROBLEM - OPERATIONAL
What type of system should be put into place to successfully
implement Integrated Systems Management [ISM]
operationally to
Reduce Laboratory Error?

7. SOLUTION - OPERATIONAL
IT SEEMS WE DON’T DO THIS ENOUGH
The optimal solution is The Scientific Method [TSM].*
TSM is a knowledge acquisition tool traditionally used by the scientific community
to establish Scientific Fact.
It imposes a rigorous but flexible set of standards to this acquisition.
It requires that we always:
 ESTABLISH THE FACT BEFORE WE ACT 
Therefore TSM can be used in designing our methodologies, validating our
instruments, and directing investigation of laboratory error thereby unifying the
entire Risk Management process.
*Gusack, M.; Integrated Quality Management and The Scientific Method; MBG Industries, Inc. 1997.

8. CONCEPTUAL DEFINITION
ARE WE ACTUALLY DOING THIS?
TSM provides a positivist, nonjudgmental approach to establishing observational
fact as distinct from speculation, hypothesis, and theory.
TSM provides numerous cybernetic feedback loops that establish a structure for
integrating elements most critical to successful laboratory practice.*
TSM directs our efforts through formulation of an hypothesis as to cause of
observed error or validation of a methodology before we act; not after.
TSM means we carry out an experiment – Testing- and follow up results with a
check through monitoring and through additional testing and/or intervention with
outcomes evaluated for the need for additional follow up.
*Spear, S., Bowen, H.; Decoding the DNA of the Toyota Production System; Harvard Business Review, Sep – Oct 1999.

9. THE SCIENTIFIC METHOD – OPERATIONAL SCHEMA
THIS IS A CLOSED CYBERNETIC FEEDBACK SYSTEM
THE SCIENTIFIC
METHOD
MONITOR/EVENT
CONCLUSION
CHECK
MATERIALS
METHOD
OBSERVATION
EXPERIMENT
RESULTS
CALCULATION
HYPOTHESIS
RESEACH
INTERPRETATION

10. TSM– EXAMPLE TABULAR ORGANIZATION OF TEST VALIDATION*
THIS SLIDE DOES NOT ILLUSTRATE THE FLEXIBLE FEED BACK CAPABILITIES OF TSM
STEP DESCRIPTION
EVENT A More Reliable or New Test is Requested or Required to Meet Clinical Practice Standards
OBSERVATION The Instrument Market is Canvased and the Frequency of Need Tracked for Feasibility
RESEARCH Vendor Literature, Journal Review, and Consultation are Carried Out
HYPOTHESIS New Instrument is No More Reliable than Old Instrument – the Null Hypothesis!
MATERIALS Instruments, Calibrators, Reagents, Controls, Samples from Vendor, Standards Institute, etc.
METHODOLOGY Standard Operating Procedure for Carrying out a Validation
EXPERIMENT Samples are Tested on Both Instruments (multiple if multiple POCT’s are being validated)
RESULTS Test Results are Documented Either on Structured Paper Forms or in a Computer Database
CALCULATIONS Statistical Analysis is Carried Out Either Manually or by Computer Automation
INTERPRETATION Vendor/Laboratory Report and Graphical Information is Reviewed by Appropriate Persons
CHECK If New Instrument Implemented Reliability and Clinical Value Monitored Prospectively
CONCLUSION New Instrument has Adequate Reliability Clinical Value Does/ Does Not Justify New Instrument
*McNeil, B.J., et.al.; Primer on Certain Elements of Medical Decision Making; NEJM Vol 293 No 5 Jul 1975 pg 211 – 215.
SCHEMA

11. TSM – OPERATIONAL SCHEMA – PART I
OBSERVATION [SEARCH FOR PATTERNS]
1 History and Review of Prior Data
2 Examination of Test System
3 Retesting of Specimen/Control/Etc.
CONSULTATION [RESEARCH]
1 Laboratory Knowledge / Experience
2 Practice Guidelines Local/National
3 Consultative Resources
CHECK – ACT
PRESENTATION [EVENT(S)]
1 Complaint – Provider/Patient/Inspector
2 Calibration Results
3 Quality Control/Proficiency Results

12. TSM – OPERATIONAL SCHEMA – PART II
POSSIBLE CAUSE [HYPOTHESIS]
1 Problem Listing
2 Grouping into One or More Causes
3 Initial Prioritization on Likelihood
REAGENTS/SPECIMENS [MATERIALS]
1 Orders for Specimens/Reagents
2 Resource Scheduling
3 Personnel Assignment
VALIDATION/ [METHOD]
1 Patient Specimen Testing Procedure
2 Vendor Specimen Testing Procedure
3 Proficiency Specimen Testing Procedure
PLAN – DO
PLAN – DO

13. TSM – OPERATIONAL SCHEMA – PART III
TESTING [EXPERIMENT]
1 Patient Specimen Testing
2 Vendor Specimen Testing
3 Proficiency Specimen Testing
STATISTICAL ANALYSIS [ CALCUATIONS]
1 Linear Regression
2 Accuracy and Precision
3 Other
DATA [RESULTS]
1 Test Results – Patient
2 Test Results – Vendor
3 Test Results - Proficiency

14. TSM – OPERATIONAL SCHEMA – PART IV
CHECK – ACT
ASSESSMENT [INTERPRETATION]
1 Evaluation of Statistics
2 Narrowing of Causal Possibilities
3 Working “Diagnosis”
DISPOSITION [ CONCLUSION]
1 Monitoring of Outcomes
2 Reassessment of Effective Solution
3 Final Conclusions
IMPLEMENTATION [CHECK]
1 New Instrumentation
2 New Reagents
3 New Procedures
FAILURE
FAILURE

15. THE SCIENTIFIC METHOD PROVIDES AN INTEGRATED SYSTEMS TOOL
An example of an implementation of TSM as the foundation of an
Integrated Validation System [IVS].
The IVS would allow for flexible reconfiguration of the verification process to
include a key elements of TSM while assuring:
 Each step is executed in correct order
 All information obtained is evaluated
 All necessary actions are taken
For clarity only the three most critical categories of information or task are shown
for each step in the process.

16. CYBERNETICS IS INHERENT IN THE SCIENTIFIC METHOD
The Cybernetic Feedback System Requires All Information generated during the
validation be:
 Evaluated
 Branch Points Followed
 Actions Taken
 In a timely manner.
Based on scientifically established:
 Knowledge
 Experience, and
 Judgment
With follow up monitoring of outcomes.

17. RCA, DEMING, TQM, PARTS OF ISO 9000 AND EVEN EBM ARE SUBSETS OF TSM!*
TSM IS THE SUPER SET OF ALL APPROACHES TO INVESTIGATION; ALL
TSM RCA DEMING
EVENT EVENT DESCRIPTION -
OBSERVATION CHRONOLOGY OF EVENT ~CHECK - ACT
RESEARCH - -
HYPOTHESIS POSSIBLE ROOT CAUSES -
MATERIALS INVESTIGATIVE TEAM -
METHODOLOGY METHOD PLAN
EXPERIMENT - DO
RESULTS FINDINGS -
CALCULATIONS - -
INTERPRETATION ROOT CAUSE -
CHECK CORRECTIVE ACTION(S) CHECK - ACT
CONCLUSION - “ADJUST” [Variable]
*Total Quality Management: In Its Prime or Past Its Peak?; Medical Laboratory Observer, September 1994, pages 22-32

18. CONCLUSION - OPERATIONAL
The judicious and rigorous application of TSM to design and run:
 Instrument Validation
 Quality Control Processes
 Error Investigation
 Document Results
Establishes the most effective means of assuring the appropriate laboratory
results are reported in a timely fashion and acted upon appropriately. In addition,
the cybernetic feedback system assures that those failures that do occur are
identified as soon as possible, effects mitigated, and actions taken to branch back
through the logical system until the correct method of testing, monitoring, and
reporting laboratory studies is identified or until it is determined there is none
better.