SEM100 - MTAP100 - MLSCI 100 | MEDICAL LABORATORY SCIENCE INTERNSHIP

QUALITY ASSURANCE, QUALITY CONTROL, LIS

Jan Micah Ticzon, RMT and Keith Grijaldo, RMT September 11 & 23, 2021

OUTLINE B. LABORATORY INFORMATION SYSTEM

I. Laboratory Information II. Pre-Analysis and ● Laboratory Information System (LIS) is a type of relational
System Post-Analysis database
INDEX: APPENDIX ● The LIS is a database that establishes and maintains
I. LABORATORY INFORMATION SYSTEM standard definitions and information processing
procedures
● A part of HIS
● Used to communicate with analyzers and the external
Data system (Hospital Information System)
● Computers process and store data with numbers ● Hierarchy:
● Used as a workflow to collect the data needed for → HIS > LIS > miscellaneous departments of laboratory
examination (billing, nursing, triage, etc.)
● Binary (base 2) Parts of LIS
→ computers use a series of 0’s (zeroes) and 1’s (ones)
1. Patient demographics
→ 0 is off and 1 is on
2. Worklists
● Bit: 0 or 1
→ All encoded laboratory procedures can be found here
● Byte is a series of 8 bits
→ Can be connected to triage (i.e. triage requests for a
→ 1 byte = 1 character
specific test and it automatically shows up in the
→ 28 or 256 combinations of bytes
worklist)
● Storage capacity is measured in:
3. Data retrieval (inquiry)
→ Kilobytes (KB) = 1024 bytes
→ Generate patient results: Flag critical values, print
→ Megabytes (MB) = 1024 kilobytes
reports if requested, etc
→ Gigabytes (GB) = 1024 megabytes
→ Perform delta checks: results of an analyte assay are
A. DATABASE compared to the most recent previously performed
● Building blocks of information systems which are results on the same patient
structured collections of records comprised of data fields ▪ Incident report (IR) AKA narrative reporting: made
● Two types of Databases to verify what exactly happened in a situation;
detecting where the procedure went wrong
Flat-File Database Relational Database
→ Patient results can be retrieved electronically at a client
a very simple database uses two or more tables or via the internet with a web browser
which holds all of the data link together to form a ▪ Patients may undergo data inquiry
in one table only relationship ▪ Watcher or doctor may retrieve results as well
4. Reflex testing
→ If an initial test result is positive or outside normal
parameters, the LIS can automatically order a second
appropriate test
→ Similar to a confirmatory test
→ The LIS can request a secondary/confirmatory test
→ Engineers place pre-determined results on the
machine, and when the machine detects these results,
Flat-file database it automatically performs a secondary test
→ e.g. random blood sugar, when positive, may undergo
reflex testing (HBA1C)
5. Current procedural terminology (CPT) codes
→ The CPT codes describe medical, surgical, and
diagnostic services and are designed to communicate
information about medical services and procedures
among physicians and other healthcare professionals.
Relational database CPT codes are used for billing purposes and can be
How to Form A Relationship Between Two Tables programmed into the LIS
Used in a Relational Database → Standardized codes
● Relationship is formed when our two tables are joined ▪ e.g. HCT: hematocrit, HGB: hemoglobin
together 6. Quality Control
● Relationships make use of key fields and primary keys to → A LIS can analyze quality control specimens and
allow the two tables to communicate with each other and prepare charts and reports (e.g., Westgard rules,
share their data Levey-Jennings charts).
→ key field: categories (e.g. name, date of birth, gender, ▪ Quality control is done every day using pathogenic
phone number) and non-pathogenic sample
▪ patient ID is also a key field, but it is also a primary ▪ Normal is usually white or green
key for another database ▪ High control is either yellow or red
● Primary key of: (refer to the table above) 7. Quality Assurance
→ Patient’s table - Patient ID → Can provide reports on turnaround time, documentation
→ Doctor’s table - Doctor ID of critical result reporting (i.e. how many results are
● In order to link the tables we need to use a common field positive in a certain test), and corrected reports (i.e.
→ Common field between the patient and doctor table is manually corrected results are also reflected in the LIS)
the doctor ID

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8. Management reports
→ Cost per billable test calculation, test volume,
turnaround time, employee hours, workload data, etc.
9. Encoding systems
→ Systematized Nomenclature of Medicine - Clinical
Terms (SNOMED-CT)
▪ Is a comprehensive database of standardized
terminology for healthcare. Once implemented, it will
allow automatic data analysis over a wide range of
clinical information systems.
▪ Diagnostic codes in SNOMED-CT:
− DF: dengue fever
− DFWS: dengue fever warning signs
− HTN: hypertension
− HDN: hemolytic disease of the newborn/infant
− CAPMR: community-acquired pneumonia with
moderate risk
− HACT: HIV and AIDS Core Team (in SPMC)
→ Logical observation identifiers names and codes
(LOINC)
▪ is another database of universal standards for
healthcare
Laboratory Information Flow
1. Register patient
→ assign unique ID; done during admission, discharge, or
transfer
→ No test should be ordered until a patient record is
created
→ Social security numbers or institution-generated
numbers exclusive to registration should be utilized
because these are unique identifiers.
→ RFID can be used; excitation signal from the scanner
energizes the RFID tag, RFID tag emits a return signal
which contains patient identification.
→ RFID benefits include:
▪ passive operation and dynamic data storage
▪ features that favor its use in sample collection and
tracking
▪ beside testing
▪ drug management and infection control
2. Order tests
→ Can be through the Clinical Information System, sent
electronically to the LIS
→ Computerized pathology test order entry has also been
shown to reduce the lab turnaround time
→ Data pertaining to the request should be automatically
generated at this time.
3. Collect sample
4. Receive sample
5. Run sample
→ The analyzer can communicate with LIS unidirectionally
or bi-directionally
→ Unidirectional: Analyzer → LIS
→ Bidirectional: Analyzer → LIS → LIS is capable of
sending results back to the analyzer
6. Review sample
7. Release result
→ Regardless of whether the results are manually entered
or automatically transferred, the computer always
performs a validity check
→ Panic values can be flagged
→ Auto-Validation protocols can be used to automatically
release results without review.
8. Report result

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II. PRE-ANALYSIS AND POST-ANALYSIS
● Quality
→ Accurate & precision
▪ accuracy: closeness to the actual value
▪ precision: repetition of values
→ Reproducible
→ Reliable
Ways of Ensuring Quality
● Quality Assurance - a broader concept
→ encompasses preanalytical, analytical, and
post-analytical processes
● Quality Control
→ document assayed validity, external quality, and internal
quality assessment, publication, therapeutic ranges,
and lot to lot validation
→ External Quality Assessment Scheme
▪ The samples sent are usually called ‘survey’ or
‘proficiency testing’ specimens
▪ Separate target values may be assigned for various
assay methods and instruments, as feasible.
▪ A certain level of error is tolerated.
→ Internal QC: controls utilized daily, must be used every
shift; check if values exceed ±3SD. Control results
must fall within predetermined dispersal limits, typically
+2 SD.
▪ In institutions that perform continuous runs, controls
should be run at least once per shift, e.g. 7AM, 3PM,
11PM.
▪ In laboratories where assay runs are discrete events,
two controls are assayed with each run.
→ Reference range: range of value of analyte in healthy
individuals
→ Lot-to-lot validation:
▪ laboratory managers reach agreements with vendors
to sequester kits and reagent lots thereby ensuring
infrequent lot changes
▪ optimistically no more than once a year
▪ reagent lot must arrive approximately a month before
the lab runs out
▪ This ensures a lot-to-lot comparison may be
completed and differences resolved, if necessary.
→ Document assayed validity
▪ record of standard forms (7-10 years)
See in appendix
Preanalytical Errors
● Wrong specimen obtained from the patient
● Wrong specimen procured at the wrong time
● Wrong specimen collected in the wrong tube
● Blood specimens collected in the wrong order
● Incorrect labeling
● Improper processing of the specimen
A. PREANALYTICAL QUALITY ASSURANCE
COMPONENTS AND LABORATORY STAFF
RESPONSIBILITY
● ‘pre-pre’ analytical variables
→ includes physician test ordering patterns
● ‘post-post’ analytical variables
→ appropriate application of laboratory assay results
● 17% medical error rate associated with pre-pre and
post-post analytical phases combined.
→ Clinical query system: guides physicians in laboratory
assay selection
● Physicians base 70% of their clinical decision-making on
lab results.
● Test orders (so diri dapit na time nag linog guys)
→ Conduct continuous utilization reviews to ensure that
physician-generated orders are comprehensive and
appropriate to patient indications
→ Inform the physician about laboratory
→ Reduce unnecessary repeat testing
● Test request forms
→ Are requisition forms legible?
→ Can the phlebotomist confirm patient identity?
→ Are physician orders promptly and correctly interpreted
and transcribed?
→ Are adequate diagnostic, treatment, and patient
preparation information provided to assist the
laboratory staff to appropriately test and interpret
results?
● STAT orders and timeliness
→ Stat ⇒ statin to “rush” in Latin
→ Do turnaround time expectations match clinical
necessity and ensure that stat orders are reserved for
medical emergencies?
→ Does laboratory management meet established
turnaround time requirements?
Specimen Collection
● Is the patient correctly identified, prepared, and available
for specimen collection?
● Is fasting and therapy status appropriate for the assay?
● Is the tourniquet correctly applied and released at the right
time?
● Are venipuncture sites appropriately cleansed?
● Are the timed specimens collected at the specified
intervals?
● Are the specimen tubes collected in the specified order?
● Are additive tubes properly mixed?
● Are specimen tubes labeled correctly?
On additional information
● OGTT is collected every 1 hour
→ The first sample is for FBS
→ Measured per 100grams
→ Glucose juice will be given to the patient, samples will
be collected hourly
● Posture
→ Lying down = hemodilution (dec PCV by 8%, dec WBC)
▪ significant increase in lipids, enzymes, proteins
→ Standing up: increase PCV and WBC
● Diurnal rhythm
→ daily body fluctuations that occur with some
constituents of the blood
PARAMETER MORNING AFTERNOON
Iron High Low
Eosinophil Low High
TSH High Low
Low High throughout
WBC
the day
Cortisol High Low
● Exercise
→ Activates coagulation and fibrinolysis
→ Increases platelets and WBC count
→ Also elevates creatinine, protein, creatine kinase,
aspartate transaminase, lactate dehydrogenase
● Stress
→ Anxiety can cause a temporary increase in white blood
cells (not clinically significant)
● Diet
→ Fasting (NPO – non per orem)
→ 8-12 hours before a draw of blood
→ If RBS (random blood sugar) - if the patient is
nonfasting, there will be a temporary increase in
glucose in the blood within 2 hours after the meal

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● Age ● Px suffers from dengue: machine gives low WBC, rerun
→ Newborns: reticulocytes are increased due to higher the test and release immediately
red marrow (2-6% reticulocyte count) → Depending on px condition and physician’s orders, it is
▪ 0.5-1.5% adults reticulocyte count critical to provide accurate test results in a timely
● Gender manner
→ Men - higher ALP, Aminotransferase, CK, Aldolase → It is a possibility that a numeric value is outside the
→ Women - decrease magnesium, calcium, albumin, analytical range of the method
hemoglobin, serum iron, and ferritin ● Delta checks
→ Androgen stimulates EPO production → Comparing a current lab result with results obtained on
→ Estrogen inhibits EPO production a previous specimen from the same patient
● Smoking → Check the history of a patient before releasing results
→ Smoking before blood collection increases WBC count ▪ Check if patient underwent surgery or transfusion
and cortisol levels ▪ If no remarkable history, delta check failure can
→ Long term smoking indicate an analytical error or mislabeled specimen.
▪ decrease pulmonary function; thus, decreasing Hgb ▪ Results should be sequestered until the cause is
levels found.
Specimen Transport ▪ Delta errors only identify gross errors.
▪ Random errors, shifts, or trends will not be identified
● Are specimens delivered intact, sealed, and within in delta checking.
specified time limits? → Types of error detected:
● Are specimens maintained at the correct temperature? ▪ Preanalytic - e.g., mislabeling of specimen
Specimen Management ▪ Analytic - e.g., aspiration of insufficient sample
● Are specimens centrifuged correctly? volume
→ Check for chyle wring it once then centrifuge it again to
remove chyle
→ Let clot for 10 minutes and centrifuge for 5 minutes
→ However, chylous samples should not be wrung; should
only be centrifuged
→ Wringing chylous samples can affect analytes in
chemistry
● Are specimens and aliquots stored properly?
● Are coagulation specimens consistently platelet-poor?
Specimen Rejection
● Inappropriate specimen type
● Wrong preservatives
● Hemolysis
● Lipemia
● Clots → When aspirating blood yields a small amount,
possible that the blood sample is clotted
● Misidentification of patients (transfusion)
● Reasons to avoid specimen rejection:
→ Costly for the lab
▪ “another costing for the syringe”
→ Time-consuming
→ Painful for the patient
Analytical Errors
● Systemic Errors
→ errors within the test system or method
→ e.g., out of control QC results
● Random Errors
→ errors occur without prediction or regularity

B. POST ANALYTICAL PHASE

Test Results
● The value must undergo a 2-step post-analytic evaluation
process
→ Analytic correctness: performing lab
→ Clinical significance: clinical team
Assessment of Analytic Correctness of Results
● Alarms and flags
→ Prevent the release of erroneous results
→ Can indicate:
▪ Problem with the specimen
▪ An issue with the result
▪ The need for confirmation by an additional assay
● If hematocrit is low, sip EDTA and capillary tube and
centrifuge
→ Manually measure the hematocrit.
→ Correlate with results given by machine
→ Manually perform white blood cell count

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Assessment of Clinical Significance of Results Variability of Laboratory Results
● Critical values ● Interindividual
→ AKA panic or alert values → Factor specific to individual patients
→ When seen, report immediately ● Intraindividual
→ Lab results that may represent a life-threatening → Due to biologic changes that causes the analyte to
situation fluctuate over time
→ INR: International normalized ratio → E.g. diurnal variations, food intake,
▪ where: ● Random
− INR: International normalized ratio → Sum of analytic and interindividual variability
− PTtest: tested prothrombin time ● Analytic
− PTnormal: normal prothrombin time → Result of assay imprecision
− ISI: International sensitivity index

Publication of Reports
● Are the results accurately transcribed into the information
system?
● Are they reviewed for errors by additional laboratory staff?
● If auto verification is in effect, are the correct parameters
employed?
● Do reports provide reference intervals (RIs)?
● Do they flag abnormal results?
● Are the result narratives appended when necessary?
● Does the laboratory staff conduct in-service education to
support test result interpretation?
● Are critical values provided to nursing and physician staff?
● Are verbal reports confirmed with feedback? (physician)
● Are anomalous findings resolved?
See in appendix
Timeliness
References Ranges
● Are turnaround times recorded and analyzed?
● Range of values into which 95% of non-diseased values ● Are laboratory reports being posted to patient charts in a
(normal) will fall timely fashion?
● Minimum number of subjects to develop a reference range
● High or low Patient Satisfaction
● Carefully defines their normal values ● Does the institution include laboratory care in patient
● New assay with no established reference, minimum of 120 surveys?
data points ● Was specimen collection explained to the patient?
● Transference Relevant Acronyms:
→ Once the manufacturer’s reference interval is validated, ● Systematized Nomenclature of Medicine - Clinical Terms
the laboratorian may transfer the reference intervals
(SNOMED-CT)
into the institution ● Logical observation identifiers names and codes
→ Local laboratory practitioners need only 30 specimens (LOINC)
to validate the manufacturer’s reference range. ● Hospital Insurance Portability and Accountability Act -
→ Should be locally validated and the samples should be HIPAA
from 15 males and 15 females.
– FIN.
Control vs. Calibrator
● It is ideal that a laboratory director insists that controls be Chandler’s quote:
purchased from distributors different from those who
supply their calibrates
● Calibrators are used to adjust instrumentation to
develop a standard curve
● Controls are used independently of the calibration
process so that systematic errors can be detected
through internal quality control.
→ Are inexpensive and have the same matrix as the
sample to be tested
Factors that Affects Reference Range
● Age
● Genetic background
● Exposure to different environmental factors
● Containers
● Mode of transport
● Time between specimen collection and analysis
● Storage conditions of the specimens before analysis
● Tested pt/normal pt x international sensitivity index

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 INDEX: APPENDIX

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