POL and POCT Flashcards
Instruments for large and small hospitals did not meet
Physicians’ office requirements based on space and size
Personnel at physicians office is not
Always Laboratory specialists
Special Instrumentation–Why It Exists
- Instruments designed for large or small hospital
laboratories did not meet needs of the physician’s
office - Personnel at physician’s office were not always
laboratory specialists - Government regulations increased
POL- POCT
POC
POL
- Usually performed by non-laboratory personnel
- POC
Point-of-Care Instrumentation - POL
Physician’s Office Laboratory
POL-POCT regulatory
- Regulatory
- International Organization for Standardization (ISO)
- CLIA ‘88
- FDA
- CAP
- The Joint Commission (formerly JCAHO)
- COLA
FDA is very regulatory of
Blood bank because of the fresh human blood requirement
CLIA is top
regulatory agency
What is under CLIA
Cola, FDA, and CAP
Cola
Inspects physicians office laboratories
CAP does
Hospital lab inspections
TJC inspects what type of testing
Waived
POL physician office laboratory Instrumentation
- User friendly
- Provide rapid laboratory test results
- Provide convenient and effective means of monitoring patient
disease - Increase efficiency and profitability of physician’s office
- Provide a new market for manufacturers
Physicians office Laboratory Instrumentations
- Many models and designs
- Hematology
- Coagulation
- Chemistry
- Immunology
- Microbiology
- Urinalysis
POLI concerns
Office space concerns – size of analyzers
Training of personnel – analyzer ease and simplicity of
operation
Assists POL in regulatory issues and compliance
Interface capabilities
Hematology analyzers
are what type
Small cell counters
Hematology analyzers
3 part Diff use
Electrical Impedance to size & count
cells
Hematology analyzers require
blank mode features
Interface capabilities with
Store what and what
Small cell counters
* 3 Part Diff using Electrical Impedance to size & count
cells
* Minimum training to operate
* Closed mode features – graphic results
* Interface capabilities to LIS or EMR
* Stores QC and patient data with easy retrieval of data
Coagulation analyzers
common tests
- Common tests
- pt, appt, fibrinogen, bleeding times
Coagulation analyzers
common analyzers
- Common analyzers
- Fibrometer, MLA, Sysmex
Coagulation analyzers
POC- point of care anaylyzer
- POC – point of care analyzer
- Coaguchek – PT, INR
Chemistry analyzers- Urinalysis analyzers
- Benchtop vs POC
- Both:
- Dipstick
- Colorimetry
- Interface – LIS, EMR
VItros Dry-Slide system
- DT-60—limited general chemistries
- Glucose, BUN, cholesterol, amylase, hemoglobin,
phosphorus, lactic acid
DTE—electrolytes
Na, K, Cl, CO2
DTSC—enzymes
LD, AST, ALT, CK, CK-MB, GGT,
ALP
DT-60- electrolytes ( type of Vitros dry slide system)
DTE—electrolytes
Na, K, Cl, CO2
DT-60- enzyme ( type of Vitros dry slide system)
DTSC—enzymes
LD, AST, ALT, CK, CK-MB, GGT,
ALP
Current POCT
Most common POC test is
Most POCT testing is
- Most common POC test is glucose
- Most POCT testing is classified as waived testing under CLIA
Current POCT testing
where is most testing done
Concerns with
Generally more what
- Most testing performed by lab personnel in STAT labs or site labs
- Concerns with accuracy, quality control, connectivity to LIS
- Generally, more expensive than tests performed in the laboratory,
but readily available and quicker turnaround time
What Is a waived test
- Under CLIA, tests are categorized by complexity
- Waived, moderate, high and PPM
- Waived tests are:
- Simple to perform
- Cleared by FDA for home use
- Negligible likelihood for errors
- No reasonable risk of harm if performed incorrectly
Components of Instrumentation
- Operator interface
- Bar code reader
- Sample delivery
- Reaction cell (strip, flow through, cartridge)
- Sensor
- Read-out – instrument, LIS
Reaction cell
- Reaction cell (strip, flow through, cartridge)
Glucometers
- Good reliability
- Simple to use – patients often have their own for home use
- Training by video
- Critical limits (<40 and >400) usually followed with drawn blood
sample for testing on chem analyzer for confirmation
EPOC-EPOCAL
- Smart card technology
- Blood gas, electrolyte and metabolite panel
consisting of the following: - measured analytes: pH, pCO2, pO2, Na+, K+,
Ca++, Glu, Lac, Hct - calculated values: cTCO2, cHCO3-, BE(ecf),
BE(b), cSO2, cHgb
EPOC- EPOCAL measured analytes
measured analytes: pH, pCO2, pO2, Na+, K+,
Ca++, Glu, Lac, Hct
Epoc® - Epocal
calculated values
- calculated values: cTCO2, cHCO3-, BE(ecf),
BE(b), cSO2, cHgb
I-STAT Abbott
Hand-held what
Multi- what
Self what
- Hand-held, microprocessor controlled
- Multi-analyte disposable cartridge
- Self-calibrated
I-STAT-abbott
what specimen
Test menu includes
blank turn around time
- Whole blood, 65 μL
- Test Menu includes Na, K, Cl, glucose,
urea, blood gases, ionized Ca,
Hematocrit, hemoglobin - 90 sec. Turn-around time
Lab-on-a-chip
- “Lab-on-a-chip” (nanotechnology) technology will expand
POCT to include biotechnology, oncology, molecular, and
virology (just to name a few!) - Faster analysis with reduced cost and size….portability and
disposability - Goal is to make state-of-the-art technologies accessible for a
wider population…delivering faster and lower-cost disease
diagnosis, prognosis, and screening
A lab on a chip
water fab
Cartridge assembly
- Fabrication of silicon-based circuits with biologically reactive electro-sensors
Precision fluidics and self-calibration in a tiny package
Fast
Accurate
Reliable
Disposable
POCT policies and procedures
- Method validation
- Patient preparation
- Specimen collection and preservation
- Instrument calibration
- Quality control
- Equipment maintenance
- Test performance
- Result reporting (interface)
Daily QC
Temp monitoring
QU performance ( hi and low controls)
Cleaning/ Disinfection
Weekly QC
Reagent inventory and recording
Monthly QC requirements
POCT compliance checks ( all instruments)
QA reports generated
Biannual QC requirements
Calibrations ( send out)
POCT records
- Time and date of test
- Patient results
- Operator
- QC
- Maintenance
- Training and competency testing
- Dates of use
- Policies and procedures
Supplies for glucometers
control solution
OneTouch lancing device
Onetouch ultra blue tests strips
Onetouch ultra meter
Glucometer instructions
Insert tests strip
Make sure the bars are facing you
Controls for glucometers
- Important to test low/high controls daily (per shift?)
- Record results
- Log book
- Docking station
- Abnormal results
Sample collection
Wash hands thoroughly and wear gloves
Always observe universal precautions
Capillary sample collection from finger
Wash hands and wear gloves
Identify appropriate puncture site- middle or ring finger preferred
Prick on side of finger but not into nail
Capillary sample collection from finger
Have the patient hold hand in a
Downward position to allow gravity to help increase blood flow to the capillary bed of the hand
Capillary sample collection from finger
Avoid
Thumb( calloused)
Index finger ( sensitive)
Fifth finger ( Insufficient tissue depth)
Capillary puncture finger
procedure
- Grasp the finger to be used
- Cleanse the site according to site policy:
- soap and water
- alcohol (circular motion)
- Allow the site to air dry completely to provide effective
disinfection and to prevent hemolysis of specimen if
using alcohol - Grasp and steady the patient’s finger slightly below the
first knuckle
Lacing and sampling from your fingertip
Puncture your finger
Hold the lancing device firmly against the side of your finger
Pressure the button
Remove the lancing device from your finger
Applying blood
- Squeeze and release the finger to initiate blood flow
- Avoid “milking” which may cause hemolysis or tissue-fluid contamination
- Wipe away first drop of blood with a clean gauze
- Again, squeeze the finger until a large drop of blood forms
on the puncture - Place next drop of blood on sample strip
Applying blood and reading results
Keep your finger straight
Move the meter and test strip toward the blood drop
Applying blood do not
DO not Apply blood on the top of the test strip
Do not hold the meter and test strip underneath the blood drop ( this can damage the meter).
Results of applying blood
- After blood is collected, wipe the site dry and apply direct pressure
with gauze until bleeding has stopped - Bandage if appropriate
- Read and record test results – patient chart
- Record QC and patient results – log book
