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Point Of Care Testing:A Primer
Mark Ellsworth, BSN, CCHP
Dorinne Peery, RN, MT(ASCP)
Todd Wilcox, MD, MBA, CCHP
www.wellcon.net
Case 123 year old college student arrestedBinge drinking / withdrawal symptoms
Seen in Comprehensive Nurse Exam day 2
Referred to MD for vague stomach pain
MD follows pt with serial labs
White count spikes day 2 to 24,000 / shift
Sent to ED--esophageal rupture secondaryto vomiting (Boerhaave’s Syndrome)
Pt had good outcome--caught early
Case 259 year old chronic alcoholic arrestedPMH: hypertension, cirrhosis
Meds: too drunk to remember
CIWAs: 4, 7, 11, 14 over first day
MD requests labs secondary to updwardCIWA trend
K+ = 7.9 / only subtle EKG changes
Send to ED--dialyzed
Advantages of On-siteTesting
Rapid turnaround
Lower cost
More accurate for some tests
Allows linkage of healthcare visit withresults--better medical logic
Credibility in the ER on sendouts
Patients get better care Salt Lake County On-siteLab Tests
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Salt Lake County On-SiteWaived Lab Tests
Rapid strepUrine pregnancy
Guaiac
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Disadvantages of on-sitetesting
Regulations
Maintenance
In our experience, the advantages faroutweigh the disadvantages
Regulations
•Clinical Laboratory Improvement Act(CLIA)• Original act 1967
• Amended act 1988
•Fairly rigid requirements for operation of alab
CLIA Certification
It is a process
Requires a good operational manual
Minimal training
Pay a fee
Site inspection
Coordination with inspectors
Proficiency Testing
RequirementSend mystery samples to analyze
Staff must run samples and report results
Straight-forward process
Minimally disruptive
Maintainence
Serviced by companyCovered by warranty
Minimal impact
Defining a Lab
Waived testingPhysician performed microscopy
Moderate-complexity tests
High complexity tests
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7 Criteria to Determine Complexity1.User Knowledge2.Training and experience
3.Reagents and material preparation
4.Operational steps
5.Calibration, quality control, andproficiency requirements
6.Trouble shooting and instrumentmaintenance
7.Interpretation and judgment
Waived testing
Point of Care used to be synonymous with“at the bed side, simple complexity”With advancement in technology newPoint of Care equipment is available that isno longer “waived”
Waived Examples
Urine dip stickBlood sugar
Guaiac card for occult blood
POC MenuCBC
Electrolytes
PT/INR
Urinalysis
Thyroid function tests
Diagnostic drug levels
HgA1C
PSA
Cardiac isoenzymes
Hepatitis C
Moderate Complexity
CBCTherapeutic drug levels
Chem 7 (i-Stat)
Cardiac enzymes
CLIA Requirements for moderatecomplexity lab
Physician Laboratory DirectorPolicies
Training and expertise by the staff whowill perform the tests
Proficiency testing
Back up lab
Accrediting agency (typically a specifiedstate agency)
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Current Cost AnalysisLab Current $ On-site $ SavingsCBC 36,210 5,298 30,912
PT/INR 2584 2380 204Electrolytes 56,447 29,230 27,217
Drug levels 22,500 5200 17,300
TSH 56,100 10,300 45,800Hep C 13,700 6030 7,670PSA 5,617 1852 3,765
Cardiacs 590 (8780) (8,190)HgA1C 11,447 6474 4,980
Cost SavingsDiagnosis Current $ Estimated
Savings
Chest pain 697,000 196,671
Abdominalpain 289,360 130,678
Seizure 120,106 46,101
Infection 79,290 19,882
Cellulitis 369,654 92,413
Totals 1,555,410 485,745
Capital Costs to Convert toPOC
Instrument CostCBC 21,000I-Stat 5,600
DCA 2000 0.00Axsym 0.00
Centrifuge 1,600
Total 28,200
Other costs to convert toPOC
Item Cost
Supplies
Labor
CLIA
Accreditation fee
CAP proficiency
Total
SummaryPoint of Care Testing is the futureGreatly assists clinicians in making gooddecisions
Minimizes transports
Cost savings are very possible
CLIA is nothing to be feared
Point of Care testing makes the systembetter
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