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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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