Vuosiseminaari 05 Ravi Nemana POC

High Impact Technology: 

High Impact Technology Point of Care Testing Technologies

Agenda: 

Agenda Definition of Point of Care Testing Point of Care Testing Overview Drivers and Barriers Technology Development Timeline Competing Technologies What will happen to Central Laboratories? Regulatory Issues Impact On Clinical Care and Quality Impact on Workforce Impact on Cost and Revenue Adoption Scenario Planning Key Impacts of Point of Care Testing Technology

Definition of Point of Care Testing: 

Definition of Point of Care Testing Analytic patient testing performed outside the physical facilities of clinical laboratories. POCT employs kits and instruments that do not require permanent dedicated space like a central laboratory. Laboratory without walls: 25% of current lab diagnostics $4.9 billion worldwide Expected double within next 10 years (Source: HealthTech Expert Interviews)

Point of Care Testing Overview: 

Point of Care Testing Overview Point of Care Testing (point of care testing) Devices Available Today Blood gases and electrolytes analyzers Coagulation Blood Chemistries Drug abuse Pregnancy screening Infectious disease markers Cardiac markers Hemoglobin and Hematocrit Common Locations of Point of Care Testing Devices Intensive/critical care units Operating rooms, Med/Surg units Emergency departments Ambulances, first responders Home care (field personnel) Homes (increasing)

Drivers And Barriers For Point Of Care Testing: 

Drivers And Barriers For Point Of Care Testing Drivers Micromachining technology  production of sensors Advances in MEMS  size of devices Advances in molecular chemistry  biosensors, Biomarker research Higher throughput in hospitals Shortages of medical laboratory technologists Recently established connectivity standards Clinical demand for shorter turnaround times Incorporation of wireless Barriers Low sensitivity and specificity v. labs Fewer tests on POCT devices Cannot replicate central lab with POCT Turf battles between lab and medical departments Regulatory issues– quality control, proficiency testing, training, and cost of complying Legislative restrictions Work shifting Lack of comparative studies, training, and resolution of management issues Current lack of reimbursement for many POCT devices

Technologies at a Glance: 

Technologies at a Glance

Competing Technologies: 

Competing Technologies POCT will replace: Stat labs Satellite devices Pneumatic tube system to the lab Mobile labs Some in-house tests POCT will be substituted by: Noninvasive diagnostic tests Implantable monitors Home test kits Lab-on-a-chip Tests embedded in cell phones and PDAs

What will become of the traditional lab?: 

What will become of the traditional lab?  Lab-on-a-chip  Autologous tissue, stem cell, and other tissue implants Therapeutic drug monitoring Implantable monitors Home test lab kits available Slight  lab volumes # of POCT available # of POCT on same machine  QA software cap. short-term duplication Long term Cost: connectivity & productivity gains POCT embedded in consumer devices Data capture & transmission capabilities Current test lab volumes Reference lab role immunoassay tests, hematology, and nucleic acid-based tests Sample size - move to non invasive ? Impact on space in acute care facilities

Regulatory Issues: 

Regulatory Issues FDA – responsible for test categorization: Laboratory test classifications: “Highly Complex” “Moderately Complex” Point of Care Testing Devices CLIA certification required “Waived” “so simple that there is little risk of error”– approved for home use. point of care testing devices as adjunct to established tests CMS – Clinical Lab Improvement Amendments (CLIA) Regulates all laboratory testing (except research), fees, surveys, certification, training, among other roles Laboratory Director requirement JCAHO requirements also impact Laboratories

Regulations: Implications Of “Moderately Complex” Classification: 

Regulations: Implications Of “Moderately Complex” Classification Testing facilities must meet specified standards in the following areas: Personnel qualification Administration Participation in proficiency testing Patient test management Quality control and assurance Laboratory information systems and inspections Implications: Physician offices unlikely to adopt Reimbursement may hinder adoption too. “Waived” tests will diffuse much faster

Impact On Clinical Care And Quality: 

Impact On Clinical Care And Quality POCT eliminates: Acquisition of blood sample Preparation of sample for lab Transport issues Some biohazards Impact on care: Test is now portable Immediate results No phlebotomy Higher throughput

Impact On Facilities: 

Impact On Facilities Major Impacts on Facility Utilization Hospitals  Patient throughput  Care efficiency Adminstrative overhead due to CLIA requirements  Costs if test frequency rises with no reimbursement In the next 3 years Cost per test will be the largest barrier to rapid diffusion of point of care testing technology Consumables will also increase costs In the next 10 Years In 6-8 years role of hospital lab will be different Rapid technology evolution will support point of care testing technology diffusion into: Inpatient facilities Ambulatory setting Home care setting

Impact On Clinical Care And QualityKey Applications of Point of Care Testing in the Next 5 Years: 

Impact On Clinical Care And Quality Key Applications of Point of Care Testing in the Next 5 Years

Impact On Workforce: 

Impact On Workforce 3-8 Years Hospital laboratory technician: Deployed to bedside Replaced by nurses Decreased demand on phlebotomists Decreased labor costs Work shifting to Nurses Potential union issues Automation and Robotics Will decrease need for non-technical staff Will create need for additional IT staff Improved safety for healthcare workers A new clinical job category Oversee devices and manage data

Impact On Cost And Revenue: 

Major point of care testing Costs Capital investment in devices Testing Supplies Staff Training Impact On Cost And Revenue Reimbursement Inpatient Covered under DRG’s for Medicare Patients Per diem contracts for Medicaid and insured  (slight) income from DRG’s due to throughput Fixed payments will not be adjusted for costs Additional costs of POCT may be considered for future adjustments of DRG rates Outpatient Costs billed directly to insurer and will be subject to coverage policies Payment by APC’s Fixed payments will not be adjusted for increased equipment costs Care settings affected: Hospital Outpatient Services Skilled Nursing Facilities Home Health Services Ambulatory Surgery Centers

Impact On Cost And RevenueCost Impacts vs. Potential Benefits for Point of Care Testing: 

Impact On Cost And Revenue Cost Impacts vs. Potential Benefits for Point of Care Testing

Impact On Cost And RevenueBasic Cost Comparison Between A Traditional Laboratory Testing And Point Of Care Testing: 

Impact On Cost And Revenue Basic Cost Comparison Between A Traditional Laboratory Testing And Point Of Care Testing

Adoption Scenario Planning: 

Adoption Scenario Planning In the next 3 to 5 years Early adopters will expand applications of point of care testing technology Other adoption groups will implement point of care testing technology in limited settings Consumers and patients will become aware of point of care testing technology Facilities that employ point of care testing may have a competitive advantage Beyond 5 years Transition of central hospital lab to regional lab centers for non-critical testing Change in payer reimbursement policies Rapid technology development will lead to sophisticated point of care testing devices

Technology Adoption Timeline: 

Technology Adoption Timeline

Key Impacts of Point of Care Testing Technology: 

Key Impacts of Point of Care Testing Technology Testing moves to the bedside 0- 3 years: POCT for blood analysis will be standard of care Hospital lab evolves to resemble a reference lab In 6 to 8 years, lab may be replaced by regional lab Future technology developments Minimal to noninvasive test sampling Immunoassay tests, hematology testing, therapeutic drug monitoring, and nucleic acid-based testing Compliance with CLIA and JCAHO regulation will require increased training Regulations: Will limit POCT into physician offices Developers: CLIA waivers to increase adoption of home test kits Hospitals: POCT adoption will depend on workforce and culture Costs: capital investments, testing supplies, staffing, and staff training Reimbursement unlikely to directly compensate for increased equipment costs

Unanticipated consequences: 

Unanticipated consequences Triage Device Unsupervised, in emergency room move to head of queue if result is abnormal Recording / charges for the test result are a problem “Silo Economics” Bedside versus central lab testing is well studied Cost of service deficit due to central lab testing is NOT well studied IT costs often not included Forcing re-evaluation of hospital financial structure Increasing confidence lowers central lab use POCT must delivery high quality, calibrated results ONLY THEN will central lab volumes decline GLUCOSE: complements lab tests Cultural issues MD Trust of POCT data v. lab accuracy Work shifting to nurses, unions Alternate approach: satellite laboratory facilities Health Record gaps will reduce cultural resistance to POCT IT interfaces not simple and require resource (people and money)

Continued: 

Continued if you maintain glucose levels to a normal level during surgery and 3 days afterwards, they recover faster, fewer complications, less inpatient stay; big push to do intensive insulin therapies Diagnosis v. management Data portability challenges Proprietary software, not same DB or format Need desktop computer to download data from device and combine with data from other devices, then ship data to clinical information system That’s where data managers come in No uniform connections Standards exist: CLIA clinical lab Point of care testing 1A document 40-60% compliance (Emery Stevens)

Key Themes in Point of Care Testing: 

Key Themes in Point of Care Testing Samples  small samples  no samples/continuous results Shorter turnaround time  Efficiency  Throughput Transformation of hospital lab More like reference lab Central lab that provides services to a group of facilities. Disruptive for hospitals Work shifting, Financial incentives & Turf battles

POCT - Summary: 

POCT - Summary Lab testing volumes continue to decrease More tests on fewer machines will be available for bedside testing POCT machines more sophisticated – QA, data transfer, test volumes Decreasing sample size Increased testing and training for POCT moves to nursing New genetic testing and tissue growth labs will be needed