Goal Goal in Point of Care? Goal in the Laboratory?

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  • Goal in Point of Care?

  • Goal in the Laboratory?

  • Goal in the Hospital?


  • Discuss quality

  • Three things you must do…

  • Device Classes

  • Data Management

  • Standardization

  • Billing

To Err is Human - Building a Safer Health System A Report From The National Academies of Science, Institute of Medicine

  • 44,000 – 98,000 patients killed each year by medical mistakes

  • Key Recommendations

    • Center for patient safety
    • National mandatory reporting
    • Peer review protections
    • Focus greater attention on patient safety
    • FDA should increase attention to safe use of drugs

Causes of Medical Mistakes

  • 60-80% is human error

    • Active errors

Three approaches to quality

  • Remedial

    • Alleviate the symptoms of the existing problem
  • Corrective

    • Eliminate the cause of existing problems or undesirable situation to prevent recurrence
  • Preventative

    • Eliminate the cause of potential problems

Is 99.9% Good Enough?

  • 1 hour of unsafe drinking water every month;

  • There will be no telephone, electricity or television for 15 minutes each day.

  • 315 entries in Webster's Dictionary will be misspelled

  • 114,500 mismatched pairs of shoes will be shipped/year

  • 811,000 faulty rolls of 35MM film will be purchased this year.

  • 880,000 credit cards in circulation will turn out to have incorrect cardholder information on their magnetic strips

  • 2,488,200 books will be shipped in the next 12 months with the wrong cover.

  • 5,517,200 cases of soft drinks produced in the next year will be flatter than a bad tire.

  • 1,314 phone calls will be misplaced by telecommunications services every minute.

  • 18,322 pieces of mail will be mishandled/hour

  • 22,000 checks will be deducted from the wrong bank accounts in the next 60 minutes.

  • 2,000,000 documents will be lost by the IRS this year

  • Your heart fails to beat 32,000 times each year.

  • Twelve babies will be given to the wrong parents each day.

  • 2,500 newborn babies will be dropped in the next month.

  • 107 incorrect medical procedures will be performed by the end of the day today.

  • 500 incorrect surgical operations each week;

  • 200,000 drug prescriptions will be filled incorrectly in the next 12 months.

  • A typical day would be 24 hours long (give or take 86.4 seconds)


  • Our healthcare delivery system is NOT safe for the patient

  • You can’t manage

  • what you can’t measure.

  • Bill Hewlett

Technology can benefit quality

  • CBT – Computer based training for nursing

  • Barcoded patients

    • - Mercy Health System, Philadelphia

Three things you MUST DO!

  • Barcode your patients & operators

82% of Patient Data Still Manually Recorded

  • Exuberant Connectivity

Fetters POC Device Classes

  • 0 – Manual testing

Standard Data Management Schema

Standard Data Management Schema

Standard Data Management Schema

Standard Data Management Schema

Standard Data Management Schema

Standard Data Management Schema

Standard Data Management Schema


  • Time savings (up to 1/3 of POCC)

  • Ability to bill

  • Results on EMR

  • QC tracking / regulatory viability

  • Improved user compliance

    • “What I do matters to somebody”
    • QC/Operator Lockout
  • Early problem detection (liability)


  • Doesn’t inherently save *nursing* time

  • Timeline

  • Apparent Price (Sticker-shock)

  • Manual testing

  • Interfaces

  • Multiple analytes / multiple DM systems

Connectivity Scored Worst

Vision Statement

POC Testing Environments

  • Testing performed at the patient’s side


  • Abbott Diagnostics

  • Agilent Technologies

  • Bayer Diagnostics

  • BD

  • Instrumentation Laboratory

  • LifeScan/Johnson & Johnson

  • Medical Automation Systems

  • Radiometer Medical

  • Roche Diagnostics

  • Sunquest

  • Banner Health System

  • Bradford Royal Infirmary

  • Geisinger Health System

  • Hospital Costa del Sol

  • John Hopkins Medical Institutions

  • Kaiser-Permanente

  • Mayo Clinic

  • The Mount Sinai Hospital

  • St. Vincent Mercy Medical Center

  • University of Iowa

Existing Communication Standards

Top User Requirements

  • 1. Bi-directional connectivity

  • 2. Standardized device connections

  • 3. Use existing hospital infrastructure

  • 4. Interoperability with commercial software

  • 5. Security

CIC Specifications


  • Publication and maintenance

  • Aggressive Timeline

  • Subcommittee on POC Connectivity

  • Formatted and Framed CIC’s work

  • www.nccls.org

Structure of POCT1-A

  • Introduction

  • Scope

  • Definitions

  • Specifications (Overview)


  • (A) Device and Access Point Specification

  • (B) Device Messaging Specification

  • (C) Observation Reporting Specification

  • (D) CIC Provider Review Committee Needs Document

  • (E) Architecture Documents

  • (F) Vendor Codes

Why has it worked?

  • The People

  • Russ Mock, Bayer Diagnostics * Imre Trefil, Lifescan, Inc. * Greg Menke, Medical Automation Systems, Inc. * Leslie Leonard, Agilent Technologies * Nonato Bautista, Lifescan, Inc. * Becky Clarke, Telcor Inc. * Jeff Sutherland, IDX * Sidney Goldblatt, Sunquest Information Systems * John Low, Instrumentation Laboratory * Taia Ergueta, Agilent Technologies * Marcia Zucker, International Technidyne Corporation * Gerald Kost, University of California - Davis Medical Center * Vladimir Ostoich, Abaxis * Rorie Morgan, Lifescan, Inc. * Kevin Callahan, Spectrx * Larry Cohen, HemoSense Inc. * Jeffrey Perry, Agilent Technologies * James E. Robinson, Lifescan, Inc. * Petrie Rainey, University of Washington * Dan Nowicki, GE Marquette Medical Systems * Joachim Koeninger, Agilent Technologies * Rodney Kugizaki, Lifescan, Inc. * Thomas Bluethner, Roche Diagnostics Corporation * Dominique Freeman, Agilent Technologies * Charles Schindler, POC Consultant * Jacqueline Baker, Roche Diagnostics Corporation * Ken Gary, Abbott Diagnostics * Mike Higgins, Agilent Technologies * Christopher Fetters, Medical Automation Systems, Inc. * Miguel Blanc, Motorola * Borzu Sohrab, Lifescan, Inc. * Stephen Kellet, Agilent Technologies * Christian Kargl, AVL Scientific * Ellis Jacobs, Mount Sinai Medical Center * Syrous Parsay, Lifescan, Inc. * Rick Hrabe, Medical Automation Systems, Inc. * Jon Kitahara, Lifescan, Inc. * Gerhard Pross, Agilent Technologies * Bryan Allen, Bayer Diagnostics * Matthias Essenpreis, Roche Diagnostics Corporation * Deepak Narsipur, Lifescan, Inc. * Jack Harrington, Agilent Technologies * Tom Braithwaite, Medical Automation Systems, Inc. * Stephen Lee, Medical Devices Agency * Dirk Boecker, Agilent Technologies * Paula Santrach, Mayo Medical Center * Kendra Whittier, Agilent Technologies * Wayne Mullins, Medical Automation Systems, Inc. * Bob Anders, Agilent Technologies * Andrew St. John, AVL Scientific * Roger D. Hughes, SCC Clinical Information Systems * Craig Robinson, SMS * Allan Soerensen, Radiometer Medical * Chris Melo, Agilent Technologies * Thomas Downey, Avocet Medical, Incorporated * Gerd Grenner, Roche Diagnostics Corporation * Daniel Trainor, Agilent Technologies * Steve Lundy, AVL Scientific * Michael Vock, IGEN International, Inc. * Paul Chirico, Avocet Medical, Incorporated * * William J. Fannon, Instrumentation Laboratory * Jody Tirinato, i-STAT Corporation * Horst Merkle, AVL Scientific * Kent Lewandrowski, Massachusetts General Hospital * Alan Greenburg, Roche Diagnostics Corporation * David Frey, Agilent Technologies * James LaFrance, Bayer Diagnostics * Roger Kaltefleiter, Cerner Corporation * Kevin Bryan, Citation Computer Systems, Inc. * Bill Lesar, Telcor Inc. * Sean Field, AVL Scientific * Jim Terrano, Telcor Inc. * Rick Lebo, Geisinger Medical Center * Forrest Kneisel, Department of Defense Office of Clinical Laboratory Affairs * Mike Gavin, International Technidyne Corporation * Jared Monaco, AVL Scientific * Billie Keller, Medical Automation Systems *Candi Barker, Citation Computer Systems, Inc. * Jim Macemon, VIA Medical Corp * Bruce Noon, Sunquest Information Systems * Suzanne Cross, Lifescan/OCD * Louis J. Dunka, Lifescan, Inc. * Wolfgang Janschitz, AVL Scientific * Heiko Ziervogel, Agilent Technologies * Kenneth Powell, BD * Stephanie Higgins, Kaiser-Permanente * Stephen Zweig, Avocet Medical, Incorporated * Paul Schluter, GE Marquette Medical Systems * Sharon Sampson, Agilent Technologies * Anwar Azer, Instrumentation Laboratory * John Quigley, Chiron Diagnostics Corporation * Robin Zimmerman, Kaiser-Permanente * Klaus Kjoller, Radiometer Medical * Kendra Whittier, Agilent Technologies * Joe Rodgers, i-STAT Corporation * Teresa Prego, Bayer Diagnostics * Dana Landry, Instrumentation Laboratory * Barry Willis, Agilent Technologies * Charles Balas, International Technidyne Corporation * Marcy Anderson, Medical Automation Systems, Inc. * Mary Audette, Medtronic * Charles Laughinghouse, AVL Scientific * Fabienne Sebire, FluorRX, Inc. * Nancy Newton, Mayo Medical Center * Robert Uleski, FluorRX, Inc. * Robert J. Knorr, Lifescan, Inc. * Daniel Cheek, Medtronic * Kamran Rastgooy, Roche Diagnostics Corporation * Jay B. Jones, Geisinger Medical Center * Kenneth Levy, Roche Diagnostics Corporation * Jason Ratcliffe, AVL Scientific * Mark Maund, i-STAT Corporation * Gerhard Krammer, Agilent Technologies * Brent Lowensohn, Kaiser-Permanente * Jim Lindauer, Agilent Technologies * Anne LeBlanc, Bayer Diagnostics * Paul Fernandes, CompuCyte Corporation * Tony Nugent, Cholestech Corp * Paul Fingerman, Kaiser-Permanente * Jim Nichols, Johns Hopkins Hospital Department of Pathology * Gert Fendesak, Roche Diagnostics Corporation * Mark Cederdahl, Telcor Inc. * Rick Pittaro, Agilent Technologies * Per Matsonn, Pharmacia & Upjohn * Gerd Grenner, Roche Diagnostics * Emery Stephans, Enterprise Analysis Corporation

AACC Industrial Liaison Committee

  • Worksheets on the web

  • Vendor download

  • Fill-out and sign

    • 510K approved instruments
  • Send to ILC

  • Chronological list of “compliant” components

  • Use CIC logo

Purchasing - Future Planning

  • Devices that capture enough info (POCDeC Level ii, iii, iv)

  • NCCLS POCT1-A / CIC compliant devices

  • Data Manager from vendor or partner of:

    • Glucose
    • Blood Gas
    • Coag
  • Add other CIC Compliant vendors for Patient / QC capture

Questions to ask - Device

  • Is your device POCT1-A compliant (most are not yet, because the standard was just approved and a new device has not been sent to and approved by the FDA.)?

  • When will your device be POCT1-A compliant?

  • Will you update the devices I currently have with firmware which adheres to POCT1-A?

  • Is an upgrade to POCT1-A compliant devices part of the contract?

  • Does your device download via an infrared port or a cable? Infrared is preferred.

  • Does your device allow the data manager to automatically update the time according to POCT1-A?

  • Does your device collect all the information I need to make a full patient record - Date/Time, Global Id, Result, Patient ID, Operator ID, QC Lot#, Strip/Cartridge lot #, etc.?

  • Tell me about the bidirectional information which travels back and forth in a non-POCT1-A (proprietary) format. Tell me about the information and features which are relayed according to POCT1-A Device Messaging Layer.

  • Assure me that I could connect your device to any POCT1-A compliant data manager and access point and transfer basic patient, QC, operator, device event, and time data back and forth.

  • Will you provide a CD with “POC Device Drivers” to enable plug and play operability and results processing for non-partner data management systems (assuming they are CIC compliant.)

Questions to ask – Access Point

  • Is the access point POCT1-A compliant?

  • Does the access point have both cable and infrared port capabilities on it?

  • How many cabled ports does the access point have? (This is how many cabled devices (POCT and critical care) you will be able to connect.)

  • Does the access point automatically register, using "find-and-bind," the data managers which are advertising SNMP services?

  • Please confirm that I will be able to use this access point for any POCT1-A compliant device download.

  • Is this access point a universal access point according to the IEEE MIB standard which will allow me to download both POC devices as well as compliant Critical Care Instruments (Heart Rate Monitors?)

Questions to ask – Data Manager

  • Is your data manager POCT1-A compliant on the device side?

  • Is your data manager POCT1-A compliant on the EDI side?

  • Does your data manager advertise itself to access points using SNMP on the hospital network?

  • Does your data manager support the addition of new POCT1-A compliant devices?

  • If so, how would this process of adding a new device take place? Explain the steps because I want to see how plug and play you are.

  • How does your system facilitate the collection of manual POCT data?

  • What bidirectional functionality will I get with your partner device companies and what functionality will I get with non-partner (but still POCT1-A compliant) companies?

  • Does your EDI interface support enhanced acknowledgement?

  • Will I be able to see the LIS Accession Number of the result in the data manager?

  • Will I see results that are delivered to (basic acknowledgement) but not accepted by the LIS in my data manager as an error? Or do I have to go to an LIS error log to see these results?

  • Does your data manager broadcast CIC compliant time for any CIC compliant device to update against?

  • Do you accept CD’s with “POC Device Drivers” to use analytes from non-partner vendor devices enabling true plug and play when adding new devices?

Questions to ask – LIS Interfaces

  • Does your LIS support POCT1-A HL7 interfaces?

  • Does your LIS support enhanced acknowledgement (application acknowledgement) and let my data manager know when a result is not put into the LIS database?

  • How much will it cost to add more devices, more analytes to the POCT1-A compliant EDI interface?

3-part Billing Consulting

    • I. Informational seminar 2-4 hrs with hospital staff – Nsg, Lab, Finance, etc.
    • II. Feasibility study Payor mix Actual volumes Program Costs (disposable, workload, indirect costs) Etc…
    • III. Implementation LIS Setup, Charge master, CPT, Charges Auditing (denials) 3,6 mo outcomes

A Penny Saved is

  • A Penny Saved is

  • A Penny Earned.


  • You should bill for point of care testing!

  • Point of care billing is profitable!

  • Billing for point of care improves patient care!

We S-H-O-U-L-D bill for Point of Care Testing

We should bill for point of care testing.

  • HOW?

  • Q. WHY?

Point of Care Testing is Lab Testing

  • Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)

  • American Medical Association (AMA)

  • Medicare

CLIA ‘88

  • Certifies testing

AMA’s CPT Codes

  • Defines code for medical procedures

  • Laboratory testing in the range: 80000 to 89399


  • Clinical Laboratory Fee Schedule

    • Covers procedures in CPT Range 80000-89399
    • Set reimbursement rate (Medicare Part B)
    • Update yearly by Medicare

Setting charges for analytes

  • Using the Clinical Lab Fee Schedule

    • DON’T
    • Glucose (82962) $3.23


  • Medicare Part A

    • Inpatient
    • Reimbursed by Fiscal Intermediary
  • Medicare Part B

    • Outpatient/POL’s
    • Reimbursed by Carrier

Inpatient Medicare Billing Process

Use of the cost report

  • Globally

    • PPS based on averages
    • Set next year’s DRG reimbursement schedule
  • Locally

    • Cost to charge ratio

Example DRG

  • Primary Diagnosis:

  • ICD-9 36.1 – “Bypass, aortocoronary”

Medicare Payment Policies

  • National

    • National Coverage Decisions
    • 23 lab analytes
    • In effect Nov, 2002
    • Final Rule: Federal Register 11/23/2001
    • Administered by Federal Law

Medicare National Coverage Decision

  • Specifically addresses glucose testing

  • Lists ICD-9 for medical necessity

  • Lists reasons for denial

  • Also covers CPT 82947

Who says I can bill for POCT?

  • Medicare

Who says I can bill for POCT?

  • Medicare

What hospitals?

What is required to bill lab tests?

  • CLIA Number

  • Physician order

  • Reasonable and necessary (SSA 1862(a)(1)(A))

  • Physician must use to manage pt care (42 CFR 410.32, 411.15)

  • Result to physician promptly (implicit)

Medicare National Coverage Decision

  • Specifically addresses glucose testing

  • CPT Codes

  • ICD-9 for medical necessity

  • Reasons for denial

    • Absence of signs or symptoms
    • Routine physical (such as employee physical or community health fair)
    • Failure to provide medical necessity
    • Not ordered by physician
    • Failure to have CLIA certificate
    • Testing performed on device not FDA approved

How do I bill?

  • Manual Billing

“If you don’t do it excellently, don’t do it at all.

  • “If you don’t do it excellently, don’t do it at all.

  • Because if it’s not excellent, it won’t be profitable.

  • If it is not excellent, it won’t be fun and if you’re not in business for fun or profit, what the hell are you doing here?”

  • Robert Townsend

Payor mix (typical)

  • Medicare / Medicaid (45-60%)

  • Managed care (20-40%)

  • Private payor (15-25%)

  • Other (remaining)

Laboratory Trends

  • Profits

Where have all the grey tubes gone?

Point of Care Billing is

  • Point of Care Billing is


Billing can improve Patient Care!


  • You should bill for point of care testing!

  • Point of care billing is profitable!

  • Billing for point of care improves patient care!

Your mission…

  • POC Committee

  • Create an impact worksheet

    • Pt volumes X Charges = Gross Charges
    • Gross Charges X Fee for service % = Net Revenue Potential
  • Billing investigation committee (Ad hoc)

    • POC Coordinator (& Staff)
    • Medical Director
    • Lab Manager / Administrative Director
    • Lab Business Operations Mgr
    • LIS Supervisor
    • Patient Accounting
    • Nursing Admin
    • Managed Care Contracts


Impact Worksheet

  • Presentations around country

    • Audience: Point of Care Coordinators (POCC)
    • Analyze: 4 analytes
    • Hospital size: 300-500 bed hospitals
    • Factors: Patient volume X current lab charges
    • Sum for Total billables
    • Result:
      • $6-15M in POC billable
      • $1-3M in POC revenue (quantifiable fee-for-service)

Point of Care Billing Impact

  • (Inpatient)

  • Inpatient volume: 100,000

  • Charge per test: $14.60 (avg. $12-25)

  • Yearly charges: $1.5 M


  • Medicare/Medicaid (55%): $0

  • Managed Care (30%): $0

  • Fee-for-Service (15%): $219,000

  • TOTAL IP REVENUE: $219,000

Point of Care Billing Impact

  • (Outpatient)

  • Outpatient volume: 100,000

  • Charge per test: $14.60 (avg. $12-25)

  • Yearly charges: $1.5 M


  • Medicare/Medicaid (55%): $177,650 ($3.23 CLFS on 55,000 tests)

  • Managed Care (30%): $0

  • Fee-for-Service (15%): $219,000

  • TOTAL IP REVENUE: $396,650

Point of Care Billing Impact

  • Glucose:

  • Inpatient: $219,000

  • Outpatient: $396,650

  • Revenue: $615,650

  • ACT:

  • Volume: 48,000 pt tests

  • Charge: $28.00

  • Billables: $1.3M

  • Revenue: $195,000

  • Urine dipstick:

  • Volume: 35,000 pt tests

  • Charge: $9.00

  • Billables: $315,000

  • Revenue: $47,250



  • Strip usage: 300,000 (total)

  • Revenue: $615,650

  • Vial cost: $25

  • Strip cost: $.50

  • Total strip cost: $150,000

  • Gloves, gauze, alcohol, lancet: $.50

  • Total disposables: $150,000

  • FTE (POCC): $45,000

  • Data Management: $75,000

AACC Listserv

  • Subscribing: aacc-poct-div@yahoogroups.com

    • No cost
    • Not necessary to belong to AACC
  • Confirmatory email

  • Unsubscribe anytime

  • No vendor publicity / No personal communication

  • Digest to reduce emails

  • Archive of old messages on website

    • www.yahoogroups.com (Search “point-of-care”)

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