The Impact of

Informatics on Lab

Services

4750 Venture Drive, Suite 400  Ann Arbor, MI 48108  (800) 860-5454  (734) 662-6363  (734) 662-7118 (FAX)  www.pcslabservices.com

Jan W. Steiner, MD, FRCP(C)

Park City Solutions/Laboratory Services Group

Ann Arbor, Michigan

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“Nothing is permanent but change.”

Heraclitus

500, B.C.

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The Vision of Regionalization of Hospital

Laboratories

➢ Multi-institutional ventures, coordinated to eliminate undue

duplication of resources

➢ High quality through sharing of expertise and technology transfer

➢ Client responsiveness

➢ Unified terminologies, normal values and ranges

➢ Integrated information system with compatible regional database

➢ Shared outreach infrastructure

➢ Unified operational philosophy attuned to clinical goals

➢ Standardized equipment, methodologies and procedures

➢ In-common medical, technical and administrative leadership

➢ In-common purchasing

➢ Dedication to Innovation

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Goals of Regionalized Laboratory Systems

◆ Seamless delivery of laboratory services (equal patient access to high

quality laboratory services);

◆ Continuity of care - provision of a regional compatible laboratory

database covering services from cradle to grave which would allow

for movement from M.D. office to Hospital to Nursing Home, etc.

without repeat pre-admission or pre-examination testing;

◆ Regional purchasing plans to standardize equipment, reagents and

supplies to reduce cost of laboratory activities;

◆ Reduction of fixed costs by sharing of high cost human resources;

◆ Low cost structure and competitive pricing;

◆ Institutionalized technologic innovation and technology transfer;

◆ Joint managed care bidding through control of a large population

base and geographic coverage combined with optimum quality of

service;

◆ Inreach lab services development taking advantage of the traditional

allegiance of medical staffs to their institutions;

◆ Joint inreach and outreach infrastructure through creation of

Laboratory Service Organizations which share the cost and activities

of marketing and sales, client servicing, logistical services (couriers),

billing, form design, etc.

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Dissociated Regional Laboratory System

“The Tower of Babel Syndrome”

Hospital

Lab

Hospital

Lab

Hospital

Lab

III

Hospital

Lab

POL

Reference

Lab C

Reference

Lab B

Reference

Lab A

NH: Nursing Home

POL: Physician’s

Office Laboratory

PO: Physician’s Office

P: Patient Self-Testing

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Integrated Regional Laboratory System

Reference

Lab

Hospital

HospitalHospital

Hospital

CORE

LAB

STATSTATSTAT

STAT

POPOPO

POL

P P P P P

POL

Key

Rapid Service Labs

Specialized Core Lab

PO: Physician’s Office

POL: Physician’s Office Lab

P: Patient Self-Testing

NH: Nursing Home

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RRL

Referral

Lab

Core

Outreach

Core

RRL

Laboratory Cooperative In-common Model

MD Offices and Clinics

Cafeteria Style Services

1 Hospitals buy tests from lab core

2 Hospitals buy outreach support

from outreach core

Test Send Outs

Marketing, Sales,

Logistics, Billing

NB: There is only one Routine Core

Lab but there may be multiple

specialized cores (e.g., coagulation,

molecular diagnostics, virology) and

multiple Rapid Response

Laboratories (RRLs)

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Concept Validation

Market Share Trends for Medicare Lab Services

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1995 1996 1997 1998 1999 2000 2001

Independent Lab POL OP Hospital

Percent Market Share

34%

24%

42%

23%

35%

41%

23%

36%

46%

22%

34%

Source: HCFA Office of the Actuary, 1999

Notes: 1. 1995-1997 figures are actual.

2. 1998 figures are preliminary estimated.

3. 1999-2001 figures are projected.

Conceptual Integration Architecture

Heterogeneous LISs

STS Specimen Tracking System

DW Data Warehouse

CDR Clinical Data Repository

GPI Global Patient Index

O Orders

R Results

KEY

B Billing Data

REC Records

ENQ Enquiries

RESP Responses to Enquiries

SLI Specimen Location Info

STS

GPI

O, R, SLI

CDR

Data

Billing

Service

Client

Services

INTERFACE

ENGINE

Ref

Out

Data

Core Inst. I

Orders

Results

Ref

Out

Data

Core Inst. II

Orders

Results

DataRef Out

LIS

HIS

Hospital 2

DataRef Out

LIS

HIS

Hospital 1

O R

Ref

Out

Data

Buffer Hosp.

Orders

Results

O R

Source: D. Covvey and J.W. Steiner, MD

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Integration System Capabilities

The Interface Engine has a number of components and an associated

system that provide the infrastructure for the laboratory environment.

Information Systems Solutions

Maintains overview of whereabouts of all specimens and report.

◆ Specimen Tracking System

A component of the integration system that links institution-specific

patient identifiers to unique enterprise identifier, enabling the

development of a longitudinal patient record regardless of the locus

of care.

◆ Global Patient Index

A system that, via the interface engine, requests and stores all lab-related

data (testing, financial, operational) to support management analysis,

managed care reporting, and other analytic processing.

◆ Data Warehouse

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Information Systems Solutions (cont.)

A system that, via the interface engine, requests and stores all clinical

data, making it available for clinician access in support of the patient

care process.

◆ Clinical Data Repository

◆ Transaction Management System

A component of the integration system that vectors orders, results,

records, and other data from a source to a destination based on

rules (conditional statements) that can be revised as required, and

allows monitoring of system performance.

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The Clinical Laboratory Cost Effectiveness

Assumed that cost-effectiveness could be achieved by streamlining

and automating laboratory processes and providing LIS support to

ensure accuracy and performance monitoring and speeding result

transmission.

◆ Old Paradigm

Overall cost-effectiveness hinges upon appropriate test selection and

sequencing, and the presentation of results in a manner which

facilitates clinical decision-making at the right time.

◆ New Paradigm

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Age of Methodology

Developing New Tests

Age of IV Diagnostic

Technology

Developing Innovative

Processing Machines

Concurrent

Telling

physicians

what they

need

Age of Informatics

Improving the usefulness

of lab data for the physician

and the patient

Age of Data

Process Technology

Developing information

systems to improve

processing of samples and

streamline operations and

management

Concurrent

Listening to

physicians and

meeting their

needs

The Ages of Change in Laboratory Medicine

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Clinical Application

For

Decision Making

Knowledge

Information

Basic Medical Informatics

Data

Intelligence Tools

Facilitate Process

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Info-Catenation

Linking data in a chain or series of values (catena – Lat.

Chain) to create clinically useful information for

diagnostic and therapeutic decision making.

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◆ Methods

◆ 19,557 elective cataract operations

◆ Standard battery of medical tests (electrocardiography,

complete blood count, and measurement of serum levels of

electrolytes, urea nitrogen, creatinine, and glucose)

◆ Conclusions

◆ Routine medical testing before cataract surgery does not

measurably increase the safety of the surgery. (N Engl J Med

2000;342:168-75)

The Value of Routine Preoperative Medical Testing

Before Cataract Surgery

Oliver D Schein, MD, MPH, et. al.

Source: The New England Journal of Medicine, January 2000

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Vital Statistics

◆ Almost 70% of a patient’s medical record is generated by

diagnostic procedures

◆ About 60% of medical decisions depend totally or in part on

laboratory test results

Source: The Genesis Report, September 1998

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Clinicians Face Increasing Time Pressures

◆ Increasingly complex clinical environment

◆ More and faster communication channels

◆ Care process interruptions by external overseers

◆ Intrusive para-clinical documentation demands

◆ Demands for higher clinical productivity

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 What tests to order

 How to appropriately sequence testing

 How to interpret large sets of data points

 How to aggregate data from other sources with

lab data (e.g., imaging, electrodiagnostics, etc.)

to form integrated information

Generally, physicians do not know:

Basic Assumptions

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The Process of Medical Care

◆ The physician depends on

◆ History taking

◆ Physical examination

◆ Knowledge of disease processes

◆ Consideration of experience

◆ Laboratory information is critical in

◆ Confirming or ruling out or suggesting diagnoses

◆ Optimizing the choice and application of therapy

\ Integration of laboratory data into the clinical workflow

constitutes the basis for cost-effective use of clinical

laboratory data and information

◆ The burden

◆ Educate the physician in the appropriate use of constantly

changing test methodologies in an environment of privacy and

confidentiality - i.e., the best practices solution to achieve the

optimal outcome.

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The Clinical Support System Demands

Old System

◆ Lose few specimens

◆ Perform the right test

consistently

◆ Report results accurately and in

a timely fashion

◆ Provide reports on paper or by

phone

New System

Provide:

◆ Test method and process

information

◆ Cost information

◆ Assessment of appropriateness

of testing

◆ Evidence of overlapping test

orders

◆ Status of specimen at time of

inquiry*

◆ Expected time of result

availability

◆ Seamless integration between

ordering and result reporting

◆ A variety of notification choices

(phone, fax, palm pager, PC,

paper, etc.)

*Equivalent of Federal Express or UPS shipment status report

Adult Treatment Algorithm for Preference of

Lipid-Lowering Therapy

(1) Statin Titrated to LDL-C <100 mg/dL

(2) If LDL-C  100 mg/dL Despite

Maximal-Dosage Statin and

TG <200 mg/dL, Add Resin

(3) If TG >250 mg/dL Despite Above,

Consider Addition of Fibrate

Intervention

Yes

(1) Statin Titrated to LDL-C <100 mg/dL

(2) If LDL-C  100 mg/dL Despite

Maximal-Dosage Statin and

TG <200 mg/dL, Add Resin

(3) If TG >250 mg/dL or HDL-C <35 mg/dL

Despite Above, Consider Addition of

Fibrate or Niacin

Intervention

LDL-C <100 mg/dL

TG <150 mg/dL

Goals

Diabetes

Mellitus

Present?

CHD

Present?

Primary

Prevention

Low Risk/Desirable

LDL-C <130 mg/dL

and HDL-C >40 mg/dL

and TG  150 mg/dL

Intermediate Risk

LDL-C = 131-160 mg/dL

or HDL-C = 31-40 mg/dL

or TG = 151-250 mg/dL

Moderately High Risk

LDL-C = 161-190 mg/dL

or HDL-C = 25-30 mg/dL

or TG = 251-400 mg/dL

High Risk

LDL-C >190 mg/dL

or HDL-C <25 mg/dL

or TG >400 mg/dL

Primary Prevention Goals

LDL-C <130 mg/dL, TG <150 mg/dL, HDL-C >40 mg/dL (Men), HDL-C >50 mg/dL (Women)

LDL-C indicates low-density lipoprotein cholesterol; TG, triglycerides; HDL-C, high-density lipoprotein cholesterol; CHD, coronary heart

disease

To convert LDL-C and HDL-C from milligrams per deciliter to millimoles per liter, multiply by 0.02586. To convert triglycerides from milligrams

per deciliter to millimoles per liter, multiply by 0.01129.

Source: JAMA, December 1, 1999, p. 2056.

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Past Misdeeds of Commercial Laboratories

Commercial labs did a great disservice to Medicine:

➢ They encouraged the unnecessary use of testing by clever

packaging of tests which prevented logical medical decisions,

e.g.:

• Including differential counts in CBCs

• Offering T

tests in profiles when a TSH would suffice

• Including Iron and Ferritin in profiles even if hemoglobin and

RBC count is normal

➢ They created a format of report but did not invest in developing a

better means of transforming data into information.

➢ They disdained the advice of pathologists in the formulation of

reports for MDs.

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Information Integration

Vertical Information Integration

➢ Information from all IDS testing units during patient’s lifetime based

on hospitalization, outpatient visits, home nurse visits, physician

office visits, hospice care, rehab stays and screening or preventive

care programs using HL7 for health data record.

Horizontal Information Integration

➢ Lab results of all labs in an IDS + POC results, reference results +

POL results + pathology results + pharmacy + radiology, etc.

Clinical Problem - Centered Integration

➢ e.g., diabetes view: glucose (fasting and time of day), glycated

hemoglobin, creatinine, urinary sugar and ketones, microglobulin, etc.

Instrument - Driven Integration

➢ e.g., hemogram, leukocyte differential count listed in consistent

sequence

➢ Cumulative reports – collate all results for day

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Interpretation via Multifactorial Analysis

1 32

5 6

1211

Normal

Elevated

Low

1 32

5 6

Laboratory Findings

Interpretation Interpretation

Imaging

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Best Practices (in Relation to Laboratory

Information)

Assist physicians to identify necessary tests and eliminate redundant

testing which defies medical logic

Develop regional clinical data repositories to achieve continuity of

laboratory care – data compatibility and cradle to grave data

coordination through data mining technology

Re-educate physicians to order only:

➢ Tests which are medically necessary

➢ Tests which meet federal necessity guidelines

➢ Tests which are less costly (do not order esoteric tests if routine

test will provide answer)

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Technologic Innovation:

Web-Based Laboratory Reporting

“Under managed care, LISs are being integrated rapidly into the larger group of

hospital-based clinical information systems . . .The LIS architecture of the

future most certainly will be Web-based.”

Bruce A. Friedman, MD

◆ Transmit test results quickly to off-site locations.

◆ Transmit simultaneously to parties on a need-to-know basis.

◆ Capture and integrate test results from off-site POCT testing into a single

patient report.

◆ Transmit images for physician interpretation (microbiology, electrophoresis).

◆ Permit on-line consultations.

◆ Provide data links to other sites and reference to the medical literature.

◆ LIS Linkage to the Health Center’s Intranet for PC or laptop access.

Advantages

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E Commerce Domain

LIS / HIS Domain

Business Domain

Physician Office/

Clinic

Necessity

Prompting

Diagnostic

Algorithmic

Prompting

Global Patient Index

Order Generation

Barcoding

Phlebotomy

Transmission

Business Functionality

Biographic Information

Demographic Information

Billing Information

ABN Form

Billing

Collection

Statistics

Physician Office/

Clinic

Data Mining

Longitudinal

Data Display

Comparative

Analysis

Multifactorial

Analysis-Result

Interpretation

Rules Based

Routing

Phone

Fax

Pager

E-mail

Internet

Outreach Connectivity Model

Accessioning

Aliquoting

Routing

Analysis

Report Generation

Data

Warehouse

Clinical Data

Repository

External

Ref Lab

Specimen Storage

Internal

Workstations

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Standards for Establishing Unambiguous

Laboratory Communications

Snowmed RT

➢ This upcoming release provides clinical reference terminology for storing, receiving, and

analyzing clinical information.

Snowmed International

➢ Snowmed provides a systemized nomenclature of human and veterinary medicine - a

hierarchical terminology coding system organized in different axes and chapters. The

chapters include laboratory and imaging procedures.

Logical Observation Identifier Names and Codes

➢ LOINC is a set of universal names and codes for identifying clinical observations and

laboratory results. It is the basis of the ICD-10-PCS codes.

Health Level 7

➢ Its mission is to provide HL7 standards for the exchange and integration of data that

support clinical management of patients and the evaluation of healthcare services.

Extensible Markup Language

➢ XML serves to format material for presentation to a browser and via HTML (hypertext

marking language) to navigate among pages and sites of the WWW. Next generation of

Netscape and Microsoft will support the display and manipulation of XML documents

using HL7, LOINC, and Snowmed standards.

The future lies in the merger of LOINC and Snowmed to cover all detailed laboratory terms

and their classification.