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- Atlas Medical; Woodland Hills, CA; consultant
- Consultants in Laboratory Medicine (CLM); Toledo, OH; consultant
- Consultants in Medical Information Technology (CIMIT); Bay Harbor, MI;
president
- Pathology Education Consortium (PEC); Bay Harbor, MI; president
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- List the top ten current trends in information technology in healthcare
as a whole and in the clinical laboratory industry
- Describe why web-enabled lab applications are a disruptive technology
and were only slowly adopted by classic LIS vendors
- Define the centralized lab model; discuss why it is weakening in
parallel with the dis-integration of hospital laboratory operations
- Describe emergence of the decentralized LIS (D-LIS) in parallel with the
centralized LIS (C-LIS) and the lab portal as a D-LIS precursor
- Discuss information technology & informatics as one of the prime
value-driving components for the clinical lab of the new millennium
- Highlight direct access testing (DAT) and [billable] clinical lab
consultations as two new lab product lines spawned by the web
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- Dis-integration of lab processes manifested by weakened central lab
model and performance of more tests in decentralized venues
- Classic LISs emphasize/support internal operations & are less
obvious to customers; evolution of new LIS and parallel architecture
(D-LIS)
- Increased commoditization of most lab tests; IT & informatics emerge
as the major value-driving & differentiating factors for clinical
labs
- Validation of hospital lab data replicated from the C-LIS database
(“source of truth”) to other clinical systems becomes more challenging
- Web-based lab portal applications dominate order-entry/results
reporting, provide new functionality and dominate lab outreach biz
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- Approximately 50% of testing moves out of central lab; challenge of
capturing\integrating remote test results & supervising remote QC
- Acute care & lab testing blend with both home healthcare and
telehealth; this change enhances new testing options and venues
- Hospitals with CIS’s/CDRs & physician offices with PMSs evolve into
two data domains requiring seamless exchange of clinical data
- Consumers increasingly order complex tests for themselves (DAT) and
auto-perform tests with retail kits and home instruments
- Clinicians faced with increasingly complex tests; lab medicine
consultations emerge as new product line for the clinical laboratory
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- Disruptive technologies are simple, convenient innovations that are
initially used at low end of markets (e.g., the PC)*
- Christensen defines two types of technology: sustaining technology and
disruptive technology
- Sustaining technology provided by companies on basis of requests from
customers of the company based on common practices
- Disruptive technologies are usually simpler and cheaper than the
sustaining technology but also offer less capability [initially]
- Disruptive technologies do not fit into the sustaining market provide
lower profit margins; usually shunned by well-managed companies
- A disruptive technology can quickly develop into a competitive threat,
dramatically transforming the market
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- LIS vendors have historically had difficulty moving to any new
architecture (including web architecture) for following reasons:
- Installed customer base is conservative and suspicious of innovations
that are expensive and require additional training
- Installed customer base also places premium on the smooth
upgrade-ability of current LIS so their systems do not outdate
- Vendor software developers & companies have large investment in
current products & software development tools
- Integrated vendors now placing most their R&D investments in CIS
products & view the lab market as mature
- Classic LIS products architected on basis of hospital work/information
flows which satisfy most hospital-based labs
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- Lab portal software provides connectivity to MD offices &
applications such as OE/RR; also information about test ordering such as
tube type
- Utilizes Internet to provide “free” connectivity; individual
applications accessed using a browser (thin client); thick client (PC)
also possible
- Strategy originally driven by need for access to MD offices not served
by IDN networks; equally good solution for hospitals/legacy systems
- Lab portals example of traditional LIS functionality (e.g., OE/RR)
moving to web; software can run remotely as ASP rather than in-house
- For labs with outreach programs, lab portal provides opportunity to
compete with reference labs in providing sophisticated IT solutions
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- Lab portal OE/RR will allow office practice to operate more
efficiently; can avoid patient calls to office staff for
result-reporting
- Lab portal software as “wraparound” can also provide single on-ramp to
hospital-based lab, radiology, & cardiac diagnostic
- Integration of OE/RR into office-based physician management systems
(PMSs) will promote efficiencies/development of EMR
- Decentralization of lab testing (POCT; biotechs offering retail
genomic testing) will present new data integration challenges
- DAT for consumers/patients will confound their relationship with MDs;
patients may bring complex results to MDs for interpretation
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- Centralized lab model has dominated landscape in this era of modern
medicine; specimens transported to hospital “lab factories”
- Lab factories with assembly-line workflow spawned need for
high-throughput analyzers & skilled personnel to support the line
- Lab operations as wholesale business with copious amounts of raw data reported to customers (MDs)
who finish (i.e., interpret) product
- Lab infrastructure such as blood drawing centers, LISs, and analyzers
are expensive, discouraging new entrants into the field
- Hospital labs & national reference labs enjoyed quasi-monopoly in
their market, sustained by high test volume & low unit cost
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- Healthcare, in general, becoming less centralized & remote from
hospitals to reduce costs & increase patient convenience
- Clinicians and nurses demanding faster TAT and greater control over
testing process; they are less concerned about cost-per-test
- IVD manufacturers marketing POCT devices directly to clinical units;
emphasizing benefits for their workflow and efficiency
- New POCT data management and communication standards facilitate order
and result integration into LIS/CDR databases
- Hospital labs will play their trump cards such as cost-per-test, data
integration, & quality issues; may not resonate with clinicians
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- Consequences of POCT, home testing, & expanded office testing is
that hospital-based lab may lose control of lab data & lab franchise
- Phenomenon has both quality and political implications because lab power
& influence associated with role of lab data stewardship
- Logical conclusion is for lab is to embrace testing decentralization
when demanded by customers but also emphasize data re-integration
- Reasonable business strategy because test performance much more
commoditized; lab data integration/management value-adding step
- Re-integration of lab data important process for clinicians who desire
info. management tools; also platform for lab medicine consulting
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- Sophisticated genomic/genetic testing offered by biotech companies to
retail market
- Outpatient testing when rx or procedure dependent on results (e.g.,
outpatient surgery)
- Testing in skilled nursing facilities and chronic care facilities;
emerging venue for POCT
- Self-performed home-testing (e.g., glucometers, kit testing such as
pregnancy, Hemoccult®, HIV)
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- Home health, supported by home lab testing, will be next lab
frontier; logical extension of POCT as care migrates to home
- Cascade effect to reduce healthcare costs; less sick patients
migrate from ICUÜgeneral care unitsÜoutpatient unitsÜhome
- Home care workers will draw blood from their patients and [soon] perform
tests in-home using portable analyzers with broad test menu
- Such instruments will upload data to nurses/MDs for real-time assessment
and/or to hospital databases and to PHRs on web
- Entrepreneurial IDNs will pursue home health as logical extension
of other health services to shave costs and retain patient
business
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- Routine genomic & proteomic testing will overwhelm clinicians with
complexity; need IT tools & laboratory consultation to manage
patients
- Current LISs cannot acquire & manage deluge of data that will be
presented to them from both volume & complexity perspectives
- Biotech companies, holding patents to new tests, may not “kit-ize”
testing for hospital labs or will license testing only to selected labs
- Exquisite consumers sensitivity to consequences of genetic testing; may
balk at results integration into hospital databases & favor
web-based labs
- Current testing model may not lend itself to genomics/proteomics; labs
may need to create lifelong “alerts”/subscription relationship
with patients
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- Hospital labs with outreach programs & lab portals for office-based
OE/RR getting requests from MDs for PMS integration
- Lab professionals torn between dual challenge of enhancing and
integrating lab data across hospital and MD office PMS/EMRs
- PMS vendors often view their products as office EMR platforms which can
also accommodate lab & retail pharmacy ordering
- Hospital-based lab in unique position of being able to span gap and
serve patients & MDs in both hospital/office setting
- Integrating hospital & office-based lab testing admirable goal for
continuity of longitudinal care & opportunity to capture business
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- Lab portals sales will stimulate acceptance of the D-LIS web-based
model, starting with OE/RR supporting lab outreach
- Some lab portals will evolve into broader “clinical support” portals,
providing OE/RR for lab, radiology, & cardiac diagnostic testing
- For consolidated health systems with multiple classic LISs,
lab portal can be used as OE/RR wrap-around with same look/feel
- Classic LISs (i.e., C-LISs) will migrate to back-end & specialize in
lab internal operations like specimen tracking, triage, and lab QC
- New functions may be added to D-LISs rather than the C-LISs because
often more flexible due to modern web architecture
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- Because of lab inspections & quality control, assumption made by
customers that most routine testing is roughly equivalent
- Value of lab services then calibrated by information TAT, communication,
integration, and storage/archival services
- Particularly true in service-oriented lab outreach sector
where hospital labs must compete with national reference labs
- No accident that reference labs pioneered use of lab portal software to
push electronic OE/RR into MD private offices
- Lab portal software, e-commerce, and direct access testing are also
shaping emergence of genomic testing in its early forms
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- Weakening of centralized lab model has served to weaken centralized LIS
model which provided an integrated database
- Need shift of raison d’etre of central lab from primarily data creation
to data creation + data integration & management
- Hopefully and ideally, the hospital lab will remain as a data hub
through which diverse data streams will converge/integrate
- Pathology informaticians need to develop a global strategy for
presenting a coherent rational view of data downstream
- Biggest challenges will be recruiting sufficient talented personnel
& developing revenue source for these data management efforts
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- DAT enables consumer to order a menu of high-quality
lab tests via the web without [obvious] MD intermediary
- Although concept not new, web-mediated OE/RR has taken this new this lab
product-line into homes of all consumers
- DAT not a new form of alternate healthcare but rather
a new approach to case-finding/wellness-monitoring
- DAT only one facet of larger phenomenon of consumer-controlled
selection/utilization of healthcare services
- Surge of media interest prompted by keen interest on part of readers in
new web initiatives and connection to healthcare
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- Seeing more patients per hour without allowing quality to suffer while
maintaining respect & confidence of patients
- Laboring under increasing regulatory & payor documentation burden,
serving to distract them from time spent with patients
- Malpractice & insurance crisis, driving MD increasingly out of
private practice & increasing their estrangement from system
- Increasing capital and training costs to enhance the IT capabilities of
office practice; physicians often cyberphobic
- Patients surfing the web and increasingly IT savvy; higher expectations
about office information-access capabilities
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- Tradition in clinical pathology [not surgical pathology] of reporting
raw data, providing little interpretation for customers
- History of automated “lab consults” that report redundant or obvious
information to MDs; heavy burden to overcome this bias
- Physician orders for lab medicine consults must generally be obtained on
a priori basis at the time the
test order is placed
- Value-adding consulting now provides opportunity for additional lab
revenue which could be billed under existing CPT codes
- Sophisticated lab medicine consulting programs should be
initiated now; prepare for complex genomic/proteomic testing
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- Laboratorians & clinical labs are in the information business; the
web
and the Internet are radically changing the way that we do
business
- Information technology and molecular diagnostics are the future of the
lab-business and the key value-adding services for lab of future
- Lab portals & web-based LIS architecture are examples of disruptive
technology that will ultimately supplant earlier forms of computing
- Movement away from centralized lab model an example of
dis-integration
of lab testing; necessary
to now embrace all decentralized testing
- D-LIS base on web architecture will evolve in parallel with C-LIS based
on hospital business practices; will enable new product lines
like DAT
- Information technology will also act as enabler of reimbursable clinical
lab consulting; necessary in a era of overworked physicians and complex
testing
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Notes