This is part 1 of our white paper, it discusses what is a POL, history and trends, why POLs exist, and other introductory material. All of the sections for this paper have a youtube video as well.

1. The practical guide to the U.S. Physician office
laboratory (POL)
Part one: What is a POL?
Laboratory Informatics Institute
May 2014

2. The practical guide to the U.S. Physician office
laboratory (POL)
Part one: What is a POL?
Laboratory Informatics Institute
May 2014

3. ● Types of POLs and workflow.
● History and market trends.
● Why do POLs exist?
● Advantages and Disadvantages of running a
POL.
● How POL integrates with the entire practice.
● POL or reference lab?

4. What is a POL?
● POLs are laboratories that are owned,
operated, and managed by physicians.
● In some states POLs are managed only by
individual physicians, not physician groups.
● POLs are NOT laboratories that are owned,
operated, and managed by hospitals,
managed care organizations, or other
corporate entities.

5. Types of POLs
● Primary Care: Doctors trained to provide
primary care to patients.
● Specialist: Doctors trained to provide
specialized care to patients.
● For more information about this go to the
white paper using the link at the end of the
slideshow.

6. Workflow

7. History and Trends
● Early Diagnostic Testing.
●
Diagnostic Testing in the 20th
Century.

8. Early Diagnostic Testing
● Hippocrates in Ancient Greece.
● Instituted diagnostic criteria including: listening
to patient lungs, observing skin color, and
examining urine.
● 50 A.D. Blood in urine is linked to renal failure.
● 180 A.D. Galen links a normal fluid intake to
normal urine output amounts. Describes
Diabetes as “diarrhea of urine.”

9. ● 900 A.D. Isaac Judaeus established a protocol
for using urine in patient diagnosis.
● 1300 A.D. Examination of urine under a
microscope becomes nearly universal in
Europe.
●
17th
century sees many innovations in
diagnostic technique, including literature
related to body structures and the formation of
scientific societies.

10. ● First attempt to use pulse and temperature as
indicators of illness.
● Intravenous drug injections.
● Identification of sweet tasting urine in patients
with Diabetes.
●
18th
century also saw many innovations in
diagnostic testing.

11. ● William Hewson develops methods for
measuring coagulants in blood. This set the
stage for modern diagnostic laboratory
practices.
● Methodology for the use of blood pressure
and temperature as diagnostic indicators
refined.
● James Currie treats his Typhoid patients by
putting them in a cold bath.

12. ● Sir John Floyer's pulse measuring technique.
● Tichy's urine analysis technique.
● Dobson proves that sweetness in blood and
urine for patients with Diabetes is caused by
sugar.
● Homes develops a yeast test for sugar in
urine.

13. ●
19th
century is the era of Public Health.
● Independent laboratories begin to develop.
● Many American physicians go to Europe for
training in laboratory techniques.
● American opposition to laboratory practice
wanes, as older physicians retire from faculty
positions.

14. ● Pasteurization
● Aseptic methodologies resulting in fewer
deaths after surgery.
● Greater emphasis on hygiene practices.
● X-Ray.
● Microscopy.
● ~1850 first hospital laboratories established.
Prior to this testing is done in the physician
office or at the patient bedside.

15. Diagnostic Testing in the 20th
Century
● Stratification begins: Public Health, Forensic,
and Clinical.
● 1928 Alexander Fleming accidentally
discovers penicillin.
● Domagk discovers sulphonomides do not
harm humans, possess antibacterial
attributes.
● Fleming ushers in the antibiotic age, and
combined with Domagk's work, allows for new
treatments of infections.

16. ● Organizations are founded to certify laboratory
personnel. American Society for Clinical
Pathology (ASCP) founded in 1922.
● Organizations like ASCP, combined with the
new treatments coming out of laboratories
earn professional respect and legitimacy for
laboratory personnel by the end of the 1950s.
● 1965 Medicare is seen as “Free money” in the
health care industry.

17. ● 1967 Clinical Laboratory Improvement Act
(CLIA) took effect as an attempt to regulate
laboratory practice across state lines.
● 1988 CLIA is amended to include nearly all
laboratories operating in the U.S.
● 1989 an estimated 98,400 POLs operated in
the U.S.
● 20,000-200,000 variation is due to lack of
standard definition of POL and self reporting
of status by physicians.

18. ● Some issues related to standardized
definitions persist today.
● 1989: 25% of all laboratory testing conducted
in POLs.
● 1989: $20 Billion spent annually on laboratory
testing. POLs received $5 Billion.
● 1989: Medicare was paying over $400 million
to POLs.
● 1989: 16 states had laws related to POLs.

19. ● 1995 onward finds that clearer understanding
of regulations and acceptance of regulations
results in CLIA waived tests growing from 8 to
40.

20. Market Trends
● December 2013 number of POLs 120,399 or
49% of all laboratories in the U.S.
● 2013: 60% of POLs running CLIA waived
testing.
● 2013: 24% hold certifications for provider
performed microscopy (PPM) testing.

21. ● Growth of POLs is expected to increase.
● Aging population of baby boomers with money
to finance laboratory tests.
● Increased awareness of health care topics.
● Softening stance of payors related to testing.
● Expansion of CLIA waived testing list.

22. Why do POLs exist?
● Subset of point of care testing (POCT).
● Testing done at the patient's location.
● Clinical medicine became more complicated
and physicians needed to perform these tests.
● Industry was looking for a cheaper way to
provide laboratory services.
● Additional revenue stream for physician.
● Provide quality diagnoses, treatment, and care
to patients.

23. Advantages and disadvantages of
running a POL
● In the early days lack of regulation could have
been considered a disadvantage.
● These lists are not exhaustive.

24. Advantages
● Quicker access to laboratory test results for
the clinician, resulting in expanded pool of
treatment options for patients.
● Greater efficiency of clinical workflow.
● Cheaper testing: subject to individual test
pricing.
● Patient comfort and happiness, including time
saved by having to go to only one location.

25. Disadvantages
● Physician office being the only point of
access: some physicians may be reluctant to
release results to a third party e.g. hospitals.
● This may be eliminated per the February 2014
changes that require a laboratory to give
results directly to patients when requested.
● Physicians may not see the value in having a
laboratory as part of their practice.

26. ● Patients may feel uncomfortable about the
physician office being a central repository of
information.
● Cost of compliance with local, federal, and
state regulations dependent upon the
regulatory environment of individual practice.
● Not an exhaustive list.

27. How the POL integrates with the entire
practice
● Stores patient laboratory data in a form that
improves information exchange between
laboratory and broader patient record.
● Avoids disconnect between reference lab and
physician office, allowing for tighter
integration.
● POL can assist the financial department by
supplying data to track cost and revenue
trends.

28. ● POL can use laboratory data to assist with
population trends, leading to appropriate
interventions such as community education
programs.

29. POL or reference lab?
● Many POL tests are CLIA waived and simple
to perform.
● In a rural environment the POL may be the
only option.
● The decision should be based on a balance of
appropriate measures that serve the needs of
both practitioner and patient.

30. For more information
● Link to white paper with references:
http://tinyurl.com/oqorxvu
● Contact the institute via our website:
http://tinyurl.com/o5o23fp