practical guide to the u.s. physician office laboratory (pol) part 1

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The practical guide to the U.S. Physician office laboratory (POL)Part one: What is a POL?

Laboratory Informatics InstituteMay 2014

The practical guide to the U.S. Physician office laboratory (POL)Part one: What is a POL?

Laboratory Informatics InstituteMay 2014

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?

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.

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.

Workflow

History and Trends

Early Diagnostic Testing.

Diagnostic Testing in the 20th Century.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

For more information

Link to white paper with references: http://tinyurl.com/oqorxvu

Contact the institute via our website: http://tinyurl.com/o5o23fp