Difference between revisions of "LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/The clinical environment"

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==1. The Clinical Environment==
==1. The Clinical Environment==
===The clinical laboratory and its equipment===
===The clinical laboratory and its equipment===
The POL is a [[clinical laboratory]] located in an ambulatory or outpatient care setting, specifically in the physician office. The clinical laboratory is used to test specimens from human patients to assist with the diagnosis, treatment, or monitoring of a patient condition. Testing in the clinical lab generally depends on three common methodologies to meet those goals: comparing the current value of a tested substance to a reference value, examining a specimen with microscopy, and detecting the presence of infection-causing pathogens.<ref name="GarrelsOatis">{{cite book |url=https://books.google.com/books?id=LM9sBQAAQBAJ |title=Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Healthcare Professionals |author=Garrels, Marti; Oatis, Carol S. |publisher=Elsevier Health Sciences |edition=3rd |year=2014 |pages=3–6 |isbn=9780323292368 |accessdate=18 April 2015}}</ref>
These three methodologies depend on clinical expertise from staff. Managerial staff like laboratory directors and laboratory department supervisors, for example, are responsible for the planning, management, and administration of the lab's operations as well as applying and enforcing quality systems and regulatory requirements. The lab itself is staffed with pathologists, cytotechnologists, histotechnologists, and clinical laboratory assistants, performing and interpreting specimen tests using one or more techniques.<ref name="ASCPCareers">{{cite web |url=http://www.ascp.org/pdf/CareerBooklet.aspx |format=PDF |title=Careers in Pathology and Medical Laboratory Science |publisher=American Society for Clinical Pathology |accessdate=18 April 2015}}</ref> Those methodologies and tests also require a wide variety of instruments and equipment. A histotechnologist will require a [[wikipedia:microtome|microtome]] to prepare a specimen for an [[anatomical pathology]] examination, and blood chemistry analyses depend on sample tubes, centrifuges, and blood analyzers. More advanced clinical laboratories performing [[wikipedia:Molecular pathology|molecular diagnostics]] techniques will use specialty tools like fluorescence microscopes and spectrometers. And all that equipment must meet manufacturing, testing, and calibration standards to ensure the utmost accuracy of tests.<ref name="ANSISafety">{{cite web |url=http://webstore.ansi.org/laboratory_safety/ |title=Laboratory Safety Standards |publisher=American National Standards Institute |year=2015 |accessdate=18 April 2015}}</ref>


===Laboratory safety===
===Laboratory safety===

Revision as of 17:29, 18 April 2015

The physician office laboratory (POL) is a clinical laboratory that is owned, operated, and managed by a physician office. Definitions, as noted in The Practical Guide to the U.S. Physician Office Laboratory, vary from state to state, but this is a solid enough definition.

This first chapter on the topic of the clinical working environment has 10 sections.

-----Return to the beginning of this guide-----

1. The Clinical Environment

The clinical laboratory and its equipment

The POL is a clinical laboratory located in an ambulatory or outpatient care setting, specifically in the physician office. The clinical laboratory is used to test specimens from human patients to assist with the diagnosis, treatment, or monitoring of a patient condition. Testing in the clinical lab generally depends on three common methodologies to meet those goals: comparing the current value of a tested substance to a reference value, examining a specimen with microscopy, and detecting the presence of infection-causing pathogens.[1]

These three methodologies depend on clinical expertise from staff. Managerial staff like laboratory directors and laboratory department supervisors, for example, are responsible for the planning, management, and administration of the lab's operations as well as applying and enforcing quality systems and regulatory requirements. The lab itself is staffed with pathologists, cytotechnologists, histotechnologists, and clinical laboratory assistants, performing and interpreting specimen tests using one or more techniques.[2] Those methodologies and tests also require a wide variety of instruments and equipment. A histotechnologist will require a microtome to prepare a specimen for an anatomical pathology examination, and blood chemistry analyses depend on sample tubes, centrifuges, and blood analyzers. More advanced clinical laboratories performing molecular diagnostics techniques will use specialty tools like fluorescence microscopes and spectrometers. And all that equipment must meet manufacturing, testing, and calibration standards to ensure the utmost accuracy of tests.[3]

Laboratory safety

Point-of-care testing

Regulatory compliance: HIPAA and PPACA

Regulatory compliance: CLIA

Good laboratory practices

Microscope procedures

Industry trends

Economic issues related to the POL

Data management

References

  1. Garrels, Marti; Oatis, Carol S. (2014). Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Healthcare Professionals (3rd ed.). Elsevier Health Sciences. pp. 3–6. ISBN 9780323292368. https://books.google.com/books?id=LM9sBQAAQBAJ. Retrieved 18 April 2015. 
  2. "Careers in Pathology and Medical Laboratory Science" (PDF). American Society for Clinical Pathology. http://www.ascp.org/pdf/CareerBooklet.aspx. Retrieved 18 April 2015. 
  3. "Laboratory Safety Standards". American National Standards Institute. 2015. http://webstore.ansi.org/laboratory_safety/. Retrieved 18 April 2015.