LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/The clinical environment
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.
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]
However, the clinical environment of the POL is somewhat different than your average reference or diagnostic lab that receives, processes, and reports on specimens en masse. The POL is typically a smaller operation, performing simple laboratory testing that can produce useful diagnostic data cheaply and rapidly. Rather than performing advanced pathology procedures that require specific equipment and expertise, the POL typically focuses on blood chemistry, urinalysis, and other testing domains that can don't require significant resources and provide rapid results. This can be seen in Centers for Medicare and Medicaid Services statistics reported in November 2014 that show nearly 61 percent of POLs in the U.S. are certified to provide CLIA-waived tests[4], "simple tests with a low risk for an incorrect result."[5] These "simple tests" don't require advanced equipment and highly-trained physicians. Urinalysis reagent strips, influenza nasal swabs, and whole blood mononucleosis kits are all CLIA-waived testing devices that can be used by well-trained phlebotomists, nurses, or laboratory assistants.[6] Some POLs opt to provide more advanced testing services, however, with 23 percent of all POLs holding provider performed microscopy (PPM) certificates to perform moderate-level CLIA testing.[4] This allows POLs to perform moderate complexity tests like urine sediment analysis and the determination of "the presence or absence of bacteria, fungi, parasites, or cellular elements" in a specimen.[7] However, the majority of POLs remain smaller and simpler than their diagnostic lab counterparts.
Laboratory safety
Point-of-care testing
Regulatory compliance: HIPAA and PPACA
Regulatory compliance: CLIA
Good laboratory practices
Microscope procedures
Industry trends
Data management
References
- ↑ 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.
- ↑ "Careers in Pathology and Medical Laboratory Science" (PDF). American Society for Clinical Pathology. http://www.ascp.org/pdf/CareerBooklet.aspx. Retrieved 18 April 2015.
- ↑ "Laboratory Safety Standards". American National Standards Institute. 2015. http://webstore.ansi.org/laboratory_safety/. Retrieved 18 April 2015.
- ↑ 4.0 4.1 Centers for Medicare and Medicaid Services, Division of Laboratory Services (November 2014). "Enrollment, CLIA exempt states, and certification of accreditation by organization" (PDF). http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf. Retrieved 18 April 2015.
- ↑ Centers for Disease Control and Prevention (31 May 2013). "Clinical Laboratory Improvement Amendments (CLIA): Test complexities". http://wwwn.cdc.gov/clia/Resources/TestComplexities.aspx. Retrieved 18 April 2015.
- ↑ "CLIA - Clinical Laboratory Improvement Amendments - Currently Waived Analytes". U.S. Food and Drug Administration. 13 April 2015. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm. Retrieved 18 April 2015.
- ↑ Kulczycki, Michael (1 April 2014). "Focusing on Provider-Performed Microscopy Procedure Requirements for Ambulatory Health Care". Ambulatory Buzz. The Joint Commission. http://www.jointcommission.org/musingsambulatory_patient_safety/focusing_provider_microscopy_procedure_req_ambulatory_health_care/. Retrieved 18 April 2015.
