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. Nearly 49 percent of all clinical laboratories in the U.S. were POLs according to Centers for Medicare and Medicaid Services statistics in November 2014.

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

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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.

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. 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.

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, "simple tests with a low risk for an incorrect result." 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. 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. 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. However, the majority of POLs remain smaller and simpler than their diagnostic lab counterparts.

Laboratory safety

Like any other laboratory, safety in the clinical laboratory is of vital importance. Good safety practices ensure the sample being tested is not contaminated, and they also protect the person doing the testing from infection or other issues resulting from exposure.

Quality control guidelines and standards ensure procedures are followed and equipment is checked, lowering specimen contamination risk and improving the accuracy of test results. Laboratory safety guidelines assist professionals with managing risk from biohazards, chemical hazards, or physical hazards that may be present in the laboratory. The two U.S government agencies that primarily set safety guidelines are the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA). CDC training involves learning about the chain of infection and standard precautions for infection control, while OSHA biohazard training involves the blood borne pathogen standard (BBPS) as well as the exposure control plans and guidelines that promote staff health and safety. OSHA also requires training to deal with chemical hazards in the laboratory.

Laboratories of any size must also deal with physical hazards such as obstructions, electrical equipment, fires, floods, earthquakes. Preparing for these possible hazards in some cases can be as simple as ensuring a box is not placed where someone walking could trip over it. OSHA has numerous guidelines related to the physical hazard training, including how to conduct a fire drill. Other beneficial preparatory activities include organizing and documenting clearly labeled chemical inventories, providing clear access to material safety data sheets (MSDS), enacting a hazard communication program, and providing training on OSHA adherence protocols.

The POL is not exempt from these quality control and safety considerations simply because it's smaller and simpler, however. It may not have the chemical stocks and testing hazards of a large diagnostic lab, but specimens must still be kept uncontaminated and procedures for using even the simplest of CLIA-waived test devices must be followed. Biohazards are still generated and must be treated appropriately using work-practice controls, personal protective equipment, and engineering controls. And bleach (sodium hypochlorite), one of the most prevalent chemicals in labs, must still be handled properly to ensure human safety and equipment longevity.

Point-of-care testing

The College of American Pathologists (CAP) defines point-of-care testing as "any type of laboratory testing that takes place at or near where the patient is located." Historically this sort of testing was mundane due to the nature of the available methods; however, today these tests have advanced to include tests such as glucose testing. POCT testing can be a nice addition to the POL, as it can allow patients to monitor themselves between visits. Like waived CLIA tests, POCT can also be performed by laboratory personnel. Both personnel and patients (those who use testing devices at home) must be trained on how to use POCT devices in order to get the most accurate results.

Some POCT devices are gradually allowing the patient to send data from their instruments directly to the physician office. However, this is not always a straightforward procedure. As the CAP notes in its point-of-view on POCT, "interoperability should be developed or expanded ... to provide better oversight and incorporation of results into the electronic medical record." As Meaningful Use Stage 3 rules for electronic health records (EHRs) — which will require the acceptance of patient generated data — go into effect in 2016, questions still remain about how interoperable POCT devices and EHRs will actually be. (This will be discussed in more detail in the data management section below).