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 11 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 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.

Good laboratory practices

As previously stated, the ultimate goal of the clinical laboratory — and by extension, the POL — is to test specimens from human patients to assist with the diagnosis, treatment, or monitoring of a patient condition. This, of course, requires accurate results to ensure the best result. In the 1970s the U.S. Food and Drug Administration noted non-clinical laboratories in many cases conceived experiments poorly, failed to inform laboratory personnel of protocol, and didn't regard strict laboratory procedure to be necessary. This brought about the Good Laboratory Practice regulations in November 1976. Clinical laboratories were not left out of improvements, however. Though the Clinical Laboratories Improvement Act of 1967 brought about some reforms to laboratory practices, the act wasn't doing enough by the mid-1980s. The regulations were revised and put into effect on October 31, 1988 as the Clinical Laboratory Improvement Amendments of 1988. Known as CLIA, the regulations have helped shape the policy and procedure of clinical laboratories of all types, including how training and experience is gauged and documented, reagents are prepared, and quality control is approached.

Today in the U.S., like any other clinical lab, physician office laboratories must follow good laboratory practices to ensure the best outcomes for its associated patients. These practices must be engaged in at every stage of the laboratory testing process. During the initial test ordering process, for example, lab personnel must review orders for accuracy and seek verification from the physician if there are any questions. Following order entry, staff should complete a requisition and explain all preparation procedures to the patient. When the patient arrives, staff should use appropriate procedures and containers to collect the specimen(s) from the patient. Processing of the specimen should include proper storage, preservation (if required), labeling, and transportation. The POL must run quality control tests prior to testing the patient sample to ensure instruments are properly calibrated and appropriate testing proficiency is met. After test completion, a laboratory report is printed and the physician notified. Patients should also be notified per the policy of the physician practice. Disposal of laboratory waste is also part of good laboratory practice, as is proper documentation in the patient record regarding testing and results.

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.

Regulatory compliance: HIPAA and PPACA

Clinical laboratories must comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Among HIPAAs many goals is the desire to improve privacy and security protections for an individual's personal and identifying health information. As such, laboratories are required to implement measures that prevent unauthorized disclosure of and access to a patient's protected health information (PHI) in the laboratory. In the original implementation of HIPAA, this meant that laboratory staff were discouraged from giving laboratory test results to a patient without physician permission. However, in February 2014, the Department of Health and Human Services wanted to encourage patients to take a more proactive approach to their own health care by giving them a mechanism to learn more about their own health. The HHS put into place an amendment to CLIA that became effective in April 7 2014, allowing patients to request laboratory results directly from a laboratory. Under the change, laboratories (including POLs) are now required to give patients their laboratory results within 30 days of a written request by the patient or authorized agent. Other safeguards related to patient data and HIPAA are still applicable. However, it's still not clear how this change impacts the POL, by definition located in the physician's office. As such, the physician's office-based procedures for acquiring PHI also likely apply to the in-office laboratory.

Another federal statute that impacts laboratory testing is the Patient Protection and Affordable Care Act (PPACA), signed in 2010 by President Barack Obama. This law cut fees paid for laboratory testing and established accountable care organizations (ACOs). Both the cuts to the Medicare Clinical Laboratory Fee Schedule and the creation of ACOs (which may decrease laboratory testing volume) present additional challenges to the laboratory — especially in the physician office — as economic concerns may cause a laboratory to no longer have incentive to offer some forms of testing.

Regulatory compliance: CLIA

In 1988 the Clinical Laboratory Improvement Amendments (CLIA) were passed as an amendment to the original 1967 legislature. CLIA attempts to ensure the accuracy, reliability, and timeliness of test results regardless of where the test was performed. As part of this process, seven different criteria are used to gauge and assign one of three complexity levels to laboratory devices, assays, and examinations: high, moderate, and waived. Clinical laboratories handling specimens originating from the U.S. and its territories must apply for a CLIA certificate that is appropriate for the type of testing it performs.

The POL largely conducts CLIA-waived tests, with 60.5 percent of all POLs in the U.S. running on a CLIA certificate of waiver as of November 2014. These tests are recognized as simple to perform with a low risk of erroneous results and include among others urinalysis for pregnancy and drugs of abuse, blood glucose and cholesterol tests, and fertility analysis. Despite the simplicity of a wiaved test, it "needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed." As such, the Centers for Medicare and Medicaid Services provides additional enforcement of labs with CLIA certificates of waiver, conducting on-site visits to approximately two percent of such labs to verify quality testing, regulatory compliance, and test appropriateness. In some cases a POL may also offer moderate-level provider performed microscopy (PPM) testing (23.3 percent of all POLs as of November 2014), depending on the office specialty. To perform this type of testing in addition to waived testing, a PPM certificate is also required.

Since most POL testing is waived, anyone can be the laboratory director at a POL; however, some states have different requirements, so it is important to check with your local regulatory body when hiring staff for the laboratory. POLs that also incorporate PPM testing have different requirements for directors, who "must meet specific education, training and experience under subpart M of the CLIA requirements." More information can be found regarding the CLIA complexity levels and what is required under each on the FDA's website, the references in this section, and the CLIA waived test list.

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).