CHAPTER 32
Implementation of a Moderate-Complexity Clinical Laboratory
Lynn R. Glass
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URGENT CARE CENTERS HAVE become an important component in health-care delivery, bridging the gap between the traditional physician practice and the emergency department.
Typically, an urgent care center treats patients who do not have serious illnesses or life-threatening injuries but do require immediate attention. Providing on-site laboratory testing affords added value and quality of service for the patient and timely results for the caregiver to provide evaluation, diagnosis, and treatment while the patient is on-site (Figure 1).
Figure 1. The value of on-site laboratory testing.
Implementation of laboratory testing is not a plug-and-play operation, however, and a timeline should be established to ensure that critical elements are not missed during the implementation process, causing delays in licensing, validation, and completion of go-live testing.
The Clinical Laboratory Improvement Amendments (CLIA) define a laboratory as “a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.”
Every urgent care laboratory must have a CLIA license before patient testing begins. A license can be waived or nonwaived, but for the purposes of this timeline, the assumption is that you are establishing a nonwaived laboratory. You can download the CLIA application form, CMS-116, from the Centers for Medicare & Medicaid Services (CMS) website, www.cms.gov. Revisions to this form are made periodically; make sure that you submit the most recent form.
If only a CLIA application is warranted, submission may not be necessary 3 months before initiation of laboratory testing; however, there are often state-specific rules and regulations and separate state applications and designations to deal with. A listing of state offices with contact information can be found at www.cms.gov. States with additional licensure requirements may require up to 3 months for approval and scheduling of an on-site inspection before issuance of a license. Table 1 lists state-specific licensure and regulations requirements.
Table 1. State-Specific Licensure and Regulations Requirements