Textbook of Urgent Care Management: Chapter 32, Implementation of a Moderate-Complexity Clinical Laboratory
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About this ebook
Chapter 32 includes:
Three Months Out...
- Applying for Licensure
- Negotiating Insurance Contracts
- Contacting a Laboratory Equipment and Supply Distributor and a Technical Consultant
- Selecting a Test Menu
- Selecting Analyzers, Test Systems, and Test Kits
Two Months Out...
- Personnel and Laboratory Support Staff Members
- Reagent and Analyzer Contracts
- Laboratory Information Systems
- Completion of Physical Site
One Month Out...
- Hire Personnel
- Delivery, Training, and Validation of Analyzers
- Integration of the Laboratory Information System
- Policies and Procedures
- Quality-Assessment Plan
- Proficiency Testing
- Setup of Patient Draw Site
- Preparation for Inspection Process
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Textbook of Urgent Care Management - Lynn R. Glass
CHAPTER 32
Implementation of a Moderate-Complexity Clinical Laboratory
Lynn R. Glass
from
CHAPTER 32
Implementation of a Moderate-Complexity Clinical Laboratory
Lynn R. Glass
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.
THREE MONTHS OUT . . .
Applying for Licensure
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