Business Plan
Development of a thorough business plan is vital to the implementation of a successful service. There are a variety of available resources to guide the development process and the consideration of important factors such as service design, billing for services, and service evaluation.
Billing
Service sustainability is dependent on the ability to receive payment for service provision.
Legal/Regulatory
Laboratory Certification
In order to perform point-of-care testing, a pharmacy must obtain and maintain certification. The Clinical Laboratory Improvement Amendments (CLIA) are a set of standards for the regulation of laboratory testing utilized to ensure the accuracy, reliability, and timeliness of results. Certain tests, those considered to have a low risk for having an incorrect result, can be performed without the need to establish a full laboratory. Facilities performing these tests are required to apply for and be granted a CLIA waiver in order to perform these tests.
For additional training see: CDC CLIA waived testing CE Course
Examples of CLIA-waived tests
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm)
- Glycated hemoglobin (A1c)
- Blood glucose
- Cholesterol (Total, HDL, LDL, Triglycerides)
- Creatinine
- Influenza A/B
- Urine glucose
- Urine ketone
- Urine protein (dipstick)
Obtaining a CLIA waiver
Additional information coming soon!
References:
