Physician office laboratories are regulated by federal regulations.
Public Health Law
In New York State, there are 2 programs that issue CLIA certificates based on the exception in the Public Health Law (§579.1) that dictates to which Program the facility will submit an application. In order to meet the POL exception, the facility must be entirely owned and operated by a physician or group of physicians, perform laboratory tests, personally or through their own employees, solely as an adjunct to the treatment of their own patients.
To read this law, please follow the link, then click "PBH", then "Article V", then "Title 5" and finally "579".
- Blood Lead Screening Using Waived Test Devices
- Throat Culture Screen for Presumptive Identification of Group A Streptococci
- CDC Ready, Set, Test booklet with sample forms, Temperature and QC logs
- Many resources on the topic of Individualized Quality Control Plan (IQCP) are available from CMS.
- Updated Regulations
- Verification of Performance Specifications
- Calibration and Calibration Verification
- How to Obtain a CLIA Certificate
- How to Obtain a CLIA Certificate of Waiver
- Laboratory Director Responsibilities
- Proficiency Testing
- Personnel Competency