Regulations
Physician office laboratories (POL) are regulated by federal regulations.
Public Health Law
In New York State, there are two programs that issue Clinical Laboratory Improvement Amendments (CLIA) certificates based on the exception in the Public Health Law (§579.1) that dictates to which Program the facility will submit an application. To meet the POL exception, the facility must be entirely owned and operated by medical professionals allowed in §579.1 and 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".
Guidance
- 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.
Brochures
- Updated Regulations
- Verification of Performance Specifications
- Calibration and Calibration Verification
- How to Obtain a CLIA Certificate of Waiver
- Laboratory Director Responsibilities
- Proficiency Testing
The following updated CLIA brochures can be found on this CLIA webpage
- CLIA Certification
- Laboratory Complaints
- Assessing Personnel Competency
- Laboratory Director Responsibility