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Point of Care Toolkit: Regulations

 

The PA Department of Health, Bureau of Laboratories updated their website early 2017 to be a much more comprehensive, clear site with useful resources. Please consider going through these documents and if you have any questions, Pam Groeff, who is listed on the website is a wonderful resource.

Click here for the link to the Bureau of Laboratories.

 

Federal Regulations

The Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) website provides information on federal requirements.

Click here for this link.

 

Pennsylvania Clinical Laboratory Act

Click on the link below for the specifics for the PA Pharmacy Act.

Act 122-2013: Pennsylvania Clinical Laboratory Act

 

Pennsylvania Clinical Laboratory Regulations

Chapter 5.: Clinical Laboratories

 

Instructions for Completing the Clinical Laboratory Application for PA

The Laboratory Director must submit the following:

1- Hold a doctorate and who qualifies under Section 5.21 of the Clinical Laboratory Regulations

  • must also submit a (1) copy of the curriculum vitae (CV), (2) a copy of any board certifications and a (3) a copy of the director’s medical license must be enclosed

2- The director must be the same for both State and CLIA purposes (co-directors are not recognized) 

  • A supervisor may be added to the license who the director adequately trains - this is not required to be submitted with the application

3- A photocopy of the physician’s medical license who will serve as the protocol physician

4- A Proficiency Testing Program (if applicable) along with proof of enrollment with the application

 

When submitting the application, it must be signed by the director/owner. Applications must all be sent in together fully executed.

 

Applications

One will need the CLIA waiver + one (or both) of the laboratory permits to conduct screenings.

 

Department of Health and Human Services; Centers for Medicare and Medicaid Services: Clinical Laboratory Improvement Amendments (CLIA) Application for Certification

 

Clinical Laboratory Permit Application for In State:  The application for a laboratory license costs $100 + an initial $25 processing fee and can be found here: PA Department of Health Clinical Laboratory Application

This laboratory license is useful for those who are interested in conducting all their screenings at one location.

 

Clinical Laboratory Permit Application for Screening: The application for a screening license costs $100 and can be found here: PA Department of Health Clinical Laboratory Screening License

This laboratory license is useful for those who are interested in conducting screenings at various locations. Important to note with this license *you need pay for this annually and the fee will change depending on number of screenings off-site. It is required that you track your off-site screenings and submit it annually to the state.

 

Department of Health and Human Services; Centers for Medicare and Medicaid Services:
Clinical Laboratory Improvement Amendments (CLIA) Application for Certification

 

Change of Status: If any changes to your licenses, please use this form: Change of status form

 

Maintenance of License

Once a pharmacist has his/her laboratory license, he/she will need to renewal it annually on August 15.  The fee to maintain the license is $100 per laboratory license. In addition, the CLIA waiver must be renewed biennially. U.S. Department of Health & Human Services will mail a coupon for CLIA Certificate of Waiver six months prior to your current certificate expirations date and after full payment is received, the next two year certificate cycle is considered renewed. The new certificate will be received about 2 weeks prior to your current certificate expiring.

For more information on the CLIA waiver, please click here.

 

OSHA

Pharmacies offering immunizations need to follow OSHA guidance on Blood Borne pathogens.  Information coming soon.

 

 

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