STATE AND FEDERAL
GOVERNMENT ISSUES

• Licensure
• Bureau of Labs
• Knowing your state Senator/Representative (link to Harrisburg, Washington)
• CLIA 88 and Physician Office Labs

Within a state, to safeguard the public good in areas such as nursing, physical therapy, pharmacy, funeral directing or hair dressing, an agency of government can grant a license to those persons who have attained the degree of competency necessary to ensure that the public health, safety and welfare will be reasonably well protected.  States which have mandatory personnel standards for clinical laboratories (such as California, Florida, Tennessee) can document that such licensure:

• Improves the quality of laboratory testing
• Is the simplest form of regulation for laboratories because it does not require the state to spend large amounts of money, time and data collection to monitor every laboratory in the state.
• Protects the public from untrained individuals who make critical mistakes because they do not have the scientific background to evaluate results.

If you wish more information about clinical
laboratory personnel issues in Pennsylvania, please contact the webmaster.

The Pennsylvania Bureau of Laboratories provides a "facility license" to those institutions in the Commonwealth which perform laboratory testing.  This license stipulates personnel requirements for the laboratory director but not for any testing personnel.  It also excludes any requirement for personnel standards for laboratory testing done in physician offices.  Therefore, at this time, if you have laboratory testing done in your doctor's office, it may be legally performed by someone with no formal laboratory training in quality assurance or quality control.  Therefore, even in Pennsylvania which has "facility licensure", there is no guarantee that a qualified laboratory professional will perform your lab work in all settings. There are over 5,000 facilities in Pennsylvania which are designate "clinical laboratories." They range in size from the smallest physician office laboratory, to those in any size hospital as well as large commercial labs.  They even include testing being done in shopping mall health
screenings.

Know your state Senator/Representative (link to Harrisburg, Washington)