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CAP Home > CAP Reference Resources and Publications > CAP Public Policy Compendium > Pharmacist Scope of Practice and Laboratory Testing Responsibility

  Pharmacist Scope of Practice
  and Laboratory Testing
  Responsibility

 

 

 

Policy Synopsis

The College of American Pathologists believes that the interpretation of laboratory tests constitutes the practice of medicine, for which pharmacists should not be licensed. The College also believes that no test is so simple and straightforward to perform that erroneous results cannot occur and that no incorrect test result is “risk free” or inconsequential with regard to potential harm.

Policy

The College believes that the interpretation of laboratory tests, used for the diagnosis, prevention, treatment, or assessment of human disease, or for purposes of drug therapy management, constitutes the practice of medicine, for which pharmacists should not be licensed. The College also believes that no test is so simple and straightforward to perform that erroneous results cannot occur and that no incorrect test result is “risk free” or inconsequential with regard to potential harm. The College, therefore, recommends that any legislation or regulation addressing the ability of pharmacists to order, perform or evaluate laboratory tests should be based on the following principles:

Except for individuals requesting a test for themselves as authorized by state law, the ordering of clinical laboratory tests should be limited to licensed physicians, licensed dentists, or licensed health care practitioners under the supervision of a licensed physician or licensed dentist who is providing treatment for the patient.

Diagnostic laboratory testing should only be performed by those individuals who possess appropriate clinical education and training, and under the supervision of licensed physicians, or consistent with moderate and high complexity testing requirements under CLIA 88.

The interpretation of clinical laboratory tests is the practice of medicine and should, therefore, be done solely by licensed physicians.

All clinical laboratory testing used for the diagnosis, prevention, treatment or assessment of human disease, and laboratory testing for purposes of drug therapy management should be subject to quality control and proficiency testing.

When individuals perform any test on a person other than themselves, it should be construed as the practice of laboratory medicine, subject to all of the above listed principles, unless such test is approved by the Food and Drug Administration as an “over-the-counter” test that is available for use to the general public without a prescription and used by a home health care attendant or caregiver under the supervision of a licensed physician.

The College of American Pathologists offers this policy for consideration by any government agency or legislature and for use by state pathology societies for legislative or regulatory advocacy.

Revision History

Adopted May 2002
Revised November 2002

   
 

 

 

   
 
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