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Bureau of Laboratories
Division of Chemistry and Toxicology
M. Jeffrey Shoemaker, Ph.D.
Director
The Division of Chemistry and Toxicology works with various state and private agencies to monitor lead levels in children, oversees the Pennsylvania Newborn Screening Testing Program for inherited metabolic disorders, conducts toxicology proficiency testing and performs alcohol and drug testing on persons involved in fatal traffic accidents.
Toxicology Approval and Proficiency Testing Programs
Laboratories performing tests for blood lead, erthrocyte protoporphyrin, alcohol,and drugs of abuse must obtain the approval of the Division of Chemistry and Toxicology, enroll in the appropriate proficiency testing program, and continue to demonstrate satisfactory performance. The division also approves testing devices used by law enforcement officials to determine the alcohol content of blood by analysis of a person's breath.
Obtaining Approval
The following documents describe the requirements a laboratory must meet to obtain approval.
Toxicology Proficiency Testing
The Division of Chemistry and Toxicology operates proficiency testing programs for the analytes listed below. Labs that have been approved to test Pennsylvania patients for these analytes must participate in the relevant proficency tesing program(s). Enrollment is part of the approval process as indicated in the documents in the section above.
The proficiency testing programs are also open to laboratories not seeking approval for patient testing. The Alcohol in Blood and/or Serum program is approved by the federal Centers for Medicare and Medicaid Services. Participation in the program meets the proficiency testing requirement for this analyte under the Clinical Laboratory Improvement Amendments.
Approved Laboratories
The Pennsylvania Bulletin is published semi-annually and contains lists of approved laboratories and breath testing devices. The following links provide lists of currently approved labs and devices.
Approved Prearrest and Evidential Breath Testing Devices [41 Pa.B. 84] [Saturday, January 1, 2011]
Laboratories Approved to Determine Analyses of Blood and/or Serum for Controlled Substances under the Clinical Laboratory Act, the Vehicle Code, the Fish and Boat Code, and the Game and Wildlife Code [41 Pa.B. 89][Saturday, Jan. 1, 2011]
[41 Pa.B. 91] [Saturday, Jan. 1, 2011]
[41 Pa.B. 99] [Saturday, Jan. 1, 2011]
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