Laboratories that intend to test specimens collected in Pennsylvania for blood lead, erythrocyte protoporphyrin, alcohol and drugs of abuse must obtain the approval of the Division of Chemistry and Toxicology, enroll in the appropriate proficiency testing program(s) administered by the Bureau of Laboratories and continue to demonstrate satisfactory performance.
The Alcohol in Blood and Lead in Blood programs are approved by the United States Department of Health and Human Services Centers for Medicare and Medicaid Service. Participation in those programs meets the proficiency testing requirements for those analytes under the federal Clinical Laboratory Improvement Amendments.
The proficiency testing programs are also open to laboratories that do not require approval from the Bureau of Laboratories.
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.
- Toxicology Proficiency Testing Programs 2024 Fees
- Toxicology Proficiency Testing Programs 2024 Schedule
- Drugs of Abuse in Blood, Serum, and Urine 2024 Drug Codes
- NEW: Important Rule Change for CLIA and Pennsylvania Proficiency Testing
Obtaining Approval
The following documents describe the requirements a laboratory must meet to obtain approval.
- Requirements for Laboratories that Perform Blood Lead Analysis
- Requirements for Laboratories that Perform Erythrocyte Protoporphyrin and/or Zinc Protoporphyrin Analysis
- Alcohol in Blood and/or Serum Testing Approval Requirements
- Drugs of Abuse in Blood and/or Serum Testing Approval Requirements
- Drugs of Abuse in Urine Testing Approval Requirements
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.
- Laboratories Approved to Determine Analyses of Blood or Serum or Both for Controlled Substances Under The Clinical Laboratory Act, the Vehicle Code, the Fish and Boat Code and the Game and Wildlife Code [47 Pa.B. 5865] [Saturday, September 16, 2017]
- Laboratories Approved to Determine Blood Alcohol Content under The Clinical Laboratory Act, the Vehicle Code, the Fish and Boat Code and the Game and Wildlife Code [47 Pa.B. 5867] [Saturday, September 16, 2017]
- Laboratories Approved to Determine Analyses of Urine for Controlled Substance Content Under The Clinical Laboratory Act, the Vehicle Code, the Fish and Boat Code and the Game and Wildlife Code [47 Pa.B. 5876] [Saturday, September 16, 2017]
- Laboratories Approved to Perform Blood Lead and/or Erythrocyte Protoporphyrin Determinations Under The Clinical Laboratory Act [47 Pa.B. 5892] [Saturday, September 16, 2017]
- Minimum Levels of Controlled Substances or their Metabolites in Blood to Establish Presence of Controlled Substance [47 Pa.B. 4045] [Saturday, July 22, 2017]
- Approved Prearrest and Evidential Breath Testing Devices [47 Pa.B. 5858] [Saturday, September 16, 2017]
Important Rule Change for CLIA and Pennsylvania Proficiency Testing
The Pennsylvania Department of Health Bureau of Laboratories (Bureau) implements state and federal laboratory licensure laws. Participation in the Bureau's Proficiency Testing (PT) Programs is one of these state requirements. The Bureau's blood lead and blood alcohol PT programs have been approved by the Centers for Medicare and Medicaid Services (CMS) in accordance with the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). Participation in the Bureau's program satisfies both Pennsylvania and federal PT requirements.
- There will be a rule change (to be implemented January 1, 2025) that will affect how the Bureau will grade its participants' submitted results.
- Note: the rule change will affect all complexity testing platforms.
- The new rules for the aforementioned CMS-regulated analytes will tighten the acceptance ranges. Consequently, some results that previously had passed may fall outside the new acceptance ranges. Again, the implementation time frame is January 1, 2025.
- The tighter ranges reflect the need for greater accuracy and precision in patient measurements. This need is especially evident for blood lead, considering the historical trend towards lower blood lead levels at which certain actions are recommended. Recommended Actions Based on Blood Lead Levels | Lead | CDC.
- Below, please find a chart that summarizes the current and future rules.
| New proficiency testing grading rules for CMS-regulated analytes | ||
|---|---|---|
CMS-regulated
Analyte
| Current CMS
Criteria
| Future CMS
Criteria
|
| Blood Alcohol | Target Value +/- 25% | Target Value +/- 20% |
| Blood Lead | Target Value +/- 10% or 4 µg/dL (whichever is greater) | Target Value +/- 10% or 2 µg/dL (whichever is greater) |
On July 11, 2022, CMS and the Centers for Disease Control and Prevention issued a final rule, CMS-3355-F, to update PT regulations related to analytes, acceptable performance for laboratories, and administrative processes for proficiency testing programs established under CLIA. For more information, please see CMS-3355-F.
For more information, please refer to the Federal Register.
If you have questions related to the new requirements, don't hesitate to contact the Bureau's Toxicology PT Program at RA-DHTOXPTPROGRAMS@pa.gov or 610-280-3464.