Program Description and Background

Background

The OSHA Lead Standard requires biological monitoring of workers exposed to airborne lead above the action level. Employers must have these samples analyzed by a laboratory which meets OSHA accuracy requirements in blood lead proficiency testing (PT). Samples must be analyzed for lead and zinc protoporphyrin (or free erythrocyte protoporphyrin).

Since 1979 OSHA and CDC have monitored laboratory performance in blood lead proficiency testing. Each laboratory is graded for 12 months (or equivalent time period) and the OSHA approved list is updated. Laboratories with 89% or greater acceptable sample results are approved.

As of September 30, 1986 the CDC Laboratory Program Office ceased its blood lead proficiency testing program. The program was transferred to the College of American Pathologists (CAP) and resumed in January 1987.

The CDC Center for Environmental Health terminated its blood lead proficiency testing program with the end of the fiscal year September 30, 1987. The program resumed at the Wisconsin State Laboratory of Hygiene (WSLH). The CDC Center for Environmental Health continued to analyze and report the data. As of July 1995 all activities of this program were assumed by the WSLH.

As of December 31, 1987 the CDC Laboratory Program Office ceased monitoring laboratory performance for OSHA in the proficiency testing programs. Since then, OSHA has reviewed data from PT programs and evaluated results based on current criteria.

The List of Laboratories Approved for Blood Lead Analysis will be updated and distributed as performance data are received. The Health Care Financing Administration continues its role in jurisdictional matters for laboratories licensed and accredited under the Clinical Laboratory Improvement Act (CLIA) and Medicare.

Accuracy/Non-Reporting

Individual sample results are acceptable if within 6 ug/dL of the target value (or all-method mean) if that value is less than 40 ug/dL; or within 15% of the target value (or all-method mean) if that value is greater than 40 ug/dL.

All results outside acceptable performance limits will be treated as errors.

Results reported or received after the survey deadline will not be accepted. It is the responsibility of the laboratory to assure timely receipt of results by the PT organization.

Non-participation in a survey will not be accepted without prior exemption from OSHA. Contact OSHA prior to the survey deadline with a detailed explanation for non-participation. Exempted laboratories will not be listed as OSHA approved until successful completion of a survey subsequent to the exempted survey. No occupational samples should be analyzed during the exempt period.

Approval Status

Blood lead testing is to be provided only by laboratories that are currently approved based on the most recent proficiency testing. Laboratories whose approval status is suspended because of a cumulative score less than 89% or because of failure to participate in a PT survey may no longer analyze occupational blood lead specimens.

Non-approved laboratories may arrange to have the analysis performed by an approved laboratory until their laboratory has been reinstated. The laboratory must inform clients of any change in approval status immediately upon receipt of the latest survey results rather than awaiting the publication of an official OSHA list. Laboratories should maintain records of the cumulative score and approval status based on OSHA criteria.

The current list is comprised of laboratories that have met the OSHA requirements for blood lead analysis. Laboratories enrolled in programs offered by the College of American Pathologists, New York State Department of Health (NYS), or Wisconsin State Laboratory of Hygiene are evaluated upon request. Approval is based on the most recent 12 months of testing. Problems with samples or data should be resolved between the laboratory and the PT program organization.

It is the responsibility of the laboratory to assure that data has been reported to OSHA. To prevent possible omission from the OSHA list:

• Check CAP reports for the words "COPY TO: OCCUPATIONAL SAFETY & HEALTH". This indicates that OSHA has received the CAP report. If this notation is missing, contact OSHA and the CAP immediately.
• Check WSLH report booklets for laboratory results listing. If results are not listed, contact OSHA and the WSLH immediately.

Change of Address

This list applies only to laboratories corresponding to the names and addresses listed and is NOT valid for any other laboratory with the same or similar name, or for any branch at a different location that is not so listed. As a convenience, laboratories are listed by state. Employers may use any approved laboratory. Changes in laboratory name or address should be sent to OSHA to prevent deletion from the list.

Eligibility/Multiple Enrollment

Laboratories currently participating in the CAP, NYS, or WSLH blood lead programs may submit a written request to the organization for release of performance data. A written request must also be submitted to OSHA and should include the individual laboratory code number assigned by the program.

Laboratories with multiple enrollment will be evaluated based on results in one program only. The program of choice must be designated to OSHA. Since failure in any program indicates problems which may be affecting occupational samples, program "switching" does not mitigate unacceptable results obtained in the program of choice.

Laboratories participating in the CAP program which have requested CAP to send results to OSHA are evaluated based on the CAP results only. Laboratories which wish to be evaluated based on another program must contact the program organization and OSHA.

State Adult Blood Lead Reporting Requirements

OSHA is committed to protecting workers from exposure to lead. The National Institute for Occupational Safety and Health’s (NIOSH) Adult Blood Lead Epidemiology and Surveillance program, called ABLES, is an important nationwide surveillance system designed to accurately measure trends in adult blood lead level and identify where workplace lead exposure occurs. The 41 states participating in ABLES require laboratory reporting of adult blood lead levels to their state health departments under state public health reporting regulations.

OSHA encourages all laboratories on the List of Laboratories Approved for Blood Lead Analysis to comply with state adult blood lead reporting requirements. This involves reporting to the appropriate state agency all required data elements, including industry and occupation, and timely submission as required by state regulations.

A list of states with adult blood lead reporting requirements and contact persons is available on the State Registries page. State requirements have been supplied by NIOSH for inclusion in this document.