COMMENTS and RESPONSES to PROPOSED BLOOD LEAD STANDARDS - Reporting and Confirmatory Testing Guidance

Q: What reporting elements must the laboratory include under BL S12 and BLS S13?

The laboratory report must include the methodology used in analysis and, for test results on exposed adults, a reference interval of <5 ug/dL (as stated in the proposed guidance).

Q: How does the department define an elevated blood lead level (BLL) for adults in RESPONSE 1?

The Center for Environmental Health (CEH) considers a blood lead level (BLL) of greater than or equal to 5 ug/dL to be elevated for all adults exposed to lead, including those with occupational exposures.

Q: What confirmatory testing steps are required when venous samples meet the stated blood lead concentration thresholds?

If venous blood lead concentrations meet or exceed the specified thresholds, the laboratory must either refer the specimen to a NYS-permitted comprehensive toxicology laboratory for confirmatory testing by a high complexity reference method (ICP-MS or GFAAS), or indicate on the report that the result requires confirmation using such methods.

Sep 30, 2026

Uploaded by Rhys

COMMENTS and RESPONSES to PROPOSED BLOOD LEAD STANDARDS summarizes the circulated proposed Toxicology – Blood Lead standards and the resulting comments received during the April 1 to May 27, 2016 comment period. It specifies laboratory reporting requirements, including required methodologies and reference interval thresholds for exposed adults, and defines confirmatory testing workflows using high complexity reference methods such as ICP-MS and GFAAS. It also addresses release of preliminary results and specimen handling guidance.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages5

Reading Time13 min

AccessFree to download

Proposed standards overview

Reporting requirements (BL S12, BLS S13)

Comment and response to reference interval requirement

Confirmatory testing (BLS S10, BLS S11)

COMMENTS and RESPONSES to PROPOSED BLOOD LEAD STANDARDS The Proposed Standards in the areas of Toxicology – Blood Lead were circulated for comment on April 1, 2016. The announcement was sent to NYS-permitted facilities that held or were in application for a permit (facilities) . This distribution was by e-mail to the facility and laboratory contact person’s e-mail address. The documents were posted to the CLEP website. The comment period ended May 27, 2016. Three comments were received. The standards are considered to be accepted and will be adopted and effective as of August 5, 2016. | Proposed Standard | Proposed Guidance | | --- | --- | | Blood Lead Sustaining Standard of Practice 12 (BL S12): Reporting
In addition to the report requirements defined in Reporting Sustaining Standard of Practice 1 (Reporting S1): Report Content, the laboratory report must contain:
a) the methodology used in analysis; and
b) for test results on exposed adults, a reference interval of <5 ug/dL. | | | Blood Lead ASV Sensors Sustaining Standard of Practice 13 (BLS S13): Reporting
In addition to the report requirements defined in Reporting Sustaining Standard of Practice 1 (Reporting S1): Report Content, the laboratory report must contain:
a) the methodology used in analysis; and
b) for test results on exposed adults , a reference interval of <5 ug/dL. | | Comment 1: Do the proposed changes apply to workplace exposure to lead where the samples are submitted using the blood lead standard profile? Comment 2: In regards to the new section BL S12 under Reporting (see below) it is requiring we place a specific reference interval on the final report for exposed adults, I would propose that a reference to OSHA’s website for workplace information be substituted for a specific reference interval. For laboratories such as ours who service multiple states it would reduce conflict between varying state requirements. RESPONSE 1: The department’s Center for Environmental Health (CEH) considers a blood lead level (BLL) of greater than or equal to 5 ug/dL to be elevated for all adults who have been exposed to lead including those with occupational exposures (see attached letter). | Standard | Guidance | | --- | --- | | Blood Lead ASV Sensors Sustaining Standard of Practice 10 (BLS S10): Confirmatory Testing with LeadCare and/or LeadCare II
When blood lead concentrations greater than or equal to 5 micrograms/dL are obtained from a venous sample the laboratory must either:
a) if sufficient sample remains, refer the specimen to a NYSpermitted laboratory holding the permit category of Toxicology – Blood Lead-Comprehensive for confirmatory testing by a high complexity reference method (ICP-MS or GFAAS); or
b) indicate on the report the method used and that the result needs to be confirmed by a high complexity reference method (ICP-MS or GFAAS) . | a) An unopened venous specimen is preferable for confirmatory testing. When this is not possible or feasible (e.g. with young children), and the confirmed result is also elevated, the confirming laboratory can acknowledge the issue on the test report. Test result comment example: “The test specimen may have been compromised during previous testing. Result should be confirmed with another venous blood specimen.”
b) Preliminary results may be released with a comment that results of confirmatory testing by a high complexity reference method are pending.
b) Examples of reference methods include high complexity tests such as inductively coupled mass spectrometry (ICP-MS) and graphite furnace atomic absorption spectrometry (GFAAS) .
b) The following comment can be used on laboratory test reports to clinical health care providers: “For children 5 years old and younger, blood lead levels ≥5 μg/dl indicate that they may have been exposed to lead at levels higher than most children. The blood lead level should be confirmed using a venous blood sample and a NYS-permitted high

FAQs

What reporting elements must the laboratory include under BL S12 and BLS S13?

The laboratory report must include the methodology used in analysis and, for test results on exposed adults, a reference interval of <5 ug/dL (as stated in the proposed guidance).

How does the department define an elevated blood lead level (BLL) for adults in RESPONSE 1?

The Center for Environmental Health (CEH) considers a blood lead level (BLL) of greater than or equal to 5 ug/dL to be elevated for all adults exposed to lead, including those with occupational exposures.

What confirmatory testing steps are required when venous samples meet the stated blood lead concentration thresholds?

If venous blood lead concentrations meet or exceed the specified thresholds, the laboratory must either refer the specimen to a NYS-permitted comprehensive toxicology laboratory for confirmatory testing by a high complexity reference method (ICP-MS or GFAAS), or indicate on the report that the result requires confirmation using such methods.

Sep 30, 2026

Uploaded by Rhys