Guidance for Point-of-Care Blood Lead Testing and Reporting

October 2011

Childhood lead poisoning remains a serious New York State (NYS) public health problem. In 2009, over 2,700 of NYS' children under the age of six were diagnosed with lead poisoning, defined as a confirmed blood lead level greater than or equal to 10 micrograms per deciliter (µg/dL). Lead poisoning is associated with serious, lifelong adverse effects on children's physical, cognitive, and behavioral development. Routine blood lead testing of young children is essential to assure early identification and coordination of follow-up to prevent further exposure.

As lead crosses the placenta, a pregnant woman with an elevated blood lead level (EBLL) may expose her fetus to the toxic effects of lead. In 2009, 86 NYS pregnant women were identified as having EBLLs greater than or equal to 10 µg/dL. For women who are pregnant, postpartum, or of reproductive age, lead poisoning prevention education, risk assessment and blood lead testing if a risk is identified, and management of pregnant and postpartum women with EBLLs are essential elements of a comprehensive approach to preventing and eliminating lead poisoning in NYS.

Under NYS Public Health Law (PHL) and regulations, health care providers are required to:

  • Test all children for lead at or around age one year and again at or around age two years.
  • Assess all children ages six months to six years for lead exposure using a risk assessment tool at least annually, with blood lead testing for children identified as being at risk for lead exposure.
  • Assess all pregnant women for lead exposure using a risk assessment tool at the initial prenatal visit, with blood lead testing for women identified as being at risk for lead exposure.

NYS PHL and regulations require all laboratories that conduct blood lead testing, including physician office laboratories (POLs) and limited service laboratories (LSLs), to report all results of such testing to the Department. The Department recognizes the availability of, and access to, blood lead testing using "point-of-care" technologies and requires all entities that perform blood lead testing on humans hold the appropriate level of approval to conduct such testing. The Medicaid program, Medicaid Managed Care, and Family Health Plus plans provide reimbursement for "point-of-care" blood lead testing of children under age six years and pregnant women performed by practitioners operating POLs that hold appropriate Clinical Laboratory Improvement Amendment (CLIA) certification, and clinics that operate LSLs registered by Wadsworth Center for blood lead analysis.

This document summarizes the requirements for laboratories that offer blood lead testing using a CLIA waived point-of-care LeadCare®II device. Information regarding testing and reporting requirements for each type of laboratory is summarized below. Additional guidance documents are available at http://www.health.ny.gov/environmental/lead/.

Laboratory Types

Any entity that performs blood lead testing must have the appropriate level of approval to conduct testing on human specimens as determined by NYSDOH's Wadsworth Center. The requirements for each laboratory type are explained in this section.

Physician Office Laboratories (POLs): Individual practitioners or group private practices that conduct in-house laboratory testing on their own patients must be certified by the federal Centers for Medicare and Medicaid Services (CMS) though the NYSDOH Physician Office Laboratory Evaluation Program (POLEP). In order to qualify as a POL, the practice must be operated by individual health care providers or be part of a legally constituted, independently owned and managed partnership or group practice. Laboratories that are owned, managed and/or operated by managed care organizations, hospitals or consulting firms do not qualify for the POL exception and should apply for a clinical laboratory permit through the Clinical Laboratory Evaluation Program (CLEP).

For additional information, call POLEP at 518-485-5352, or email CLIA@health.state.ny.us, or visit www.wadsworth.org/labcert/polep/. The Blood Lead Practice Standards are posted at www.nyhealth.gov/environmental/lead/ and attached (Appendix A).

Limited Service Laboratories (LSLs): LSLs include hospital extension clinics, nursing homes, home health care agencies, school/student health services, dialysis facilities, ambulatory surgery centers, county health departments, correctional facilities, ambulance/rescue squads and other direct patient care facilities performing only waived and/or provider-performed microscopy procedures (PPMP). These facilities must register with NYSDOH CLEP by completing an "Initial Limited Service Laboratory Registration Application, form DOH-4081." Facilities that are currently registered as LSLs may add waived blood lead testing to their registration by completing a "Limited Service Laboratory Registration Notification to Add and/or Delete Test Procedure(s) form, DOH-4336(e)."

Note: All LSLs must include a copy of their blood lead protocol with the appropriate application and/or change form. A thorough understanding of the manufacturer's instructions is required. A checklist to guide the development of the protocol is attached (Appendix B).

For additional information, call CLEP at 518-402-4141, or email CLEPLtd@health.state.ny.us or visit www.wadsworth.org/labcert/limited/. The Blood Lead Practice Standards are posted at www.wadsworth.org/labcert/clep/Administrative/lab-standards-lead-testing-wd.pdf and attached (Appendix A).

Permitted Clinical Laboratories: Facilities that do not qualify as a POL and perform testing categorized by the Food and Drug Administration as moderate or high complexity must hold a permit issued by the NYSDOH Clinical Laboratory Evaluation Program (CLEP) in either the category of Toxicology – Blood Lead-Comprehensive or Toxicology – Blood Lead-Screening Tests. The category of Toxicology – Blood Lead-Comprehensive is for laboratories that perform blood lead measurements using reference systems based on atomic absorption spectrometry (AAS) and/or induction coupled plasma mass spectrometry (ICP-MS); or bench-top anodic stripping voltammetry (ASV; i.e. Model 3010B by ESA Biosciences, Inc.). Laboratories that perform only screening tests using point-of-care lead analyzers such as the LeadCare® II (ESA Biosciences, Inc.) may apply for the category of Toxicology – Blood Lead-Screening Tests. For additional information, call 518-485-5378, or email CLEP@health.state.ny.us, or visit www.wadsworth.org/CLEP.

Reporting

Reporting of all blood lead test results is essential to assure timely and appropriate follow-up, and complete data for public health surveillance purposes. All laboratories that conduct blood lead testing are required to report the results to NYSDOH. NYS PHL and regulations specify the information that must be reported, the timeframes for reporting and the mechanisms for reporting, which vary by type of laboratory, as summarized below. (PHL Sections 576-c, 579(3)c, 1370-e and 2168; NYCRR Subparts 67-1.2 and 67-1.3)

All Laboratories Must:

  1. Have individual NYS Health Commerce System (HCS) accounts for staff assigned to report blood lead test results. For each member of your organization who will be submitting data to the NYSDOH, your HCS Coordinator will need to complete a HCS Individual User Security and Use Policy Application form online. To find out who your HCS Coordinator is, call the Commerce Account Management Unit (CAMU) at 1-866-529-1890 or email hinhpn@health.state.ny.us.
  2. Include with the blood lead test results: the subject's name, date of birth, race, gender, address, county of residence, type of sample (venous or capillary) and blood lead level; the health care practitioner ordering the test, laboratory identifiers, the date the sample was collected and the date of analysis. In addition, to facilitate timely follow-up, it is recommended that reports include parent or guardian information (for children < 18 years of age) or employer information (for adults).

Physician Office Laboratories (POLs) Only

POLs located outside of NYC are required to report electronically through the New York State Immunization Information System (NYSIIS)'s lead module. For POLs located in New York City (NYC), the preferred method to report electronically is through the NYC Department of Health and Mental Hygiene (DOHMH)'s Online Registry.

AFTER receiving a CLIA waiver certificate from POLEP and BEFORE testing begins:

Physician Office Laboratories Located Outside of New York City

  1. POLs must have a New York State Immunization Information System (NYSIIS) organization account and staff assigned to report blood lead test results must be added as users by the administrative user in the organization. Call the NYSIIS Helpdesk 1-866-389-0371 to obtain an account or if any questions.
  2. Enroll for reporting by contacting the NYSDOH Lead Poisoning Prevention Program (LPPP) at 518-402-7600 or email lppp@health.state.ny.us and enter "Enroll for Reporting Blood Lead Test Results" in the subject line. Please have the facility's CLIA certificate available and the name of your NYSIIS organization when enrolling.
  3. LPPP staff will fax or email instructions for reporting to a primary contact and to the CLIA certificate holder in the laboratory. Instructions will include a customized NYS Blood Lead Test Report form (optional-for your office use as a method to capture essential information required for reporting), contact information for DOH LPPP and local health department (LHD) LPPPs, and NYSIIS–Lead module training materials.
  4. After enrollment with LPPP, at least one staff member must complete the recorded NYSIIS-Lead Module webinar training availableonline at: http://nysdoh.webex.com. To locate the training, click on the tab labeled "Recorded Sessions" on the left side of the screen. Under "Topic", locate the "NYSIIS- Lead Training", and click on the green playback tab on the right side of the screen.
  5. After viewing, contact DOH LPPP for access to NYSIIS lead data entry screen.
  6. Your office may begin testing when steps 1-5 have been are completed.

*NOTE: POLs located outside of New York City (NYC) must report blood lead test results to NYSDOH within 14 business days of the date of analysis.

Physician Office Laboratories Located in New York City

  1. Enroll for reporting by contacting the NYSDOH LPPP at 518-402-7600 or email lppp@health.state.ny.us and enter "Enroll for Reporting Blood Lead Test Results" in the subject line. Please have your facility's CLIA certificate available when enrolling.
  2. NYCDOHMH LPPP will contact you with instructions for reporting. The preferred method of electronic reporting to NYCDOHMH is through the NYCDOHMH's Online Registry located at https://a816-healthpsi.nyc.gov/cir/provider-client/servlet/PC. For information on POLs reporting in NYC, please contact NYCDOHMH LPPP at (212) 676-6352.
  3. Your office may begin testing when steps 1 and 2 have been completed.

*NOTE: POLs located in New York City must report results of 10 µg/dL or greater within 24 hours of analysis (NYC Health Code § 11.03 (b) (2), and blood lead test results below 10 µg/dL must be reported within five business days of analysis (NYC Health Code § 11.09) to the NYCDOHMH.

Limited Service and Permitted Clinical Laboratories Only

Limited Service and Permitted Clinical Laboratories are required to report results of all blood lead tests electronically to the NYSDOH's Electronic Clinical Laboratory Reporting System (ECLRS) within five business days of the date of analysis.

AFTER registering and receiving protocol approval from CLEP and BEFORE testing begins:

  1. Enroll for reporting with the NYSDOH LPPP by calling 518-402-7600 or email lppp@health.state.ny.us and enter "Enroll for Reporting Blood Lead Test Results" in the subject line. You will need to have the facility's CLIA certificate available when enrolling.
  2. LPPP staff will fax or email instructions for reporting to a primary contact and to the Laboratory Director. Instructions will include a customized NYS Blood Lead Test Report form, contact information for DOH LPPP, and local health department (LHD) LPPPs.

    *Note: For residents of NYC, blood lead test results of 10 µg/dL or greater must be reported to the NYCDOHMH within 24 hours of receipt of the test results (NYC Health Code §11.03 (b) (2)). Blood lead test results below 10 µg/dL must be reported to NYCDOHMH within five business days of results availability (NYC Health Code §11.09, reporting requirements).

  3. Once a HCS account has been obtained, you will need to apply for access privileges to ECLRS. Log onto the Health Commerce System, and on the homepage, click on the HCS Applications button at the top center of the page. Scroll down to find "Electronic Clinical Laboratory Reporting System (ECLRS)" and click on the link. A request for access form will appear that will need to be completed and submitted. For additional assistance, contact the ECLRS Help Desk at 1-866-325-7743 or email ECLRS@health.state.ny.us.
  4. Each laboratory must complete a certification process to participate in electronic reporting. The laboratory certification process is divided into three phases: enrollment, pre-certification and certification.

*Note: Until certified to report electronically using ECLRS, LSLs and permitted laboratories must use NYSDOH Blood Lead Test Report form DOH-4430 for reporting all blood lead test results to the NYSDOH LPPP. Fax form(s) DOH-4430 to 518-474-8136.

ECLRS Certification Process for LSLs and Permitted Clinical Laboratories

Enrollment: ECLRS staff will contact the laboratory to determine capability of participation in the ECLRS program. If the laboratory does not have a HCS account and access to ECLRS, the applications must be completed at this time. The ECLRS Help Desk will assist the laboratory in determining whether the laboratory should create a HL7 or ASCII file, or perform HTML data entry for their laboratory results.

Precertification: The type of electronic reporting will determine what is necessary for precertification. Precertification is the ability of a laboratory to successfully generate and transmit laboratory test result data in a format consistent with established ECLRS specifications. During this phase, the laboratory enters live patient data into the ECLRS test system and faxes the corresponding paper records to the NYSDOH LPPP at 518-474-8136. A minimum of ten records must be submitted before the laboratory may be promoted to the certification process.

Certification: Certification is the final step for electronic reporting of blood lead test results. ECLRS staff will send an excel spreadsheet with at least ten records to LPPP staff to compare to the corresponding paper records. LPPP staff will provide feedback to ECLRS staff whether the electronic data quality is acceptable. Unacceptable data quality includes: inconsistencies between paper and electronic records or missing/invalid data. ECLRS staff will relay to the laboratory all LPPP feedback prior to accepting additional electronic records, and assist the laboratory to report quality data. When LPPP staff determines a laboratory has met expected certification criteria, ECLRS will send the laboratory and LPPP staff an email notice informing them of the final approval for certification.

*Note: Laboratories considering changing their electronic method of reporting must contact ECLRS prior to doing so. A modified certification process comparing the data in the two electronic reporting platforms will be followed before the laboratory is approved to change methods.

APPENDIX A

Blood Lead Screening Standards of Practice for WAIVED Testing Devices
(e.g., Lead Care® II)
Standard Guidance
Consent for Testing of a Minor

To offer lead screening of children during community screening events, the laboratory must establish a procedure for determining whether the person arranging for testing for a minor has a legal right and the capacity to consent to testing of the minor.
Consent for Testing of a Minor

A minor is an unmarried person under the age of 18.
As part of the process for obtaining approval to perform lead testing in outreach settings, the laboratory must attest that it has a procedure for establishing proof of a person's right of guardianship and eligibility to provide informed consent for any test subject who is a minor.
Specimen Collection

To avoid lead contamination from dust, regularly clean work surfaces by wet wiping.
Prior to skin puncture thoroughly clean finger by scrubbing area with soap and water and then with an alcohol swab.
Obtain whole blood samples using lead-free capillary collection tubes provided with the test kit or use vacuum tubes certified for lead (or trace element) analysis.
Reject venous blood specimens with visible clots, and, when using EDTA as anticoagulant, reject specimens when the collection tube is not at least one half full.
Specimen Collection

Directions for specimen collection, handling, and storage are included in the product insert and must be followed explicitly. Staff should document their having read and understood the insert.
Persons collecting patient specimens should have a thorough understanding of the specimen type, proper collection method (including the need to clean the skin area), and specimen handling.
For venous blood collected in a vacuum tube, use lead-free capillary tubes to transfer sample to the treatment reagent tube.
Be conscious of environmental requirements as described in the user's guide to ensure reliable test results. Test environment requirements apply to all test settings, e.g., in-office and community outreach venues including mobile vans.
Record keeping

Keep records of instrument calibration, and kit lot numbers and quality control results for each day's runs.
Record keeping

Records should allow cross-reference of each patient's results with kit lot number and quality control data to retrospectively identify patients in order to contact them for retesting if there is a product recall or problem with test performance.
Confirmatory Testing

Refer for confirmation testing all cases with a lead test result greater than or equal to 8 micrograms per deciliter (µg/dL).

NOTE: The level of 8 µg/dL is the confirmation threshold recommended by the manufacturer of the Lead Care® II device to minimize possible false negatives.
Confirmatory Testing

Whenever lead results generated by a waived device are greater than or equal to 8 µg/dL:
record results with a comment that results of confirmatory testing are pending
refer a properly collected venous sample to a NYS DOH laboratory permitted for blood lead confirmation testing, or refer the patient to that laboratory's patient service center for collection of a venous blood sample. If venous blood was collected in-office, that specimen may be referred or a new specimen may be collected.
Quality Assurance

Have product insert and device user's guide available to staff in the testing area.
Periodically compare blood lead results obtained from the waived device with results obtained from confirmatory laboratories.
Periodically review quality control records for irregularities.
Quality Assurance

Compile a procedures manual that minimally includes written policies to: ensure compliance with manufacturer's requirements for quality control; report results as applicable to your provider type; and assess personnel competency. Competency reviews of testing personnel should consider collection technique as well as performance of quality control and proficiency testing. Participation in proficiency testing is strongly recommended.
Ensure device operators are familiar with requirements for routine quality control (new lot, new shipment, new operator) and use of control materials to investigate suspect problems.
Differences greater than 3 µg/dL should be investigated.
If a control material value is not within proper range, refer to the trouble shooting section of user guide.
Public Health Reporting

Report all results of blood lead analyses to NYS DOH, with demographic data as required by Subparts 67-1 and 67-3. NOTE: residents of NYC must have their results reported to the NYCDOHMH.
Within 24 hours of analysis, notify the health care practitioner ordering the lead screening of the results of any analysis in a child (less than eighteen years of age) that is equal to or greater than 45 µg/dL.
Public Health Reporting

Department regulations call for reporting of test results and subject's name, date of birth, race, gender, address, county of residence, type of sample (fingerstick or venous), health care practitioner ordering the test, date sample was collected, date sample was analyzed, and identification of the testing laboratory.
Whenever a specimen is referred to a permitted laboratory for confirmatory blood lead analysis, the information listed above should be provided to the laboratory.
Revised 4/18/11

NOTE: For standards applicable to laboratories holding a NYS permit clinical laboratory permit in Toxicology - Blood Lead see www.wadsworth.org/labcert/clep/files/BloodLeadTraceElementsEP.pdf

APPENDIX B

Checklist for Limited Services Laboratories Submitting Lead Protocols to the Clinical Laboratory Evaluation Program for Review

  1. OVERVIEW
    This section should include a brief description of the organization's policy for when lead testing is performed. The facility's laboratory director must review and approve its policy and procedures for lead screening.
    NOTE: Procedures should include standing orders to screen individuals using a point-of-care device if a health care provider is not present at the time of the screening to order the test, how to obtain legal consent for testing those less than 18 years of age, and follow-up steps for results of 8 µg/dL or greater.
  2. EQUIPMENT AND MATERIALS REQUIRED
    All equipment used to perform testing should be included in this section (i.e. analyzer, treatment tubes, space where testing is performed, disposable workspace cover, etc.).
  3. ENVIRONMENTAL CONDITIONS
    This section should include:
    ___ how and when work surfaces are cleaned to avoid lead contamination from dust
    ___ how the laboratory stores reagents and quality materials and how the temperatures are monitored to make certain that these materials are stored at the temperatures required by the manufacturer
    ___ site(s) where testing will occur, including off-site screenings, such as health fairs or home visits
  4. CALIBRATION
    This section should include an explanation of how the device is calibrated in accordance with the manufacturer's package insert.
  5. QUALITY CONTROL
    This section should include:
    ___ a description of the quality control materials used
    ___ an explanation of when and under what circumstances quality control is performed (i.e. on each new test kit, with each new operator, etc.)
    ___ an explanation of next steps if the quality control is not within the manufacturer's acceptable range (i.e. rerun quality control, open new quality control, contact the manufacturer, etc.)
  6. COLLECTION REQUIREMENTS AND SPECIMEN REJECTION CRITERIA
    This section should include:
    ___ a description of how specimens are collected
    ___ an explanation of when specimens are unacceptable for testing and a follow-up plan of action for next steps (i.e. collect another specimen, etc.)
  7. RECORD KEEPING
    This section should describe how the laboratory records instrument calibration, and kit lot numbers and quality control results for each day's runs.
  8. RESULTS AND INTERPRETATIONS
    This section should include:
    ___ a description of how results are reported including the result obtained and the unit of measurement (i.e. 10.2 µg/dL, <3.3 µg/dL)
    ___ an explanation of when specimens are referred to a laboratory holding a New York State permit for confirmatory testing
    ___ an explanation of when follow-up testing will be performed
  9. CONFIRMATORY TESTING
    This section should include:
    ___ a description of when specimens are collected for confirmatory testing by a Laboratory holding a New York State permit
  10. PUBLIC HEALTH REPORTING
    This section should include:
    ___ an explanation of how and when blood lead results are reported
    ___ an explanation of who receives the laboratory's reports (i.e. NYS DOH, NYCDOHMH)
    ___ an explanation of the timeframe in which the laboratory reports (i.e. within 24 hours of analysis, etc)

APPENDIX C

RESOURCES FOR LEADCARE ® II USERS

Physician Office Laboratories

For questions related to provider certification to conduct in-house laboratory testing:

Physician Office Laboratory Evaluation Program (POLEP)
Phone: 518-485-5352
Email CLIA@health.state.ny.us
Website: www.wadsworth.org/labcert/polep/

For questions related to POL enrollment for lead testing reporting:

For POLs Located Outside of NYC

New York State Immunization Information Registry (NYSIIS)
NYSIIS Help Desk
Phone: 1-866-389-0371
NYSIIS-Lead Module Webinar:http://nysdoh.webex.com.

For POLs Located in New York City

NYC Department of Health and Mental Hygiene LPPP
Phone: 212-676-6352.
NYCDOHMH's Online Registry: https://a816-healthpsi.nyc.gov/cir/provider-client/servlet/PC

Limited Service Laboratories

For questions related to laboratory registration:

Clinical Laboratory Evaluation Program (CLEP)
Phone: 518-402-4141
Email: CLEPLtd@health.state.ny.us
Applications and forms are available at: www.wadsworth.org/labcert/limited/

For questions related to approval of electronic reporting:

Electronic Clinical Laboratory Reporting System (ECLRS)
Phone: 1-866-325-7743
Email: ECLRS@health.state.ny.us

Permitted Clinical Laboratories

For questions related to obtaining a laboratory permit for blood lead testing:

Clinical Laboratory Evaluation Program (CLEP)
Phone: 518-485-5378
Email: CLEP@health.state.ny.us
Website: www.wadsworth.org/CLEP

For questions related to approval of electronic reporting:

Electronic Clinical Laboratory Reporting System (ECLRS)
Phone: 1-866-325-7743
Email: ECLRS@health.state.ny.us

All Laboratories

For questions about lead testing requirements and enrollment for reporting of lead test results:

NYSDOH Healthy Homes and Lead Poisoning Prevention Program (HHLPPP)
Phone: 518-402-7600
Email: lppp@health.state.ny.us
Website: www.health.ny.gov/environmental/lead/laboratories.htm

For questions related to obtaining an online account for reporting via ECLRs NYSIIS:

Access to NYSDOH Health Commerce System (HCS)

NYSDOH Commerce Account Management Unit
Phone: 1-866-529-1890
Email: hinhpn@health.state.ny.us