Questions and Answers Related to the Use of a LeadCare II Device - October 2010

1. Can a Local Health Department (LHD) give a LeadCare II device to a WIC clinic to perform blood lead testing?

Local Health Departments (LHDs) may purchase a LeadCare II device for use by WIC or another public health program administered by the LHD/County. However, lead testing by WIC-funded staff is not allowed under the Department's contract with the sponsoring agency for the WIC Program. If lead testing is performed on-site at a WIC clinic, Lead Poisoning Prevention Program (LPPP) staff or other appropriate resources must be allocated to this activity. If LHD staff are dually employed by the WIC and LPPP, appropriate time and activity records must be kept that delineates lead testing as part of LPPP staff time and activity.

A LHD may hold a clinical laboratory permit and concurrently operate a Limited Service Laboratory ("LSL") at the same address. A LHD that operates a permit-holding clinical laboratory may either conduct lead testing of any complexity under its clinical laboratory permit, or may conduct waived lead testing under its registration as a LSL in a mobile unit or a unit at the same address but physically and administratively separate from the permit-holding clinical laboratory (e.g., an on-site clinic), provided the unit was identified on a LSL registration form. A LHD without a permit-holding clinical laboratory would register the on-site clinic or mobile unit(s) as a LSL, or add such units to an existing LSL registration held by the LHD. The LHD is legally responsible for LSL operation including test reliability and timely confirmation of presumptive high blood lead levels, and for ensuring that laboratory services are integrated into a comprehensive lead poisoning prevention program.

Performance of blood lead testing using a CLIA-waived LeadCare II device requires the LHD or other operator to have the appropriate level of approval, as determined by the New York State Department of Health (NYSDOH)'s Wadsworth Center. Facilities other than private solo/group practices qualifying as a Physician's Office Laboratory ("POL") and permitted clinical laboratories, must register as Limited Service Laboratories (LSLs) with the NYSDOH Clinical Laboratory Evaluation Program (CLEP) if they seek to conduct testing using CLIA-waived devices. Information about laboratory registration is available at Limited Service Laboratory Registration - Wadsworth Center, New York State Department of Health

2. Is a WIC Clinic considered a point-of-care site for reimbursement?

Effective September 1, 2009 Medicaid reimburses Medicaid-enrolled hospital clinics and free standing Diagnostic and Treatment Centers (D&TC) for point-of-care blood lead testing provided the testing entity holds appropriate certification from the Department for its laboratory testing menu. Even if lead testing were to take place in the WIC clinic setting under the umbrella of a LHD's public health program, the LHD program would be billing Medicaid as an enrolled D&TC for the lead testing service, not the WIC clinic. A WIC clinic is not a stand-alone Medicaid provider. There can be no charge to a WIC recipient for blood work taken and analyzed by the WIC Program.

3. Can a WIC Clinic be a Limited Service Laboratory (LSL)?

See the response to Question 1. Many WIC clinics already have LSL registrations as they perform on-site hemoglobin testing for anemia which is a funded requirement of the WIC Program. A WIC clinic site may register as an LSL or may incorporate its testing services under an existing LSL registration or a permit held by the LHD that administers the WIC program. If the registration does not already address lead testing, the clinic must contact the NYSDOH's Wadsworth Center to seek the necessary registration amendment. WIC funding, including WIC-funded staff, can not be used to provide lead testing.

4. Can LHDs use LeadCare II devices in home settings to do blood lead testing if they meet Wadsworth Lab requirements as a clinical laboratory?

If by "clinical laboratory" you mean a laboratory holding the necessary clinical laboratory permit authorizing such testing, the answer is yes, provided the person administering the test in the home setting is a licensed professional (e.g., nurse, medical technologist). If by "clinical laboratory" you mean a LSL authorized to perform such testing pursuant to its registration as a limited service laboratory the answer is yes, provided the person administering the test in the home setting is trained in such testing by the LSL director. Appropriate approval for use of devices in an off-site setting, such as the home, must be obtained from the NYS DOH's Wadsworth Center.

5. Can LeadCare II devices be used at health fairs or community screening?

LeadCare II devices may be used by permitted clinical laboratories at health fairs and by registered LSLs during community screening events provided Department approval has been granted through the Wadsworth Center for such testing for these particular settings. For events testing children, approval would require a process to establish proof of guardianship and document consent of the guardian, as well as triage of children with elevated blood lead levels to the appropriate level of medical care. The physician authorizing the screening test is responsible for confirmation as needed and patient triage. Note: Medicaid reimbursement is not provided for a health fair or community event.

6. How can consent be obtained for children at health fairs/community screenings?

Permitted clinical laboratories or LSLS that wish to offer lead screening at health fairs or other settings at which community screenings occur, must establish a procedure for determining whether the person arranging testing for a minor (i.e. unmarried person under age 18) has a legal right and the capacity to consent to testing of the minor. As part of the process for approving lead testing in outreach settings, the lab must attest it has a procedure for establishing proof of guardianship and recording consent, as well as procedures for ensuring minors with elevated blood lead levels receive timely confirmation and, as needed, triage into an appropriate level of medical care. The physician authorizing the screening test, who may be associated with a LHD's lead poisoning prevention program, is responsible for confirmation and patient triage. Policies and procedures for lead screening in outreach settings must be approved by the laboratory director. The Department will not review and approve the laboratory's consent policy. Each laboratory should consider its liability and may refuse to conduct a test on a minor absent proof of guardianship or whenever capacity to consent cannot be determined. Factors the lab may wish to consider, among others, in making this determination include language barriers, hearing impairment, and the lack of capacity to consent due to permanent or temporary illness or disability.

7. Must only licensed personnel (i.e. MD, RN, and LPN) use this device? Or can others be trained to use the device? Who does the training?

Use of LeadCare II in a permitted clinical laboratory is restricted to professionals licensed by the State Education Department (SED) and persons specifically exempted from holding a license in laboratory technology by the SED. Persons using CLIA-waived devices in LSLs or physician office laboratories do not require a license; testing personnel in these settings must be provided on the job training. The laboratory director is responsible for training personnel who will operate the point-of-care devices and periodically assessing their competency.

8. Is there some PHL/LHD exception regarding administering blood lead screening when not seeking Medicaid reimbursement?

No such exception exists. Blood lead screening is laboratory testing and requires Department approval in any setting.

9. What policies and procedures (i.e., lead protocol) must a LSL submit for lead testing using a CLIA waived device?

LSLs seeking approval to perform lead screening must provide the Wadsworth Center's Clinical Laboratory Evaluation Program with a written protocol detailing how testing is performed in accordance with the manufacturer's requirements. The protocol must address the following items: specimen collection, record keeping, quality assurance and public health reporting. Practice standards for lead screening are available at the following website:

10. Are there samples of policies and procedures that are available for LHDs to use?

Each entity seeking approval to perform point-of-care testing must understand – and be able to describe – how the device is used in their particular setting. Each person involved in testing must read the manufacturer's instructions for the device and be trained in its use. The director of the laboratory is responsible for establishing standard operating policies and procedures for the organization.

11. Is there training available for LHDs to learn how to do capillary testing or to teach others how to do it?

The Centers for Disease Control has produced a video that explains the process for obtaining a lead specimen by finger stick (i.e., capillary collection). The Lead Poisoning Prevention Program (LPPP) has reproduced the CDC video and copies will be sent to local LPPPs for use with providers in their communities. Local LPPPs will be notified when copies are available. The video is also available via web streaming at CDC Guidelines for Collecting and Handling Blood Lead Samples - Centers for Disease Control and Prevention.