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Wisconsin Blood Lead Registry Security and Confidentiality Agreement

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WISCONSIN BLOOD LEAD REGISTRY

ORGANIZATION SECURITY AND CONFIDENTIALITY AGREEMENT

DEPARTMENT OF HEALTH SERVICES
Division of Public Health
F-00116 (01/2010)

STATE OF WISCONSIN
Bureau of Environmental and Occupational Health

I. Purpose

Pursuant to its public health authority under Wis. Stat. §§ 250.04 and 254.15, to prevent, suppress, and conduct surveillance of diseases and environmental hazards and to develop and implement a comprehensive statewide lead poisoning prevention and treatment program, the Department of Health Services (DHS) has created the Wisconsin Blood Lead Registry. The purpose of the Wisconsin Blood Lead Registry is to provide screening providers with the information necessary to determine whether a child should be tested for blood lead. Often this information is not otherwise available, or is not reliable.

Under Wis. Stat. § 254.13, a person who screens a child under 6 years of age is required to report the result of the screening to the Department. The Department maintains a statewide database of these test results. Test results in this database are used to populate the Registry.

If a screening provider wishes to participate in the Registry, this Organization Security and Confidentiality Agreement must be signed by a designated representative of the provider’s organization. The Organization Security and Confidentiality Agreement sets out the requirements for using the data contained in the Registry. Staff of the screening provider’s organization who will be given access to the Registry must read this agreement and sign the User Security and Confidentiality Agreement (F-00103).

Registry data are confidential patient health care records under Wis. Stat. § 146.82. Breach of any part of the confidentiality requirements will subject the user to termination from participation in the Registry and may result in civil or criminal penalties for improper disclosure of health information.

Protecting the privacy of a child and the security of information contained in the Registry is a high priority for the Department.

II. Definitions

In this agreement unless the context otherwise requires:

(1) “Blood lead records” means the recorded results of all blood lead tests for a particular child, along with relevant information, including test date, test type, test result, and screening provider.

(2) “Blood lead test” is synonymous with “screen,” and means the collection of a blood sample (either venous or capillary) for the purpose of determining the concentration of lead in the blood.

(3) “Child” means a minor child who is a current or potential patient of a screening provider.

(4) “Department” means the Wisconsin Department of Health Services and its employees and authorized agents, including contract employees, local health departments under Wis. Stat. §. 254.152, and the University of Wisconsin Department of Population Health Sciences employees and interns under contract to, or a memoranda of understanding with, the Department of Health Services.

(6) “In their care” means the relationship between a child and the child’s screening provider with respect to blood lead testing.

(7) “Organization” means an individual, corporation, agency or other entity that represents, employs or contracts with one or more individual registry user. An organization may be a single user (as in the case of a screening provider who is the sole individual in a private practice), or may include multiple individual registry users (as in the case of a health care clinic or system).

(8) “Registry” means the Wisconsin Blood Lead Registry (WBLR) maintained by the Department

(9) “Registry user” is synonymous with “user,” and means any person with authorized access to the Blood Lead Registry.

(10) “Screening provider” means a physician, physician assistant, nurse, nurse practitioner, health maintenance organization, WIC project, or health care provider as identified by Wis. Stat. §. 146.81 (1) who is involved in the health care of individual children, including the testing of children for blood lead levels. This may also include the Department agents and schools who have a legitimate interest in a child’s blood lead testing status per Wis. Stats. 254.162 and 146.82(2)(a)(12).

(11) “Site Administrator” means the designated person within the Organization who has the authority and responsibility for administering the WBLR within that Organization.

(12) “WCLPPP” means the Wisconsin Childhood Lead Poisoning Prevention Program.

III. Access to and Disclosure of Registry Information

In order to gain access to the Registry, a user must first submit a signed Registry User Security and Confidentiality Agreement (F-00103). Users are broadly categorized into one of the following types:

1. Screening providers;

2. Health Maintenance Organizations (HMO);

3. Public schools;

4. DHS employees, and authorized agents.

The following table outlines the different types of Registry access allowed for each user group type.

User Type View Blood Lead Records of Individual Children In Their Care View Demographics of Individual Children in Their Care Add/Edit Information
Screening providers • • •
HMO • •
Schools • •
DHS/Agents • • •

• - Authorization to access all Registry information associated with children in the user’s care (Users may not view information about children who are not in their care.)

View Blood Lead Records means the user has permission to view the entire blood lead history and status of a child in the user’s care in order to determine whether the child is up-to-date with recommended blood lead testing.

View Demographics means the user can view information about children in the user’s care, including a child’s name, date of birth, mother’s maiden name, address, and telephone number.

Add/Edit Information means the user can add new test results to a child’s record and edit blood lead results previously recorded in a child’s record. The user may add a new child record into the Registry database or alter the details on a child already contained in the Registry database.

IV. User Participation

Every individual who wishes to participate as a user of the Registry must read this Organization Security and Confidentiality Agreement and sign and comply with the Registry User Security and Confidentiality Agreement (F-00103). The Department administers and controls access to the Registry and the data contained therein. Any use of the Registry that violates the User Security and Confidentiality Agreement will subject the user to revocation of the user’s access privileges and may result in civil or criminal penalties for improper disclosure of health information under Wis. Stat. §. 146.84. In addition, egregious or repeated violations by an organization’s users may result in revocation of the organization’s access privileges.

The Registry Organization Security and Confidentiality Agreement must be signed by a representative of the organization prior to any training of staff on use of the Registry, or access to the Registry data. This person shall serve as the organization’s Site Administrator, and shall have responsibility for all individual users within the organization. The Site Administrator shall complete the Department administered training for Registry. Having completed the training, the Site Administrator may enroll users who have been trained in the use of the Registry at the appropriate access level and have signed the Registry User Security and Confidentiality Agreement. The Site Administrator shall maintain a file of signed Registry User Security and Confidentiality Agreements and ensure that each user within the organization renews his or her agreement every two years. Users with expired agreements, or revoked privileges shall not access the Registry. The Site Administrator shall be responsible for each user within the organization.

Only personnel whose assigned duties include functions associated with the blood lead testing of children may be given access to Registry information. All such personnel, including permanent and temporary employees, volunteers, contractors, and consultants shall be required to sign a Registry User Security and Confidentiality Agreement before gaining access to the Registry. Whenever a user terminates his or her working relationship within the organization, the user’s account shall be immediately deactivated by the Site Administrator. When a user takes an extended leave of absence, the Site Administrator shall deactivate the user’s account. Accounts that remain inactive for more than 60 consecutive days shall be deactivated by the Site Administrator.

Access to the Registry will be allowed only through Registry-approved access procedures. Each person granted access to the Registry must have a unique login ID and password to the Wisconsin Immunization Registry (WIR) portal and a unique Registry access code. Shared login IDs, passwords, and access codes are not permitted. Users are prohibited from disclosing Registry access codes or protocol to unauthorized persons. Site Administrators will ensure that users have been adequately trained to use the Registry and are not given any higher level of access than necessary to perform their assigned duties.

The information contained in the Registry may only be used to:

1. provide information useful for determining whether a child is due a blood lead test;

2. assist a user in keeping a child’s blood lead testing status up-to-date; or

3. eliminate the administration of duplicate blood lead tests.

Any other use of Registry data is prohibited. No user may attempt to copy the Registry database or software used to access the Registry without written consent from the manager of the WCLPPP. Requests for data for research or purposes other than those listed above shall be forwarded to the Department via the manager of the WCLPPP.

The Registry shall not be used to provide address or contact information for individual children. Unless the disclosure is approved by the Department Registry staff in accordance with applicable laws, or the parent, guardian, or legal custodian has consented to the disclosure, Registry data concerning an identifiable child may not be disclosed to anyone other than an authorized Registry user.

Registry data identifying children shall not be disclosed to unauthorized individuals, including law enforcement, without the approval of the manager of the WCLPPP. All such requests for data, including subpoenas, court orders, and other legal demands for Registry data shall be referred to the Department in a timely manner.

The Department shall review and audit activities on the Registry to ensure the ongoing security of the data contained therein. The undersigned has read, understands, and agrees to abide by this Registry Organization Security and Confidentiality Agreement.

Check the type of Registry access requested:

SIGNATURE – Site Administrator

Date Signed

SIGNATURE – Main Contact

Date Signed

Enter text✕

What this Security and Confidentiality Agreement covers

The Wisconsin Blood Lead Registry Security and Confidentiality Agreement establishes the terms governing authorized access, use, and protection of blood lead test results and related personally identifiable information submitted to the Wisconsin Blood Lead Registry. It defines permitted users, access purposes, technical and administrative safeguards, data-sharing limits, breach notification obligations, and the recordkeeping required to comply with state public health rules and federal privacy laws such as HIPAA. The agreement also documents attestations by signatories that they will handle registry data only for authorized public health purposes and in accordance with applicable law.

Why a formal security and confidentiality agreement matters

A written agreement clarifies legal responsibilities for protecting sensitive health data, supports compliance with HIPAA and state public health rules, and documents user consent and accountability. Under the ESIGN Act (15 U.S.C. ch. 96) and applicable state law, an electronically signed agreement can be enforceable if intent, consent, attribution, and retention are met.

Why a formal security and confidentiality agreement matters

Organizations and roles that typically complete this agreement

The agreement is used by entities and individuals who need authorized registry access to report, review, or manage blood lead test results.

  • Clinical laboratories and reference labs reporting test results to the state registry for public health surveillance and case management.
  • Healthcare providers, pediatric clinics, and community health centers accessing results for patient follow-up and care coordination.
  • Local public health agencies, environmental health teams, and childcare oversight programs that investigate exposures or oversee interventions.

Completing the agreement assigns clear responsibilities and documents who may query, export, or share registry records for authorized public health purposes.

Signatories who may bind an organization

Authorized User

Typically an individual clinician or lab technician whose job requires registry access. The user attests to limited-purpose use, safeguards account credentials, and follows role-based access controls set by their employer and the registry administrator.

Program Official

A supervisor, laboratory director, or public health program manager who certifies institutional compliance, requests access on behalf of staff, and accepts responsibility for training, audits, and breach reporting obligations under the agreement.

Core elements to include in a professional agreement

A robust Security and Confidentiality Agreement should be concise but comprehensive, covering who may access registry data, permitted uses, technical safeguards, and procedures for incidents and termination.

Purpose and scope

Describe why access is granted, which registry data sets are covered, and the specific public health activities permitted under the agreement.

Data access limits

Specify role-based access levels, queries allowed, export rights, and any prohibitions on redisclosure or re-identification of individuals.

Confidentiality obligations

Require compliance with applicable privacy laws, internal policies, minimum necessary use, and any required confidentiality acknowledgments by individuals.

Security controls

List required technical safeguards such as unique user IDs, strong authentication, encrypted transmission and storage, and session timeout policies.

Breach notification

State timeframes and procedures for reporting suspected breaches to the registry and affected parties, and for cooperating with investigations.

Signatory attestations

Require signers to certify authority, training completion, and acceptance of sanctions for noncompliance or unauthorized disclosures.

Essential information to capture on the form

Patient identifiers: Name, DOB, and MRN
Test results: Lead value, units, specimen date
Ordering provider: Name and NPI
Authorized user: Name, title, contact email
Access purpose: Public health case or clinical follow-up
Effective dates: Access start and end dates

Step-by-step: completing the agreement

Follow these sequential steps to prepare, sign, and submit the agreement to gain authorized registry access.

  • 01
    Start: Confirm authority to request access and gather organizational details.
  • 02
    Enter parties: Complete legal names, roles, and contact information accurately.
  • 03
    Set controls: Choose minimum necessary access level and authentication requirements.
  • 04
    Sign and submit: Sign using an authorized signer and send to the registry or local health authority.

Configuring an online workflow for the agreement

Configure fields, authentication, and routing rules so submissions are auditable and compliant with registry requirements.

Field Configuration
Authentication Method Email link, SMS code, or stronger multi-factor authentication
Access Expiration Set automatic expiration date matching Effective Date end
Data Export Permission Enable or disable CSV/PDF export based on role
Audit Trail Retention Retain logs for minimum period required by registry

Where to send completed agreements

Completed agreements must follow the registry's submission path so access provisioning and audits are applied correctly.

  • Submit to Registry: Upload or email to the Wisconsin Blood Lead Registry intake address.
  • Local Health Department: Copy local public health unit when requested for jurisdictional oversight.
  • Laboratory Records: Retain a signed copy in the laboratory's compliance file.
  • Secure Archive: Store final executed agreements in an encrypted, access-controlled repository.

Digital signing and technical compatibility

Use a document platform that supports secure signatures, audit trails, and required file formats to preserve evidentiary integrity.

  • Formats Supported: PDF, Word DOCX, and archived copies (PDF/A)
  • Integrations: Connectors for EHRs and cloud storage reduce manual uploads
  • Authentication Options: Email, SMS, KBA, or enterprise SSO

Ensure the selected platform can produce an immutable audit trail, support required authentication strength, and integrate with your records management system; common integrations include EHR connectors and cloud storage providers.

Penalties and risks for improper handling or errors

HIPAA Violations: Potential civil and criminal penalties
Civil Penalties: Fines, corrective action plans
Data Breach: Notification, mitigation, reputational harm
Unauthorized Access: User account suspension or revocation
Misreporting: Public health investigation consequences
Contract Voidance: Access privileges rescinded

Common mistakes to avoid when preparing the agreement

  • Using informal or abbreviated organization names that prevent verifying signatory authority and delay access approvals.
  • Granting broader access than necessary for the stated public health purpose, increasing exposure and audit findings.
  • Failing to record effective dates or expiration, which complicates audits and can allow unintended long-term access.
  • Neglecting to require periodic review or reauthorization, leaving stale accounts active and increasing breach risk.

Key timing expectations and statutory deadlines

Be aware of submission windows, review cycles, and incident notification timeframes to maintain compliance and timely access.

Access Request Submission:

Submit before needed access start date to allow verification and provisioning

Annual Review:

Reauthorize or review user access at least annually per policy

Breach Notification Timing:

Report breaches without unreasonable delay; HIPAA guidance limits to 60 days for large breaches

Audit Log Retention:

Retain access logs for a minimum period required by registry or law

Record Amendment Requests:

Process patient amendment requests per state public health procedures

Real-world scenarios showing how the agreement is used

These illustrative examples show typical ways organizations use the agreement to enable authorized registry access while protecting privacy.

County Health Department

A county epidemiologist requests access for case investigations

  • Access limited to case management tools and export disabled
  • The signed agreement documents responsibilities, triggers annual reauthorization, and supports audit requests from state public health.

Pediatric Clinic

A clinic clinician needs results to manage a child's care

  • Clinic selects view-only access for clinicians and export for supervisors
  • Signed attestations require staff training and immediate reporting of any suspected unauthorized access to the registry.

Practical tips for accurate and efficient completion

Adopt consistent processes and produce executable records that support audits and rapid provisioning.

Use minimal access
Grant only the specific permissions required for the task; document justification and review access at least annually to reduce exposure.
Standardize names
Use legal entity and job titles consistently across agreements to speed verification and avoid authority disputes.
Keep audit trails
Ensure your platform records signer identity, IP, timestamp, and actions so the registry can verify provenance and the organization can demonstrate compliance.
Choose compliant eSign
Select an eSignature provider that supports required technical safeguards; signNow, for example, supports HIPAA with a BAA and produces detailed audit trails.

Sample eSignature vendor comparison for executing the agreement

Basic pricing and feature availability across common eSignature vendors to consider when enabling electronic execution of the agreement.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day free trial, no credit card required Varies by plan Varies by plan Varies by plan Varies by plan
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes (BAA available) Yes (BAA available) Yes (BAA available) No No

Frequently asked questions about execution and enforcement

Answers to common questions on electronic signing, authority, breach handling, and retention to help complete the agreement correctly.


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