Healthcare BCG Policy

HEALTHCARE BCG POLICY

Purpose and Scope

This policy authorizes administration of Bacillus Calmette–Guérin (BCG) vaccine or BCG intravesical therapy in accordance with institutional clinical protocols. It sets forth eligibility criteria, contraindications, informed consent requirements, documentation obligations, patient responsibilities and privacy assurances. By completing and signing this policy form, the patient authorizes treatment and acknowledges receipt of information required for informed decision-making.

Patient Information

Emergency Contact

Insurance Information

Medical History

Pregnancy or breastfeeding status: I am pregnant or planning pregnancy I am breastfeeding

Immunosuppression / current cancer therapy: I am immunosuppressed or on systemic immunosuppressive therapy

Prior BCG or tuberculosis testing: Prior BCG vaccination Prior positive TB test or active TB

Indications, Contraindications and Protocol

Indication for BCG administration must be confirmed by the ordering clinician and documented in the medical record. Contraindications include but are not limited to pregnancy, active tuberculosis, significant immunosuppression, recent live virus vaccination, and severe allergy to vaccine components. The provider will verify eligibility immediately prior to administration.

I acknowledge that the clinician reviewed contraindications and eligibility with me: Acknowledged

Procedure, Risks and Benefits

The BCG product to be administered may be given as a vaccine (for tuberculosis prevention) or as intravesical therapy (for bladder conditions) as indicated. The clinician has explained the procedure, expected course, common and rare adverse events, and potential benefits. Known risks include localized inflammation, fever, allergic reaction, infection at the administration site, dissemination of mycobacterial infection in immunocompromised persons, and interference with tuberculosis diagnostic testing.

Alternatives to BCG therapy were discussed, which may include observation, alternative pharmacologic therapy, different vaccine strategies, or no treatment. I understand the alternatives and decline or accept as indicated by my clinician.

I understand I may withdraw consent at any time prior to administration by notifying the treating clinician. Withdrawal of consent after administration does not negate documentation of the procedure already performed.

Post-Administration Care and Reporting

Post-administration instructions and monitoring requirements will be provided. Serious adverse events should be reported immediately to the treating facility. The facility will record the lot number, site, and clinician performing the administration in the medical record.

Privacy and Authorization

By signing below, I authorize release of relevant medical information necessary to provide care, bill for services, and report adverse events. I acknowledge receipt of the facility's privacy practices and understand that my health information will be handled in accordance with applicable privacy laws.

This authorization expires on:

Statements of Understanding and Consent

Patient Name:    Date of Birth:

I have read (or had read to me) and received an explanation of the information contained in this Healthcare BCG Policy form. I have had the opportunity to ask questions and have received satisfactory answers. My signature below indicates that I voluntarily consent to the administration of BCG per the treating clinician's orders and institutional protocols.

I attest under penalty of perjury that the information I have provided on this form is true and complete to the best of my knowledge.

Emergency contact and next steps have been reviewed with me and I understand the plan for follow-up care and reporting of adverse events.

Consent given for: BCG vaccine (tuberculosis prevention) Intravesical BCG therapy

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