8551 Rixlew Lane Suite #140 A, Manassas, VA, 20109 | 11885 Holly Lane Suite 4, Woldorf, MD 20601 | 9816 Winchester Rd, Front Royal, VA 22630 | 7700 Little River Turnpike Suite 104 Annandale, VA 22003 Ph: (703) 361

INFORMED CONSENT(S) FOR TESTOSTERONE REPLACEMENT THERAPY: 

This document is intended to serve as my informed consent to receive Testosterone Hormone Replacement Therapy via IM Injection as requested by me to the “provider” Doctor's IV Wellness Clinic.

I understand that:

1. Although Testosterone Replacement Therapy (“TRT”) has been utilized safely and effectively, it is necessary to discuss potential risks. You should also be aware of the alternatives to TRT, including not receiving the treatment. It is important that you consider the information we have provided you. Be sure that you are doing what is right for you. If you are unsure, then perhaps you should take some time to weigh your options or consult another health care provider. Please review the following items, which discuss informed consent. Your clinical provider will attempt to answer all of your questions to your satisfaction.  This is my consent for Dr. Gerald K. Lee, including any clinical provider who works with Randolph Practice, to begin treatment for TRT in injection or gel form.

2. It has been explained to me, and I fully understand, that occasionally there are complications with this treatment such as gynecomastia and acne.

3. I understand I may retain extra fluid in the body – This can cause problems for patients with heart, kidney, or liver disease.

4. Patients should not be on TRT if attempting to father a child.

5. I have been informed that Testosterone may lead to liver inflammation and damage. I have been informed that I will be monitored for liver problems before starting TRT and periodically during therapy.

6. TRT may cause changes in cholesterol levels, red blood cell levels, PSA levels, liver function enzymes, and other hormone levels which will be monitored with periodic blood tests.

7. I understand it is my responsibility to be aware of the above complications and let my clinical provider know when I have a concern.

8. I understand that I will have periodic blood tests to monitor my blood levels.

9. I understand there is no guarantee as to the result and that if I stop treatment, my condition may return or get worse.

10. I have provided my clinical provider with my complete past medical and health history. I have had an opportunity to discuss with my clinical provider my complete past medical and health history. All of my questions concerning the risks, benefits, and alternatives have been answered. I am satisfied with the answers.

11. I agree that TRT works best when I change lifestyle habits such as limiting alcohol, stopping smoking, exercising, and eating correctly. All of my questions and concerns regarding treatment have been answered to my satisfaction. I further acknowledge that the risks and benefits of this treatment have been explained to me. I am of sound mind, under no undue influence and am competent to make this decision and do so of my own free will. I have no further questions. I consent to taking Testosterone as proposed by my clinical provider. I have complete understanding of and agree to follow the terms of this Informed Consent. If you experience a serious side effect while you are at home, you should contact the provider, otherwise contact the medical provider or call 911.   

IM Injection INFORMED CONSENT:

I consent to an IM Injection; I understand that I may be sore or experience mild pain at the site of the injection. I understand that elevation and the use of a cold pack will alleviate any symptoms. Depending on the supplement that is applied I may experience constipation, heartburn or diarrhea.

 

LAB TESTS SAMPLE COLLECTION INFORMED CONSENT:

I consent to have a sample of my blood and have the sample submitted to a third-party affiliated laboratory for analysis. To do this a sample of my blood may be taken that are like samples that are normally taken for testing when you are sick. You may also ask to take more samples in the future. These samples may include blood, serum or plasma.

When blood is taken you may feel a slight sting or “pinch” in your arm. You might also get a small bruise from the needle. Rarely, some people faint. There is also a very small risk of an infection any time that blood is taken. 

I Consent to have a sample of my blood drawn and have such samples sent to a third-party affiliated laboratory. This consent applies only to the collection sample, I will be signing another consent before any treatment is started. This consent outlined above is: entirely voluntary and I have not been offered any inducement to consent. I have not been given any guarantees or assurances regarding the effectiveness of the treatment.

These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.  These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

Statement of Person Giving Informed Consent:

I have read this consent form and understand the information contained in it. I understand the risks and benefits and have had the opportunity to have all my questions answered to my satisfaction. I am aware that other unforeseeable complications could occur. I do not expect the provider(s) to anticipate and or explain all risk and possible complications. I rely on the provider(s) to exercise judgment during the course of treatment with regards to my procedure. My signature on this form affirms that I give my consent. 

The Health Insurance Portability and Accountability Act (HIPAA) provides safeguards to protect your privacy. Implementation of HIPAA requirements officially began on April 14, 2003. Many of the policies have been our practice for years. This form is a “friendly” version. A more complete text is posted in the office. What this is all about: Specifically, there are rules and restrictions on who may see or be notified of your Protected Health Information (PHI These restrictions do not include the normal interchange of information necessary to provide you with office services. HIPAA provides certain rights and protections to you as the patient. We balance these needs with our goal of providing you with quality professional service and care.

Additional information is available from the U.S. Department of Health and Human Services. www.hhs.gov We have adopted the following policies:

1. Patient information will be kept confidential except as is necessary to provide services or to ensure that all administrative matters related to your care are handled appropriately. This specifically includes the sharing of information with other healthcare providers, laboratories, health insurance payers as is necessary and appropriate for your care. Patient files may be stored in open file racks and will not contain any coding which identifies a patient’s condition or information which is not already a matter of public record. The normal course of providing care means that such records may be left, at least temporarily, in administrative areas such as the front office, examination room, etc. Those records will not be available to persons other than office staff. You agree to the normal procedures utilized within the office for the handling of charts, patient records, PHI and other documents or information.

2. It is the policy of this office to remind patients of their appointments. We may do this by telephone, e mail, U.S mail, or by any means convenient for the practice and/or as requested by you. We may send you other communications informing you of changes to office policy and new technology that you might find valuable or informative.

3. The practice utilizes a number of vendors in the conduct of business. These vendors may have access to PHI but must agree to abide by the confidentiality rules of HIPAA.

4. You understand and agree to inspections of the office and review of documents which may include PHI by government agencies or insurance payers in normal performance of their duties.

5. You agree to bring any concerns or complaints regarding privacy to the attention of the office manager or the doctor.

6. Your confidential information will not be used for the purposes of marketing or advertising of products, goods or services.

7. We agree to provide patients with access to their records in accordance with state and federal laws.

8. We may change, add, delete or modify any of these provisions to better serve the needs of the both the practice and the patient.

9. You have the right to request restrictions in the use of your protected health information and to request change in certain policies used within the office concerning your PHI. However, we are not obligated to alter internal policies to conform to your request.

I do hereby consent and acknowledge my agreement to the terms set forth in the HIPAA INFORMATION FORM and any subsequent changes in office policy. I understand that this consent shall remain in force from this time forward.