NEW Patient Paper Work with Consent

Patient hereby voluntarily consents to wound care treatment by provider at Havilah Mobile Wound Care and their respective employees, agents, representatives, and affiliated companies (hereinafter sometimes collectively referred to as Havilah Wound Care– “HWC”). Patient understands that this Consent Form will be valid and remain in effect from the date of signature, as long as the patient receives care, treatment and services at the Havilah Wound Care. A new consent will be obtained when a patient is discharged from the HWC and returns for care, treatment or services. Patient has the right to give or refuse consent to any proposed procedure or treatment at any time prior to its performance.

1. General Description of Wound Care Treatment: Patient acknowledges that provider has explained that treatment in the HWC may include, but shall not be limited to: debridements, dressing changes, biopsies, skin grafts, off-loading devices, physical examinations and treatment, diagnostic procedures, laboratory work (such as blood, urine and other studies), x-rays, hyperbaric oxygen therapy, other imaging studies and administration of medications prescribed by a provider. Patient acknowledges that provider has given Patient the opportunity to ask, Patient has asked, and provider has answered all Patient’s questions regarding the treatments that may be provided in the HWC.
2. Benefits of Wound Care Treatment: Patient acknowledges that the provider has explained that the benefits of treatment in the HWC include: enhanced wound healing and reduced risks of amputation and infection.
3. Risks/Side Effects of Wound Care Treatment: Patient acknowledges that provider has explained that treatment in the HWC may cause side effects and risks including, but not be limited to: infection, ongoing pain and inflammation, potential scarring, possible damage to blood vessels, possible damage to surrounding tissues, possible damage to organs, possible damage to nerves, bleeding, allergic reaction to topical and injected local anesthetics or skin prep solutions, removal of healthy tissue, and prolonged healing or failure to heal.
4. Likelihood of achieving goals: Patient acknowledges that provider has explained that by following the provider’s plan of care he or she is more likely to have a better outcome; however, any procedures/treatments carry the risk of unsuccessful results, complications, and injuries, from both known and unforeseen causes. Therefore, Patient specifically agrees that no representation made to him or her by the provider, clinic or BSH, Sc dba Havilah Wound Care constitutes a Warranty or Guarantee for any result or cure.
5. Alternative to Wound Care Treatment: Patient acknowledges he or she has been made aware that he or she may refuse treatment in the HWC. Patient acknowledges that if he or she refuses treatment in the HWC, he or she will not gain the benefits of treatment (see Benefits of Wound Care Treatment above). In lieu of treatment in the HWC, Patient may continue a course of treatment with his or her personal provider or forgo any treatment.
6. Benefit of Alternative to Wound Care Treatment: Patient acknowledges that provider has explained that if he or she chooses to continue a course of treatment with his or her personal provider or forego any treatment, he or she may not experience the risks/side effects associated with treatment in the HWC (see Risks/Side Effects of Wound Care Treatment above).
7. Risks/Side Effects of Alternative for Wound Care Treatment: Patient acknowledges that the provider has explained that the risks of alternative wound care treatment include prolonged healing or failure to heal, infection and possible amputation if wound is on a limb.
8. General Description of Wound Debridements: Patient acknowledges that the provider has explained that wound debridement means the removal of unhealthy tissue from a wound to promote healing. During the course of treatment in the HWC, multiple wound debridements may be necessary and will be performed by an authorized practitioner.
9. Risks/Side Effects of Wound Debridement: Patient acknowledges that provider has explained that the risks or complications of wound debridement include, but are not limited to: potential scarring, possible damage to blood vessels or surrounding areas such as organs and nerves, allergic reactions to topical and injected local anesthetics or skin prep solutions, excessive bleeding, removal of healthy tissue, infection, ongoing pain and inflammation, and failure to heal. Patient specifically acknowledges that the provider has explained that bleeding after debridement may cause rapid deterioration of an already compromised patient. Patient specifically acknowledges that the provider has explained that drainage of an abscess or debridement of necrotic tissue may result in dissemination of bacteria and bacterial toxins into the bloodstream and thereby cause severe sepsis. Patient specifically acknowledges that the provider has explained that debridement will make the wound larger due to the removal of necrotic (dead) tissue from the margins of the wound.
10. Cellular Tissue-Products: Patient has been advised and consulted about the use of cellular tissue-products (hereinafter referred to as CTPs). This procedure involves the application of CTP directly onto Patient’s tissue including bone, muscle, fascia, hypodermis and/or epidermis.
    1. CTPs definition: CTPs are classified into the following types:
       • Human skin allografts derived from donated human skin
       • Allogeneic matrices derived from human tissue (fibroblasts or membrane)
       • Composite matrices derived from human keratinocytes, fibroblasts and xenogeneic collagen
       • Acellular matrices derived from xenogeneic collagen or tissue
    2. Donor Screening: The donated CTP’s have been determined to be eligible for transplantation by a Licensed Physician who is retained by the tissue bank to make such determinations. Review of donor records includes analysis of the donor medical history, performance of a risk behavior assessment, review medical records and recent physical examinations. This review allows the tissue bank to determine whether the donor is free from risk factors or whether there is clinical evidence of infection due to relevant communicable diseases and other exclusionary disease conditions. Where such potential for infection due to communicable diseases exists, the tissue is rejected. All labs performing the tests are registered with the Food and Drug Administration (FDA) and certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments (CLIA) Act of 1988 and 42 CFR part 493. An allograft of donated human tissue is deemed qualified for transplantation by a tissue bank if it meets the following criteria: 1) the results from the donor pre-screening lab tests specify the donor to be free from risk factors and active infections of applicable communicable disease agents and diseases as required by the FDA, and 2) donor results from the pre-screening lab tests must be negative and/or non-reactive for the following applicable communicable disease agents determined by the following: testing for Hepatitis B and C Viruses (HCV/HBV); testing for Human Immuno-Deficiency Viruses Types I and II (HIV I/II AB); Nucleic Acid Testing (NAT) for HIV, and Hepatitis B and C; Core Antibody Testing for Hepatitis B (HBC AB); Testing for Hepatitis B Surface Antigen (HBS AG); Human T-Cell Lymphotropic Viruses I and II (HTLV I/II); and testing for Reactive Plasma Reagin (RPR) (which tests for non-specific antibodies that may indicate a syphilis infection). The tissue bank that provides allografts our office uses for this procedure has informed this office that the allografts and donor have met the above requirements. By law, the laboratories performing human specimen tests are certified and meet the requirements as determined by the Centers for Medicare and Medicaid (CMS), per CLIA and 42 CFR part 493, and the FDA. Each lab is additionally required to maintain appropriate records of the donor with allograft ID number (lot number) for purposes of tracking the allograft post treatment.
    3. Additional Risks: While great measures to ensure the safety of the allograft product have been taken by the supplier, I understand that current technologies cannot preclude the transmission of certain diseases known or unknown, and that neither the supplier of the injectable nor the medical professional performing this procedure can make any claims concerning the biologic properties and safety of allograft tissues despite the tissue bank confirming it has collected, processed, screened, tested, stored, and distributed the product in compliance with all current regulations.
11. Patient Identification and Wound Images: Patient understands and consents that image (digital, film, etc.), may be taken by the WCC of Patient and all Patient’s wounds with their surrounding anatomic features. The purpose of these images is to monitor the progress of wound treatment and ensure continuity of care. Patient further agrees that their referring provider or other treating providers may receive communications, including these images, regarding Patient’s treatment plan and results. The images are considered protected health information and will be handled in accordance with federal laws regarding the privacy, security and confidentiality of such information. Patient understands that the HWC will retain the ownership rights to these images, but that the patient will be allowed access to view them or obtain copies according to state and Federal law. Patient understands that these images will be stored in a secure manner that will protect privacy and that they will be kept for the time period required by law and/or hospital policy. Patient waives any and all rights to royalties or other compensation for these images. Images that identify the Patient will only be released and/or used outside the WCC upon written authorization from the Patient or Patient’s legal representative.
12. Use and Disclosure of Protected Health Information (PHI): Patient consents to BSH, Sc dba Havilah Wound Care use of PHI, results of patient's medical history and physical examination, and wound images obtained during the course of Patient’s wound care treatment and stored in the wound database for purposes of, education, research, quality assessment and improvement activities, and development of proprietary clinical processes and healing algorithms. Patient’s PHI may be disclosed by the HWC to its affiliated companies, and third parties who have executed a Business Associate Agreement. Disclosure of Patient’s PHI shall be in compliance with the privacy regulations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Patient specifically authorizes use and disclosure of patient's PHI by BSH, Sc dba Havilah Wound Care, its affiliates, and business associates for purposes related to treatment, payment, and health care operations.
13. Financial Responsibility: Patient understands that regardless of his or her assigned insurance benefits, Patient is responsible for any amount not covered by insurance. Patient authorizes medical information about Patient to be released to any payor and their respective agent to determine benefits or the benefits payable for related services.

The patient hereby acknowledges that he or she has read and agrees to the contents of sections 1 through 12 of this document. Patient agrees that his or her medical condition has been explained to him or her by the provider. Patient agrees that the risks, benefits and alternatives of all care, treatment and services that Patient will undergo while a patient at the HWC have been discussed with Patient by provider. Patient understands the nature of his or her medical condition, the risks, alternatives and benefits of treatment, and the consequences of failure to seek or delay treatment for any conditions. Patient has read this document or had it read to him/her and understands the contents herein. The Patient has had the opportunity to ask questions of the provider and has received answers to all of his or her questions.

By signing below, Patient: (1) consents to the care, treatment, and services described in this document and orally by the provider, (2) consents to the creation of images to record his or her wounds; and (3) consents to the transfer of health information protected by HIPAA between provider, Hospital and BSH, Sc dba Havilah Wound Care.