Penetrating Keratoplasty (PK) Corneal Transplant Consent Form
The cornea is the clear, outermost layer of the eye. Vision is lost if the cornea becomes swollen, cloudy, or damaged from infection, disease, trauma, or aging. If the cornea does not heal, it needs to be removed surgically in order for vision to improve. You can decide not to have the corneal transplant. If you don’t have the surgery, your vision loss from the damaged cornea will remain and may continue to get worse.
BESIDES PK CORNEAL TRANSPLANT SURGERY, HOW ELSE CAN MY DAMAGED CORNEA BE TREATED?
Patients with certain corneal conditions and disorders may be treated with eyeglasses, rigid gas permeable corneal lenses (RGP), Intacs® (intrastromal corneal ring segments), or theBostonscleral lens prosthetic device (BSCPD). The choice of treatment depends upon the type and severity of the corneal condition or disorder. In some patients, only the inner layer of the cornea, the endothelium, needs to be replaced. These patients can be treated with a different type of corneal transplant surgery known as Descemet’s stripping endothelial keratoplasty or DSEK.
HOW WILL HAVING A PK CORNEAL TRANSPLANT AFFECT MY VISION?
The goal of a PK corneal transplant is to improve the decreased vision that was caused by the diseased or damaged cornea; a PK corneal transplant will not correct decreased vision caused by other eye conditions such as a cataract or glaucoma. The eye surgeon or ophthalmologist removes the three layers of the damaged cornea by making a circle cut or incision, and replaces the damaged cornea with a donor cornea, which is kept in place with stitches (sutures). This type of surgery can be combined if needed with other eye surgeries, such as cataract removal or glaucoma surgery. The operation takes from 45 to 60 minutes.
WHAT ARE THE MAJOR RISKS OF A PK CORNEAL TRANSPLANT?
As with all eye surgery, you may experience an infection, bleeding, swelling of the retina causing temporary or permanent blurring of vision, a retinal detachment, glaucoma or high pressure in the eye, rejection of the transplanted tissue, chronic swelling or inflammation, double vision, a droopy eyelid, loss of corneal clarity, poor vision, total loss of vision, or even loss of the eye. Rarely, the transmission of infectious diseases can occur such as Hepatitis, AIDS, and syphilis, although the corneal donor is routinely tested for these diseases before the tissue is approved and released for transplantation.
There are also complications from the local anesthesia including perforation of the eyeball, damage to the optic nerve, a droopy eyelid, interference with the circulation of the blood vessels in the retina, respiratory depression, and hypotension. On rare occasions, useful vision can be permanently lost or you may die.
The donor cornea is kept in place with stitches or sutures. The sutures can come loose, cause infections, or change the shape of the cornea. This changed corneal shape is called astigmatism and can cause blurry vision. Astigmatism can be treated with glasses, but if it is severe, contact lenses or more surgery may be needed. Once the cornea is cut, it remains more delicate, and can break open from trauma or injury, even several years after the surgery.
It takes about 6 to 12 months for your vision to improve. Corneal transplants are successful in 90 out of 100 patients. The transplant is rejected by the body in 8 out of 100 patients. If the surgery is not successful, or the transplant is rejected, you will need another corneal transplant to see well.
There is no guarantee that PK corneal transplant will improve your vision. As a result of the surgery and/or anesthesia, it is possible that your vision could be made worse. In some cases, complications may occur weeks, months or even years later. These and other complications may result in poor vision, total loss of vision, or even loss of the eye in rare situations. You may need additional treatment or surgery to treat these complications. This additional treatment is not included in the fee for this procedure.
PATIENT’S ACCEPTANCE OF RISKS
I understand that it is impossible for the doctor to inform me of every possible complication that may occur. By signing below, I agree that my doctor has answered all of my questions, that I have been offered a copy of this consent form, and that I understand and accept the risks, benefits, and alternatives of PK corneal transplant surgery.
I wish to have a PK corneal transplant procedure on my _________ (state “right” or “left” eye).
_____________________________________ ________________
Patient’s signature (or person authorized to sign for patient) Date
_____________________________________
Patient name
HIPAA/HITECH Resources
OMIC Business Associate Agreement
OMIC has completed its revision of the HIPAA Business Associate (BA) Agreement it maintains between itself and each of its insureds. You can download a copy here: Business Associate Agreement-OMIC-9.1.2013. A hard copy is also being sent to OMIC insureds by mail. Please understand that because OMIC has 4,500 physician insureds, it would be administratively burdensome for OMIC to review and sign individual BA Agreements provided by each of its insureds. OMIC’s BA Agreement meets the latest HIPAA and HITECH standards as promulgated in the Omnibus HIPAA/HITECH Final Rule and is the only BA Agreement that OMIC will maintain between itself and its insureds. Please retain your copy of the OMIC BA Agreement with your HIPAA compliance materials.
Sample Documents for Your Practice
OMIC has drafted several sample documents that you may download and use in your practice. These samples are a starting point for ophthalmology practices. They should be customized, as necessary, to meet your practice’s specific needs and circumstances. These materials do not constitute the provision of legal advice by OMIC and are not a substitute for legal or professional advice.
- Sample Notice of Privacy Practices
- Sample Notice of Privacy Practices Acknowledgment
- Sample Authorization for Use and Disclosure of Health Information
- Sample Business Associate Agreement
- Sample Breach Notification Letter to Patients
- Sample Breach Notification Policy
The Department of Health and Human Services (HHS) has also created several sample documents for use in your practice. The can be found by following these links:
Guidance Tools
The American Medical Association has prepared a booklet explaining the changes to the HIPAA regulations: AMA HIPAA Privacy and Security Toolkit.
See also the following free resources, which include webinars and guidance documents to train yourself and your staff. The webinar series was presented by the Workgroup for Electronic Data Interchange (WEDI) and the Office of the Inspector General (OIG). The Office of Civil Rights (OCR) has useful guidance documents for physician offices.
- WEDI Webinar Series > HIPAA Privacy and Security Training and Resources
- HIPAA Privacy Page
- Omnibus Rule
- OCR’s Protecting Patient Rights Resource Center (Registration Required)
- Are You a Covered Entity?
- For Small Providers, Small Health Plans, and Other Small Businesses
- Summary/Guidance on Significant Aspects of the Privacy and Security Rules
- Fast Facts for Covered Entities
- Business Associates FAQs
- Security Rule Guidance Material
- Guidance on Risk Analysis
- Mobile Device Security
- Communicating with a Patient’s Family, Friends, or Others Involved in The Patient’s Care
- FAQs About the Disposal of Protected Health Information
- Training Materials on the HIPAA Privacy Rule
- Resources for Consumer
REMEMBERING STACEY
In memory of Stacey Meyer, a beloved family member here at OMIC. We miss you so much. We miss your smile, your sense of humor, your undeniable and uncompromising love for animals, and your friendship. You are irreplaceable. DONATE: A few months ago, Stacey passed away unexpectedly, but she lives on in our hearts. For all of Stacey’s friends within our extended OMIC family of policyholders, attorneys, partners, and supporters who would like to contribute in Stacey’s honor to Pet’s Lifeline, please visit: www.petslifeline.org.
9/2013 Policy & 5/2015 Update
2013 Policy Booklet
9/2013 Policy. Click on the policy booklet image to download a PDF copy of the policy.
1/2015 and 5/2015 Policy Update. OMIC has updated its 9/2013 professional and limited office premises liability policy effective January 1, 2015, via policy insert. Most significantly, OMIC has increased the limit on its broad regulatory protection and eMD™ cyber liability coverage from $50,000 to $100,000 for all claims/proceedings per policy period. OMIC has also revised its Terrorism Insurance Coverage Endorsement per federal law. Finally, OMIC slightly revised its Surgery Class 1 and Surgery Class 2 definitions. In May 2015 the Board of Directors liberalized its oculofacial procedure coverage and made a few other minor updates to the policy, as reflected in the revised insert. Download a PDF copy of the update here: Policy Update 2015 Insert 1.1 changes and 5.2 changes
Retina Surgery Consent (Addendum to General Consent Form)
[ADDENDUM TO GENERAL CONSENT FORM]
RETINA SURGERY
Complications which could occur weeks, months, or even years later
- Failure to accomplish intent of surgery
- Retinal detachment that may require additional surgery or may be inoperable
- Vitreous hemorrhage
- Infection
- Elevated eye pressure (glaucoma)
- Poorly healing or non-healing corneal defects
- Corneal clouding and scarring
- Cataract, which might require eventual or immediate removal of lens
- Double vision
- Eyelid droop
- Loss of circulation to vital tissues in the eye, resulting in decrease or loss of vision
- Permanent blindness, or diminished visual acuity or field
- Loss of eye
CRYOPEXY
In addition to the risks for retina surgery:
- Retinal detachment or macular puckering that may require additional surgery
- Inflammation
- Pigmentary disturbances
Additional comments:
Patient (or person authorized to sign for patient) Date
Witness Date
