EVERSIGHT SERVICES
SURGEON FORMS
RECIPIENT INFORMATION TRACKING
M1.511 Recipient Information Tracking Procedure
Effective Date : 05 / 01 / 2015 Supersedes : 05 / 01 / 2014
The eye bank shall obtain the name and address of the consignee on each eye tissue used for transplantation . The eye bank shall seek recipient information from the transplanting surgeon for eye tissue distributed by the eye bank .
Recipient follow-up information is collected by telephone and by written forms from the surgeon . For all surgical tissue provided , Post-Operative Outcome forms will be sent to surgeons three to six months post-operatively , confirming in writing the recipient information . For any forms not received within specified time frame , a second notice will be sent to the surgeon requesting recipient follow-up information .
Completed forms become part of the Case Record . Reports of Post-Operative Outcome forms sent will be maintained .
Regulations
EBAA Medical Standard M1.500 Recipient Follow-Up Information EBAA Medical Standard L1.200 Package Insert Form 21 CFR § 1271.290 Tracking State of New York Subpart 52-2.9 Required Records
Procedure
1 . Patient information is typically obtained from the surgeon / office and entered into the database at the time of surgery scheduling . If the recipient information is not available at the time of scheduling , a Recipient Information form is sent with the tissue to be completed by the surgeon for return to the eye bank .
Note : Corneas in long-term preservation media and sclera may be stocked at an institution only if it is for single patient use . The distributing eye bank must be able to track the tissue to the consignee .
Patient information to be documented includes :
• Name ( if allowed by law )
• Age / date of birth
• Race
• Sex
• Address
• Diagnosis
• Surgery date
• Type of surgery
• Location of use
• Surgeon ’ s name
• Unique ID number
• Chart number
• Insurance ID
• Driver ’ s license number
• Hospital medical record number
• Alien identification
• Passport number
• Other unique identifier appropriate to the health care delivery system where the surgery is performed .
2 . Tissue is offered and accepted ; patient to receive transplant is confirmed for domestic recipients and the schedule information is linked to the appropriate tissue ID .
3 . Tissue is shipped to the hospital or facility ; a designated area at the hospital or facility ( e . g ., OR , blood bank , etc .) receives and logs appropriate tissue / patient information in accordance with Joint Commission requirements and FDA regulations .
4 . The Tissue Information Form and Adverse Reaction Report Form remain with patient ’ s medical record .
5 . Corrections and / or changes to recipient information are entered into database .
6 . A Post-Operative Outcome form is sent three to six months post-operatively , seeking recipient information and verifying that the tissue indicated by the unique tissue ID number was used for that patient .
7 . Returned forms are reviewed ; any changes with regard to recipient information and / or surgeon ’ s comments are entered into the database . Completed forms are filed in the case record .
8 . For any forms not received within specified time frame , a second notice will be sent to the surgeon requesting recipient follow-up information .
* Revised February 16 , 2017
Tissue Placement : ( 866 ) 900-8119 • Fax ( 734 ) 780-2730 • distribution @ eversightvision . org