Case Study Guide & Template Aurora Awards
Description: Case Study Guide Template Aurora Awards Competition 2022 US Aurora Awards 2022 Guidelines Each case submitted must be used on patients according to the FDA intended uses A minimum of three cases is preferred Case series that illustrates
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slide1. Case Study Guide & Template
Aurora Awards Competition 2022
US<br>
slide2. Aurora Awards 2022 Guidelines Each case submitted must be used on patients according to the FDA intended uses
A minimum of three cases is preferred
Case series that illustrates the use of Kerecis Omega3 MariGen, MariGen Micro GraftGuide, SurgiClose, SurgiClose Micro, or SurgiBind
The case series should be new and current
All case submissions must have healed surgical, acute, or chronic wounds.
Complete and submit the required forms for the selected category
Send the completed forms to aurora@kerecis.com
All Cases must be submitted by December 1st, 2022 (Outpatient Wound and Lower Extremity Surgery) and February 24, 2023 (Surgical and Burn)
Winners will be announced December, 2022 (Outpatient Wound and Lower Extremity Surgery) and March 2023 (Surgical and Burn)<br>
slide3. HIPAA-PHI: List of 18 IDENTIFIERS AND DEFINITION of PHI Names: all geographical subdivisions smaller than a state, including street address, city, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code, if according tot the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all of the zip codes with he same three initial digits contains more than 20,000 people; and
The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
Phone numbers;
Fax numbers;
Electronic mail addresses;
Social Security numbers;
Medical record numbers;
Health plan beneficiary numbers;
Account numbers;
Certificate license numbers;
Vehicle identifiers and serial numbers, including license plate numbers;
Device identifiers and serial numbers;
Web Universal Resource Locators (URLs);
Internet Protocol (IP)address numbers;
Biometric identifiers, including finger and voice prints;
Full face photographic images and any comparable images; and
Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code data)
Please ensure all patient identifiers are removed per the HIPAA Guidelines<br>
slide4. Recommendations for photo documentation Photos should be in focus and well-lit with patient in same anatomical position with same vantage point in each photo
Any identifying features (e.g., patient initials, tattoos, scars) that appear in the photo should be covered or removed
Attempt consistent distance from the wound in each photo
Blue or darker background is best
Consider image size and any methods to ensure photographs are not enhanced or altered
JPEGs or PNG files are best<br>
slide5. Case Study Template<br>
slide6. Category Template Requirements<br>
slide7. Aurora Submission Form – Practitioner Information<br>
slide8. Chronic Wound Category Form submission<br>
slide9. Chronic Wound – Form 1 Patient Presents – Wound History & Management<br>
slide10. Chronic Wound – Form 2 Kerecis Omega3 Wound Application Insert Image of Wound This form should be submitted for each application of Kerecis and/or documented healing progression.<br>
slide11. Chronic Wound – Form 3 Treatment Outcome Insert Image of Healed/Closed Wound<br>
slide12. Surgical Wound Category Form submission<br>
slide13. Surgical Wound – Form 1 Patient Presents – Wound History & Injury Information<br>
slide14. Surgical Wound – Form 2 Kerecis Omega3 OR Application Insert Image of Wound This form should be submitted for each application of Kerecis and/or documented healing progression.<br>
slide15. Surgical Wound – Form 3 Treatment Outcome Insert Image of Healed/Closed Wound<br>
slide16. Burn Wounds Category Form submission<br>
slide17. Burn Wound – Form 1 Patient Presents – Burn Injury Information<br>
slide18. Burn Wound – Form 2A Kerecis Omega3 Burn - Application Insert Image of Wound This form should be submitted for each application of Kerecis and/or documented healing progression.<br>
slide19. Burn Wound – Form 2B Kerecis Omega3 Burn - Dressing Change Insert Image of Wound This form should be submitted for each dressing change and/or documented healing progression.<br>
slide20. Burn Wound – Form 3 Treatment Outcome Insert Image of Healed/Closed Wound<br>
slide21. Aurora Award Winners<br>
slide22. Aurora Awards Case Study Competition Winners All Wound Cases must be submitted by December 1st, 2022
Winners will be announced December 2022
All Surgical Cases must be submitted by February 24th, 2023
Winners will be announced March 2023
4 winners will be chosen from each category, 8 Grand Prize Winners Total
Educational grants will be given to each of the winners
Each Aurora winner can submit their case(s) to National or Regional Conference
Educational grants will be provided to present at these conferences
Poster Honorarium
Flights to/from conference
2 Hotel Nights<br>
slide23. Aurora Awards Grand Prize Awards Additional educational grants will be awarded to the top cases overall
All Aurora Award Winners will have a chance to win the grand prize
Grand Prize Award includes an educational grant to attend and present their cases at the Northern Lights Workshop in Iceland in February 2023 and at the Midnight Sun Workshop in Iceland in June 2023<br>
slide24. Aurora Awards Terms & Conditions Cases submitted must be used on patients according to the FDA intended uses. Kerecis Omega3 MariGen or Kerecis Omega3 GraftGuide intended use is for the management of wounds including partial and full thickness wounds, trauma wounds (abrasions, lacerations, second-degree burns, skin tears).
All case submission must include completed case study template forms for chosen submission category.
Any Practitioner presentation, manuscript, abstract, poster or publication (each, a “Presentation”) regarding Kerecis and/or Fish Skin for Wound Management shall be submitted to Kerecis for approval at least forty-five (45) days prior to submission. Kerecis may, in its sole discretion, remove any confidential information from such proposed Presentation. Practitioner hereby grants to Kerecis, a royalty-free, irrevocable, worldwide, perpetual license to use and distribute such Presentations.
Neither party will use the name, brand, logo, trademark, symbols, or other markings of the other party in any Presentation, advertising or other form of publicity without prior written approval of such party.
Kerecis shall have the unrestricted free right to use any information set forth on such evaluations, including, without limitation, any case descriptions, photographs or de-identified medical information. Irrespective of information being considered de-identified medical information it shall be the responsibility of the Practitioner to gain appropriate patient consent acknowledging that their information may be used for marketing, educational, or other purposes. Additionally, Practitioner understands that the sharing of such information and receipt of it does not constitute Kerecis acting as a Business Associate under the Health Insurance Portability and Accountability Act.
Kerecis and submitting Practitioner agree to adhere to comply with all fraud, waste, and abuse laws, including, but not limited to the Federal Anti-Kickback Statute set forth at 42 U.S.C. §1320a-7b and the related safe harbor regulations (“Anti-Kickback Statute”); the Limitation on Certain Physician Referrals set forth at 42 U.S.C. § 131395(n) (“Stark Law”); the False Claims Act set forth at 31 U.S.C. §§ 3729-3733; and the Physician Payments Sunshine Act of 2009 (“Sunshine Act”). Practitioner accepts that only fair market value will be paid to Practitioner for the nature of the types of services that will be provided to the Company and such payment is in no way tied to any past, present or future referrals associated with the purchase of any of Company’s products. Nor can it be said that any payment made to Practitioner is related to any volume of products purchased by the Practitioner from the Company.<br>
Aurora Awards Competition 2022
US<br>
slide2. Aurora Awards 2022 Guidelines Each case submitted must be used on patients according to the FDA intended uses
A minimum of three cases is preferred
Case series that illustrates the use of Kerecis Omega3 MariGen, MariGen Micro GraftGuide, SurgiClose, SurgiClose Micro, or SurgiBind
The case series should be new and current
All case submissions must have healed surgical, acute, or chronic wounds.
Complete and submit the required forms for the selected category
Send the completed forms to aurora@kerecis.com
All Cases must be submitted by December 1st, 2022 (Outpatient Wound and Lower Extremity Surgery) and February 24, 2023 (Surgical and Burn)
Winners will be announced December, 2022 (Outpatient Wound and Lower Extremity Surgery) and March 2023 (Surgical and Burn)<br>
slide3. HIPAA-PHI: List of 18 IDENTIFIERS AND DEFINITION of PHI Names: all geographical subdivisions smaller than a state, including street address, city, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code, if according tot the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all of the zip codes with he same three initial digits contains more than 20,000 people; and
The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
Phone numbers;
Fax numbers;
Electronic mail addresses;
Social Security numbers;
Medical record numbers;
Health plan beneficiary numbers;
Account numbers;
Certificate license numbers;
Vehicle identifiers and serial numbers, including license plate numbers;
Device identifiers and serial numbers;
Web Universal Resource Locators (URLs);
Internet Protocol (IP)address numbers;
Biometric identifiers, including finger and voice prints;
Full face photographic images and any comparable images; and
Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code data)
Please ensure all patient identifiers are removed per the HIPAA Guidelines<br>
slide4. Recommendations for photo documentation Photos should be in focus and well-lit with patient in same anatomical position with same vantage point in each photo
Any identifying features (e.g., patient initials, tattoos, scars) that appear in the photo should be covered or removed
Attempt consistent distance from the wound in each photo
Blue or darker background is best
Consider image size and any methods to ensure photographs are not enhanced or altered
JPEGs or PNG files are best<br>
slide5. Case Study Template<br>
slide6. Category Template Requirements<br>
slide7. Aurora Submission Form – Practitioner Information<br>
slide8. Chronic Wound Category Form submission<br>
slide9. Chronic Wound – Form 1 Patient Presents – Wound History & Management<br>
slide10. Chronic Wound – Form 2 Kerecis Omega3 Wound Application Insert Image of Wound This form should be submitted for each application of Kerecis and/or documented healing progression.<br>
slide11. Chronic Wound – Form 3 Treatment Outcome Insert Image of Healed/Closed Wound<br>
slide12. Surgical Wound Category Form submission<br>
slide13. Surgical Wound – Form 1 Patient Presents – Wound History & Injury Information<br>
slide14. Surgical Wound – Form 2 Kerecis Omega3 OR Application Insert Image of Wound This form should be submitted for each application of Kerecis and/or documented healing progression.<br>
slide15. Surgical Wound – Form 3 Treatment Outcome Insert Image of Healed/Closed Wound<br>
slide16. Burn Wounds Category Form submission<br>
slide17. Burn Wound – Form 1 Patient Presents – Burn Injury Information<br>
slide18. Burn Wound – Form 2A Kerecis Omega3 Burn - Application Insert Image of Wound This form should be submitted for each application of Kerecis and/or documented healing progression.<br>
slide19. Burn Wound – Form 2B Kerecis Omega3 Burn - Dressing Change Insert Image of Wound This form should be submitted for each dressing change and/or documented healing progression.<br>
slide20. Burn Wound – Form 3 Treatment Outcome Insert Image of Healed/Closed Wound<br>
slide21. Aurora Award Winners<br>
slide22. Aurora Awards Case Study Competition Winners All Wound Cases must be submitted by December 1st, 2022
Winners will be announced December 2022
All Surgical Cases must be submitted by February 24th, 2023
Winners will be announced March 2023
4 winners will be chosen from each category, 8 Grand Prize Winners Total
Educational grants will be given to each of the winners
Each Aurora winner can submit their case(s) to National or Regional Conference
Educational grants will be provided to present at these conferences
Poster Honorarium
Flights to/from conference
2 Hotel Nights<br>
slide23. Aurora Awards Grand Prize Awards Additional educational grants will be awarded to the top cases overall
All Aurora Award Winners will have a chance to win the grand prize
Grand Prize Award includes an educational grant to attend and present their cases at the Northern Lights Workshop in Iceland in February 2023 and at the Midnight Sun Workshop in Iceland in June 2023<br>
slide24. Aurora Awards Terms & Conditions Cases submitted must be used on patients according to the FDA intended uses. Kerecis Omega3 MariGen or Kerecis Omega3 GraftGuide intended use is for the management of wounds including partial and full thickness wounds, trauma wounds (abrasions, lacerations, second-degree burns, skin tears).
All case submission must include completed case study template forms for chosen submission category.
Any Practitioner presentation, manuscript, abstract, poster or publication (each, a “Presentation”) regarding Kerecis and/or Fish Skin for Wound Management shall be submitted to Kerecis for approval at least forty-five (45) days prior to submission. Kerecis may, in its sole discretion, remove any confidential information from such proposed Presentation. Practitioner hereby grants to Kerecis, a royalty-free, irrevocable, worldwide, perpetual license to use and distribute such Presentations.
Neither party will use the name, brand, logo, trademark, symbols, or other markings of the other party in any Presentation, advertising or other form of publicity without prior written approval of such party.
Kerecis shall have the unrestricted free right to use any information set forth on such evaluations, including, without limitation, any case descriptions, photographs or de-identified medical information. Irrespective of information being considered de-identified medical information it shall be the responsibility of the Practitioner to gain appropriate patient consent acknowledging that their information may be used for marketing, educational, or other purposes. Additionally, Practitioner understands that the sharing of such information and receipt of it does not constitute Kerecis acting as a Business Associate under the Health Insurance Portability and Accountability Act.
Kerecis and submitting Practitioner agree to adhere to comply with all fraud, waste, and abuse laws, including, but not limited to the Federal Anti-Kickback Statute set forth at 42 U.S.C. §1320a-7b and the related safe harbor regulations (“Anti-Kickback Statute”); the Limitation on Certain Physician Referrals set forth at 42 U.S.C. § 131395(n) (“Stark Law”); the False Claims Act set forth at 31 U.S.C. §§ 3729-3733; and the Physician Payments Sunshine Act of 2009 (“Sunshine Act”). Practitioner accepts that only fair market value will be paid to Practitioner for the nature of the types of services that will be provided to the Company and such payment is in no way tied to any past, present or future referrals associated with the purchase of any of Company’s products. Nor can it be said that any payment made to Practitioner is related to any volume of products purchased by the Practitioner from the Company.<br>