REQUIREMENTS:

• Surgical experience

The applicant surgeon/facility has performed at least 125 qualifying hernia surgery procedures in the preceding 12 months (of which a minimum of 40 should be AWR), all of which should be verifiable. Also, each applicant surgeon should have performed at least 200 qualifying hernia surgery procedures in their lifetime.

• Qualifying Procedures:

All hernia surgical procedures, whether open, laparoscopic, or robotic would qualify. AWR procedures would include:

1. Open/lap/robotic Rives-Stoppa
2. Lap/robotic TAPP for ventral and incisional hernias
3. Lateral hernia surgeries
4. Parastomal hernia surgeries
5. Management of abdominal wound dehiscence, including ECF/EAF
6. Component separation through any platform
7. Abdominoplasty
8. Documented incisional hernia preventive abdominal wall closure
9. Management of post-operative abdominal wall complications (conservative/interventional of any sort)
10. Adjunctive interventional procedures, eg, Botox, PPP, Abthera, etc.
11. Emergency management of hernias or of post-operative complications

• Data recording:

Registry participation in the AWRSC Registry (under construction) is mandatory. Delay of data inputs beyond a month would elicit monthly reminders. A delay beyond 3 months would lead to a suspension of COE status (evidenced by the centre/surgeon being invisible to searches from the AWRSC website), and non-compliance beyond 6 months would lead to permanent deletion as COE. After such an eventuality, a minimum period of one year would need to elapse before the centre/surgeon is reconsidered for COE, and the reassessment process would have to be very robust indeed, after a formal submission to the Board as to the steps taken to overcome the major lapses that led to revocation of COE status. Charges of 1 lac INR would be needed to initiate the reassessment process. Lifting of suspension would be done after payment of 50,000 INR.

• Outcomes Benchmarks:

The Board of the AWRSC does not mandate specific outcome numbers, given the wide disparity of the patients and the possibility that more complications may happen in the more advanced centres that handle greater volume of critical cases. However, data tracking would have to be shown and a random audit by  an appointed expert representative of the Board would need to be accepted by the program director of the COE. If significant lapses are revealed, the Director would be given suggestions to improve those parameters and demonstrate progress to acceptable levels after a period of 6 months. During this process, the COE/SOE would enjoy visibility in the website, but not allowed to advertise as a COE/SOE. Violations would mandate punitive action including fines and suspension. The Board would be the final arbiter of such decisions, and need a 4/5th majority in case of divergence of opinions

• Programme Director:

The applicant/hernia surgeon would be the Programme Director (PD). There should be 2 surgeons at the centre, with the PD being an identified expert. If not, then a letter from at least one locum surgeon who will look after cases and data inputs in absence of the PD is favored, but not mandated. These judgments would be the discretion of the Board or appointed representative/s.

•  MDT:

A multidisciplinary team is mandatory to ensure good outcomes in complex hernia surgery. Such a team should, at the least, comprise of the following:

• An Anesthesiology team who supervise anesthesia on all hernia surgery patients and are physically present on site or on demand for 24 hours.
• A fully equipped Intensive Care Unit with a full time Critical Care Team (CCM) who manage the patient in the immediate postoperative period and during any sudden emergency. If not, it is necessary to furnish the details of ICU which would be available when needed with letter from the said hospital.
• Physician, or an acute response team, at least one of whom is available on site at all times when patients are present, with an established protocol to follow in the event of a sudden emergency, respiratory or cardiac arrest.
• Radiologist/s trained in interpreting hernia investigations are helpful but not mandatory.
• A physiotherapist, including a pulmonary rehab therapist, is mandatory.
• A nutritionist is necessary to prepare patients before complex AWR, as well as ensure good nutritional supplementation to help the team handle complications in the perioperative period. In the absence of a trained nutritionist, the onus would be on the PR to demonstrate how s/he would handle nutritional challenges in the complex patients in the centre under evaluation.
• Wound care technician/stoma therapist is a crucial component of any team handling complex AWR, especially those involving open surgery and parastomal hernias or infected wounds. The onus is on the PD to convince the inspectors of having a system where wound problems are handled safely and effectively. This includes modern wound management systems and a minimalistic antibiotics usage policy.
• Plastic surgeon: unless the PD is himself expert at doing relevant plastic surgical procedures in abdominal wall reconstruction and handling complications of such, there should be one identified surgeon of the speciality who certifies his/her availability to the PD/COE.

• Equipment and instruments:

The Board representative conducting the on site assessment must be convinced that the centre possesses laparoscopic, open and/or robotic equipment that is compatible with accepted standards prevailing in the community. Such discretion is allowed in good faith, and the Board must not, at any time, have any doubt as to the scientific and honest thought process behind such judgement.

• Surgeon dedication and call coverage:

The applicant facility should demonstrate the existence of policies and guidelines  in place that require all hernia surgeons to have qualified call coverage, and the applicant surgeon should certify that each covering surgeon is capable of identifying and treating a broad spectrum of hernia surgery complications. The applicant surgeon should demonstrate that s/he spends a significant portion of their efforts in the field of hernia surgery and completes continuing medical education. The applicant surgeon is a general/ gastrointestinal (or other speciality) surgeon. The applicant surgeon has privileges as both a hernia and general surgeon at the applicant facility.

• Clinical pathways and Standard Operating Procedures (SOP):

The applicant should prove that s/he formally adopts and implements clinical pathways that standardise the perioperative care, especially in terms of:

• Standards of sterilisation would have to be excellent, at the minimum, in a COE. This would be a critical component of assessment, and the use of formalin, glutaraldehyde or similar chemicals for usage in laparoscopic or open surgical instruments would be a disqualification, irrespective of all other points in favour. The centre/PD would need to prove beyond any doubt that the lapses have been corrected. The use of unsterile cameras and cables in laparoscopic surgery should be accompanied by proper use of sterile, disposable drapes. Using these after cleaning them with alcohol is unacceptable practice.
• Proof of a scientific, modern antibiotic usage policy. Blanket usage of antibiotics for a period of several (arbitrary) days is unacceptable.
• Anesthesia, including monitoring of vital parameters, airway pressures and airway management.
• Perioperative care, including monitoring and airway management.
• Deep vein thrombosis (DVT) prophylaxis.
• Identification and evaluation of early warning signs of complications.
• Management of wound complications including dehiscences and peritonitis.
• Preoperative multidisciplinary evaluation, education, preparation, admission and informed consent of the hernia surgery candidate.
• Pain management.
• Postoperative follow up, including entering all data in the Registry.

1. Patient Education:

The applicant provides formal or informal education about hernias and procedures for all patients who may undergo or have undergone hernia surgery. The onus is on the PD to prove that s/he does so, especially in the absence of structured patient group meetings.

• Continuing Medical Education:

The applicant / facility would be committed to spread the science of safe hernia surgery.  At least two courses/ CME’S under the AWRSC banner would need to be conducted every year by the facility/PD  to impart teaching and training of surgeons in the field of hernia surgery.

• On-site Inspection and costs for accreditation:

1. The application for the accreditation will be sent to the AWRSC Board with a deposit of 50% of the assessment fees. The Director will appoint two assessors for an onsite inspection. The cost of travelling and local hospitality for the assessors will be taken care by the applicant/facility.

Subsequent to the inspection, if the facility is approved for the accreditation the applicant/facility will need to submit the remainder of the total fees of Rs 100,000 with a cheque in favour of the AWR Trust sent to the President of the AWRSC for a one-year certificate, or Rs. 200,000 for a 3 year one. Bank transfers may also be acceptable. Cash is forbidden.

2. The accreditation will be valid for a period of 1 to 3 years.

In case the assessors suggest certain changes, the same would need to be completed in a period of one month by the applicant/facility and proof of the same would need to be submitted to the assessors for the final report. If the assessors are convinced of the desired changes the applicant/facility would be informed to submit the remaining fees as above to the President.

3. Review assessment and revalidation may be done by local assessor only. Check list of tick marks would be given. No subjective criteria would be used anywhere excepting those mentioned above.

4. Revalidation of the applicant/ facility will take place after 1 to 3 years, as per duration chosen by applicant, with full payment made in advance. An onsite inspection of the facility by a single assessor will be done. The cost of travelling and local hospitality for the assessor will be taken care by the applicant/ facility. The revalidation fees of Rs 50,000 (for one year) or 1,25000 (for 3 years) is to be submitted with a cheque to the President of the AWRSC. Bank transfers may also be acceptable. Cash is forbidden.

4. If the Programme Director leaves the facility, it would cease to exist as a  “Centre Of Excellence”.  A fresh application with a new Programme Director would need to reapply and meet the desired criteria. Full charges would be necessary for a fresh assessment. In case the PD desires to get a COE recognition for a new centre where s/he is now working, full charges would need to be paid for a fresh designation for the facility. Where a SOE certificate is concerned, no further charges need to be paid, but the SOE needs to prove that the standards are being maintained at the new centre.
5. If the proposed COE/SOE is a member of the Certification Board, a separate extramural assessment will be done by 2 assessors appointed by the Board, one of whom will be a Trustee and the other a Core Committee member not in the Certification Board. The assessment will then be handled by the Board and ratified by the assessors as part of a fair process.

• LOGO and certificate:

The certification would carry the seal of the Centre of Excellence, name of the Facility, the name of the Programme Director and duration of the certification. Signatories to the seal would be:

1. Director of the COE Certification Board
2. A Trustee of the AWR Trust
3. President of the AWR Surgeons’ Community
4. Another member of the Certification Board who was involved in the assessment

• Certification Board of the AWRSC:

Executive Director: Arun Prasad Chairman (advisory): AWRSC President (Ramesh Punjani) Members (proposed): Sharad Sharma Pramod Shinde Aparna Deshpande M Kanagavel Yogesh Mishra Meenakshi Sharma Vivek Bindal Sreejoy Pattnaik Tirumala Prasad Sudhir Kalhan Premkumar Balachandran Muralidhar Kathalagiri Deepak Subramanian Deeksha Kapoor Rahul Mahadar

1. Honoraria

For every assessment or reassessment, an honorarium will be offered to the assessors as follows: Visiting assessor: 10,000 INR Director: 5,000 INR This fee would be all inclusive till the assessment decision is completed.

1. Code of conduct
2. No office bearer of the Board of Certification will entertain any requests from the assessed or anyone else on the assessed’s behalf.
3. If any request or approach to provide a favorable assessment has been made, it is incumbent on the member to share this officially with the Board and recuse himself or herself from the assessment process immediately. The Board would have the authority to dismiss the assessment request for COE without further explanation. The assessed would forfeit the monies paid for assessment.
4. If the assessed is part of the Board, s/he should recuse herself or himself from the Board till such time as the process is completed. The post will remain vacant till such process is completed, or 3 months lapse, whichever is earlier.
5. Acceptance of any gift or favour before, during or after an assessment from the parties concerned would be unacceptable and a breach of the code of conduct.
6. Any complaint against the assessor would be taken seriously, and investigated by a Committee comprising the Director, a Trustee and a senior member of the Certification Board. All decisions taken by the committee would be final and binding.

LEVELS OF COE Level 1 COE will be a world class centre of hernia care, education and training and one that provides a benchmark for the community. Criteria in addition to those set in “REQUIREMENTS” above would include all of the following:

1. Annual performance of 200 hernia operations, of which at least 75 should be a qualifying AWR procedure. For list of such procedures, please refer to Clause B above.
2. The centre would be NABH (or equivalent) accredited.
3. There is a structured training program (ideally, this should be an AWRSC program like FAHS).