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OPERATION SMILE'S

14 GLOBAL STANDARDS OF CARE

Revised as of September 30, 2010

Standard 1

 

Requirements for Pre-Operative Patient Screening & Assessment

Appropriate equipment, laboratory support and trained personnel will be available to perform comprehensive screening and evaluation in order to properly assess our candidates' indications for any possible risks of surgery.

The essentials for patient evaluation and preparation for treatment include:

1.1-    Equipment for measuring vital signs (including pulse oximetry). 
1.2-    Equipment and venue suitable for the psychological preparation of the patient and family.
1.3-    Photographic equipment for pre operative imaging.
1.4-    In those special circumstances where secondary pharyngeal sphincter surgery is being considered, either a subjective or objective (for example nasopharyngoscope) evaluation by a speech pathologist or a surgeon experienced in the treatment of velopharyngeal insufficiency. 
1.5 -   Hematocrit and/or hemoglobin (glucose and electrolytes if indicated)
A clinical laboratory and blood bank capable of supporting the mission goals.

STANDARD 2

 

Required Anesthesia Equipment and Supplies

Only state-of-the-art, currently calibrated anesthetic delivery and support equipment, supplies and pharmaceuticals will be employed by our medical professionals to provide the safest in reliable anesthesia.

2.1-    An Anesthesia Machine with the following:
2.1.1 Ability to deliver medicinal Oxygen.
2.1.2 Ability to accommodate administration of volatile agents.
2.1.3 Annual calibration of the machine and vaporizer. 
2.1.4 If the machine requires electricity then a back up battery is essential.
2.1.5 An oxygen concentration monitor to test the purity of oxygen supply on site
2.1.6 A Secure oxygen supply with an alarm warning of hypoxic mixture and an 
          appropriate back up supply in the operating room

2.2-    Equipment appropriate for the ages of the patients being treated that includes 
2.2.1 - ventilation masks
2.2.2 - appropriate endotracheal tubes with stylets 
2.2.3 - oral and nasopharyngeal airways
2.2.4 - laryngoscopes 


2.2.5- a positive pressure ventilation system with a peep valve 
2.2.6 - intravenous fluid administration equipment including pediatric volumetric administration devices
2.2.7 - Non invasive monitoring equipment for the measurement of 
electrocardiography, blood pressure, pulse oximetry, capnography,and  temperature
2.2.8 - Appropriate equipment must be included to manage an unanticipated difficult 
airway
2.2.9 - Emergency equipment as well as a defibrillator (with pediatric paddles)
2.2.10 - equipment for administration of fluids through the intra-osseous route
2.2.11 – appropriate equipment and an environment must suitable for local anesthesia 
2.3-    Sevoflurane is the only volatile anesthesia agent that should be used.
2.4-    Dantrolene should be available at every surgical site.
2.5-    Resuscitation cardiac drugs of appropriate concentrations including a resuscitation dosage schedule should be available. 
2.6-     Blood and blood products that have been screened for HIV, Hepatitis A and B should be available.

STANDARD 3

 

Required Surgical Equipment

Comprehensive, well-maintained surgical instruments, sutures, and supplies will be provided for each patient, customized to the particular operative procedure received by each of our patients.

3.1-    Equipment and supplies appropriate for the surgery – instruments, sutures, suction
3.2-    Availability of an electrocautery machine
3.3-    Proper illumination of the surgical field 
3.4-    Equipment and supplies properly sterilized

STANDARD 4

 

Requirements for the Recovery Room – Post Anesthesia Care Unit (PACU)

All our patients will receive specialized recovery care as they awaken from anesthesia, in an environment fully equipped with specialized instrumentation, personnel and pharmaceuticals.

4.1-     All anesthesia equipment and drugs specified in standard 2 should be available for 
patients in the PACU.
4.1.1 – Resuscitation drugs of appropriate doses (with available standard code sheet).
4.2-     Every patient admitted to the PACU should have his/her vital signs monitored.
4.3-     Suction equipment and oxygen should be available at each bedside.
4.4-     A respiratory oxygen delivery system should be available for use in the transport from 
the operating room to the post anesthesia care unit when medically indicated.

STANDARD 5

 

Post Operative Intensive Care

Any of our patients requiring additional post-operative  care to support their successful recovery will be managed in a suitable, well staffed intensive care environment.

5.1-     Patient care facilities that perform operative procedures for which post operative 
intensive care is not anticipated should have a clearly delineated plan to transfer patient to an appropriate facility when unexpected complications arise. 
5.2     If appropriate facilities cannot be identified prior to initiating surgery, then preparation must be made to have all necessary equipment and personnel available in case of emergency.

STANDARD 6

 

Patient Consent

All of our patients and their families will receive understandable information and education in their native language allowing them to make an informed decision about surgery.

A consent for treatment by Operation Smile should include:

6.1-     A description of the surgery and anesthesia proposed. 
6.2-     Permission for picture taking for clinical and research purposes
6.3-     The administration of blood products as required
6.4-     Consent to provide personal / demographic information to Operation Smile 
6.5-     Consent to include medical record data in any research developed and conducted by    
           Operation Smile
6.6-     Consent for testing for HIV /AIDS should a needle stick injury occur to one of the health   
           care team.
6.7-     Permission that a patient's story or picture might be used for publication

STANDARD 7

 

Surgical Priority

Our patients will receive surgery based on appropriate, well tested and proven priority systems, developed to maximize the expected benefit with primary consideration to safety and the allocation of time and resources.

Please refer to the Medical Policies and Procedures 
Age Minimums and Scheduling Policy (Appendix A)
Surgical Priorities Policy (Appendix B)

STANDARD 8

 

Preventing transmission of Blood Borne Pathogens

Universal precaution protocols will be followed to help minimize infection, transmission of disease, and wrong site surgery.

The following strategies should be considered in limiting exposure to blood borne pathogens:
8.1-    Appropriate handling and disposal of sharps.
8.2-    Appropriate intervention in case of needle stick injuries.

STANDARD 9

 

Pain Management

Alleviation of pain and anxiety during every phase of our peri-operative care is of primary concern.  Each patient will receive the safest, most effective analgesic medication under strict monitoring from our doctors and nurses.

Operation Smile guidelines for pain control on missions
 
9.1-      INTRAOPERATIVE PAIN MANAGEMENT:
Multi modal analgesia will be used for pain relief including local blocks, local infiltration, per-rectal and intravenous titration of appropriate drugs.
9.2-     Morphine use in pediatric cleft lip and palate patients is not sanctioned. 
9.3-      RECOVERY ROOM PAIN MANAGEMENT
Analgesia will be maximized with due consideration for awakening from anesthesia, 
9.4-      POST OP WARDS PAIN MANAGEMENT
Oral and rectal analgesia will be the preferred routes of administration provided at this stage, under the direction of a physician.

STANDARD 10

 

Operation Smile Team

Operation Smile believes a team approach to the care of our patient provides the highest level of care and safety.   Team compositions are comprehensive, deep and broad in their expertise, drilled in fluid teamwork and effective communication, and most importantly, unified by the single desire to achieve the very best outcome for each of our patients.

The following core competencies are recommended for the conduct of a safe mission:

10.1    Logistics Coordinator
10.2    Clinical Coordinator
10.3    Surgical Specialist
10.4    Anesthesiologist
10.5    Operating Room Nurses
10.6    Ward Nurses
10.7    PACU Nurses
10.8    Pediatrician
10.9    PACU Physician
10.10    Dentist
10.11    Medical Records Specialist
10.12    Medical Photographer
10.13    Biomedical Technician
10.14    Speech Pathologist
10.15  The team care provided by the team listed above can be further enhanced by the 
inclusion of the following team members:
a.    ENT surgeon
b.    Geneticist
c.    Child life therapist/child psychologist
d.    Occupational/ Physical Therapist

Notes:    1)  Specialty mission core positions may vary.  
    2)  Multiple core competencies may be covered by one individual.

STANDARD 11

Each of our volunteers is extensively interviewed, credentialed and proctored prior to joining an operative team.  Skills required from each of our specialists meet or exceed those of his or her core discipline. Ongoing mentoring, evaluation, performance review and professional growth is central to maintaining a top volunteer corps.

The following items are considered the minimum requirements to participate as a volunteer in an Operation Smile Program:

11.1  Pediatrician
    11.1.1 Registered in Specialty – achieved highest level of certification available
    11.1.2 Graduate of specialty training in pediatrics
11.1.3 Demonstrated clinical competence including current certification of Pediatric 
     Advanced Life Support (PALS) or equivalent course. 
11.1.4 Currently caring for pediatric patients

11.2  Anesthesiologists
11.2.1    Registered in Specialty  – achieved highest level of certification available
11.2.2    Graduate of specialty training in anesthesia
11.2.3    Demonstrated clinical competence through observed practice.  Current certification of Pediatric Advanced Life Support (PALS) and/or equivalent course is required and Advanced Cardiac Life Support (ACLS) is recommended.
11.2.4     Recommended for participation in programs by current superior/senior OpSmile volunteer
11.2.5    Currently caring for pediatric patients
          

 CRNA’s (limited to certain countries)
11.2.6    Registered in Specialty  – achieved highest level of certification available
11.2.7    Graduate of specialty training in anesthesia
11.2.8    Demonstrated clinical competence through observed practice.  Current certification of Pediatric Advanced Life Support (PALS) and/or equivalent course is required and Advanced Cardiac Life Support (ACLS) is recommended.
11.2.9     Recommended for participation in programs by current superior/senior Operation Smile volunteer
11.2.1    Currently caring for pediatric patients

11.3  Cleft Surgeon
11.3.1   Registered in Specialty – achieved highest level of certification available
    11.3.2   Graduate of specialty training in surgery that included cleft lip and palate 
         surgery
    11.3.3   Current cleft experience
    11.3.4   Demonstrated clinical competence
    11.3.5   Recommended for participation in programs by peers 

11.4 Other Surgical Specialties
11.3.1   Registered in Specialty – achieved highest level of certification available
11.3.2   Graduate of specialty training in surgery 
11.3.3   Current clinical experience in surgical specialty
11.3.4   Demonstrated clinical competence
11.3.5   Recommended for participation in programs by peers 

11.5  Dentist
11.4.1     Currently licensed and in good standing
11.4.2   Be competent treating children in the operating room
11.4.3   Aware of effects of extraction on the developing occlusion
11.4.4   Trained/experienced in taking impression of patients with cleft palate, 
  fabricating and adjusting obturators

11.6  Nursing
11.5.1   Graduate from a Nursing School
11.5.2   Clinical Competence
11.5.3   BLS or equivalent, with current unrestricted license where applicable
11.5.4   PALS and/or equivalent required for international participation
11.5.5   At least 2 years current experience in their specialty 

11.7  Recovery Room Physician
11.6.1   A physician trained and experienced in pediatric perioperative care, the 
  recognition of post-operative complications and cardiopulmonary resuscitation 
    11.6.2  PALS certification or its equivalent is required

11.8 Speech Pathologist
    11.7.1  Hold a degree and licensure in Speech Language Pathology or its equivalent 
              certification within a country
    11.7.2  Clinically competent in cleft lip and palates and other craniofacial syndromes
    

11.7.3  Ability to educate counterparts
    11.7.4  Recommended by superior/ senior Operation Smile volunteer

11.9  Physical or Occupational Therapist
    11.8.1  Hold a degree and licensure in Physical or Occupational Therapy or its equivalent 
              certification within a country
    11.8.2  Clinically competent in the area of the specialty mission
    11.8.3  Ability to educate in-country personnel
    11.8.4  Recommended by superior/ senior Operation Smile volunteer

STANDARD 12

 

Minimum Patient Follow-up

Effective post-operative care is essential for a good surgical result and effective planning for further treatment. Post-Operative care requires good documentation and extensive education of parents and clinicians to be effective.  When and wherever possible, our patients will receive short, intermediate and long term follow-up and care.  Post-Operative care from an Operation Smile organized team should review patients at least at the following intervals:

12.1  One week post-surgery (4 – 7 days post-op). The goal is to recognize and manage   
           immediate surgical complications
12.2  Six months – 1 year.  Team evaluation for documenting outcomes of surgeries and 
          planning for future treatment

STANDARD 13

 

Proper Translation

13.1  Operation Smile missions will have sufficiently qualified translators to ensure proper   communication amongst team members, support personnel, families and patients. Proper translation is considered to be a matter of safety, quality and respect of our patient’s rights.

STANDARD 14

 

A Standard of Documentation

The purpose of documentation is to protect the patient, protect the health care personnel, and to provide an accurate record for the basis of outcome assessment.  Each of our patients will be monitored through a well documented and protected medical record, whether paper or electronic.


Adequate Medical Records must include:

14.1 – Demographic details; with special care to clarify family name, given name, and a unique identifier (number or bar code)
14.2 – History
14.3 – Examination (physical)
14.4 – Diagnosis 
14.5 – A clear indication of the operation intended.
14.6 – A clear indication of the operation performed.
14.7 – The total clinical pathway (PACU, Post-op, Discharge) 
14.8 – This documentation is the responsibility of all team members.

APPENDIX A — AGE MINIMUMS AND SCHEDULING POLICY

I.    PURPOSE:

To ensure the safety and quality of care for all patients being treated during Operation Smile medical missions. This document outlines the minimums for age and scheduling requirements to be followed on any Operation Smile medical mission. Actual age and scheduling rules may vary, as long as these minimums are respected.  Team Leaders should explore the team’s comfort level as well as mission country expectations and specific hospital norms.

II.    POLICY:

Patients under 3 months of age should NOT be considered for
any surgery on Operation Smile medical missions.

•    For cleft lip repair:

Over 6 months of age: Operation Smile expects team leaders will use 6 months as the minimum age standard for patients eligible for surgery at most Operation Smile mission sites. However, each patient should be discussed individually, and team leaders must agree ahead of time if the standard age should be elevated to 1 year depending on hospital or country conditions.
3 to 6 months of age: A patient in the 3 to 6 month age range may be scheduled only if there is total agreement from the Field Medical Director, Anesthesia Team Leader, Plastic Surgery Team Leader, Clinical Coordinator and Pediatric Intensivist on patient health and hospital facilities.  Patients in this age range selected for surgery should be documented on a “Diversion from Age and Scheduling Policy” form.

•    For cleft palate repair:

Over 12 months of age: The standard practice for Operation Smile missions is to select for palate surgery patients over 12 months of age.
9 to 12 months of age: A patient in the 9 to 12 month age range may be scheduled only if there is total agreement from the Field Medical Director, Anesthesia Team Leader, Plastic Surgery Team Leader, Clinical Coordinator and Pediatric Intensivist on patient health and hospital facilities.  Patients in this age range selected for surgery should be documented on a “Diversion from Age and Scheduling Policy” form.

•    For combo repairs:

Combination operations should be considered only for patients over 1 year of age.  In addition to agreement by the Field Medical Director, Anesthesia Team Leader, Plastic Surgery Team Leader, Clinical Coordinator and the Pediatric Intensivist, the operating surgeon must agree to the combo surgery before scheduling and appropriate post operative care must be assured in advance.

III.    CONSIDERATIONS:

All patients in consideration for surgery must be in good general health, as agreed on by the Plastic Surgery Team Leader, Anesthesia Team Leader, Clinical Coordinator, Pediatric Intensivist and Field Medical Director.
Volunteers should pay special attention to children with asthma, gastro-esophageal reflux or who are malnourished or emaciated. Special concern must 
also be given to scheduling patients with difficult intubations, such as microstomia and small mandibles, wide bilateral clefts and children with syndromes or cardiac problems.

Hospital Facilities:

•    When considering the surgical schedule and patient age, the Field Medical Director and the Pediatric Intensivist must ensure that the mission site hospital is equipped with an appropriate pediatric intensive care unit (PICU), and that appropriate equipment is in working order and available (blood gas machine and pediatric ventilator/s). 
•    If the mission hospital is not equipped with an appropriate PICU, the Field Medical Director, Pediatric Intensivist, Mission Coordinator and an in-country Operation Smile representative must identify another local hospital that is equipped with an appropriate PICU. Arrangements must be formally agreed upon with that hospital director for the facility’s use along with patient use.

IV.    SCHEDULING REQUIREMENTS:

•    The surgical schedule should be arranged so that the Anesthesia Team Leader can assign a pediatric anesthesiologist or an experienced Operation Smile anesthesia provider for all children under the age of 2 years.  
•    Patients under the age of 2 years must be scheduled as early as possible in the day. 
•    Do not schedule any cleft palate repairs for the last day of surgery.  

**Operation Smile expects that all teams will follow the details outlined above. Occasionally, Team Leaders may feel it is appropriate to divert from a point outlined in this policy.  In this case, Team Leaders must obtain official Regional Medical Officer signoff on any diversions before they can take effect (using the Diversion from Age and Scheduling Policy form).**

APPENDIX B — SURGICAL PRIORITIES POLICY

Operation Smile International (OSI) has developed priorities for patient selection as a means to address our primary concerns of the safe surgery and healthy recovery of our patients.  We must approach each case with patient safety in mind.  Local conditions are a factor in patient selection; please think of follow-up care, rehabilitation, or other therapy, which would be required to improve the patient’s condition.  
 
Along with these Surgical Priorities, please refer also to the “Age and Scheduling Policy” when selecting patients for surgery.  Our goal is to provide the highest standard of care, safety and professionalism for our mission environments.

SURGICAL PRIORITIES

Priority 1

Primary Repair of Cleft Lip - Ages 6 months and older 
This procedure can be accomplished safely, quickly, and with a near-guarantee of vastly improving the patient’s appearance.  We can generally restore the child’s face and smile to normal.  We should complete all primary lip cases that are healthy enough for surgery.  The safe minimum age and body weight of the patient depends on the setting, the equipment, and the experience level of the anesthesia staff and capability of the nursing staff to monitor the patient.
- Please refer to the “Age and Scheduling Policy” for patients ages 3 - 6 months
- Patients outside of the above age categories should be marked “Priority 1, Not Cleared for Surgery This Mission” and then note too young, potential for future surgery, and/or other conditions as applicable.

Patients Returning with Surgical Complications
Dehiscence of Operation Smile Repaired Cleft Lip – All ages
    Patients whose cleft lip was surgically treated by Operation Smile and presenting with dehiscence of the lip are also to be classified as Priority 1 and included among the first patients selected for surgery.  These patients are to be screened in full to determine if their health is appropriate for surgery.  This assumes the surgical treatment is expected to be successful and not expected to dehisce again due to poor tissue conditions.

Priority 2

Primary Repair of Cleft Palate - Ages 1 – 6 years
These cases have the greatest success in enabling the patient to develop normal speech.  The operation can be done safely, in most children over 12 months.  Younger patients have a better chance for developing normal speech, even when no speech therapy is available in the country.  The safe minimum age and body weight of the patient depends on the setting, the equipment, and the experience level of the anesthesia staff and capability of the nursing staff to monitor the patient.
- Please refer to the “Age and Scheduling Policy” for patients ages 9 - 12 months 
- Patients younger then the above age category should be marked “Priority 2, Not Cleared for Surgery This Mission” and then note too young, potential for future surgery, and/or other conditions as applicable.

Patients Returning with Surgical Complications
Complications of Operation Smile Repaired Cleft Palate – All ages
    Patients whose cleft palate was surgically treated by Operation Smile and presenting with a fistula/dehiscence of the palate or other related failures are also to be classified as Priority 2 and selected for surgery accordingly.  These patients are to be screened in full to determine if their health is appropriate for surgery.  This assumes the surgical treatment is expected to be successful and not expected to fail again due to poor tissue conditions.

Priority 3

Primary Repair of Cleft Palates - Age 6 to Adult
When possible, older children and adults should have the opportunity for reconstruction.  While perfect speech will not be possible, a great deal of improvement can be achieved safely and in a short period of time.  Additionally, the psychosocial benefits to the patient are enormous.  These patients will require good follow-up care and must be told that additional surgery may be necessary.

Priority 4

Secondary Repairs of Lips and Palates - All ages
If time allows, and priority 1, 2, and 3 patients have been accommodated, secondary repairs can be scheduled.  Each case should be considered on its merits and the benefits compared to competing cases.

Priority 5

Other Conditions - All ages
Despite the temptation to try to help patients with severe deformities and burn contractures, we should avoid cases requiring prolonged anesthesia, extensive grafting, or prolonged complicated follow-up care or rehabilitation.  Most sites will not be able to provide the follow-up care or therapy necessary for the patient to gain functional improvement or improved appearance.  If for political or other reasons these cases can not be avoided, be very selective in what is done and advise the patient and family on the potential for no improvement.  Parental and patient expectations may be beyond the goals of the scheduled procedure.  Expectation management is essential and requires that the procedure to be performed be clearly defined, that the parent/patient be informed the condition may require further surgery and that Operation Smile cannot make a commitment to further surgery.
In addition to the above five priorities, there are two other categories in which a patient may be placed:

*Not a Candidate

A patient’s condition does not fall within any of the above categories treated by Operation Smile and is not a candidate for the current mission, any future mission, nor World Care.

*Potential World Care Candidate

Candidates for surgery whose condition is too complex to be treated during an Operation Smile Mission or are unable to receive surgery due to mission time or resource constraints. No promises should be made to any potential World Care candidates.  Final evaluations are done at OSI Headquarters by the Chief Medical Officer. 

SURGERIES NOT DONE ON OSI MISSIONS

The focus of OSI is on the social acceptance of the patient, by repairing the cleft lip/palate and restoration of normal speech.  Most other congenital and acquired deformities fall outside our scope and developed expertise.  Often we are tempted to try to help patients with other conditions, but it must be realized, that in a one-week mission, with only three more days for follow-up, and possibly little chance for the patients to be helped locally, the majority of health care needs cannot be addressed by OSI.
We, as representatives of Operation Smile, are pleased to announce the agreement of the preceding Global Standards of Care, in order to provide the highest level of safe surgical care to our patients around the world.

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