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Based on observation, interview and record review, the Governing Body:

Failed to ensure a Governing Body that was effective, legally responsible, responsible for the conduct of the hospital, and accountable to the governing body for the quality of care provided to patients (Refer to A 049).

Failed to ensure that the staff selection criteria included training and experience for Cardiothoracic Physician Assistance (PA)'s (Refer to A 050).

Failed to ensure that the Medical Staff operated under the bylaws approved by the Governing Body (Refer to 338)

Failed to ensure that the Surgical Services were provided in accordance with facility policy and acceptable standards of practice (Refer to 940).

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.

Based on observation, interview and record review, the Governing Body failed to ensure that the Medical Staff was accountable to the governing body for the quality of care provided to patients when Physician Assistant (PA)'s were allowed to perform surgery as first assistants in Cardiothoracic (Heart/Lung) Bypass surgery (surgically creating a new bloodflow pathway around a blockage to improve the blood supply to the heart muscle) that required an Extra Corporeal Bypass (Heart/Lung Machine, Diversion of blood flow through a circuit located outside the body but continuous with the bodily circulation) procedure. (PAs 1 - 4) This failure increased the risk of complications including death for all Cardiothoracic Bypass patients that required Extra Corporeal Bypass.

Findings:

1. During a review of the article in the Journal of the American Academy of Physician Assistants, dated 4/10/12, entitled, "The safety and efficacy of physician assistants as first assistant (assist) surgeons in cardiac surgery," written by a former facility Physician Assistant (PA). The abstract indicated that "a retrospective analysis was performed on all patients undergoing cardiac surgery over a 4-year period (N=956) at ..medical center ....PA's assisted in 22% of all cases (N=208)." The article further indicated that "Six PA's functioned as first assistants ...cardiothoracic surgery.."

During a review of the Amended and Restated Bylaws of Enloe Medical Center, dated 9/26/2011, indicated "The Medical Staff shall conduct an ongoing review and appraisal of the quality of professional care rendered in the Medical Center and shall report such activities and their results to the Board."

Review of the Approval page of the Medical Staff Rules & Regulations, dated 3/26/12, indicated, "These Rules & Regulations have been approved by the Medical Executive Committee and the Board of Trustees and shall replace any previous Rules and Regulations." Signed by the Board of Trustees, Chair. This means that the Medical Staff is responsible to the Governing Body and must abide by the Rules and Regulations set by the Governing Body.

Review of the Bylaws of the Medical Staff, dated 7/12/12, indicated under duties of the department chair, "Determine qualifications and competence of department/division personnel who are not licensed independent practitioners and who provide patient care services." Under Application for Appointment, "each applicant...pledges to...refrain from providing "ghost" (pretend procedure) surgical or medical services, and refrain from delegating patient care responsibilities to nonqualified or inadequately supervised practitioners."

Review of the Guidelines for Allied Health Professionals and Standardized Procedures, dated 5/2009, under General Standards for Allied Health Professionals indicated, "F. Possess and document the background, training, experience, judgment, ability and...authorized in accordance with generally recognized professional standards of quality and efficiency."

Review of the facility policy entitled "Procedures Requiring A Surgeon Assistant Or Assistants to the Surgeon," dated 3/2007, indicated, under "Cardio thoracic: "All procedures requiring Extra Corporeal Bypass." Meaning that the facility policy requires a Medical Doctor (MD) assistant to be present and participate in all cardiothoracic procedures requiring the patient to be "on pump (Heart/Lung machine)."

Review of the "Physicians as Assistants at Surgery: 2011 Study," undertaken by the American College of Surgeons and other surgical specialty organizations, indicated which surgical procedures need an MD as a first assistant at surgery. The consensus for "almost always" needing an MD assistant was indicated for all cardiothoracic procedures. For all coronary artery procedures (surgically creating a new bloodflow pathway around a blockage to improve the blood supply to the heart muscle), an MD assistant was "almost always" needed and a second MD assistant was "almost always" needed as well. This consensus means that these cardiothoracic procedures are complex and sophisticated and usually require one or more experienced MD assistants to provide safe patient care.

During an interview on 1/14/13, at 9:40 am, with the Chief Executive Officer (CEO), he stated the facility has employed PA's as first assistants for cardiothoracic surgeries since 2007. He also clarified that if a first assistant is needed on an emergent basis, and the MD first assistant is not on call, the PA is called into the hospital to be the first assistant for the emergency cardiothoracic surgical case. The CEO also brought up the fact that "there was some confusion, on the facilities part, about how long the MD first assistant is required to stay in the surgical case." He questioned if the MD first assistant should stay one minute, one hour or just as long as the MD first assistant is needed." During a second interview with the CEO on 1/16/13 at 10:20 am while discussing the cardiothoracic surgery MD first assistant, he stated, "the surgeon can appoint anyone he/she wants as first assist."

During the initial tour on 1/14/13, at 12:05 pm, it was observed that MD 2 was performing cardiothoracic surgery in Operating Room (OR) 1. Across from MD 2 was PA 1, acting as a first assistant. MD 5, the MD first assistant, was observed to be standing outside of OR 1. Also, two surgical technicians and two Registered Nurse (RN)'s were present in the OR (OR RN 1 & OR RN 2), per a concurrent interview with the Director of Surgical Services (DSS), who identified all surgical participants. Therefore, at that time there was only one MD present in the OR during a complex, specialized cardiothoracic surgery and his/her assistant was PA 1.

During an interview on 1/14/13, at 12:05 pm, with MD 5 outside of OR 1, MD 5 stated that his/her duties as MD first assist include holding forceps, facilitating and increasing exposure for MD 2. MD 5 further stated that when an emergency cardiothoracic case comes into the hospital, MD 5 is called if the patient is "on the pump (Heart/Lung Machine)" However, if the patient is not "on the pump" he/she "stays home waiting and MD 2 and the PA open the chest." Therefore in many cases there is only one MD present in the OR during a complex, specialized, emergency cardiothoracic surgery, and that physician's first assistant is a PA.

During an observation on 1/15/13, at 6:45 am, in OR 1, Patient 27 was wheeled into the OR and prepared for surgery. At 7:30 am, the surgical time out was performed. At that time, all staff, including MD 2, was present in the OR except for MD 5, the MD first assistant. At that time, the PA began to perform the vein harvesting. At 7:45 am, MD 2 entered the OR scrubbed and took his/her place at the chest of the patient. At 7:50 am, MD 2 and the scrub technician began to open the patient's chest. At 8:15 am, MD 5, the MD first assist, popped his/her head into the OR and then scrubbed in preparation to assist MD 2 with the surgical case.

During an interview on 1/16/13, at 3:50 pm, MD 2 was asked when the MD first assistant was expected to arrive in the OR to assist with surgery? MD 2 answered, "when I need them." When asked regarding the qualifications of the PA's who perform as first assist, MD 2 stated that he only needed an "assistant who has the dedicated time to be available to assist him for his cases." When MD 2 was told that the PA's did not have any documented cardiothoracic training, he stated that there was some "on the job training" that occurred with the PA's. When questioned about the PA's list of privileges, MD 2 stated that he "does the chest tubes (a tube inserted into the thoracic cavity for the purpose of removing air, or fluid, or both), the PA's don't. The PA's don't do invasive things on their own." However, when it was suggested that the PA privilege list could be shortened to reflect actual PA practice, MD 2 stated that he/she would prefer to keep the privileges as they were, "in case something happened to me and I was unavailable."

During a review of the credential files for all PA's assisting in cardiothoracic surgery (PA 1, PA 2, PA 3, and PA 4) on 1/15/13, at 11:20 am, and again at 3:55 pm, it was noted that there was no objective documentation of the education, competencies or past experience to justify the PA's performing complex, specialized surgery. During a concurrent interview with the Medical Staff Coordinator (MSC), he/she confirmed the lack of documentation of specialized education, experience or training of the PA's assisting in cardiothoracic surgery.

Review of the facility form, Surgery Services/Cardiac Physician Assistant Annual Competency Assessment Tool (ACAT), dated 5/4/11, for PA 1, indicated "First assists the supervising surgeon during the procedure...Chest tube insertion, Insertion of intra-aortic balloon ( a mechanical aid to the circulatory function of the heart)." The form was signed by MD 2 as the validator, and by the Perfusionist (a technologist who operates the heart-lung machine during cardiopulmonary bypass) as the manager.

During a review of the credential file for PA 3, it was noted on the AAPA (American Academy of Physician Assistants) Physician Assistant Profile, dated 2/5/2010, under Self Reported Practice Specialty he/she indicated "Surgery: Orthopedics." Documentation of proctoring at initial appointment was lacking, as it was for most of the cardiothoracic PA's. Recent activity at the facility was lacking from PA 3's file, as it was lacking from all PA files reviewed. It was difficult to generate a case volume quality report because all procedures performed were documented under the supervising physician's name. This made it difficult to objectively evaluate PA competency for each privilege granted. This means there was no documented process evident to assess the competency of the cardiothoracic PA's to perform the privileges granted. Review of the Cardiothoracic & Vascular Surgery Delineation of Privileges Physician Assistant form, approved by the governing board on 8/22/11, included Emergency sternotomy (incision at breast bone to get to the heart) and Swan-Ganz catheter (internal monitoring of heart introduced into an internal jugular vein or subclavin vein) insertion.

During an interview on 1/15/13, at 1:40 pm, with MD 1, a board of trustee member and Chief of Medical Staff, he/she stated "each department drives it's qualification requirements and how they evaluate staff competence." Also, that standards of practice were determined by evidence based practice and organizational standards. He stated he had "no first-hand knowledge of what the PA's were doing besides pre-operative, post-operative, and vein harvesting. Anything else was "not in their scope of practice." He also volunteered that he "doubted the PA's were doing what the article said," referring to an article published by a former facility PA, which claimed that "six PA's functioned as first assistants...cardiothoracic surgery..." When the MD 1 was shown the list of surgical privileges the PA's were granted, and asked if it was a standard of practice for PA's to be doing these procedures? The MD 1 stated the PA's were doing "a little more than I thought they would." When told there appeared to be no documented mechanism to capture their function and job performance, he/she was asked if the PA's were qualified to perform as first assistants in cardiothoracic surgery, he stated "I don't know."

2. Review of the Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners who are not Anesthesia Professionals, approved 10/25/2005, by the American Society of Anesthesiologists, indicated, "Individuals ...who are not anesthesia professionals may not recognize that sedation and general anesthesia are on a continuum and thus deliver levels of sedation that are, in fact, general anesthesia without having the training and experience to recognize this state and respond appropriately.... Only physicians....who are qualified by education, training and licensure to administer moderate sedation should supervise the administration of moderate sedation."

Review of the Statement on Granting Privileges to Non-Anesthesiologist Physicians for Personally Administering or Supervising Deep Sedation, approved 10/17/12, by the American Society of Anesthesiologists, indicated "Because of the significant risk that patients who receive deep sedation...privileges for deep sedation should be granted only to non-anesthesiologist physicians who are qualified and trained in the medical practice of deep sedation and the recognition of and rescue from general anesthesia...Non-anesthesiologist physicians may neither delegate nor supervise the administration or monitoring of deep sedation by individuals who are not themselves qualified and trained to administer deep sedation, and the recognition of and rescue from general anesthesia. "

Review of the facility policy and procedure entitled Procedural Sedation, dated 1/13/12, indicated underneath Policy: "Regulatory standards for sedation and anesthesia will be followed." Also, "The Physician supervising the administration ... will be deemed competent to perform procedural sedation as evidenced by completion of the criteria stated below, Current Advance Cardiac Life Support/Pediatric Advance Life Support (ACLS/PALS) as appropriate." (ACLS requirement, effective 1/1/13). " Exemptions from ACLS/PALS... include...Verified Procedural Sedation in their clinical training program." Under References: ASA Guidelines are cited.

Review of Appendix A of the Procedural Sedation policy cited above, indicated "Physicians..desiring to obtain Procedural Sedation Privileges must comply... every two year re-granting of privileges." Also, "All physicians performing procedural sedation must comply with all criteria relevant to patient monitoring, levels of sedation,...all standards of care..." Also "ACLS and/or PALS certified and current."

During the initial facility observation on 1/14/13 at 1:35 pm in Radiology, Patient 22 was followed through his/her procedure, which included procedural sedation. After the nursing assessment, MD 6 met the patient for the first time and explained the risks and benefits of the procedure. No physical assessment by MD 6 was observed at that time. MD 6 proceeded with the procedure and at 2:15 pm MD 6 ordered sedation for Patient 22 without performing an airway assessment.

During an interview with MD 6 on 1/14/13 at 3 pm, he/she was questioned about his/her lack of patient physical assessment before the procedure, and patient airway assessment before sedation was given. MD 6 responded that he meets the patient on the day of the procedure, reviews their records and does not examine the heart and lungs or airway. Instead, he/she relies on the nursing pre-screening and his/her years of experience. When questioned, MD 6 stated there was no moderate sedation criteria and replied that he/she does not have ACLS certification. MD 6 stated that the nurses have ACLS, if it was needed.

Review of the credential files for MD 6 and MD 7 indicated that they were both granted procedural sedation privileges which include both Moderate and Deep sedation. However, further review of the credential files for MD 6 and MD 7 indicated no documented evidence of ACLS certification, airway management training or intubation training. There was no documented evidence that MD 6 or MD 7 was qualified by education, training and licensure to administer moderate sedation or deep sedation. Similar findings were found for MD 2, MD 8 and MD 9. These findings were confirmed by the MSC on 1/16/13 at 9:30 am.

Record review of the Short Form History & Physical for Patient 22, dated 1/14/13 at 2:10 pm, indicated Physical Exam: The boxes for current vital signs reviewed, heart normal and lungs normal were all checked. Under Mallampati Classification (Visual examination to evaluate tongue size relative to the oral cavity): this airway assessment tool was left blank. Under conscious sedation, the box for patient re-evaluated immediately prior to sedation was checked. These records have been documented as above, despite the lack of observed physical and airway assessments.

Review of the clinical record for Patient 23 indicated that he/she presented to radiology for an ultrasound guided paracentesis (surgical puncture of a cavity for the removal of fluid). A review of the Short Form History & Physical for Patient 23, dated 1/14/13, indicated a line drawn through the entire History and Physical portion of the form. There was no documentation of any kind on the History and Physical, meaning it was left completely blank. Under Sedation/Analgesia planned: local was checked.

During an interview on 1/15/13, at 1:40 pm, with the MD 1, a board of trustee member and Chief of Medical Staff, he/she stated that the expectations for History and Physical exams, is that they be performed within 30 days, and an interval update be performed the day of the procedure. This requirement is for all procedures, even those under local anesthesia. Also, this includes the expectation that a physical exam will be performed preoperatively and an airway assessment be completed before sedation is administered.

During an interview on 1/17/13, at 10 am with MD 1, he/she confirmed that the Governing Body was ultimately responsible for all care provided to the patients at the Medical Center.

Based on observation, interview and record review, the Governing Body did not ensure that Allied Health Professional (AHP) staff was selected based on competence, training and judgment. (Physician Assistants 1 - 4) This failure increased the risk of complications and poor quality healthcare for cardiothoracic (heart/lung) patients.

Findings:

During a review of the article in the Journal of the American Academy of Physician Assistants, dated 4/10/12, entitled "The safety and efficacy of physician assistants as first assistant surgeons in cardiac surgery," written by a former facility PA (Physician Assistant), the abstract indicated that "a retrospective analysis was performed on all patients undergoing cardiac surgery over a 4-year period (N=956) at ..medical center ....PA's assisted in 22% of all cases (N=208)." The article further indicated that "Six PA's functioned as first assistants ...cardiothoracic surgery. " The article abstract further indicated that "Experience in cardiothoracic surgery for these PA's ranged from several months to great than ten years."

Review of the Bylaws of the Medical Staff of Enloe Medical Center, dated 7/12/12, it indicated under Conditions and Duration of Appointment "Privileges. Appointment to the Medical Staff shall confer on the appointee only such clinical privileges as have been granted by the Board of Trustees, in accordance with these Bylaws within the scope of the practitioner's license.

During a review of the Amended and Restated Bylaws of Enloe Medical Center, dated 9/26/2011, indicated "The Medical Staff shall conduct an ongoing review and appraisal of the quality of professional care rendered in the Medical Center and shall report such activities and their results to the Board...The Medical Staff shall make recommendations to the Board concerning: Granting of specific clinical privileges based upon the individual physician's demonstrated ability to perform competently in those areas at time of appointment and at least biennially thereafter." Also, under Allied Health Professionals, "The Medical Staff shall establish a process, subject to the approval of the Board, for review and evaluation of the patient care services of AHPs granted such practice privileges and shall periodically report to the Board on the performance of such personnel." Review of the facility policy General Standards for Allied Health Professionals, under E. 3 indicated "If its recommendation is favorable to the Allied Health Professional, the Medical Executive Committee shall forward it, together with any supporting documentation, to the Board of Trustees for its ultimate decision." This means that the Governing Body has the final responsibility to ensure that the PA staff was selected according to appropriate training and competence.

Review of the Bylaws of the Medical Staff, dated 7/12/12, indicated under duties of the department chair, "Determine qualifications and competence of department/division personnel who are not licensed independent practitioners and who provide patient care services." Under Application for Appointment, "each applicant...pledges to...refrain from providing "ghost" surgical or medical services, and refrain from delegating patient care responsibilities to nonqualified or inadequately supervised practioners."

Review of the Guidelines for Allied Health Professionals and Standardized Procedures, dated 5/2009, under General Standards for Allied Health Professionals indicated, "F. Possess and document the background, training, experience, judgment, ability and...authorized in accordance with generally recognized professional standards of quality and efficiency."

During an interview on 1/14/13 at 9:40 am, with the Chief Executive Officer (CEO), he stated the facility has employed PA's as first assistants for cardiothoracic surgeries since 2007. He also clarified that if a first assistant is needed on an emergent basis, and the MD first assistant is not on call, the PA is called into the hospital to be the first assistant for the emergency cardiothoracic surgical case. The CEO also brought up the fact that "there was some confusion, on the facilities part, about how long the MD first assistant is required to stay in the surgical case." He questioned if the MD first assistant should stay one minute, one hour or just as long as the MD first assistant is needed." During a second interview with the CEO on 1/16/13 at 10:20 am, while discussing the cardiothoracic surgery MD first assistant, he stated, "the surgeon can appoint anyone he/she wants as first assist."

During the initial tour on 1/14/13 at 12:05 pm, it was observed that MD 2 was performing cardiothoracic surgery in Operating Room (OR) 1. Across from MD 2 was PA 1, acting as a first assistant. MD 5, the MD first assistant, was observed to be standing outside of OR 1. Also, two surgical technicians and two Registered Nurses (RN)'s were present in the OR (OR RN 1 & OR RN 2), per a concurrent interview with the Director of Surgical Services (DSS), who identified all surgical participants. Therefore, at that time there was only one MD present in the OR during a complex, specialized cardiothoracic surgery and his/her assistant was PA 1.

During an observation on 1/15/13, at 6:45 am, in OR 1, Patient 27 was wheeled into the OR and prepared for surgery. At 7:30 am, the surgical time out was performed. At that time, all staff, including MD 2, was present in the OR except for MD 5, the MD first assistant. At that time, the PA began to perform the vein harvesting. At 7:45 am, MD 2 entered the OR scrubbed and took his/her place at the chest of the patient. At 7:50 am, MD 2 and the scrub technician began to open the patient's chest. At 8:15 am, MD 5, the MD first assist, popped his/her head into the OR and then scrubbed in preparation to assist MD 2 with the surgical case.

During a review of the credential files for all PA's assisting in cardiothoracic surgery (PA 1, PA 2, PA 3, and PA 4) on 1/15/13 at 11:20 am, and again at 3:55 pm, it was noted that there was no objective documentation of the education, competencies or past experience to justify the PA's performing complex, specialized surgery. During a concurrent interview with the Medical Staff Coordinator (MSC), he/she confirmed the lack of documentation of specialized education, experience or training of the PA's assisting in cardiothoracic surgery.

Review of the facility form Surgery Services/Cardiac Physician Assistant Annual Competency Assessment Tool (ACAT), dated 5/4/11, for PA 1, indicated "First assists the supervising surgeon during the procedure...Chest tube insertion (a tube inserted into the thoracic cavity for the purpose of removing air, or fluid, or both), Insertion of intra-aortic balloon ( a mechanical aid to the circulatory function of the heart)." The form was signed by MD 2 as the validator, and by the Perfusionist (a technologist who operates the heart-lung machine during cardiopulmonary bypass) as the manager.

During a review of the credential file for PA 3, it was noted on the AAPA (American Academy of Physician Assistants) Physician Assistant Profile, dated 2/5/2010, under Self Reported Practice Specialty he/she indicated "Surgery: Orthopedics." Documentation of proctoring at initial appointment was lacking, as it was for most of the cardiothoracic PA's. Recent activity at the facility was lacking from PA 3's file, as it was lacking from all PA files reviewed. It was difficult to generate a case volume quality report because all procedures performed were documented under the supervising physician's name. This made it difficult to objectively evaluate PA competency for each privilege granted. This means there was no documented process evident to assess the competency of the cardiothoracic PA's to perform the privileges granted. Review of the Cardiothoracic & Vascular Surgery Delineation of Privileges Physician Assistant form, approved by the governing board on 8/22/11, included Emergency sternotomy (incision at breast bone to get to the heart) and Swan-Ganz catheter (internal monitoring of heart introduced into an internal jugular vein or subclavian vein) insertion.

During an interview on 1/15/13 at 1:40 pm, with MD 1, a board of trustee member and Chief of Medical Staff, he/she stated "each department drives it's qualification requirements and how they evaluate staff competence." Also, that standards of practice are determined by evidence based practice and organizational standards. He stated he had "no first-hand knowledge of what the PA's were doing besides pre-operative, post-operative and vein harvesting. Anything else was "not in their scope of practice." He also volunteered that he "doubted the PA's were doing what the article said," referring to an article published by a former facility PA, which claimed that "six PA's functioned as first assistants...cardiothoracic surgery.." When MD 1 was shown the list of surgical privileges the PA's were granted, and asked if it was a standard of practice for PA's to be doing these procedures? MD 1 stated the PA's were doing "a little more than I thought they would." When told there appeared to be no documented mechanism to capture their function and job performance, he/she was asked if the PA's were qualified to perform as first assistants in cardiothoracic surgery, he stated "I don't know."

During an interview on 1/17/13, at 10 am with MD 1, he/she confirmed that the Governing Body was ultimately responsible for all care provided to the patients at the Medical Center.

Based on observation, interview and record review, the facility did not ensure the organization of the Medical Staff and it's accountability to the Governing Body because:

1. There was a lack of documented evidence of qualifications, education and training of PA's to perform specific, highly complex surgical privileges (Refer to A 363, finding 1).
2. The staff did not follow facility policy and standards of practice regarding presence and participation of the physician first assistant surgeon during cardiothoracic procedures (Refer to A 951).
3. Lack of documented evidence that physicians granted sedation privileges are qualified by education, training, experience and competency in accordance with organizational standards (Refer to A 363, finding 2).
4. Airway assessments were not performed and/or documented for all sedation patients (Refer to 358).
5. Incomplete or inconsistent documentation of informed consents (Refer to A 955).
6. Lack of completion and documentation of a History and Physical for each patient requiring anesthesia services (Refer to A 358).

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Medical Staff.

Based on observation, interview and record review, the facility did not ensure that a comprehensive history and physical examination, including an airway assessment (Visual examination to evaluate tongue size relative to the oral cavity), was completed and documented for 2 of 27 sampled patients (Patients 22 and 23) requiring a procedure or surgery. This failure increased the risk of complications and poor health outcome for all facility patients receiving a procedure or surgery.

Findings:

Review of the facility policy and procedure entitled Procedural Sedation (Sedation medication given during procedure for comfort and pain), dated 1/13/12, indicated underneath Pre-Procedure: Each patient will be assessed prior to the start of procedure...Confirmation of a completed history and physical (H&P) in the patient's chart per Medical Staff Rules and Regulations and organizational policy. Documented physical assessment including level of consciousness."

Review of the Medical Staff Rules & Regulations, dated 3/26/12, under Medical Records indicated "A complete History and Physical Examination..shall be recorded prior to any operation or procedure. If the History and Physical ...recorded any day prior to the day of admission ...an interval note that includes any ... subsequent changes in the physical findings...must be completed. If it is found that a required History and Physical has not been recorded, surgery will be postponed."

Review of the facility policy and procedure entitled Procedural Sedation, dated 1/13/12, indicated underneath Policy: "Regulatory standards for sedation and anesthesia will be followed." Also, "The Physician supervising the administration... will be deemed competent to perform procedural sedation as evidenced by completion of the criteria stated below, Current Advanced Cardiac Life Support/Pediatric Advance Life Support (ACLS/PALS, specific training to respond to life threatening changes in heart rhythm for adults and children) as appropriate." (ACLS requirement effective 1/1/13). "Exemptions from ACLS/PALS... include...Verified Procedural Sedation in their clinical training program." Under References: ASA (American Society of Anesthesiologists) Guidelines were cited.

Review of Appendix A of the Procedural Sedation policy cited above, indicated "Physicians..desiring to obtain Procedural Sedation Privileges must comply...every two year re-granting of privileges." Also, "All physicians performing procedural sedation must comply with all criteria relevant to patient monitoring, levels of sedation...all standards of care..." Also "ACLS and/or PALS certified and current."

During the initial facility observation on 1/14/13 at 1:35 pm in Radiology (X-ray Department), Patient 22 was followed through his/her procedure, which included procedural sedation. After the nursing assessment, MD 6 met the patient for the first time and explained the risks and benefits of the procedure. No physical assessment by MD 6 was observed at that time. MD 6 proceeded with the procedure and at 2:15 pm, MD 6 ordered sedation for Patient 22 without performing an airway assessment. Therefore, the physician did not perform a physical exam as part of the Patient

During an interview with MD 6 on 1/14/13 at 3 pm, he/she was questioned about his/her lack of patient physical assessment before the procedure, and patient airway assessment before sedation was given. MD 6 responded that he meets the patient on the day of the procedure, reviews their records and does not examine the heart and lungs or airway. Instead, he/she relies on the nursing pre-screening and his/her years of experience. Meaning, that MD 6 does not perform a physical examination as part of the Patient History and Physical before the procedure. Also, that MD 6 does not examine the patient's airway before the patient is given sedation. When questioned about qualifications for sedation privileges including ACLS, MD 6 stated that he/she does not have ACLS certification. MD 6 stated that the nurses have ACLS, if it was needed.

Record review of the Short Form History & Physical for Patient 22, dated 1/14/13 at 2:10 pm, indicated Physical Exam: The boxes for Current vital signs reviewed, heart normal and lungs normal were all checked. Under Mallampati Classification (Visual examination to evaluate tongue size relative to the oral cavity): this airway assessment tool was left blank. Under conscious sedation, the box for Patient re-evaluated immediately prior to sedation was checked. These records have been documented as above, despite the lack of observed physical and airway assessments.

Review of the clinical record for Patient 23 indicated that he/she presented to radiology for an ultrasound guided paracentesis (machine guided to identify fluid for surgical puncture of a cavity for the removal of fluid). A review of the Short Form History & Physical for Patient 23, dated 1/14/13 indicated a line drawn through the entire History and Physical portion of the form. There was no documentation of any kind on the History and Physical, meaning it was left completely blank. Under Sedation/Analgesia planned: local (medication given so there was no feeling of discomfort to the area) was checked.

During an interview on 1/15/13, at 1:40 pm, with the MD 1, a board of trustee member and Chief of Staff, he/she stated that the expectations for History and Physical exams, is that they be performed within 30 days, and an interval update be performed the day of the procedure. This requirement is for all procedures, even those under local anesthesia. Also, this includes the expectation that a physical exam will be performed preoperatively and an airway assessment be completed before sedation is administered.

Based on observation, interview and record review, the facility did not ensure surgical privileges were granted according to education, competencies or past experience for Physician Assistant (PA)'s performing complex, specialized surgery. Also, the facility failed to ensure that physicians granted sedation privileges (supervise Registered Nurses administering and monitoring patients that received sedation) were qualified by education, training, experience and competency for PAs 1 - 4. This failure increased the risk of complications and poor quality of care for surgery patients during bypass surgery and xray procedures.

Findings:

1. During a review of the article in the Journal of the American Academy of Physician Assistants, dated 4/10/12, entitled "The safety and efficacy of physician assistants as first assistant (assist) surgeons in cardiac surgery," written by a former facility PA, the abstract indicated that "a retrospective analysis was performed on all patients undergoing cardiac surgery over a 4-year period (N=956) at..medical center....PA's assisted in 22% of all cases (N=208)." The article further indicated that "Six PA's functioned as first assistants...cardiothoracic surgery.."

Review of the Bylaws of the Medical Staff, dated 7/12/12, indicated under duties of the department chair, "Determine qualifications and competence of department/division personnel who are not licensed independent practitioners and who provide patient care services." Under Application for Appointment, "each applicant..pledges to..refrain from providing "ghost" surgical or medical services, and refrain from delegating patient care responsibilities to nonqualified or inadequately supervised practioners."

Review of the Guidelines for Allied Health Professionals and Standardized Procedures, dated 5/2009, under General Standards for Allied Health Professionals indicated, "F. Possess and document the background, training, experience, judgment, ability and...authorized in accordance with generally recognized professional standards of quality and efficiency."

Review of the facility policy entitled Procedures Requiring A Surgeon Assistant Or Assistants to the Surgeon, dated 3/2007, indicated, under "Cardio thoracic: "All procedures requiring Extra Corporeal Bypass (Diversion of blood flow through a circuit located outside the body but continuous with the bodily circulation)." Meaning that the facility policy requires a Medical Doctor (MD) assistant to be present and participate in all cardiothoracic procedures requiring the patient to be "on pump (Heart/Lung Machine)."

Review of the "Physicians as Assistants at Surgery: 2011 Study," undertaken by the American College of Surgeons and other surgical specialty organizations, indicated which surgical procedures need an MD as a first assistant at surgery. The consensus for "almost always" needing an MD assistant was indicated for all cardiothoracic procedures. For all coronary artery procedures (surgically creating a new bloodflow pathway around a blockage to improve the blood supply to the heart muscle), an MD assistant was "almost always" needed and a second MD assistant was "almost always" needed as well. This consensus means that these cardiothoracic procedures are complex and sophisticated and usually require one or more experienced MD assistants to provide safe patient care.

During an interview on 1/14/13, at 9:40 am, with the Chief Executive Officer (CEO), he stated the facility has employed PA's as first assistants for cardiothoracic surgeries since 2007. He also clarified that if a first assistant is needed on an emergent basis, and the MD first assistant is not on call, the PA is called into the hospital to be the first assistant for the emergency cardiothoracic surgical case. The CEO also brought up the fact that "there was some confusion, on the facilities part, about how long the MD first assistant is required to stay in the surgical case." He questioned if the MD first assistant should stay one minute, one hour or just as long as the MD first assistant is needed." During a second interview with the CEO on 1/16/13 at 10:20 am while discussing the cardiothoracic surgery MD first assistant, he stated, "the surgeon can appoint anyone he/she wants as first assist."

During the initial tour on 1/14/13, at 12:05 pm, it was observed that MD 2 was performing cardiothoracic surgery in Operating Room (OR) 1. Across from MD 2 was PA 1, acting as a first assistant. MD 5, the MD first assistant, was observed to be standing outside of OR 1. Also, two surgical technicians and two RN's were present in the OR (OR, Registered Nurse, RN 1 & OR RN 2), per a concurrent interview with the Director of Surgical Services (DSS), who identified all surgical participants. Therefore, at that time there was only one MD present in the OR during a complex, specialized cardiothoracic surgery and his/her assistant was PA 1.

During an interview on 1/14/13, at 12:05 pm, with MD 5 outside of OR 1, MD 5 stated that his/her duties as MD first assist include holding forceps, facilitating and increasing exposure for MD 2. MD 5 further stated that when an emergency cardiothoracic case comes into the hospital, MD 5 is called if the patient is "on the pump." However, if the patient is not "on the pump." he/she "stays home waiting and MD 2 and the PA open the chest." Therefore in many cases there is only one MD present in the OR during a complex, specialized, emergency cardiothoracic surgery, and that physician's first assistant is a PA.

During an observation on 1/15/13 at 6:45 am, in OR 1, Patient 27 was wheeled into the OR and prepared for surgery. At 7:30 am, the surgical time out was performed. At that time, all staff, including MD 2, was present in the OR except for MD 5, the MD first assistant. At that time, the PA began to perform the vein harvesting. At 7:45 am, MD 2 entered the OR scrubbed and took his/her place at the chest of the patient. At 7:50 am, MD 2 and the scrub technician began to open the patient's chest. At 8:15 am, MD 5, the MD first assist, popped his/her head into the OR and then scrubbed in preparation to assist MD 2 with the surgical case.

During an interview on 1/16/13, at 3:50 pm, MD 2 was asked when the MD first assistant was expected to arrive in the OR to assist with surgery? MD 2 answered, "when I need them." When asked regarding the qualifications of the PA's who perform as first assist, MD 2 stated that he only needed an "assistant who has the dedicated time to be available to assist him for his cases." When MD 2 was told that the PA's did not have any documented cardiothoracic training, he stated that there was some "on the job training" that occurred with the PA's. When questioned about the PA's list of privileges, MD 2 stated that he "does the chest tubes (a tube inserted into the thoracic cavity for the purpose of removing air, or fluid, or both), the PA's don't. The PA's don't do invasive things on their own." However, when it was suggested that the PA privilege list could be shortened to reflect actual PA practice, MD 2 stated that he/she would prefer to keep the privileges as they were, "in case something happened to me and I was unavailable."

During a review of the credential files for all PA's assisting in cardiothoracic surgery (PA 1, PA 2, PA 3, and PA 4) on 1/15/13 at 11:20 am, and again at 3:55 pm, it was noted that there was no objective documentation of the education, competencies or past experience to justify the PA's performing complex, specialized surgery. During a concurrent interview with the Medical Staff Coordinator (MSC), he/she confirmed the lack of documentation of specialized education, experience or training of the PA's assisting in cardiothoracic surgery.

Review of the facility form Surgery Services/Cardiac Physician Assistant Annual Competency Assessment Tool (ACAT), dated 5/4/11, for PA 1, indicated "First assists the supervising surgeon during the procedure...Chest tube insertion, Insertion of intra-aortic balloon (a mechanical aid to the circulatory function of the heart)." The form was signed by MD 2 as the validator, and by the Perfusionist (a technologist who operates the heart-lung machine during cardiopulmonary bypass) as the manager.

During a review of the credential file for PA 3, it was noted on the AAPA (American Academy of Physician Assistants) Physician Assistant Profile, dated 2/5/2010, under Self Reported Practice Specialty he/she indicated "Surgery: Orthopedics." Documentation of proctoring at initial appointment was lacking, as it was for most of the cardiothoracic PA's. Recent activity at the facility was lacking from PA 3 s file, as it was lacking from all PA files reviewed. It was difficult to generate a case volume quality report because all procedures performed were documented under the supervising physician's name. This made it difficult to objectively evaluate PA competency for each privilege granted. This means there was no documented process evident to assess the competency of the cardiothoracic PA's to perform the privileges granted. Review of the Cardiothoracic & Vascular Surgery Delineation of Privileges Physician Assistant form, approved by the governing board on 8/22/11, included Emergency sternotomy (incision at breast bone to get to the heart) and Swan-Ganz catheter (internal monitoring of heart introduced into an internal jugular vein or subclavian vein) insertion.

During an interview on 1/15/13, at 1:40 pm, with MD 1, Chief of Medical Staff, he/she stated "each department drives it's qualification requirements and how they evaluate staff competence." Also, that standards of practice are determined by evidence based practice and organizational standards. He stated he had "no first-hand knowledge of what the PA's were doing besides pre-operative, post-operative and vein harvesting. Anything else was "not in their scope of practice." He also volunteered that he "doubted the PA's were doing what the article said," referring to an article published by a former facility PA, which claimed that "six PA's functioned as first assistants...cardiothoracic surgery..." When the MD 1 was shown the list of surgical privileges the PA's were granted, and asked if it was a standard of practice for PA's to be doing these procedures? The MD 1 stated the PA's were doing "a little more than I thought they would." When told there appeared to be no documented mechanism to capture their function and job performance, he/she was asked if the PA's were qualified to perform as first assistants in cardiothoracic surgery, he stated "I don't know."


2. Review of the Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners who are not Anesthesia Professionals, approved 10/25/2005 by the American Society of Anesthesiologists (ASA), indicated, "Individuals...who are not anesthesia professionals may not recognize that sedation and general anesthesia are on a continuum and thus deliver levels of sedation that are, in fact, general anesthesia without having the training and experience to recognize this state and respond appropriately....Only physicians....who are qualified by education, training and licensure to administer moderate sedation should supervise the administration of moderate sedation."

Review of the Statement on Granting Privileges to Non-anesthesiologist Physicians for Personally Administering or Supervising Deep Sedation (Patient non breathing and responding to pain), approved 10/17/12, by the American Society of Anesthesiologists, indicated "Because of the significant risk that patients who receive deep sedation...privileges for deep sedation should be granted only to non-anesthesiologist physicians who are qualified and trained in the medical practice of deep sedation and the recognition of and rescue (administering medication to reverse effects of deep sedation) from general anesthesia...Non-anesthesiologist physicians may neither delegate nor supervise the administration or monitoring of deep sedation by individuals who are not themselves qualified and trained to administer deep sedation, and the recognition of and rescue from general anesthesia."

Review of the facility policy and procedure entitled Procedural Sedation, dated 1/13/12, indicated underneath Policy: "Regulatory standards for sedation and anesthesia will be followed." Also, "The Physician supervising the administration...will be deemed competent to perform procedural sedation as evidenced by completion of the criteria stated below, Current Advanced Cardiac Life Support/Pediatric Cardiac Life Support (ACLS/PALS) as appropriate." (ACLS requirement, effective 1/1/13). "Exemptions from ACLS/PALS... include...Verified Procedural Sedation in their clinical training program." Under References: ASA Guidelines were cited.

Review of Appendix A of the Procedural Sedation policy cited above, indicated "Physicians..desiring to obtain Procedural Sedation Privileges must comply...every two year re-granting of privileges." Also, "All physicians performing procedural sedation must comply with all criteria relevant to patient monitoring, levels of sedation,..all standards of care..." Also "ACLS and/or PALS certified and current."

During the initial facility observation on 1/14/13 at 1:35 pm in Radiology, Patient 22 was followed through his/her procedure, which included procedural sedation. After the nursing assessment, MD 6 met the patient for the first time and explained the risks and benefits of the procedure. No physical assessment by MD 6 was observed at that time. MD 6 proceeded with the procedure and at 2:15 pm MD 6 ordered sedation for Patient 22 without performing an airway assessment.

During an interview with MD 6 on 1/14/13 at 3 pm, he/she was questioned about his/her lack of patient physical assessment before the procedure, and patient airway assessment before sedation was given. MD 6 responded that he meets the patient on the day of the procedure, reviews their records and does not examine the heart and lungs or airway. Instead, he/she relies on the nursing pre-screening and his/her years of experience. When questioned, MD 6 stated there was no moderate sedation criteria and replied that he/she does not have ACLS certification (specific training to respond to life threatening changes in heart rhythm for adults). MD 6 stated that the nurses have ACLS, if it is needed.

Review of the credential files for MD 6 and MD 7 indicated that they were both granted procedural sedation privileges which include both Moderate and Deep sedation. However, further review of the credential files for MD 6 and MD 7 indicated no documented evidence of ACLS certification, airway management training (knowledge of keeping airway open) or intubation training (special training to place a hollow tube down throat safely for breathing). There was no documented evidence that MD 6 or MD 7 was qualified by education, training and licensure to administer moderate sedation or deep sedation. Similar findings were found for MD 2, MD 8 and MD 9. These findings were confirmed by the Medical Staff Coordinator on 1/16/13/at 9:30 am..

Record review of the Short Form History & Physical for Patient 22, dated 1/14/13 at 2:10 pm, indicated Physical Exam: The boxes for Current vital signs reviewed, heart normal and lungs normal were all checked. Under Mallampati Classification (Visual examination to evaluate tongue size relative to the oral cavity): this airway assessment tool was left blank. Under conscious sedation, the box for Patient re-evaluated immediately prior to sedation was checked. These records have been documented as above, despite the lack of observed physical and airway assessments.

Review of the clinical record for Patient 23 indicated that he/she presented to radiology for an ultrasound guided paracentesis (surgical puncture of a cavity for the removal of fluid). A review of the Short Form History & Physical for Patient 23, dated 1/14/13, indicated a line drawn through the entire History and Physical portion of the form. There was no documentation of any kind on the History and Physical, meaning it was left completely blank. Under Sedation/Analgesia planned: local was checked.

During an interview on 1/15/13, at 1:40 pm, with MD 1, Medical Chief of Staff, he/she stated that the expectations for History and Physical exams, was that they be performed within 30 days, and an interval update be performed the day of the procedure. This requirement was for all procedures, even those under local anesthesia. Also, this includes the expectation that a physical exam will be performed preoperatively and an airway assessment be completed before sedation is administered.

Based on observation, interview and record review, the facility did not ensure that the Surgical Services were provided in accordance with facility policy and acceptable standards of practice because:


1. The facility did not ensure that surgical privileges were granted according to education, competencies or past experience for PA's performing specific, highly complex surgical privileges (Refer to A 945, finding 1 and A 363, finding 1).
2. The facility did not ensure that procedural sedation privileges were granted according to education, experience and competencies (Refer to A 945, finding 2 and A 363, finding 2).
3. The staff did not follow facility policy and acceptable standards of practice regarding presence and participation of the physician first assistant surgeon during cardiothoracic procedures (Refer to A 951, finding 1).
4. Airway assessments were not performed and/or documented for all sedation patients (Refer to A 358).
5. Incomplete or inconsistent documentation of all surgical participants on patient informed consents (Refer to A 951, finding 4, A 945, finding 1, and A 955).
6. All surgical participants were not present during the Universal Time Out (Refer to A 951, finding 5)


The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Surgical Services.

Based on observation, interview and record review, the facility did not ensure surgical privileges were granted according to education, competencies or past experience for Physician Assistant (PA)'s performing complex, specialized surgery. (PAs 1 - 4) Similarly, the facility failed to ensure that physicians granted sedation privileges were qualified by education, training, experience and competency. (Medical Doctor, MDs 2, 6, 7, 8, and 9) Also the facility failed to ensure that all surgical participants were present during the Universal Time Out (Standard of Practice for all participates involved in a procedure or surgery to confirm correct patient, correct procedure, and correct site), for cardiothoracic (heart/chest) surgeries (Patients 1, 3, 4, 6, 7, 8, 9, 12, 13, 15, 16, 17, 18, and 27) This failure increased the risk of complications and poor quality of care for surgery patients.

Findings:

1. During a review of the article in the Journal of the American Academy of Physician Assistants, dated 4/10/12, entitled "The safety and efficacy of physician assistants as first assistant (assist) surgeons in cardiac surgery," written by a former facility PA, the abstract indicated that "a retrospective analysis was performed on all patients undergoing cardiac surgery over a 4-year period (N=956) at..medical center....PA's assisted in 22% of all cases (N=208)." The article further indicated that " Six PA's functioned as first assistants...cardiothoracic surgery.."

Review of the Bylaws of the Medical Staff, dated 7/12/12, indicated under duties of the department chair, "Determine qualifications and competence of department/division personnel who are not licensed independent practitioners and who provide patient care services." Under Application for Appointment, "each applicant..pledges to..refrain from providing "ghost (pretend procedure)" surgical or medical services, and refrain from delegating patient care responsibilities to nonqualified or inadequately supervised practitioners."

Review of the facility Guidelines for Allied Health Professionals and Standardized Procedures, dated 5/2009, under General Standards for Allied Health Professionals indicated, "F. Possess and document the background, training, experience, judgment, ability and...authorized in accordance with generally recognized professional standards of quality and efficiency."

Review of the facility policy Universal Protocol for Ensuring Correct Site, Correct Procedure, Correct Person for Surgery and Other Invasive Procedures (Universal Time Out Policy), under Policy: 3. "It is initiated by a designated member of the team...and involves all of the immediate members participating in the procedure."

Review of the facility form Consent to Surgery or Special Procedure, dated 5/18/12 at 9 am indicated "The Centers for Medicare and Medicaid Services require that you be informed of the name of each practitioner performing significant surgical tasks during your operation. "Significant surgical tasks" include, but are not limited to, opening (cutting into the skin) and closing (Sewing or clipping the edges of the skin to close area), harvesting grafts (to remove leg vein and use it for improving blood flow to the heart muscle), dissecting (to cut apart or separate) tissue, removing tissue, implanting devices (to insert or graft material into a body cavity) and altering (interrupt or changing) tissues. You have informed that the following practitioner(s) will be performing surgical tasks: Surgical Assistant(s). In the event that the clinicians noted above are unable to perform or complete the task, a substitute may be assigned. This information will be documented in your medical record."

Review of the facility policy entitled Procedures Requiring A Surgeon Assistant or Assistants to the Surgeon, dated 3/2007, indicated, under "Cardio thoracic: "All procedures requiring Extra Corporeal Bypass (Heart/Lung Machine, Diversion of blood flow through a circuit located outside the body but continuous with the bodily circulation." Meaning that the facility policy required a Medical Doctor (MD) surgeon assistant to be present and participate in all cardiothoracic procedures requiring the patient to be "on pump (Heart/Lung Machine)."

Review of the "Physicians as Assistants at Surgery: 2011 Study," undertaken by the American College of Surgeons and other surgical specialty organizations, indicated which surgical procedures need an MD as a first assistant at surgery. The consensus for "almost always" needing an MD assistant was indicated for all cardiothoracic procedures. For all coronary artery procedures (surgically creating a new bloodflow pathway around a blockage to improve the blood supply to the heart muscle), an MD assistant was "almost always" needed and a second MD assistant was "almost always" needed as well. This consensus means that these cardiothoracic procedures are complex and sophisticated and usually require one or more experienced MD assistants to provide safe patient care.

During the initial facility tour on 1/14/13 at 12:05 pm, it was observed that MD 2 was performing cardiothoracic surgery in Operating Room (OR) 1. Across from MD 2 was PA 3, acting as a first assistant. MD 5, the physician first assistant, was noted to be standing outside of OR 1. Also, two surgical technicians (technicians trained in assisting the surgeon with the sterile procedure) and two Registered Nurse (RN)'s were present in the OR (OR RN 1 & OR RN 2), per a concurrent interview with the Director of Surgical Services (DSS), who identified all surgical participants. Therefore, at that time there was only one MD present in the OR during a complex, specialized cardiothoracic surgery and his assistant was PA 3.

During an interview with MD 5 on 1/14/13, at 12:05 pm, outside of OR 1, he/she stated that his/her duties as MD first assistant include holding forceps (two bladed instrument with a handle used for grasping or compressing tissues in surgical operations), facilitating (assisting the process )and increasing exposure (moving tissue for increased visualization of area) for MD 2. MD 5 further stated that when an emergency cardiothoracic case comes into the hospital, MD 5 is called into the hospital, if the patient is "on the pump." However, if the patient is not "on the pump" he/she "stays home waiting and MD 2 and the PA open the chest." Therefore in many cases there is only one MD present in the OR during a complex emergency cardiothoracic surgery, and his/her first assistant is a PA.

During an observation on 1/15/13, at 6:45 am in OR 1, Patient 27 was wheeled into OR 1 and prepared for surgery. At 7:30 am, the surgical time out was called with all staff present, except for MD 5, the MD first assistant. The PA began to perform the vein harvesting (to remove leg vein and use it for improving blood flow to the heart muscle) and at 7:50 am, MD 2 and the surgical technician began to open (incision at breast bone to get to the heart) the patient's chest. At 8:15 am, MD 5 arrived to assist with the surgical case.

During an interview on 1/16/13 at 3:50 pm, MD 2 was asked when the MD first assistant was expected to arrive in the OR to assist with surgery? MD 2 answered, "when I need them." When asked regarding the qualifications of the PA's who perform as first assist, MD 2 stated that he only needed an "assistant who has the dedicated time to be available to assist him for his cases." When MD 2 was told that the PA's did not have any documented cardiothoracic training, he stated that there was some "on the job training" that occurred with the PA's. When questioned about the PA's list of privileges, MD 2 stated that he "does the chest tubes (a tube inserted into the thoracic cavity for the purpose of removing air, or fluid, or both), the PA's don' t. The PA's don' t do invasive things on their own." However, when it was suggested that the PA privilege list could be shortened to reflect actual PA practice, MD 2 stated he would prefer to keep the privileges as they were, "in case something happened to me and I was unavailable."

During an interview on 1/15/13, at 1:40 pm, Medical Chief of Staff, MD 1 stated "each department drives it's qualification requirements and how they evaluate staff competence." Also, that standards of practice were determined by evidence based practice and organizational standards. He stated he had "no first-hand knowledge of what the PA's were doing besides pre-operative, post-operative and vein harvesting. Anything else was "not in their scope of practice." He also volunteered that he "doubted the PA's were doing what the article said," referring to the article published in the Journal of the American Academy of Physician Assistants, dated 4/10/12, by a former facility PA, which claimed that "six PA's functioned as first assistants...cardiothoracic surgery..." When MD 1 was shown the list of surgical privileges granted to the cardiothoracic PA's and asked if it was a standard of practice for PA's to be doing these procedures? MD 1 replied, "PA's are doing a little more than I thought they would." When MD 1 was told there was no documented mechanism to capture the PA's function and job performance and he/she was asked if the PA's were qualified to perform as first assistants in cardiothoracic surgery, he stated "I don't know."

During an interview on 1/14/13, at 9:40 am, with the Chief Executive Officer (CEO), he stated the facility has employed PA's as first assistants for cardiothoracic surgeries since 2007. He also clarified that if a first assistant is needed on an emergent basis, and the MD first assistant is not on call, the PA is called into the hospital to be the first assistant for the emergency cardiothoracic surgical case. The CEO stated, "there was some confusion, on the facilities part, about how long the MD first assistant is required to stay in the surgical case." He questioned if the assistant should stay one minute, one hour or just as long as the MD first assistant is needed." During a second interview with the CEO on 1/16/13 at 10:20 am, while discussing the cardiothoracic surgery first assistant, he stated, "the surgeon can appoint anyone he/she wants as first assist."

During a second interview with MD 5, on 1/16/13, at 5:25 pm, he/she stated that the "new agreement" reached between MD 5 and the facility, was that he/she will be first assisting in all cardiothoracic surgeries as the MD first assist.

During a review of the credential files for all PA's assisting in cardiothoracic surgery (PA 1, PA 2, PA 3, and PA 4) on 1/15/13 at 11:20 am, and again at 3:55 pm, it was noted that there was no objective documentation of the education, competencies or past experience to justify the PA's performing complex, specialized surgery. During a concurrent interview with the Medical Staff Coordinator (MSC), he/she confirmed the lack of documentation of specialized education, experience or training of the PA's assisting in cardiothoracic surgery.

Review of the facility form Surgery Services/Cardiac Physician Assistant Annual Competency Assessment Tool (ACAT), dated 5/4/11, for PA 1, indicated "First assists the supervising surgeon during the procedure...Chest tube insertion, Insertion of intra-aortic balloon ( a mechanical aid to the circulatory function of the heart)." The form was signed by MD 2 as the validator and by the Perfusionist (a technologist who operates the heart-lung machine during cardiopulmonary bypass) signed as manager.

During a review of the credential file for PA 3, it was noted on the AAPA (American Academy of Physician Assistants) Physician Assistant Profile, dated 2/5/2010, that under Self Reported Practice Specialty he/she indicated "Surgery: Orthopedics." Documentation of proctoring at initial appointment was lacking, as it was for most of the cardiothoracic PA's. Recent activity at the facility was lacking from PA 3's file, as it was lacking from all PA files reviewed. It was difficult to generate a case volume quality report because all procedures performed were documented under the supervising physician's name. This made it difficult to objectively evaluate PA competency for each privilege granted. This means there was no documented process evident to assess the competency of the cardiothoracic PA's to perform the privileges granted. Review of the facility Cardiothoracic & Vascular Surgery Delineation of Privileges Physician Assistant form, approved by the governing board on 8/22/11, included Emergency sternotomy (incision at breast bone to get to the heart) and Swan-Ganz catheter (internal monitoring of heart introduced into an internal jugular vein or subclavian vein) insertion.

Record review of multiple surgical cases indicated that there was limited, or lack of, participation by the MD first assist in many of the cardiothoracic surgical cases reviewed.

Review of the Intra-operative Record form for Patient 2, dated 5/8/12, at 1:04 pm indicated that the surgical staff entered the OR on 5/8/12 at 12:06 pm and exited the OR at 4:45 pm. Under Case Staff, Assistant Surgeons, MD 5 was listed and it indicated that MD 5 entered the OR at 4:16 pm and exited the OR at 4:17 pm, for 1 minute, near the end of the surgery. Under Staff, two PA's (PA 3 & PA 2) were listed as First Assistant. According to the record, PA 2 entered the OR at 1:45 pm and exited at 2:12 pm. PA 3 had no OR in and out times listed, however, PA 3 was mentioned under Notes as follows: "Right leg vein out by PA 3 (12:57 - 1:24 pm), Left leg vein out by PA 3 (1:30 - 1:53 pm)...Chest Xray at end of case cleared by PA 3."

Review of the Report of Operation dictated by MD 2 on 5/8/12, indicated under Assistant, all three assistants, MD 5 , PA 2 and PA 3, however the report did not specify that PA 3 performed the secondary procedure, the harvest of the vein graft.

Review of the Consent to Surgery or Special Procedure dated 5/8/12, at 9 am, the consent indicated: "require that you be informed of the name of each practitioner performing significant surgical tasks during your operation...include...opening and closing, harvesting grafts." You have been informed that the following practitioner(s) will be performing surgical tasks: Surgical Assistant(s): MD 5 was indicated. No other surgical participants were noted on the consent form. "In the event that the clinicians noted above are unable to perform or complete the task, a substitute may be assigned." This means that the patient consented to MD 2 and MD 5 performing his/her surgery, and if something unusual occurred, the patient consented to a substitute. Because many of the cardiothoracic surgeries were scheduled, the facility is aware, at the time of patient Informed Consent, which Surgical Assistants will be participating in the surgical procedure.

During an interview with OR RN 1 on 1/15/13 at 3:20 pm, she stated that when the RN documented the OR in and out time, they were documented exactly as they occur. The RN documents the OR times while watching the clock. Therefore, the documentation that MD 5 was only in the OR for one minute can be expected to be accurate. When asked why MD 5 was listed as the first assistant in that case, since he/she was only in the OR for one minute, OR RN 1 stated "it's the only way you can put MD 5 into the computer." She also stated "only the PA performs the vein harvesting procedure, never MD 5." Therefore, for every case that the PA performs the vein harvesting procedure, it would be expected that the PA would be listed on the Consent to Surgery or Special Procedure under Surgical Assistant. When asked about surgical assistants for MD 2, OR RN 1 stated, the surgical assistant "could be anyone, a scrub technician, first assistant or a doctor."

2. Review of the Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners who are not Anesthesia Professionals, approved 10/25/2005 by the American Society of Anesthesiologists, indicated, "Individuals ...who are not anesthesia professionals may not recognize that sedation and general anesthesia are on a continuum and thus deliver levels of sedation that are, in fact, general anesthesia without having the training and experience to recognize this state and respond appropriately .... Only physicians .... qualified by education, training and licensure to administer moderate sedation should supervise the administration of moderate sedation."

Review of the Statement on Granting Privileges to Non-Anesthesiologist Physicians for Personally Administering or Supervising Deep Sedation, approved 10/17/12, by the American Society of Anesthesiologists, indicated "Because of the significant risk that patients who receive deep sedation ...privileges for deep sedation should be granted only to non-anesthesiologist physicians who are qualified and trained in the medical practice of deep sedation and the recognition of and rescue from general anesthesia...Non-anesthesiologist physicians may neither delegate nor supervise the administration or monitoring of deep sedation by individuals who are not themselves qualified and trained to administer deep sedation, and the recognition of and rescue from general anesthesia. "

Review of the facility policy and procedure entitled Procedural Sedation, dated 1/13/12, indicated underneath Policy: "Regulatory standards for sedation and anesthesia will be followed." Also, "The Physician supervising the administration ... will be deemed competent to perform procedural sedation as evidenced by completion of the criteria stated below, Current Advance Cardiac Life Support/Pediatric Advance Life Support (ACLS/PALS) as appropriate." (The ACLS requirement became effective 1/1/13). "Exemptions from ACLS/PALS ... include ...Verified Procedural Sedation in their clinical training program." Under References: ASA Guidelines are cited.

Review of Appendix A of the Procedural Sedation policy cited above, indicated "Physicians..desiring to obtain Procedural Sedation Privileges must comply...every two year re-granting of privileges." Also, "All physicians performing procedural sedation must comply with all criteria relevant to patient monitoring, levels of sedation...all standards of care ..." Also, "ACLS and/or PALS certified and current."

During the initial facility observation on 1/14/13 at 1:35 pm in Radiology (x-ray), Patient 22 was followed through his/her procedure, which included procedural sedation. After the nursing assessment, MD 6 met the patient for the first time and explained the risks and benefits of the procedure. No physical assessment by MD 6 was observed at that time. MD 6 proceeded with the procedure and at 2:15 pm, MD 6 ordered sedation for Patient 22 without performing an airway assessment.

During an interview with MD 6 on 1/14/13 at 3 pm, he/she was questioned about his/her lack of patient physical assessment before the procedure, and patient airway assessment before sedation was given. MD 6 responded that he meets the patient on the day of the procedure, reviews their records and does not examine the heart and lungs or airway. Instead, he/she relies on the nursing pre-screening and his/her years of experience. When questioned, MD 6 stated there was no moderate sedation criteria and replied that he/she does not have ACLS certification. MD 6 stated that the nurses have ACLS, if it is needed.

Review of the credential files for MD 6 and MD 7 indicated that they were both granted procedural sedation privileges which include both Moderate and Deep sedation. However, further review of the credential files for MD 6 and MD 7 indicated no documented evidence of ACLS certification, airway management training or intubation training. There was no documented evidence that MD 6 or MD 7 was qualified by education, training and licensure to administer moderate sedation or deep sedation. Similar findings were found for MD 2, MD 8 and MD 9. These findings were confirmed by the Medical Staff Coordinator on 1/16/13 at 9:30 am.

Record review of the Short Form History & Physical for Patient 22, dated 1/14/13 at 2:10 pm, indicated Physical Exam: The boxes for Current vital signs reviewed, heart normal and lungs normal were all checked. Under Mallampati Classification (Visual examination to evaluate tongue size relative to the oral cavity): this airway assessment tool was left blank. Under conscious sedation, the box for Patient re-evaluated immediately prior to sedation was checked. These records have been documented as above, despite the lack of observed physical and airway assessments.

Review of the clinical record for Patient 23 indicated that he/she presented to radiology for an ultrasound guided paracentesis (surgical puncture of a cavity for the removal of fluid). A review of the Short Form History & Physical for Patient 23, dated 1/14/13, indicated a line drawn through the entire History and Physical portion of the form. There was no documentation of any kind on the History and Physical, meaning it was left completely blank. Under Sedation/Analgesia planned: local was checked.

During an interview on 1/15/13, at 1:40 pm, with the MD 1, Chief of Medical Staff, he/she stated that the expectations for History and Physical exams, was that they be performed within 30 days, and an interval update be performed the day of the procedure. This requirement was for all procedures, even those under local anesthesia. Also, this includes the expectation that a physical exam will be performed preoperatively and an airway assessment be completed before sedation is administered.


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3. According to Patient 4's operative report (MD 2's documentation of procedure), on 10/7/11, on Friday, Patient 4 went into surgery for a urgent redo (repeat) coronary artery bypass surgery. Endoscopic (instrument used for direct visual inspection of hollow organs or body cavities) saphenous vein harvest (Vein in leg used for heart surgery) was performed. The operative report dictated that MD 2 performed the procedure assisted by MD 5, PA 1 and PA 2.

The intraoperative report (IR), OR RN's documentation of procedure) on 10/7/11, recorded that Patient 4's procedure started at 7:04 am and ended at 10:14 am. MD 5 was present in the OR from 9:20 am to 9:42 am, for 22 minutes. PA 1 had no recorded in and out time listed. PA 2 was present in the OR from 8:15 am to 9 am. The operative dictated from MD 2 did not agree with the IR.

4. According to Patient 13's operative report, on 7/6/11, on Wednesday Patient 13 went into surgery for aortic valve (valve from the heart to the rest of the body) replacement. The operative report dictated that MD 2 performed the procedure assisted by MD 5 and PA 3.

The IR on 7/6/11, recorded that Patient 13's procedure started at 8:16 am and ended at 11 am. MD 5 was present in the OR from 9:21 am to 10 am, 39 minutes. PA 3 was present in the OR from 8:20 am to 9:23 am, and then again starting at 10 am with no out time. There was only one assistant during the surgery in the room.

5. According to Patient 15's operative report, on 2/15/12, on Wednesday Patient 15 went into surgery for aortic valve replacement and coronary artery bypass surgery with endoscopic saphenous vein harvest was performed. The operative report dictated that MD 2 performed the procedure assisted by MD 5 and PA 2.

The IR on 2/15/12, recorded that Patient 15's procedure started at 3:21 pm and ended at 7:25 pm. MD 5 was present in the OR from 4:31 pm to 5:40 pm, 71 minutes. PA 2 was present in the OR from 3:21 pm to 4:15 pm. PA 1 was present in the OR from 3:55 pm to 4:33 pm.

6. According to Patient 17's operative report, on 12/25/12, Patient 17 went into surgery for an urgent coronary artery bypass surgery. The operative report dictated that MD 2 performed the procedure assisted by MD 5 and PA 1.

The IR on 12/25/12, recorded that Patient 17's procedure started at 6:25 pm and ended at 11:30 pm. MD 5 was present in the OR from 8:51 pm to 9:17 pm, 26 minutes. PA 1 had no recorded in and out time.

7. According to Patient 18's operative report, on 12/31/12, on Monday Patient 18 went into surgery for an urgent coronary artery bypass surgery with endoscopic saphenous vein harvest. The operative report dictated that MD 2 performed the procedure assisted by MD 5 and PA 2. There was no documentation that MD 10 was involved in the surgery.

The IR on 12/31/12, recorded that Patient 18's procedure started at 8 am and ended at 11:54 am. MD 5 was present in the OR from 10 am to 11 am, 60 minutes. MD 10 was documented present in the operating room OR from 11 am to 11:20 am, 20 minutes. PA 2 had no documented in and out time recorded.

8. According to Patient 7's operative report, on 3/15/12, on Thursday Patient 7 went into surgery for a aortic valve replacement and coronary artery bypass surgery with endoscopic saphenous vein harvest. The operative report dictated that MD 2 performed the procedure assisted by MD 5 and PA 1.

The IR on 3/15/12, recorded that Patient 7 procedure started at 8:10 am and ended at 11:56 am. MD 5 was present in the operating room OR from 8:51 am to 9:11 am, 20 minutes. PA 1 had no documented in and out time recorded.


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9. Patient 1's IR dated 8/19/11 (Friday), noted that the coronary artery bypass surgery with a saphenous vein graft (leg vein) started at 12:23 pm and ended at 4:45 pm. Endoscopic and open saphenous vein harvest was also performed by PA 1 per IR.

The IR dated 8/19/11, noted that the Assistant Surgeon, MD 5 entered the OR 1 at 2 pm and left at 2:31 pm, 31 minutes. PA 1 was listed as First Assistant with no times and PA 2 time in was 2:05 pm with no time noting that they left the room.

10. Patient 6's IR dated 5/1/2012 (Tuesday), noted that Patient 6 had a coronary artery bypass surgery with an endoscopic saphenous vein harvest starting at 8:23 am and ending at 12:45 pm.

The IR dated 5/1/2012, noted that the Assistant Surgeon, MD 5 entered the OR 1 at 8:11 am and left at 8:12 am, for 1 minute. PA 3 was listed as First Assistant for the entire surgery with PA 2 entering at 8:27 am and leaving at 9:20 am.

11. Patient 8's IR dated 6/6/2012 (Wednesday), noted that Patient 8 had an urgent aortic valve replacement starting at 12:19 pm and ending at 2:25 pm. The IR dated 6/6/2012 noted that PA 1 was listed as First Assistant for the entire surgery.

12. Patient 12's IR by MD 2 dated 2/21/2012 (Tuesday), noted that Patient 12 had a coronary artery bypass surgery with a saphenous vein graft that started at 2:53 pm and ended at 5:36 pm. PA 1 took a vein from the left and right leg endoscopically (instrument used for direct visual inspection of hollow organs or body cavities). The IR dated 2/21/2012, noted that the Assistant Surgeon, MD 5 entered the OR 1 at 4:07 pm and left at 5 pm, 53 minutes. PA 1 was listed as First Assistant from 2:43 pm to 4:11 pm and from 4:54 pm to the end of the surgery. PA 4 was also listed as first assistant from 3:43 pm to 4:11 pm.

13. Patient 3's IR dated 5/3/2012 (Thursday), noted that Patient 3 had an mitral valve (located between the left atrium and ventricular chambers of the heart) and aortic valve (located replacement that started at 3:46 pm and ended at 8:32 pm. The IR dated 5/3/12 noted that the Assistant Surgeon, MD 5 re-entered the OR 1 at 5:12 pm and left at 5:47 pm and then entered at 6:13 pm and left at 6:17 pm, for total of 39 minutes . PA 2 was listed as the First Assistant.

14. Patient 9's IR dated 6/29/12 (Friday), noted that Patient 9 had a coronary artery bypass surgery with saphenous vein graft. The IR notes that the PA 3 took a vein from the left leg. The IR dated 6/29/12, noted that the Assistant Surgeon, MD 5 entered the OR 1 at 10:40 am and left OR 1 at 10:41 am, for 1 minute. PA 3 was listed as First Assistant for the entire surgery.

15. Patient 16's IR dated 12/20/12 (Thursday), noted that Patient 16 had a coronary artery bypass surgery with saphenous vein graft, off pump starting at 9:07 am and ending at 12:03 pm. The IR notes that the PA 3 took a vein from the right leg. The IR dated 12/20/12 noted that the Assistant Surgeon, MD 5 entered the OR 1 at 8:44 am and left OR 1 at 8:46 am, for 2 minutes. PA 3 was listed as First Assistant for the entire surgery and entered at 9:55 am and left at 10:42 am.

During an interview with OR RN 1 on 1/15/13 at 3:20 pm, she stated that the times were entered as the MD's and PA's enter and exit the OR. The times of exit are only documented if they leave prior to the close of the surgical procedure. OR RN 1 stated that the times were accurate.

Based on observation, interview and record review, the facility did not ensure that policies for surgical services were uniformly implemented throughout the facility, wherever surgical procedures were performed. The facility failed to ensure that these facility policies were followed: Surgical privileges and Medical Doctor (MD) first assistant (assist) surgeon, sedation privileges, patient History and Physical (H & P) requirements, Informed Consent and Universal Time Out. These failures increased the risk of complications and a poor health outcome for surgical patients.

Findings:

1. Surgical privileges and MD first assistant surgeon policies:

Review of the Bylaws of the Medical Staff, dated 7/12/12, indicated under duties of the department chair, "Determine qualifications and competence of department/division personnel who are not licensed independent practitioners and who provide patient care services." Under Application for Appointment, "each applicant..pledges to..refrain from providing "ghost" (pretend) surgical or medical services, and refrain from delegating patient care responsibilities to nonqualified or inadequately supervised practitioners."

Review of the facility Guidelines for Allied Health Professionals and Standardized Procedures, dated 5/2009, under General Standards for Allied Health Professionals indicated, "F. Possess and document the background, training, experience, judgment, ability and...authorized in accordance with generally recognized professional standards of quality and efficiency."

Review of the facility policy entitled Procedures Requiring A Surgeon Assistant or Assistants to the Surgeon, dated 3/2007, indicated, under "Cardio thoracic (Heart/Lung): "All procedures requiring Extra Corporeal Bypass (Heart/Lung Machine, Diversion of blood flow through a circuit located outside the body but continuous with the bodily circulation)." Meaning that the facility policy requires an MD surgeon assistant to be present and participate in all cardiothoracic (heart/lung) procedures requiring the patient to be "on pump (Heart/Lung Machine)."

During the initial facility tour on 1/14/13, at 12:05 pm, it was observed that MD 2 was performing cardiothoracic surgery in Operating Room (OR) 1. Across from MD 2 was Physician Assistant (PA) 3, acting as a first assistant. MD 5, the physician first assistant, was observed to be standing outside of OR 1. Also, two surgical technicians (technicians trained in assisting the surgeon with the sterile procedure) and two Registered Nurse (RN)'s were present in the OR (OR RN 1 & OR RN 2), per a concurrent interview with the Director of Surgical Services (DSS), who identified all surgical participants. Therefore, at that time there was only one MD present in the OR during a complex, specialized cardiothoracic surgery and his assistant was Physician Assistant (PA) 3.

During an interview with MD 5 on 1/14/13, at 12:05 pm, outside of OR 1, he/she stated that his/her duties as MD first assistant include holding forceps (two bladed instrument with a handle used for grasping or compressing tissues in surgical operations), facilitating (assisting the process) and increasing exposure (moving tissue for increased visualization of area) for MD 2. MD 5 further stated that when an emergency cardiothoracic case comes into the hospital, MD 5 is called into the hospital, if the patient is "on the pump (Heart/Lung Machine)." However, if the patient is not "on the pump" he/she "stays home waiting and MD 2 and the PA open the chest." Therefore in many cases there is only one MD present in the OR during a complex emergency cardiothoracic surgery, and his/her first assistant is a PA.

During an observation on 1/15/13, at 6:45 am in OR 1, Patient 27 was wheeled into OR 1 and prepared for surgery. At 7:30 am, the surgical time out was called with all staff present, except for MD 5, the MD first assistant. The PA began to perform the vein harvesting (to remove leg vein and use it for improving blood flow to the heart muscle) and at 7:50 am, MD 2 and the scrub technician began to open (incision at reast bone to get to the heart) the patient's chest. At 8:15 am, MD 5 arrived to assist with the surgical case.

During an interview on 1/16/13, at 3:50 pm, MD 2 was asked when the MD first assistant was expected to arrive in the OR to assist with surgery? MD 2 answered, "when I need them." When asked regarding the qualifications of the PA's who perform as first assist, MD 2 stated that he only needed an "assistant who has the dedicated time to be available to assist him for his cases." When MD 2 was told that the PA's did not have any documented cardiothoracic training, he stated that there was some "on the job training" that occurred with the PA's. When questioned about the PA's list of privileges, MD 2 stated that he "does the chest tubes (a tube inserted into the chest cavity for the purpose of removing air, or fluid, or both) , the PA's don't. The PA's don't do invasive things on their own." However, when it was suggested that the PA privilege list could be shortened to reflect actual PA practice, MD 2 stated he would prefer to keep the privileges as they were, "in case something happened to me and I was unavailable."

During an interview on 1/15/13, at 1:40 pm, Chief of Medical Staff, MD 1 stated "each department drives it's qualification requirements and how they evaluate staff competence." Also, that standards of practice are determined by evidence based practice and organizational standards. He stated he had "no first-hand knowledge of what the PA's were doing besides pre-operative, post-operative and vein harvesting. Anything else was "not in their scope of practice." He also volunteered that he "doubted the PA's were doing what the article said," referring to the article published in the Journal of the American Academy of Physician Assistants, dated 4/10/12, by a former facility PA, which claimed that "six PA's functioned as first assistants...cardiothoracic surgery..." When MD 1 was shown the list of surgical privileges granted to the cardiothoracic PA's and asked if it was a standard of practice for PA's to be doing these procedures? MD 1 replied, "PA's are doing a little more than I thought they would." When MD 1 was told there was no documented mechanism to capture the PA's function and job performance and he/she was asked if the PA's were qualified to perform as first assistants in cardiothoracic surgery, he stated "I don't know."

During an interview on 1/14/13, at 9:40 am, with the Chief Executive Officer (CEO), he stated the facility has employed PA's as first assistants for cardiothoracic surgeries since 2007. He also clarified that if a first assistant is needed on an emergent basis, and the MD first assistant was not on call, the PA is called into the hospital to be the first assistant for the emergency cardiothoracic surgical case. The CEO stated, "there was some confusion, on the facilities part, about how long the MD first assistant is required to stay in the surgical case." He questioned if the assistant should stay one minute, one hour or just as long as the MD first assistant is needed." During a second interview with the CEO on 1/16/13 at 10:20 am, while discussing the cardiothoracic surgery first assistant, he stated, "the surgeon can appoint anyone he/she wants as first assist."

During a second interview with MD 5, on 1/16/13, at 5:25 pm, he/she stated that the "new agreement" reached between MD 5 and the facility, was that he/she will be first assisting in all cardiothoracic surgeries as the MD first assist.

During a review of the credential files for all PA's assisting in cardiothoracic surgery (PA 1, PA 2, PA 3, and PA 4) on 1/15/13 at 11:20 am, and again at 3:55 pm, it was noted that there was no objective documentation of the education, competencies or past experience to justify the PA's performing complex, specialized surgery. During a concurrent interview with the Medical Staff Coordinator (MSC), he/she confirmed the lack of documentation of specialized education, experience or training of the PA's assisting in cardiothoracic surgery.

Review of the facility form Surgery Services/Cardiac Physician Assistant Annual Competency Assessment Tool (ACAT), dated 5/4/11, for PA 1, indicated "First assists the supervising surgeon during the procedure...Chest tube insertion (a tube inserted into the thoracic cavity for the purpose of removing air, or fluid, or both), Insertion of intra-aortic balloon ( a mechanical aid to the circulatory function of the heart)." The form was signed by MD 2 as the validator, and signed by the perfusionist (a technologist who operates the heart-lung machine during cardiopulmonary bypass surgery) as manager.

During a review of the credential file for PA 3, it was noted on the American Academy of Physician Assitants (AAPA) Physician Assistant Profile, dated 2/5/2010, that under Self Reported Practice Specialty he/she indicated "Surgery: Orthopedics." Documentation of proctoring at initial appointment was lacking, as it was for most of the cardiothoracic PA's. Recent activity at the facility was lacking from PA 3's file, as it was lacking from all PA files reviewed. It was difficult to generate a case volume quality report because all procedures performed were documented under the supervising physician's name. This made it difficult to objectively evaluate PA competency for each privilege granted. This means there was no documented process evident to assess the competency of the cardiothoracic PA's to perform the privileges granted. Review of the facility Cardiothoracic & Vascular Surgery Delineation of Privileges Physician Assistant form, approved by the governing board on 8/22/11, included Emergency sternotomy (incision at breast bone to get to the heart) and Swan-Ganz catheter (internal monitoring of heart introduced into an internal jugular vein or subclavian vein) insertion.

Record review of multiple surgical cases indicated that there was limited, or lack of, participation by the MD first assist in many of the cardiothoracic surgical cases reviewed.

Review of the Intra-operative Record form for Patient 2, dated 5/8/12, at 1:04 pm indicated that the staff entered the OR on 5/8/12 at 12:06 pm and exited the OR at 4:45 pm. Under Case Staff, Assistant Surgeons, MD 5 was listed and it indicated that MD 5 entered the OR at 4:16 pm and exited the OR at 4:17 pm, near the end of the surgery. Under Staff, two PA's (PA 3 & PA 2) were listed as First Assistant. According to the record, PA 2 entered the OR at 1:45 pm and exited at 2:12 pm. PA 3 had no OR in and out times listed, however, PA 3 was mentioned under Notes as follows: "Right leg vein out by PA 3 (12:57 - 1:24 pm), Left leg vein out by PA 3 (1:30 -1:53 pm)...Chest Xray at end of case cleared by PA 3."

Review of the Report of Operation dictated by MD 2 on 5/8/12, indicated under Assistant, all three assistants, MD 5, PA 2 and PA 3, however the report did not specify that PA 3 performed the secondary procedure, the harvest of the vein graft.

During an interview with OR RN 1 on 1/15/13, at 3:20 pm, she stated that when the RN documented the OR in and out time, they are documented exactly as they occur. The RN documents the OR times while watching the clock. Therefore, the documentation that MD 5 was only in the OR for one minute can be expected to be accurate. When asked why MD 5 was listed as the first assistant in that case, since he/she was only in the OR for one minute, OR RN 1 stated "it's the only way you can put MD 5 into the computer." She also stated "only the PA performs the vein harvesting procedure, never MD 5." Therefore, for every case that the PA performs the vein harvesting procedure, it would be expected that the PA would be listed on the Consent to Surgery or Special Procedure under Surgical Assistant. When asked about surgical assistants for MD 2, OR RN 1 stated, the surgical assistant "could be anyone, a scrub technician, first assistant (PA) or a doctor."

2. Sedation privileges were as follows:

Review of the facility policy and procedure entitled Procedural Sedation, dated 1/13/12, indicated underneath Policy: "Regulatory standards for sedation and anesthesia will be followed." Also, "The Physician supervising the administration...will be deemed competent to perform procedural sedation as evidenced by completion of the criteria stated below, Current Advanced Cardiac Life Support/Pediatrics Advanced Life Support (ACLS/PALS) as appropriate." (ACLS requirement effective 1/1/13). "Exemptions from ACLS/PALS... include...Verified Procedural Sedation in their clinical training program." Under References: ASA (American Society of Anesthesiologists) Guidelines are cited.

Review of Appendix A of the Procedural Sedation policy cited above, indicated "Physicians...desiring to obtain Procedural Sedation Privileges must comply...every two year re-granting of privileges." Also, "All physicians performing procedural sedation must comply with all criteria relevant to patient monitoring, levels of sedation....all standards of care..." Also "ACLS and/or PALS certified and current."

During the initial facility observation on 1/14/13 at 1:35 pm in Radiology (x-ray), Patient 22 was followed through his/her procedure, which included procedural sedation. After the nursing assessment, MD 6 met the patient for the first time and explained the risks and benefits of the procedure. No physical assessment by MD 6 was observed at that time. MD 6 proceeded with the procedure and at 2:15 pm, MD 6 ordered sedation for Patient 22 without performing an airway assessment.

During an interview with MD 6 on 1/14/13 at 3 pm, he/she was questioned about his/her lack of patient physical assessment before the procedure, and patient airway assessment before sedation was given. MD 6 responded that he/she meets the patient on the day of the procedure, reviews their records and does not examine the heart and lungs or airway. Instead, he/she relies on the nursing pre-screening and his/her years of experience. When questioned, MD 6 stated there was no moderate sedation criteria and replied that he/she does not have ACLS certification (specific training to respond to life threatening changes in heart rhythm for adults and children). MD 6 stated that the nurses have ACLS, if it is needed.

Review of the credential files for MD 6 and MD 7 indicated that they were both granted procedural sedation privileges which include both Moderate and Deep sedation. However, further review of the credential files for MD 6 and MD 7 indicated no documented evidence of Advance Cardiac Life Support (ACLS) certification, airway management training (knowledge of keeping airway open) or intubation training (special training to place a hollow tube down throat safely for breathing). There was no documented evidence that MD 6 or MD 7 was qualified by education, training and licensure to administer moderate sedation or deep sedation. Similar findings were found for MD 2, MD 8 and MD 9. These findings were confirmed by the Medical Staff Coordinator (MSC) on 1/16/13 at 9:30 am.

Record review of the Short Form History & Physical for Patient 22, dated 1/14/13 at 2:10 pm indicated Physical Exam: The boxes for Current vital signs reviewed, heart normal and lungs normal were all checked. Under Mallampati Classification (Visual examination to evaluate tongue size relative to the oral cavity): this airway assessment tool was left blank. Under conscious sedation, the box for Patient re-evaluated immediately prior to sedation was checked. These records have been documented as above, despite the lack of observed physical and airway assessments.

Review of the clinical record for Patient 23 indicated that he/she presented to radiology for an ultrasound guided paracentesis (surgical puncture of a cavity for the removal of fluid). A review of the Short Form History & Physical for Patient 23, dated 1/14/13, indicated a line drawn through the entire History and Physical portion of the form. There was no documentation of any kind on the History and Physical, meaning it was left completely blank. Under Sedation/Analgesia planned: local was checked.

During an interview on 1/15/13, at 1:40 pm, with the Chief of Medical Staff (MD 1), he/she stated that the expectations for History and Physical exams, was that they be performed within 30 days, and an interval update be performed the day of the procedure. This requirement was for all procedures, even those under local anesthesia. Also, this includes the expectation that a physical exam will be performed preoperatively and an airway assessment be completed before sedation is administered.

3. History and Physical:

Review of the facility policy and procedure entitled Procedural Sedation, dated 1/13/12, indicated underneath Policy: "Regulatory standards for sedation and anesthesia will be followed." Also, "The Physician supervising the administration... will be deemed competent to perform procedural sedation as evidenced by completion of the criteria stated below, Current ACLS/PALS as appropriate." (ACLS requirement effective 1/1/13). "Exemptions from ACLS/PALS... include...Verified Procedural Sedation in their clinical training program." Under References: ASA Guidelines were cited.

Review of Appendix A of the Procedural Sedation policy cited above, indicated "Physicians..desiring to obtain Procedural Sedation Privileges must comply...every two year re-granting of privileges." Also, "All physicians performing procedural sedation must comply with all criteria relevant to patient monitoring, levels of sedation...all standards of care..." Also "ACLS and/or PALS certified and current."

During the initial facility observation on 1/14/13 at 1:35 pm, in Radiology, Patient 22 was followed through his/her procedure, which included procedural sedation. After the nursing assessment, MD 6 met the patient for the first time and explained the risks and benefits of the procedure. No physical assessment by MD 6 was observed at that time. MD 6 proceeded with the procedure and at 2:15 pm, MD 6 ordered sedation for Patient 22 without performing an airway assessment.

During an interview with MD 6 on 1/14/13 at 3 pm, he/she was questioned about his/her lack of patient physical assessment before the procedure, and patient airway assessment before sedation was given. MD 6 responded that he meets the patient on the day of the procedure, reviews their records and does not examine the heart and lungs or airway. Instead, he/she relies on the nursing pre-screening and his/her years of experience. When questioned, MD 6 stated there was no moderate sedation criteria and replied that he/she does not have ACLS certification. MD 6 stated that the nurses have ACLS, if it is needed.

Record review of the Short Form History & Physical for Patient 22, dated 1/14/13 at 2:10 pm indicated Physical Exam: The boxes for Current vital signs reviewed, heart normal and lungs normal were all checked. Under Mallampati Classification: this airway assessment tool was left blank. Under conscious sedation, the box for Patient re-evaluated immediately prior to sedation was checked. These records have been documented as above, despite the lack of observed physical and airway assessments.

Review of the clinical record for Patient 23 indicated that he/she presented to radiology for an ultrasound guided paracentesis. A review of the Short Form History & Physical for Patient 23, dated 1/14/13, indicated a line drawn through the entire History and Physical portion of the form. There was no documentation of any kind on the History and Physical, meaning it was left completely blank. Under Sedation/Analgesia planned: local was checked.

During an interview on 1/15/13, at 1:40 pm, with the Chief of Medical Staff (MD 1), he/she stated that the expectations for History and Physical exams, was that they be performed within 30 days, and an interval update be performed the day of the procedure. This requirement was for all procedures, even those under local anesthesia. Also, this includes the expectation that a physical exam will be performed preoperatively and an airway assessment be completed before sedation is administered.


4. Informed Consent:

Review of the facility form Consent to Surgery or Special Procedure, dated 5/18/12 at 9 am, indicated "The Centers for Medicare and Medicaid Services require that you be informed of the name of each practitioner performing significant surgical tasks during your operation. "Significant surgical tasks" include, but are not limited to, opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices and altering tissues. You have informed that the following practitioner(s) will be performing surgical tasks: Surgical Assistant(s). In the event that the clinicians noted above are unable to perform or complete the task, a substitute may be assigned. This information will be documented in your medical record.

During a review of the article in the Journal of the American Academy of Physician Assistants, dated 4/10/12, entitled "The safety and efficacy of physician assistants as first assistant surgeons in cardiac surgery," written by a former facility PA, the abstract indicated that "a retrospective analysis was performed on all patients undergoing cardiac surgery over a 4-year period (N=956) at..medical center....PA's assisted in 22% of all cases (N=208)." The article further indicated that "Six PA's functioned as first assistants...cardiothoracic surgery.."

During the initial facility tour on 1/14/13, at 12:05 pm, it was observed that MD 2 was performing cardiothoracic surgery in OR 1. Across from MD 2 was PA 3, acting as a first assistant. MD 5, the physician first assistant, was observed to be standing outside of OR 1. Also, two surgical technicians and two RN's were present in the OR (OR RN 1 & OR RN 2), per a concurrent interview with the Director of Surgical Services (DSS), who identified all surgical participants. Therefore, at that time there was only one MD present in the OR during a complex, specialized cardiothoracic surgery and his assistant was PA 3.

During an interview with MD 5 on 1/14/13, at 12:05 pm, outside of OR 1, he/she stated that his/her duties as MD first assistant include holding forceps, facilitating and increasing exposure for MD 2. MD 5 further stated that when an emergency cardiothoracic case comes into the hospital, MD 5 was called into the hospital, if the patient was "on the pump." However, if the patient is not "on the pump" he/she "stays home waiting and MD 2 and the PA open the chest." Therefore in many cases there is only one MD present in the OR during a complex emergency cardiothoracic surgery, and his/her first assistant is a PA.

During an observation on 1/15/13 at 6:45 am, in OR 1, Patient 27 was wheeled into OR 1 and prepared for surgery. At 7:30 am, the surgical time out was called with all staff present, except for MD 5, the MD first assistant. The PA began to perform the vein harvesting and at 7:50 am, MD 2 and the scrub technician began to open the patient's chest. At 8:15 am, MD 5 arrived to assist with the surgical case.

During an interview on 1/16/13, at 3:50 pm, MD 2 was asked when the MD first assistant was expected to arrive in the OR to assist with surgery? MD 2 answered, "when I need them." When asked regarding the qualifications of the PA's who perform as first assist, MD 2 stated that he only needed an "assistant who has the dedicated time to be available to assist him for his cases." When MD 2 was told that the PA's did not have any documented cardiothoracic training, he stated that there was some "on the job training" that occurred with the PA's. When questioned about the PA's list of privileges, MD 2 stated that he "does the chest tubes, the PA's don' t. The PA's don' t do invasive things on their own." However, when it was suggested that the PA privilege list could be shortened to reflect actual PA practice, MD 2 stated he would prefer to keep the privileges as they were, "in case something happened to me and I was unavailable."

During an interview on 1/15/13, at 1:40 pm with Chief of Medical Staff (MD 1), he/she stated "each department drives it's qualification requirements and how they evaluate staff competence." Also, that standards of practice were determined by evidence based practice and organizational standards. He stated he had "no first-hand knowledge of what the PA's were doing besides pre-operative, post-operative, and vein harvesting." Anything else was "not in their scope of practice." He also volunteered that he "doubted the PA's were doing what the article said," referring to the article published by a former facility PA, which claimed that "six PA's functioned as first assistants...cardiothoracic surgery.." When MD 1 was shown the list of surgical privileges granted to the cardiothoracic PA's and asked if it was a standard of practice for PA's to be doing these procedures? MD 1 replied, "PA's are doing a little more than I thought they would." When MD 1 was told there was no documented mechanism to capture the PA's function and job performance and he/she was asked if the PA's were qualified to perform as first assistants in cardiothoracic surgery, he stated "I don't know."

Review of the Intra-operative Record form for Patient 2, dated 5/8/12 at 1:04 pm, indicated that the staff entered the OR on 5/8/12 at 12:06 pm and exited the OR at 4:45 pm. Under Case Staff, Assistant Surgeons, MD 5 was listed and it indicated that MD 5 entered the OR at 4:16 pm and exited the OR at 4:17 pm, near the end of the surgery. Under Staff, two PA's (PA 3 & PA 2) were listed as First Assistant. According to the record, PA 2 entered the OR at 1:45 pm and exited at 2:12 pm. PA 3 had no OR in and out times listed, however, PA 3 was mentioned under Notes as follows: "Right leg vein out by PA 3 (12:57 - 1:24 pm), Left leg vein out by PA 3 (1:30 - 1: 53 pm)...Chest Xray at end of case cleared by PA 3."

Review of the Report of Operation dictated by MD 2 on 5/8/12, indicated under Assistant, all three assistants, MD 5, PA 2 and PA 3, however the report did not specify that PA 3 performed the secondary procedure, the harvest of the vein graft.

Review of the Consent to Surgery or Special Procedure dated 5/8/12, at 9 am, the consent indicated: "require that you be informed of the name of each practitioner performing significant surgical tasks during your operation...include...opening and closing, harvesting grafts." You have been informed that the following practitioner(s) will be performing surgical tasks: Surgical Assistant(s): MD 5 was indicated. No other surgical participants were noted on the consent form. "In the event that the clinicians noted above are unable to perform or complete the task, a substitute may be assigned." This means that the patient consented to MD 2 and MD 5 performing his/her surgery, and if something unusual occurred, the patient consented to a substitute. Because many of the cardiothoracic surgeries are scheduled, the facility was aware, at the time of patient Informed Consent, which Surgical Assistants will be participating in the surgical procedure.

During an interview with OR RN 1 on 1/15/13, at 3:20 pm, she stated that when the RN documented the OR in and out time, they are documented exactly as they occur. The RN documents the OR times while watching the clock. Therefore, the documentation that MD 5 was only in the OR for one minute can be expected to be accurate. When asked why MD 5 was listed as the first assistant in that case, since he/she was only in the OR for one minute, OR RN 1 stated "it's the only way you can put MD 5 into the computer." She also stated "only the PA performs the vein harvesting procedure, never MD 5." Therefore, for every case that the PA performs the vein harvesting procedure, it would be expected that the PA would be listed on the Consent to Surgery or Special Procedure under Surgical Assistant. When asked about surgical assistants for MD 2, OR RN 1 stated, the surgical assistant "could be anyone, a scrub technician, first assistant or a doctor."


5. Universal Time Out

Review of the facility policy Universal Protocol for Ensuring Correct Site, Correct Procedure, Correct Person for Surgery and Other Invasive Procedures (Time Out Policy), under Policy: 3. "It is initiated by a designated member of the team...and involves all of the immediate members participating in the procedure."

During the initial facility tour on 1/14/13, at 12:05 pm, it was observed that MD 2 was performing cardiothoracic surgery in OR 1. Across from MD 2 was PA 3, acting as a first assistant. MD 5, the physician first assistant, was observed to be standing outside of OR 1. Also, two surgical technicians and two RN's were present in the OR (OR RN 1 & OR RN 2), per a concurrent interview with the Director of Surgical Services (DSS), who identified all surgical participants. Therefore, at that time there was only one MD present in the OR during a complex, specialized cardiothoracic surgery and his assistant was PA 3.

During an interview with MD 5 on 1/14/13, at 12:05 pm, outside of OR 1, he/she stated that his/her duties as MD first assistant include holding forceps, facilitating and increasing exposure for MD 2. MD 5 further stated that when an emergency cardiothoracic case comes into the hospital, MD 5 is called into the hospital, if the patient is "on the pump." However, if the patient is not "on the pump" he/she "stays home waiting and MD 2 and the PA open the chest." Therefore in many cases there was only one MD present in the OR during a complex emergency cardiothoracic surgery, and his/her first assistant was a PA.

During an observation on 1/15/13, at 6:45 am in OR 1, Patient 27 was wheeled into OR 1 and prepared for surgery. At 7:30 am, the surgical time out was called with all staff present, except for MD 5, the MD first assistant. The PA began to perform the vein harvesting and at 7:50 am, MD 2 and the scrub technician began to open the patient's chest. At 8:15 am, MD 5 arrived to assist with the surgical case.

During an interview on 1/16/13, at 3:50 pm, MD 2 was asked when the MD first assistant was expected to arrive in the OR to assist with surgery? MD 2 answered, "when I need them." When asked regarding the qualifications of the PA's who perform as first assist, MD 2 stated that he only needed an "assistant who has the dedicated time to be available to assist him for his cases." When MD 2 was told that the PA's did not have any documented cardiothoracic training, he stated that there was some "on the job training" that occurred with the PA's. When questioned about the PA's list of privileges, MD 2 stated that he "does the chest tubes, the PA's don't. The PA's don't do invasive things on their own." However, when it was suggested that the PA privilege list could be shortened to reflect actual PA practice, MD 2 stated he would prefer to keep the privileges as they were, "in case something happened to me and I was unavailable."

During an interview on 1/14/13, at 9:40 am, with the Chief Executive Officer (CEO), he stated that in 2007, the facility "checked the legal definition of a first assistant." The facility asked for legal clarification of a first assistant, and was satisfied that the PA's could be used. Thus, the facility has employed PA's as first assistants for cardiothoracic surgeries since 2007. He also clarified that if a first assistant is needed on an emergent basis, and the MD first assistant was not on call, the PA was called into the hospital to be the first assistant for the emergency cardiothoracic surgical case. The CEO stated, "there was some confusion, on the facilities part, about how long the MD first assistant is required to stay in the surgical case." He questioned if the assistant should stay one minute, one hour or just as long as the MD first assistant is needed." During a second interview with the CEO on 1/16/13 at 10:20 am, while discussing the cardiothoracic surgery first assistant, he stated, "the surgeon can appoint anyone he/she wants as first assist."

Record review of multiple surgical cases indicated that there was limited, or lack of, participation by the MD first assist in many of the cardiothoracic surgical cases reviewed.

Review of the Intra-operative Record form for Patient 2, dated 5/8/12, at 1:04 pm, indicated that the staff entered the OR on 5

Based on interview and record review, the facility failed to inform cardiac/thoracic (heart/lung) surgery patients, who the team of professionals would be assisting the surgeon for 12 or 27 sampled patients (Patients 1, 3, 4, 6, 7, 8, 9, 12, 13, 15, 17, and 18) per facility policy. This lack of documentation had the potential for patients not to be fully informed of all the individuals involved in their surgical procedure.

Findings:

During the review of the facility's policy titled, "Informed Consent," dated 10/10, read, "When patients are undergoing treatments or procedures that are considered complex, they have the right to be informed of the available alternative methods of treatment, and their risks and benefits, as well as the person performing the procedure, or the person(s) performing significant surgical tasks. Significant surgical tasks, include but are not limited to, opening and closing, harvesting grafts, dissecting tissues, removing tissue, implanting devices and altering tissues. The practice is known as informed consent."

During an interview and record review on 1/16/13 at 10:35 am, with the CEO (Chief Executive Officer) and VP-PCS (Vice President of Patient Care Services) both stated that a surgical informed consent needs to contain all the required elements, in order to ensure that the patient is fully informed. This would include all the individuals involved within their planned surgical procedure.

During an interview on 1/16/13 at 3:55 pm, with MD 2, he confirmed that the PAs do all of the endoscopic vein harvesting, which would be considered a significant surgical task.

1. According to Patient 4's operative report, on 10/7/11 (Friday), Patient 4 went into surgery for a urgent redo (repeat) coronary artery bypass surgery with saphenous vein graph (Vein in leg used for heart surgery). Endoscopic (instrument used for direct visual inspection of hollow organs or body cavities) saphenous vein harvest was performed. The operative report indicated that MD (Medical Doctor) 2 performed the procedure assisted by MD 5, Physician Assistant (PA) 1 and PA 2.

The surgical consent signed by Patient 4 on 10/6/11, only indicated that MD 2 and PA 1 would be involved in the surgical procedure.

2. According to Patient 13's operative report, on 7/6/11, Patient 13 went into surgery for aortic valve (valve from the heart to the rest of the body) replacement. The operative report indicated that MD 2 performed the procedure assisted by MD 5 and PA 3.

The surgical consent signed by Patient 13 on 7/6/11, only indicated that MD 2 and MD 5 would be involved in the surgical procedure.

3. According to Patient 15's operative report, on 2/15/12, Patient 15 went into surgery for aortic valve replacement and coronary artery bypass surgery with saphenous vein graft. Endoscopic saphenous vein harvest was performed. The operative report indicated that MD 2 performed the procedure assisted by MD 5 and PA 2.

The surgical consent signed by Patient 15 on 2/15/12, only indicated that MD 2 would be involved in the surgical procedure.

4. According to Patient 17's operative report, on 12/25/12, Patient 17 went into surgery for an urgent coronary artery bypass surgery with left saphenous vein harvest performed. The operative report indicated that MD 2 performed the procedure assisted by MD 5 and PA 1.

The surgical consent signed by Patient 4 on 12/25/12, only indicated that MD 2 would be involved in the surgical procedure.

5. According to Patient 18's operative report, on 12/31/12, Patient 18 went into surgery for an urgent coronary artery bypass surgery with endoscopic saphenous vein harvest performed. The operative report indicated that MD 2 performed the procedure assisted by MD 5 and PA 2.

The intraoperative report dated 12/31/12 indicated that MD 5 and MD 10 were involved in Patient 18's procedure.

The surgical consent signed by Patient 18 on 12/30/12, only indicated that MD 2 would be involved in the surgical procedure.

6. According to Patient 7's operative report, on 3/15/12, Patient 7 went into surgery for a aortic valve replacement and coronary artery bypass surgery with endoscopic saphenous vein harvest performed. The operative report indicated that MD 2 performed the procedure assisted by MD 5 and PA 1.

The surgical consent signed by Patient 7 on 3/15/12, only indicated that MD 2 and MD 5 would be involved in the surgical procedure.


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7. Patient 1's operative report by MD 2 dated 8/19/2011, noted that Patient 1 had an urgent coronary artery bypass surgery. Endoscopic and open saphenous vein harvest was also performed. MD 2 documented in the operative report that MD 5, PAs 1, and 2 assisted in the surgical procedures.

The consent signed by Patient 1 on 8/18/2011 at 3:15 pm, indicated that MD 2 would be the ordering physician for coronary artery bypass graft. The consent form did not have documentation of MD 5 or PA 1 and PA 2 that the operative report reflected as participating in the surgical procedures.

8. Patient 6's operative report by MD 2 dated 5/1/2012, noted that Patient 6 had an urgent coronary artery bypass surgery with an endoscopic saphenous vein harvest. MD 2 documented in the operative report that MD 5, PA 2, and PA 3 assisted in the surgical procedures.

The consent signed by Patient 6 on 4/30/2012 at 9:50 pm, indicated that MD 2 would perform the surgical procedures. The consent did not contain documentation that MD 5, PA 2, and PA 3 would be participating in the surgicial procedure.

9. Patient 8's operative report dated 6/6/2012, noted that Patient 8 had an urgent aortic valve replaement. MD 2 documented in the operative report that PA 1 assisted in the surgical procedure.

The consent signed by Patient 8 on 6/6/2012 at 9:20 pm, indicated that MD 2 would be the surgeon to perform the aortic valve replacement. The consent did not reflect that PA 1 would particpate in the surgical procedure.

10. Patient 12's operative report dated 2/21/2012, noted that Patient 12 had a coronary artery bypass surgery. Endoscopic saphenous vein harvest was also performed. MD 2 documented in the operative report that MD 5 and PA 1 assisted in the surgical procedures.

The consent signed by Patient 12 on 2/21/2012 at 12 pm, indicated that MD 2 would be the physician for coronary artery bypass graft and MD 5 was listed as the surgical asisstant. PA 1 was not listed on the consent form dated 2/21/2012.

11. Patient 3's operative report, dated 5/3/2012, noted that Patient 3 had an emergency mitral valve and aortic valve replacement. MD 2 documented in the operative report that MD 5 and PA 2 assisted in the surgical procedures.

The consent signed by Patient 3 on 12/19/2012, indicated that MD 2 would be the surgeon to perform the surgical procedure. The consent did not reflect that MD 5 or PA 1 participated in the in the surgical procedures as reflected in the operative report.

12. Patient 9's operative report, dated 6/29/12, noted that Patient 9 had an urgent coronary artery bypass surgery. The operative report notes that the PA 3 took a vein from the left leg. MD 3 documented in the operative report that MD 5 and PA 3 assisted in the surgical procedures.

The consent signed by Patient 9 on 6/28/2012 at 11:45 pm, indicated that MD 3 was the physician for coronary artery bypass graft. The consent did not reflect that MD 5 or PA 3 were to participate in the surgical procedures.