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Based on interview and record review, the facility failed to meet the requirements of licensure according to:

1. CCR, Title 22, §70435(b)(2) by failing to ensure that the requirement for having three surgeons (two with a program flex) being present during cardiac surgery with extracorporeal bypass, were met (A022);

2. CCR, Title 22, §70435(b)(1) by failing to ensure that the chief of the cardiovascular surgery service participated in training nursing staff to be competent to staff cardiovascular surgeries (A022); and,

3. CCR, Title 22, §70435(d) by failing to ensure that the cardiovascular surgical service was available at all times for emergencies (A022).

The cumulative effect of these systemic problems resulted in the failure of the facility to ensure compliance with licensing requirements, to operate a cardiovascular service in the State of California.

Based on interview and record review, the facility failed to meet the requirements for licensing
as a cardiovascular service according to:

1. CCR, Title 22, §70435(b)(2) by failing to ensure for five of ten patients reviewed, that the requirement for having three surgeons present (two surgeons with an approved program flex) during cardiac surgery with extracorporeal bypass, were met (Patients 103, 107, 110, 203, and 216) (A022);

2. CCR, Title 22, §70435(b)(1) by failing to ensure that the chief of the cardiovascular surgery service participated in training nursing staff to be competent to staff cardiovascular surgeries (A022); and,

3. CCR, Title 22, §70435(d) by failing to ensure that the cardiovascular surgical service was available at all times for emergencies (A022).

These failures resulted in the inability to ensure compliance with licensing requirements to operate a cardiovascular service in the State of California, and the potential for substandard health outcomes for all patients having cardiovascular surgery at the facility.

Findings:

1. According to CCR, Title 22, §70435 (b)(2), a minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass.

A program flex was issued by the Department on December 9, 1994, which allowed the facility to perform cardiovascular operative procedures requiring extracorporeal bypass with a minimum of two surgeons. (Extracorporeal bypass is a technique that temporarily takes over [bypasses] the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body).


a. The record for Patient 103 was reviewed on October 18, 2011. Patient 103, a 68 year old female, was admitted on June 20, 2011, with diagnoses that included thoracic aortic aneurysm (a weakened and bulging area in the upper part of the aorta, the major blood vessel that feeds blood to the body). The patient underwent a repair of the aneurysm (a procedure that required extracorporeal bypass) on June 20, 2011.

According to the Perfusionist Record, the patient was placed on bypass at 10:16 a.m., and taken off of bypass at 1:48 p.m.

According to the Intraoperative Nurse's Notes, the assistant surgeon entered the operating room at 9:59 a.m., left the room at 12:58 p.m., and re-entered the room at 2:26 p.m.

The assistant surgeon was out of the room for 29 minutes while the patient was on bypass.

b. The record for Patient 107 was reviewed on October 18, 2011. Patient 107, a 70 year old male, was admitted to the facility on July 12, 2011, with diagnoses that included CAD. The patient underwent four vessel CABG surgery (veins from elsewhere in the body are attached to the coronary arteries to bypass blockages and improve the blood supply to the heart) on July 14, 2011.

According to the Perfusionist Record, the patient was placed on bypass at 3:46 p.m., and taken off of bypass at 5:17 p.m.

According to the Intraoperative Nurse's Notes, the assistant surgeon entered the operating room at 3:27 p.m., left the room at 4:35 p.m., and did not return.

The assistant surgeon was out of the room for 42 minutes while the patient was on bypass.

c. The record for Patient 110 was reviewed on October 20, 2011. Patient 110, a 66 year old male, was admitted to the facility on August 22, 2011, with diagnoses that included AMI (heart attack), severe CAD, and severe aortic valve regurgitation (the heart's aortic valve was not closing tightly).

The patient underwent emergency three vessel CABG surgery and aortic valve replacement on August 22, 2011.

According to the Perfusionist Record, the patient was placed on bypass on August 22, 2011, at 11:01 p.m., and taken off of bypass on August 23, 2011, at 1:44 a.m.

According to the Intraoperative Nurse's Notes, the assistant surgeon entered the operating room on August 22, 2011, at 10:30 p.m., left the room on August 23, 2011, at 12:35 a.m., and did not return.

The assistant surgeon was out of the room for one hour and nine minutes while the patient was on bypass.


d. On October 6, 2011, the record for Patient 203 was reviewed. Patient 203, a 68 year old male, was admitted to the facility on July 8, 2011, with diagnoses including mitral valve disorder (nonfunctioning valves between the left heart chambers) and coronary atherosclerosis (inflammatory disease with fibrous tissue or plaque on the walls of coronary arteries that supplies heart muscle).


Patient 203 had surgery on July 8, 2011. The documentation on the perioperative record indicated the procedures performed included, "Redo Sternotomy (incision into chest), CABG (bypass surgery), maze procedure (surgical procedure using incisions to form a maze through which impulses can travel to treat irregular electrical activity of the upper chambers of the heart), Mitral Valve repair/replace".


The following start and stop times were indicated in the operative record:


Anesthesia start: 7:32 a.m.
Anesthesia end: 4:36 p.m.
Surgery start: 9 a.m.
Surgery end: 4:31 p.m.


Assisting Surgeon:
Time In: 9:30 a.m. / Time Out: 12:55 p.m.; and,
Time In: 2:35 p.m. / Time Out: 4:27 p.m.


Perfusion Time: 11:47 a.m. to 3:06 p.m.; a total of 3 hours and 19 minutes.


The assisting surgeon, Surgeon 4, arrived in the operating room 30 minutes after the surgery began. Surgeon 4 left the operating room between 12:55 p.m. and 2:35 p.m., for one hour and 40 minutes, while the patient was on bypass.


On October 6, 2011, at 2:15 p.m., the Perioperative Services Director stated she was upset when she heard Surgeon 4 was out of the room, and stated administration had been notified. The Director could not confirm the situation had been resolved.


e. On October 21, 2011, Patient 216's record was reviewed. Patient 216 was admitted on September 22, 2011, with diagnoses including aortic insufficiency (inadequate blood supply to the largest artery in the body), status post aortic valve replacement. Patient 216 had surgery on September 22, 2011, for aortic valve replacement and repair of an ascending aortic aneurysm.


The following start and stop times were indicated on the perioperative record:


Anesthesia start: 7:45 a.m.
Anesthesia end: 2:10 p.m.
Surgery start: 8:52 a.m.
Surgery end: 1:41 p.m.


Assisting Surgeon:
Time In: 8:25 a.m. / Time Out: 9:40 a.m.,
Time In: 10:34 a.m. / Time Out: 12:09 p.m.; and,
Time In: 12:32 p.m. / Time Out: 1 p.m.


Perfusion Time: 10:13 a.m. to 12:29 p.m.; a total of 2 hours and 41 minutes.


The assisting surgeon (Surgeon 4) arrived in the operating room 21 minutes after the bypass pump was on and left the room 20 minutes before the bypass pump was off. Assisting Surgeon 4 was out of the room for 41 minutes while the pump was on.


On October 6, 2011, at 10:20 a.m., Nurse 228 stated, "...not always two surgeons in the room. I document when they leave the room and when they come back. I go straight to the managers. I tell them you have to be here, you are jeopardizing the patients..."


On October 6, 2011, at 10:25 a.m., Nurse 227 stated, "We have to document, otherwise we will be fired. There was an ascending aortic aneurysm surgery, I wrote an incident, only the PA (was) left in room while the patient was warming, (Physician 232) left. I called the charge nurse, the charge nurse called the manager, the manager called the director. The doctor was gone for 12 minutes. There is too much in and out for doctors. It has always been the practice."


During an interview on October 6, 2011, at 7:50 a.m., the Director of Perioperative Services stated the scheduler had a grid in the scheduling policy indicating which cases needed an assistant.


During an interview with the Director of Perioperative Services on October 20, 2011, at 1:05 p.m., she stated the nurses reported to her that the assisting cardiovascular surgeons were leaving the room while the patients were on the bypass pump.


During an interview with Surgeon 2 (a cardiovascular surgeon) on October 21, 2011, at 2:30 p.m., he stated it was not uncommon for a surgeon to leave the room during the rewarming process (while the patient was still on bypass).

The Medical Staff Bylaws were reviewed on October 20, 2011. The preamble of the bylaws indicated members of the medical staff at the facility were expected to follow state laws applicable to the practice of medicine.

The Medical Staff Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated the operating surgeon must have an assistant at all major operations designated by the department.

The Surgical Department Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated each section would be responsible for listing the procedures where a surgical specialist was required as an assistant.

The surgical department policy titled, "Assistants During Cardiovascular Surgery," was reviewed on October 20, 2011. The policy indicated a qualified assistant surgeon would be present for cardiovascular surgical cases while the patient was on extracorporeal bypass.


2. According to CCR, Title 22, §70435(b)(1), a physician shall have overall responsibility for the cardiovascular service. This physician shall be responsible for training and supervising the nurses and technicians in special techniques.


During an interview with the Director of Perioperative Services on October 20, 2011, at 1:05 p.m., she stated Surgeon 3 (the cardiovascular surgery section chief) was not involved in training of the OR staff.


During an interview with the COO on October 20, 2011, at 1:20 p.m., he stated the chief of the cardiovascular surgery service (Surgeon 3) was not contributing to training the OR staff.


3. According to CCR, Title 22, §70435(d), the cardiovascular surgical service shall be available at all times for emergencies.


During an interview with the Director of Perioperative Services on October 20, 2011, at 1:05 p.m., she stated she was not sure if staff being used as the cardiovascular second team were trained to participate in cardiovascular surgeries. She stated that CVOR staff frequently worked late and were not available to act as "on call" staff due to their union contract, although they were scheduled to be on call.


In an interview conducted on October 19, 2011, at 9:15 a.m., Surgeon 1 stated the hospital was a STEMI Center and should have two cardiovascular teams available. He stated they did not have two teams and had to, "Scramble with anesthesia and staff to find a team if there was an emergency." Surgeon 1 further stated they had to postpone morning cases because nurses had worked the night before and there was only one heart team. He stated the team varied from day to day and they may not have the ability to do the cases coming in to the ER.


The nursing union contract was reviewed on October 19, 2011. The contract indicated the nursing staff was entitled to an eight hour break every 24 hour period. The contract indicated the staff did not have to respond to an emergency if they did not have their eight hour break.

Based on interview and record review, the Governing Body failed to ensure the facility functioned effectively, by failing to:


1. Ensure compliance with licensing requirements to operate a cardiovascular service in the State of California (A020);


2. Develop, implement, and maintain a QAPI program to ensure the quality and safety of surgical services offered by the cardiovascular surgery section (A263);


3. Ensure the Medical Staff was responsible and accountable for the quality of medical care provided to the patients (A338); and,


4. Ensure the competency of nursing staff on the cardiovascular surgery team (A397).


The cumulative effect of these systemic problems resulted in failure to ensure medical and nursing care was provided in a safe and effective manner.

Based on interview and record review, the facility failed to:


1. Ensure the integrity of the appraisal process for two surgeons (Surgeons 1 and 5), creating the risk of substandard services being provided to all patients receiving services from those surgeons (A340);


2. Ensure the medical staff was accountable to the governing body for the quality of patient care provided, by failing to:


a. Ensure physicians conducted themselves in a professional and cooperative manner during surgical procedures, resulting in the potential for errors to be made by staff (A347); and,


b. Ensure members of the medical staff were in compliance with their Rules and Regulations, Surgical Department Rules and Regulations, and the facility policy requiring two surgeons to be present in the operating room during cardiovascular surgery requiring bypass, resulting in the potential for harm to patients undergoing cardiovascular surgery (A347);


3. Ensure enforcement of their bylaws by failing to ensure an adequate and effective peer review process was completed for one surgeon (Surgeon 1), resulting in the potential for poor health outcomes for the surgeon's patients (A353);


4. Obtain a list of requested privileges for one surgeon (Surgeon 5) who was acting as an assisting surgeon. The facility failed to identify all of the types of surgeries Surgeon 5 was planning to assist with, and allowed him to be scheduled to assist with surgeries for which he was not privileged, resulting in the risk of substandard surgical outcomes for patients having surgery with Surgeon 5 as the assisting surgeon (A355); and,


5. Identify specific privileges for one surgeon (Surgeon 1) who was actively performing cardiovascular surgeries, and to document the reason for the department chair not recommending granting of the privileges, resulting in the risk of a substandard surgical outcome for patients treated by Surgeon 1 (A355).


The cumulative effect of these systemic problems resulted in the failure to ensure that patients at the facility were receiving safe and effective medical care by physicians.

Based on interview and record review, the facility failed to ensure the integrity of the appraisal process for two surgeons (Surgeons 1 and 5), resulting in the risk of substandard services being provided to all patients receiving services from those surgeons.

Findings:

1. During a review of the credential file for Surgeon 1 on October 21, 2011, the periodic performance evaluation data was reviewed, and a discrepancy between the data recorded on October 18, 2010, and that documented on the data summary form dated November 10, 2010, was noted.

During a concurrent interview with the Director of Medical Staff, she reviewed the October 18, 2010, quality data and the November 10, 2010, summary form for the data in Surgeon 1's file. The Director of Medical Staff stated it looked like the data regarding concerns about Surgeon 1 had, in error, not been carried forward to the summary form, which was one of the documents reviewed at the time of Surgeon 1's last reappointment.

2. During a review of the credential file for Surgeon 5 on October 18, 2011, there were two letters of reference noted in the file for his last reappointment.

During a concurrent interview of the Medical Staff Assistant, she stated the facility required three letters of reference for physician reappointment. She was unable to explain why only two letters of reference were seen for Surgeon 5's 2011 reappointment.

Based on interview and record review, the facility failed to ensure that the medical staff was accountable to the governing body for the quality of patient care provided, by failing to:

1. Ensure physicians conducted themselves in a professional and cooperative manner during surgical procedures, resulting in the potential for errors to be made by staff; and,

2. Ensure members of the medical staff were in compliance with their Rules and Regulations, Surgical Department Rules and Regulations, and the facility policy requiring two surgeons to be present in the operating room during cardiovascular surgery requiring bypass, resulting in the potential for harm to patients undergoing cardiovascular surgery.

Findings:

1a. The Medical Staff Bylaws were reviewed on October 20, 2011. Section 2 indicated successful candidates for clinical privileges must adhere to professional and cooperative behavior, and demonstrate their ability to work with others with sufficient adequacy to assure the Board of Directors that any patient treated by them in the hospital would be given a high quality of medical care.

The Medical Staff Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated unacceptable physician behavior would be dealt with according to the Medical Staff Physician/AHP Behavior Policy.

The Medical Staff Physician/AHP Behavior policy was reviewed on October 6 and 20, 2011. The policy indicated the following:

aa. All physicians and AHPs were required to conduct themselves in a professional manner;

bb. To ensure quality care, the medical staff leadership produced the policy to provide a process to identify and address individual practitioner behavior that was not conducive to quality patient care, including a high level of service and teamwork;

cc. Interdisciplinary communication/interaction issues (defined as behavior that was disruptive [e.g. unprofessional interactions with staff]) would be investigated, with the results of the investigation referred to the department/section chairman for review and adjudication; and,

dd. An identified pattern or trend, defined as five or greater incidents in a rolling six month period, would be referred to the president of the medical staff.

1b. A confidential group interview was conducted with OR staff members on October 19, 2011, starting at 2 p.m. The OR staff members expressed their frustration and concerns about a very tense and punitive working environment. The following were issues the staff members stated were occurring in the OR:

aa. hesitation to be trained for cardiovascular surgery due to unprofessional treatment by the physicians; and,

bb. failure of management to follow up on reports of physician behavior;

1c. A facility report was reviewed on October 20, 2011, indicating Surgeon 1 was yelling and being verbally abusive. The note on the report indicated it was sent to the medical staff on July 27, 2011, but no investigation or discussion with Surgeon 1 was documented.

During an interview with the Director of Risk Management on October 21, 2011, at 10 a.m., the Director of Risk Management stated she would have expected the incidents involving the OR to be investigated and the physician(s) interviewed, but she did not see evidence of such investigations.

During an interview with the Director of Perioperative Services on October 21, 2011, at 11 a.m., the Director stated she routed the reports to the medical staff and QA, but she did not investigate or ask anyone else to investigate the incidents. She stated she thought QA or the medical staff would do the investigation. She stated she did not recall any training in how the reports were to be handled by facility management staff.

2. The Medical Staff Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated the operating surgeon must have an assistant at all major operations designated by the department.

The Surgical Department Rules and Regulations were reviewed on October 20, 2011. The rules and regulations indicated each section would be responsible for listing procedures that a surgical specialist was required as an assistant.

The surgical department policy titled, "Assistants During Cardiovascular Surgery," was reviewed on October 20, 2011. The policy indicated a qualified assisting surgeon would be present for cardiovascular surgical cases while the patient was on extracorporeal bypass. (Extracorporeal bypass is a technique that temporarily takes over [bypasses] the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body).

A memorandum from the Chairman of the Surgical Department dated September 21, 2011, and a letter dated October 7, 2011, from the Medical Director of Perioperative Services both advised the medical staff that surgical assistants were to remain present during cardiovascular surgery until the portion of the surgery requiring bypass was completed.

a. The record for Patient 103 was reviewed on October 18, 2011. Patient 103, a 68 year old female, was admitted on June 20, 2011, with diagnoses that included thoracic aortic aneurysm (a weakened and bulging area in the upper part of the aorta, the major blood vessel that feeds blood to the body).

The patient underwent a repair of the aneurysm (a procedure that required extracorporeal bypass) on June 20, 2011.

According to the Perfusionist Record, the patient was placed on bypass at 10:16 a.m., and taken off of bypass at 1:48 p.m.

According to the Intraoperative Nurse's Notes, the assisting surgeon entered the operating room at 9:59 a.m., left the room at 12:58 p.m., and re-entered the room at 2:26 p.m.

The assisting surgeon was out of the room for 29 minutes while the patient was on bypass.

b. The record for Patient 107 was reviewed on October 18, 2011. Patient 107, a 70 year old male, was admitted to the facility on July 12, 2011, with diagnoses that included CAD.

The patient underwent four vessel CABG surgery (veins from elsewhere in the body are attached to the coronary arteries to bypass blockages and improve the blood supply to the heart) on July 14, 2011.

According to the Perfusionist Record, the patient was placed on bypass at 3:46 p.m., and taken off of bypass at 5:17 p.m.

According to the Intraoperative Nurse's Notes, the assisting surgeon entered the operating room at 3:27 p.m., left the room at 4:35 p.m., and did not return.
The assisting surgeon was out of the room for 42 minutes while the patient was on bypass.

c. The record for Patient 110 was reviewed on October 20, 2011. Patient 110, a 66 year old male, was admitted to the facility on August 22, 2011, with diagnoses that included AMI (heart attack), severe CAD, and severe aortic valve regurgitation (the heart's aortic valve was not closing tightly).

The patient underwent emergency three vessel CABG surgery and aortic valve replacement on August 22, 2011.

According to the Perfusionist Record, the patient was placed on bypass on August 22, 2011, at 11:01 p.m., and taken off of bypass on August 23, 2011, at 1:44 a.m.

According to the Intraoperative Nurse's Notes, the assisting surgeon entered the operating room on August 22, 2011, at 10:30 p.m., left the room on August 23, 2011, at 12:35 a.m., and did not return.

The assisting surgeon was out of the room for one hour and nine minutes while the patient was on bypass.


d. On October 6, 2011, the record for Patient 203 was reviewed. Patient 203, a 68 year old male, was admitted to the facility on July 8, 2011, with diagnoses including mitral valve disorder (nonfunctioning valves between the left heart chambers) and coronary atherosclerosis (inflammatory disease with fibrous tissue or plaque on the walls of coronary arteries that supplies heart muscle).


Patient 203 had surgery on July 8, 2011. The documentation on the perioperative record indicated the procedures performed included, "Redo Sternotomy (incision into chest), CABG (bypass surgery), maze procedure (surgical procedure using incisions to form a maze through which impulses can travel to treat irregular electrical activity of the upper chambers of the heart), Mitral Valve repair/replace".


The following start and stop times were indicated in the operative record:

Anesthesia start: 7:32 a.m.
Anesthesia end: 4:36 p.m.
Surgery start: 9 a.m.
Surgery end: 4:31 p.m.

Assisting Surgeon:
Time In: 9:30 a.m. / Time Out: 12:55 p.m.; and,
Time In: 2:35 p.m. / Time Out: 4:27 p.m.

Perfusion Time: 11:47 a.m. to 3:06 p.m.; a total of 3 hours and 19 minutes.

The assisting surgeon, Surgeon 4, arrived in the operating room 30 minutes after the surgery began.

Surgeon 4 left the operating room between 12:55 p.m. and 2:35 p.m., for one hour and 40 minutes, while the patient was on bypass.

On October 6, 2011, at 2:15 p.m., the Perioperative Services Director stated she was upset when she heard Surgeon 4 was out of the room, and stated administration had been notified. The Director could not confirm the situation had been resolved.

e. On October 21, 2011, Patient 216's record was reviewed. Patient 216 was admitted on September 22, 2011, with diagnoses including aortic insufficiency (inadequate blood supply to the largest artery in the body), status post aortic valve replacement. Patient 216 had surgery on September 22, 2011, for aortic valve replacement and repair of an ascending aortic aneurysm.

The following start and stop times were indicated on the perioperative record:

Anesthesia start: 7:45 a.m.
Anesthesia end: 2:10 p.m.
Surgery start: 8:52 a.m.
Surgery end: 1:41 p.m.

Assisting Surgeon:
Time In: 8:25 a.m. / Time Out: 9:40 a.m.,
Time In: 10:34 a.m. / Time Out: 12:09 p.m.; and,
Time In: 12:32 p.m. / Time Out: 1 p.m.

Perfusion Time: 10:13 a.m. to 12:29 p.m.; a total of 2 hours and 41 minutes.

Assisting surgeon (Surgeon 4) arrived in the operating room 21 minutes after the bypass pump was on and left the room 20 minutes before the bypass pump was off.

Assisting Surgeon 4 was out of the room for 41 minutes while the pump was on.

On October 6, 2011, at 10:20 a.m., Nurse 228 stated, "...not always two surgeons in the room. I document when they leave the room and when they come back. I go straight to the managers. I tell them you have to be here, you are jeopardizing the patients..."

On October 6, 2011, at 10:25 a.m., Nurse 227 stated, "We have to document, otherwise we will be fired. There was an ascending aortic aneurysm surgery, I wrote an incident, only the PA (was) left in room while the patient was warming, (Physician 232) left. I called the charge nurse, the charge nurse called the manager, the manager called the director. The doctor was gone for 12 minutes. There is too much in and out for doctors. It has always been the practice."

During an interview on October 6, 2011, at 7:50 a.m., the Director of Perioperative Services stated the scheduler had a grid in the scheduling policy indicating which cases needed an assistant.

During an interview with the Director of Perioperative Services on October 20, 2011, at 1:05 p.m., she stated the nurses reported to her that the assisting cardiovascular surgeons were leaving the room while the patients were on the bypass pump.

During an interview with Surgeon 2 (a cardiovascular surgeon) on October 21, 2011, at 2:30 p.m., he stated it was not uncommon for a surgeon to leave the room during the rewarming process (while the patient was still on bypass).

Based on interview and record review, the Medical Staff failed to ensure the enforcement of the bylaws, by failing to ensure an adequate and effective peer review process was completed for one surgeon (Surgeon 1), resulting in the potential for poor health outcomes for the surgeon's patients.

Findings:

During an interview with the VPQ on October 18, 2011, at approximately 10 a.m., the VPQ stated an external review had been done on 12 cases performed by Surgeon 1, that resulted in the patient leaving the operating room after open heart surgery with an open chest (temporarily leaving the chest cavity open rather than sewing it shut). The VPQ stated all of the cases had been found by the outside reviewers to be appropriate care.

During a review of the January 26, 2011, presentation by Surgeon 3 to the CT Surgery Committee, regarding the external peer review of the 12 cases performed by Surgeon 1, there was no mention in the summary of the presentation that the cases were found to be appropriate care.

During a review of the February 9, 2011, presentation by Surgeon 3 to the Surgical QRC, regarding the external peer review of the 12 cases performed by Surgeon 1, there was no mention in the summary of the presentation that the cases were found to be appropriate care.

During an interview with the VPQ on October 21, 2011, at approximately 3 p.m., she stated there was no handout with full results of the outside reviews, including the fact that the cases were found to be appropriate care, provided to committee attendees.

During a review of the February 17, 2011, discussion with the Surgical QRC regarding the outside peer review of 12 cases performed by Surgeon 1, there was no presentation of the external peer review seen.

The Bylaws of the Medical Staff dated January 2010, were reviewed. Article X, Section 4B4 indicated the duties of sections included meeting to discuss specific issues related to performance improvement, peer review, and/or credentialing, and the Section would report their findings directly to the Department Chairman and/or relevant QRC. However, documentation of a full discussion of the results of the external peer review with the Surgical QRC, including the care by Surgeon 1 that was found to be appropriate, was not present.

During a review of the credential file for Surgeon 1 on October 19, 2011, at 3:05 p.m., Surgeon 1 had a case reviewed internally on January 24, 2011. The Medical Staff sent a letter on August 18, 2011, to Surgeon 1 as a result of the peer review, asking Surgeon 1 to complete a discharge summary on the case. No evidence of completion of the request was found in the file, and no follow-up contact was documented.

During an interview with the VPQ on October 19, 2011, at 3:05 p.m., she stated there was no apparent follow-up to the peer review of Surgeon 1. She stated a letter of explanation from Surgeon 1 had been requested, but was not received, and no follow-up of the issue was seen. The VPQ was not able to explain why follow-up had not occurred.

Based on interview and record review, the facility failed to:

1. Obtain a list of requested privileges for one surgeon (Surgeon 5) who was acting as an assisting surgeon. The facility failed to identify all of the types of surgeries that Surgeon 5 was planning to assist with, and allowed him to be scheduled to assist with surgeries for which he was not privileged. These failures resulted in the risk of substandard surgical outcomes for patients having surgery with Surgeon 5 as the assisting surgeon; and,

2. Identify specific privileges for one surgeon (Surgeon 1) who was actively performing cardiovascular surgeries, and to document the reason for the department chair not recommending granting of the privileges. These failures resulted in the risk of a substandard surgical outcome for patients treated by Surgeon 1.

Findings:

1. During a review of the credential file of Surgeon 5, the documentation contained a note with the application indicating he wished to be of assistance to any surgeon who would benefit from his assistance. There was no specific request for privileges as a surgical assistant in any specific type of surgery.

During an interview with the Medical Staff Assistant on October 18, 2011, at 2:50 p.m., she reviewed the file and stated she was not able to determine which privileges had been approved.

During a review of the surgery schedule for October 18, 2011, Surgeon 5 was scheduled to assist Surgeon 1 in a cardiovascular (open heart surgery) case.

During an interview with Surgeon 1 on October 20, 2011, at 10:30 a.m., he stated Surgeon 5 assisted him in the majority of his cardiovascular cases.

The electronic list of privileges granted to Surgeon 5, reviewed with the Surgery Scheduler on October 18, 2011, was limited to neurosurgery assisting surgeon privileges.

The Medical Staff Bylaws from January 2011, read in part, "The completed reapplication form, requested privileges, peer references and other pertinent information including a query to the National Practitioner Data Bank for each reapplication as required in the initial application process, will be forwarded to the Section Chairman for his recommendation. Where nonreappointment or a change in clinical privileges is recommended, the reason for such recommendations shall be documented."

Section 3C indicated appointments to the medical staff would confer on the appointee only such clinical privileges as were specified in the notice of appointment.

There was no indication clinical privileges to assist in cardiovascular surgery were granted to Surgeon 5.

2. During a review of the credential file for Surgeon 1, a pre-printed, "Request for Clinical Privileges," dated October 27, 2010, was completed by Surgeon 1 during an application for reappointment. The form had many privileges requested designated by written check marks, however the adjacent columns for granting or denying the procedures was left blank. The second page of the form, likewise, had blank columns for granting or denying privileges. The line for the chair of cardiovascular surgery to sign was blank, and the form was signed by the Chairman of the Surgery Department on February 15, 2011, and approved by the MEC and the Board of Directors.

During a confidential employee interview on October 19, 2011, at 1:15 p.m., the employee stated the department chairman would not sign and it was not a mistake.

According to the Medical Staff Bylaws dated January 2011, the application for privileges would be forwarded to the section chairman for his signature, and where nonreappointment or a change in clinical privileges was recommended, the reason for such recommendations would be documented.

Based on interview and record review for one surgeon who was actively performing surgeries, (Surgeon 1), the facility failed to identify specific privileges that were being granted, and failed to document the reason for the department chair not signing the form. This failure created the risk of a substandard surgical outcome for patients treated by Surgeon 1.

Findings:

During a review of the credential file of Surgeon 1, a pre-printed "Request for Clinical Privileges" form dated October 27, 2010, was viewed with many privileges requested, designated with written check marks, however the adjacent columns for granting or denying the procedures was left blank. The second page of the form, likewise, had blank columns for granting or denying privileges. The signature line for the chair of cardiovascular surgery to sign was left blank, but the form was signed by the Chairman of the Surgical Department on February 15, 2011, and approved by the Med Exec and the Board of Directors.

Based on interview and record review, the facility failed to ensure that cardiovascular operating room personnel were trained and competent in cardiovascular thoracic procedures, including the use of cardiovascular equipment and supplies, resulting in the potential to cause a delay in providing patient care, the risk of a poor surgical outcome, and substandard care for all patients undergoing cardiovascular surgery in the facility (A397).

The cumulative effect of these systemic problems resulted in the failure of the facility to ensure nursing services were provided in a safe and effective manner.

Based on interview and record review, the facility failed to ensure that cardiovascular operating room personnel were trained and competent in cardiovascular thoracic procedures, including the use of cardiovascular equipment and supplies, resulting in the potential to cause a delay in providing patient care, the risk of a poor surgical outcome, and substandard care for all patients undergoing cardiovascular surgery in the facility.

Findings:

1. An interview was conducted with the surgery nurse educator on October 6, 2011, at 9:15 a.m.. The surgery nurse educator stated the resource nurse for cardiovascular surgery was out on leave. The nurse educator stated RN 224 had been training on the CVOR team for about one and one half months. The nurse educator stated another nurse on the team, RN 225, had no heart experience, and the Director was aware of this. A third nurse, RN 226, going through training on the cardiovascular team, was "new". The surgery nurse educator stated the doctors were telling the staff that they did not know what they were doing. She stated it had gotten worse, and the doctors did not have patience with the staff. She stated the CVOR nurses were feeling like they were incompetent. She stated some nurses had recently asked for more education in heart surgery. The surgery nurse educator stated the cardiovascular surgeons did not provide education or inservice to the cardiovascular team. She stated she was not a CVOR nurse and she was not able to determine the competency of the CVOR staff.

2. During an interview on October 6, 2011, at 10:40 a.m., RN 228 stated one nurse, who said she had experience in cardiovascular surgery, was thrown into a case but did not know sterility, how to insert a urinary catheter, or how to prep for a heart procedure. RN 228 stated the heart was a critical area and they must have high standards. RN 228 stated they were looking for experienced nurses because the doctors had no patience and didn't want to teach new staff.

3. On October 6, 2011, the CVOR team personnel files for five RNs and four STs were reviewed. Two of the five RN files (RNs 224 and 225) had no documentation of CVOR competencies. Another RN (RN 226) had the CVOR competency extended due to identified weaknesses in her job performance.

The ST's files indicated one of the four STs (ST 221) was still being checked off for CVOR competency and was still in orientation. ST 222 had not been checked off for CVOR competency since his hire date of August 2008, but he was doing cases independently. In a concurrent interview at 3:40 p.m., the surgery nurse educator stated ST 222 was one of two experienced STs, and ST 222 was the mentor for recently hired ST 221.

One traveler ST (ST 223) had no CVOR competency verification in the personnel file.

During an interview on October 6, 2011, at 3:40 p.m., the surgery nurse educator stated, "I did not do a CVOR competency for him because he's only here for 13 weeks."

4. On October 19, 2011, at 8 a.m., Surgeon 3, Section Chief of Cardiovascular Surgery Services, was interviewed. Surgeon 3 stated he would desire competency of the OR to be better. He stated, "It gets very ugly and frustrating, the patient's life is at hand, lack of knowledge and training can cause longer pump (on bypass) time."

5. On October 19, 2011, at 9:45 a.m., Surgeon 1 stated the turnover of nurses resulted in the lack of CVOR trained nurses, and there was a similar problem with the STs.

6. During an interview on October 20, 2011, at 1:25 p.m., the Director of Perioperative Services stated the cardiovascular surgeons were not currently involved in training of the CVOR staff. The Director stated, "I don't know if the staff that helps in the cardiovascular room is trained."

6. During an interview with Surgeon 1 on October 20, 2011, at 10:30 a.m., Surgeon 1 stated the OR staff was inexperienced, did not have established competency, and there was only one experienced scrub tech. He stated there had been episodes when the circulating nurse was not able to identify the instruments needed. He stated he had tried to call the problems to the attention of the Director of Perioperative Services, Chief of Surgery, and Chief of the Medical Staff, but his concerns "fell on deaf ears".

7. During an interview with the Chief of Medical Staff on October 21, 2011, at 8:35 a.m., he stated Surgeon 1 approached him regarding the limited capabilities of the CVOR staff.

8. During an interview with the VPQ on October 21, 2011, at 10:05 a.m., she stated she was not aware of the problems with staff competency in cardiovascular surgery.

9. The facility policy, "Competency Program", revised August 2009, read in part, "The Hospital provides an adequate number of staff members whose competencies are consistent with job responsibilities. The Directors/Managers ensure that the competence of all staff members is continually assessed, maintained, demonstrated, and improved."

10. An interview was conducted with the director of surgery on October 20, 2011, at 1 p.m. The Director of Perioperative Services stated she had two cardiovascular teams available. She stated each team consisted of two RNs and one OR technician. The cardiovascular staffing schedule was reviewed with the director. There were several days that only had two or three nurses scheduled to work. The director stated she could, "pull nurses from the main OR," to make a heart team if needed. The director, when asked if the nurses she was pulling to create a team for cardiovascular surgery were competent to do the job, stated, "I'm not sure."

A list of the OR nurses that were pulled from the main OR to create the cardiovascular surgery team for emergency surgeries, was requested.

The director provided a list with four names on it (RNs 237, 238, 239, and 240). All four RN's personnel and training records were reviewed. There was no record of any competencies for cardiovascular surgeries present for any of the four nurses.

An interview was conducted with the OR educator on October 21, 2011, at 10 a.m. The educator stated the four RNs whose names the director provided were not trained and did not have competencies for cardiovascular surgery. The educator stated cardiovascular surgery was a specialty that required additional training. She stated the nurses had been asking for the training for a while, but it had been very difficult to schedule the training for the nurses because they were often short staffed. The educator stated there had been times when the nurses were scheduled to take a training class, and then were called out of the course because they were needed for surgery. The OR educator stated it had been very frustrating for everyone.

11. An interview was conducted with the Director of Perioperative Services on October 21, 2011, at 11:50 a.m. The director stated she recognized about six to eight months ago, that the OR cardiovascular nurses were lacking competencies in cardiovascular procedures. The director stated she was aware that the four nurses she had been using to create the additional cardiovascular surgery team did not have cardiovascular competencies. She stated she used those nurses because they had been in the OR the longest.

12. A confidential group interview was conducted with OR staff members on October 19, 2011, starting at 2 p.m.. The OR staff members expressed their frustration and concerns about a very tense and punitive working environment. The staff members stated, because they were usually short staffed, there was no time given for training. They stated, "We need help."

Based on interview and record review, lab tests that were ordered stat (to be done immediately) for one patient needing cardiovascular surgery (Patient 1), were not completed for over two hours from the time ordered, creating the risk of a poor health outcome for the patient due to a delay in surgery.

Findings:

A facility investigation was conducted on August 23, 2011, due to inappropriate medical record documentation of Surgeon 1 in the record of Patient 1, who was transferred in for an emergent surgery and had to wait for room availability. A dictated medical record note for Patient 1, that was completed by Surgeon 1, regarding an August 23, 2011, surgery for an aortic dissection included the assertion, and included "we basically brought the patient in and consent was done and there was a further delay of the aspects of type and cross even though the order was given in the morning, the type and cross was not done until a couple of hours after the order was given."

During a review of the medical record of Patient 1, the record indicated stat (immediate) lab test orders were placed at 6:55 a.m., entered in the computer at 7:21 a.m., but the blood was not collected until 8:40 a.m., with no result available until 8:57 a.m., more than two hours after the order was placed.

During an interview with the VPQ on October 19, 2011, at 2 p.m., she stated there was no investigation of Surgeon 1's allegation that there was a delay in obtaining the lab results.

The facility policy titled, "Turn-Around Time for Laboratory Tests," (Revised April 2010), indicated the lab TAT would be less than 60 minutes for tests ordered on a STAT basis."