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Based on staff interview, clinical record and administrative document review, the hospital failed to ensure quality medical care was provided to patients and failed to ensure Medical Staff Bylaws and regulations were enforced when Cardiovascular Surgeon 1 (CV 1) left an open heart surgery prior to the closure of the chest. CV 1 instructed a non-surgeon practitioner (Physician Assistant 1) to close the chest and did not appoint a qualified medical professional in his absence. The dictated operative report for Patient 1's surgery did not reflect the participation of the non-surgeon. The operative report for Patient 1 did not reflect the critical condition of the patient after surgery. (A 353)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure Medical Staff Bylaws and regulations were enforced when Cardiovascular Surgeon 1 (CV 1) left an open heart surgery prior to the closure of the chest. CV 1 instructed a non-surgeon practitioner (Physician Assistant 1) to close the chest and did not appoint a qualified medical professional in his absence. CV 1's operative report for Patient 1's surgery did not reflect the participation of the non-surgeon. CV 1's operative report for Patient 1 did not reflect the critical condition of the patient after surgery.

These failures resulted in the medical staff bylaws not being enforced and resulted in Patient 1 incurring acute kidney injury after prolonged surgery, cardiac arrest after code blue, multiple blood transfusions and respiratory failure.

Findings:

The clinical record for Patient 1 was reviewed. Patient 1 underwent open heart surgery on 4/2/12. The anesthesia record, dated 4/2/12, indicated the surgery started on 4/2/12 at 7:22 a.m. Due to complications, the anesthesia was not stopped until 9:46 p.m. on 4/2/12- fourteen hours later. After surgery the patient was transferred to the Cardiac Intensive Care Unit in critical condition.

On 7/13/12 at 10:35 a.m., during an interview, CV 1 stated he directed PA (Physician Assistant) 1 to finish the case which meant she was to perform the remainder of the surgery - closure of the chest with wires (reference to the staples) and the rest of the closing. CV 1 stated he had checked all the tubes and all was routine. CV 1 stated he allowed PA 1 to practice above her privilege card as "she was preparing for an Advanced Quality Practice Exam and for that, she needed so many cases with opening and closing the chest, and to cannulate [the insertion of a cannula or tube into a hollow body organ] the heart..." CV 1 said he was " ... always there when she did this, until this time." CV 1 stated he left the surgery and went up to the unit to complete orders for the patient at about 11:30 a.m. and then left the hospital premises at about 12:40 p.m. PA 1 was out of the country and was unavailable for interview.

On 7/13/12 at 11:40 a.m., during an interview, CV 1 acknowledged the entry that Patient 1 was transferred to the surgical intensive care unit in stable condition was an error. He stated this was his routine entry but it did not happen ( meaning the patient was not transferred to the SICU in stable condition but was transferred to the cardiovascular intensive care unit in critical condition) in this case.

During an interview on 7/16/12 at 11:30 a.m., MD 2 and Administrative (Admin) Staff 2, both stated CV 1 left the operating room prior to closure/stapling of the bones back together. MD 2 and Admin Staff 2 stated PA 1 had stapled the bones in this case without the Cardiovascular Surgeon being present. MD 2 and Admin Staff stated that CV 1 violated the hospital's Rules and Regulations under the Bylaws which does not permit the primary surgeon to leave the operating room prior to the patient being established as stable.

Patient 1's Operative Report, dated 4/2/12 and dictated on 4/2/12 at 12:15 p.m., did not document a practitioner other than CV 1 closed the surgical site as required by the facility's Medical Staff rules and regulations. The operative report indicated "After satisfactory hemostasis [the stopping of bleeding in an organ or body part], sternum [breast bone] was approximated using K wires. Subcutaneous tissue [tissue immediately beneath the skin] was closed with Vicryl [a type of suture] in layer and PDS [a type of suture] and skin was approximated [brought together] using 4-0 Monocryl [a type of suture]...The patient tolerated the procedure well and was transferred to the surgical intensive care unit in stable condition."

Patient 1's post-operative Nephrology consultation report dated 4/2/12 at 10:03 p.m. indicated "Impression: ...Possible acute kidney injuries after prolonged surgeries and cardiac arrest after code blue. ...Multiple blood transfusions. ... Respiratory failure."

Patient 1's discharge summary dated 6/6/12 indicated "Discharge Diagnoses ...Cardiogenic postoperative shock [a state in which the heart has been damaged so much that it is unable to supply enough blood to the organs of the body] ...AKI (acute kidney injury) [rapid loss of kidney function]".

The Rules and Regulations and Policies of the Medical Staff dated 2011 were reviewed on 7/12/12 and contained the following documentation under section D: "... Coverage Arrangement - Each attending physician shall personally provide or otherwise arrange for continuous care and coverage for each of his or her patients... Failure to arrange appropriate coverage shall be grounds for corrective action as defined in articles VI and VII of the Medical Staff Bylaws..."

The Bylaws of the Medical Staff dated 2011 were reviewed on on 7/12/12. Under D. Coverage Arrangement; ...If a physician is unable to provide care for his or her patients, then the physician must provide coverage through another appropriately credentialed physician. The covering physician must be available and qualified to assume responsibility for the patients during the entirety of the attending physician's absence...It is expected that a physician on call will respond to pages regarding a hospital inpatient within fifteen (`15) minutes of being called and will be available in the hospital within thirty (30) minutes of any call to provide necessary medical evaluation treatment and stabilizing treatments. In certain specialties more restrictive availability may be required. Under Article VI Corrective Action and section 6.1.1 the following documentation was noted: When a member may have exhibited conduct likely to be (1) detrimental to patient safety or to the delivery of quality patient care within the hospital;...(4) below applicable professional standards...may be initiated by the President of the Committee..."

The facility's "Rules and Regulations and Policies of the Medical Staff" dated 2011 indicated "c. The operative report shall include: ...3. The specific procedures performed and a description of significant surgical tasks that were conducted by practitioners other than the primary LIP [Licensed Independent Practitioner] (significant surgical procedures include: opening and closing...) ..."

Based on observation, staff interview, and clinical record and administrative document review, the hospital failed to ensure surgical services were provided in accordance with acceptable standards of practice when:

1. Cardiovascular Surgeon 1 (CV 1) left the operating room and the hospital premises prior to the stapling of the ribs back to the sternum (bone to bone closure) and prior to the closure of the remainder of the surgical site (fascia - tissue that holds soft organs in place, muscles and skin) during an open heart surgery for Patient 1 in violation of the hospital's "Rules and Regulations". (A 951, finding 1)

2. Surgical staff in the restricted and semi-restricted zones failed to ensure head coverings and masks completely covered all hair and earrings as directed by hospital policy and procedure and guidelines from the Association of periOperative Registered Nurses (AORN). (A 951, finding 2)

3. The CV 1 did not accurately dictate the operative report to reflect non-surgeon participation in the closing of the chest surgical site for Patient 1 and did not accurately reflect the condition of Patient 1 after the surgical procedure. (A 951, finding 3)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on administrative document review and staff interviews, the hospital failed to ensure the staff of the surgical services were appropriate to the scope of services offered when 8 of 11 personnel files (E 2, E 3, E 4, E 5, E 6, E 8, E 9, E 11) lacked unit specific competencies, performance evaluations and job descriptions that defined what employees were required to have as competencies.

Findings:

On 7/16/12 personnel records were reviewed. During the review no specific surgical requirements were listed for the clinical nurse supervisor (E 2), Interim Director of Surgical Services (E 3), Clinical Nurse 1 (E 9), Clinical Nurse 2 (E's 4, 6, and 11), or Clinical Nurse 3 (E 5). Employee 8 was an interim permittee (IP) and for competencies listed, the only area covered were the requirements for the IP.

On 7/16/12 at 2:10 p.m. during an interview, Administrative Staff 6 stated the job descriptions, and therefore the unit specific competencies and performance evaluations were general and not specific to show the specialized skills and knowledge requirements needed in surgery.

As an example of the complexity and breadth of surgeries in this facility, on 7/12/12 there were sixty-two surgeries in the 2 main operating rooms. The complexity of the surgeries ranged from a lymph node biopsy to orthopedic surgery (surgery on bones, tendons and ligaments) to cervical diskectomy (surgery on the spinal column of the neck). On 7/13/12 there were also cardiac surgeries and brain surgery performed.

Mosby's "Medical-Surgical Nursing" Sixth Edition, published in 2000 indicated "Nursing care of the surgical patient requires an understanding of surgery and surgical interventions. This knowledge allows the nurse to monitor the patient's response to the stressors related to the surgical experience."

Based on observation, staff interview, clinical record and administrative document review, the hospital failed to ensure surgical services achieved and maintained high standards of medical practice and patient care when:

1. Cardiovascular Surgeon 1 (CV 1) left the operating room and the hospital premises prior to the stapling of the ribs back to the sternum (bone to bone closure) and prior to the closure of the remainder of the surgical site (fascia - tissue that holds soft organs in place, muscles and skin) during an open heart surgery for Patient 1 in violation of the hospital's "Rules and Regulations".

2. Surgical staff in the restricted and semi-restricted zones failed to ensure head coverings and masks completely covered all hair and earrings as directed by hospital policy and procedure and guidelines from the Association of periOperative Registered Nurses (AORN).

3. The CV 1 did not accurately dictate the operative report to reflect non-surgeon participation in the closing of the chest surgical site for Patient 1 and did not accurately reflect the condition of Patient 1 after the surgical procedure.

These failures resulted in not maintaining high standards of medical practice in the surgical setting and resulted in Patient 1 incurring acute kidney injury after prolonged surgery, cardiac arrest after code blue, multiple blood transfusions and respiratory failure.


Findings:

1. Clinical record review conducted on 7/17/12 indicated Patient 1 was admitted to the hospital on 3/30/12. Patient 1's chief complaints (reason for admission to the hospital) were chest pain and rapid pulse. Heart work ups and exams (Chest x-ray, Electrocardiogram - measures electrical impulses of the heart, Echocardiogram - an image of the heart produced by sound waves) were conducted on 3/30/12 and 4/1/12. Patient 1 was notified on 4/1/12 and consented for the open heart surgery scheduled for 4/2/12. The procedures to be done were repair of an ascending aortic aneurysm (a ballooning of the wall of the main blood vessel of the heart), a heart valve (valves separating the chambers of the heart and allows only one-way blood flow) replacement and replacement of the aortic root (beginning of the aorta -discovered during surgery which required further heart interventions). The anesthesia record, dated 4/2/12, indicated the surgery started on 4/2/12 at 7:22 a.m. Due to complications the anesthesia was not stopped until 9:46 p.m. on 4/2/12- fourteen hours later. The anesthesia note, dated 4/2/12 at 11:45 a.m., indicated the patient was removed from Cardiovascular Bypass (machine that circulates blood to allow open heart surgery). At 12:50 p.m. the anesthesia note documented there was 1500 cc's (cc is a unit of volume measurement; 1500 cc's is about 6 and a quarter cups or about 50 ounces) of chest tube drainage and the blood pressure dropped to 60 millimeters of mercury systolic (60 mm Hg systolic is considered very low systemic blood pressure; systolic blood pressure is the pressure required within the heart in order to move the circulating blood into the body's blood vessels). The anesthesia note documented "... massive transfusion continued; called surgeon".

On 7/13/12 at 10:35 a.m., during an interview, CV 1 stated he directed PA (Physician Assistant) 1 to finish the case which meant she was to perform the remainder of the surgery - closure of the chest with wires (reference to the staples) and the rest of the closing. CV 1 stated he had checked all the tubes and all was routine. CV 1 stated he allowed PA 1 to practice above her privilege card as "she was preparing for an Advanced Quality Practice Exam and for that she needed so many cases with opening and closing the chest, and to cannulate the heart..." CV 1 said he was " ... always there when she did this, until this time." CV 1 stated he left the surgery and went up to the unit to complete orders for the patient at about 11:30 a.m. and then left the hospital premises at about 12:40 p.m. PA 1 was out of the country and was unavailable for interview.

On 7/13/12 at 10:42 a.m., during an interview, RN 5 stated that at about 12:40 p.m. a call was placed to CV 1 to inform him there was about 700 cc's (cubic centimeters - a liquid measurement) to 900 cc's in the pleurovac (tubing and a container to drain and collect fluids-blood from the chest). RN 5 had stated the operating team had been in contact with CV 1 prior to this and had received orders to give another round of transfusion of blood product which included platelets (blood cellular fragments critical to the clotting of blood), Fresh Frozen Plasma (FFP - the fluid non-cellular portion of blood), packed red blood cells (concentrated red blood cells) if needed and Factor VII (blood protein that causes blood to clot). When the drainage increased to 1500 cc's the anesthesiologist (MD 5) stated the team needed to call a code (a 'code' is routinely called for immediate resuscitative care in the event of cardiac arrest [no heart rate] or respiratory arrest [not breathing). The code was initiated. The PA 1 opened the chest and massaged the heart. Over the phone at 1:15 p.m., CV 1 communicated to PA 1 about cannulating Patient 1 (cannulating the heart means to place the patient back on the heart by-pass machine). PA 1 was unsuccessful in completing the cannulation of the heart. At 1:30 p.m., CV 1 arrived back in the operating room. Resuscitative and other activities continued until 9:46 p.m. when anesthesia was stopped and the patient was sent to the heart unit on Extra Corporeal Membrane Oxygenation (ECMO - a technique of providing both heart and the lungs support with supplying oxygen to patients whose heart and lungs are severely damaged and can no longer serve their normal function.

During an interview on 7/16/12 at 11:30 a.m., MD 2 and Administrative (Admin) Staff 2, both stated CV 1 left the operating room prior to closure/stapling of the bones back together. MD 2 and Admin Staff 2 stated PA 1 had stapled the bones in this case without the Cardiovascular Surgeon being present. MD 2 and Admin Staff stated that CV 1 violated the hospital's Rules and Regulations under the Bylaws which does not permit the primary surgeon to leave the operating room prior to the patient being established as stable.

Patient 1's post-operative Nephrology consultation report dated 4/2/12 at 10:03 p.m. indicated "Impression: ...Possible acute kidney injuries after prolonged surgeries and cardiac arrest after code blue. ...Multiple blood transfusions. ... Respiratory failure."

Patient 1's discharge summary dated 6/6/12 indicated "Discharge Diagnoses ...Cardiogenic postoperative shock [a state in which the heart has been damaged so much that it is unable to supply enough blood to the organs of the body] ...AKI (acute kidney injury) [rapid loss of kidney function]."

The Rules and Regulations and Policies of the Medical Staff dated 2011 were reviewed on 7/12/12 and contained the following documentation under section D: "... Coverage Arrangement - Each attending physician shall personally provide or otherwise arrange for continuous care and coverage for each of his or her patients... Failure to arrange appropriate coverage shall be grounds for corrective action as defined in articles VI and VII of the Medical Staff Bylaws..."

The Bylaws of the Medical Staff dated 2011 were reviewed on on 7/12/12. Under D. Coverage Arrangement; ...If a physician is unable to provide care for his or her patients, then the physician must provide coverage through another appropriately credentialed physician. The covering physician must be available and qualified to assume responsibility for the patients during the entirety of the attending physician's absence...It is expected that a physician on call will respond to pages regarding a hospital inpatient within fifteen (`15) minutes of being called and will be available in the hospital within thirty (30) minutes of any call to provide necessary medical evaluation treatment and stabilizing treatments. In certain specialties more restrictive availability may be required. Under Article VI Corrective Action and section 6.1.1 the following documentation was noted: When a member may have exhibited conduct likely to be (1) detrimental to patient safety or to the delivery of quality patient care within the hospital;...(4) below applicable professional standards...may be initiated by the President of the Committee..."


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2) On 7/13/12 at 9:55 a.m., during an observation of an open heart surgery, RN 1 was observed within the sterile field with hair exposed from under her cap and her earrings were exposed and not covered. Staff 6 was asked if this was acceptable practice and stated it was acceptable as long as the earrings were not dangling. Staff 6 did not comment on the exposed hair.

On 7/13/12 at 11:50 a.m., during an interview, when asked if it was acceptable for hair to be exposed and for earrings to be exposed in the operating room, RN 1 stated it depends but she usually tried to keep her hair and earrings covered.

On 7/13/12 at 2:45 p.m., during a concurrent interview and record review, Admin Staff 1 stated the exposed earrings and hair were not allowed in the sterile field (the area of the operating room where the surgery is being performed).

On 7/16/12 at 4:00 p.m., during an interview, Admin Staff 6 stated it was not acceptable to have exposed hair and earrings in the sterile field.

On 7/17/12 at 8:00 a.m., during an observation, RN 6 was observed with hair exposed from under her cap. She was observed walking from the unrestricted areas of the surgical department throughout the semirestricted areas of the surgical area.

On 7/17/12 at 8:05 a.m., during an observation of surgical suite T3, RN 7 was wearing earrings that were not covered by her cap while she was in the sterile field. MD 4 was observed with his sideburns exposed and not covered by his cap.

On 7/17/12 at 8:20 a.m., during an observation, while setting up surgical suite T10 for surgery, RN 8 was observed with hair exposed from underneath her cap.

On 7/17/12 at 11:00 a.m., during a concurrent interview and record review, Admin Staff 6 stated the hospital followed The Association of periOperative Registered Nurses (AORN) and Lippincott guidelines related to traffic patterns and attire within the surgical department. The article "Traffic Patterns, perioperative area" 2012, Lippincott Williams & Wilkins - Traffic patterns, perioperative area" was reviewed. While reviewing a map of the facility's operating room layout, Admin Staff 6 confirmed that the central corridor of the trauma surgical department was unrestricted, the corridors immediately outside the surgical suites were semi-restricted and the surgical suites were restricted. According to the Lippincott article received from the facility, restricted areas include the operating room, clean core area, and wherever sterile supplies were open. The article directed that in restricted areas, all head and facial hair must be covered, surgical scrubs, a cap, and shoe covers were required. Semi-restricted areas included hallways within the surgical suite, storage areas, peripheral support areas and work areas. According to the article, in semi-restricted areas, surgical scrubs, a cap and shoe covers were required. All head and facial hair must be covered.

The facility's policy and procedure titled "OR - Surgical Attire and Restrictions" dated 6/18/2009, indicated "...1. All persons who enter the restricted and semi-restricted areas of the operating room are to wear clean surgical attire (scrubs) and other protective coverings. 3. Other protective coverings: a. Head/hair covering - "caps" ...ii Caps should confine all head hair, beards, and earrings (see jewelry below). ...2. Jewelry of any kind worn in restricted areas of the OR [operating room] is discouraged. The following restrictions apply: ...2. Dangling earrings are not allowed. Small post earrings are to be completely covered by a cap when the individual is scrubbed into the sterile field. ...III. REFERENCES AORN Standards, Recommended Practices & Guidelines, (latest version)."

The AORN, 2012, Perioperative Standards and Recommended Practices section titled "Recommended Practices for Surgical Attire" indicated "Recommendation IV. All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semi-restricted and restricted areas."


3. The clinical record for Patient 1 was reviewed. Patient 1 underwent open heart surgery on 4/2/12. The anesthesia record, dated 4/2/12, indicated the surgery started on 4/2/12 at 7:22 a.m. Due to complications, the anesthesia was not stopped until 9:46 p.m. on 4/2/12- fourteen hours later. After surgery the patient was transferred to the Cardiovascular Intensive Care Unit in critical condition.

On 7/13/12 at 10:35 a.m., during an interview, CV 1 stated he directed PA (Physician Assistant) 1 to finish the case which meant she was to perform the remainder of the surgery - closure of the chest with wires (reference to the staples) and the rest of the closing. CV 1 stated he had checked all the tubes and all was routine. CV 1 stated he allowed PA 1 to practice above her privilege card as "she was preparing for an Advanced Quality Practice Exam and for that she needed so many cases with opening and closing the chest, and to cannulate the heart..." CV 1 said he was " ... always there when she did this, until this time." CV 1 stated he left the surgery and went up to the unit to complete orders for the patient at about 11:30 a.m. and then left the hospital premises at about 12:40 p.m.

On 7/13/12 at 11:40 a.m., during an interview, CV 1 acknowledged the entry that Patient 1 was transferred to the surgical intensive care unit in stable condition was an error. He stated this was his routine entry but it did not happen ( meaning the patient was not transferred to the SICU in stable condition) in this case.

Patient 1's Operative Report, dated 4/2/12 and dictated on 4/2/12 at 12:15 p.m., did not document a practitioner other than CV -1 closed the surgical site as required by the facility's Medical Staff rules and regulations. The operative report indicated "After satisfactory hemostasis, sternum was approximated using K wires. Subcutaneous tissue was closed with Vicryl [a type of suture] in layer and PDS [a type of suture] and skin was approximated using 4-0 Monocryl [a type of suture]...The patient tolerated the procedure well and was transferred to the surgical intensive care unit in stable condition."

The facility's "Rules and Regulations and Policies of the Medical Staff" dated 2011 indicated "c. The operative report shall include: ...3. The specific procedures performed and a description of significant surgical tasks that were conducted by practitioners other than the primary LIP [Licensed Independent Practitioner] (significant surgical procedures include: opening and closing...) ..."

Intakes: CA00317566

Based on staff interview and clinical record review the facility failed to maintain a complete operating room (OR) register when the OR log did not contain the Pre-operative diagnosis, the post-operative diagnosis, the name of the Patients and any complications occurring during surgery. This failure resulted in the potential for the continuum of care provided to the patient to be impaired.

Findings:

On 7/17/12 a review of the facility's operating log indicated the pre-operative diagnosis, post-operative diagnosis, patient name and complications were not included on the report.

On 7/17/12 at 10:35 a.m., during an interview, Admin Staff 7 stated she did not know why those fields did not populate.

The facility was not able to provide an operating log that included those fields.