The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ORANGE COAST MEMORIAL MEDICAL CENTER 9920 TALBERT AVENUE FOUNTAIN VALLEY, CA 92708 June 11, 2015
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview, and record review, the hospital failed to ensure the GB effectively carried out its responsibilities for the conduct of the hospital as evidenced by:

1. The quality of contracted services was not ensured through quality review of the contracted service to provide CV surgery and perfusion services. Cross reference to A0083.

2. The hospital failed to ensure the contracted CV services were performed in a safe manner. Cross reference to A0084.

3. The hospital failed to implement and maintain a data-driven QAPI program designed to maximize the quality of care and safety of services provided to the patients. Cross reference to A0263.

4. The hospital failed to ensure surgical services were organized and staffed to ensure the health and safety of patients. Cross reference to A0940.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment to the patients.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on interview and document review, the GB failed to ensure the quality of the contracted CV surgery group and perfusionist services, creating the increased risk of substandard healthcare outcomes for the patients requiring those services in the hospital.

Findings:

1. The hospital's contract with the CV surgical group for Medical Director and professional services for cardiovascular surgery was reviewed on 6/11/15.

The contract showed the agreement effective 7/31/12, outlined the Medical Director's obligations for governance and leadership of the program, including to ensure 24/7 coverage for all CV services, as well as obligations to assist with evaluation and implementation policies and the training and supervising of perfusionists.

During a review of 13 CV surgery patient records, deviations from standard and required practice were found regarding the number of surgical personnel present during surgery, the intra-operative counting procedure and response to discrepancies in the instrument count, medical record documentation, and oversight of perfusion services. Cross references to A0084; A0951, examples #1, #2, #3, and #12; and A0955.

During a review of the hospital's list of contracted service providers on 6/11/15, the contracted CV group did not appear on the list.

In an interview with the CNO on 6/11/15, she stated the evaluation of contracted services was done by the department Director; the Board did not look at the evaluation forms. The CNO stated the evaluation forms were looked at by the Performance Improvement Patient Safety Committee.

In an interview with the Director of Performance Improvement on 6/10/15 at 1350 hours, he stated QA for contracted services was delegated by the GB to the QA department and was performed annually, using a form with five standard criteria. However, the Director stated no QA was performed on the contracted CV surgery group's services.

During an interview with the Director of QA on 6/11/15 at 1150 hours, she confirmed the Director of Performance Improvement told her there was no quality review of the CV surgery services contract.

2. During an interview with the Director of QA on 6/11/15 at 1150 hours, she stated the Performance Improvement Patient Safety Committee had not reviewed the perfusionist contract for more than one year.

During an interview with the Medical Director of CV Surgery on 6/10/15 at 1520 hours, he stated he had asked the perfusionist team to not return to the hospital due to quality of care concerns, but the perfusionist team was still sent out.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure the contracted CV services were performed in a safe manner as evidenced by:

1. Failure to have the required number of qualified medical staff and assistants present during the cardiopulmonary bypass surgery (a technique that temporarily takes over the function of the heart and the lungs to maintain the circulation of the blood and oxygen during the surgery. The cardiopulmonary bypass pump is referred to as heart-lung machine and was operated by a perfusionist) for eight of 13 patients (Patients 1, 4, 5, 6, 7, 15, 21, and 28) reviewed undergoing CV surgery.

2. Failure to ensure the hospital's P&P was followed regarding instrument counts, surveillance for lost needles, and time out for eight of 13 patients (Patients 1, 2, 3, 4, 5, 6, 7, and 21) reviewed undergoing CV surgery.

3. Failure to ensure the contracted perfusion provider's personnel administered the medications during the CV surgery with orders signed by the physician for Patient 15, the perfusion provider's personnel were evaluated monthly for the first six months of the contract, and training and supervision of perfusionists were documented prior to their providing services at the hospital for Patient 1.

These failures create the increased risk of poor healthcare outcomes for the patients undergoing CV surgery in the hospital.

Findings:

1. Review of the contract between the hospital and corporation supplying CV surgeon services effective 7/31/12, showed the Medical Director's job description under the contract included to "Ensure 24/7 coverage for all Cardiovascular services."

The Department of Surgery Rules and Regulations, page 7 (undated), read in part, "In all operative procedures except cardiovascular surgery and robot assisted radical prostatectomy it is up to the discretion of the surgeon if an assistant is required. The number of assistants required for CV surgery procedures is determined by state law and any state-approved program flexibility, as applicable."

California State law requires the presence of three surgeons during cardiopulmonary bypass surgery. However, review of a State program flexibility waiver for the hospital allowed the third surgeon to be a PA or RNFA.

The hospital's Plan for the Provision of Patient Care Services 2015 (undated), read in part, "Minimum staffing requirements for procedures requiring extracorporeal bypass: Three surgeons or two surgeons and an allied health professional (physician assistant, registered nurse first assistant)."

During a review of CV surgery patient records from one complaint, one hospital identified adverse event, and 11 randomly selected records, the records showed for eight of 13 CV procedures reviewed that used cardiopulmonary bypass, surgical staff were not supplied in the numbers required by the California State regulations and the hospital's Plan for the Provision of Patient Care Services.

a. Medical record review showed Patient 1 had an elective aortic valve replacement on 11/5/14. The Personnel listed on the OR record showed Surgeon 1 as the primary surgeon; a Surgical PA was present, but there was no assisting surgeon.

The perfusion record for the same date listed the surgeon and Surgical PA as the first assistant. Documentation showed the patient was on the cardiopulmonary bypass machine from 0911 until 1420 hours.

The Associated Procedure/Staff section of the OR record listed Surgeon 1 as both the primary surgeon and procedure surgeon.

b. Medical record review showed Patient 4 had an elective coronary artery bypass procedure on 11/3/14. The Personnel listed on the OR record showed Surgeon 1 as the primary surgeon, Surgeon 5 as the assisting surgeon, and PA 1 as also present. However, the record showed Surgeon 5 left the OR at 1510 hours, 20 minutes after the surgery began and 50 minutes before Patient 4 was placed on the bypass machine.

Review of the perfusion record showed Patient 4 was on cardiopulmonary bypass from 1600 to 1742 hours, and PA 1 was the first assistant.

c. Patient 5 had an aortic valve replacement on 12/11/14. The Personnel listing on the OR record showed Surgeon 2 was the primary surgeon and Surgeon 4 was the assisting surgeon. There was no qualified second assisting surgeon listed.

The perfusion record showed Patient 5 was on cardiopulmonary bypass from 1030 until 1230 hours, and listed Surgeons 2 and 4, respectively as the primary surgeon and assistant.

d. Medical record review showed Patient 6 was scheduled for an elective robotic assisted mitral valve procedure, a tricuspid valve procedure, and a maze procedure (a procedure in which surgical cuts are made to disrupt abnormal electrical patterns in the heart) on 11/4/14. However, an unexpected complication early in the surgery required emergency interventions.

The Personnel listed on the OR record showed Surgeon 2 was the surgeon and Surgeon 4 was the assistant surgeon. There was no qualified second assisting surgeon listed.

The perfusion record showed the patient was on cardiopulmonary bypass from 0927 until 1140 hours.

e. Medical record review showed Patient 7 had a coronary artery bypass surgery on 4/23/15. The personnel listed on the OR record included Surgeon 1 as primary surgeon and Surgeon 3 as the assisting surgeon. The Surgical PA was also present. However, the record showed Surgeon 3 left the OR at 1716 hours while the patient was still on the cardiopulmonary bypass machine.

According to the perfusion record, the patient was on the cardiopulmonary bypass machine from 1625 until 1750 hours.

f. Medical record review showed Patient 15's medical record review was initiated on 6/8/15. The patient had a coronary artery bypass graft on 6/2/15. The Cardiopulmonary Bypass Record dated 6/2/15, showed the patient was on the cardiopulmonary bypass machine from 1545 to 1711 hours.

The section of Personnel on the OR record showed Surgeon 1 was the primary surgeon, Surgical PA 1 was the PA, and Surgeon 3 was the surgeon assistant. Surgeon 3's time ended at 1652 hours while the patient was still on the cardiopulmonary bypass machine.

g. Medical record review showed Patient 21 had an aortic valve replacement surgery on 3/24/15. The section of Personnel on the OR record included Surgeon 2 as the primary surgeon, Surgeon 4 as an assistant, and Surgeon 3 as an assistant. However, the record also showed Surgeon 3 did not arrive in the OR until 1115 hours. The patient was placed on cardiopulmonary bypass previous to that time, from 1036 to 1340 hours.

h. Medical record review showed Patient 28 had a mitral valve surgery on 4/28/15. The Perfusion Record dated 4/28/15, showed the patient was on the cardiopulmonary bypass machine from 1739 to 1902 hours.

The section of Personnel on the OR record showed Surgeon 2 was the primary surgery and Surgeons 4 and 1 were the surgeon assistants. Surgeon 1's time was started at 1900 and ended at 1934 hours after the patient was removed from the cardiopulmonary bypass machine.

During an interview with Surgeon 2 on 6/10/15 at 1600, he stated scheduling of surgeons was done by his office. Surgeon 2 stated the scheduler knew the standard was to have two surgeons and one PA present, but that it was not the general practice to have three surgical staff present during valve replacements.

Surgeon 2 stated it was up to the surgeon to decide what assistance he needed.

2.a. The hospital' P&P titled Counts reviewed/revised 6/12, read in part, "Sponges, sharps, and other miscellaneous items are counted on ALL procedures."..."Instruments are counted for all procedures in which the likelihood exists that an instrument could be retained ..."

Review of the medical records for Patients 1, 2, 3, 4, 5, 6, 7, and 21 failed to show documentation the hospital's P&P on instrument counts was implemented during the CV surgery because some of the counts were waived and incorrect counts were documented without explanation or follow-up. Cross reference to A0951, example #2.

During an interview with the Medical Director of Cardiovascular services on 6/10/15 at 1610 hours, he stated he thought instrument counts were detrimental to patient well-being because they diverted the staff's attention from other patient care activities.

b. The hospital's P&P titled Counts reviewed/revised 6/12, read in part, "Circulating nurse informs and receives an acknowledgement from surgeon and team as soon as a discrepancy is identified. Department Director/Manager or designee is notified of all incomplete or incorrect counts immediately. Director/Manager/designee directs the search and communication with Imaging; this occurs prior to patient leaving operating suite."... "If patient's condition permits, an intra-operative x-ray is taken before final closure of the wound, and read by the surgeon or radiologist before patient leaves surgical/procedural suite. If patient's condition is unstable, an x-ray is taken as soon as possible. Final result is read by the radiologist, if not done in the operating room. Document all measures taken and outcomes on patient's record. "

Review of the medical record for Patient 4 showed the patient had a coronary artery bypass graft and lung biopsy on 11/3/14. During the surgery, a needle was lost.

Further review did not show the hospital's P&P on surveillance for lost sharps was implemented when Surgeon 1 decided not get an x-ray to attempt to locate the lost needle. Cross reference to A0951, example #1.

c. The hospital's P&P titled Universal Protocol: Prevention of Wrong Site, Wrong Procedure, Wrong Patient Surgery/Procedure reviewed/revised 4/28/14, read in part, "TIME OUT A pause immediately prior to the procedure where ALL members of the procedural team actively, verbally verify the patient, procedure, site, side, position, implants and equipment." "TIME OUT is conducted in the location where the procedure will be done, just before starting the procedure. No procedure begins until all questions and concerns are resolved."

Review of the medical record for Patient 6 showed the patient was scheduled for an elective robotic assisted cardiovascular surgery on 11/4/14. The anesthesia record showed at 0747 hours, a coronary sinus catheter was placed (a tube introduced through a neck vein, advanced into the heart blood vessels).

The catheter perforated the vessel, causing bleeding into the pericardium (sack surrounding the heart). The time out for the surgery did not occur until 0902 hours.

The patient required an emergency thoracotomy (surgical midline opening of the chest) and cardiopulmonary resuscitation due to bleeding into the pericardium.

During an interview with Anesthiologist 1 on 6/9/15 at 1415 hours, he stated the time out should occur prior to the coronary sinus catheterization; the surgeon should be nearby during the catheterization.





3. Review of the Hospital Ancillary Services Agreement between the hospital and contracted perfusion provider showed the agreement was effective on 4/28/15. Further review of the agreement showed the following:

* The contracted perfusion provider's personnel will be evaluated by the hospital's Cardiovascular surgery operation leadership and the hospital's surgery medical leadership in accordance to the standards set forth in amSECT (American Society of ExtraCorporeal Technology Standards and Guidelines for Perfusion Practice) upon placement at the hospital and monthly thereafter for the first six months.

* The contracted perfusion provider will administer drugs provided by the hospital as generally administered in connection with the Ancillary Services and as supervised and Directed by the physician in charge. The hospital shall ensure that a physician's order or the hospital's requisition, as applicable, is issued for the Ancillary Services prior to the time the Ancillary Services are provided; and all verbal orders related to the Ancillary Services, whether given during the course of treatment or otherwise, are documented and signed by the physician or other authorized health care provider.

a. Review of Patient 15's medical record was initiated on 6/8/15. The patient was admitted on [DATE], and had a heart surgery on 6/2/15.

Review of the Cardiovascular Operating Room form dated 6/2/15, showed the surgery began at 1445 hours and ended at 1805 hours.

Review of the Anesthesia Record dated 6/2/15, showed the cardiopulmonary bypass was on at 1545 hours and was off at 1711 hours.

Review of the Cardiopulmonary Bypass Record dated 6/2/15, documented by a perfusionist showed Heparin (an anticoagulant medication) was administered at 1524 hours. The initial dose of heparin was 15,000 units and the additional dose of heparin was 15,000 units and 200 mg protamine (a medication used to neutralize heparin) were administered. However, the section for Physician Verification of Verbal Orders was left blank.

A second Cardiopulmonary Bypass Record dated 6/2/14, documented by the perfusionist showed in the section "Fluids/Drugs/Comments/Verbal Orders," 5,000 units heparin was administered at 1641 hours, 2 gm of magnesium sulfate (an electrolytes) was administered at 1705 hours, and 1 g calcium chloride (an electrolyte) was administered at 1711 hours. The form failed to show a physician's order was written and signed by the surgeon and/or anesthesiologist when the above medications were administered.

An interview and concurrent review of Patient 15's medical record was conducted with the Director of CV on 6/10/15 at 1000 hours. The Director stated the surgeon had his own preference sheet for perfusion during the surgery. The surgeon and perfusionist huddled prior to the surgery and the perfusionist received verbal orders from the surgeon for what medications would be administered during the surgery.

When asked, the Director of CV was unable to find documented evidence to show the physician's verbal order was written and signed by the physician when the perfusionist administered the medications during Patient 15's surgery.

b. An interview and concurrent review of documentation was conducted with the Director of CV on 6/10/15 at 1000 hours.

Review of the CVOR Logs showed there were 17 cases with the use of cardiopulmonary bypass performed from 4/28 to 5/28/15. The Director of CV confirmed the documentation.

The Director of CV confirmed the agreement between the hospital and contracted perfusion provider was effective beginning 4/28/15. The agreement indicated the contracted perfusion provider's personnel would be evaluated monthly thereafter for the first six months of the contract.

The Director of CV stated the surgeon would evaluate the perfusionist's performance; however, the Director confirmed the contracted perfusion provider was not evaluated for the first month of the agreement (from 4/28 to 5/28/15) as per the contract.

c. The contract between the CV service and hospital was reviewed. The Medical Director's duties included training and supervising perfusionists, "The contracted perfusion provider's personnel will be evaluated by the hospital's Cardiovascular surgery operation leadership and the hospital's surgery medical leadership in accordance to the standards set forth in amSECT (American Society of ExtraCorporeal Technology Standards and Guidelines for Perfusion Practice) upon placement at the hospital and monthly thereafter for the first six months."

Medical record review showed Patient 1 had surgery on 11/5/15, requiring cardiopulmonary bypass. The record showed Perfusionist 1 provided care during Patient 1's surgery.

The personnel record of Perfusionist 1 showed he was a certified perfusionist and was providing services in the hospital as of 10/27/14. A New Hire Orientation/Mentor Checklist was found in the file, but it was signed by Surgeon 1 and dated 11/7/14, after the date of Patient 1's surgery.

A Contract Personnel - Information/Orientation/Initial Competencies form was also found in Perfusionist 1's file, signed and dated on 11/14/14, after the date of Patient 1's surgery.
VIOLATION: PATIENT RIGHTS: REVIEW OF GRIEVANCES Tag No: A0119
Based on interview and record review, the hospital failed to ensure all concerns were investigated during the grievance process for one of two patients (Patient 17) reviewed for grievances. This failure created the increased risk of a failed grievance process.

Findings:

Review of the hospital's P&P titled Complaint/Grievance Process reviewed/revised 3/13 showed the purpose of the policy was to provide a system of complaint resolution whereby patients/patient representatives can voice concerns about any aspect of their care experience at the hospital. This system assures that the issues are addressed through a timely and thorough process.

All grievances are submitted to the Patient Relations Manager whose role is to coordinate an investigation of issues identified by the patient/representative. Committee meets weekly, as needed, to review all grievances filed within that workweek. Grievance Committee's investigation of a grievance may include review of the patient's medical record or other documents regarding the concerns, in order to obtain information regarding the patient's clinical condition. All grievances receive priority and are investigated with efforts made toward resolution within seven (7) business days.

An interview and concurrent document review and Patient 17's medical record review was conducted with the Director of Performance Improvement and Patient Relations Manager on 6/9/15 at 1332 hours.

Patient 17's grievance was randomly selected from a list of grievances provided by the hospital for review on 6/9/15. Review of Patient 17's family concerns showed a complaint was filed for Patient 17 on 4/6/16. On 4/8/15, the patient's family member was contacted and expressed concern the patient had pain and discomfort during a CT procedure.

Documentation showed the Imaging Services Director spoke to two staff and indicated Patient 17 was very fragile, in a lot of pain, and wincing in certain positions due to pain.

Review of Patient 17's medical record showed Patient 17 went to the ED on 4/2/15. The following was identified:

* The ED to Hosp-admitted d 4/2/15 at 1814 hours, showed Patient 17's pain level was 9 out of 10 on a 0 to 10 pain scale (0 = no pain and 10 = worst pain).

* The physician's order showed Patient 17 was to receive 2 mg morphine (a pain medication) for pain.

* The ED Notes dated 4/2/15 at 1830 hours, showed Patient 17 denied pain while resting. The patient was having mid to lower back pain when moved. The patient was taken from the ED for a CT of the head and spine. However, there was no documented evidence to show the pain medication was provided to the patient prior to transporting the patient for the CT.

* The CT C-spine (cervical spine) W/O (without) Contrast dated 4/2/15, showed the exam began at 1828 hours and ended at 1838 hours.

* The CT Head W/O Contrast dated 4/2/15, showed the exam began at 1837 hours and ended at 1842 hours.

* The ED Notes dated 4/2/15 at 1915 hours, showed Patient 17 complained of severe back pain. However, there was no documented evidence to show the pain medication was provided to the patient.

The Patient Relations Manager was asked about her investigation of the above concern. The Manager stated the Imaging Services Director and Manager of Telemetry were involved during the investigation process.

The Imaging Services Director reviewed the case and indicated the patient had pain during the above exams. When asked, the Patient Relations Manager was unable to find documented evidence to show the family's concern was thoroughly investigated and/or the patient's medical record was reviewed regarding the family's concerns of pain and discomfort during the CT.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure the informed consent process was conducted as per the hospital's P&Ps for 11 of 30 sampled patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 10, 15, and 21) as evidenced by:

1. An informed consent signed by Patient 10, who was assessed as confused and disoriented, was not written fully as per the physician's order and/or the performed procedures.

2. An informed consent for Patient 15 was not completed regarding the use of an interpreter.

3. A Conditions of Admission form was not signed and completed by Patient 8 and/or the patient's representative.

4. The required documentation of the names of the surgeons and assistants was not documented in the Operative Consent Form for eight of 13 reviewed CV surgical patients (Patients 1, 2, 3, 4, 5, 6, 7, and 21).

These failures could lead to the patients not being informed fully about proposed treatment and not being involved in making decision about their plan of care.

Findings:

Review of the hospital's P&P titled Consent: Documentation of Informed reviewed/revised 9/12 showed consent for hospital services and simple procedures are obtained via Conditions of Admission Inpatient Services form, Conditions of Admission for Outpatient Services form, or the Service Agreement Clinic and/or Therapy form. If recommended treatments involve performance of a complex, invasive, or operative procedures, then informed consent must be provided by the physician performing invasive or operative procedures. Further document review showed the following:

* Staff provides interpreter service to patient or patient's legal representative to remove any communication barriers that may exist to patient's or patient's legal representative's understanding of proposed treatment or procedures.

* Focus of hospital staff member in informed consent process is in witnessing the signature on the Verification and inquiring as to whether patient or patient's legal representative has read the form, and notifying the physician if patient or patient's legal representative expresses doubt or confusion regarding the procedure.

* Prior to obtaining signatures on verification, the staff must complete the first and the last name of physician(s) performing procedures and the name of the procedure(s) to be performed is written out fully.

1. On 6/8/15 at 0900 hours, an interview and concurrent medical record review for Patient 10 was conducted with the Manager of Critical Care Services. The patient was admitted on [DATE].

a. Review of the physician's order dated 5/26/15 at 1254 hours, showed to consent for a CT, Guided Suprapubic Catheter (a flexible rubber or plastic tube was placed directly into the bladder by the physician) Placement under Moderate Sedation.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form showed Patient 10 signed the consent on 5/26/15 at 1340 hours, for a suprapubic catheter placement under moderate sedation.

The name of the procedure was not written fully as per the physician's order.

Review of Patient 10's Study Result dated 5/26/15 at 1504 hours, showed a suprapubic catheter placement, ultrasound and fluoroscopic guidance, and conscious sedation procedures were performed on Patient 10.

The Manager of Critical Care Services confirmed the informed consent signed by Patient 10, was not fully written to reflect the physician's order and/or the performed procedures.

b. Review of the section of Cognitive/Perceptual/Neuro (Neurological) of the Critical Care Assessment showed Patient 10 was assessed as confused on 6/3/15 at 0000 hours. At 0800 hours, the patient was alert, but confused and disoriented to time and place.

Review of the physician's order dated 6/3/15 at 0812 hours, showed an order for a bronchoscopy (an instrument is inserted into the patient's airway, usually through the nose or mouth to visualize the airway) with bronchial (two tubes that branch off windpipe) and alveolar (tiny air sacs of the lungs) lavage (washing), possible biopsy (the removal of tissue) or brushing.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form showed Patient 10 signed the consent on 6/3/15 at 0930 hours, for a bronchoscopy with bronchial and alveolar lavage, possible biopsy or brushing under moderate sedation.

The Manager of Critical Care Services confirmed Patient 10 signed the informed consent on 6/3/14 at 0930 hours, for the above procedure when the patient was assessed as confused and disoriented on 6/3/14 at 0800 hours, one and a half hours previously.

2. An interview and concurrent review of Patient 15's medical record was conducted with the Manager Telemetry, Manager of Critical Care Services, and Director of Critical Care Services on 6/9/15 at 0850 hours. Patient 15 was admitted on [DATE] at 1015 hours.

Review of the Patient 15's Patient Learning Assessment form dated 5/30/15 at 0211 hours, showed Patient 15 preferred the patient's primary language receiving verbal and written health care information; the factor that impacted the patient's learning was language.

a. The Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures forms signed by Patient 15 on 5/29/15 at 1103 hours, for a procedure and on 6/2/15 at 1204 hours, for a surgery showed the forms were written in English. The section of interpreter's verification was left blank.

The Manager Telemetry, Manager of Critical Care Services, and Director of Critical Care Services confirmed the above findings.

During an interview with Patient 15 with the assistance of Interpreter A on 6/9/15 at 1055 hours, Patient 15 was asked about informed consent prior to the procedure and/or surgery. The patient stated the physician spoke to him in his primary language. The patient had a family member who was able to speak English. Patient 15 stated he signed the forms prior to the procedure and the surgery. Patient 15 stated the forms were written in English; he did not understand what the form was when he signed it.

3. Review of the hospital's P&P titled Conditions of Admission reviewed 7/12/10, showed the Condition of Admission form establishes the contractual relationship between the hospital and the patient. One of the three primary functions of the Condition of Admission form was to document the patient's consent to the hospitalization and to routine services.

Depending upon the type of patient arrival, the conditions of admissions should be obtained from all patients within 24-48 hours of admission on to the patient care unit or upon pre-admission of elective procedures. If the Condition of Admission signature cannot be obtained prior to or at admission, then the Admitting representative will enter this information in account notes on the referral or auth/cert form.

A Condition of Admission not signed needs further follow up. An Admitting Representative will be assigned to the to the patient's bedside to obtain the Condition of Admission signature on a daily basis by the Admitting Supervisor. The Admitting Supervisor will monitor this activity on a daily basis.

An interview and concurrent review of Patient 8's medical record was conducted with the Manager Telemetry, Manager of Critical Care Services, and Director of Critical Care Services on 6/8/14 at 1115 hours. Patient 8 was admitted on [DATE] at 2150 hours.

Documentation on the Conditions of Admission showed Patient 8 was unable to sign on 5/28/15 at 1129 hours. The section of acknowledgement of receipt of patient's rights was left blank.

Further review of the patient's medical record failed to show the Conditions of Admission was signed by Patient 8 and/or the patient's representative. There was no documented evidence to show the patient's rights were provided to the patient and/or the patient's representatives.

The Manager Telemetry, Manager of Critical Care Services, and Director of Critical Care Services confirmed the findings.





4. The hospital's P&P titled Consent: Documentation of Informed revised 9/12, indicated "If recommended treatment(s) involve(s) performance of a complex, invasive, or operative procedure(s), then informed consent must be provided by physician performing invasive or operative procedure(s) ...Verification that physician has explained the following: Nature of proposed care, treatment, services, medications, interventions, or procedure(s) ...Prior to obtaining signatures on Verification, the following must be completed: Name of patient, First and last name of physician(s) performing procedure(s)."

During a review of the medical records of Patients 1, 2, 3, 4, 5, 6, 7, and 21, the consents for CV surgery procedures did not contain the names of assistant surgeons who could be performing portions of the surgery. Cross reference to A0955.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview, and record review, the hospital failed to ensure the patients received care in a safe environment as evidenced by:

1. Nursing staff failed to check the oxygen tank of a neonatal crash cart (used for emergencies) to ensure it was filled with oxygen and was ready to use. This failure would potentially delay the process of resuscitate in an emergency situation.

2. One lab technician student failed to remove a gown and gloves prior to exiting an isolation room. This failure would potentially create the risk of transmission of infections.

3. A defibrillator pad of the Transport Monitor had expired. This posed the potential in delay resuscitate in an emergency situation.

Findings:

1. On 6/815 at 0855 hours, inspection of the neonatal crash cart was initiated with RN A. When asked how the oxygen tank on the crash cart was checked, the RN stated the tank was empty; it was not necessary to keep the full tank of oxygen with the crash cart.

Review of the hospital's Crash Cart Checklist for NICU showed the oxygen cylinder pressure should be greater than 1500 psi (pounds per square inch, a measuring unit of pressure).

2. Review of the hospital's P&P titled Isolation, Contact Precautions dated 6/10 showed staff should remove gloves and gown before leaving the patient's environment.

On 6/8/15 at 0940 hours, during the tour of Medical Unit with the Med/Surgical Manager, a lab technician student was observed walking out from Patient 13's isolation room wearing gloves and a gown.

The staff walked across the hallway to the isolation cart to take a clean item from the laboratory supply box on the top of the cart and then returned back inside the patient's room.

The staff handed the new item to the lab technician who was drawing blood inside the room. The lab technician student took an unused item from the lab technician. The lab technician student's gown touched the bedside table and the patient's curtain.

When the lab technician student stepped out the isolation room a second time, wearing a gown. The Med/Surgical Manager asked the staff to not wear the gowns and glove from an isolation room in the hallway. The lab technician student stated she had not touched the patient.

Review of Patient 13's medical record showed an order dated 6/6/15, the patient was on contact isolation due to MRSA of the nares.

On 6/10/15 at 1056 hours, during an interview, the IP RN stated the staff including students should remove gowns and gloves used in the isolation room prior to leaving the room; the staff might not have contact with the patient but might have an environmental contact. The IP RN stated students received orientation including infection control prior to go to the patient floors.





3. An initial tour of the ICU was conducted with the Manager of Critical Care Services on 6/8/15 at 0840 hours. A defibrillator pad on the Transport Monitor was observed with an expiration date of 3/28/15.

The Manager confirmed the finding and stated a charge nurse would check the Transport Monitor daily and should check the defibrillator pad for the expiration.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0173
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and medical record review, the hospital failed to ensure the hospital's P&P for restraints was implemented for one of one patient (Patient 10) reviewed for the use of restraints when the physician's order was not renewed within the three day timeframe of the hospital. This posed the potential for unnecessary use of restraint.

Findings:

Review of the hospital's P&P titled Restraints for Patients with Non-violent/Non-self-destructive Behavior effective 4/27/15, showed orders obtained for restraint in non-violent/non-self-destructive behavior are in force for three days, which includes the day the order was obtained.

An interview and concurrent review of Patient 10's medical record was conducted with the Manager of Critical Care Services on 6/8/15 at 0900 hours. Patient 10 was admitted on [DATE].

Review of the restraint section showed bilateral soft wrist restraints were initiated for Patient 10 on 6/4/15 at 2230 hours.

Review of the physician's order dated 6/4/15 at 2317 hours, showed to use soft wrist restraints for Patient 10. The reason for the use of restraint was due to pulling of lines and removing of equipment. The restraint order would not be exceed three days.

Review of the restraint section showed Patient 10 was still restrained on the bilateral wrists with soft restraints on 6/8/15 at 0000, 0200, and 0400 hours.

However, there was no documented evidence to show the physician's order for the use of bilateral soft wrist restraints was renewed on 6/7/15 at 2317 hours, as per hospital's P&P.

The Manager of Critical Care Services stated the physician's order for restraint use should be renewed every three days. When asked, she was unable to find documented evidence to show the physician's order for the use of soft restraints for Patient 10 was renewed on 6/7/15 at 2317 hours as per hospital's P&P.
VIOLATION: QAPI Tag No: A0263
Based on observation, interview, and record review, the hospital failed to implement and maintain a data-driven QAPI program designed to maximize the quality of care and safety of services provided to the patients as evidenced by:

1. The hospital failed to ensure the QAPI program analyzed and tracked quality indicators that assessed important processes of care and hospital services and failed to ensure the program data was complete and accurate. Cross reference to A0273.

2. The hospital's QAPI program did not use the data collected to identify opportunities for improvement and did not focus on improving health outcomes and patient safety by following through on intended improvements. Cross reference to A0283.

3. The hospital failed to ensure adverse events, such as surgical complications were analyzed and formed the basis for learning and improvement of services. Cross reference to A0286.

4. The GB was not responsible for the implementation of the QAPI program as it did not receive timely and detailed accounts of incidents and adverse events and did not provide direction for follow up of incidents and adverse events. Cross reference to A0309.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interview and record review, the hospital failed to ensure the QAPI program analyzed and tracked quality indicators that assessed important processes of care and hospital services and failed to ensure the program data was complete and accurate as evidenced by:

* Failure to ensure all Code Blue (an emergency situation when a patient is in cardiopulmonary arrest requiring a team to begin immediate resuscitative efforts) data was forwarded to the Code Blue committee for review,

* Failure to ensure data regarding cardiopulmonary bypass perfusion was subject to review.

* Failure to ensure one patient (Patient 3), who had morbidity associated with an aborted surgery, was integrated into performance data.

* Failure to monitor surgical counts during CV surgery were performed and documented per hospital policy.

* Failed to ensure complete and accurate data was submitted to the ICC regarding BI monitoring in the SPD.

These failures created the increased risk of substandard healthcare outcomes to the patients in the hospital.

Findings:

1. The medical record for Patient 22 was randomly selected from the cath lab log for review. Patient 22 came to the ED with an acute MI on 12/15/14, and had a cardiac catheterization procedure. The record showed the patient developed deadly irregular heart rhythms while in the cath lab; emergency interventions including emergency medications and intubation (insertion of a breathing tube) were required.

During the interviews with the QA Manager on 6/8/15 at 1115 and 1330 hours, he stated the case of Patient 22 was not reviewed by the Code Blue Committee. The Manager stated a Code Blue emergency might not have been declared, although the ED physician was called to intubate the patient.

During an interview on 6/8/15 at 1120 hours, with the Manager of Critical Care Services from the Code Blue Committee, she stated the committee reviewed all Code Blues. The Director stated she received information about codes by getting copies of the Code Blue written record, or by obtaining information from the ED electronic health record.

The hospital telephone operator's log was obtained for review. Patient 22 was the subject of a Code Blue on 12/15/14. The operator's log showed in December 2014. There were 13 Code Blue emergencies announced on 12/1, 12/2, 12/4 (3 times), 12/9, 12/11 (2 times), 12/12, 12/15, 12/29, and 12/30 (2 times).

The lists of patient codes reviewed by the Code Blue Committee were provided. The list showed five Code Blues from December 2014 were critiqued. Another three were listed with "no critique" written. However, five of the 13 code blues from December 2014 were not known to the Code Blue Committee, including Patient 22.

During an interview with the Manager of Critical Care Services on 6/8/15 at 1400, she concurred not all Code Blues shown on the operator's log were forwarded to the Code Blue Committee for review; Patient 22's Code Blue care was not reviewed by the committee.

2. During an interview with the Director of Performance Improvement regarding Patient 2's CV surgery on 6/11/15 at 0900 hours, the Director stated peer review identified issues with prolonged cardiopulmonary bypass pump times, but the quality program felt the pump times were not out of range, so there was no follow up. The Director stated he was not sure why the cross clamp time for CABG with MVR increased from 2013 to 2014.

During a review of data submitted by the hospital to a national society, the data showed the cross clamp time during coronary artery bypass surgery increased from 54 to 64.5 minutes between 2013 and September 2014. The cardiopulmonary bypass time increased from 77.5 to 90.5 minutes.

During an interview with the Quality Data Abstractor on 6/9/15 at 1045, she stated data regarding cardiopulmonary bypass time and cross clamp time were submitted to a national society database; however, she had not looked at or graphed the data. The Quality Data Abstractor stated she asked if anyone wanted to trend the data, but this was not done.

In an interview with the Director CV Services on 6/9/15 at 1150 hours, she stated she collected perfusion data for January and February 2015 once, but that it was not presented.

3. Patient 3 had surgery on 10/27/15. The surgery planned included an aortic valve replacement and lung biopsy. The operative note indicated a right anterior thoracotomy was performed. The surgical team then decided the patient could not tolerate the surgery and the procedure was aborted.

Prior to surgery, the patient's oxygen saturation was 93-94% on 12 liters of oxygen. However, after the surgery, the patient required a breathing tube and a mechanical ventilator until she was extubated and allowed to expire on 11/8/15.

During an interview with the Director of Performance Improvement on 6/9/15 at 0905 hours, he stated QA staff collected data on CV surgery outcomes for integration into the data set. When CV quality indicators were low, they were reviewed by the CV advisory committee.

Review of the CV Surgery outcomes data did not show the 10/27/14 case of Patient 3 was included in the data.

Review of the surgery quality indicator list showed the indicators listed included aborted surgery.

The CV surgery outcomes data was discussed with the Quality Data Abstractor on 6/9/15 at 1050 hours. The Data Abstractor stated she thought Patient 3's case did not need to be included in the data because the surgery was aborted. The Data Abstractor stated she was not aware the patient had surgery by the CV surgeon and believed the surgery was not performed as it was aborted by the anesthesiologist prior to initiation of the surgery.

4. The hospital's P&P Counts reviewed/revised 6/12 read in part, "Sponges, sharps, and other miscellaneous items are counted on ALL procedures."...."Instruments are counted for all procedures in which the likelihood exists that an instrument could be retained ..."

For eight of 13 cardiovascular surgical patients reviewed (Patients 1, 2, 3, 4, 5, 6, 7, and 21), documentation showed the hospital's P&P on instrument counts was not implemented during surgery. Cross reference A 0951, example #2.

During an interview with the Director Performance Improvement on 6/10/15 at 1020 hours, he stated he was not aware surgical counts were not conducted per hospital P&P.





5. On 6/9/15 at 1012 hours, during an interview, the IP RN stated the hospital's IC Committee met quarterly for an evaluation of IC practices. The IC program for tracking and trending SSIs included a review sterilizer BI monitoring compliance. The report would come from the SPD Supervisor on a quarterly report.

Review of the IC Committee meeting minutes dated 5/19/15, showed the SPD reports listed monitoring data for the 1st, 2nd and 3rd quarters of 2015. The IP RN stated those were not accurate reports for the SPD as they were only on the second quarter and there should be only one quarter data for review. The IP RN was not aware inaccurate data was reported to the ICC.

In a follow-up interview with the SPD Supervisor on 6/10/15 at 1420 hours, he stated the wrong reports were pulled from 2014 and sent to the IP RN. The Supervisor further stated the BI monitoring was not complete as there was a sterilizer utilized in the CV OR service; the BI monitoring report was not included in the report.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on observation, interview, and record review, the hospital failed to ensure findings from QA activities were used to form the basis for performance improvement activities because errors identified in the care of Patient 22 did not give rise to changes in policy and practice, creating the risk of persistent poor practices and substandard healthcare outcomes to the patients in the hospital.

Findings:

The Performance Improvement and Patient Safety Plan CY 2015 read, "The Performance Improvement/Patient Safety Department is responsible for supporting the organization's performance improvement principles, strategies, priorities, approach and methodologies, which include but are not limited to: ...Ensuring that important internal processes and activities throughout the organization are continuously and systematically measured, assessed, and improved; ...Identifying and correcting conditions which have caused or could cause injury or loss..."

Medical record review showed Patient 22 came to the hospital with an acute MI (heart attack). He was taken to the cardiac catheterization laboratory where he received treatment to try to remove blockage in an artery of the heart; however, a medication to prevent clots was typically provided before such a procedure. This medication was not provided to Patient 22. Subsequently, the patient was taken for emergency cardiac surgery and he expired more than 30 days later.

Based on the hospital's intensive review of Patient 22's care dated 3/3/15, five changes in practice were proposed, including providing time out before both diagnostic and interventional components of cath lab procedures, requiring verbal read back and authorization confirmation for verbal orders, providing additional training for staff responding to Code Blue emergencies in the cath lab, determining the feasibility of changing from a three person to a four person STEMI team, and ensuring completion of an equipment check list prior to procedure start.

1. The implementation of the two time out processes during STEMI related procedures in the cath lab was documented as implemented in March 2015.

Review of the hospital's P&P titled Universal Protocol: Prevention of Wrong Site, Wrong Procedure, Wrong Patient Surgery/Procedure showed the policy, which described the time out process, was last reviewed and revised 4/28/14; however, no information about separate time outs during the diagnostic and interventional portions of cath lab interventions on STEMI patients was included.

During an interview with the Director of CV Surgery on 6/11/15 at 1330 hours, she confirmed the P&P was not changed to reflect the plan of requiring two time outs prior to STEMI related cath lab interventions.

2. During an interview with the Director of CV Surgery on 6/11/15 at 1330 hours, she stated there was no auditing to determine whether the proposed changes in the time out process or the changes in the verbal ordering in the cath lab were actually put in place.

3. During a tour of the cath lab on 6/8/15 at 0830 hours, the crash cart review log showed the cart was not checked on some dates, including 5/9, 5/10, 5/16, 5/17, 5/24, 5/25, 5/30 and 5/31/15, as the spaces on the form were blank for those dates.

However, review of the cath lab procedure log for above dates showed cases took place on 5/10 (2 cases), 5/17, 5/ 25, and 5/30/15.

During a concurrent interview with the Executive Director of CV Surgery, she stated the crash cart was to be checked daily prior to the room being used, but it looked like that had not occurred.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure comprehensive review and follow up of incidents and adverse events for one cath lab patient (Patient 22) and for five of 13 CV surgery patients reviewed (Patients 1, 2, 3, 4, and 6). In addition, errors in medical records that were reviewed by the QA department were not identified and addressed. These failures created the risk of persistent poor practices and substandard healthcare outcomes to the patients in the hospital.

Findings:

The Performance Improvement and Patient Safety Plan CY 2015 read, "The Performance Improvement/Patient Safety Department is responsible for supporting the organization's performance improvement principles, strategies, priorities, approach and methodologies, which include but are not limited to: Working with the Medical Staff, patient care; and other services, teams, or task forces to effectively measure, assess, and improve the quality of care and services; ...Ensuring that important internal processes and activities throughout the organization are continuously and systematically measured, assessed, and improved; ...Identifying and correcting conditions which have caused or could cause injury or loss..."

1. Patient 22's medical record was randomly selected from the cardiac catheterization laboratory log for review. Patient 22 came to the ED with an acute MI (heart attack due to blocked blood vessels in the heart) on 12/15/14, and had a cardiac catheterization procedure.

The record showed the patient developed deadly irregular heart rhythms while in the cath lab and emergency interventions, including emergency medications and intubation (insertion of a breathing tube) were required. The record showed no clot inhibitors, such as Heparin or Angiomax were administered to the patient in the ED or the cath lab. The patient was then sent for an emergency heart surgery and subsequently expired on [DATE].

Further review of the cath lab record showed discrepancies in information about when medications were administered and in the documented condition of the patient.

During a discussion with the Director of QA on 6/8/15 at 1425 hours, he stated an incident report was made regarding Patient 22's care on 12/17/14.

During an interview on 6/8/15 at 1120 hours with the Manager of Critical Care Services from the Code Blue Committee, she stated the committee reviewed all Code Blues. The Manager stated she received information about codes by getting copies of the Code Blue written record or by obtaining information from the ED electronic health record. However, the Manager stated no Code Blue report was received regarding Patient 22, so the Code Blue Committee had not reviewed the case.

Review of the Code Blue Committee case list did not contain information regarding Patient 22.

During a second interview with the Manager of Critical Care Services on 6/8/15 at 1400 hours, she concurred not all Code Blues shown on the telephone operator's log were forwarded to the Code Blue Committee for review. Patient 22's care therefore was not reviewed by the Code Blue Committee.

During an interview with the Director of CV on 6/8/15 at 1410 hours, she stated there was a AMI-PCI Committee that reviewed all AMI cases. The Director stated the committee reviewed Patient 22's care on 12/15/14; however, they did not note the patient did not receive a blood thinner, which should routinely occur prior to a cath lab procedure. The Director stated the AMI-PCI Committee was not aware of the problem with Patient 22's treatment.

Review of the AMI-PCI Committee minutes showed Patient 22's case was reviewed; however, there was no evidence of discussion regarding the medications administered or the discrepancies in documentation of care given or in the patient's condition. The minutes showed the Director of CV was not present at the meeting.

During an interview with the Director of QA on 6/8/15 at 1100 hours, he stated Patient 22's care was the subject of an intensive review due to the incident report on 3/3/15. The Director stated there was a blood clot inhibiting medication (Angiomax) the patient did not receive.

The Director stated the review revealed the physician gave a verbal order for the medication, Angiomax, but it was not provided to the patient by the RN. The Director stated the RN who failed to provide the medication was not present at the intensive review, having left the service of the hospital.

During an interview with the Director of CV on 6/10/15 at 1430 hours, she stated she was told by the cath lab RN he placed the Angiomax (clot inhibiting medication) on the counter but forgot to provide it to the patient.

However, review of the electronic pharmacy system log from the cath lab showed the cath lab RN never retrieved Angiomax for use.

During a continuing interview with the Director of CV, she stated in accordance with the review of the case that was done, the Angiomax should have been signed out of the automated medication dispensing unit, but it was not.

Further review of Patient 22's medical record showed discrepancies in the medications given and documented and in the documented condition of the patient.

The Cardiac Catheterization Report for Patient 22 contained a comment at 2100 hours, "Per the physician's order the circulation RN has begun sedation for the procedure to be performed. The patient's vital signs will be monitored per policy." The comments at 2104 hours read, "Pt (patient) unresponsive with VF."

However, the section of the Cardiac Catheterization Report for medication documentation showed the patient did not receive any medications until 2112, when the medication was administered in response to the patient's becoming hypotension (low blood pressure). It was unclear whether the patient received medication prior to becoming unresponsive or whether the medication could have contributed to his change in condition.

Documentation of the patient's condition, as recorded on the Sedation Record and the comments section, was conflicting. At 2104 hours, the comments section read, "Pt unresponsive with VF." At 2145 hours, the comment section read, "Pt becomes unresponsive, labored breathing and reduction in arterial pressure ..."

The sedation record listed Patient 22's vital signs and Aldrete score (a system to assess consciousness, respiration, skin color, muscle function and circulation) every one to three minutes from 2053 until 2239 hours.

All of the Aldrete scores for the patient were a perfect 10, indicating all of the parameters were assessed and found to be normal, including the patient being fully awake and able to take a deep breath. The patient's Aldrete score for circulation was documented as "2", indicating a blood pressure within 20% of baseline, even at 2105 hours, when the patient's systolic blood pressure was recorded as dropping from 99 to 62 (normal 100-140 mmHg).

During an interview with the Director of Performance Improvement on 6/10/15 at 1020 hours, he stated the QA staff performed a directed review and was not expected to look at all issues in a record under review.

During an interview with MD 1, he concurred there were discrepancies in the medical record regarding the medications provided and the patient's condition. MD 1 stated the discrepancies were not discussed in the review of the case.

Additional review of the record showed there was only one RN present, listed as both the circulating nurse and the conscious sedation monitoring nurse on the cath lab documentation.

The hospital's P&P titled Sedation, Moderate reviewed/revised 11/12, read in part, "The individual whose responsibility is directed only to the patient, administering medication, monitoring the patient, and observing the patient's response to both the sedative medication and the procedure."

The nursing documentation for Patient 22's 12/15/14, procedure listed the same name as circulating RN and as the conscious sedation RN. There was no documentation to show the ICU charge RN was called to assist as the circulating RN.

Documentation from the electronic pharmacy machine showed the cath lab RN was on duty since at least 0829 hours on the morning of 12/15/14, and was still working at 2204.

During an interview with MD 1 on 6/9/15 at 1515 hours, he stated the ICU Charge RN could be called to assist during procedures in the cath lab requiring conscious sedation. MD 1 concurred the documentation did not support a second RN was present during Patient 22's cath lab procedure.

There was no analysis found of the issue of whether there should be a four-person rather than a three-person team, with one RN as circulator administering medications and another RN as a monitor for the patient's airway. Response to the issue was recorded as, "Determined to not be practical at this time."

2. During a review of the cardiovascular surgery records of Patients 1, 2, 3, 4, and 6, concerns regarding the care of the patients and the documentation prepared were identified.

During an interview with the Director of Performance Improvement on 6/9/15, he stated peer review was triggered by department indicators and quality reviews were triggered by event reporting.

During a second interview on 6/11/15 at 1330 hours, the Director stated the cases of Patients 1, 2, 3, 4, and 6 did not receive intensive review.

In an interview with MD 1 on 6/10/15 at 1440 hours, he stated the CV Committee met to follow up with all cases called out by the indicator list. MD 1 stated it was a closed surgery program with two surgeons acting as the cardiovascular surgeons. MD 1 stated cardiologists as well as the CV surgeons attended the CV Committee.

During an interview with the Director of Performance Improvement on 6/11/15 at 0920 hours, he stated the assistant surgeons did not usually attend the CV Committee meetings, nor did the perfusionists operating the cardiopulmonary bypass machine.

a. Medical record review for Patient 1 showed the patient had an aortic valve replacement. After the surgery, his heart did not resume beating. Patient 1 was placed on a transport ECMO device and was transferred to another hospital where he expired.

The operative record showed documentation "After 1 liter of antegrade cardioplegia (medication to stop the beating heart) was given; I proceeded to give the retrograde cardioplegia. However, the pressure reading was high and I was unable to deliver antegrade cardioplegia at this time. Eventually during the case, the retrograde catheter connection was adjusted and worked properly."

In an interview with the Medical Director of CV Surgery on 6/10/15, he stated it was the perfusionist's job to ensure the cardioplegia was delivered with adequate pressure and flow. The Medical Director stated the line for delivering the cardioplegia was not hooked up properly and that there was disagreement about who was to hook up the line.

Review of the contract between the CV service and the hospital showed the Medical Director's duties included training and supervising perfusionists. "The contracted perfusion provider's personnel will be evaluated by the hospital's Cardiovascular surgery operation leadership and the hospital's surgery medical leadership in accordance to the standards set forth in amSECT (American Society of ExtraCorporeal Technology Standards and Guidelines for Perfusion Practice) upon placement at the hospital and monthly thereafter for the first six months."

During a review of patient records and the OR log, Perfusionist 1 was documented as providing services in the hospital since at least 10/27/14.

Review of Perfusionist 1's personnel record showed he was a certified perfusionist. A New Hire Orientation/Mentor Checklist was found in the file, but was signed by Surgeon 1 and dated 11/7/14, after the date of Patient 1's surgery.

A Contract Personnel-Information/Orientation/Initial Competencies form was also found in Perfusionist 1's file, signed by the Director of CV, and dated 11/14/14, after the date of Patient 1's surgery.

Neither of the documents appeared to contain the signature of Perfusionist 1.

b. The Medical Director of CV Surgery stated on 6/10/15 at 1530 hours, the cases involving issues with the perfusionist were discussed at the CV Committee.

During an interview with the Director of Performance Improvement on 6/11/15 at 0920 hours, he stated the assistant surgeons did not usually attend the CV Committee meetings, nor did the perfusionists who operated the cardiopulmonary bypass machine.

During a review of CV Committee meeting minutes from 2014 and 2015, the names of the perfusionists were not included in the list of participants.

The hospital did not ensure that a comprehensive review of a possible medication errors occurred because key staff involved, the perfusionists, were not present at the departmental review, and no intensive review of the incident was undertaken.

c. Medical record review for Patient 2's CV surgery showed the patient had a surgery that included a coronary artery bypass graft, MVR, tricuspid valve repair, and a maze procedure. The perfusion record indicated a cross clamp time of 268 minutes.

After the surgery, the patient began bleeding and had to return to the OR. The patient's heart ceased functioning. The patient was placed on an ECMO device and was transferred to another hospital where he expired.

The CV surgery was identified on the consent form as "Coronary Artery Bypass Graft Repair/Replace Mitral Valve and Cox IV Maze Procedure Under General Anesthesia," signed by the patient on 11/24/14. The patient's data sheet from the morning of the procedure also identified the intended procedure as a coronary artery bypass graft with mitral valve replacement surgery.

Review of the Anesthesia Record for the 11/24/14 surgery on Patient 2 showed documentation the "proposed operation" was "CABG, MV repair, TV (tricuspid valve) repair, Maze."

Surgeon 1's operative note documented "Preoperative Diagnoses: 1. Severe tricuspid regurgitation. 2. Moderate tricuspid regurgitation. 3. Persistent atrial fibrillation. 4. Multivessel coronary artery disease."

The "history" section of the operative report documented the patient had a transesophageal echocardiogram about a month prior, which showed severe [DIAGNOSES REDACTED] and moderate tricuspid regurgitation.

The operation performed included, "tricuspid valve repair, with ring insertion." There was no documentation to show the surgery on the tricuspid valve was performed as a result of an emergency.

The documentation supported the tricuspid surgery was performed, and was likely anticipated prior to surgery; however, the procedure was not included in the surgical consent.

During a discussion of the follow up of Patient 2's surgery with the Director of Performance Improvement on 6/11/15 at 0900 hours, he stated the medical staff's follow up of the care provided produced concerns about the duration of the surgery attempt and the duration of the pump run; however, the Director did not state the surgeon was found to perform surgery for which the patient was not consented.

Review of the perfusion record for Patient 2's 11/24/14, surgery showed the patient was on cardiopulmonary bypass for 334 minutes, with a cross clamp time of 268 minutes.

The hospital's data for CABG with MVR cross clamp times for the period ending 9/30/14, were reviewed. There was no data found for the years 2013 or 2014.

The data for like hospitals for 2014 showed a median cross clamp time of 130 minutes or less than half of the cross clamp time for Patient 2, with 75% of surgeries performed with a cross clamp time under 165 minutes.

The hospital did have one data point for 2014, for the cross clamp time for MVR with CABG. The data point showed a cross clamp time of 168 minutes, an increase from a median time of 78 minutes in 2013.

For the 2014 period, like hospitals had a mean cross clamp time of 120 minutes.

During an interview with the Director of Performance Improvement on 6/11/15 at 0900 hours, he stated peer review identified issues with prolonged surgery and prolonged pump times; however, the quality program felt pump times were not out of range, so there was no follow up. The Director stated he was not sure why the cross clamp time for CABG with MVR increased from 2013 to 2014.

In an interview with the Director of CV on 6/11/15 at 0910 hours, she stated there were no QA issues present in Patient 2's case.

d. Medical record review for Patient 3 showed the patient had a surgery on 10/27/15. The surgery planned included an aortic valve replacement and lung biopsy.

The operative note indicated a right anterior thoracotomy (surgical opening of the chest wall) was performed and the surgeon dropped the right lung in order to divide the third rib and to repair the pericardium (sack surrounding the heart).

The surgical team then decided the patient could not tolerate the surgery and the procedure was aborted. Prior to surgery, the patient's oxygen saturation was 93-94% on 12 liters of oxygen per minute.

However, after the surgery the patient continued to require a breathing tube and a mechanical ventilator and required a higher level of nursing care until she was extubated (breathing tube removed) and allowed to expire on 11/8/15.

Patient 3's anesthesiologist's pre-anesthesia assessment documentation did not contain specific information about the patient's pre-operative respiratory status. The assessment showed the patient had a "diagnosis of [DIAGNOSES REDACTED]

Patient 3's operative record showed Surgeon 1 documented the anesthesiologist noted pus-like secretions from the endotracheal tube (breathing tube attached to the ventilator) during the surgery.

Patient 3's transesophageal echocardiogram (a special probe placed within the esophagus, that employs ultrasound waves to make images of the heart chambers, valves and surrounding structures) dated 8/20/14, showed the patient had a calculated aortic valve area of 1.3 cm2, which was consistent with "mild [DIAGNOSES REDACTED]" (narrowing of the aortic valve, the valve between the left ventricle of the heart and the aorta. This narrowing impedes the delivery of blood to the body through the aorta and makes the heart work harder). This study result was also recorded on the anesthesiologist's pre-anesthesia evaluation.

A transthoracic echocardiogram report dated 8/27/14, showed the patient had "Mild to moderate valvular [DIAGNOSES REDACTED]."

The pre-operative transesophageal echocardiogram on the date of surgery 10/27/14, again showed a calculated valve area of 1.3 cm2 but was interpreted as "moderate to severe [DIAGNOSES REDACTED]."

Review of the surgery department indicators showed "aborted surgery" and "transfer to higher level of care unplanned" were indicators on the list.

During an interview with the Director of Performance Improvement on 6/9/15, he stated peer review was triggered by department indicators.

During an interview with the Director of CV on 6/9/15, she stated all patient deaths were to be reviewed at the CV surgery quality meetings.

During an interview with the Director of Performance Improvement on 6/8/15 at 1430 hours, he stated no intensive review of Patient 3's case was done.

During a second interview with the Director of Performance Improvement on 6/11/15 at 1035 hours, he stated Patient 3's case was not reviewed by the CV surgery department and no peer review was done on the case.

e. The hospital's P&P Counts reviewed/revised 6/12 read in part, "Circulating nurse informs and receives an acknowledgement from surgeon and team as soon as a discrepancy is identified. Department Director/Manager or designee is notified of all incomplete or incorrect counts immediately. Director/Manager/designee directs the search and communication with Imaging; this occurs prior to patient leaving operating suite." ... "If patient's condition permits, an intra-operative x-ray is taken before final closure of the wound, and read by the surgeon or radiologist before patient leaves surgical/procedural suite. If patient's condition is unstable, an x-ray is taken as soon as possible. Final result is read by the radiologist, if not done in the operating room. A. Document all measures taken and outcomes on patient's record."

Review of Patient 4's medical record showed the patient had a CABG and lung biopsy on 11/3/14.

The nurses' notes showed documentation, "needle count wrong. (Surgeon 1) aware, x-ray deferred."

The surgeon's Operative Report showed documentation, "The needle and sponge counts were off by one 7-0 needle which was lost during the saphenous vein harvest. Since the needle was too small, I decided not get an x-ray."

During an interview with the Director of CV on 6/9/15 at 1310 hours, she stated if a needle count was off the staff was to look for it and to ask to get an x-ray.

During an interview with the Director of Performance Improvement on 6/10/15 at 1010 hours, he stated no x-ray was done in response to the lost needle; it should have been done.

During an interview with the CV Nurse Manager on 6/9/15 at 1400 hours, she stated if a needle count was off, they would search the operative field and do an x-ray, or they might do two x-rays.

During an interview with Surgeon 2, the Medical Director of Cardiovascular Surgery on 6/10/15 at 1530 hours, he stated he was not sure what the hospital's P&P was regarding lost needles; the staff usually asked if he wanted an x-ray.

During an interview with the Director of Performance Improvement on 6/10/15 at 1010 hours, he stated there was a process for reporting incidents; however, the lost surgical needle was not reported and should have been.

f. Review of Patient 6's medical record showed the patient's intra-operative course included catheterization of the coronary sinus (a blood vessel in the heart) that resulted in perforation of the sinus, necessitating an emergency thoracotomy procedure. The catheterization of the coronary sinus occurred prior to the timeout. Cross reference to A0951, example #3.

Documentation showed Patient 6 was scheduled for an elective robotic assisted CV surgery on 11/4/14. The anesthesia record showed at 0747 hours, a coronary sinus catheter was placed (a tube introduced through a neck vein, advanced into the heart blood vessels).

Fluoroscopic imaging was performed from 0829 to 0839 hours and a transesophageal echocardiogram was performed at 0854 hours. The perfusion record showed the patient had a baseline hematocrit (the volume percentage of red blood cells in blood. It is normally 45% for men and 40% for women) of 40. At 0835 hours, the hematocrit decreased to 26.

At 0900 hours, the surgeon documented arriving in the room and at 0902 hours, well after the coronary sinus catheter was placed, a time out was documented. Surgeons 2 and 4 were documented as participating in the case; however, no second assisting surgeon was listed. The patient died on [DATE].

According to the operative report, "In the course of the prep, drape and initial incision, he developed cardiac tamponade (heart unable to fill due to compression from the blood surrounding it) with a low blood pressure." The operation was converted to a sternotomy (surgical opening of the chest at the midline), with intermittent CPR performed along with the sternotomy.

During an interview with Surgeon 2 on 6/10/15 at 1610 hours, he stated he was in the control room outside the CV OR prior to the case and reviewed the images but was not told the hematocrit dropped.

Surgeon 2 stated the fluoroscopic images showed the catheter perforated through the heart blood vessel, causing bleeding into the sack surrounding the heart and a tamponade. Surgeon 2 stated he then scrubbed in and opened the patient's chest right away.

During an interview with the Director of Performance Improvement on 6/10/15 at 1030 hours, he stated a possible delay in the arrival of the surgeon and the absence of the third member of the surgical team was not discussed during the review of the case.

During a second interview on 6/11/15 at 0930, the Director of Performance Improvement stated the drop in the patient's hematocrit from the baseline to the 0835 hours value was not called out during the review.

In an interview with the Director of CV on 6/10/15 at 1400 hours, she stated it was not brought to their attention if there was a delay in care for the patient. After review of Patient 6's OR record, the Director stated the times did not jive as the surgeon was documented as arriving later than she would have thought. The Director stated the number of surgeons and assisting surgeons present was not discussed in peer review.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on interview and record review, the GB failed to ensure full implementation of the QAPI program. Incidents and adverse events were found not fully investigated and reported to the GB and there was no evidence to show the GB provided direction regarding the follow-up of adverse events. This created the risk of persistent poor practices and substandard healthcare outcomes to the patients in the hospital.

Findings:

The hospital's Performance Improvement and Patient Safety Plan CY 2015 read, "All governing boards are responsible for support of Performance Improvement by: ...Overseeing prioritization, assessment, design, implementation and ongoing monitoring, Allocating resources and providing supportive infrastructure, Receiving regular and thorough reports on performance improvement and patient safety, including risks, hazards and progress towards objectives."..."The OCMMC (Orange Coast Memorial Medical Center) Board of Directors meets ten times per year and receives regular reports from the PIPS Committee and Medical Executive Committee as it pertains to the quality, safety and staffing effectiveness of patient care rendered by the hospital."

The Board of Directors Meeting Minutes from the year 2014 and 2015 were reviewed. No information was found regarding incidents or adverse events. The section on the meeting minutes for follow up was left blank on every set of meeting minutes.

During an interview with the CNO on 6/11/15 at 1130 hours, she stated she attended the Governing Board Quality Committee and the Board of Directors Meetings. The CNO stated there was a Governing Board Quality Committee that focused on quality issues, but incidents and adverse events were not discussed at that committee. The CNO stated adverse events were discussed at the Board of Directors meeting.

The CNO stated many of the Board members were non-clinical. No information on adverse events or incidents was presented to the Board members in advance of the board meeting, but a summary of events was presented to the Board at the meeting and they could ask questions if they wished. The CNO stated the Board was mostly non-clinical and had very limited knowledge of clinical issues.

The CNO reviewed the Board of Director's meeting minutes. She stated she was not sure why adverse events were not found on the minutes. The Board was told what was planned when there was an adverse event. The CNO concurred the follow-up section of the minutes was blank and she was not sure why that was.

During an interview, the CNO was asked about a review of Patient 22's care in the cardiac catheterization laboratory. Cross reference to A0286, example #1.

The CNO stated she recalled the incident review but could not recall why the change from a three to a four person team was found to not be practical.

During an interview with the GB representative on 6/11/15 at 1305 hours, he stated the Board discussed and suggested follow-up of issues presented; however, he concurred this should be documented and this was not done on the Board minutes.

The GB representative stated he could not recall hearing about the incident related to Patient 22's care and was not aware of a problem with the number of CV surgeons present during surgery.

During an interview with the Director of Performance Improvement on 6/11/15 at 1320 hours, he stated the Board received information about some peer review actions but was not told there was an issue with the number of CV surgeons present during surgery.

The Director stated information about incidents and peer review were not included in the information supplied to the Board through the Boards's electronic information system.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, interview and record review, the hospital failed to ensure surgical services were organized and staffed to ensure the health and safety of patients as evidenced by:

1. Failure to ensure the quality of contracted CV surgery and perfusion services. Cross reference to A0083.

2. Failure to ensure requirements for minimum staffing of CV surgery during the use of cardiopulmonary bypass were met for eight of 13 patients reviewed undergoing CV surgery (Patients 1, 4, 5, 6, 7, 15, 21, and 28). Cross reference to A0084, example #1.

3. Failure to provide a safe and effective environment and maintain high standards of care for the patients receiving surgical services. Cross reference to A0951.

4. Failure to ensure an updated H&P examinations were completed prior to a surgical procedure. Cross reference to A0952.

5. Failure to ensure the required documentation of the names of all the surgeons and assistants, as well as the description of the significant surgical tasks to be performed were documented in the Operative Consent forms. Cross reference to A0955.

6. Failure to ensure the emergency crash cart (contains medications and equipment for resuscitation) in the cardiac catheterization laboratory procedure room was checked and maintained prior to procedures performed in the room. Cross reference to A0956.

7. Failure to ensure adequate post-operative care was provided for one of 30 sampled patients (Patient 30) when the patient was not reassessed by the physician prior to discharge home as per the hospital's P&P. Cross reference to A0957.

8. Failure to ensure an operative note/report was written immediately after surgery and the required documentation of the names of the surgeons and assistants, as well as the description of the significant surgical tasks they had performed were documented in the Operative Notes. Cross reference to A0959.

The cumulative effect of these systemic practices resulted in the hospital's inability to provide safe and effective surgical services.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the hospital failed to provide a safe and effective environment and maintain high standards of care for the patients receiving surgical services as evidenced by:

1. Failure to implement interventions per the hospital's P&P after the discrepancy of needle count was identified for one of 13 patients (Patient 4) reviewed undergoing CV surgery.

2. Failure to implement the hospital's P&P on surgical instrument counts for eight of 13 patients (Patients 1, 2, 3, 4, 5, 6, 7, and 21) reviewed undergoing CV surgery.

3. Failure to conduct the time out prior to the coronary sinus catheterization for Patient 6. The intra-operative course included catheterization of the coronary sinus that resulted in perforation of the sinus necessitating an emergency thoracotomy surgery.

4. Failure to show evidence a system was in place for evaluating the environmental cleaning of the Perioperative services areas, L&D, and CVOR.

5. Failure to ensure documentation from environmental rounds in the Peri-operative Services areas showed who conducted the rounds and any findings for improvement or any recommendations for follow up. In addition, there was no documented evidence to show a clinical person attended the rounds to evaluate the questions related to the clinical assessment of infection control and patient safety on the Environmental Rounds Survey Checklists.

6. Failure to ensure complete and consistent monitoring of BI results for two of two sterilizers in SPD.

7. Failure to ensure a product stored in the medication freezer of the anesthesia work room was stored at the temperature recommended by the manufacturer.

8. Failure to ensure technicians in the SPD and L&D cleaned surgical instruments in enzyme solutions according to the manufacturer's instructions.

9. Failure to ensure a system was developed for monitoring the drop off and pick up of sterile instruments for the L&D OR and instruments brought in from outside clinics. In addition, there was no system in place for tracking of surgical instruments used on surgical patients.

10. Failure to ensure implementation of the AORN standards for wearing surgical attire in the surgical services area.

11. Failure to lock an anesthesiologist's medication cart when unattended in the CVOR. This practice increased the risk of medication diversion and possible adverse outcomes.

12. Failure to ensure medications administered by the perfusionist during CV surgery were verified by the physician for two of 13 patients (Patients 15 and 29) reviewed undergoing CV surgery. This would potentially cause errors in medication administration.

13. Failure to ensure Patient 14 was correctly scheduled in an OR room for robotic assisted surgery. The discrepancy in the assigned OR setting and patient's surgical consent was not identified by the Preop RNs.

These failures created the risk of substandard healthcare outcomes associated with the provision of surgical services to the patients in the hospital.

Findings:

1. The hospital's P&P titled Counts reviewed/revised 6/12 read in part, "Circulating nurse informs and receives an acknowledgement from surgeon and team as soon as a discrepancy is identified. Department Director/Manager or designee is notified of all incomplete or incorrect counts immediately. Director/Manager/designee directs the search and communication with Imaging; this occurs prior to patient leaving operating suite;" .... "If patient's condition permits, an intra-operative x-ray is taken before final closure of the wound, and read by the surgeon or radiologist before patient leaves surgical/procedural suite. If patient's condition is unstable, an x-ray is taken as soon as possible. Final result is read by the radiologist, if not done in the operating room. ...A. Document all measures taken and outcomes on patient's record."

Review of Patient 4's medical record showed the patient had a CABG and lung biopsy on 11/3/14. The Nurse's notes read in part, "needle count wrong. (Surgeon 1) aware, x-ray deferred."

The surgeon's Operative Report read, "The needle and sponge counts were off by one 7-0 needle which was lost during the saphenous vein harvest. Since the needle was too small, I decided not get an x-ray."

During an interview with the Manager Critical Care Services on 6/9/15 at 1310 hours, she stated if a needle count was off; the staff was to look for it and ask the physician to get an x-ray.

During an interview with the Director of Performance Improvement on 6/10/15 at 1010 hours, he stated no x-ray film was done in response to the lost needle; it should have been done.

During an interview with the CV Nurse Manager on 6/9/15 at 1400 hours, she stated if a needle count was off, they would search the operative field and do an x-ray, or they may do two x-rays.

During an interview with Surgeon 2, the Medical Director of CV Surgery, on 6/10/15 at 1530 hours, he stated he was not sure what the hospital's P&P was regarding lost needles. The staff usually asked him if he wanted an x-ray.

2. The hospital's P&P titled Counts reviewed/revised 6/12 read in part, "Sponges, sharps, and other miscellaneous items are counted on ALL procedures." ... "Instruments are counted for all procedures in which the likelihood exists that an instrument could be retained ..." ... "Documentation of counts on patient care records include: A. Types of counts. B. Number of counts. C. Name and titles of personnel performing counts. D. Result of counts. E. Any item intentionally retained as packing. F. Action taken if count discrepancies occur and outcome of actions taken. G. Rationale if counts are not performed or completed as prescribed by policy. and H. Any deviation from policy is documented on the intraoperative patient care record."

Medical record review for Patients 1, 2, 3, 4, 5, 6, 7, and 21 showed the hospital's P&P on instrument counts was not implemented during CV surgery as follows:

a. Patient 1 had an aortic valve replacement surgery on 11/5/14. The Nurses' Notes read in part, "surgical instrument count waived by Dr (Surgeon 1)."

b. Patient 2 had a MVR and CABG surgery on 11/24/14. The Nurses' Notes read in part, "surgical instrument count waived by Dr (Surgeon 1)."

c. Patient 3 had a planned aortic valve replacement surgery but actually had a thoracotomy and lung wedge resection on 10/27/14. The Nurses' Notes read in part, "surgical instrument count waived by Dr (Surgeon 1)."

d. Patient 4 had a CABG and lung biopsy on 11/3/14. The Nurses' notes read, "surgical instrument count waived by Dr (Surgeon 1)."

e. Patient 5 had an aortic valve replacement on 12/11/14. The Nurses' notes read in part, "surgical instrument count waived by Dr (Surgeon 2)."

f. Patient 6 had an intraoperative complications during a mitral valve and tricuspid valve surgery on 11/4/14. The Nurses' notes read in part, "surgical instrument count waived by Dr (Surgeon 2)."

g. Patient 7 had a CABG and lung biopsy on 4/23/15. The Nurses' notes read in part, "all sponges accounted for." There was no documentation of whether sharps and instruments were accounted for also.

h. Patient 21 had an aortic valve replacement surgery on 3/24/15. The Nurses' notes read in part, "all sponges accounted for," with no documentation of needle and instrument counts. The Counts documentation showed the first, cavity, closing and final counts of sponges, sharps, instruments, and other were all documented as "incorrect." No further information was found to indicate why the counts were incorrect.

During an interview with the Director CV Services on 6/9/15 at 1310 hours, she stated instrument counts were performed three times during surgery and instrument counts were not waived. The Director stated the hospital followed World Health Organization's recommendations.

During an interview with the Director Performance Improvement on 6/10/15 at 1010 hours, he stated the OR Manager could be called to assist when needed and should have been called to assist in completing instrument counts.

During an interview with Surgeon 2, Medical Director of CV Surgery on 6/10/15 at 1610 hours, he stated he thought instrument counts were detrimental to patient well-being because they diverted the staff's attention from other patient care activities.

3. The hospital's P&P tiled Universal Protocol: Prevention of Wrong Site, Wrong Procedure, Wrong Patient Surgery/Procedure reviewed/revised 4/28/14, read in part, "TIME OUT A pause immediately prior to the procedure where ALL members of the procedural team actively, verbally verify the patient, procedure, site, side, position, implants and equipment." "TIME OUT is conducted in the location where the procedure will be done, just before starting the procedure. No procedure begins until all questions and concerns are resolved."

Patient 6's medical record review showed the patient was scheduled for an elective robotic assisted CV surgery on 11/4/14. The anesthesia record showed at 0747 hours, a coronary sinus catheter was placed (a tube introduced through a neck vein, advanced into the heart blood vessels).

Subsequent imaging at 0830 and 0854 hours, showed the catheter perforated through the heart blood vessel, causing bleeding into the sack surrounding the heart. At 0900 hours, documentation showed the surgeon arrived in the room and at 0902 hours, long after the coronary sinus catheter was placed, a timeout was documented.

According to the operative report, "In the course of the prep, drape and initial incision, he developed cardiac tamponade with a low blood pressure." The operation was converted to a sternotomy (surgical opening of the chest at the midline) with intermittent CPR performed along with the sternotomy.

During an interview with Anesthesiologist 1 on 6/9/15 at 1415 hours, he stated the time out should occur prior to the coronary sinus catheterization and the surgeon should be nearby during the catheterization.





4.a. Review of the hospital's P&P titled Cleaning of Perioperative Areas revised 2/12 showed Daily Terminal Cleaning of Perioperative areas included: all sub-sterile rooms, all scrub sinks, front desk area, staff lounge/bath rooms/shower areas; pre and post-operative areas, all floors and hallways, and central processing area.

The weekly cleaning of other Perioperative areas included cabinets in staff lounge and carts in the main hallway. The monthly cleaning included clean and soiled storage areas.

The Perioperative area was toured with the Director of Perioperative on 6/8/15 at 1335 hours.

Observation of the SPD decontamination room showed one ceiling vent with heavy dust and the second vent was half open. In the storage room, two boxes of sterile supplies were placed on the bottom of a metal rack lying on the floor; paper trash was also observed.

During the tour, the Director of Perioperative Services stated the cleaning of Perioperative areas was done by the OR PCAs. The Director was responsible for supervising the terminal cleaning services of the PCAs.

The Director utilized a log for PCAs to document the daily, weekly, and monthly cleaning. The Director reviewed the log sheet and stated the log documented the PCA cleaned the eight ORs daily, weekly, and monthly terminal cleaning. The Director stated the log did not include common areas, for example, the storage room, SPD areas, and hallway.

b. On 6/9/15 at 0920 hours, the L&D area was toured with the Director of the Education Department. L&D OR 1 was observed for post-procedural cleaning.

During a concurrent interview, the Clinical Supervisor of L&D stated EVS staff cleaned this area. The Clinical Supervisor stated she would communicate with EVS services if there was a concern regarding the cleaning of the ORs. The Supervisor stated there was no formal system in place for evaluation of the EVS services provided in the L&D area.

5. Review of the hospital's Management Plan for Safety showed the authority for overseeing and monitoring the safety management program is the EOC Committee for the purpose of ensuring that safety management activities are identified, monitored, and evaluated and for ensuring that regulatory activities are monitored and enforced as necessary.

The Committee members review and approve the Environment of Care reports. Committee members represent clinical, administrative and support services, address environment of care issues in a timely manner, making recommendations as appropriate for approval.

The P&P for Environment of Care effective date 5/25/12, showed the purpose was to ensure a process is in place by which environmental surveillance is conducted at each facility. The EOC Committee is responsible for overseeing environmental surveillance and development of the schedule.

a. On 6/8/15 at 1102 hours, during the OR tour with Director of Perioperative Services, observation of eight of the eight OR doors showed visible damage on the door edges. The Director stated the damage on the doors was there for years and she discussed it with the Director of Plaint Operation last week.

On 6/8/15 at 1030 hours, the Director of Plant Operations was interviewed. The Director stated rounds were done in the OR area every six months per schedule.

The Director provided Environmental Rounds by utilizing a Survey Checklist. The document showed the last visit to the OR was on 4/2/15. Documentation showed the OR was 100% compliant with all listed requirements. However, the documentation did not show who conducted the EOC rounds and any findings for improvement or any recommendations.

During an interview, the Director for Plant Operations stated he was made aware of the OR door issues when the Director of Perioperative contacted him. The Director toured with the Director last week and pressed orders for repair of the doors. When asked, the Director was unable to locate findings regarding the OR doors in his rounding document.

b. On 6/9/15 at 1120 hours, during an interview, the Director of Plant Operations stated he and the Coordinator of Plant Operations made environmental rounds in the patient care areas two times in a year.

The Director provided a documented Environmental Rounds Survey Checklists for L&D. The documentation showed the last evaluation was conducted on 1/27/15. There was no documented evidence to show a clinical person from the L&D area also attended the rounds. The Comment section for Fire Prevention showed documentation "Exiting light not on w/o;" however, there was no further discussion or recommendation documented.

The Director of Plant Operations was asked about utilizing the checklist during EOC rounds to ensure the compliance of the standard of patient care practices. The Director stated during the evaluation process, he would randomly interview employees and went through listed questions. The Director stated his work was not clinical; he was not comfortable to evaluate the questions related to the clinical assessment of infection control and patient safety on the Environmental Rounds Survey Checklists.

On 6/10/15 at 1130 hours, during an interview the IP RN stated she made EOC rounds to the kitchen area monthly; the Director of Plant Operations was responsible for rounding on other areas as per schedule.

6. On 6/8/15 at 1332 hours, the SPD was toured with the Supervisor of SPD. Two Sterrad sterilizers were observed: #8 and #9.

Review of the the Biological Monitoring Log (the only type of monitor that provides direct evidence that sterilization process conditions are sufficient to kill spores) for Sterrad #8 showed the test results for the control and BI tests were left blank for 5/21 and 6/1/15.

For Sterrad #9, the test results for the control and BI tests were left blank left blank on 5/21, 5/22, and 5/31/15. On 6/4/15, the documentation for "Initials" was blank. On 6/5/15, the documentation for BI test result, log #, expiration date, date/time in and date/out, initials, and test results were all missing.

The SPD Supervisor reviewed the log sheets for Sterrad #8 and #9. The Supervisor stated the two logs were not in the same format. The Supervisor stated he was responsible for ensuring the log was complete and the correct forms were used, but he was not aware of the missing documentation and that the staff did not utilize the new log sheet.

In a follow-up interview with the Director of Perioperative Services, the Director stated she oversaw the SPD Services and met with the SPD Supervisor biweekly to ensure sterilization compliance was met. The Director reviewed the above records but stated she not aware of the missing and incomplete documentation.

7. Review of the hospital's P&P for Storage of Drugs and Biologicals effective date 5/18/15, showed drugs are stored at the temperatures recommended by the manufacturers. To ensure the temperatures, all drug refrigerators/freezers are monitored by a wireless temperature monitoring system. The Pharmacy Director or designee checks daily the temperature data for all drug refrigerators and freezers via a server at a secure website.

On 6/8/15 at 1330 hours, during the tour of the Anesthesia work room, a medication freezer registered a temperature of - (minus) 15C. Ten boxes of 10 ml Tisseal (a fibrin sealant indicated for use as an adjunct to hemostasis in adult undergoing surgery when control of bleeding by conventional surgical techniques) and 18 boxes of 4 ml Tisseal were observed.

Review of the manufacturer's recommendations showed to store Tisseal below or equal -20C. In a concurrent interview, the Director of Perioperative Services stated the pharmacy was responsible for setting and monitoring the freezer temperature per the manufacturer's instructions.

On 6/9/15 at 1331 hours, the Pharmacy Director was interviewed. The Director stated Tisseal was a not pharmaceutical agent; therefore, the Pharmacy was not responsible for monitoring the product.

8. According to CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, for cleaning surgical instruments, a neutral or near-neutral pH detergent solution commonly is used because such solutions generally provide the best material compatibility profile and good soil removal. Enzyme solutions should be used in accordance with manufacturer's instructions which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time specified on the label.

Review of the enzymatic agent used by the hospital "Prolystica Enzymatic Solution 2" showed the manufacturer's instructions for this agent were to add 1/8 to 1/2 oz (3.75 to 15 ml) of the detergent mixed with one gallon of water.

a. On 6/8/15 at 1332 hours, Instrument Tech 1 was observed cleaning soiled surgical instruments in the SPD decontamination room. The Tech stated he filled the water in the sink up to half of the marked level and mixed with 2 oz of the enzymatic solution.

The Tech stated he might add more enzymatic solution if he felt that was necessary; however, the Tech did not specify "necessary." The Tech did not measure the amount of the water to reach half of the marked level of the sink.

In a follow-up interview with the SPD Supervisor, she stated the marked level of the water in the sink was 10 gallons but without a measurement. The Supervisor stated there was no way to know the accurate amount of the water Tech 1 added.

b. On 6/9/15 at 1150 hours, the Scrub Technician in the L&D areas was interviewed. The Scrub Tech explained her process for decontaminating soiled surgical instrumentations. The Scrub Tech stated she used some hot water (not specific amount) mixed with one scoop of enzymatic solution (no specific measurement) and soaked for 3-5 minutes. The Scrub Tech stated she could not recall if there was a training for properly diluting the enzymatic agent or cleaning instruments. No clock or a timer was observed nearby for monitoring the immersion time.

9.a. The hospital's P&P for Borrowing/Lending Equipment revised 11/10 showed the requests to borrow or loan equipment and/or supplies from the department must have prior approval of the department manager or OR Material Coordinator. Any instrument/equipment borrowed or loaded to another department or hospital is signed out in the loan/borrow notebook. The requesting facility must provide transportation for the borrowed item. Requesting facility must return the item as soon as possible. All instruments brought in from the outside are inventoried, documented, cleaned, and rematerialized in the hospital.

On 6/8/15 at 1332 hours, during an interview, the SPD Supervisor stated the SPD processed sterile instruments for the main OR, other departments, and adjacent physician clinics if requested. The SPD utilized documentation for instrumentation Drop off and Pick Up, but the information was not reviewed or reconciled by the SPD staff.

The Supervisor reviewed the documentation's for Drop Off and Pick Up dated from 2014 to 2015. The Supervisor stated there were multiple entries on the log showing "WCS" dropped off and picked up instrument trays, but the Supervisor could not identify who was "WCS." According to the SPD supervisor, there was no system developed for monitoring the drop off and pick up of sterile instruments. The Supervisor stated he had found out that "WCS" was a physician's clinic adjacent to the hospital. The clinic sent in soiled trays for SPD processing.

Review of the "Floor Instrument Drop Off Log" showed the log documented entries from January 2014 to November 2014. There were instruments dropped off from NICU, L&D, WCS, and CCU.

Review of the "Floor Instrument Pick Up Log" showed the entries for the pick up of instruments from WCS were dated August 2014 to April 2015; however, there was no documented evidence to show consistency of instrument trays dropped off and trays returned to the same unit.

Documentation showed on 4/1/15, L&D dropped off two C/S trays. The Pickup log had no evidence to show those two trays were returned to L&D.

On 6/9/15 at 0920 hours, during an interview, the L&D Scrub Technician stated there were some surgical procedures performed in the L&D. The most common surgeries were C/S. L&D had 10 sets of C/S instruments and the L&D staff had numbers for each tray.

The Tech took out of all the trays and packages kept in the L&D OR cabinets and noted there were two C/S trays with L&D marked outside, but there were no numbers. The Tech found more unassembled C/S instruments in the Soiled Utility Room. The Tech stated those instruments were for one C/S tray the L&D staff had sent out for contracted maintenance services.

The Technician was unable to identify those instruments belonged to which numbered C/S tray. The Technician found one used C/S instrument tray in the decontamination room. The Tech stated the tray was going back to the SPD for processing and a number tag of #1 was noted.

The Tech stated there was no system for L&D or SPD staff to track or trace any C/S tray. When asked about the drop off and pick up mechanism, the L&D Scrub Technician stated it depended the availability. If the L&D staff had time, they would send back the dirty trays to SPD or SPD staff would come and pick up.

For returning trays, the Tech stated the SPD staff delivered to L&D or the L&D staff went to SPD and took the trays from the area for "Out of Department Trays." The Tech stated she was not aware there was a log for to document drop off/pick up. The Tech stated there was no log in L&D for tracking instruments sent out and returned.

The L&D Scrub Technician was requested to check other instrument trays and packs stored in the L&D ORs (1 and 2). Four packs were labeled "GYN D/C trays." The processing dates shown on the trays were varied. The Technician stated both the OR and L&D would use D/C trays for patients. The Tech could not locate a label for "L&D" on the instrument trays to identify if the trays were L&D instruments or not.

Review of the hospital's P&P tilted Sterilization Documentation revised 3/13 showed guidelines the Sterilizer Load/Recall Form is used for all prevac sterilization loads. The form details contents of each load by listing items, descriptions, quantities, and departments from which items are from.

On 6/10/15 at 1040 hours, sterilizer Load/Recall Forms dated 6/8/15, were reviewed with the SPD Supervisor. The documentation on the forms showed there were four D/C trays processed within 24 hours on different loads with different sterilizers.

The Supervisor stated he could not locate information to identify the ownership of the D/C trays for L&D or the OR. The Supervisor stated SPD staff should specify in the documentation of the instrument ownership. The Supervisor stated there was no mechanism in the SPD for tracking instruments used for a patient if they were identified with a SSI. In a further interview with the Director of Perioperative Service, she confirmed the finding.

b. On 6/10/15, the Director of Perioperative Services provided a P&P for Flash Sterilization. The Director stated the P&P was adopted for Flash and regular sterilization practices in the hospital.

The P&P for Flash Sterilizer showed a revised date 3/13. The guidelines showed it is necessary to document and monitor each load that is flash sterilized (a modification of conventional steam sterilization (either gravity, prevacuum, or steam-flush pressure-pulse) in which the flashed item is placed in an open tray or is placed in a specially designed, covered, rigid container to allow for rapid penetration of steam).

The following information was to be recorded for each load on the ticket: initials of the person responsible for load, item sterilized, patient sticker attached to back of the ticket or patient name hand written in sterilizer printout, make entry in flash sterilizer log with patient sticker, medical record number, operating room number, date/time, load contents, code number, load number, parameter met, and signature.

On 6/10/15 at 1300 hours, during an interview, the IP RN stated on May 2015, L&D had two identified SSI events of patients post C/S. The IP RN stated her investigations included surgical instrument sterilization. The RN coordinated reports that came from the Director of Perioperative Services, but she was not aware there was no tracking of the surgical instrument used on the surgical patients.

10. According to the AORN 2015, Guideline for Surgical Attire, the recommended practice I.b.1. showed scrub attire should be donned in a designated dressing area before entry from the outdoors into the semi-restricted and restricted areas. Recommendation III showed personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair. Head coverings are part of the scrub attire.

The following observations were made between 6/8 and 6/11/15:

* On 6/8/15 at 0934 hours, an anesthesia provider walked into the Preop area and assessed a patient at the bedside. A surgical mask was hanging on his neck. The provider was also wearing a surgical cap.

* On 6/9/15 at 0815 hours, two employees were observed wearing surgical caps in the cafeteria.

* On 6/9/15 at 0830 hours, one employee was observed wearing a surgical cap in the conference room.

* On 6/11/15 at 1113 hours, an employee was observed wearing surgical boots in the public restroom.

The above findings were shared with the IP RN on 6/11/15 at 1130 hours.





11. The hospital's P&P titled Medication Access and Security originated 4/13 showed "Operating room suites are considered secure when the suite is staffed and staff is actively providing patient care ...Due to their mobility, mobile nursing medication carts, Anesthesiologist carts, epidural carts, and other medication carts containing drugs or biologicals (hereafter, all referred to as "carts") must be locked ..."

During a tour of the CVOR on 6/9/15 at 1420 hours, observation of the anesthesiologist's medication cart showed it contained 18 vials of propofol (anesthetic medication). The cart was left unlocked and unattended after the patient was taken out of the room.

Anesthesiologist 1 was interviewed on 6/9/15 at 1425 hours, in the CVOR. The open drawers of the medication cart were brought to Anesthesiologist 1's attention. He stated the expectation was the medication cart should be always locked.





12. Review of the Hospital Ancillary Services Agreement between the hospital and the contracted perfusion provider showed the agreement was effective on 4/28/15. Further review showed the contracted perfusion provider will administer drugs provided by the hospital as generally administered in connection with the ancillary services and as supervised and directed by the physician in charge. The hospital shall ensure a physician's order or the hospital's requisition, as applicable, is issued for the ancillary services prior to the time the ancillary services are provided and all verbal orders related to the ancillary services, whether given during the course of treatment or otherwise, are documented and signed by the physician or other authorized health care provider.

a. Review of Patient 15's medical record was initiated on 6/8/15. The patient was admitted on [DATE], and had a heart surgery on 6/2/15.

Review of the CVOR form dated 6/2/15, showed the surgery was started at 1445 hours and finished at 1805 hours.

Review of the Anesthesia Record dated 6/2/15, showed the cardiopulmonary bypass pump was on at 1545 hours and off at 1711 hours.

* Review of the Cardiopulmonary Bypass Record dated 6/2/15, showed the following documentation:

- Heparin was administered at 1524 hours. The initial dose was 15,000 units and the additional dose was 15,000 units.

- Protamine (Heparin antagonist) 200 mg was administered.

However, the section for Physician Verification of Verbal Orders for the above medications was left blank.

* Review of the Cardiopulmonary Bypass Record dated 6/2/14, showed the section of "fluids/drugs/comments/the following documentation:

- Heparin (anticoagulant) 5,000 unit was administered at 1641 hours.

- Magnesium sulfate (an electrolyte to treat cardiac arrhythmias) 2 gm was administered at 1705 hours

- Calcium chloride (an electrolyte to improve weak or ineffective myocardial contractions) 1 gm was administered at 1711 hours.

However, the form failed to show a physician's order was written and signed by the surgeon and/or anesthesiologist when the above medications were administered.

b. On 6/10/15, Patient 29's medical record review showed the patient was admitted on [DATE], for a coronary artery bypass (a healthy artery or vein from the body is connected, or grafted to the blocked coronary artery; the grafted artery or vein bypasses the blocked portion of the coronary artery) on 5/28/15, and was discharged home on 6/1/15.

Review of the CVOR form dated 5/28/15, showed the surgery was started at 0847 hours and finished at 1112 hours.

Review of the Anesthesia Record dated 5/28/15, showed the cardiopulmonary bypass pump was on at 0857 hours and off at 1023 hours.

Review of the Cardiopulmonary Bypass Record dated 5/28/15, showed the perfusionist administered the following medications:

- Mannitol (crystalline solid used in to preserve renal function during the times of low blood flow and pressure, while the patient is on bypass) 12.5 gm at 0930 hours.

- Heparin 15,000 units two times during the bypass.

- Calcium chloride 1 gm at 1019 hours.

- Magnesium sulfate 2 gm was administered at 1705 hours.

However, the section for Physician Verification of Verbal Orders for the above medications was left blank. There was no documentation to show the physician's orders for the above medications.

During an interview and concurrent medical record review with the Director of CV on 6/10/15 at 1000 hours, she stated the surgeon had his own preference sheet for perfusion during the surgery. The team would have a huddle prior to the surgery.

The Director stated the perfusionist received verbal orders from the surgeon for what was to be administered during the surgery. However, when asked, the Director was unable to find documented evidence to show physician's verbal orders were written and signed by the physician for the medications administered by the perfusionist during Patient 15 and 29's surgery.

13. On 6/8/15 at 0900 hours, Patient 14 was
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and medical record review, the hospital failed to ensure an updated H&P examination for two of 30 sampled patients (Patients 14 and 25) was completed prior to a surgical procedure. This failure could create the risk of substandard healthcare outcomes to these patients.

Findings:

1. On 6/10/15, Patient 25's medical record review showed the patient had a permanent pacemaker implantation procedure on 4/29/15. The patient's last H&P was completed on 4/6/15, 23 days ago. The patient registered at the hospital on [DATE] at 0556 hours, and the procedure was conducted at 1002 hours. There was no documented evidence of an updated H&P was completed prior to the procedure.

On 6/10/15 at 1440 hours, during an interview, MD 1 acknowledged the above finding.

2. On 6/8/15 at 0900 hours, Patient 14 was observed in the Preop for a scheduled surgery.

At 0926 hours, Surgeon 6 walked in to the Preop area and visited the patient and a family member at the bedside. Surgeon 6 advised the patient there would be a change in the procedure; instead of a robotic assisted surgery, there would no robot involved.

Reviewed of the EMR at 0920 hours showed an H&P was signed by Surgeon 6 on 6/4/15 at 1536 hours. The surgeon documented the patient was to have a robotically-assisted surgery.

Review of the updated H&P signed by Surgeon 6 on 6/8/15 at 0916 hours, documented the H&P was reviewed, the patient was assessed, and no change had occurred in the patient's condition since the H&P was completed. However, the time documented on the updated H&P (0916 hours) was before Surgeon 6 walked in to the patient's bed side. There was no documentation to show a change in the surgical approach.
VIOLATION: INFORMED CONSENT Tag No: A0955
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure the required documentation of the names of all the surgeons and assistants, as well as the description of the significant surgical tasks to be performed were documented in the Operative Consent forms for eight of 13 CV surgery patients reviewed (Patients 1, 2, 3, 4, 5, 6, 7, and 21). In addition, Patient 2 was not consented for a procedure that was performed. These practices increased the risk of substandard surgical outcomes for the patients in the hospital.

Findings:

The hospital's P&P titled Consent: Documentation of Informed revised 9/12, indicated "If recommended treatment(s) involve(s) performance of a complex, invasive, or operative procedure(s), then informed consent must be provided by physician performing invasive or operative procedure(s) ...Verification that physician has explained the following: Nature of proposed care, treatment, services, medications, interventions, or procedure(s) ...Prior to obtaining signatures on Verification, the following must be completed: Name of patient, first and last name of physician(s) performing procedure(s)."

1. Medical record review showed Patient 1 had an elective aortic valve replacement with coronary artery bypass surgery on 11/5/14. Review of the operative note dated 11/5/14, indicated Surgeon 1 was listed as the primary surgeon and was assisted by Surgeon 3 and Surgical PA 1.

Review of the Surgery Scheduling form dated 10/27/14, showed documentation Surgeon (Surgeon 1) and Assistant (Surgical PA 1/ Surgeon 3) were scheduled to perform the surgery on 11/5/14.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form dated 11/5/14, and signed by Patient 1, showed the documentation: "Your physician or surgeon is:" Surgeon 1's name was handwritten into the space. Directly underneath Surgeon 1's name was a blank line intended to allow documentation of the names of other surgeons or practitioners who would be involved in the patient's surgical care. This space was left blank.

2. Medical record review showed Patient 2 had a mitral valve replacement with coronary artery bypass surgery on 11/24/14. Review of the operative note dated 11/2/4/14, documented Surgeon 1 was the primary surgeon and he was assisted by Surgeon 3 and Surgical PA 1.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form dated 11/24/14, and signed by Patient 2 showed documentation "Your physician or surgeon is: Surgeon 1's name was handwritten into the space. Directly underneath Surgeon 1's name was a blank line intended to allow documentation of the names of other surgeons or practitioners who would be involved in the patient's surgical care. This space was left blank.

Patient 2's operation was identified as "Coronary Artery Bypass Graft Repair/Replace Mitral Valve and Cox IV Maze Procedure Under General Anesthesia" on the consent form signed by the patient on 11/24/14. The consent did not include documentation of a possible tricuspid valve procedure.

Review of the patient's data sheet from the morning of the procedure identified the intended procedure as a coronary artery bypass graft with MVR surgery.

Review of the Anesthesia Record for Patient 2's 11/24/14 surgery showed documentation the "proposed operation" was "CABG, MV repair, TV repair (tricuspid valve), Maze."

Surgeon 1's operative note showed documentation the "Preoperative Diagnoses: 1. Severe tricuspid regurgitation (leakage of blood backward through the valve each time the left ventricle contracts). 2. Moderate tricuspid regurgitation. 3. Persistent [DIAGNOSES REDACTED](abnormal heart rhythm). 4. Multivessel coronary artery disease." The "history" section of the operative report indicated the patient had a transesophageal echocardiogram about a month prior which showed severe [DIAGNOSES REDACTED] and moderate tricuspid regurgitation.

Review of the documentation showed the operation performed included a "tricuspid valve repair, with ring insertion." Documentation of the course of the procedure showed "While the heart was being resuscitated, attention was then turned to the tricuspid valve. I placed horizontal mattress sutures around the tricuspid valve annulus avoiding the AV node. I decided to use a size #28 tricuspid annuloplasty ring. The tricuspid annulus sutures were then placed through the annuloplasty ring. The ring was then lowered into position and tied using the Cor-Knot device. The right atriotomy was then closed in two layers with Prolene." There was no documentation found to indicate the surgery on the tricuspid valve was performed as a result of an emergency.

The Discharge Summary by Surgeon 1 dictated 12/9/14, read in part, "(Patient 2)...was admitted for elective mitral and tricuspid valve surgery, in addition to Maze procedure and coronary revascularization."

The documentation showed tricuspid surgery was performed and was likely anticipated prior to surgery but was not included in the surgical consent.

3. Medical record review showed Patient 3 was originally scheduled for an aortic valve replacement, but instead, a thoracotomy and a lung wedge resection were performed on 10/27/14.

Review of the operative note dated 10/27/14, showed Surgeon 1 was listed as the primary surgeon and was assisted by Surgical PA 1.

Review of the "Consent for observers during surgery" form dated 10/27/14, and signed by Patient 3 indicated the name of one observer who would be present in the OR during Patient 3's procedure.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form dated 11/24/14, and signed by Patient 3 indicated "Your physician or surgeon is:" Surgeon 1's name was handwritten into the space. Directly underneath Surgeon 1's name, there was a blank line intended to allow documentation of the names of other surgeons or practitioners who would be involved in the patient's surgical care. This space was left blank.

4. Medical record review showed Patient 4 had an elective coronary artery bypass graft procedure and a lung biopsy on 11/3/14. Review of the operative note, dated 11/3/14, indicated Surgeon 1 was listed as the primary surgeon and was assisted by Surgeon 5 and Surgical PA 1.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form dated 11/3/14, and signed by Patient 4 indicated "Your physician or surgeon is:" Surgeon 1's name was handwritten into the space. Directly underneath Surgeon 1's name there was a blank line intended to allow documentation of the names of other surgeons or practitioners who would be involved in the patient's surgical care. This space was left blank.

5. Medical record review showed Patient 5 had an aortic valve replacement with coronary bypass on 12/11/14. Review of the operative note dated 12/22/14, indicated Surgeon 2 was listed as the primary surgeon and was assisted by Surgeon 4.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form dated 12/10/14, and signed by Patient 5 indicated "Your physician or surgeon is:" Surgeon 2's name was handwritten into the space. Directly underneath Surgeon 2's name there was a blank line intended to allow documentation of the names of other surgeons or practitioners who would be involved in the patient's surgical care. This space was left blank.

6. Medical record review showed Patient 6 was scheduled for an elective robotic assisted MVR surgery with cardiopulmonary bypass on 11/4/14. Review of the operative note dated 11/4/14, indicated Surgeon 2 was listed as the primary surgeon and was assisted by Surgeon 4.

Review of the "Surgery Scheduling" form dated 10/8/14, indicated Surgeon (Surgeon 2) and Assistant (Surgeon 4) were scheduled to perform the surgery on 11/4/14.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form dated 11/4/14, signed by Patient 6 indicated "Your physician or surgeon is:" Surgeon 2's name was handwritten into the space. Directly underneath Surgeon 2's name, there was a blank line intended to allow documentation of the names of other surgeons or practitioners who would be involved in the patient's surgical care. This space was left blank.

7. Medical record review showed Patient 7 had a coronary artery bypass graft surgery on 4/23/15. Review of the operative note dated 4/23/15, indicated Surgeon 1 was listed as the primary surgeon and was assisted by Surgeon 3 and Surgical PA 1.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form dated 4/23/15, signed by Patient 7 indicated "Your physician or surgeon is:" Surgeon 1's name was handwritten into the space. Directly underneath Surgeon 1's name, there was a blank line intended to allow documentation of the names of other surgeons or practitioners who would be involved in the patient's surgical care. This space was left blank.

8. Medical record review showed Patient 21 had an aortic valve replacement surgery on 3/24/15. Review of the Surgical Postoperative note dated 3/24/15, indicated Surgeon 2 was listed as the primary surgeon and was assisted by Surgeon 3 and Surgeon 4.

Review of the Verification of Consent and Authorization for Surgery, Obstetrical, Special Diagnostic, or Therapeutic Procedures form dated 3/24/15, and signed by Patient 21 indicated "Your physician or surgeon is:" Surgeon 2's name was handwritten into the space. Directly underneath Surgeon 2's name there was a blank line intended to allow documentation of the names of other surgeons or practitioners who would be involved in the patient's surgical care. This space was left blank.

During an interview regarding intra-operative division of labor with the Medical Director CV Surgery on 6/10/15 at 1520 hours, he stated the PA or surgeon, either one, could have harvested the veins from the patient's legs during the CV surgery.

During an interview with Director of Performance Improvement on 6/10/15, at 1020 hours, he was asked if the names of all of the surgical participants were supposed to be listed on the patient surgery consent form. The Director stated, "I'll check on that."
VIOLATION: REQUIRED OPERATING ROOM EQUIPMENT Tag No: A0956
Based on observation, interview, and record review, the hospital failed to ensure the emergency crash cart (contains medications and equipment for resuscitation) in the cardiac catheterization laboratory procedure room was checked and maintained prior to procedures performed in the room. In addition, a suction machine had not received preventative maintenance since 2012. These increased the risk of equipment failure and possible adverse patient outcomes to the patients in the hospital.


Findings:

The hospital P&P titled Code Blue/White Crash Cart reviewed/revised 6/13, read in part, "For departments that close, crash cart(s) must be checked prior to first patient arrival."

1. During a tour of the cardiac catheterization lab (a procedure for inserting small tubes into the blood vessels in or near the heart to obtain images or to improve blood flow) procedure room on 6/8/15 at 0830 hours, review of the crash cart log showed the cart was not checked on 5/9, 5/10, 5/16, 5/17, 5/24, 5/25, 5/30, and 5/31/15, as the spaces on the form were blank for those dates.

However, review of the cath lab procedure log for those dates showed cases took place on 5/10 (two cases), 5/17, 5/25 and 5/30/15.

During a concurrent interview with the Director of CV, she stated the crash cart was to be checked daily before the room was used, but it looked like that had not occurred for the above dates.





2. The hospital's P&P titled EOC-ME-05, Medical Equipment effective 9/1/12, read in part, "To provide processes for assessing and minimizing clinical and physical risks of equipment use through inspection, testing and maintenance, inclusive of rented or leased equipment, or medical equipment brought in to the medical center by physician ...It is the policy of the hospital to provide the highest level of safety for medical equipment that is used upon all patients that enter the hospital or off site area."

The hospital's P&P titled EOC-ME-01, Medical Equipment effective 9/16/14,read in part, "Preventive Maintenance Schedule. Medical equipment is on a preventive maintenance schedule, and every consideration should be given to ensure the medical equipment is available for Biomedical staff when service is due."

The hospital's Management Plan for Medical Equipment revised 5/14, indicated "Inspection, testing and maintenance on a regular and consistent basis is part of the process to assure equipment performance ...Ongoing inspections, testing and maintenance increases the reliability of equipment life and user confidence."

During an observation in the cardiac catheterization lab procedure room on 6/6/15 at 0925 hours, the MoblVac III suction machine showed the preventive maintenance had not been performed on the machine since 5/12.

During an interview with the Director of CV on 6/9/15 at 0850 hours, she stated the MoblVac III suction machine was a rental and it "slipped through the cracks." The Director confirmed no preventive maintenance had been performed on the machine since 2012.
VIOLATION: POST-OPERATIVE CARE Tag No: A0957
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and medical record review, the hospital failed to ensure adequate post-operative care was provided for one of 30 sampled patients (Patient 30) when the patient was not reassessed by the physician prior to discharge home as per the hospital's P&P. This failure had the potential for inappropriate care or discharge for this patient.

Findings:

Review of the hospital's P&P titled Angiography Care (a medical imaging technique, performed by the physician used to visualize the inside, or lumen, of blood vessels and organs of the body) approved 1/12 showed the physician should reassess the patient prior to discharge and document in the EMR.

Review of Patient 30's medical record was initiated on 6/10/15. The patient was admitted on [DATE] at 0624 hours, for a heart cath (or cardiac catheterization, a procedure performed by the physician by insertion of a catheter into a chamber or vessel of the heart) procedure and was discharged from the CVOU on 6/4/15 at 1453 hours.

Review of the Cardiac Catheterization Report dated 6/4/15, showed Patient 30's procedure was started at 0851 hours and completed at 0926 hours. At 0945 hours, the patient was transferred to the CVOU.

Review of the Hearth Catheterization Procedure Note dated 6/4/15 at 0944 hours, showed the procedures of angiography and right heart catheterization were performed for Patient 30.

Further review of Patient 30's medical record failed to show documented evidence of the physician had reassessed Patient 30 prior to discharge.

During an interview and concurrent medical record review with the Director of CV on 6/11/15 at 1430 hours, the Director confirmed there was no documented evidence to show the physician had reassessed Patient 30 prior to discharge as per hospital's P&P.
VIOLATION: OPERATIVE REPORT Tag No: A0959
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and medical record review, the hospital failed to ensure an operative note/report was written immediately after surgery for one of 30 sampled patients (Patient 8). In addition, the required documentation of the names of the surgeons and assistants, as well as the description of the significant surgical tasks they had performed were not documented in the Operative Note for eight of 30 sampled patients (Patients 1, 2, 3, 4, 5, 6, 7, and 18). These posed the potential for lack of knowledge for health care providers delivering care to the patients.

Findings:

Review of the hospital's General Rules and Regulation revised 4/27/15, showed an operative note must be written after surgery including the post diagnosis, name of surgeon and assistant, if applicable, procedure or operation performed, technical procedures used, specimens removed, findings, estimated blood loss, blood products administered, if applicable, any unusual events or postoperative complication and management of such events.

1. Review of Patient 8's medical record was initiated on 6/8/15. The patient was admitted on [DATE]. The patient had surgery on 6/4/15 from 1537 hours to 1742 hours.

Further medical record review failed to show the surgeon wrote or dictated an operative note for the surgery performed on 6/4/15.

An interview and concurrent medical record review was conducted with the Manager of Telemetry, Manager of Critical Care Services, and Director Critical Care Services on 6/8/14 at 1115 hours. The Manager Telemetry confirmed Patient 8's surgery was on 6/4/15. When asked, the Manager Telemetry and Manager of Critical Care Services were unable to find an operative report was written and/or dictated for the surgery performed on 6/4/15.

During a follow-up interview with the Manager of Critical Care Services on 6/10/15 at 1025 hours, she stated she was unable to find an operative note and/or an operative report for Patient 8's surgery performed on 6/4/15. The Manager stated it should be written and/or dictated immediately after the surgery.





2. Medical record review showed the names of the surgeons and assistants and the description of the significant surgical tasks they performed were not documented in the Operative Note as follows:

a. Patient 1 had an elective aortic valve replacement with coronary artery bypass on 11/5/14. Surgeon 1 was listed as the primary surgeon and assisted by Surgeon 3 and Surgical PA 1. Review of the Operative Note did not show documentation of which specific surgical tasks were performed by Surgeon 3 and Surgical PA 1.

b. Patient 2 had a mitral valve replacement with coronary artery bypass on 11/24/14. Surgeon 1 was listed as the primary surgeon and assisted by Surgeon 3 and Surgical PA 1. According to the Operative Note dated 11/24/14, "The left internal mammary artery was harvested as a skeletonized graft. Simultaneously, the left greater saphenous vein was harvested endoscopically." There was no documentation to show which practitioners performed the left internal mammary artery harvest and which practitioners performed harvest of the greater saphenous vein (vein running near the inside surface of the leg from ankle to the groin) as they were performed simultaneously.

Patient 2 was returned to the OR the next day, 11/25/14, due to a bleeding complication. Surgeon 1 was listed as the primary surgeon and assisted by Surgeon 2 and Surgical PA 1. According to the Operative Note dated 11/25/14, "Of note, we placed posterior mitral annular sutures in the normal fashion ..." There was no documentation of which specific surgical tasks were performed by Surgeon 3 and Surgical PA 1 during the placement of the posterior mitral annular sutures.

c. Patient 3 was scheduled for an aortic valve replacement instead had a thoracotomy (an operation to enter the chest) and a lung wedge resection on 10/27/14. Surgeon 1 was listed as the primary surgeon and assisted by Surgical PA 1. Review of the Operative Note dated 10/27/14, showed no documentation of which specific surgical tasks were performed by Surgical PA 1.

d. Patient 4 had an elective coronary artery bypass graft and lung biopsy on 11/3/14. Surgeon 1 was listed as the primary surgeon and assisted by Surgeon 5 and Surgical PA 1. Review of the Operative Note dated 11/3/14, showed "The left internal mammary artery was harvested as a skeletonized graft. Simultaneously, the left greater saphenous vein was harvested endoscopically." There was no documentation of which practitioners performed the left internal mammary artery harvest and which practitioners performed the greater saphenous vein harvest as they were performed simultaneously.

e. Patient 5 had an aortic valve replacement with coronary bypass on 12/11/14. Surgeon 2 was listed as the primary surgeon and assisted by Surgeon 4. Review of the Operative Note dated 12/11/14, showed no documentation of which specific surgical tasks Surgeon 4 performed.

f. Patient 6 was scheduled for an elective robotic assisted MVR with cardiopulmonary bypass on 11/4/14. Surgeon 2 was listed as the primary surgeon and assisted by Surgeon 4. Review of the Operative Note dated 11/4/14, showed no documentation of which specific surgical tasks Surgeon 4 performed.

g. Patient 7 had a coronary artery bypass graft surgery on 4/23/15. Surgeon 1 was listed as the primary surgeon and assisted by Surgeon 3 and Surgical PA 1. Review of the Operative Note dated 4/23/14, showed documentation "To look for left internal mammary ...Simultaneously, the left greater saphenous vein was harvested endoscopically." There was no documentation of which specific surgical tasks Surgeon 3 and Surgical PA 1 performed. There was no documentation of which practitioners looked for the left internal mammary (artery) and which one performed the greater saphenous vein harvest as they were performed simultaneously.

h. Patient 18 had a mitral valve replacement with cardiopulmonary bypass on 5/27/15. Surgeon 1 was listed as the primary surgeon and assisted by Surgeon 3 and Surgical PA 1. Review of the Operative note dated 5/27/15, showed no documentation of which specific surgical tasks were performed by Surgeon 3 and Surgical PA 1.