HospitalInspections.org

Based on observation, interview and document review, the hospital did not have an effective governing body that carried out the functions required of a governing body to provide a safe and secure environment for patients by the following:

1. The hospital failed to ensure that the bulk Oxygen tank was installed in a secure manner and its proximity was within the required distance from the main building. (A Tag 144 #1, A Tag 710 [K76]).

2. The hospital failed to ensure that air handler units were installed in a secure manner. (A Tag 144 #2, A Tag 710 [K67])

3. The reverse osmosis machine was plugged into a power strip which was not in accordance to manufacturers guidelines. (A Tag 144 #3)

4. The hospital failed to ensure that care was provided in a safe setting when power strips were not used in accordance to manufacturers guidelines. (A Tag 144 # 3)

5. The hospital's QAPI program failed to set priorities for its performance improvement activities that affect patient safety and quality of care related to a LVAD. In addition, the hospital failed to establish a current written organizational performance improvement plan.
(A Tag 283 #1, 2)

6. The QAPI program failed to effectively monitor provided services that could affect patient safety and quality of care. The hospital failed to ensure that routine environmental monitoring captured equipment, electrical, and other structural patient safety hazards to identify opportunities for improvement. The hospital failed to use its own occurrence reporting system in an effort to collect, track, and trend errors and concerns associated with use of a new and unfamiliar LVAD. In addition, the hospital failed to establish a current written organizational performance improvement plan.
(A Tag 286 # 1, 1a-1o, 2, 3)

7. The hospital did not develop a policy for the care and management of a LVAD patient. In addition, the hospital assigned untrained Registered Nurses to provide care to a patient who had an unfamiliar medical device.
(A Tag 144 #4a, 4b)

8. The medical staff did not ensure that one patient who had an left ventricular assist device (LVAD- a device that assists the heart with pumping blood throughout the body) that was unfamiliar to the hospital, received quality medical care in a safe setting.
(A Tag 347)

9. There was no documented evidence of the attendance and completion of the LVAD training course for multiple Registered Nurses (RNs). In addition, multiple LVAD competencies were missing from the personnel files related to the care and management of LVAD patients. (A Tag 397)

10. Failed to obtain a physician's order for the care and management of a left ventricular assist device. (A Tag 395 #2)

11. Multiple care plans were not developed, updated, or implemented to reflect the current status of multiple patients.
(A Tag 396 # 1, 2a-2f, 3)

An interview with members of the Governing Body was conducted on 9/2/14 at 4:35 P.M. The Director of Quality and Risk Management (DQRM), the Chief Clinical Officer (CCO), the interim Chief Executive Officer (CEO), Executive Assistant, Chief Financial Officer (CFO), Chief of Staff (COS), Executive Vice President (EVP), Regional Director of Quality and Director of Business Development (DBD) were present and/or in attendance via telephone. The EVP and CEO acknowledged that the Governing Body was responsible and had oversight over all the hospital's conduct and function:

1. The EVP and CEO stated they were aware of the concern regarding the bulk oxygen's proximity to the building, as well as the installation issues. The members acknowledged that they were aware for two years, and that no action had been implemented to address the safety concerns.

2. The EVP was not aware of the situation with the unsafe installation of the air handler units however, the CEO stated that the Environment of Care (EOC) minutes back in November 2013 indicated the safety concerns related to the air handler units. EOC minutes were reported up to Quality and the Governing Body.

3. When new devices were presented to the hospital, the oversight included ensuring that appropriate clinical procedures, policies, and training were in place prior to the implementation of the particular device. New clinical procedures required the development of a policy and training which needed to be presented to the Medical Executive Committee (MEC) for review, discussion and feedback. The EVP stated that he deferred to the clinical staff's expertise to ensure education which included training and competencies had taken place with nursing and the medical staff prior to the admission of the LVAD patient. The CEO stated that he was unaware that some of the RNs assigned to the LVAD patient had not received the training and completed competencies related to the care and management of the LVAD patient.

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide a safe and secure environment for patients.

Based on observation, interview, record and document review, the hospital did not promote patient's rights to all patients when care was not provided in a safe setting for the following:

1. The hospital failed to ensure that the bulk Oxygen tank was installed in a secure manner and its proximity was not within the required distance from the main building. (A Tag 144 #1, A Tag 710 [K76]).

2. The hospital failed to ensure that air handler units were installed in a secure manner. (A Tag 144 #2, A Tag 710 [K67])

3. The reverse osmosis machine was plugged into a power strip which was not in accordance to manufacturers guidelines. (A Tag 144 #3)

4. The hospital failed to ensure that care was provided in a safe setting when power strips were not used in accordance to manufacturers guidelines. (A Tag 144 # 3)

5. The hospital did not develop a policy for the care and management of a LVAD patient. In addition, the hospital assigned untrained Registered Nurses to provide care to a patient who had an unfamiliar medical device.
(A Tag 144 #4a, 4b)


The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Patient Rights to ensure patient safety.

Based on observation, interview, record and document review, the hospital did not ensure that an effective Quality Assessment and Performance Improvement program (QAPI) was implemented when the hospital:

1. Failed to set priorities for its performance improvement activities that affect patient safety and quality of care related to a LVAD. In addition, the hospital failed to establish a current written organizational performance improvement plan.
(A Tag 283 #1, 2)

2. Failed to effectively monitor provided services that could affect patient safety and quality of care. The hospital failed to ensure that routine environmental monitoring captured equipment, electrical, and other structural patient safety hazards to identify opportunities for improvement. The hospital failed to use its own occurrence reporting system in an effort to collect, track, and trend errors and concerns associated with use of a new and unfamiliar LVAD. In addition, the hospital failed to establish a current written organizational performance improvement plan.
(A Tag 286 # 1, 1a-1o, 2, 3)

The cumulative effect of this systemic practice resulted in the failure of hospital to deliver statutorily mandated compliance with the condition of participation for Quality Assessment and Performance Improvement to ensure a safe environment to all patients.

Based on interviews, record and document reviews, the hospital failed to maintain an organized nursing service that meets the needs of the patients as evidenced by:


1. Failure to ensure that effective hand off communication related to swallowing precautions and fluid restrictions occurred between the Registered Nurses and Certified Nursing Assistants.
(A Tag 395 #1a, 1b, 3)

2. Failure to consistently follow the physician's order for two patients.
(A Tag 395 #1b, 3)

3. Failed to obtain a physician's order for the care and management of a left ventricular assist device (LVAD- a device that assists the heart with pumping blood throughout the body).
(A Tag 395 #2)

4. Multiple care plans were not developed, updated, or implemented to reflect the current status of multiple patients.
(A Tag 396 # 1, 2a-2f, 3, 4)

5. Failed to ensure that assigned RNs had been trained and their competencies were validated to care and manage of a LVAD.
(A Tag 397)


The cumulative effects of these systemic problems resulted in the hospital's inability to provide nursing services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Nursing Services.

Based on observations, interviews and document reviews the hospital failed to ensure a safe physical environment for patients, visitors and staff by the following:


1. Failure to ensure that nine roof air handler units were properly secured.
(A Tag 710 [K67] and 724)

2. Failure to ensure the 1500 gallon liquid oxygen tank was properly installed. The tank was installed five feet from the wall of the building with wooden construction.
(A Tag 710 [K76] and 724)

3. Failure to substantially comply with 42 CFR (Code of Federal Regulations) 482.41 (B) (1) for General Acute Care Hospitals. This was evidenced by the facility failing to meet provisions under the NFPA (National Fire Protection Association) 101, Life Safety Code 2000 Edition. As a result, this increased the risk of injury to the patients, staff, and visitors in the event of a fire or disaster.
A Tag 710 (refer to K tags)

4. The reverse osmosis machine was plugged into a power-strip which was not in accordance to manufacturer's guidelines. (A Tag 724)

5. The hospital failed to ensure that use of portable humidifiers were in accordance to the manufacturer guidelines and should not be used in anesthetizing areas. (A Tag 710 K78)

6. Power-strips were not used in accordance to manufacturer's guidelines. (A Tag 724)



The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation for Physical Environment to ensure that a safe environment was provided to all patients, visitors, and staff.

Based on observation, interview and document review, the hospital failed to ensure that care was provided in a safe setting when a 1500 gallon liquid oxygen tank was installed unsecurely 5 feet away from the wall of the building and 9 air handlers on the roof that were not secured from falling off. Seven of the nine air handlers were dual units connected to natural gas lines. During an earthquake, these units could move and disconnect from the gas lines which could result in a fire, explosion, and lack of functioning ventilation affecting all patients, staff and visitors.

The hospital also failed to provide care in a safe setting for 1 of 30 sampled patients (11) when Patient 11's reverse osmosis dialysis equipment (RO - a system designed to purify water) was plugged into a power strip. The RO had tubing which extended from the unit into the bathroom sink, which allowed for drainage of the patient's dialysate (fluid that cleans the blood). The power strip was placed in a wet location that posed a risk for electrical shock during the dialysis treatment. The power strip was used by staff not in accordance with the manufacturer's guidelines.

In addition, the hospital failed to develop a policy for the care and management of a left ventricular assist device (LVAD- a device that assists the heart with pumping blood throughout the body) for 1 of 30 sampled patients (1) when Patient 1 was cared for by untrained Registered Nurses (RNs). One of the untrained nurses, RN 2 was unfamiliar with the LVAD when she provided care to Patient 1. RN 2 attempted to change the back-up battery, and in the process she damaged the controller which caused the device to alarm. The failure to develop a policy for the care and management of the LVAD, and the lack of training for the assigned RNs did not ensure quality and safe medical care. This could result in the potential failure of the LVAD, loss of Patient 1's heart function and/or death.

On 8/25/14 at 1:25 P.M., a situation of Immediate Jeopardy was determined to be present due to the findings outlined in A Tag 144, 710 (K67 and K76), and 724. The interim Chief Executive Officer, the Chief Clinical Officer, Director of Pharmacy, Director of Human Resources, Director of Business Development, Chief Financial Officer, Director of Plant Operations, and the Director of Quality and Risk Management were present. The Immediate Jeopardy was abated on 8/28/14 at 7:00 P.M. after an acceptable corrective action plan was implemented.

Findings:

1. During a tour of the facility with the Director of Plant Operations (DPO), the oxygen storage area was observed. On 8/25/14 at 10:35 A.M., a 1500 gallon liquid oxygen tank was installed 5 feet from the building wall (a wooden frame constructed building) and not anchored properly to the concrete floor. The State Agency submitted a field visit report on 5/19/14 indicating that the facility was notified in November 2012 that the installation of the liquid oxygen tank was not in compliance with applicable codes. The tank was installed without approval from the State's Authority having jurisdiction and was not properly anchored to the concrete floor.

An interview with the DPO was conducted on 8/25/14 at 10:36 A.M. The DPO acknowledged that the liquid bulk oxygen tank was installed without obtaining prior approval from State's Authority. He also acknowledged that the bulk oxygen tank was not securely installed and was placed too close to a wooden frame construction.

2. During a tour of the facility with the Director of Plant Operations (DPO), the roof Air Handlers were observed. On 8/25/14 at 11:05 A.M. The State Agency submitted a field visit report on 4/11/13 indicating that on 11/1/12, during a facility visit, the facility was notified that air handlers (air handler units were numbered: #6, #15, #7, #22, #23, #30, #31, #33, and #44) posed a hazard because they were not anchored securely to the roof. Seven of the nine were dual air handlers (heating and cooling) with gas lines attached to them. Five of nine air handlers installed on elevated platforms ranging from 18 inches to approximately 3 feet above the roof. Eight of nine air handlers were resting on 4 by 4 un-anchored wood blocks. The air handlers were not secured to the wood blocks, and the wood blocks were not secured to the roof.

On 8/25/14 at 11:08 A.M., air handler units #22, #30 and #33 were observed to be dual units with gas line attached and were elevated on the wood blocks without being secured to the platforms and roof.

On 8/25/14 at 11:25 A.M., during an interview with the DPO, he stated that the hospital could not provide documentation to show air handlers were installed with approval from State Agency having jurisdiction. He acknowledged that the air handler units were not securely installed.












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3. Patient 11 was admitted to the hospital on 7/31/14 with diagnoses which included renal disease (kidney) and hemodialysis (filtering of blood via a machine) per the History and Physical, dated 8/1/14.

On 8/19/14 at 8:05 A.M. a tour of the Medical Surgical floor was conducted with a Registered Nurse (RN) 11. RN 12, a contracted dialysis nurse, was observed in Patient 11's room attending to the RO equipment in the room.

On 8/19/14 at 11:20 A.M., Patient 11 received dialysis in the room while RN 12 was present. RN 12 stated that in preparation for Patient 11's dialysis treatment, the RO unit had to have a water source and was connected to the bathroom sink. In addition, he stated that the RO unit needed to be connected to the dialysis machine which was beside the patient's bed. He further stated that the RO's cord was not long enough therefore, a power strip was used.

On 8/19/14 at 11:25 A.M., an interview was conducted with the Director of Plant Operations (DPO). The DPO acknowledged that Patient 11's room could not accommodate the dialysis equipment without the use of a power strip. At 4:15 P.M. on the same day, the DPO stated that nine additional patient rooms in the hospital did not accommodate the RO equipment because electrical outlets were not close enough to the bathroom. He stated that those nine rooms also required the use of a power strip. In addition, at 5:15 P.M. on the same day, the DPO stated he was not aware of the manufacturer's guidelines for the power strip used in Patient 11's room.

On 8/19/14 at 4:45 P.M., the RO and the power strip manufacturer's guidelines were reviewed. The RO guidelines included: Do not use an extension cord with the RO unit. The power strip guidelines included: Do not use where excessive moisture is present, use in dry locations only.

On 8/20/14 at 3:50 P.M., an interview was conducted with RN 12. RN 12 stated that Patient 11's room did not accommodate the RO equipment. He stated that it could have been a hazard for electrical shock if the power strip had contact with the water source in the bathroom. In addition, after reviewing the manufacturer guidelines for the RO and the power strip, RN 12 stated that patients' safety were at risk for electrical shock and equipment failure. RN 12 acknowledged that the manufacturer's guidelines specified to not plug the RO into an extension cord (power strip), and not use power strips in areas with excessive moisture.

On 8/21/14 at 4:25 P.M., an interview was conducted with the DPO. The DPO stated that the hospital relied on the fact that the power strip was hospital grade (circuit breaker protection ) and that it was not necessary to further review the manufacturer guidelines. The DPO acknowledged that he had not seen or read the manufacturer's guidelines or the label on the bottom of the power strip.

The hospital's policy titled "Patient Rights and Responsibilities", dated 10/06, was reviewed. Per the policy, it referred to the use of the Patient Handbook. The Patient Handbook stipulated that patients in the hospital, you or your representative had the right to care in a safe setting.

On 8/26/14 at 4:00 P.M., a telephone interview was conducted with the dialysis acute coordinator (DAC) and the chief clinical coordinator (CCO). The DAC stated that dialysis RNs were trained to follow manufacturer's guidelines. The DAC was not aware of the manufacturer's guidelines that the RO device should not be plugged into an extension cord (power strip), and not to use the power strip in areas with excessive moisture. The CCO and the DAC acknowledged that this could have been a hazard for electrical shock if the power strip had contact with the water source in the bathroom. The CCO stated that the hospital had oversight of the safety of the equipment used in the hospital. The CCO acknowledged that the power strip posed a risk to patients' safety when the power strips were not used in accordance to manufacturer's guidelines.


















25321


4a. A joint observation of Patient 1 and interview with Registered Nurse (RN) 1 was conducted on 8/19/14 at 8:45 A.M. Patient 1 was resting in bed with the head of the bed elevated. A black bag (fanny pack) was observed located on the left side of the patient. The fanny pack had cords which were attached to an external machine. RN 1 stated that Patient 1 had a LVAD.

A joint review of the contents of Patient 1's medical record and interview with RN 1 and the Director of Education (DE) was conducted on 8/19/14 at 4:20 P.M. Patient 1 was admitted to the hospital on 5/21/14 for further management of respiratory failure and cardiac status with a LVAD per the History and Physical, dated 5/21/14. RN 1 stated that all assigned RN's had received competency training related to the care and management of patients with a LVAD. Both the DE and RN 1 stated that Patient 1 was the first patient admitted to the hospital with this type of device.

An interview with RN 2 was conducted on 8/19/14 at 4:50 P.M. RN 2 stated that the policy titled Ventricular Assist System was located in a white binder labeled LVAD which provided guidance for the care and management of the LVAD.

An interview and joint review of the hospital's Ventricular Assist System policy with the Director of Quality and Risk Management (DQRM) was conducted on 8/19/14 at 5:30 P.M. After review of the policy, the DQRM stated that the current policy located in the white binder was from a sister facility. He stated that the current policy (the one from the sister facility) that was presented by the DE, was being used but it had not gone through the hospital's policy approval process.

A joint interview with the CCO and the DQRM was conducted on 8/20/14 at 10:00 A.M. The CCO stated that their own LVAD policy was currently going through the approval process; however, the policy from the sister facility was available as a reference.

A joint interview with the DE and the Director of Business Development (DBD) was conducted on 8/20/14 at 10:35 A.M. The DE stated the policy was going through the approval process and was usually not available to nursing until the policy was final. The DE stated that she could not provide a reason why the current unapproved policy was available to the nursing staff.

A joint interview with the CCO and the DQRM was conducted on 8/20/14 at 3:15 P.M. The CCO stated the unapproved policy should not be available. He acknowledged that an unapproved policy for the LVAD was available for the nursing staff to use.

An interview with the Chief of Staff was conducted on 8/21/14 at 9:10 A.M. The COS stated that he was unaware that the hospital had admitted a patient with a LVAD. The COS stated that there must be a policy in place to define how to care and manage the LVAD. He stated that before a policy was used, the policy should have gone through the Medical Executive Committee (MEC) for review, discussion, and approval.

An interview and joint review of the physician's orders with RN 1, RN 4, and the DQRM was conducted on 8/21/14 at 10:15 A.M. There was no physician's order found to address the care and management of Patient 1's LVAD. They stated that there should have been a physician's order. After further review of all orders, the DQRM, RN 1, and RN 4 acknowledged that no physician's order had been obtained upon Patient 1's admission to the hospital, on 5/21/14.

The CCO, COS, and the CEO acknowledged that the hospital had not implement the appropriate steps when Patient 1 had been admitted prior to the development and approval of a LVAD policy.

4b. A joint review of the Nursing Flowsheet of Patient 1's medical record with the Director of Quality and Risk Management (DQRM) and the Director of Business Development (DBD) was conducted on 8/20/14 at 8:45 A.M. The Flowsheet indicated, on 8/13/14 at 7:25 A.M., that there was an alarming battery on the LVAD which had been detached by the night [noc] RN- she was unable to change the battery. The morning RN documented that she had received report from the night RN that she had attempted to change the LVAD battery but was unable to pull the controller and the system was alarming. The House Supervisor, the Director of Education (DE), and the Chief Clinical Officer (CCO) were notified. At 9:00 A.M., the LVAD controller was exchanged by the DE. The DQRM stated that it seemed like the night shift RN caused the LVAD to malfunction but needed to further investigate.

At the same time on 8/20/14, a review of the physician's progress note was conducted. Per the note, on 8/13/14 at 11:22 A.M., the LVAD coordinator documented, "Replaced backup controller and battery with damaged prongs..." At 12:45 P.M., on the same date the primary physician documented, "Had LVAD issues, changed battery."

A joint interview with the CCO and the DQRM was conducted on 8/20/14 at 10:00 A.M. The CCO stated he was not sure if troubleshooting information was available in the room; however, the LVAD coordinators number was on the actual device and should have been called for advice.

A joint interview with the DE and the DBD was conducted on 8/20/14 at 10:35 A.M. The DE stated that the morning of 8/13/14, she and the CCO realized that the assigned night shift RN had not been trained on the care and management of the LVAD. At 4:15 P.M. on the same day, the DE stated that the LVAD competency documents were missing therefore, she could not provide proof of completion. The DE stated that she believed the competencies copies may be in the employees' personnel files located in human resources.

An interview with the Chief of Staff (COS) was conducted on 8/21/14 at 9:10 A.M. The COS stated that he was unaware that the hospital had admitted a patient with a LVAD. The COS stated he had been informed by the Chief Executive Officer (CEO) that training on the LVAD had occurred; however, the paperwork was missing. The COS stated that when patients were admitted with unfamiliar and/or new medical devices, his expectation was that medical staff were made aware and that the nursing staff received proper training. He acknowledged that the hospital did not follow the appropriate steps to ensure that medical staff were made aware of admitting LVAD patients, a LVAD policy was developed, and nursing staff received proper training and competency before Patient 1's admission.

A review of the hospital's nursing assignment for Patient 1, dated 5/21/14 thru 8/21/14, and LVAD training records to include evidence of competency documentation was conducted on 8/21/14 at 4:15 P.M. There were a total of eight RNs and one registry (contracted staff) RN who cared for Patient 1. There was no documented evidence to demonstrate that the RNs had LVAD training and that competencies were established.

A joint telephone interview with RN 2, the CCO, and the DQRM was conducted on 8/21/14 at 4:45 P.M. RN 2 stated that during the change of shift, the morning RN informed her that Patient 1's battery needed to be changed. When she went to change the battery on the LVAD, she could not insert the new battery, and believed it was broken. RN 2 stated that on 8/12/14, it was her first time working with a LVAD. Prior to the training on 8/19/14, she stated she was unfamiliar with the device and did not think to question or refuse the assignment. RN 2 acknowledged that she cared for Patient 1 without proper training to manage the LVAD.

A joint interview with RN 3, the CCO, and the DQRM was conducted on 8/21/14 at 5:30 P.M. RN 3 stated that during shift change and hand off communication on 8/12/14, RN 2 was shown the LVAD and asked, "What is this?," at that point she was told that she needed special training on the LVAD but she said that she could care for it. The next morning, 8/13/14, RN 2 was told to change the LVAD battery. RN 3 stated that as she entered the room, RN 2 stated that the battery could not be changed. RN 3 stated that the male and female connector would not connect, "looked like something was bent."

The hospital's policy titled "Competency Assessment" was reviewed. The policy dated 12/19/12, indicated, "Policy: ...The staff shall be competent to fulfill their assigned technical, professional, managerial, clinical and support responsibilities based on education, experience, specialty training, certification and applicable laws/regulations. Procedure: B. Competency Assessment Mechanism- 7. New Equipment/Procedure Training. J. Registry & Travelers: 1. It is the responsibility of the department manager/supervisor that utilizes the registry or traveler staff member to certify their competency to perform their assignment duties before they commence working."

An interview with the CEO was conducted on 8/25/14 at 10:30 A.M. The CEO stated that it was his responsibility to ensure that the appropriate staff received training on the LVAD. He stated that it was his expectation that the training and competency had been completed prior to Patient 1's admission. The CEO acknowledged that a safe setting was not ensured when Patient 1's LVAD was cared for and managed by untrained staff.

Based on observation, interview, and record review the hospital's Quality Assessment and Performance Improvement (QAPI) program failed to set priorities for its performance improvement activities that affect patient safety and quality of care related to the use of a left ventricular assist device (LVAD- a device that assists the heart with pumping blood throughout the body) for 1 of 30 sampled patients (1).

The hospital did not consider or determine that a patient who was admitted to the hospital with an LVAD as high risk patient/population when the hospital had never admitted this patient type before, nor had hospital staff ever provided care to a patient with an LVAD.

Improper handling of an LVAD and its components could lead to the loss of heart functioning and death. When Registered Nurse (RN) 2 attempted to change the battery; RN 2 damaged the controller which caused the LVAD to malfunction. The failure to consider patients with an LVAD, as a high risk population, prevented the hospital from setting priorities and ensuring that all assigned RNs were trained and competent to appropriately care and manage the LVAD.

In addition, the hospital failed to establish a current written Organizational Performance Improvement Plan (OPIP) that had been presented, discussed, and approved by the Governing Body and Medical Executive Committee (MEC). The hospital's written performance improvement plan was dated 2013.

Findings:

1. A review of the hospital's Organizational Performance Improvement Plan (OPIP), dated 2013 was conducted. Per the plan, "Organizational leaders have the responsibility to create an environment that promotes improvement through safe delivery of patient care, quality outcomes and patient satisfaction. Per the plan, a way to achieve that goal was to give high priority to high-volume, high risk, or problem prone processes."

A joint review of the medical record and interview with RN 1 and the Director of Education (DE) was conducted on 8/19/14 at 4:20 P.M. Patient 1 was admitted to the hospital on 5/21/14 with diagnosis that included end-stage non-ischemic cardiomyopathy (heart muscle that results in abnormal cardiac function) and an LVAD device per the History and Physical, dated 5/21/14. RN 1 stated that all assigned RNs had received competency training on care of the LVAD. Both the DE and RN 1 stated that Patient 1 was the first patient admitted to the hospital with this type of device.

An interview and review of the Occurrence Report policy, dated 12/19/12, with Chief Clinical Officer (CCO) and the Director of Quality and Risk Management (DQRM) was conducted on 8/20/14 at 3:15 P.M. The CCO stated that the discussion to admit LVAD patients occurred prior to his hire date of 3/17/14. He stated the following:
The hospital understood that "they were not taking care of the LVAD, only the patient and not the device.
Patient (1) was admitted and trained on battery changing.
Patient came to the hospital as a DO NOT RESUSCITATE [DNR]; no intervention for staff if she coded.
The hospital was told that Patient and family had been trained to care for that LVAD and emphasized the LVAD coordinator [they] be called if any issues arised from that device.
He was unaware that RN 2 had not gone through the competency training. He said he had been told she was only missing the initial training. The CCO then stated he was made aware that RN 2 had not been trained on the LVAD on 8/13/14 when the controller had to be changed."

During the same interview, both the CCO and the DQRM stated neither could see that the LVAD was discussed in QAPI, MEC, or Governing Body.

An interview with Patient 1 and the Director of Education (DE) was conducted on 8/24/14 at 4:10 P.M. Patient 1 stated, she had some knowledge of the LVAD but a family member managed and cared for the device and its components. Two visitors were at the bedside, one confirmed to be a family member stated was somewhat familiar with the LVAD. The family member stated, she did not assist with the care and management of the device, it was another family member. That family member was not available for an interview.

On 9/2/14 at approximately 2:40 P.M., during the QAPI group interview, the DQRM, the CCO and the CEO acknowledged that the hospital's QAPI program did not have oversight over the care and management of LVAD patients. The CEO stated that the DQRM was not included or involved in the planning and meetings related to the admission of LVAD patients to the hospital. The CCO acknowledged that even though this was a new patient population and new medical device to the facility, they did not consider this patient population as high risk, because the patient was familiar with the device and they were treating the patient and not the device.

The hospital failed to consider the patient's current medical status and the fact that this patient was not independent and not responsible for the management of the LVAD while hospitalized. Despite the staff's inexperience and unfamiliarity with this new device, the hospital did not prioritize the LVAD patient population as high risk when a malfunction could lead to a patient's demise. The patient was dependent on this device to sustain the patient's life.

2. A review of the hospital's OPIP, dated 2013, was conducted. Per the plan, "It is the responsibility of the Hospital Department/Service Director in collaboration with Director of Quality/Risk Management to develop a written department/service-specific performance improvement plan consistent with the mission of the organization. The plans shall describe their scope of service and goals and specific measurements to be evaluated. It is expected that this document should serve as a guide to the development of necessary policies, procedures, training programs and guidelines that are responsive to the needs of the patient population served, the scope and complexity of patient care needs, and the knowledge and skill of staff members providing care."

A group interview with the members of the QAPI committee was conducted on 9/2/14 at 2:00 P.M. The Director of Quality and Risk Management (DQRM), the Chief Clinical Officer (CCO), the interim Chief Executive Officer (CEO), The Director of Education (DE), the Director of Plant Operations (DPO), the Director of Human Resources (DHR), and the Director of Pharmacy (DOP) were present. The DQRM stated that the OPIP dated 2013 was the most current plan. He stated the 2013 PIP goals and improvement plans were carried over to 2014; therefore, it was the same plan. The DQRM further stated that the OPIP plan did not change.

According to the hospital's OPIP, dated 2013, "The Quality Council has been empowered by the Governing Board to develop and oversee the organization-wide performance improvement program. Membership in the Quality Council is comprised of the organizational leaders... The Quality Council has responsibility to the Governing Board for: Prioritizing performance measurement and improvement efforts to enhance the mission, vision, and strategic goals of the organization. Submits an annual report on the effectiveness of the performance improvement plan to the Governing Board." Per the same plan, "Organization-wide performance improvement activity will be reported at least quarterly through the appropriate medical staff committees and to the Governing Board. The performance improvement plan and program will be evaluated and approved annually. The Quality Council will ensure the integration and coordination of medical staff, nursing, and support service performance improvement plans and activities, including patient safety related initiatives. They will also facilitate integration of performance improvement functions by ensuring necessary training and education...and improve specific processes and/or systems across interdisciplinary lines."

An interview with the CEO was conducted during the QAPI meeting on 9/2/14 at 2:40 P.M. The CEO stated that he had oversight of the OPIP to ensure that the OPIP was in place and had current goals. He acknowledged that there was no official 2014 OPIP available.

Based on observation, interview, and record review the hospital's Quality Assessment and Performance Improvement (QAPI) program failed to effectively monitor provided services that could affect patient safety and quality of care. In addition, the hospital failed to ensure that routine environmental monitoring captured equipment, electrical, and other structural patient safety hazards in an effort to identify opportunities to enhance patient safety, reduce risk and improve outcomes, which was in accordance with the hospitals own Organizational Performance Improvement Plan (OPIP).

The hospital failed to use its own occurrence reporting system in an effort to collect, track, and trend errors and concerns associated with use of a new and unfamiliar left ventricular assist device (LVAD- a device that assists the heart with pumping blood throughout the body) for 1 of 30 sampled patients (1). When RN 2 attempted to change the LVAD battery, she damaged the controller which caused the LVAD to malfunction; this could have led to a loss in the patient's heart function and death.

There was no occurrence report developed; therefore, there was no investigation or an action plan in place to prevent future incidents or occurrence. The failure to complete an occurrence report after the LVAD malfunctioned prevented the hospital from identifying improvement opportunities such as the verification that all assigned RNs were trained and had completed the LVAD competency training; the consistent monitoring of the effectiveness of care and management of the LVAD; and the safety evaluation of services and quality of care provided.

In addition, the hospital failed to establish a current written Organizational Performance Improvement Plan (OPIP) that had been presented, discussed, and approved by the Governing Body and Medical Executive Committee (MEC). The hospital written performance improvement plan was dated 2013.

Findings:

The following equipment, electrical and structural safety hazards were identified during the survey:

1. The hospital failed to maintain electrical safety as evidenced by the usage of multi-plug power strips and the presence of an alcohol based hand rub dispenser over a light switch, and a wall outlet was not covered. The usage of multi-plug power strips and extension cords could cause circuits to be overloaded and the start of a building fire. The hospital used power strips for permanent wiring due to the shortage of outlets or outlets that were installed too far from the equipment.

The following observations were in violation of the NFPA (National Fire Protection Association) 101 and Life Safety Code (LSC-Life Safety Code 2000 edition), existing codes:

1a. On 8/19/14 at 8:05 A.M., a contracted dialysis Registered Nurse (RN) 12, was observed in Patient 11's room attending to the reverse osmosis dialysis equipment (RO - a system designed to purify water) in the room.

On 8/19/14 at 11:20 A.M., RN 12 stated that in preparation for Patient 11's dialysis treatment, the RO unit had to have a water source and was connected to the bathroom sink. In addition, he stated that the RO unit needed to be connected to the dialysis machine which was beside the patient's bed. He further stated that the RO's cord was not long enough therefore, a power strip was used.

On 8/19/14 at 5:15 P.M., an interview was conducted with the Director of Plant Operations (DPO). The DPO stated he was not aware of the manufacturer's guidelines for the power strip used in Patient 11's room.

On 8/19/14 at 4:45 P.M., the RO and the power strip manufacturer's guidelines were reviewed. The RO guidelines included: Do not use an extension cord with the RO unit. The power strip guidelines included: Do not use where excessive moisture was present, use in dry locations only.

On 8/20/14 at 3:50 P.M., an interview was conducted with RN 12. RN 12 stated that Patient 11's room did not accommodate the RO equipment. He stated that it could have been a hazard for electrical shock if the power strip had contact with the water source in the bathroom. In addition, after reviewing the manufacturer's guidelines for the RO and the power strip, RN 12 stated that patients' safety were at risk for electrical shock and equipment failure. RN 12 acknowledged that the manufacturer's guidelines specified to not plug the RO into an extension cord (power strip), and not use power strips in areas with excessive moisture.

On 8/21/14 at 4:25 P.M., an interview was conducted with the DPO. The DPO stated that the hospital relied on the fact that the power strip was hospital grade (circuit breaker protection) and that it was not necessary to further review the manufacturer's guidelines. The DPO acknowledged that he had not seen or read the manufacturer's guidelines, or the label, on the bottom of the power strip.

On 8/26/14 at 4:00 P.M., a telephone interview was conducted with the dialysis acute coordinator (DAC) and the Chief Clinical Officer (CCO). The DAC was not aware of the manufacturer's guidelines that the RO device should not be plugged into an extension cord (power strip), and not to use the power strip in areas with excessive moisture. The CCO and the DAC acknowledged that this could have been a hazard for electrical shock if the power strip had contact with the water source in the bathroom. The CCO stated that the hospital had oversight of the safety of the equipment used in the hospital. The CCO acknowledged that the power strip posed a risk to patients' safety and that they should not have been used.

1b. (A Tag 710) On 8/20/14 at 4:41 P.M., the hospital failed to maintain the integrity of the main hospital's building construction. This was evidenced by penetrations in fire-rated ceiling not sealed with correct material to maintain its fire rating. This affected 5 of 5 smoke compartments of the Main Hospital. This could result in rapid spread of smoke and fire throughout the building and possible harm to patients, staff and visitors, during fire. A portable air conditioning unit exhaust duct was taped to the rated ceiling of the Medication Room on Central Medical-Surgical Nurses Station. The penetration around the air-condition duct was sealed with non-fire rated material. The ceiling was a hard/fire rated ceiling.

1c. (A Tag 710) On 8/26/14 at 3:53 P.M., the hospital failed to maintain its smoke barrier doors. This was evidenced by a plastic door wedge blocking the closing of smoke barrier doors. This affected 2 of 5 smoke compartments in the Behavioral Center. This finding could result in the spread of smoke from one smoke compartment to another and an increased risk of injury to patients and staff in the event of a fire. The Facility Staff had to remove the plastic door wedge before the door could be closed. In the main hospital, there was a non fire-rated wood door to cover the entrance to the smoke- barrier attic space in a fire-rated ceiling by radiology. In addition, there was a 2 by 2 feet opening in the draft stop in the smoke-barrier attic space by Medical Surgical Nurses Station.

1d. (A Tag 710) 8/26/14 at 4:00 P.M., the hospital failed to maintain their automatic sprinkler system in reliable operating condition. This was evidenced by patient equipment resting on and by the sprinkler riser pipes. This affected 1 of 5 smoke compartments of the Main Hospital. This could result in reduced effectiveness of the sprinkler system and cause injury to patients from fire.

1e. (A Tag 710) On 8/28/14 in the main hospital's designated smoking area, combustible trash and cigarette butts were in four of four open top ashtrays. The designated smoking area was not equipped with metal containers with self-closing devices for appropriate cigarette disposal. The hospital failed to ensure fire safety from careless disposal of cigarette butts, and failed to provide safety type ashtrays in their designated smoking areas.

1f. (A Tag 710) On 8/25/14 at 3:51 P.M., a 18000 BTU gas-water heater tank in the main hospital was installed in the main electrical room. The gas-water heater was installed approximately 2 feet from the Computerized Tomography electrical transformer in the electrical room. The State Authority facility visit report, dated 8/25/14, indicated the piping for the water heater was not firmly secured. The water heater tank could fall off during an earthquake. The proximity of the electrical transformer to the water heater pose a hazard from fire. There was no documentation of approval for the installation of the gas water heater tank to ensure compliance to applicable codes.

1g. (A Tag 710) On 8/28/14, The hospital failed to provide an ABC ( A= TRASH-WOOD-PAPER, B= LIQUIDS, C = ELECTRICAL EQUIPMENT) fire extinguisher in their main hospital cooking area. This was evidenced by the kitchen not equipped with an ABC fire extinguisher. This could cause a delay in reaching the fire extinguisher and the potential of the fire spreading and causing harm to patients and staff in the event of a fire emergency. This affected 1 of 5 smoke compartments of main hospital. The hospital's kitchen was not equipped with an ABC fire extinguisher nor was there one within 75 feet travel distance from the furthest point of the kitchen to the next fire extinguisher outside in the corridor. The kitchen housed combustible materials such as papers, and electrical equipment.

1h. (A Tag 710) On 8/28/14 at 4:36 P.M., the hospital failed to maintain means of egress free from obstructions. This was evidenced by two commercial refrigerators in the main hospital, approximately 8 feet in height were stored in the egress path corridor blocking the east kitchen exit door-way in the kitchen. This affected 1 of 5 smoke compartments of the Main Hospital. This could delay evacuation and possible harm to patients, staff and visitors, in the event of a fire.

1i. On 8/21/14 at 3:40 P.M., a tour of the Operating Room (OR) was conducted. Four of 4 ORs were observed to have portable humidifiers stored in each room.

On 8/21/14 at 3:47 P.M., an interview was conducted with the Plant Operation Engineer. He stated that all 4 ORs humidity levels were controlled with the portable humidifiers.

A review of the manufacturer's instructions for the portable humidifiers was reviewed on 8/21/14 at 5:10 P.M. Per the instructions, the humidifiers were "not intended for commercial use."

1j. On 8/20/14 at 3:51 P.M. an alcohol based hand rub dispenser was observed mounted directly over a light switch in the Business Development Office. The dispenser contained 62 % (per cent) alcohol per the label on the bag in the dispenser.

1k. On 8/20/14 at 4:01 P.M., a printer and facsimile machine in the Case Management office was plugged into a multi-plug power strip. Two additional power strips were plugged into each other (daisy chain) with a small refrigerator and fan plugged into the first one.

1l. On 8/20/14 at 4:41 P.M., in the Medication Room at the Central Medical Surgical nurses station, a small refrigerator was plugged into a multi-plug power strip.

1m. On 8/21/14 at 12:07 P.M. through 12:10 P.M., during a tour of the Radiology Department a printer, an extension cord, a hot light for the X-ray machine, and a digitizer that converts the X-ray film to digital were observed plugged into multi-plug power strips.

1n. On 8/21/14 at 2:32 P.M., an observation of the Physical Therapy Room was conducted. The hospital had converted a 2 socket wall outlet (double receptacle) into a four socket wall outlet (quad receptacle) which was screwed into a 4 socket adapter to the 2 socket wall outlet, this created a permanent attachment. There were two small refrigerators, a microwave and a network industrial printer plugged into the 4 socket wall adapter.

1o. On 8/21/14 at 3:00 P.M., an observation in the pharmacy revealed a multi-plug power strip plugged into another multi-plug power strip. Computers and printers were plugged into both the multi-plug power strips.

Per the hospital's Organizational Improvement Plan, dated 2013, "The Performance Improvement (PI) Plan provided the framework for (hospital's name) to systematically design, measure, assess, and improve processes, structures, and outcomes by utilizing the principles of continuous quality improvement (CQI)." Per the plan, data would be collected and reported to the Environment of Care (EOC) Committee. Data would be utilized to identify opportunities to enhance patient safety, reduce risks and improve outcomes.

On 8/19/14 at 11:25 A.M., an interview was conducted with the Director of Plant Operations (DPO). The DPO stated that the purpose of the hospital's safety plan (which was part of the hospital-wide PI Plan) was to ensure the safety of the environment. He stated that daily hazard surveillance rounds were conducted throughout the hospital. Per the DPO, his findings/observations were documented on an unofficial "notepad." There was no evidence of a formal checklist, or the establishment of something similar, to ensure consistency and thoroughness when monitoring the environment on a daily basis for potential safety hazards or conditions. Per the DPO, he brought his notepad to the EOC Committee every other month.

The hospital's documented EOC minutes, dated July 2013 through November 2013, January 2014, and March 2014, did not include findings or concerns related to the use of numerous multi-plug power strips in the hospital, and the use of power strips for dialysis equipment, or any of the other environmental concerns identified by the survey team.


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2. A joint observation of Patient 1 and interview with Registered Nurse (RN) 1 was conducted on 8/19/14 at 8:55 A.M. Patient 1 was observed to rest in the bed with the head of the bed elevated and a black bag to the left side (fanny pack) with cords attached. RN 1 stated that Patient 1 had an LVAD device.

A review of the physician's progress note was conducted. On 8/13/14 at 11:22 A.M., the LVAD coordinator documented, "Replaced backup controller and battery with damaged prongs..." At 12:45 P.M., on the same date the primary physician documented, "Had LVAD issues, changed battery."

A group interview with the members of the QAPI committee was conducted on 9/2/14 at 2:00 P.M. The Director of Quality and Risk Management (DQRM), the Chief Clinical Officer (CCO), the interim Chief Executive Officer (CEO), The Director of Education (DE), the Director of Plant Operations (DPO), the Director of Human Resources (DHR), and the Director of Pharmacy (DOP) were present. The DQRM stated that when new devices were introduced to the hospital, the particular device would be presented and evaluated by MEC and the Governing Body for approval. The DQRM stated that there was no occurrence report developed after the LVAD incident on 8/13/14 therefore, no data was collected to monitor the effectiveness of the staff training, the care, and the management of the LVAD.

According to the hospital's policy titled "Occurrence Report Process," dated 12/19/12, under "Purpose: A. To advise Risk Management/Administration in a timely manner of events which could lead to liability to the hospital. B. To identify trends that may require staff education and training to improve patient care and services, that may require action to improve safety, that may benefit from implementation of a performance improvement process. Procedure: B. Submit completed Occurrence Report Form to the immediate supervisor for investigation and follow-up. F. Information from Occurrence Report Form will be compiled quarterly and will be reported to the Performance Improvement Committee and Medical Executive Committee. A synopsis of Risk Management issues will be included in the Quarterly Performance Improvement Report to the Board."

According to the hospital's policy titled "Patient Safety And Risk Reduction Plan," dated 12/19/12, "An effective Patient Safety Program cannot exist without optimal reporting of medical/health care errors and occurrences... All personnel are required to report suspected and identified medical/health care errors... This organization supports the concept that errors occur due to a breakdown in systems and processes and will focus on improving systems and processes... A focus will be placed on remedial actions to assist... the individual staff member's department supervisor determining the appropriate course of action to prevent error reoccurrence."

According to the hospital's Organizational Performance Improvement Plan (OPIP), dated 2013, "The organization has developed and implemented an integrated risk management program to collect data and investigate occurrences related to patient safety and welfare. Hospital occurrences that may reasonably relate to patient safety and welfare are reported to the hospital risk manager through the hospital occurrence report form... The organization will collect data to monitor processes that may result in adverse outcomes or sentinel events. Data will be used to identify, analyze and manage adverse outcomes, unusual occurrences, sentinel events and "near misses" in order to prevent further occurrences."

On 9/2/14 at approximately 2:40 P.M., during the QAPI group interview, the DQRM, the CCO and the CEO confirmed that the hospital's QAPI program did not include data collection when there was no occurrence report developed after the 8/13/14 LVAD incident. The DQRM acknowledged that the data collection would indicate that an action plan had been developed and implemented to ensure that patients with an LVAD were cared for in a safe environment.

3. A review of the hospital's Organizational Performance Improvement Plan (OPIP), dated 2013, was conducted. Per the OPIP, "the Quality Council has been empowered by the Governing Board to develop and oversee the organization-wide performance improvement program. The Quality Council has responsibility to the Governing Board for: Prioritizing performance measurement and improvement efforts to enhance the mission, vision, and strategic goals of the organization." Per the same plan, "Responsibilities of Hospital Department/Service Directors: It is the responsibility of the Hospital Department/Service Director in collaboration with Director of Quality/Risk Management to develop a written department/service-specific performance improvement plan consistent with the mission of the organization."

A group interview with the members of the QAPI committee was conducted on 9/2/14 at 2:00 P.M. The Director of Quality and Risk Management (DQRM), the Chief Clinical Officer (CCO), the interim Chief Executive Officer (CEO), The Director of Education (DE), the Director of Plant Operations (DPO), the Director of Human Resources (DHR), and the Director of Pharmacy (DOP) were present. The DQRM stated that the OPIP dated 2013 was the most current plan. He stated the 2013 OPIP goals and improvement plans were carried over to 2014; therefore, it was the same plan. The DQRM further stated that the OPIP plan did not change.

According to the hospital's OPIP, dated 2013, "Program Overview, Objectives and Goals: Patient Safety and Error Reduction Plan: The Quality Council will provide oversight for implementation of the Patient Safety and Error Reduction Plan. The leaders will seek to proactively identify and collect data on processes, functions and services that impact patient safety. Per the same plan, "Organization-wide performance improvement activity will be reported at least quarterly through the appropriate medical staff committees and to the Governing Board. The performance improvement plan and program will be evaluated and approved annually. The Quality Council will ensure the integration and coordination of medical staff, nursing, and support service performance improvement plans and activities, including patient safety related initiatives. They will also facilitate integration of performance improvement functions by ensuring necessary training and education...and improve specific processes and/or systems across interdisciplinary lines."

An interview with the CEO was conducted during the QAPI meeting on 9/2/14 at 2:40 P.M. The CEO stated that he had oversight of the OPIP to ensure that the OPIP was in place and had current goals. He acknowledged that there was no official 2014 OPIP available.

Based on interview and document review, the hospital failed to ensure that the medical staff of the hospital was accountable to the governing body by the following:

The medical staff did not ensure that Patient 1 who had a LVAD (left ventricular assist device), a device that assists the heart with pumping blood throughout the body that was unfamiliar to the hospital, received quality medical care in a safe setting which could have led to the potential failure of the LVAD and loss of Patient 1's heart function and death.

A review of Patient 1's medical record was conducted on 8/25/14 at 3:00 P.M. Patient 1 was admitted on 5/21/14 with diagnoses of acute respiratory failure, heart disease and a LVAD. There was no documentation of a physician order giving direction to the nursing staff regarding Patient 1's LVAD. There was no documentation of a nursing care plan regarding Patient 1's LVAD.

A review of the Medical Staff Bylaws was conducted on 8/25/14 at 3:30 P.M. The Bylaws specified that the ongoing responsibilities of each member of the medical staff include: providing patients with the continuous quality of care meeting the professional standards of the medical staff of this hospital, participate in actions that assist in measuring, assessing and improving processes that depend on the activities of the medical staff being actively involved in Quality Improvement activities to include the following: medical assessment and treatment of patients.

An interview with the COS (Chief of Staff) was conducted on 8/26/14 at 4:00 P.M. He stated that he was not notified that a patient with a LVAD was being admitted to the hospital. He stated that he should have been notified and involved in planning the care for this patient because the hospital had not had experience in the past of caring for a LVAD patient. He stated that it was important that the COS and medical staff be involved in coordinating the care of this type of patient to ensure that staff are trained and prepared for potential emergencies. He stated that he was unaware that the hospital did not have a policy regarding the LVAD that was specific to the hospital and approved by the governing body. He stated that he was not aware that a RN, who was untrained in the care of a LVAD patient was assigned to Patient 1, had attempted to change the battery of the device which resulted in damage to the device and required repair. He said that potential failure of the LVAD could lead to Patient 1 losing heart function and possible death.

An interview with the Chief Executive Officer (CEO) of the hospital was conducted on 8/25/14 at 10:45 A.M. He stated that Patient 1 was admitted to the hospital from another acute care hospital for management of Patient 1's medical conditions and the LVAD. He stated that this hospital had not had experience in taking care of a patient with a LVAD. He stated that prior to the patient being admitted to the hospital, there had been discussions between hospital administration and nursing staff leadership to arrange for nursing training for the care of this patient. He stated that the Chief of Staff or other representatives from the medical staff were not included in these discussions. He stated that the Director of Quality and Risk Management (DQRM) of the hospital was not included in these planning meetings. He could not provide any documentation of these meetings.

During the same interview with the CEO, he stated that he was unaware that there was no physician order giving direction to the nursing staff regarding the LVAD and no nursing care plan. He stated that there was no policy regarding the treatment and care of a patient with a LVAD that was specific for this hospital and approved by the governing body. He stated that the hospital was using a guideline from another hospital. He stated that he was unaware that an RN who was assigned to care for Patient 1 did not receive training on the LVAD and when she attempted to change the battery, she damaged the device which then required repair. He stated that the hospital did not have a policy or written process regarding the planning and care of a patient with an unfamiliar medical device. He acknowledged that the hospital should have a process in place that includes a representative from the medical staff leadership, DQRM and other key representatives to ensure that a patient with a specialized medical device receive quality medical care in a safe setting.

Based on observation, interview, and record review the hospital failed to ensure that effective hand off communication occurred between the Registered Nurse (RN) and Certified Nursing Assistant (CNA), for 2 of 30 sampled patients (8, 12). There was no hand off communication for Patient 8's swallowing precautions and Patient 12's fluid restriction. Failure to communicate pertinent patient information amongst the nursing staff impeded the opportunity for discussion between the giver and receiver of patient information to facilitate continuity care in a safe and effective manner.

In addition, physician's orders related to swallowing precautions and fluid restriction was not consistently followed, for 2 of 30 sampled patients (8, 12). There was no physician's order obtained for the care and management of a left ventricular assist device (LVAD- a device that assists the heart with pumping blood throughout the body), for 1 of 30 sampled patients (1). The failure to follow a physician's order and/or obtain a physician's order could negatively impact patients' medically fragile health status such as fluid overload, choking, or inappropriate care and management of a LVAD. In addition, without a physician's order, it would be difficult to determine if the nursing care and interventions were authorized by the physician and part of the medical treatment plan.

Findings:

1a. On 8/19/14 at 8:50 A.M., during an initial tour of the hospital, a joint observation of Patient 8, and interview with Registered Nurse (RN) 1 was conducted. Patient 8 rested in the bed with the head of the bed elevated. A plastic tube was inserted into the nasal cavity which was connected to a pump. RN 1 stated that Patient 8 had a nasogastric tube (NGT- a special tube that carries food and medicine to the stomach through the nose for those who have swallowing problems) with Fibersource HN (tube feeding formula) at 80 milliliters (ml) per hour.
A review of the contents of Patient 8's medical record was conducted. Patient 8 was admitted to the hospital on 8/11/14 for continued medical management per the History and Physical dated, 8/11/14. On 8/19/14 at 11:30 A.M., the speech therapist (ST) documented that a modified barium swallow (MBS- video exam performed to evaluate safe swallowing) had been completed. The results indicated that it was safe for Patient 8 to begin an oral, finely chopped diet with nursing supervision. Per the same results, it included a recommendation to remove the NGT prior to meals. The ST documented that the primary RN had been notified that Patient 8 needed to be fed by an RN or licensed vocational nurse (LVN) only. At 2:30 P.M. on the same day, the ST wrote a telephone order to indicate that Patient 8 "must be fed by RN or LVN."

A joint interview and review of the Nursing Flowsheet with RN 4 and the Director of Business Development (DBD) and the Director of Quality Risk Management (DQRM) was conducted on 8/20/14 at 9:45 A.M. RN 4 confirmed that Patient 8 had to be fed by an RN or LVN only due to swallowing precautions. He stated that he was not able to give report this morning, because he had responded to a code blue in the intensive care unit (ICU). RN 4 stated that upon his return to Patient 8's room, the breakfast tray was almost gone. RN 4 stated that a certified nursing assistant (CNA) had fed Patient 8.

The hospital's Hand-Off Communication policy and procedure, dated 10/06, was reviewed. The policy indicated its purpose was to ensure the continuity and safety of the patient's care. Both the DBD and the DQRM acknowledged that this policy was not implemented when nursing staff failed to communicate Patient 8's ordered feeding guidelines.

1b. A review of the contents of Patient 8's medical record was conducted. Patient 8 was admitted to the hospital on 8/11/14 for continued medical management per the History and Physical, dated 8/11/14. On 8/19/14 at 11:30 A.M., the speech therapist (ST) documented that a modified barium swallow (MBS- video exam performed to evaluate safe swallowing) had been completed. At 2:30 P.M. on the same day, the ST wrote a telephone order to indicate that Patient 8 "must be fed by RN or LVN."

A joint interview and review of the Nursing Flowsheet with RN 4 and the Director of Business Development (DBD) and the Director of Quality Risk Management (DQRM) was conducted on 8/20/14 at 9:45 A.M. RN 4 confirmed that Patient 8 had to be fed by an RN or LVN only due to swallowing precautions. RN 4 stated that upon his return to Patient 8's room, the breakfast tray was almost gone. RN 4 stated that a certified nursing assistant (CNA) had fed Patient 8.

The hospital's policy titled "Admit Treatment Clarification Orders", dated 12/19/12, indicated its purpose was to provide guidelines in regards to attainment and processing of physician orders that are service specific for the care and management of the patient that will assist in meeting the physician's plan of care management for the patient." Both the DBD and the DQRM acknowledged that Patient 8's physician's order had not been followed when nursing staff failed to communicate Patient 8's ordered feeding guidelines.

2. A joint observation of Patient 1 and interview with Registered Nurse (RN) 1 was conducted on 8/19/14 at 8:55 A.M. Patient 1 was resting in bed with the head of the bed elevated. A black bag (fanny pack) with cords attached was observed located on the left side of the patient. RN 1 stated that Patient 1 had a LVAD.

A joint review of the medical record and interview with RN 1 and the Director of Education (DE) was conducted on 8/19/14 at 4:20 P.M. Patient 1 was admitted to the hospital on 5/21/14 with a diagnosis that included end-stage nonischemic cardiomyopathy (heart muscle that results in abnormal cardiac function) and a LVAD per the History and Physical, dated 5/21/14. RN 1 stated that all assigned RNs had received competency training on care of the LVAD. Both the DE and RN 1 stated that Patient 1 was the first patient admitted to the hospital with this type of device.

An interview and joint review of the physician's orders with RN 1, RN 4, and the DQRM was conducted on 8/21/14 at 10:15 A.M. There was no physician's order found to address the care and management of the LVAD. They stated that there should have been a physician's order. After further review of all orders, the DQRM, RN 1, and RN 4 acknowledged that no physician's order had been obtained upon Patient 1's admission to the hospital, on 5/21/14.

An interview with the Chief Clinical Officer (CCO) and the DQRM was conducted on 8/21/14 at 2:40 P.M. The CCO stated that there should be a physician's order for the care and management of the LVAD. He was unaware that a physician's order for the LVAD had not been obtained.

A review of the hospital's policy titled "Admit Orders", dated 12/19/12, was conducted. The policy indicated its purpose was to provide a guideline for attainment of orders for patient care management." Both the CCO and the DQRM acknowledged that a physician's order should have been obtained for the care and management of the LVAD.




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3. On 8/19/14 at 9:20 A.M., a tour of the Medical Surgical floor was conducted with Registered Nurse (RN) 11. Patient 12 was observed to have a blue pitcher and a carton of nutrition supplement on the bedside table, in the room.

During the tour, an interview was conducted with a RN 13. She observed Patient 12's pitcher to have 300-400 milliliters (ml) of water in it however, she was not sure how much the patient had already consumed. RN 13 was not aware if Patient 12 had a fluid restriction until she located a sign above the patient's bed which indicated a fluid restriction of 1200 ml.

On 8/19/14 at 9:30 A.M., an interview was conducted with a Certified Nursing Assistant (CNA) 14. CNA 14 was not aware that Patient 12 had a fluid restriction. She stated that she did not receive that information during her shift change report.

On 8/20/14 at 9:06 A.M., a review of Patient 12's medical record was conducted with RN 13.

Patient 12 was admitted to the hospital with diagnoses which included heart failure per the History and Physical, dated 6/20/14.

Physician's orders,dated 7/6/14, indicated fluid restriction under 1200 ml daily.

Patient 12's twenty-four hour fluid intake (documentation), indicated the following dates and amount of fluid Patient 12 had consumed:

8/13/14 - 1257 ml
8/14/14 - 1434 ml
8/16/14 - 1577 ml
8/17/14 - 1457 ml.

Per this documentation, Patient 12's fluid consumption exceeded his 1200 ml fluid restriction that was ordered by the physician.

RN 13 stated that she did not verify or communicate Patient 12's fluid restriction to CNA 14. RN 13 further stated that the fluid restriction was not communicated to her. She stated that she was not aware of how much fluid Patient 12 should be receiving from nursing and dietary during each shift. RN 13 acknowledged that the fluid intake documentation revealed that Patient 12's fluid consumption had exceeded the physician orders restriction value. In addition, she acknowledged that this should have been communicated during the shift reports amongst the nursing staff.

On 8/20/14 at 9:19 A.M., an interview was conducted with the Registered Dietician (RD). The RD stated that she was aware of Patient 12's 1200 ml fluid restriction. In addition, she stated that she reviewed the patient's intake record that was completed by the nursing staff. She acknowledged that the record had documented evidence that Patient 12's fluid consumption had exceeded his fluid restriction order. She acknowledged that the physician's order was not consistently followed. In addition, the RD stated that she would have talked to the nursing staff and called the physician if the patient's intake consistently exceeded 1500 ml. In addition, she stated that she made that decision based on the patient's normal electrolyte lab results. According to the RD, Patient 12's heart failure was stable however, she acknowledged that the orders were for 1200 ml and not 1500 ml.

On 8/20/14 at 10:00 A.M., the hospital's Hand-Off Communication policy and procedure, dated 10/06, was reviewed with the chief clinical officer (CCO). The policy indicated that its purpose was to ensure the continuity and safety of the patient's care. The CCO acknowledged that this policy was not implemented when nursing staff failed to communicate Patient 12's ordered fluid restriction. The lack of communication did not ensure effective monitoring of the patient's fluid intake when Patient 12's intake record indicated that his fluid consumption exceeded his fluid restriction order. In addition, the CCO stated that the RD and the nursing staff should have communicated with the physician that Patient 12's fluid consumption exceeded his fluid restriction order.

Based on observation, interview, and record review, the hospital failed to ensure that care plans were developed, updated, or implemented for 9 of 30 sampled patients (1, 2, 3, 4, 5, 6, 7, 8, 12). A care plan was not developed for a left ventricular assist device (LVAD- a device that assists the heart with pumping blood throughout the body) device, contact isolation precautions, a seizure disorder, and pain management. The care plan was not followed for swallowing precautions and fluid restriction. Failure to develop, update, or implement a care plan could lead to the implementation of inappropriate nursing intervention due to the lack of guidance and developed goals. This failure also had the potential to negatively impact patients and cause a delay in the implementation of interventions, in an effort to safely meet the patients' needs.


Findings:

1. A joint observation of Patient 1 and interview with Registered Nurse (RN) 1 was conducted on 8/19/14 at 8:55 A.M. Patient 1 was resting in bed with the head of the bed elevated. A black bag (fanny pack) with cords attached was observed located on the left side of the patient. RN 1 stated that Patient 1 had a LVAD.

A joint review of the contents of Patient 1's medical record and interview with RN 1 and the Director of Education (DE) was conducted on 8/19/14 at 4:20 P.M. Patient 1 was admitted to the hospital on 5/21/14 with diagnosis that included end-stage nonischemic cardiomyopathy (heart muscle that results in abnormal cardiac function) and a LVAD per the History and Physical, dated 5/21/14. Both the DE and RN 1 stated that Patient 1 was the first patient admitted to the hospital with this type of device.

An interview with the DQRM was conducted on 8/19/14 at 5:30 P.M. The DQRM stated that a care plan should have been developed for the care and management of the LVAD.

A joint interview with RN 4 and the DQRM was conducted on 8/20/14 at 10:10 A.M. RN 4 confirmed that he had received training on the LVAD which should have a care plan.

A joint telephone interview with RN 2, the CCO, and the DQRM was conducted on 8/20/14 at 4:45 P.M. RN 2 stated that she had been assigned to care for Patient 1 on 8/12/14 thru the morning of 8/13/14. She stated that she had not seen a care plan for the LVAD but acknowledged that there should have been a care plan for it.
The hospital's Interdisciplinary Care Plan policy and procedure, dated 10/06, was reviewed. The policy indicated that "This plan will include problem/needs, goals and interventions available to all members of the health team. The plan will serve to facilitate continuity, coordination and communication among team members." Both the CCO and the DQRM acknowledged that a care plan for the LVAD had not been developed.

2a. An observation of Patient 2 was conducted on 8/19/14 at 10:45 A.M. A sign was posted on the door, outside Patient 3's room, to indicate contact precaution.

A review of the contents of Patient 2's medical record with the Director of Education (DE) was conducted. The DE stated Patient 2 was on contact isolation for Acinetobacter baumannii (a multi-drug resistant bacterial infection) in the urine. A Critical Value Verbal Report Sticker, dated 8/8/14 at 11:30 A.M., indicated urine culture result of greater than 100,000 negative gram rods. The care plan for Actual Infection did not indicate the actual urine infection nor interventions for contact isolation. The DE stated that the care plan may not always indicate the isolation; however, there was no documentation found during 8/8/14 thru 8/10/14 that contact isolation had been implemented.

The hospital's Interdisciplinary Care Plan policy and procedure, dated 10/06, was reviewed. The policy indicated that "This plan will include problem/needs, goals and interventions available to all members of the health team. The plan will serve to facilitate continuity, coordination and communication among team members." The DE acknowledged that a care plan for the contact isolation had not been developed.

2b. A joint observation of Patient 3 and interview with RN 1 was conducted on 8/19/14 at 8:30 A.M. A sign was posted on the glass just outside Patient 3's room to indicate contact precaution. RN 1 stated that Patient 3 was on contact isolation for Methicillin-resistant Staphylococcus aureus (MRSA- an infection resistant to certain antibiotics) in the nares (nose).

A review of the contents of Patient 3's medical record with RN 1 was conducted. Patient 3 was admitted to the hospital on 8/4/14 per the Face Sheet. A Critical Values Verbal Report Sticker, dated 8/7/14 at 4:12 A.M., indicated that a positive result for MRSA. The Actual Infection care plan, dated 8/8/14, indicated MRSA with contact precaution as an intervention. RN 1 stated that care plans should be updated whenever a change in condition occurred. RN 1 also acknowledged that there was no way to ascertain when contact precautions were actually implemented.

The hospital's Interdisciplinary Care Plan policy and procedure, dated 10/06, was reviewed. The policy indicated that "This plan will include problem/needs, goals and interventions available to all members of the health team. The plan will serve to facilitate continuity, coordination and communication among team members." RN 1 acknowledged that the care plan had not been updated upon receipt of the positive MRSA result.

2c. A joint observation of Patient 4 and interview with RN 1 was conducted on 8/19/14 at 9:05 A.M. A sign was posted on the glass just outside Patient 4's room to indicate contact precaution. RN 1 stated Patient 4 was on contact isolation for Methicillin-resistant Staphylococcus aureus (MRSA- an infection resistant to certain antibiotics) in the lungs due to pneumonia, Vancomycin-resistant enterococci (VRE-infection have become resistant to vancomycin), and Extended spectrum beta-lactamase (ESBL-bacterial infection) in the urine.

A review of the contents of Patient 4's medical record with the Director of Business Development (DBD) and the Director of Education (DE) was conducted. The Infection care plan did not indicate MRSA, ESBL, or VRE with contact precaution as an intervention. The DE stated care plans should be developed whenever a patient was on contact precautions. RN 1 also acknowledged that there was no way to ascertain when contact precautions were actually implemented.

The hospital's Interdisciplinary Care Plan policy and procedure, dated 10/06, was reviewed. The policy indicated that "This plan will include problem/needs, goals and interventions available to all members of the health team. The plan will serve to facilitate continuity, coordination and communication among team members." The DE acknowledged that the care plan had not indicated contact precautions with the each listed infection.

2d. An observation of Patient 5 was conducted on 8/19/14 at 10:50 A.M. A sign was posted on the door outside Patient 5's room to indicate contact precaution.

A review of the contents of Patient 5's medical record with the Director of Education (DE) was conducted. The DE stated that Patient 5 was on contact precaution for vancomycin-resistant enterococci (VRE-infection have become resistant to vancomycin) in the urine. The Infection care plan did not indicate the type of infection nor the need for contact precautions. The DE stated that the Infection care plan had not been updated.

The hospital's Interdisciplinary Care Plan policy and procedure, dated 10/06, was reviewed. The policy indicated that "This plan will include problem/needs, goals and interventions available to all members of the health team. The plan will serve to facilitate continuity, coordination and communication among team members." The DE acknowledged that the care plan did not address VRE and the need for contact precautions.

2e. A joint observation of Patient 6 and interview with RN 1 was conducted on 8/19/14 at 9:15 A.M. Patient 6 rested in the bed with both eyes closed. RN 1 stated that Patient 6 had a decreased level of consciousness with history of seizures.

A review of the contents of Patient 6's medical record with the Director of Education (DE) was conducted on 8/25/14 at 9:25 A.M. The Safety care plan did not mention seizure disorders or any measures to prevent injuries in the event of a seizure. The DE stated that the Safety care plan should have mentioned the seizure disorder.

The hospital's Interdisciplinary Care Plan policy and procedure, dated 10/06, was reviewed. The policy indicated that "This plan will include problem/needs, goals and interventions available to all members of the health team. The plan will serve to facilitate continuity, coordination and communication among team members." The DE acknowledged that there was no care plan found to address Patient 6's seizure disorder.

2f. A joint observation of Patient 7's room and interview with RN 1 was conducted on 8/19/14 at 9:45 A.M. A sign was observed just outside the door that read contact isolation. Patient 7 was out of the room. RN 1 stated that Patient 7 was on contact isolation for Clostridium difficile (C-diff- bacterial infection in the stool).

A review of the contents of Patient 7's medical record with the Director of Education (DE) was conducted on 8/25/14 at 2:20 P.M. Patient 7 was admitted to the hospital on 8/15/14 with C-diff and acute chronic pain per the History and Physical, dated 8/16/14. The Alteration in Comfort care plan did not include pain nor, any interventions to implement in the event there was a compliant of pain or discomfort. The DE stated that the Alteration in Comfort care plan should have mentioned Patient 7's pain.

The hospital's Interdisciplinary Care Plan policy and procedure dated 10/06 was reviewed. The policy indicated that "This plan will include problem/needs, goals and interventions available to all members of the health team. The plan will serve to facilitate continuity, coordination and communication among team members." The DE acknowledged that there was no care plan found to address Patient 7's acute or chronic pain.


3. On 8/19/14 at 8:50 A.M., during the initial tour of the hospital, a joint observation of Patient 8 and interview with Registered Nurse (RN) 1 was conducted. Patient 8 rested in the bed with the head of the bed elevated. A plastic tube was inserted into the nasal cavity which was connected to a pump. RN 1 stated that Patient 8 had a nasogastric tube (NGT- a special tube that carries food and medicine to the stomach through the nose for those who have swallowing problems) with Fibersource HN (tube feeding formula) at 80 milliliters (ml) per hour.

A review of the contents of Patient 8's medical record was conducted. Patient 2 was admitted to the hospital on 8/11/14 for continued medical management per the History and Physical, dated 8/11/14. On 8/19/14 at 11:30 A.M., the speech therapist (ST) documented that a modified barium swallow (MBS- video exam performed to evaluate safe swallowing) had been completed. The ST documented that the primary RN had been notified that Patient 8 needed to be fed by an RN or licensed vocational nurse (LVN) only. At 2:30 P.M. on the same day, the ST wrote a telephone order to indicate that Patient 8 "must be fed by RN or LVN."

A joint interview and review of the care plan for Alteration in Nutrition with RN 4 and the Director of Business Development (DBD) and the Director of Quality Risk Management (DQRM) was conducted on 8/20/14 at 9:45 A.M. The care plan indicated under interventions on 8/19/14 that the nursing staff would need to feed Patient 8 all meals. RN 4 confirmed that Patient 8 had to be fed by an RN or LVN only due to swallowing precautions. He stated that he was not able to give report this morning and upon his return to Patient 8's room, the breakfast tray was almost gone. RN 4 stated that a certified nursing assistant (CNA) had already fed Patient 8.

The hospital's Interdisciplinary Care Plan policy and procedure, dated 10/06, was reviewed. The policy indicated that "This plan will include problem/needs, goals and interventions available to all members of the health team. The plan will serve to facilitate continuity, coordination and communication among team members." Both the DBD and the DQRM acknowledged that Patient 8's care plan had not been followed.


29499


4. On 8/19/14 at 9:20 A.M., a tour of the Medical Surgical floor was conducted with Registered Nurse (RN) 11. Patient 12 was observed to have a blue pitcher and a carton of nutrition supplement on the bedside table in the room.

During the tour, an interview was conducted with RN 13. She observed Patient 12's pitcher to have 300-400 milliliters (ml) of water in it however, she was not sure how much the patient had already consumed. RN 13 was not aware if Patient 12 had a fluid restriction until she located a sign above the patient's bed which indicated a fluid restriction of 1200 ml.

On 8/20/14 at 9:06 A.M., a review of Patient 12's medical record was conducted with RN 13.

Patient 12 was admitted to the hospital with diagnoses which included heart failure per the History and Physical, dated 6/20/14.

Physician's orders, dated 7/6/14, indicated fluid restriction under 1200 ml daily.

Patient 12's twenty-four hour fluid intake (documentation), indicated the following dates and amount of fluid Patient 12 had consumed:

8/13/14 - 1257 ml
8/14/14 - 1434 ml
8/16/14 - 1577 ml
8/17/14 - 1457 ml

Per this documentation, Patient 12's fluid consumption exceeded his 1200 ml fluid restriction that was ordered by the physician.

Patient 12's care plan related to fluid intake was blank. There were no developed goals or interventions to monitor the patient's fluid balance.

RN 13 stated that the fluid restriction was not communicated to her. She stated that she was not aware of how much fluid the patient should be receiving from nursing and dietary during each shift. RN 13 also acknowledged that nursing failed to develop a care plan specific to patient 12's fluid restriction. In addition, RN 13 stated that she was not aware of how much fluid nursing should be giving the patient. She further stated that the purpose of the care plan was to ensure that all staff were aware of goals and interventions for the patient to include how much fluid intake would be given by nursing and dietary each day.

On 8/20/14 at 9:19 A.M., an interview was conducted with a Registered Dietician (RD). The RD stated that nursing should be aware of the fluid parameters because they were posted in the medication room. The RD acknowledged that there was no documented evidence of a care plan specific to Patient 12's fluid restriction. The RD acknowledged that a care plan should have been developed to ensure that all disciplines were fully informed of the goals, interventions, parameters and monitoring.

On 8/20/14 at 10:00 A.M., the hospitals Interdisciplinary Care Plan policy and procedure, dated 10/06, was reviewed with the Chief Clinical Officer (CCO). The policy indicated that "This plan will include problem/needs, goals and interventions available to all members of the health team. The plan will serve to facilitate continuity, coordination and communication among team members." The CCO acknowledged that the care plan specific to Patient 12's fluid restriction was not developed in accordance to the hospital's policy and procedure.

Based on interview and record review, the hospital failed to ensure that competencies were completed and validated prior to the admission of left ventricular assist device (LVAD- a device that assists the heart with pumping blood throughout the body) patient, in order to provide quality care and management, for 1 of 30 sampled patients (1). The hospital assigned eight Registered Nurses (RNs) to care for Patient 1 prior to the validation that each nurse had been trained and were competent to care and manage the LVAD. The failure to provide training to assigned RNs led to an incident of a damaged controller when an attempt to change the back-up battery was performed by RN 2, an untrained RN. Additionally, failure to validate competencies in order to ensure quality medical and nursing care were provided in a safe setting, had the potential to cause further device malfunction, the potential failure of the LVAD, and loss of Patient 1's heart function and/or death.

Findings:

A joint observation of Patient 1 and interview with RN 1 was conducted on 8/19/14 at 8:55 A.M. Patient 1 was resting in bed with the head of the bed elevated. A black bag (fanny pack) with cords attached was observed located on the left side of the patient. RN 1 stated that Patient 1 had a LVAD.

A joint review of the Nursing Flowsheet of Patient 1's medical record with the Director of Quality and Risk Management (DQRM) was conducted on 8/20/14 at 8:45 A.M. The Flowsheet indicated, on 8/13/14 at 7:25 A.M., there was an alarming battery on the LVAD device which had been detached by night [noc] RN- she was unable to change the battery. The morning RN documented that she had received report from the night RN that she had attempted to change the LVAD battery but was unable to pull the controller and the system was alarming. The House Supervisor, the Director of Education (DE), and the Chief Clinical Officer (CCO) were notified. At 9:00 A.M., the LVAD controller was exchanged by the DE. The DQRM stated that it seemed like the night shift RN caused the LVAD to malfunction but needed to further investigate.

A review of the physician's progress note was reviewed during this time. On 8/13/14 at 11:22 A.M., the LVAD coordinator documented, "Replaced backup controller and battery with damaged prongs..." At 12:45 P.M., on the same date the primary physician documented, "Had LVAD issues, changed battery."

A joint interview with the CCO and the DQRM was conducted on 8/20/14 at 10:00 A.M. The CCO stated he was not sure if troubleshooting information was available in the room; however, the LVAD coordinators number was on the actual device and should have been called for help.

A joint interview with the DE and the DBD was conducted on 8/20/14 at 10:35 A.M. The DE stated that the morning of 8/13/14, she and the CCO realized that the assigned night shift RN had not been trained on the care and management of the LVAD. At 4:15 P.M. on the same day, the DE stated that the LVAD competency documents were missing therefore, she could not provide proof of completion. The DE further stated that she believed that the copies of the competencies may be in the employees' personnel files located in human resources.

An interview with the CCO and joint review of the nursing assignments and competency was conducted on 8/20/14 at 6:05 P.M. The results were the following: A Registry RN (contracted RN thru an outside agency) cared for Patient 1 on 5/21/14 and 5/22/14 on the night shift and no training or competency on the LVAD device could be found. The CCO acknowledged that there were at least eight RNs who had been assigned and cared for Patient 1 prior to receipt of training and competency validation for the care and management of the LVAD. The CCO stated he had gone thru the training but had not completed the competency. He further stated that he was in Patient 1's room on 8/13/14, and felt that since he was a nurse his advanced cardiac life support (ACLS) skills would be utilized.

An interview with the Chief of Staff (COS) was conducted on 8/21/14 at 9:10 A.M. The COS stated that he had not been aware that the hospital had admitted a patient with a LVAD. The COS stated that he had been informed by the Chief Executive Officer (CEO) that training on the LVAD had occurred; however, the paperwork was missing. The COS stated that it was his expectation that a patient not be admitted to the hospital with unfamiliar or new medical devices without properly training the nursing staff, and without the knowledge of the medical staff. He acknowledged that the hospital had not followed the appropriate steps when proper training and competency validation for the nursing and medical staff had not occurred prior to Patient 1's admission.

On 8/21/14 beginning at 4:15 P.M., the following personnel files were reviewed to determine if the RNs who cared for Patient 1 had their LVAD competencies completed: RN 2, RN 6, RN 7, RN 8, RN 9, RN 10, RN 15 and Registry RN. All the RNs' personnel files did not contain documented evidence that LVAD competencies had been performed.

A joint telephone interview with RN 2, the CCO, and the DQRM was conducted on 8/21/14 at 4:45 P.M. RN 2 stated that during the change of shift, the morning RN informed her that Patient 1's battery needed to be changed. When she went to change the battery on the LVAD, she could not insert the new battery, and believed it was broken. RN 2 stated that on 8/12/14, it was her first time working with a LVAD. Prior to the training on 8/19/14, she stated that she was unfamiliar with the device and did not think to question or refuse the assignment. RN 2 acknowledged that she cared for Patient 1 without proper training to appropriately manage the LVAD.

A joint interview with RN 3, the CCO, and the DQRM was conducted on 8/21/14 at 5:30 P.M. RN 3 stated that during shift change and hand off communication on 8/12/14, RN 2 was shown the LVAD and asked, "What is this?," at that point she was told that she needed special training on the LVAD but she said that she could care for it. The next morning, 8/13/14, RN 2 was told to change the LVAD battery. RN 3 stated that as she entered the room, RN 2 stated that the battery could not be changed. RN 3 stated that the male and female connector would not connect, "looked like something was bent."

The Hospital's policy titled "Competency Assessment" was reviewed. The policy, dated 12/19/12, indicated "Policy: ...The staff shall be competent to fulfill their assigned technical, professional, managerial, and clinical and support responsibilities based on education, experience, specialty training, certification and applicable laws/regulations. J. Registry & Travelers: 1. It is the responsibility of the department manager/supervisor that utilizes the registry or traveler staff member to certify their competency to perform their assignment duties before they commence working."

An interview with the CEO was conducted on 8/25/14 at 10:30 A.M. The CEO stated that it was his responsibility to ensure that the appropriate staff received training on the LVAD. He stated that it was his expectation that the training and competency be completed prior to Patient 1's admission. The CEO acknowledged that a safe setting was not ensured when Patient 1's LVAD was cared for and managed by untrained staff.

Based on interview and personnel file review, the hospital failed to ensure that a personnel file was complete, for 1 of 13 personnel files reviewed (Radiology Manager - RM 1). RM 1's personnel file did not contain a current performance evaluation. Failure to ensure that performance evaluations were completed on all staff made it difficult to determine if staff were current with their requirements, responsibilities and qualifications to be able to perform their role and specific job duties in accordance with the hospital's policy.

Findings:

A review of personnel files were conducted on 8/25/14 at 3:30 P.M. RM 1's personnel file was reviewed.

According to RM 1's Job Description/Evaluation form, dated 10/25/12, the form indicated that the radiology manager "... Plans, directs, coordinates, controls, and organizes staff, materials, budgets, policies and all activities of the Radioloy Department." Per the same form, RM 1 was responsible for 50% of duties as a Radiology and Computerized Tomography (CT - an imaging method that uses x-rays to create pictures of cross-sections of the body). RM 1's evaluation period was from 10/31/11 to 10/31/12. There was no documented evidence to demonstrate that a current performance evaluation for RM 1 had been performed.

The hospital's policy titled "Criteria Based Job Descriptions", dated 12/19/12, indicated that the hospital's "Criteria-Based Job Description and Performance Appraisal System is designated to assure accurate appraisal of employees' competency against predetermined standards without regard to race, sex, or age." Per the same policy, it indicated that "There will be a criteria-based job description provided for each position within the Company to be utilized as a guideline for the hiring, orientation, evaluation, and promotion of the individual employees." Within the policy, it stipulated that "The Director of Human Resources will be responsible for ensuring that each Department Director has access to the current criteria-based job description for each position within his/her department." The policy also indicated that "The job description evaluation will be reviewed and revised at least annually, when doing annual evaluation and as applicable to ensure currency of the requirements, responsibilities, qualifications, and applicability."

An interview with the Director of Human Resources (DHR) was conducted on 8/28/14 at 5:20 P.M. The DHR stated that the Human Resources Department was responsible for ensuring that personnel files were complete upon hire and annually. She stated that a complete personnel file contained the following documents: a current job description, a current performance evaluation, and at a minimum, documented evidence that initial competencies had been performed and completed. The DHR stated that the hospital had identified problems with their personnel files related to lack of initial competencies and current performance evaluations. She acknowledged that RM 1's personnel file did not contain a current performance evaluation in accordance with the hospital's policy.

K3 BUILDING: 01
K6 PLAN APPROVAL: 1973
K7 SURVEY UNDER: 2000 EXISTING
STRUCTURE TYPE: SINGLE STORY with basement, CONSTRUCTION TYPE V (111), FULLY SPRINKLERED.

The following reflects the findings of the California Department of Public Health, during a complaint validation survey. The findings are in accordance with 42 CFR (Code of Federal Regulations) 482.41 and NFPA (National Fire Protection Association) 101, Life Safety Code 2000 edition, Existing codes.

Representing the California Department of Public Health: 29566

The facility is not in substantial compliance with 42 CFR (Code of Federal Regulations) 482.41 (B) (1) for General Acute Care Hospitals.

Census: 26

Based on observation, record review, and interview, the facility failed to substantially comply with 42 CFR (Code of Federal Regulations) 482.41 (B) (1) for General Acute Care Hospitals. This was evidenced by the facility failing to meet provisions under the NFPA (National Fire Protection Association) 101, Life Safety Code 2000 Edition. As a result, this increased the risk of injury to the patients, staff, and visitors in the event of a fire or disaster. This affected 5 of 5 smoke compartments and Crestview Behavioral Center.

Findings:

K12
Based on observation and interview, the facility failed to maintain the integrity of the building construction. This was evidenced by penetrations in fire-rated ceiling not sealed with correct material to maintain its fire rating. This affected 5 of 5 smoke compartments of the Main Hospital. This could result in rapid spread of smoke and fire throughout the building and possible harm to patients, staff and visitors, during fire.


NFPA 101 Life Safety Code 2000 Editions:
8.3.6.1 Pipes, conduits, bus ducts, cables, wires, air ducts, pneumatic tubes and ducts, and similar building service equipment that pass through floors and smoke barriers shall be protected as follows:
(1) The space between the penetrating item and the smoke barrier shall meet one of the following conditions:
a. It shall be filled with a material that is capable of maintaining the smoke resistance of the smoke barrier.
b. It shall be protected by an approved device that is designed for the specific purpose.
(2) Where the penetrating item uses a sleeve to penetrate the smoke barrier, the sleeve shall be solidly set in the smoke barrier, and the space between the item and the sleeve shall meet on of the following condition:
a. It shall be filled with a material that is capable of maintaining the smoke resistance of the smoke barrier.
b. It shall be protected by an approved device that is designed for the specific purpose.
(3) Where the designs take transmission of vibration into consideration, any vibration isolation shall meet one of the following condition:
a. It shall be made on either side of the smoke barrier.
b. It shall be made by an approved device that is designed for the specific purpose.



Findings:

During tour of facility with the Director of Plant Engneer, the Medication room was observed.

Main Hospital

8/20/14

At 4:41 P.M., a portable air conditioning unit exhaust duct was taped to the rated ceiling of the Medication Room on Central Med-Surge Nurses Station. The penetration around the air-condition duct was sealed with non-fire rated material. The ceiling was a hard/fire rated ceiling.

Staff 1 stated during interview this was done couple of months ago by their air condition maintenance staff and he believe the ceiling fire rating was 1 hour.


K27
Based on observation, the facility failed to maintain its smoke barrier doors. This was evidenced by plastic door wedge blocking the closing of smoke barrier doors. This affected 2 of 5 smoke compartments and Crestview Behavioral Center. This finding could result in the spread of smoke from one smoke compartment to another and increase the risk of injury to patients and staff in the event of a fire.


Findings:

During the alarm testing with the Director of Plant Operations, the smoke barrier doors were observed.

8/26/14
Crestview Behavioral Center

1. At 3:53 P.M., the smoke barrier double doors by Activities Room in the Crestview Behavioral Center were obstructed from closing by plastic door wedge position under the door leaf. The Facility Staff had to remove the plastic door wedge before door could be closed.

9/3/14
Main Hospital

2. At 9:15 A.M., facility used a non fire-rated wood door to cover the entrance to the smoke- barrier attic space in a fire-rated ceiling by radiology.

3. At 10:05 A.M., there was a 2 by 2 feet opening in the draft stop in the smoke-barrier attic space by Med-Surge Nurses Station.


K 48
Based on record review and interview, facility failed to instruct their staff on their role in a fire and emergency procedures. This was evidenced by the staff's lack of familiarity with identifying the usage of a fire extinguisher, the usage of a smoke compartment during an evacuation and facility policy who to call during an emergency. This affected 5 of 5 smoke compartments of the Main Hospital. This could result in any one facility staff member not accomplishing the tasks required of him or her during conditions that is expected to exist in the event of a fire and the increased risk of injury to the patients and staff.

NFPA 101, Life Safety Code, 2000 Edition
19.7.1.3 Employees of health care occupancies shall be instructed in life safety procedures and devices.

Findings:

During the tour of the facility with the DQRM, staff were interviewed on the knowledge of their fire and emergency procedures.

8/28/14
Main Hospital

There were written instructions in the Emergency Management and Operations Plan dated June 5, 2013 that the fire department is contacted automatically through the fire alarm system for fire situations. The Incident Commander/Designee for non-fire situations, as appropriate, will contact fire and/ or Police Departments.

1. At 11:36 A.M., two registered nurses on the East wing Nurses station were interviewed on what is a smoke compartment. Staff stated they were not familiar with what is a smoke compartment.

2. At 11:52 A.M., the Kitchen supervisor and the Cafeteria Aide was interviewed on their knowledge of what kind of fire would the K-fire extinguisher be used on and what is a smoke compartment. Kitchen Staff stated they would use the K-fire extinguisher on gas fire from the stove and was unfamiliar with what is a smoke compartment.


3. At 4:25 P.M., the Receptionist/operator was interviewed on procedures to notify the fire department. Staff stated she would not call 911 but the staff who discover the fire or staff in the vicinity of the fire would call 911.

4. At 4:31 P.M., during an interview with executive secretary and nursing staff and they stated the receptionist/operator would call 911 for any emergency. Facility staff failed to familiarize themselves with facility's life safety procedures and policies.

K50

Based on record review and interview, the facility failed to provide documents to show 3 of 4 quarters evening shift drills were conducted and completed documentation of employees participating in 1 of 2 disaster drills for the last 12 months. This was evidenced by no employees signatures for disaster drill of 4/9/14 and no record of drills conducted for 3 of 4 quarters evening shift drills. The employees signatures are meant to show that employees have participated in the disaster drill. This finding could result in employees being unprepared for a disaster in the facility and unable to protect patients during disaster.

NFPA 101, Life Safety Code 2000
19.7.1.3 Employees of health care occupancies shall be instructed in life safety procedures and devices.


Findings:

8/26/14
Main Hospital

During record reviewed with Director of Plant Operations, the disaster drills and fire drills were reviewed. Staff evening shift work hours are 2:00 P.M. to 11:00 P.M.

At 4:50 P.M., the earthquake drills of 4/9/14, failed to show staff participating in the earthquake drills due to no nursing, environmental and kitchen staff signatures on the drill documents.

During an interview with the Executive Staff at 4:51 P.M., she stated all employees who are working participates in the disaster drills but employees do not sign in to show participation.

At 4:55 P.M. the record showed no drills were conducted for the evening shifts second-quarter April, May and June of 2014, no evening shift drills for third-quarter of July, 2014, August 2014 and September 2013, no evening shift drills for fourth-quarter of October, November and December of 2013.


8/28/14
Main Hospital

At 9:40 A.M. the Chief Executive Officer stated that staff do not sign in but they participate in the disaster drills. He confirmed the missing fire drills of 3 of 4 quarters for the last 12 months.

At 11:36 A.M., Staff were asked what were they trained to do during an earthquake. Two of two Registered Nurses on East-wing Nurses Station stated they could not recall and was unfamiliar with what they were trained to do in the event of an earthquake.

K62
Based on observation and interview, the facility failed to maintain their automatic sprinkler system in reliable operating condition. This was evidenced by patient equipment resting on and by the sprinkler riser pipes. This affected 1 of 5 smoke compartments of the Main Hospital. This could result in reduced effectiveness of the sprinkler system and cause injury to patients from fire.


Findings:

During a tour of the facility with the Director of Plant Operations on 8/26/14, the sprinkler riser was observed.

At 4:00 P.M., the sprinkler riser in the clean room by Room 14 A blocked by 14 patients IV pumps. The IV pumps were against and by the sprinkler riser pipe.


K66
Based on observation and interview, the facility failed to ensure that accidental fire was prevented from their designated smoking area. This was evidenced by cigarette butts mixed with combustibles trash in non-safety type ash trays. This affected 1 of 5 smoke compartments in the Main Hospital and could result in fire from careless disposal of cigarette butts.

NFPA 101, Life Safety Code 2000 Edition
19.7.4* Smoking regulations shall be adopted and shall include not less than the following provisions:

(1) Smoking is prohibited in any room, ward, or compartment where flammable liquids, combustible gases, or oxygen is used or stored and in any other hazardous location, and such area is posted with signs that read NO SMOKING or with the international symbol for no smoking.

(3) Ashtrays of noncombustible material and safe design are provided in all areas where smoking is permitted.

(4) Metal containers with self-closing cover devices into which ashtrays can be emptied are readily available to all areas where smoking is permitted.




Findings:

During the tour of the facility with the Director of Plant Operation, the designated smoking area was observed.

8/28/14
Main Hospital


At 5:08 P.M., in the designated smoking area, (west front of the building)combustibles trash and cigarettes butts was in the four of four open top ash-trays. The designated smoking area was not equipped with metal containers with self-closing devices in which cigarettes can be emptied. Facility failed to ensure fire safety from careless disposal of cigarettes butts, and failed to provide safety type ashtrays in their designated smoking areas.

K67

Based on observation and interview, the facility failed to ensure air handlers on the roof were installed in accordance with all applicable codes to prevent them from falling off during an earthquake. This was evidenced by 9 air handlers installed on a slanted roof that were not securely anchored to the roof. Seven of the nine air handlers were dual units connected to natural gas lines. During an earthquake, the 1,500 lb. unit could fall off from their bases and disconnected from their gas lines causing fire and explosion. This affected 5 of 5 smoke compartments and Crestview Behavioral Center and could cause harm to 27 patients, staff and visitors.

NFPA 101, Life Safety Code, 2000 Edition
9.2.1 Air Conditioning, Heating, Ventilating Ductwork, and Related Equipment. Air conditioning, heating, ventilating ductwork, and related equipment shall be in accordance with NFPA 90A, Standard for the Installation of Air Conditioning and Ventilating Systems, or NFPA 90B, Standard for the Installation of Warm Air Heating and Air-Conditioning Systes as applicable unless existing installations, which shall be permitted to be continued in service, subjected to approval by the authority having jurisdiction.

NFPA 90A, Standards for the Installation of Air-Conditioning and Ventilating System, 1999 Edition

2-1.4 Electrical Wiring and equipment shall be instaleld in accordance with NFPA 70, National Eletrical Code.

3-1.4 Other Spaces Housing Air-Handling Units. Other spaces housing air-handling units shall meet the requirments of the building code the authority having jurisdistion.

NFPA 70, National Electrical Code, 1999 Edition
110-13. Mounting. Electrical equipment shall be firmly secured to the surface on which it is mounted. Wooden plugs driven into holes in masonry, concrete, plaster or similar materials shall not be used.

Findings:


During tour of the facility with the Director of Plant Operations, the roof Air Handlers were observed. The OSHPD ACO submitted a field visit report on 4/11/13 indicating that on 11/1/12, during a facility visit, the facility was notified that air handlers posed a hazard because they were not anchored to the roof.

8/25/14
Main Hospital

At 11:05 A.M., there were 9 air handlers observed not securely anchored (#6, #15, #7, #22, #23, #30, #31, #33,and #44) to the roof. Seven of the nine were dual air handlers (heating and cooling) with gas lines attached to them. Five of nine air handlers installed on elevated platforms ranging from 18 inches to approximately 3 feet above the roof. Eight of nine air handlers were resting on 4 by 4 un-anchored wood blocks. The air handlers were not secured to the wood blocks, and the wood blocks were not secured to the roof.

At 11:08 A.M., Units #33, #30 and #22 were observed to be dual units with gas line attached and were elevated on the wood blocks without being secured to the platforms and roof.

At 11:25 A.M., during interview with Director of Plant Operations, he stated facility could not provide documentation to show air handlers were installed with approval from State Agency having jurisdiction.


K68
Based on observation, the facility failed to install their gas water heater in a safe manner. This was evidenced by the gas water heater installed in the electrical room with high voltage electrical circuits and without approval from authority having jurisdiction to ensure compliance to applicable codes. This affected 1 of 5 smoke compartments of the Main Hospital. This resulted in a hazardous condition and increase the risk of injury to patients and staff, in the event of a fire.


NFPA 101, Life Safety Code, 2000 Edition 9.2.2 Ventilating or Heat-Producing Equipment. Ventilating or heat producing equipment shall be in accordance with NFPA 91, Standard for Exhaust System for Air Conveying of Vapors, Gases, Mists, and Noncombustible Particulate Solids; NFPA 211, Standard for Chimneys, Fireplaces, Vents, and Solid Fuel Burning Appliances; NFPA 31, Standard for the Installation of Oil-Burning Equipment; NFPA 54, National Fuel Gas Code; or NFPA 70, National Electrical Code, as applicable, unless existing installations, which shall be permitted to be continued in service, subject to approval by the authority having jurisdiction.

NFPA 54, National Fuel Gas Code, 1999 Edition
3.3.6 Hangers, Supports, and Anchors.
(a) Piping shall be supported with pipe hooks, metal pipe straps, bands, brackets, or hangers suitable for the size of piping, of adequate strength and quality, and located at intervals so as to prevent or damp out excessive vibration. Piping shall be anchored to prevent undue strains on connected equipment and shall not be supported by other piping. Pipe hangers and supports shall conform to the requirements of ANSI/MSS SP-58, Pipe Hangers and Supports - Materials, Design and Manufacture.
(b) Spacings of supports in gas piping installations shall not be greater than shown in Table 3.3.6.
(c) Supports, hangers, and anchors shall be installed so as not to interfere with the free expansion and contraction of the piping between anchors. All parts of the supporting equipment shall be designed and installed so they will not be disengaged by movement of the supported piping.

5.1 General.
5.1.1* Appliances, Accessories, and Equipment to Be Approved.
Gas appliances, accessories, and gas utilization equipment shall be approved. Approved shall mean acceptable to the authority having jurisdiction. Acceptance of unlisted gas utilization equipment and accessories shall be on the basis of a sound engineering evaluation. In such cases, the equipment shall be safe and suitable for the proposed service and shall be recommended for the service by the manufacturer.


5.2.2 Clearance to Combustible Materials. Gas utilization equipment and their vent connectors shall be installed with clearances from combustible material so their operation will not create a hazard to persons or property. Minimum clearances between combustible walls and the back and sides of various conventional types of equipment and their vent connectors are specified in Chapters 6 and 7.(Reference can also be made to NFPA 211, Standard for Chimneys, Fireplaces and Solid Fuel-Burning Appliances.)


NFPA 70, National Electrical Code, 1999 Edition

110-34 ((f)) Protection of Service Equipment, Metal-Enclosed Power Switchgear, and industrial Control Assemblies. Pipes or ducts foreign to the electrical installation that require periodic maintenance or whose malfunction would endanger the operation of the electrical system shall not be located in the vicinity of the service equipment, metal-enclosed power switchgear, or industrial control assemblies. Protection shall be provided where necessary to avoid damage from condensation leaks, and breaks in such foreign systems. Piping and other facilities shall not be considered foreign if provided for fire protection of the electrical installation.


Findings:

During observation tour of the facility with Director of Plant Operations, the electrical room was observed.

8/25/14
Main Hospital

At 3:51 P.M., a 18000 BTU gas-water heater tank was installed in the main electrical room. The gas-water heater was installed approximately 2 feet from the Computerized Tomography electrical transformer in the electrical room. The State Authority facility visit report dated 8/25/14 indicated the piping for the water heater was not firmly secured. The water heater tank could fall off during an earthquake. The proximity of the electrical transformer to the water heater pose a hazard from fire. There was no documentation of approval for the installation of the gas water heater tank to ensure compliance to applicable codes.


K69
Based on observation, the facility failed to provide an ABC fire extinguisher in their cooking area. This was evidenced by the Kitchen not equipped with an ABC fire extinguisher. This could cause a delay in reaching the fire extinguisher and the potential of the fire spreading and causing harm to patients and staff in the event of a fire emergency. This affected 1 of 5 smoke compartments of main hospital.

NFPA 101, Life Safety Code 2000 Edition
19.3.2.6 Cooking Facilities. Cooking Facilities shall be protected in accordance with 9.2.3.
Exception: Where domestic cooking equipment is used for food warming or limited cooking , protection or segregation of food preparation facilities shall not be required.

9.2.3 Commercial Cooking Equipment. Commercial cooking equipment shall be in accordance with NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, unless existing installations, which shall be permitted to be continued in service, subjected to approval by the authority having jurisdiction.

NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations 1998 Edition

7-10.1* Portable fire extinguishers shall be installed in kitchen cooking areas in accordance to with NFPA 10, Standard for Portable Fire Extinguisher.


National Fire Prevention Association 10, Standards for Portable Fire Extinguishers 1998 Edition:
1-6.3 Fire extinguishers shall be conspicuously located where
they will be readily accessible and immediately available in the
event of fire. Preferably they shall be located along normal
paths of travel, including exits from areas.

Findings:

During the facility tour with the Director of Plant Operations, the kitchen was observed.

8/28/14
Main Hospital

At 11:56 A.M., facility kitchen was not equipped with an ABC fire extinguisher nor was there one within 75 feet travel distance from the futherest point of the kitchen to the next fire extinguisher outside in the corridor. The kitchen housed combustible materials such as papers, and electrical equipment.

K72
Based on observation and interview, the facility failed to maintain means of egress free from obstructions. This was evidenced by appliance stored in the corridor by the exit doors. This affected 1 of 5 smoke compartments of the Main Hospital. This could delay evacuation and possible harm patients, staff and visitors, in the event of a fire.

NFPA 101, Life Safety Code 2000 Edition 7.1.10.1* Means of egress shall be continuously maintained free of all obstructions or impediments to full instant use in the case of fire or other emergency.

Findings:

During tour of the factuality with Director of Business Affair, the kitchen was observed.


8/28/14
Main Hospital

At 4:36 P.M., two commercial refrigerators approximately 8 feet in height were stored in the egress path corridor blocking the east kitchen exit door-way in the kitchen.



K76
Based on observation and interview, facility failed to provide a safe environment from fire. This was evidenced by a 1500 gallon liquid oxgen tank installed 5 feet from the building wall and not anchored properly to the floor. The tank was located within 50 feet from oxygen cylinders. There was a flammable gas tank nearby. This affected 5 of 5 smoke compartments of the Main Hospital and Crestview Behavioral Center. During an earthquake, the approximately 16 foot tank could tip over and cause explosion and fire.

NFPA 101, Life Safety Code, 2000 Edition
SECTION 21.3 PROTECTION
21.3.2.2 Anesthetizing locations shall be protected in accordance with NFPA 99, Standard for Health Care Facilities.



NFPA 99, Health Care Facilities 1999 Edition
4-3.1.1.1 Cylinders and Container Management. Cylinders in service and in storage shall be individually secured and located to prevent falling or being knocked over.
4-3.1.1.2 (a)2* Enclosures shall be provided for supply systems cylinder storage or maniforld locations for oxidizing agents such as oxygen and nitrous oxide. Such enclosures shall be constructed of an assembly of building materials with fire resitive rating of at least 1 hour and shall not communicate directly with anesthetizing locations. Other nonflammable (inert) medical gases may be stored in the enclosure. Flammable gases shall not be stored with oxidizing agents. Storage of full or empty cylinders is permitted. Such enclosures shall serve no other purpose.
4-3.1.1.2 (a) 10. (b) Storage facilities that are outside, but adjacent to building wall, shall be in accordance with NFPA 50, Standard for Bulk Oxygen System at Consumer Sites.

NFPA 50, Standard for Bulk Oxygen System at Consumer Sites, 1996 Edition
2-1 Location of Bulk Oxygen Systems.
2.2.1 50 ft (15m) from buildings of wood frame construction.



Findings:

During a tour of the facility with the Director of Plant Operations from 8/25/14 to 9/3/14, the liquid oxygen tank was observed. The State Agency submitted a field visit report on 5/19/14 indicating that the facility was notified in Novemember 2012 that the installation of the liquid oxygen tank was not in compliance with applicable codes. The tank was installed without approval from the State's Authority having Jurisdiction and was not properly anchored to the concrete floor.


8/25/14
Main Hospital

1. At 10:35 A.M., the liquid oxygen tank was observed with 1500 gallons (90% full) of liquid oxygen and was installed less than 5 feet from the wall of a wooden frame construction hospital building. According to the State's authority having jurisdiction, the tank was not properly anchored to the concrete floor.

2. At 10:48 A.M., there were 2 propane tanks with approximately 40 gallons stored next to 24 E-Cyclinders and 24 H-cyclinders in the locked oxygen storage area next to the liquid oxygen tank.

3. At 10:50 A.M., 24 H-cylinders of oxygen were not individually secured to prevent from falling off.


K78

Based on observation and interview, the facility failed to maintain their air circulation equipment to provide a safe humidity level in their operating rooms. This was evidenced by the using portable humidifiers and de-humidifiers to control humidity in the operating rooms. The portable humidifiers in use are not approved in a commercial setting. This affected 4 of 4 operating rooms and could result in possible harm to patients during operating procedures.


NFPA 101, Life Safety Code, 2000 Edition
SECTION 21.3 PROTECTION
21.3.2.2 Anesthetizing locations shall be protected in accordance with NFPA 99, Standard for Health Care Facilities.



NFPA 99, Standards for Healthcare Facilities, 1999 Edition
5-4.1.1 The mechanical ventilation system supplying anesthetizing locations shall have the capability of controlling the relative humidity at a level of 35 percent or greater.
5-6.1.1 Ventilation and humidifying equipment for anesthetizing locations shall be kept in operable condition and be continually operating during surgical procedures (See A-5-4.1)
Findings:

During a tour of facility with Maintenance Engineer 1, 4 of 4 operating rooms were observed.

8/20/18 to 8/21/14

8/20/14

At 4:05 P.M., there were portable humidifier and de-humidifier in operating rooms 1 and 2.

At 5:40 P.M., the Director of Quality Risk and Infection Control, stated the HVAC system is not able to maintain the humidity level as it did before due to the age of the HVAC system and the building.

8/21/14

At 3:40 P.M., 4 of 4 operating rooms were observed to have portable humidifier and de-humidifier stored in each room.

At 3:47 P.M., the Plant Operation Engineer stated all 4 operating rooms had a humidifier and a de-humidifier to control the humidity in the operating room at level of 20% to 60%. This was done because the HVAC system is too old to maintain the humidity in the operating rooms. The humidity is checked by the engineer every morning and recorded, but during procedures, the operating staff checks the humidity and if out of range, they wait for correction of the humidity until after the procedures. The humidifiers are used only before and after a procedure to correct the humidity level. The facility has used the humidifiers for the last four years. The Plant Operation Engineer provided the manufacturer specifications for the humidifier and dehumidifier.

At 5:10 P.M., the manufacturer instructions for the Essick humidifier stated, "This product is not intended for commercial use."


K144

Based on observation, the facility failed to provide an emergency lighting in their generator room. This was evidenced by not having a battery operated lights used during emergency power outage. This affected 1 of 5 smoke compartments of the Main Hospital. This could result in a delay with repairs or usage of the generator by staff due to limited vision at the generator site, and possible harm to patients and staff in the event of a power outage.

Findings:

During the tour with the Director of Plant Operations, the generator room in the basement under Critical Care Unit was observed.

NFPA 110, Standard for Emergency and Standby Power Systems, 1999 Edition

3-5.3.6 Battery Charger. The generator set shall be fitted with an integral accessory battery charger, driven by the prime mover and automatic voltage regulator, capable of charging and maintaining the starting battery unit(and control battery where used) in a fully charged condition during a running condition.

5-3.1 The Level 1 or Level 2 EPS equipment location shall be provided with battery-powered emergency lighting. The emergency lighting charging system and the normal service room lighting shall be supplied from the load side of the transfer switch.

8/28/14
Main Hospital

1. At 5:04 P.M., the generator room, in the basement under the Critical Care Unit, was not equipped with battery-powered emergency lights.

2. At 5:05 P.M., in the generator room in the basement under the Critical Care Unit, the generator battery charger was plugged into an extension cord in-order to keep the generator battery charged so the generator will be able to start readily. The installation date on the battery was 3/15/12. Facility failed to ensure generator battery operates in a reliable condition by using non-permament wiring to start the generator.

3. At 5:05 P.M., the Director of Plant Operation confirmed the extension cord is needed so the facility will be able to keep the generator battery charged to readily start of the generator.

K147
Based on observation and interview, the facility failed to maintain electrical safety as evidenced by usage of multi-plug power strips, Alcohol Based Hand Rub dispenser over light switch and wall outlet not covered. The usage of multi- plug power strips and extension cord could cause the circuits to be overload and start a fire within the building. This affected 5 of 5 smoke compartments and Crestview Behavioral Center. This could result in an electrical fire and possible harm to patients and staff.

NFPA 70 Section 400-8 1999 Ed. Uses not permitted. Unless specifically permitted in section 400-7, flexible cords and cables shall not be used for the following:

(1) As a substitute for a fixed wiring of a structure
(2) Where run through holes in walls, structural ceilings, suspended ceilings, dropped ceilings, or floors.
(3) Where run through doorways, windows, or similar openings
(4) Where attached to building surfaces
(5) Where concealed behind building walls, structural ceilings, suspended ceilings, or floors

(6) Where installed in raceways, except as otherwise permitted in this code




Findings:

Main Hospital
During tour of the facility with the Director of Business Services from 8/20/14 to 9/4/14, the wall outlets were observed.

8/20/14

1. At 3:51 P.M., an ABHR dispenser was mounted directly over a light switch in the Business Development office. The ABHR dispenser contains 62% alcohol per label on the bag in the dispenser.

2. At 4:01 P.M., in the Case Manager office, a printer plugged into a multi-plug power strip, a multi-function printer fax machine plugged into multi-plug power strip, and two other power strip plugged into each other (daisy-chain) with a small refrigerator and fan plugged into the first one. Facility used power strip for permanent wiring due to shortage of outlets or outlets installed too far from equipment.
At 4:01 P.M., an interview with staff in the Case Manager office, they stated the wall outlets were too far away from the electrical equipment so multi-plug power strips have to be used in order for them to utilize the equipment.

4. At 4:41 P.M., in the Medication Room on Central Med-surged Nurses Station, there was a small refrigerator plugged into a multi-plug power strip. Facility used power strip for permanent wiring due to shortage of outlets or outlets installed too far from equipment.

5. At 4:56 P.M., in the Medication Room on East Wing Nurses Station, there was a small refrigerator plugged into a multi-plug power strip. Facility used power strip for permanent wiring due to shortage of outlets or outlets installed too far from equipment.

8/21/14

6. At 12:07 P.M., in the Radiology department reception area, an extension cord plugged into a multi-plug power strip and a network printer plugged into the multi-plug power strip. Facility used power strip for permanent wiring due to shortage of outlets or outlets installed too far from equipment.

7. At 12:08 P.M., in Radiology department reception area, another network industrial printer plugged into a multi- plug power strip. Facility used power strip for permanent wiring due to shortage of outlets or outlets installed too far from equipment.

8. At 12:10 P.M., in the Radiology department back room area, a hot light for the X-ray machine and digitizer (convert the x-ray film to digital) plugged each in a power strip. Facility used power strip for permanent wiring due to shortage of outlets or outlets installed too far from equipment.

9. At 2:32 P.M., in the Physical Therapy Room, facility converted a 2 socket wall outlet to four socket wall outlet by attached by screws 4 sockets adapter to the 2 sockets wall outlets. There were 2 small refrigerators, a microwave and a network industrial printer plugged into the 4 so

Based on observation, interview and document review, the hospital failed to ensure that equipment was installed and maintained at an acceptable level of safety and quality. A 1500 gallon liquid oxygen tank was installed unsecurely 5 feet away from the wall of the building. There were 9 air handlers on the roof that were not secured from falling off. Seven of the nine air handlers were dual units connected to natural gas lines. During an earthquake, these units could move and disconnect from the gas lines which could result in a fire, explosion, and lack of functioning ventilation affecting all patients, staff and visitors.

The hospital also failed to maintain patient equipment at an acceptable level of safety and quality, for 1 of 30 sampled patients (11). Patient 11's reverse osmosis dialysis equipment (RO - a system designed to purify water) was plugged into a power strip. The RO had tubing which extended from the unit into the bathroom sink, which allowed for drainage of the patient's dialysate (fluid that cleans the blood). The power strip was placed in a wet location that posed a risk for electrical shock during the dialysis treatment. The power strip was used by staff not in accordance with the manufacturer's guidelines.

On 8/25/14 at 1:25 P.M., a situation of Immediate Jeopardy was determined to be present due to the findings outlined in A Tag 144, 710 (K67 and K76), and 724. The interim Chief Executive Officer, the Chief Clinical Officer, Director of Pharmacy, Director of Human Resources, Director of Business Development, Chief Financial Officer, Director of Plant Operations, and the Director of Quality and Risk Management were present. The Immediate Jeopardy was abated on 8/28/14 at 7:00 P.M. after an acceptable corrective action plan was implemented.

Findings:

1. During a tour of the facility with the Director of Plant Operations (DPO), the oxygen storage area was observed. On 8/25/14 at 10:35 A.M., a 1500 gallon liquid oxygen tank was installed 5 feet from the building wall (a wooden frame constructed building) and not anchored properly to the concrete floor. The State Agency submitted a field visit report on 5/19/14 indicating that the facility was notified in November 2012 that the installation of the liquid oxygen tank was not in compliance with applicable codes. The tank was installed without approval from the State's Authority having jurisdiction and was not properly anchored to the concrete floor.

An interview with the DPO was conducted on 8/25/14 at 10:36 A.M. The DPO acknowledged that the liquid bulk oxygen tank was installed without obtaining prior approval from State's Authority. He also acknowledged that the bulk oxygen tank was not securely installed and was placed too close to a wooden frame construction.

2. During a tour of the facility with the Director of Plant Operations (DPO), the roof Air Handlers were observed. On 8/25/14 at 11:05 A.M. The State Agency submitted a field visit report on 4/11/13 indicating that on 11/1/12, during a facility visit, the facility was notified that air handlers (air handler units were numbered: #6, #15, #7, #22, #23, #30, #31, #33, and #44) posed a hazard because they were not anchored securely to the roof. Seven of the nine were dual air handlers (heating and cooling) with gas lines attached to them. Five of nine air handlers installed on elevated platforms ranging from 18 inches to approximately 3 feet above the roof. Eight of nine air handlers were resting on 4 by 4 un-anchored wood blocks. The air handlers were not secured to the wood blocks, and the wood blocks were not secured to the roof.

On 8/25/14 at 11:08 A.M., air handler units #22, #30 and #33 were observed to be dual units with gas line attached and were elevated on the wood blocks without being secured to the platforms and roof.

On 8/25/14 at 11:25 A.M., during an interview with the DPO, he stated that the hospital could not provide documentation to show air handlers were installed with approval from State Agency having jurisdiction. He acknowledged that the air handler units were not securely installed.









29499

3. On 8/19/14 at 11:25 A.M., an interview was conducted with the Director of Plant Operations (DPO). The DPO stated that the power strips used during dialysis were not monitored as part of the weekly dialysis equipment checks. At 2:00 P.M. on the same day, the DPO stated the purpose of the hospital's safety plan was to ensure the safety of the environment. He stated that daily hazard surveillance rounds were conducted throughout the hospital and documented on an "unofficial notepad" because a formal method of documentation was not implemented. In addition, the DPO stated that his surveillance from his notepad was brought to the environment of care (EOC) meetings, every other month.

The hospital's "Patient Safety and Risk Reduction Plan", dated 10/06, indicated that the hospital shall foster a safe environment by integrating safety priorities into all relevant hospital processes, functions, and services. The Plan's purpose was to improve patient safety and reduce risk to patients through an environment that encourages ongoing assessments and recognition of hazardous conditions.

On 8/19/14 at 11:25 A.M., an interview was conducted with the DPO. The DPO acknowledged that Patient 11's room could not accommodate the dialysis equipment without the use of a power strip. At 4:15 P.M. on the same day, the DPO stated that nine additional patient rooms in the hospital did not accommodate the RO equipment because electrical outlets were not close enough to the bathroom. He stated that those nine rooms also required the use of a power strip. In addition, at 5:15 P.M. on the same day, the DPO stated he was not aware of the manufacturer's guidelines for the power strip used in Patient 11's room.

On 8/19/14 at 4:45 P.M., the RO and power strip manufacturer's guidelines were reviewed. The RO guidelines included: Do not use an extension cord (power strip) with the RO unit. The power strip guidelines included: Do not use where excessive moisture is present, use in dry locations only.

On 8/21/14 at 4:10 P.M., an interview was conducted with the DPO. The DPO stated that he conducted risk assessments of equipment used in the hospital when new equipment or new programs were being implemented. Per the DPO, he stated that the hospital did not have any documented evidence that risk assessments were performed when the power strips had been in use.

At 4:25 P.M. on the same day, an interview was conducted with the DPO. The DPO stated that it was the engineering department's responsibility to approve equipment for hospital use. He stated that the hospital relied on the fact that the power strip was hospital grade (circuit breaker protection) and that it was not necessary to further review the manufacturer's guidelines. The DPO acknowledged that he had not seen or read the manufacturer's guidelines and/or label on the bottom of the power strip.

On 8/26/14 at 4:00 P.M., a telephone interview was conducted with the dialysis acute coordinator (DAC) and the chief clinical coordinator (CCO). The DAC stated that dialysis RNs were trained to follow manufacturer's guidelines. The DAC was not aware of the manufacturer's guidelines that the RO device should not be plugged into an extension cord (power strip), and not to use the power strip in areas with excessive moisture. The CCO and the DAC acknowledged that this could have been a hazard for electrical shock if the power strip had contact with the water source in the bathroom. The CCO stated that the hospital had oversight of the safety of the equipment used in the hospital. The CCO acknowledged that the power strip posed a risk to patients' safety when the power strips were not used in accordance to manufacturer's guidelines.

The hospital's documented EOC minutes dated July 2013 through November 2013, January 2014, and March 2014, did not include data for the surveillance of the safety and use of power strips in patient care areas as an agenda, discussion or an action plan to ensure patient safety was maintained.

On 8/26/14 at 4:35 P.M., an interview was conducted with the Chief Clinical Officer (CCO), the DPO and the Director of Quality and Risk Management (DQRM). They acknowledged that the use of power strips in patient care areas were not incorporated as part of the hospital's safety plan to monitor the safety of patient care services provided.