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

EL CENTRO REGIONAL MEDICAL CENTER 1415 ROSS AVENUE EL CENTRO, CA 92243 Nov. 22, 2013
VIOLATION: GOVERNING BODY Tag No: A0043
Based on 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 Governing Body failed to ensure that operating room (OR) staff maintained a safe environment in the OR when a power strip that did not have a back cover and had live electrical conductors exposed, was used. This posed a risk of equipment failure, electrical shock and fire in an oxygen rich environment.
A Tag 144 and A Tag 724

2. The Governing Body failed to ensure that Quality Assessment and Performance Improvement (QAPI) had oversight for the implementation and provision of surgical services utilizing a sophisticated robotic surgical device, impeded the hospital from identifying outcomes (such as infections and surgical complications) and opportunities for improvement related to this potentially high risk surgical device.
A Tag 263

3. There was no documented evidence that operating room nursing staff and technicians had job-specific training and competencies regarding the da Vinci Robotic surgical device.
A Tag 941

4. There was no documented evidence of their written process related to the training and competency evaluation of Registered Nurses (RNs) and Certified Surgical Technicians (CSTs) in the Operating Room (OR) related to the use of the hospital's robotic surgical device.
A Tag 951

5. The Governing Body failed to ensure that the Director of Facilities obtained California Office of Statewide Health Planning and Development (OSHPD) permits prior to construction projects and approvals. These buildings did not contain audible and visual fire detection devices which had the potential to cause injury to all.
A Tag 710 K 56, K 52 (3), K 62 (5) and K 67 (1)

6. 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)


A review of the bylaws for the board of trustees was conducted on 11/22/13 at 1:00 P.M. The bylaws specified the Governing Body ultimate responsibility under powers and duties section 3.01-7 : "The making, adopting, and modifying as necessary and appropriate, from time to time, rules and regulations governing the activities and programs of the Hospital, including its educational and medical activities and programs; the organization of services; choice of staff; appointment of physicians and other health care professionals; admission or exclusion of patients; and, in general, the governing of all internal activities at the Hospital and its activities and programs."

An interview was conducted with representatives of the Governing Body on 11/22/13 at 4:00 P.M., the members of the board stated that they were not informed that the OR staff were using a power strip that did not have a back cover which exposed live electrical conductors in the OR. They stated they were not aware that the da Vinci robotic surgical device had been installed without OSHPD approval. In addition, they were not aware that documented evidence of job-specific training and competency evaluations on the da Vinci device for nursing staff and technicians were not obtained. They stated they were not aware that the Facilities
Director had completed construction of buildings without OSHPD permits. They acknowledged that they had not validated the Facilities Director's job-specific roles and responsibilities, or his adherence to OSHPD requirements for permits, in an effort to ensure that he was following all requirements necessary for installations of devices and construction.

The cumulative effect of these systemic problems resulted in the facility'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.
VIOLATION: CONTRACTED SERVICES Tag No: A0085
Based on interview and document review, the hospital failed to ensure that it's lease agreement (contract) with a vendor to rent a building for the storage of records and equipment, contained details and specifications related to ensuring the protection and safe storage of records from damage, flood and fire. The lack of specific details in vendor contracts impedes the hospital from ensuring the integrity of medical records and the implementation of safe storage requirements.

Findings:

An interview with the interim Health Information Management manager (HIM 1) was conducted on 11/20/13 at 8:30 A.M. HIM 1 stated that the hospital stored medical records in two locations: the "barn" (a fixed trailer located on hospital property) and offsite storage facility 1 (OSF 1).

On 11/20/13 at 1:43 P.M., a tour of the hospital's older storage facility located on 2nd Street (OSF 2) was conducted with the Chief Operating Officer (COO), Chief Financial Officer (CFO), the Director of Quality and Risk Management (DQRM) and the interim Health Information Management manager (HIM 1).

Multiple boxes were found stored with medical equipment in a building that was dirty, disorganized, poor lighting and no temperature control. The boxes were dusty, dirty and difficult to reach as there were several medical equipment and other obstacles that impeded direct access to all of them.


A review of a document entitled "Agreement For Offsite Record Storage Services" for OSF 1, dated 10/2007, was conducted on 11/20/13 at 9:54 A.M. The contract contained detailed and clear storage area responsibilities and requirements for the storage of records and materials. Per the same contract, it stipulated that "Storage areas must be kept clean, free of debris and rodents, heat and moisture."

An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/22/13 at 4:03 P.M. The DQRM had confirmed that the hospital had two offsite medical storage locations: OSF 1 and an older storage facility located on 2nd Street (OSF 2). She stated that the hospital had a lease agreement (vendor contract) to rent the building at OSF 2, for the storage of medical records and medical equipment. She acknowledged that the OSF 2 vendor contract did not contain details of required services to ensure the safe storage and protection of medical records from damage, flood and fire.

A review of all the copies of the lease agreements (contract) with OSF 2, dated 6/16/93, 7/1/94 and 6/30/03, was conducted on 11/22/13, there was no documented evidence to show that clear and specific details were listed to ensure the safe storage and protection of medical records from damage, flood and fire.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, interview, and document review, the hospital failed to protect and promote each patients' rights when patient care was not provided in a safe environment for patients by the following:


1. Failure to ensure that care was provided in a safe setting when medical devices (auxiliary equipment) in the Operating Room (OR) were plugged into a 6-plug multiple outlet adapter (power strip). The back cover of the outlet adapter was missing which exposed live electrical conductors to an oxygen-enriched environment. This had the potential to cause equipment failure during a surgical procedure, electrical shock and fire.
A Tag 144

2. The Governing Body failed to ensure that the Director of Facilities obtained California Office of Statewide Health Planning and Development (OSHPD) permits prior to construction projects and approvals. These buildings did not contain audible and visual fire detection devices which had the potential to cause injury to all.
A Tag 710 K 56, K 52 (3), K 62 (5) and K 67 (1)

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)



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's Rights and failure to provide patient care in a safe and secure environment.
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
Based on observation, interview and record review, the hospital failed to ensure that confidential patient information was stored in a manner that protected its integrity from damage, water and fire. There were 9 boxes in an offsite storage facility that contained outpatient facesheets, lab requisitions and various other documents that contained confidential patient information. Failure to store records and documents containing confidential patient information impeded the hospital from ensuring that records and documents were protected from damage, water and fire, in an effort to maintain the documents integrity.

Findings:

On 11/20/13 at 1:43 P.M., a tour of the hospital's older storage facility (OSF 2) was conducted with the Chief Operating Officer (COO), Chief Financial Officer (CFO), the Director of Quality and Risk Management (DQRM) and the interim Health Information Management manager (HIM 1).

Multiple boxes were found stored with medical equipment in a building that was dirty, disorganized, poor lighting and no temperature control. The boxes were dusty, dirty and difficult to reach as there were several medical equipment and other obstacles that impeded direct access to all of them.

On 11/20/13 at 1:55 P.M., an interview and joint document review with the COO was conducted. He was asked to open one of the boxes to see what was in them. Laboratory reports containing confidential medical information was found in the box. The COO acknowledged that the box containing records with confidential patient information should not have been stored at this building. He stated that he did not know why these boxes were stored here as they should have been stored at their offsite storage facility (OSF 1). He also stated that they were not stored in a manner that protected them from damage, water and fire. The hospital was asked to take all the boxes, 4 were visible at the time, to the hospital's onsite medical record storage building called the "barn" (a fixed trailer on hospital property) for further review.

On 11/21/13 at 10:21 A.M. a thorough review of all the boxes sequestered from OSF 2 was conducted with HIM 1. There were 9 boxes that contained the following: laboratory requisitions (physician's orders), outpatient facesheets, hematology (a study of the physiology of the blood) reports and prescriptions. All the documents and records contained some, if not all of the following confidential patient information from January 2010 to May 2010: patient name, medical record number, date of birth, diagnosis, social security number, insurance information, age, sex, home address and physician name.

An interview with the CFO was conducted on 11/21/13 at 11:10 A.M. The CFO stated that the Department of Health Information Management reported to him. He stated that the 9 boxes that contained all the documents and records with confidential patient information should not have been stored at OSF 2. He acknowledged that the documents were not stored in a manner that protected their integrity from damage, water and fire.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview and document review, the hospital failed to ensure that care was provided in a safe setting when medical devices (auxillary equipment) in the Operating Room (OR) were plugged into a 6-plug multiple outlet adapter (power strip). The back cover of the outlet adapter was missing which exposed live electrical conductors to an oxygen-enriched environment. Medical devices used during surgical procedures in the OR that were plugged into an outlet adapter with exposed live electrical conductors in an oxygen-rich environment had the potential to cause equipment failure, electrical shock and an electrical fire. The hospital's failure to provide care in a safe setting had the potential to affect all the patients, staff and visitors in the OR.

On 11/19/13 at 2:55 P.M., a situation of Immediate Jeopardy was determined to be present due to that finding. (Reference A Tag 724 as well). The Chief Executive Officer, the Chief Operating Officer, the Chief Nursing Officer, and the Director of Quality and Risk Management were present. The Immediate Jeopardy was abated on 11/22/13 at 4:30 P.M. after an acceptable corrective action plan was implemented.

Findings:

On 11/19/13 beginning at 1:29 P.M., a group observation of the hospital's da Vinci "Si" HD surgical system (a sophisticated surgical robot designed to enable complex surgery using a minimally invasive approach. The robot consists of three components: surgeon console; patient cart, which holds specialized instruments; and the vision cart) located in OR #4, was conducted with the Director of Surgical Services (DSS) and the Director of Quality and Risk Management (DQRM).

The Vision Cart contained auxillary equipment which included a digital device (used in the OR; has the ability to capture images in high definition and record video in multiple formats), insufflator (a device that blows gas into a body cavity) and an electrical surgical unit (a surgical device that uses high-frequency electric current for cutting or destroying tissue, as in cauterization). The auxillary equipment were plugged into a 6-plug mutiple outlet adapter (a power strip). The back cover of the outlet adapter was missing, exposing the live electrical conductors. The outlet adapter was plugged into a 20-Amp (amperage) circuit and the circuit was observed to be in the "ON" position.

An interview with the DSS was conducted on 11/19/13 at 3:30 P.M. He acknowledged that there were 3 medical devices (the digital device, the insufflator and an electrical surgical unit) that were plugged into a power strip. He confirmed that the power strip did not have a back cover which led to the exposure of live electrical conductors to an oxygen-enriched environment. He acknowledged that auxillary equipment plugged into a power strip that had exposed live electrical conductors had the potential to cause equipment failure, electrical shock and an electrical fire. He also stated that he was not aware that the general use of power strips, even when they were marked hospital-grade and were intact, was not allowed in the OR.


According to the hospital's Chief Operating Officer (COO), robotic surgeries had been performed since 2010. A list of patients who had robotic surgery performed from 6/7/10 - 11/18/13 was reviewed. There were a total of 576 patients who had robotic surgery performed. The hospital verbalized that they were unable to determine the length of time the multiple outlet adapter with the missing cover was used in the OR during surgical procedures, and the unknown number of patients and staff that were placed at risk for potential equipment failure, electrical shock and fire due to the exposed live electrical conductors.
VIOLATION: QAPI Tag No: A0263
Based on interview and document review, the hospital failed to ensure that it's Performance Improvement Program was implemented and maintained in an on-going manner to evaluate the quality and appropriateness of services provided related to robotic surgery.

Findings:

A review of the hospital's "Organizational Quality Assessment and Performance Improvement (QAPI) Plan" dated 2013 was conducted on 11/21/13. The objectives and goals indicated that:

"This QAPI plan describes the organizational procedures to be utilized in process design, performance measurement, and performance assessment and performance improvement activities. It is the intent of the organization's leaders to develop a quality assessment and performance improvement (QAPI) program that allows all departments and services collaboratively to evaluate the provision of patient care and perform improvement activities. This plan describes communication and coordination of all organizational activities directed toward improving patient care services. As described in this plan, "departments" refers to all medical staff departments and "services" refer to all clinical and non-clinical Medical Center support services."

Per the same plan entitled "Structure of Organizational QAPI Activities", it stipulated that "The CEO/COO (Chief Executive Officer/Chief Operating Officer) shall oversee the development and implementation of QAPI activities for all [Hospital Name] support services and assure the integration and coordination of department-specific activities into the organization-wide QAPI program. Results of QAPI activities will be reported to Quality Council, the Medical Executive Committee (MEC), the Board of Quality Committee, and the Board of Trustees at least quarterly...."

The Framework for Performance Improvement indicated that "In determining organizational measures, the organization considers the dimensions of performance including efficacy, appropriateness, availability, timeliness, effectiveness, continuity of care, safety, efficiency, and respect and caring as may be appropriate in the measurement of any specific process. Also, included are high volume, high risk and problem prone processes."

The hospital's QAPI plan defined the following: " A performance improvement model is a formal description of the thinking and analysis process adopted by an organization to consider potential improvement opportunities. The performance improvement model adopted by [Hospital name/acronym] is FOCUS-PDCA which is the acronym for:

Find a process to improve
Organize a team that knows the process
Clarify current knowledge of the process
Understand causes of process variation
Select the process to improve
Plan (collect data)
Do (analysis of data)
Check (did it work?)
Act (continue to improve)"

A group interview was conducted with the Director of Quality and Risk Management (DQRM) and the Assistant Director of Quality and Risk Management (ADQRM) on 11/22/13 at 11:05 A.M. The DQRM stated that she had only been in her role as the Director of Quality and Risk Management since the end of September 2013. She did not have access to the previous Director's data and work related to the hospital's robotic surgery QAPI activities. She acknowledged that she could not validate if any QAPI activities related to the robotic surgery services were performed and what data was collected, in effort to ensure patient safety, improve health outcomes, prevention and reduction of medical errors.

The hospital's QAPI program failed to monitor and maintain oversight of the implementation and provision of surgical services utilizing a sophisticated robotic surgical device. The lack of oversight impeded the hospital from identifying outcomes (such as infections and surgical complications) and opportunities for improvement related to this potentially high risk surgical device.

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition for Quality Assessment and Performance Improvement and failure to provide robotic surgical care to their patients in a safe environment.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed to ensure that Registered Nurses (RNs) developed a written nursing care plan when an infection was identified through a diagnostic test, in accordance with the hospital's policy, for 1 of 33 sampled patients (1). Patient 1 had a positive Methicillin-Resistant Staphylococcus Aureus (MRSA - an infection caused by a strain of staph bacteria that's become resistant to the antibiotics commonly used to treat ordinary staph infections) test result in the urine on 11/13/13, there was no documented evidence to show that a nursing care plan had been developed related to the infection. Failure to establish a written care plan, related to an identified patient problem (an infection), had the potential to impede the hospital's goal of ensuring that the nursing staff were consistent in providing nursing care to meet the needs of the patient. In addition, failure to establish a written plan of care did not provide a means to determine when and if the plan of care was revised or updated as needed.

Findings:

On 11/21/13 beginning at 1:15 P.M., a tour of the medical-surgical nursing floor was conducted with the Director of Quality and Risk Management (DQRM) and the clinical nurse manager (RN 1). Patient 1's room had a contact isolation sign posted.

A review of Patient 1's medical record was conducted 11/21/13 at 1:33 P.M. Patient 1 was admitted on [DATE] with a diagnosis that included urinary tract infection per the the Facesheet. A Microbiology Report, dated 11/11/13, indicated that a urine culture had been collected and received. Patient 1's urine culture tested positive for MRSA and the lab result was released to the nursing staff on 11/13/13 at 7:38 A.M. According to a Nursing Note, dated 11/13/13 at 11:58 A.M., RN 2 was aware of Patient 1's positive MRSA result in the urine and had placed the patient on contact isolation. There was no documented evidence to show that the nursing staff had developed a written nursing care plan related to Patient 1's identified infection.

An interview and joint record review was conducted with RN 3 on 11/21/13 at 1:50 P.M. RN 3 stated that she was the nurse caring for Patient 1 on 11/21/13. She stated that Patient 1 was on contact isolation for MRSA in the urine. When RN 3 was asked to show Patient 1's nursing care plan related to the identified infection on 11/13/13, she confirmed that a written care plan had not been developed, in accordance with the hospital's policy. She stated that nursing care plans were developed when problems were identified. She acknowledged that 8 days had passed and a writtne care plan had not been developed for Patient 1's MRSA in the urine (infection).

A review of the hospital's policy entitled "Care Plan; Patient", last review date of 8/22/12, was conducted on 8/22/13. The policy indicated that "... the RN will identify the patient problems (actual/potential), and initiate the Patient Care Plan based on diagnostic test results and assessment information gathered...." Per the same policy, it stipulated that "The careplan will be updated and reviewed daily, on an ongoing basis, and whenever a patient condition changes."

An interview with RN 1 was conducted on 11/21/13 at 2:10 P.M. RN 1 acknowledged that there was no documented evidence that a written care plan had been developed when Patient 1's MRSA in the urine was identified in accordance with the hospital's policy.

An interview with the Infection Control Coordinator (ICC) was conducted on 11/22/13 at 11:18 A.M. The ICC stated that the hospital had identified problems with nursing care plans and were working on correcting the problem. However, she stated that there should have been documented evidence in Patient 1's medical record to show that a care plan had been developed when the patient's urine culture tested positive for MRSA.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review, the hospital failed to ensure that a pre-printed medication order form provided clear and specific medication orders as to which medication was to be used first for the management of nausea and vomiting for 7 of 33 sampled patients (5, 14, 17, 23, 27, 28 and 32). Furthermore, there was no documentation of nursing clarification of the order. Lack of clear and specific medication orders made it difficult for the nursing staff to determine which medication was to be administered first.
Findings:
1. A review of patients' 5, 14, 17, 23, 27, 28 and 32's medical records was conducted on 11/20/13 at 11:00 A.M.
Patient 5 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED] vomiting). There was no documentation to specify which anti-nausea medication to use and in what order. There was no documentation in the medical records that the registered nurse (RN) clarified the orders for nausea and vomiting medication.
A review of the hospital's policy entitled "Medication Orders, Resolving Questionable Physician", indicated that "clarification of orders with the physician occurs when there may <be> legibility, dosing or an incomplete order issue. Clarification also occurs when there are two orders for the same indication such as for pain. The nurse needs to clarify which of the medications the physician wants to use first and then second, etc."
An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. She stated that the RN should have clarified the order with the physician as per the hospital's policy on medication orders clarification.
2. A review of Patient 14's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 14 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documentation in the medical records that the registered nurse (RN) clarified the orders for nausea and vomiting medication.
A review of the hospital's policy entitled "Medication Orders, Resolving Questionable Physician", indicated that "clarification of orders with the physician occurs when there may <be> legibility, dosing or an incomplete order issue. Clarification also occurs when there are two orders for the same indication such as for pain. The nurse needs to clarify which of the medications the physician wants to use first and then second, etc."
An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. She stated that the RN should have clarified the order with the physician as per the hospital's policy on medication orders clarification.
3. A review of Patient 17's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 17 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED] vomiting). There was no documentation to specify which anti-nausea medication to use and in what order. There was no documentation in the medical records that the registered nurse (RN) clarified the orders for nausea and vomiting medication.
A review of the hospital's policy entitled "Medication Orders, Resolving Questionable Physician", indicated that "clarification of orders with the physician occurs when there may <be> legibility, dosing or an incomplete order issue. Clarification also occurs when there are two orders for the same indication such as for pain. The nurse needs to clarify which of the medications the physician wants to use first and then second, etc."
An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. She stated that the RN should have clarified the order with the physician as per the hospital's policy on medication orders clarification.
4. A review of Patient 23's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 23 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documentation in the medical records that the registered nurse (RN) clarified the orders for nausea and vomiting medication.
A review of the hospital's policy entitled "Medication Orders, Resolving Questionable Physician", indicated that "clarification of orders with the physician occurs when there may <be> legibility, dosing or an incomplete order issue. Clarification also occurs when there are two orders for the same indication such as for pain. The nurse needs to clarify which of the medications the physician wants to use first and then second, etc."
An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. She stated that the RN should have clarified the order with the physician as per the hospital's policy on medication orders clarification.
5. A review of Patient 27's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 27 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documentation in the medical records that the registered nurse (RN) clarified the orders for nausea and vomiting medication.
A review of the hospital's policy entitled "Medication Orders, Resolving Questionable Physician", indicated that "clarification of orders with the physician occurs when there may <be> legibility, dosing or an incomplete order issue. Clarification also occurs when there are two orders for the same indication such as for pain. The nurse needs to clarify which of the medications the physician wants to use first and then second, etc."
An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. She stated that the RN should have clarified the order with the physician as per the hospital's policy on medication orders clarification.

6. A review of Patient 28's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 28 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documentation in the medical records that the registered nurse (RN) clarified the orders for nausea and vomiting medication.
A review of the hospital's policy entitled "Medication Orders, Resolving Questionable Physician", indicated that "clarification of orders with the physician occurs when there may <be> legibility, dosing or an incomplete order issue. Clarification also occurs when there are two orders for the same indication such as for pain. The nurse needs to clarify which of the medications the physician wants to use first and then second, etc."
An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. She stated that the RN should have clarified the order with the physician as per the hospital's policy on medication orders clarification.

7. A review of Patient 32's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 32 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documentation in the medical records that the registered nurse (RN) clarified the orders for nausea and vomiting medication.
A review of the hospital's policy entitled "Medication Orders, Resolving Questionable Physician", indicated that "clarification of orders with the physician occurs when there may <be> legibility, dosing or an incomplete order issue. Clarification also occurs when there are two orders for the same indication such as for pain. The nurse needs to clarify which of the medications the physician wants to use first and then second, etc."
An interview with the Director of Quality of Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. She stated that the RN should have clarified the order with the physician as per the hospital's policy on medication orders clarification.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation, interview and record review, the hospital failed to ensure that Registered Nurses (RNs) in the Emergency Department (ED) Supertrack (an area adjacent to the ED that treated low acuity patients) locked cabinets that contained medications and biologicals, in accordance with the hospital's practice. Failure to lock cabinets that contained medications and biologicals impeded the hospital from ensuring that only authorized personnel had access to medications and biologicals.

Findings:

On 11/20/13 at 9:18 A.M., general observations were conducted in the ED Supertrack with the Director of ED services (DEDS) and the Director of Quality and Risk Management DQRM. Multiple cabinets were found unlocked containing the following medications and biologicals:

1 bottle of lidocaine (local anesthetic or numbing medication) hydrochloride/lidocaine viscous (used to treat sores inside the mouth, during dental procedures to numb the gums, and to numb the skin for a medical procedure such as getting stitches)

2 opened bottles of hydrogen peroxide dated 11/18/13

During the observation, there was a sign that was posted on the cabinet that directed the nursing staff to lock the cabinets daily.

An interview with the DEDS was conducted on 11/20/13 at 9:28 A.M. The DEDS stated that the nursing staff should have locked the cabinets as they did contain medications and biologicals that were only accessible to authorized staff. He confirmed that housekeeping or EVS (environmental services) staff entered the ED Supertrack and should not have access to medications or biologicals because they were not authorized personnel.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review, the hospital failed to ensure that a pre-printed medication order form provided clear and specific medication orders as to which medication was to be used first for the management nausea and vomiting for 7 of 33 sampled patients (5, 14, 17, 23, 27, 28 and 32). Furthermore, there was no documentation of pharmacist's clarification of the order as per the hospital's policy.
Findings:
1. A review of patients' 5, 14, 17, 23, 27, 28 and 32's medical records was conducted on 11/20/13 at 11:00 A.M.
Patient 5 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED] vomiting). There was no documentation to specify which anti-nausea medication to use and in what order. There was no documented evidence in the medical record that the pharmacist clarified the orders for nausea and vomiting medication.
A review of the hospital's policy titled "Verification of medication orders by pharmacist", was conducted on 11/22/13 at 10:00 A.M. The policy indicated that "the pharmacist will review for completeness, each prescription or order for medications...when questions arise the prescriber will be contacted for clarification."
An interview with the pharmacy co-directors was conducted on 11/22/13 at 10:30 A.M. They acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. They stated that pharmacist should have clarified the order with the physician in accordance with the hospital policy.
2. A review of Patient 14's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 14 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documented evidence in the medical record that the pharmacist clarified the orders for nausea and vomiting medication.
A review of the hospital's policy titled "Verification of medication orders by pharmacist", was conducted on 11/22/13 at 10:00 A.M. The policy indicated that "the pharmacist will review for completeness, each prescription or order for medications...when questions arise the prescriber will be contacted for clarification."
An interview with the pharmacy co-directors was conducted on 11/22/13 at 10:30 A.M. They acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. They stated that pharmacist should have clarified the order with the physician in accordance with the hospital policy.
3. A review of Patient 17's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 17 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED] vomiting). There was no documentation to specify which anti-nausea medication to use and in what order. There was no documented evidence in the medical record that the pharmacist clarified the orders for nausea and vomiting medication.
A review of the hospital's policy titled "Verification of medication orders by pharmacist", was conducted on 11/22/13 at 10:00 A.M. The policy indicated that "the pharmacist will review for completeness, each prescription or order for medications...when questions arise the prescriber will be contacted for clarification."
An interview with the pharmacy co-directors was conducted on 11/22/13 at 10:30 A.M. They acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. They stated that pharmacist should have clarified the order with the physician in accordance with the hospital policy.
4. A review of Patient 23's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 23 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documented evidence in the medical record that the pharmacist clarified the orders for nausea and vomiting medication.
A review of the hospital's policy titled "Verification of medication orders by pharmacist", was conducted on 11/22/13 at 10:00 A.M. The policy indicated that "the pharmacist will review for completeness, each prescription or order for medications...when questions arise the prescriber will be contacted for clarification."
An interview with the pharmacy co-directors was conducted on 11/22/13 at 10:30 A.M. They acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. They stated that pharmacist should have clarified the order with the physician in accordance with the hospital policy.
5. A review of Patient 27's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 27 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documented evidence in the medical record that the pharmacist clarified the orders for nausea and vomiting medication.
A review of the hospital's policy titled "Verification of medication orders by pharmacist", was conducted on 11/22/13 at 10:00 A.M. The policy indicated that "the pharmacist will review for completeness, each prescription or order for medications...when questions arise the prescriber will be contacted for clarification."
An interview with the pharmacy co-directors was conducted on 11/22/13 at 10:30 A.M. They acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. They stated that pharmacist should have clarified the order with the physician in accordance with the hospital policy.
6. A review of Patient 28's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 28 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documented evidence in the medical record that the pharmacist clarified the orders for nausea and vomiting medication.
A review of the hospital's policy titled "Verification of medication orders by pharmacist", was conducted on 11/22/13 at 10:00 A.M. The policy indicated that "the pharmacist will review for completeness, each prescription or order for medications...when questions arise the prescriber will be contacted for clarification."
An interview with the pharmacy co-directors was conducted on 11/22/13 at 10:30 A.M. They acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. They stated that pharmacist should have clarified the order with the physician in accordance with the hospital policy.
7. A review of Patient 32's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 32 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED]. There was no documentation to specify which anti-nausea medication to use and in what order. There was no documented evidence in the medical record that the pharmacist clarified the orders for nausea and vomiting medication.
A review of the hospital's policy titled "Verification of medication orders by pharmacist", was conducted on 11/22/13 at 10:00 A.M. The policy indicated that "the pharmacist will review for completeness, each prescription or order for medications...when questions arise the prescriber will be contacted for clarification."
An interview with the pharmacy co-directors was conducted on 11/22/13 at 10:30 A.M. They acknowledged that the multiple anti-nausea medication orders were not specific or clear on which medication to use first or in what order. They stated that pharmacist should have clarified the order with the physician in accordance with the hospital policy.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
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 medical equipment and supplies in the Operating Room were maintained with an acceptable level of safety and quality. Three medical devices used during surgical procedures were plugged into a power strip that did not have a back cover which led to the exposure of live electrical conductors. This posed a risk of equipment failure, electrical shock and fire in an oxygen-rich environment.
A Tag 724, A Tag 710 K 147 (1)


2. Failure to ensure that the Director of Facilities obtained California Office of Statewide Health Planning and Development (OSHPD) permits prior to construction projects and approvals. These buildings did not contain audible and visual fire detection devices which had the potential to cause injury to all.
A Tag 710 K 56, K 52 (3), K 62 (5) and K 67 (1)


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)



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 safe environment was provided to all patients, visitors and staff.
VIOLATION: LIFE SAFETY FROM FIRE Tag No: A0709
K3 BUILDING: 01
K6 PLAN APPROVAL: 1949
K7 SURVEY UNDER: 2000 EXISTING
STRUCTURE TYPE: 2 STORIES + ROOF TOP HELIPORT, CONSTRUCTION TYPE II (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: ,

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

Categorical Waiver: The facility has elected to use waiver for not meeting K78, relative humidity in anesthetizing locations at a level of 35 percent or greater.

Census: 61 (on the day the survey began)
VIOLATION: LIFE SAFETY FROM FIRE Tag No: A0710
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 2 of 2 floors in the Hospital Building, the Medical Records Storage Building, and the Information System Building.

Findings:

K12

Based on observation, the facility failed to maintain the integrity of the building construction and compartmentation. This was evidenced by penetrations in the ceiling of an operating room suite. This affected 1 of 8 smoke compartments in the Hospital Building and could allow the spread of smoke or fire, in the event of a fire.

19.1.1.3 Total Concept. All health care facilities shall be designed, constructed, maintained, and operated to minimize the possibility of a fire emergency requiring the evacuation of occupants. Because the safety of health care occupants cannot be ensured adequately by dependence on evacuation of the building, their protection from fire shall be provided by appropriate arrangement of facilities, adequate staffing, and development of operating and maintenance procedures composed of the following:
(1) Design, construction, and compartmentation
(2) Provision for detection, alarm, and extinguishment
(3) Fire prevention and the planning, training, and drilling programs for the isolation of fire, transfer of occupants to areas of refuge, or evacuation of the building

Findings:

During a tour of the facility with the Hospital Staff 11/19/2013 through 11/21/2013, the ceilings were observed.

First Floor, Hospital Building:
On 11/19/2013, at 1:47 P.M., there were two, one quarter inch round penetrations in the ceiling of Operating Room 4. These penetrations were located approximately two inches adjacent to a ceiling light, above the Da Vinci robotic machine.

K18

Based on observation, the facility failed to maintain corridor doors to resist the passage of smoke. This was evidenced by corridor doors that were obstructed from fully closing. This had the potential to allow the migration of smoke and cause harm to patients. This affected 4 of 8 smoke compartments in the Hospital Building.

Findings:

During a tour of the facility with the Hospital Staff from 11/19/2013 through 11/21/2013, the corridor doors were observed.

Second Floor Hospital Building:
1. On 11/20/2013, at 11:19 A.M., the corridor door to the Intensive Care Unit #2 Family Waiting Room was obstructed from closing by a chair.

First Floor Hospital Building:
2. On 11/21/2013, at 7:45 A.M., the corridor door to the Storage Room (door #1S055) in the Emergency Department was obstructed from closing by a cart.


First Floor Hospital Building:
3. On 11/19/2013, at 10:20 A.M., there was a door with a self-closing device in the MDF room, leading to an adjacent storage room, held open with a mobile computer work station.

First Floor Hospital Building:
4. On 11/19/2013, at 10:43 A.M., there was a door on a magnetic hold device obstructed from closure by a metal trash can in the gift shop.

K27

Based on observation, the facility failed to maintain their fire doors to prevent the passage of smoke. This was evidenced by obstructions of roll down fire doors and cross corridor fire doors at smoke/fire barrier separations that failed to close and positive latch upon activation of the fire alarm system. This could result in the spread of smoke and fire and increase the risk of injury to patients, visitors and staff in the event of a fire. This affected 3 of 8 smoke compartments in the Hospital Building.

NFPA 101, Life Safety Code, 2000 Edition
7.2.1.9.2 Doors Required to Be Self-Closing. Where doors are required to be self-closing and (1) are operated by power upon the approach of a person or (2) are provided with power-assisted manual operation, they shall be permitted in the means of egress under the following conditions:
(1) Doors can be opened manually in accordance with 7.2.1.9.1 to allow egress travel in the event of power failure.
(2) New doors remain in the closed position unless actuated or opened manually.
(3) When actuated, new doors remain open for not more than 30 seconds.
(4) Doors held open for any period of time close - and the power-assist mechanism ceases to function - upon operation of approved smoke detectors installed in such a way as to detect smoke on either side of the door opening in accordance with the provisions of NFPA 72, National Fire Alarm Code.
(5) Doors required to be self-latching are either self-latching or become self-latching upon operation of approved smoke detectors per 7.2.1.9.2(4).
(6) New power-assisted swinging doors comply with BHMA/ANSI A156.19, American National Standard for Power Assist and Low Energy Power Operated Doors.

Findings:

During a tour of the facility with the Hospital Staff from 11/19/2013 through 11/21/2013, the fire doors at the smoke/fire barrier separations were observed.

First Floor Hospital Building:
1. On 11/20/2013, at 10:18 A.M., the roll down door that opened into the corridor from the Intake/Triage Room in the Emergency Department had items obstructing the pathway of the door. The items included a box of mask, caviwipes, thermometer, trays, and other containers.

2. On 11/21/2013, at 7:55 A.M., the cross corridor fire doors (#1S027) that separates the Operating Room from the Recovery Room failed to close and positive latch 1 of 2 leaf doors upon activation of the fire alarm system. The door was observed to be dragging on the floor. The doors were equipped with an automatic door closer system and latching mechanisms.

3. On 11/21/2013, at 8:16 A.M., the cross corridor fire doors (#1X011) by the Laboratory failed to close and positive latch 1 of 2 leaf doors upon activation of the fire alarm system. The door was observed to be catching on the floor. The doors were equipped with an automatic door closer system and latching mechanisms.

K46

Based on observation and record review, the facility failed to maintain the battery powered emergency lights. This was evidenced by emergency lights that failed to illuminate when tested and by no documentation for the testing of the battery powered emergency lights for 90-minutes annually. This could result in the failure of the emergency lights in the event of a power outage. This affected the emergency power to the Hospital Building.

NFPA 101, Life Safety Code, 2000 Edition.
19.2.9.1 Emergency lighting shall be provided in accordance with Section 7.9.
7.9.3 Periodic Testing of Emergency Lighting Equipment. A functional test shall be conducted on every required emergency lighting system at 30-day intervals for not less than 30 seconds. An annual test shall be conducted on every required battery-powered emergency lighting system for not less than 11/2 hours. Equipment shall be fully operational for the duration of the test. Written records of visual inspections and tests shall be kept by the owner for inspection by the authority having jurisdiction.
Exception: Self-testing/self-diagnostic, battery-operated emergency lighting equipment that automatically performs a test for not less than 30 seconds and diagnostic routine not less than once every 30 days and indicates failures by a status indicator shall be exempt from the 30-day functional test, provided that a visual inspection is performed at 30-day intervals.

Findings:

During a tour of the facility with the Hospital Staff from 11/19/2013 through 11/21/2013, the battery powered emergency lights were observed and records for the testing of the emergency lights were requested.

Emergency Power for Hospital Building:
1. On 11/20/2013, at 1:40 P.M., the two battery powered emergency lights installed by CAT#2 generator failed to illuminate when pushing down on the "push to test" button.

2. On 11/20/2013, at 1:43 P.M., one of two battery powered emergency lights installed by CAT#1 generator failed to illuminate when pushing down on the "push to test" button.

3. On 11/21/2013, at 2:55 P.M., the records provided for the testing of the emergency lights failed to show that the battery powered emergency lights had been tested for 90-minutes at least once a year.

K 47

Based on observation, the facility failed to maintain exit signs to continuously illuminate. This was evidenced by exit signs that were not illuminating when observed. This could potentially delay evacuation in the event of a power outage and an emergency evacuation. This affected the Rooftop Heliport and the Medical Records Storage Building.

NFPA 101, Life Safety Code, 2000 Edition
19.2.10.1 Means of egress shall have signs in accordance with Section 7.10.
7.10.5.2 Continuous Illumination. Every sign required to be illuminated by 7.10.6.3 and 7.10.7 shall be continuously illuminated as required under the provisions of Section 7.8.

Findings:

During a tour of the facility with the Hospital Staff from 11/19/2013 through 11/21/2013, the exit signs were observed.

Rooftop Heliport Hospital Building:
1. On 11/20/2013, at 10:55 A.M., the exit sign (labeled #162) installed by an exit on the rooftop heliport, failed to illuminate when observed.

Medical Records Storage Building:
2. On 11/20/2013, at 11:41 A.M., the three exit signs installed in the Medical Records Storage Building, known as the "barn," failed to illuminate when observed.

K 48

Based on record review, the facility failed to provide a complete written fire safety plan. This was evidenced by the disaster plan that did not include vertical evacuation of patients. This had the potential for staff to not properly respond to a disaster that will require patients to evacuate from the second floor to the ground level. This affected 1 of 2 floors in the Hospital Building.

NFPA 101, Life Safety Code, 2000 Edition
19.7.1 Evacuation and Relocation Plan and Fire Drills.
19.7.1.1 The administration of every health care occupancy shall have, in effect and available to all supervisory personnel, written copies of a plan for the protection of all persons in the event of fire, for their evacuation to areas of refuge, and for their evacuation from the building when necessary. All employees shall be periodically instructed and kept informed with respect to their duties under the plan. A copy of the plan shall be readily available at all times in the telephone operator's position or at the security center. The provisions of 19.7.1.2 through 19.7.2.3 shall apply.
19.7.2.2 A written health care occupancy fire safety plan shall provide for the following:
(5) Evacuation of immediate area
(6) Evacuation of smoke compartment
(7) Preparation of floors and building for evacuation

NFPA 99 Standard for Health Care Facilities, 1999 Edition
11-5.3 The emergency preparedness plan, as a minimum, shall include the following.
11-5.3.4 Patient Management. Plans shall include provisions for management of patients, particularly with respect to clinical and administrative issues.

Findings:

During a tour of the facility with the Hospital Staff from 11/19/2013 through 11/21/2013, the fire safety and disaster plans were reviewed.

Second Floor Hospital Building:
On 11/21/2013, at 2:35 P.M., the disaster plans provided by staff failed to describe procedures for vertical evacuation of patients. The second floor was observed to be above grade and contain patients in the Intensive Care Unit and the Medical/Surgical Care Unit.

K 52

Based on observation and interview, the facility failed to ensure that the fire alarm system was properly installed and maintained in accordance with NFPA 101, 2000 edition and NFPA 72, 1999 edition. This was evidenced by a device that did not immediately actuate the complete fire alarm system, by a chime that failed to sound an audible alarm, and the fire alarm not heard throughout all occupied spaces. This had the potential for responders and occupants to not be notified of a fire, increasing the risk of injury to patients, visitors and staff. This affected 2 of 8 smoke compartments in the Hospital Building and the Information System Building.

NFPA 101, Life Safety Code, 2000 Edition
19.3.4.3.1 Occupant Notification. Occupant notification shall be accomplished automatically in accordance with 9.6.3.
9.6.3.7 The general evacuation alarm signal shall operate throughout the entire building.
9.6.3.8 Audible alarm notification appliances shall be of such character and so distributed as to be effectively heard above the average ambient sound level occurring under normal conditions of occupancy.
9.6.3.9 Audible alarm notification appliances shall produce signals that are distinctive from audible signals used for other purposes in the same building.
19.3.4.4 Emergency Control. Operation of any activating device in the required fire alarm system shall be arranged to accomplish automatically any control functions to be performed by that device. (See 9.6.5.)
9.6.5.4 Installation of emergency control devices shall be in accordance with NFPA 72, National Fire Alarm Code. The performance of emergency control functions shall not impair the effective response of all required alarm notification functions.

NFPA 72, National Fire Alarm Code, 1999 Edition
1-5.4.2.2 Actuation of alarm notification appliances or emergency voice communications and annunciation at the protected premises shall occur within 20 seconds after the activation of an initiating device.
Effective on January 1, 2002, actuation of alarm notification appliances or emergency voice communications and annunciation at the protected premises shall occur within 10 seconds after the activation of an initiating device.
1-5.4.4 Distinctive Signals. Fire alarms, supervisory signals, and trouble signals shall be distinctively and descriptively annunciated.

Findings:

During a tour of the facility with the Hospital Staff from 11/19/2013 through 11/21/2013, the fire alarm system was tested and observed.

First Floor Hospital Building:
1. On 11/21/2013, at 8:05 A.M., Nurse Staff 37 was asked to activate the fire alarm pull station by the ambulance entrance to the Emergency Department. The fire alarm failed to actuate within 10 seconds after Nurse Staff 37 pulled the alarm. Consultant 34 assisted with the activation of the alarm and was able to actuate the alarm 2-minutes later at 8:07 A.M.

2. On 11/21/2013, at 8:34 A.M., the strobe/chime device (labeled #16) installed in the corridor by Room 101, failed to sound an audible alarm when the fire alarm system was activated.

Information System Building:
3. On 11/21/2013, at 10:40 A.M., the fire alarm was not heard throughout the Information System Building when the Inspector's Test Valve was activated in the building. Hospital Manager 30 stated that the building was used for hospital staff training and for information system central staffing. There were no strobe or chime devices installed in the area.

K 56

Based on observation, record review, and interviews, the facility failed to obtain approvals for the newly installed automatic sprinkler system. This was evidenced by newly installed sprinklers with no approvals and no acceptance testing from the State's authority having jurisdiction in building construction. This deficiency could result in a system that may not meet Federal and State standards and may result in an improperly installed system that may cause injury to patients, staff, and visitors. This affected 2 of 2 floors in the Hospital Building, the Information System Building, and the Medical Records Storage Building:

NFPA 101, Life Safety Code, 2000 Edition
4.5.6 System Design/Installation. Any fire protection system, building service equipment, feature of protection, or safeguard provided for life safety shall be designed, installed, and approved in accordance with applicable NFPA standards.
4.6.12 Maintenance and Testing.
4.6.12.1 Whenever or wherever any device, equipment, system, condition, arrangement, level of protection, or any other feature is required for compliance with the provisions of this Code, such device, equipment, system, condition, arrangement, level of protection, or other feature shall thereafter be continuously maintained in accordance with applicable NFPA requirements or as directed by the authority having jurisdiction.
19.3.5 Extinguishment Requirements.
19.3.5.1 Where required by 19.1.6, health care facilities shall be protected throughout by an approved, supervised automatic sprinkler system in accordance with Section 9.7.
9.7.1 Automatic Sprinklers.
9.7.1.1 Each automatic sprinkler system required by another section of this Code shall be in accordance with NFPA 13, Standard for the Installation of Sprinkler Systems.

NFPA 13, Standard for the Installation of Sprinkler Systems, 1999 Edition.
1-6 Level of Protection.
1-6.1 A building, where protected by an automatic sprinkler system installation, shall be provided with sprinklers in all areas except where specific sections of this standard permit the omission of sprinklers.

NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 1998 Edition
1-4.2 The responsibility for properly maintaining a water-based fire protection system shall be that of the owner(s) of the property. By means of periodic inspections, tests, and maintenance, the equipment shall be shown to be in good operating condition, or any defects or impairments shall be revealed.
Inspection, testing, and maintenance shall be implemented in accordance with procedures meeting or exceeding those established in this document and in accordance with the manufacturer's instructions. These tasks shall be performed by personnel who have developed competence through training and experience.

Findings:

During a tour of the facility with the Hospital Staff from 11/19/2013 through 11/21/2013, the newly installed sprinkler system was observed.

Information System Building and Medical Records Storage Building:
On 11/20/2013, at 11:30 A.M., piping was observed to be connected from the hospital's existing fire sprinkler system to new sprinkler pipes and sprinkler heads that were installed in the Information System Building and the Medical Records Storage Building ("Barn"). During an interview with Hospital Manager 30 at 11:34 A.M., he stated that the new sprinklers were installed about 6-months ago. Hospital Manager 28 was interviewed on 11/21/2013 at 2:41 P.M., and he stated that he had no evidence of acceptance testing and no approvals for the new installation. On 11/19/2013, the Area Compliance Officer from the Office of Statewide Health Planning and Development (OSHPD) Facilities Development Division stated that the expanded sprinkler system was not permitted, it had been installed without verification, and with no approvals.

K 62

Based on observation, the facility failed to maintain their automatic sprinkler system. This was evidenced by sprinklers without escutcheon rings, sprinkler heads with debri, and failing to install an identification sign at an Inspector's Test Valve. Sprinkler heads and scutcheon rings are listed to respond to a calculated ceiling temperature and a missing or detached escutcheon ring could allow heat and smoke to affect other areas in the building. This could cause failure of the sprinkler system in the event of a fire and the missing signs can potentially miss the testing of a portion of the sprinkler system. This affected 4 of 8 smoke compartments in the Hospital Building and the Information System Building.

NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 1998 Edition.
2.2.1.1 Sprinklers shall be inspected from the floor level annually. Sprinklers shall be free of corrosion, foreign materials, paint and physical damage and shall be installed in the proper orientation (e.g., upright, pendant, or sidewall). Any sprinkler shall be replaced that is painted, corroded, damaged, loaded, or in the improper orientation.

NFPA 13, Standard for the Installation of Sprinkler Systems, 1999 Edition
3-2.7.2 Escutcheon plates used with a recessed or flush-type sprinkler shall be part of a listed sprinkler assembly.
3-8.3 Identification of Valves. All control, drain, and test connection valves shall be provided with permanently marked weatherproof metal or rigid plastic identification signs. The sign shall be secured with corrosion-resistant wire, chain, or other approved means.
A-3-8.3 The intent of 3-8.3 is to provide assistance in determining the area of a building served by a particular control valve.

Findings:

During a tour of the facility with the Hospital Staff from 11/19/2013 through 11/21/2013, the sprinkler system was observed.

First Floor Hospital Building:
1. On 11/19/2013, at 1:42 P.M., the sprinkler head installed on the ceiling directly above the Da Vinci Si HD Surgical System side cart, located in Operating Room 4, did not have an escutcheon ring.

2. On 11/20/2013, at 10:19 A.M., the sprinkler head installed on the ceiling in the Intake/Triage Room, located in the Emergency Department, did not have an escutcheon ring.

Second Floor Hospital Building:
3. On 11/20/2013, at 11:05 A.M., the sprinkler head installed on the ceiling in the restroom, located in Room 209, did not have an escutcheon ring.

4. On 11/20/2013, at 11:08 A.M., the sprinkler head installed on the ceiling in Room 216 had accumulation of debri on its deflector and fusible link.

Information System Building:
5. On 11/20/2013, at 11:36 A.M., the Inspector's Test Valve (ITV) installed in the office space in the Information System Building did no have an identification sign. The sprinkler system vendor conducting quarterly testing of the sprinkler system did not know that the ITV in the building existed.

First Floor Hospital Building:
6. On 11/21/2013, at 7:52 A.M., there was a one half inch gap in the ceiling where the escutcheon ring was missing from around the sprinkler in Operating Room 3, left of the entrance.

K 64

Based on observation, the facility failed to maintain their fire extinguishers as evidenced by fire extinguishers mounted above the required height. This had the potential to delay the removal of the fire extinguishers from their mounts causing potential delay in extinguishing a fire. This failure affected 2 of 8 smoke compartments in the Hospital Building.

NFPA 101, 1999 Edition. Life Safety Code.
9.7.4 Manual Extinguishing Equipment.
9.7.4.1* Where required by the provisions of another section of this Code, portable fire extinguishers shall be installed, inspected, and maintained in accordance with NFPA 10, Standard for Portable Fire Extinguishers.

NFPA 10, 1998 Edition. Standard for Portable Fire Extinguishers.
1-6.10 Fire extinguishers having a gross weight not exceeding 40 lb (18.14 kg) shall be installed so that the top of the fire extinguisher is not more than 5 ft (1.53 m) above the floor. Fire extinguishers having a gross weight greater than 40 lb (18.14 kg) (except wheeled types) shall be so installed that the top of the fire extinguisher is not more than 3 1/2 ft (1.07 m) above the floor. In no case shall the clearance between the bottom of the fire extinguisher and the floor be less than 4 in. (10.2 cm).

Findings:

During a tour of the facility with Hospital Manager 28, Hospital Staff 33, and Consultant 34, on 11/20/2013, the fire extinguishers were observed.

1. At 11:27 A.M., there was a fire extinguisher in the kitchen, mounted above sixty inches, above a counter top approximately twenty four inches in depth .

2. At 11:34 A.M., there was a fire extinguisher mounted above sixty inches in the clean equipment room above a sink.

K 67

Based on document review, observation, and interview, the facility failed to maintain their building service equipment. This was evidenced by failing to correct deficiencies reported with the dampers inspection and by temporary chillers not installed properly. The none functional dampers may fail to contain smoke in the event of a fire and the improperly installed chillers may cause structural damage and result in injury to patients, staff, and visitors. This affected 8 of 8 smoke compartments in the Hospital Building.

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 Systems, as applicable, unless existing installations, which shall be permitted to be continued in service, subject to approval by the authority having jurisdiction.
NFPA 90A, Standard for the Installation of Air-Conditioning and Ventilating Systems, 1999 Edition
2-3.4 Air duct access and Inspection
2-3.4.1 A service opening shall be provided in air ducts adjacent to each fire damper, smoke damper and smoke detector. The opening shall be large enough to permit maintenance and resetting of the device.
2-3.4.2 Service openings shall be identified with letters having a minimum height of ? in. (1.27 cm) to indicate the location of
3-4.5.1 All fire dampers and ceiling dampers shall close automatically, and they shall remain closed upon the operation of a listed fusible link or other approved heat-actuated device located where readily affected by an abnormal rise of temperature in the air duct.
3-4.6.1 The locations and mounting arrangement of all fire dampers, smoke dampers, ceiling dampers, and fire protection means of a similar nature required by this standard shall be shown on the drawings of the air duct system.
3-4.7 Maintenance. At least every 4 years, fusible links (where applicable) shall be removed; all dampers shall be operated to verify that they close fully; the latch, if provided, shall be checked; and moving parts shall be lubricated as necessary.
5-1.2 Records shall be maintained on acceptance test results and shall be available for inspection.

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 Systems 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.

Findings:

During a tour of the facility with the Hospital Staff from 11/19/2013 through 11/21/2013, the fire/smoke dampers maintenance and inspection records were requested and the temporary chillers were observed.

Cooling and Ventilation System for Hospital Building:
1. On 11/20/2013, at 1:30 P.M., the water lines for the chillers were observed to be on temporary jack stands instead of being properly anchored and secured in place. The Plant Operations Staff 35 was interviewed and he stated that the temporary chillers had been installed for over 5-years. On 11/19/2013, the Area Compliance Officer from the Office of Statewide Health Planning and Development (OSHPD) Facilities Development Division stated that the temporary chillers installed were not in compliance and that the facility had been informed of non-compliance during a field visit on 9/17/2008.


During record review on 11/21/2013, the certification for dampers was reviewed.

2. At 11:10 A.M., the vendors inspection report dated 11/4/13 indicated seven failed actuators.

3. At 11:11 A.M., the vendors inspection report dated 11/5/13 indicated eleven failed actuators.

4. At 11:12 A.M., the vendors inspection report dated 11/6/13 indicated ten failed actuators.

5. At 11:13 A.M., the vendors inspection report dated 11/7/13 indicated two failed actuators.

6. At 11:14 A.M., the vendors inspection report dated 11/12/13 indicated four failed actuators.

7. At 11:15 A.M., the vendors inspection report dated 11/13/13 indicated four failed actuators.

8. At 11:16 A.M., the vendors inspection report dated 11/6/13 indicated two dampers need repair.
There was no written evidence that these deficiencies identified were corrected.

K 69

Based on observation, the facility failed to maintain their kitchen suppression system. This was evidenced by fusible link covered with grease. This failure affected 1 of 8 smoke compartments in the Hospital Building and had the potential to increase the risk of a kitchen fire if hood service is not done according to regulation.

NFPA 101, Life Safety Code, 2000 Edition.
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, subject to approval by the authority
having jurisdiction.

NFPA 96, 1998 Edition Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations 1998 Edition.
8.2 Inspection of Fire-Extinguishing Systems.
8.2.1* An inspection and servicing of the fire-extinguishing system and listed exhaust hoods containing a constant or fire-actuated water system shall be made at least every 6 months by properly trained and qualified persons.
8.2.4* Fusible links (including fusible links on fire damper assemblies) and automatic sprinkler heads shall be replaced at least annually, or more frequently if necessary where required by the manufacturer.
8-3.1 Hood, grease removal devices, fans, ducts and other appurtenances shall be cleaned to bare metal at frequent intervals prior to surfaces becoming heavily contaminate with grease or oily sludge. After the exhaust system is cleaned to bare metal, it shall not be coated with powder or other substance. The entire exhaust system shall be inspected by a properly trained, qualified, and certified company or person(s) acceptable to the authority having jurisdiction in accordance with Table 8-3.1.

Findings:

During a tour of the facility with Hospital Manager 28 and Consultant 34, on 11/20/13, the kitchen hood was observed.

At 11:25 A.M., the fusible link over the fryer in the kitchen was covered with thick accumulation of dark grease.

K 72

Based on observation, the facility failed to ensure that all means of egress were continuously maintained free of obstructions to full instant use in the case of fire or other emergency. This was evidenced by furniture that were not properly secured. This could result in a delay in evacuation in the event of a fire, or other emergency. This affected 1 of 8 smoke compartments in the Hospital Building.

NFPA 101, Life Safety Code, 2000 Edition
7.1.10.2.2 There shall be no obstructions by railings, barriers, or gates that divide the open space into sections appurtenant to individual rooms, apartments, or other occupied spaces. Where the authority having jurisdiction finds the required path of travel to be obstructed by furniture or other movable objects, the authority shall be permitted to require that such objects be secured out of the way or shall be permitted to require that railings or other permanent barriers be installed to protect the path of travel against encroachment.

F
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation, interview and document review, the hospital failed to ensure that medical devices (auxiliary equipment) in the Operating Room (OR) were plugged into the appropriate power source, in an effort to ensure that medical equipment and supplies were maintained with an acceptable level of safety and quality. Auxiliary equipment in the OR were plugged into a 6-plug multiple outlet adapter (power strip). The back cover of the outlet adapter was missing which exposed live electrical conductors into an oxygen-enriched environment. Medical devices used during surgical procedures in the OR that were plugged into an outlet adapter with exposed live electrical conductors in an oxygen-rich environment had the potential to cause equipment failure, electrical shock and fire. The hospital's failure to ensure that medical equipment and supplies were maintained in a manner that ensured an acceptable level of safety and quality, had the potential to affect all the patients, staff and visitors in the OR.

On 11/19/13 at 2:55 P.M., a situation of Immediate Jeopardy was determined to be present due to the findings outlined in A Tag 724. The Chief Executive Officer, the Chief Operating Officer, the Chief Nursing Officer, and the Director of Quality and Risk Management were present. The Immediate Jeopardy was abated on 11/22/13 at 4:30 P.M. after an acceptable corrective action plan was implemented.

Findings:

On 11/19/13 beginning at 1:29 P.M., a group observation of the hospital's da Vinci "Si" HD surgical system located in OR #4 was conducted with the Director of Surgical Services (DSS) and the Director of Quality and Risk Management (DQRM).

The Vision Cart contained auxiliary equipment which included a digital device (used in the OR; has the ability to capture images in high definition and record video in multiple formats), insufflator (a device that blows gas into a body cavity) and an electrical surgical unit (a surgical device that uses high-frequency electric current for cutting or destroying tissue, as in cauterization). The auxiliary equipment were plugged into a 6-plug mutiple outlet adapter (a power strip). The back cover of the outlet adapter was missing, exposing the live electrical conductors. The outlet adapter was plugged into a 20-Amp (amperage) circuit and the circuit was observed to be in the "ON" position.

An interview with the DSS was conducted on 11/19/13 at 3:30 P.M. He acknowledged that there were 3 medical devices (the digital capture device, the insufflator and an electrical surgical unit) that were plugged into a power strip. He confirmed that the power strip did not have a back cover which led to the exposure of live electrical conductors to an oxygen-enriched environment. He acknowledged that auxiliary equipment plugged into a power strip that had exposed live electrical conductors had the potential to cause equipment failure, electrical shock and an electrical fire. He also stated that he was not aware that the general use of power strips, even when they were marked hospital-grade and were intact, was not allowed in the OR.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the hospital failed to ensure that medical records contained documented evidence to show that a patient was notified of a positive test result by the physician, in accordance with the hospital's practice, for 1 of 33 sampled patients (1). There was no documented evidence to show that Patient 1 was notified by the physician of a positive Methicillin-Resistant Staphylococcus Aureus (MRSA - an infection caused by a strain of staph bacteria that's become resistant to the antibiotics commonly used to treat ordinary staph infections) test result in the urine. The lack of documentation related to the notification of a patient by the physician of a positive test result, made it difficult to determine if the patient and/or the patient's representative were informed about the infection, in effort to provide education about the infection, and prevent or reduce the risk of transmission.

Findings:

On 11/21/13 beginning at 1:15 P.M., a tour of the medical-surgical nursing floor was conducted with the Director of Quality and Risk Management (DQRM) and the clinical nurse manager (RN 1). Patient 1's room had a contact isolation sign posted.

A review of Patient 1's medical record was conducted 11/21/13 at 1:33 P.M. Patient 1 was admitted on [DATE] with a diagnosis that included urinary tract infection per the the Facesheet. A Microbiology Report, dated 11/11/13, indicated that a urine culture had been collected and received. Patient 1's urine culture tested positive for MRSA and the lab result was released to the nursing staff on 11/13/13 at 7:38 A.M. According to a Nursing Note, dated 11/13/13 at 11:58 A.M., RN 2 documented that she had notified Physician 1 about Patient 1's positive MRSA test result in the urine. There was no documented evidence to show that Physician 1 or any physician had notified Patient 1 of his positive MRSA test result.

An interview with RN 1 was conducted on 11/21/13 at 2:10 P.M. RN 1 stated that there should have been documented evidence in Patient 1's medical record to show that the physician had notified the patient of the positive MRSA result.

A review of the hospital's Infection Control Plan 2013 was conducted on 11/22/13 at 6:53 A.M. The plan indicated that "The Infection Control Program provides a systematic, coordinated approach to prevent/minimize/reduce the risks of health care associated infections (HAI's) through the implementation of surveillance, prevention and control measures."

An interview with the Infection Control Coordinator (ICC) was conducted on 11/22/13 at 11:18 A.M. The ICC confirmed that Patient 1's medical record did not contain documented evidence to show that a physician had notified the patient of the positive MRSA test result in the urine. She stated that she spoke with the hospital's infectious disease physician (IDMD) about the finding and he agreed that this was not in accordance with the hospital's practice. The IDMD stated that documented notification and education should have been in Patient 1's Progress Note (the medical record).
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview and record review, the hospital failed to ensure that infection control practices were implemented in the hospital's Emergency Department (ED) Supertrack (an area adjacent to the ED that treated low acuity patients). Personal hand lotions and dietary supplies were stored in patient care areas. In addition, there were 9 of 10 overhead vents in the ED Supertrack that had dirt, dust and debris accumulation on its surfaces. Dirty vents had the potential to disseminate dirty and dusty particulates that can potentially trigger an upper respiratory reaction or asthmatic episode.

Findings:

1. On 11/20/13 at 9:18 A.M., during general observations in the hospital's ED Supertrack with the Director of ED Services (DEDS), two bottles of personal hand lotion were found in a cabinet that contained medications and medical supplies. Another cabinet had a 20 oz (ounce) container of pure sugar and a container of non-dairy powdered cream (dietary supplies).

An interview with the DEDS was conducted on 11/20/13 at 9:30 A.M. The DEDS stated that personal hand lotion and dietary supplies should not have been stored in the cabinets that contained medications and patient care items. He also acknowledged that dietary supplies should have been found in patient care areas.

According to the hospital's Guideline for Hand Hygiene in Health-care Settings dated 10/25/02, the use of petroleum-based hand lotions or creams may adversely affect the integrity of latex gloves.

An interview and joint document review with the Infection Control Coordinator (ICC) was conducted on 11/22/13 at 10:05 A.M. The ICC stated that she performed infection control rounds routinely capturing day and night shift staff. She stated that during the hospital's infection control rounds, the ICC and her staff have identified a problem of non-compliance amongst the nursing staff in the ED Supertrack related to personal hand lotions and dietary supplies in patient care areas. According to e-mails (electronic mail) dated 4/19/13 at 11:31 A.M. and 8/8/13 at 4:25 P.M. from the ICC and her staff, it indicated that "Per OSHA [Occupational Safety and Health Administration - a government agency in the Department of Labor to maintain a safe and healthy work environment] food and drinks are prohibited in patient care areas or where there is a potential for exposure with infectious materials (i.e. nurses' stations, patient registration, triage)". The ICC acknowledged that it was the nursing staff and the departmental managers' responsibility to ensure that no dietary supplies and personal lotions were found in patient care areas.

2. On 11/20/13 at 9:15 A.M., a tour of the hospital's ED Supertrack was conducted with the Director of ED Services (DEDS), there were 9 out of 10 vents that contained dirt, dust and debris accumulation on its surfaces.

According to the hospital's "Infection Control Rounds" dated 5/7/13 for the ED, it listed standard elements that each unit had to be in compliance with. One of the listed elements was "Elevated fixtures free of accumulated dust".

An interview with the Infection Control Coordinator (ICC) was conducted on 11/22/13 at 10:05 A.M. The ICC stated that the vents in the ED Supertrack should have been cleaned. She stated that when infection control rounds were performed, vents or elevated fixtures were one of many standard elements they evaluated to ensure that they were free from accumulated dust. She stated that from an infection control stance, "we don't want dust or debris flying around to our patients."
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, interview and document review, the hospital failed to maintain an organized surgical services that meets that needs of patients as evidenced by:


1. Failure to ensure that medical devices (auxiliary equipment) in the Operating Room (OR) were plugged into the appropriate power source, in an effort to ensure that medical equipment and supplies were maintained with an acceptable level of safety and quality. Auxiliary equipment in the OR were plugged into a 6-plug multiple outlet adapter (power strip). The back cover of the outlet adapter was missing which exposed live electrical conductors into an oxygen-enriched environment.
A Tag 724

2. Failure to ensure that Registered Nurses (RNs) and Certified Surgical Technicians (CSTs) in the Operating Room (OR) had documented evidence of their job specific training and competency evaluations related to the use of the hospital's robotic surgical device.
A Tag 941

3. Failure to provide documented evidence of their written process related to the training and competency evaluation of Registered Nurses (RNs) and Certified Surgical Technicians (CSTs) in the Operating Room (OR) related to the use of the hospital's robotic surgical device.
A Tag 951

4. Failure to ensure that an interval updated history and physical (H&P) examination, was performed and documented within 24 hours of admission prior to a surgical procedure per the hospital's policy.
A Tag 952 (1, 2, 3)


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 Surgical Services and failure to provide care to their patients in a safe environment.
VIOLATION: ORGANIZATION OF SURGICAL SERVICES Tag No: A0941
Based on interview and document review, the hospital failed to ensure that Registered Nurses (RNs) and Certified Surgical Technicians (CSTs) in the Operating Room (OR) had documented evidence of their job specific training and competency evaluations related to the use of the hospital's robotic surgical device (da Vinci "Si" HD (high definition) surgical system - a sophisticated surgical robot designed to enable complex surgery using a minimally invasive approach. The robot consists of three components: surgeon console; patient cart, which holds specialized instruments; and the vision cart). The lack of documented job specific training and competency evaluations for RNs and CSTs made it difficult to determine if the OR staff were properly trained and that competencies were evaluated to ensure that the OR staff were performing their job specific duties in accordance with the hospital's expectations and their scope of practice.

Findings:

On 11/19/13 beginning at 1:29 P.M., a group observation of the hospital's da Vinci "Si" HD surgical system located in OR #4 was conducted with the Director of Surgical Services (DSS) and the Director of Quality and Risk Management (DQRM).

An initial review of Personnel Files (specific to the training and competency evaluation of OR staff for the use of the robotic surgical system) was conducted 11/20/13 beginning at 10:31 A.M. A form entitled "Da Vinci Competency" was reviewed and found for all OR staff who assisted surgeons with robotic surgical procedures. The form had 3 columns, first column listed five different surgical procedures and seven various equipment set-ups, the second column labeled "met" was marked with check marks and the last column was labeled "comments". Per the same form, there was a line for the educator's signature and separate line for the name of the employee whose competency was being evaluated.

On 11/20/13 beginning at 3:15 P.M., an interview and joint document review with the Senior Director of Education (SDOE) and the DQRM was conducted. The DQRM stated that the training for RNs and CSTs related to the use of the hospital's robotic surgical system was done however, the documented evidence of the training and competency evaluation was not in a format that demonstrated the job-specific duties and step by step evaluation of the staff's competencies in accordance with their scope of practice. Both the SDOE and the DQRM stated that the documentation was not within the hospital's standards. The SDOE stated that the form used to determine competency was more of a checklist, not an evaluation form that clearly showed observed, verbalized or demonstrated competencies for the use of the hospital's robotic surgical system. In addition, the SDOE stated that this type of training should have been conducted by the hospital's education department which did not occur.

A follow-up interview with the DSS was conducted on 11/21/13 at 2:56 P.M. The DSS stated that the former Chief Nursing Officer (FCNO) was in charge of the hospital's robotic surgery program. He confirmed that the robotic surgery program started in May 2010. He was the interim Director of Surgical Services at that time. He also stated that the FCNO developed all the policies related to robotic surgery, clinical pathways and the training for surgeons and OR staff. He stated that he created the "Da Vinci Competency" form, a simple checklist that listed procedures and equipment set-up, a tool that he used to document the OR staffs' competency related to the use of the hospital's robotic surgical system. However, he acknowledged that the checklist did not contain job-specific responsibilities and there was no clear determination that the OR staffs' competency was evaluated in accordance with their scope of practice.

A review of of Personnel Files were conducted on 11/22/13 beginning at 10:45 A.M. The following OR staffs' files were reviewed (all worked with the hospital's robotic surgical system): the DSS, RN 4, RN 5, RN 6, RN 7, RN 8, RN 9, CST 1, CST 2, CST 3, CST 4, and ORT (Operating Room Technician 1). There was no documented evidence to demonstrate that the OR staff had received job-specific training and competency evaluations related to their roles and responsibilities when robotic surgeries were performed.

The hospital's failure to ensure that there was documented evidence of RNs and CSTs' job-specific training and competency evaluations for the use of the hospital's robotic surgical system, had the potential to cause an unsafe surgical environment for patients.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, interview and document review, the hospital failed to provide documented evidence of their written process related to the training and competency evaluation of Registered Nurses (RNs) and Certified Surgical Technicians (CSTs) in the Operating Room (OR) related to the use of the hospital's robotic surgical device. The lack of a written process or policy related to training and competency evaluation of RNs and CSTs related to the use of robotic surgery devices, impeded the hospital from ensuring that training, competency evaluation and staff performances met the hospital's expectation and standard of practice, in effort to provide surgical services and patient care in a safe and effective manner.

Finding:

On 11/19/13 beginning at 1:29 P.M., a group observation of the hospital's da Vinci "Si" HD surgical system (a sophisticated surgical robot designed to enable complex surgery using a minimally invasive approach. The robot consists of three components: surgeon console; patient cart, which holds specialized instruments; and the vision cart) located in OR #4 was conducted with the Director of Surgical Services (DSS) and the Director of Quality and Risk Management (DQRM).

A follow-up interview with the DSS was conducted on 11/21/13 at 2:56 P.M. The DSS stated that the former Chief Nursing Officer (FCNO) was in charge of the hospital's robotic surgery program. He confirmed that the robotic surgery program started in May 2010. He was the interim Director of Surgical Services at that time. He also stated that the FCNO developed all the policies related to robotic surgery, clinical pathways and the training for surgeons and OR staff. He stated that he created the "Da Vinci Competency" form, a simple checklist that listed procedures and equipment set-up, a tool that he used to document the OR staffs' competency related to the use of the hospital's robotic surgical system. However, he acknowledged that the checklist did not contain job-specific responsibilities and there was no clear determination that the OR staffs' competency was evaluated in accordance with their scope of practice.

On 11/22/13 at 4:03 P.M., the DQRM confirmed that the hospital was unable to find documented evidence of their written process for the training and competency evaluation of RNs and CSTS related to the use of the hospital's robotic surgical system. She stated that the hospital was able to find a policy for the surgeon's training and competency however, there was not one for the RNs and CSTs. She acknowledged that there should have been a policy to demonstrate the hospital's process related to all OR staff training and competency evaluation for the use of their robotic surgical system.
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review, the hospital failed to ensure that an interval updated history and physical (H&P) examination, was performed and documented within 24 hours of admission prior to a surgical procedure per the hospital's policy for 3 of 33 sampled patients (16, 21 and 31).
Findings:
1. A review of patient's 16, 21 and 31's medical records was conducted on 11/20/13 at 11:00 A.M.
Patient 16 was admitted on [DATE] with a diagnosis of mennorrhagia (heavy menstrual bleeding). The operative report indicated that the patient underwent a robotic assisted laparoscopic total hysterectomy (removal of uterus) on 8/9/12. A review of the H&P indicated that it was signed and dated by the physician on 8/6/12. There was no documented evidence of an updated interval physical examination within 24 hours of the admitted .
A review of the hospital's policy titled "History and Physical Compliance Monitoring" was conducted on 11/20/13 at 1:30 P.M. The policy indicated under the section preoperative history and physical that "an interval history and physical examination must be performed and recorded within 24 hours of admission."
An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the H&P's should be completed and documented within 24 hours of admission for pre-surgical patients to be in compliance with the hospital's policy.
2. A review of Patient 21's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 21 was admitted on [DATE] with a diagnosis of menorrhagia (heavy menstrual bleeding). The operative report indicated that the patient underwent a robotic assisted laparoscopic total hysterectomy (removal of uterus) and bilateral salpingooopherectomy (removal of fallopian tubes and ovaries) on 9/10/12. A review of the H&P indicated that it was signed and dated by the physician on 9/6/12. There was no documented evidence of an updated interval physical examination within 24 hours of the admitted .
A review of the hospital's policy titled "History and Physical Compliance Monitoring" was conducted on 11/20/13 at 1:30 P.M. The policy indicated under the section preoperative history and physical that "an interval history and physical examination must be performed and recorded within 24 hours of admission."
An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the H&P's should be completed and documented within 24 hours of admission for pre-surgical patients to be in compliance with the hospital's policy.
3. A review of Patient 31's medical record was conducted on 11/20/13 at 11:00 A.M.
Patient 31 was admitted on [DATE] with a diagnosis of left ovarian cyst. The operative report indicated that the patient underwent a left robotic assisted laparoscopic cyctectomy (removal of cyst) on 10/22/13. A review of the H&P indicated that it was signed and dated by the physician on 10/14/13. There was no documented evidence of an updated interval physical examination within 24 hours of the admitted .
A review of the hospital's policy titled "History and Physical Compliance Monitoring" was conducted on 11/20/13 at 1:30 P.M. The policy indicated under the section preoperative history and physical that "an interval history and physical examination must be performed and recorded within 24 hours of admission."
An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/20/13 at 11:30 A.M. She acknowledged that the H&P's should be completed and documented within 24 hours of admission for pre-surgical patients to be in compliance with the hospital's policy.