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Based upon interviews, medical record and document reviews and observation, it was determined that the hospital failed to have a Governing Body that was effective and responsible for the conduct of the hospital as evidenced by:

482.12- Governing Body: The Governing Body failed to ensure that the Systems Improvement Agreement was consistently implemented and compliance that had been achieved was sustained to meet the Conditions of Participation.

1. The Governing Body failed in their responsibilities to ensure that Quality Assessment and Performance Improvement Program addressed known issues to be identified as a priority in a high risk-problem probe area. Please refer to A0283.

2. The Governing Body failed to carry out their executive responsibilities as it relates to the hospital wide Quality Assessment and Performance Improvement Program. Please refer to A0286.

3. The Governing Body failed to ensure resources were adequate to improve quality and safety. Please refer to A0315

Areas of continued non-compliance and other deficient practices that were identified included:

482.13- Patient Rights: The hospital failed to promote the rights of each patient and provide care in a safe setting.

482.21- Quality Assessment and Performance Improvement: The hospital failed to ensure that a proactive comprehensive ongoing approach for improving quality and patient safety was hospital wide. The Governing Body failed to ensure that clear safety expectations were established for the Quality Assessment and Performance Improvement program.

482.22- Medical Staff: The hospital failed to operate under their bylaws and demonstrate responsibility for the quality of medical care provided to the patients of the hospital. The Medical staff failed to demonstrate organization and accountability for the quality of medical care provided within the institution.

482.23- Nursing Services: The hospital failed to implement physician orders and to provide the necessary care ands services to patients,

482.30- Utilization Review: The hospital failed to implement their Utilization Review plan and review services provided by the institution.

482.42- Infection Control: The hospital failed to ensure the policies for prohibiting the transmission of disease were accurate and implemented.


The continued non-compliance and the cumulative effect of the lack of oversight and actions resulted in the Governing Body ineffectiveness for the conduct of the institution.

Based upon review of hospital committee minutes and interviews, the Medical Staff did not demonstrate accountability to the Governing Body for the quality of care. Evidence includes the following.

The Medical Executive Committee (MEC) is a committee of the Medical Staff and is not to replace or assume the responsibility of an organized Medical Staff. The Executive Committee meets but there was no evidence presented as to how the Governing Body is appraised of the evaluations done by the Medical Staff and for Patient care services.


Review of the Medical Executive Committee Minutes of 3/16/11 noted issues had been identified regarding poor physician communication. The committee discussed the lack of continuity of care between physicians and some of the Chief(s) of Services. The committee at this time also mentioned the lack of responsiveness with Radiologists in the Emergency Room and the fact that 6 months of studies had not been read. Please refer to A0537.

The minutes of 2/27/12 continue to mention issues with several physicians, minutes from 6/1/12 noted there are tensions between departments, the minutes of 7/10/12 noted concerns with leadership, supplies and equipment in certain arenas, and concern regarding patient safety issues brought forth through the nursing department.

Minutes of 8/17/12 address complaints that had been received in reference to physicians and that help was requested in dealing with the issue.

The issues that had been brought to the MEC go back to 2011. They have existed for some time and continue to exist. The issues have not been successfully resolved as the concerns in many areas still exist.

Interviews throughout the survey confirmed that issues do still exist in some areas, many of the issues stay only within the MEC, are not all brought out into the open to be discussed and are not always shared with the Governing Body.
Please refer to A0388

Based upon document reviews and interviews, the hospital failed to ensure that all contracted services were evaluated for quality and safe provision of care through the hospital wide Quality Assessment and Performance Improvement Program (QAPI).

A list of contracted services were requested and received for review. During an interview with hospital leadership staff BB on 9/26/12 at 9:30 AM, it was revealed that these contracts were not integrated through the hospital Quality Assessment and Performance Improvement Program.

Although the contracts are reviewed for renewal, they are not evaluated in accordance the requirements found at 42 CFR 482. 21. During a subsequent hospital interview on 9/28/12 at 12:30 PM with hospital staff person CC, it was again confirmed the contracts are not reviewed through QAPI.

Based upon observations, medical record and document reviews and interviews, the hospital failed to ensure that the rights of patients were promoted and that their environment was safe. Evidence includes the following.

1. The hospital failed to ensure that written notices were provided to patients regarding their grievances when applicable. Please refer to A0123.

2. The hospital failed to ensure that patients rights to formulate an advance directive were explained and clearly noted in the medical record. Please refer to A0132.

3. The hospital failed to ensure that the environment was free from the risk of infection and the spread of disease by practicing safe infection control practices. Please refer to A0144.

4. The hospital failed to assess patients relative to the use of physical and chemical restraints. Please refer to A0154.

Based upon interview and document review, the hospital failed to ensure that patients received a written notice pertaining to their grievances filed in accordance with policy for four (4) patients. HC #1; HC #2; HC #3 and HC #4. Evidence includes the following.

The Patient Advocacy Monthly Activity Log was reviewed on 9/27/12. In an interview at 10:30 AM, with hospital staff person DD, it was confirmed that patients had not received a written notice of the decision or actions taken in the resolution of their grievances.

HC #1

A grievance was received on 9/18 with concerns about the care that was received from a laboratory technician. The Director of the Laboratory was informed and stated that the complaint will be addressed and the patient was informed that the complaint would be addressed. During the interview with the Patient Advocate, it was confirmed that the patient would not get a written notice in their hospital process of addressing grievances.

HC #2

On 8/17/12, a patient indicated to the Patient Advocate, that in preparing for a surgical procedure, personal items were removed and given to hospital staff. Hospital staff were unable to locate the personal items. An incident report was filed and Risk Management was notified but no written notice was sent to the patient. The activity log of complaints/grievance indicated the status remains "pending" from 8/17/12.

HC #3

On 8/30/12, an issue was filed with the Patient Advocate about the long wait in the Emergency Room when the patient was experiencing pain. The patient indicated the hospital staff stated " if you don't want to wait you should have gone private". There was no evidence that the complaint had been acted upon or that the patient had received any written notice about the status of the complaint.

HC #4

On 9/11/12, a patient filed their concern relative to their perception of care received in the emergency room. The log entered the complaint, indicated the status was pending, follow up was pending and no evidence of any written notice was provided.

Interview on 9/27/12 at 1:30 PM with Staff Person DD confirmed that the hospital had not sent written notices in accordance with the requirements.

Based on clinical record review and interview with staff, it was determined that staff failed to inform the patient of his rights to formulate an advance directive (AD).

Medical Record #13

During record review with the unit manager on 9/25/12 at 1:00 PM, the patient's Care Activity - Assessment form was reviewed. This form is an automated form and completed by the admitting nurse when the patient reaches the unit. The form include questions that when completed as per the hospital's policy, gives the nurse the opportunity to educate and inform the patient of his rights to formulate an AD, and to make an informed decision regarding resuscitation decision.

During review of this form with the unit manager it was noted that all of the questions relating to informed decisions about ADs were marked "NO" by the nurse such as: 1) Advance Directive-NO, 2) Advance Directive Information Received-NO, 3) Resuscitation-Full Code. The automated form included no explanation and there was no evidence any where in the clinical record indicating that the nurse had either informed, educated or provided the patient with any information. There was no signature from the patient or patient's family acknowledging that information/education had been received.

The unit manager acknowledged that the nurse had failed to completely fill out the form, and had failed to document as per the facility's policy regarding AD.

During interviews with several physicians throughout the survey, physicians complained about the number of codes that are called for patients who would not ordinarily be considered full code such as the very elderly, and terminally ill, had staff consistently implemented the hospital's AD policies and procedures regarding education and informed consent.

Review of minutes from the Mortality & Morbidity meeting of 12/11/11, recorded a recommendation for performance improvement that had been made. It stated..."recommend maintaining interdisciplinary communication in the care of patients...and the recommendation for early discussion and documentation of patient's desires with that patient and family members if available, to know well in advance the patient's desire for the level of treatment to be implemented if further clinical compromise/sepsis occurs, with the patient no longer able to make appropriate decisions and informed consent, if procedures are being considered."

The hospital knew at least since 2011, the process of advanced directives needed to be reviewed/updated and or addressed.

20665


Based on observation, review of hospital documents, hospital policy and procedure, and interview, the hospital staff failed to ensure that all patients received care and services in a setting that was safe, reduced their risk for infection, and the spread of disease to themselves and others.

This was observed in the Emergency Department during intravenous fluid administration (IV) to Patient #13, during wound care treatment to Patient # 1, and during isolation precautions for Patient #15.


Patient #13


On 9/25/12 at 10 AM during a tour of the Emergency Department (ED), Patient # 13 was observed lying supine on a gurney with his IV pump beeping. The nurse was summoned to the room by the hospital staff member that was accompanying the surveyor on tour. When the nurse arrived, she examined the patient ' s IV site and determined that the IV tubing had become dislodged from the patient. The tubing was hanging on or very close to the floor for an undetermined amount of time. According to the nurse she had made rounds in the patient ' s room at 9:00 AM.

After determining that the IV required restarting, the ED nurse gathered supplies needed to restart the resident's IV. Supplies included but were not limited to antiseptic wipes, gauze, tourniquet, needle and syringe. The supplies were brought to the patient ' s gurney gathered in the nurse's hands. The nurse placed the supplies directly on top of the gurney's bedding and without washing her hands, donned a pair of gloves and proceeded to prep the IV site, located a suitable vein and restarted the IV. The same tubing that had been hanging on or very close to the floor for an undetermined amount of time was reconnected to the new IV site.

Upon completion of the procedure, the nurse transported the used supplies, including the catheter, needle, and syringe, holding them up in the air as she maneuvered past two other persons who had entered the room during the procedure. The nurse walked to the opposite end of the room and disposed of the used items in the sharps container that was mounted on the wall. She removed her gloves, was not observed to wash her hands, and proceeded to the nurses ' station.


Patient #1


During wound care treatment observations with Patient #1 on 9/25/12 at 10:45 AM, the wound care nurse was observed setting up supplies to provide wound care treatment for the patient. The nurse set up her supplies to be used for the treatment on the patient's over bed tray next to an open container of orange juice and peaches that were left over from the patient ' s breakfast. The surface of the tray table was not cleaned or sanitized prior to use.

Without washing or sanitizing her hands, the nurse donned a pair of gloves and began to spray the old dressings on the resident ' s leg with normal sterile saline from a spray bottle. When the nurse attempted to peel off the old dressing that had adhered to the patient ' s wounds, he moaned out in pain. The nurse continued to spray and peel off the dressing and the patient continued to moan in pain.

The nurse did not attempt to do a pain assessment although the patient stated that he was in pain. The nurse was asked by the surveyor when the resident was last medicated for pain. She responded by saying she did not know. The nurse was asked to discontinue the treatment until the patient was assessed and medicated for pain.

After the patient was effectively medicated for pain, the nurse resumed the wound care treatment. Again, without washing or sanitizing her hands, the nurse donned a pair of gloves, sprayed the old adhered dressing that contained old dried blood and exudates, and fresh red blood. The patient tolerated the procedure without an expression of pain.

Once the old dressing was removed and discarded, the nurse removed her gloves and without sanitizing or washing her hands, donned another pair of gloves, cleaned the wound as per physician ' s order, and applied the new dressing wearing the same gloves. Still wearing the same gloves, the nurse repositioned the bed, removed the supplies, placed them on the night stand, and opened the privacy curtains.

Upon completion, the nurse removed her gloves and was observed to wash her hands for less than 15 seconds.

The facility's Hand Hygiene Policy states that personnel must perform hand hygiene before putting on gloves and after removing them, and that hand washing should occur for a minimum of 15 seconds.

Patient #15

Patient # 15 was admitted to the medical unit for sputum culture and Pulmonary Tuberculosis (TB) treatment with positive AFB sputum cultures. He was admitted into room 3119, a negative pressure room because of his active TB status.

Review of the Negative Pressure Room Log for that room indicated that on 8/9/12 the patient was admitted to that room. The negative pressure differential was recorded on the log for that day. The next negative pressure differential recorded on the log was on 8/13/12, 4 days later. After the 8/13/12 differential reading, the next recorded reading documented on the log was 9/10/12, several weeks later. The readings were documented consistently on the daily log from 9/10/12 through 9/14/12. The log contained no recorded readings on Saturday 9/15/12, and Sunday 9/16/12. Negative differential readings were recorded daily from 9/17/12 through 9/20/12. There were no readings recorded on Saturday 9/22/12 and Sunday, 9/23/12.

According to the hospital ' s Infection Control policy dated July 2011, and presented as the current policy and procedure, the air pressure reading in the negative pressure room must be monitored and documented daily when a patient is on airborne isolation. The policy stated that the Infection Control Department shall be responsible for monitoring the rooms except for weekends, holidays and administrative leave days. This was confirmed during interview with the Infection Control coordinator on 9/25/12 at 1:30 PM.

Review of the Infection Control - Standard Precautions/Isolation Check list that was developed to be used by staff to monitor compliance, revealed a discrepancy in the hospital ' s policy, and the check list as to who would be responsible for monitoring and recording the readings on weekends and holidays specifically. According to the check list the negative pressure differentials should be checked daily (Monday through Friday) by the infection control coordinator and on weekends by the Clinical Care Coordinator on duty.

The Negative Pressure Room Log did not include acceptable parameters that would alert staff if differential readings did not meet the ideal negative pressure differential readings of > -2.5 Pa as per the policy.
Please refer to A0748.

Based upon observations, interviews and medical record review, in the presence of hospital leadership, it was verified that the hospital failed to ensure that 2 of 2 patients were free from unnecessary restraints. Please refer to Medical Record #6 and Medical Record #7.

In addition, the facility failed to monitor a resident who had received a chemical restraint according to the frequency established by the hospital's policy and procedure governing this type of restraint. Please refer to Medical Record #15.

Medical Record #6

Review of the medical record for Patient #6, noted a physicians order for bilateral soft wrist restraints that was written on 9/15/12 and 9/16/12. The physician checked all of the following as clinical justifications for the use of the restraint. "...attempting to remove IV (intravenous) or arterial lines; attempting to remove NG (naso-gastric) or feeding tubes; attempting to remove Foley; attempting to remove dressings or appliances; attempting to remove respiratory device and interfering with medical devices and equipment".

Nursing staff was interviewed on 9/23/12 at 12:10 PM and unable to provide evidence of the patient demonstrating any of the behaviors that justified the use of wrist restraints. The patient behavior was only noted as "anxious" or "restless". Nursing staff was unable to explain why the physician indicated wrist restraints could be used for attempting to remove NG or feeding tube and respiratory devices when the patient did not manifest any of the behaviors.

Medical Record #7

Review of the restraint log noted that bilateral soft wrist restraints were used daily for this patient. Physician orders indicated various clinical justifications for the use of the restraints. On 9/22/12, the justification was attempting to remove IV or arterial lines, on 9/21 it was for attempting to remove NG/feeding tubes which the patient did not have.

On 9/19/12, the indicators were IV or arterial ine removal or Foley catheter removal. On 9/8/12, the indicators were attempting to remove IV or arterial lines, attempting to remove Foley catheter, attempting to removal dressings or appliances and interfering with medical devices and treatment.

During an observation on 9/23/12 at 12:35 PM, the patient was noted to be in bed, no evidence of any behaviors that warranted the use of bilateral wrist restraints.

Nursing staff was interviewed on 9/23/12 at 12:35 PM and unable to provide supporting evidence that the patient had attempted to remove any of the devices as noted in the physicians order.

Nursing staff leadership AA confirmed that there was no evidence to support the use of the physical restraints.

Medical Record # 15

Review of this medical record for Patient #15 revealed a Physician Restraint Order dated 9/16/12. The order sheet indicated bilateral soft wrist restraints to be used. Clinical justification for the restraint was non specific for the patient. The physician checked all of the reasons listed on the form such as: 1) attempting to remove IV or arterial line, which the resident did not have, 2) attempting to remove NG or feeding tube, the patient had none, 3)attempting to remove Foley catheter, the patient did not have one, 4) attempting to remove dressings or appliances, there were none.

Interview with the charge nurse on the unit, and review of the clinical record indicated that the patient was uncooperative, argumentative and combative toward staff, insistent about leaving his room where he was being isolated for medical reasons, and insistent on going home in spite of his positive sputum cultures and risk of exposure to others.

The patient's behavior persisted and escalated to the point where he became destructive, and a chemical restraint was ordered and administered.

According to the facility's Restraint and Seclusion policy, and as acknowledged by the charge nurse on the unit during interview, staff were to provide ongoing assessment and monitoring of the patient after he received the chemical restraint.

Monitoring should have occurred every 15 minutes. There was no documentation in the medical record to indicate that any monitoring had occurred. The charge nurse on the unit acknowledged that the clinical record contained no documentation to demonstrate that staff had monitored the patient after he was medicated with a sedating psychotropic medication.

Based upon interviews and hospital document review, the hospital failed to implement and maintain a hospital wide, ongoing and effective Quality Assessment and Performance Improvement Program. Evidence includes the following.

1. The hospital failed to set priorities and identify areas of improvement in high risk areas. Please refer to A0283.

2. The hospital failed to analyze, measure and trend adverse events. Please refer to A0286.

3. The Governing Body of the hospital failed to demonstrate its responsibility and accountability for the Quality Assessment and Performance Improvement Program. Please refer to A0309.

4. The Governing Body of the hospital failed to ensure that resources were adequate to improve care and services. Please refer to A0315.

Based upon interview and document review, the hospital failed to set priorities for performance improvement in the surgical arena when a known adverse event had occurred. Evidence includes the following.

During a review of adverse surgical events, it was revealed that on 3/22/12, an Infusaport placement/Infusaport removal was a procedure that had been scheduled.

During the procedure, the Infusaport in the upper left chest wall was removed but was not intact; only a portion of the catheter was removed.

An x-ray was taken which displayed the remainder of the device was left in the chest of the patient. A stat call was placed for a surgeon to come to the surgical arena and to remove the remainder of the device.

Interview with hospital leadership staff person BB on 9/24/12 at 1:30 PM revealed this event was never brought through to the Quality Assessment Improvement Program for any action(s) to be taken for analysis of this event, tracking of additional events or interventions related to any events or occurrences using devices in the surgical area.

During an interview with Physician #2 on 9/22/12 at 11:00 AM, it was revealed that when surgical staff had been approached relative to establishing surgical measures in the department , the suggestion for the department to do so were "refused" when suggested.


Interview with Physician #5 on 9/22/12 at 1:00 PM acknowledged problems within the Medical Staff, that there is a reluctance of engagement and committee attendance is often poor at meetings.

When copies of minutes of surgical committee meetings from January to present were requested, only minutes from January and April were presented. Hospital staff stated that the committee is expected to meet monthly, but does not meet at times due to lack of quorum.

Based upon review of hospital documents and interviews, the hospital failed to show measurable improvement indicators by analyzing trending and tracking adverse events. Evidence includes the following.
Adverse Event- ventilator failure

Review of an incident report noted on 4/12/12 at 3:00 AM in the intensive care unit, a Puritan Bennett 7200 #6 ventilator failed to operate appropriately. The alarm on the system went off, flashing with sounds heard. Hospital staff removed the patient from the ventilator and began to "ambu-bag" the patient to maintain respiratory function.

The ventilator was placed in an extended system test but failed. Hospital staff had to bring in another ventilator. The second ventilator was then set to the previously required ventilator settings.

Interview with hospital leadership staff BB on 9/24/12 at 1:30 PM confirmed this serious event was not followed through in the safety committee and no root cause analysis was ever done and it was never brought forth to the Quality Assessment Performance Improvement Program.

Sharps Safety

Based upon review of Infection Control Policy- titled Sharps Safety and interview with hospital staff, the hospital failed to implement their policies and provide the necessary safety devices to ensure the risk for blood borne pathogens was mitigated. Evidence includes the following.

During an interview on 9/22/12 at 1:00 PM with Physician #3, concerns relative to needlestick safety was discussed. It was stated that the hospital does not always have safety syringes/equipment available which increases the risk to patient and staff safety.

On 9/22/12, the list of needlestick injuries reported to the hospital was requested. Once received, it revealed that several staff members had experienced needlestick's from dirty syringes. Staff had reported these injuries to hospital staff. including the fact that the syringes did not have a safety feature.

Review of the policy on Sharps Safety, effective August 2011, indicated " GJLH will consider and select safe needle devices during the annual review of the exposure control plan. It further states that the Infection Control staff will work closely with Material Management staff to secure medical devices (i.e. needles; scalpels; lancets' ect that have sharp safe mechanisms. Employee Health Services will help identify medical devices that do not have safety devices. Materials Management staff will collaborate....to select and purchase sharp safe devices. Through the Product and Evaluation Standardization Committee...new sharp safety products will be introduced, evaluated and accepted."

Interview with hospital leadership staff BB on 9/24/12 stated that the Product and Evaluation Standardization Committee has never met and therefore the sharps safety practices has not been implemented thus exposing patients and staff to needlestick injuries.


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Based upon document review and interviews, the Governing Body of the hospital failed to carry out their responsibilities and ensure the effectiveness of the Quality Assessment and Performance Improvement (QAPI) program and that the hospital was in compliance with the requirements. Evidence includes the following.


Interviews with hospital leadership confirmed that the Quality Assessment and Performance Improvement Program is not integrated throughout the hospital and that the services are all not assessed to identify any quality performance problems and to take corrective actions. Please refer to A0537.

It was also further confirmed by interview that all contracted services are not integrated into the hospital wide QAPI program. Please refer to A0084.

The hospital also failed ensure resources were allocated to in order to prevent adverse events and to provide patient safety. Please refer to A0315.

Based upon observations and interviews, the hospital's Governing Body failed to allocate sufficient information systems and resources to the Quality Assessment and Performance Improvement program to improve hospital quality and reduce risks to patients. Evidence includes the following.

During a walk-though on the Medical and Surgical units of 9/22/12 and 9/23/12 in the presence of staff, the following was observed.

At 10:00 AM, Patient #21 was observed in bed without the benefit of heel protectors on. Heels were directly resting on the mattress. Also noted was a dressing on the right foot that did not have the time or date that the dressing was last done. Please refer to A0395.

Patient # 22 is at significant risk for compromised skin integrity in addition to the potential risk of infection due to his diagnoses. The patient was observed lying in bed with a wound device on the right foot and several pillows on the bed. The left foot was directly on the mattress without the benefit of pressure relief. Hospital staff stated that they do not always have heel protectors to use. The observations were confirmed by hospital leadership staff AA and CC.


During a walk- through in the surgical/anesthesia supply area, on 9/27/12 at 11:30 AM, several boxes of endo tracheal tubes were noted on the shelf. Size 5.0 endo tracheal tubes were noted and size 7.5 endo tracheal tubes were noted. Interview with hospital staff during the observation noted there were no size 6 or 6.5 endo tracheal tubes available. The size 6.0 ran out 9/26/12.

During the observation, it was also noted and reported that the hospital had only one fiberoptic bronchoscope that was broken and had been for some time. This is a surgical device that may be needed in the event of a difficult intubation.

Based upon review of committee minutes and interview, the Governing Body and hospital leadership failed to provide adequate resources for the timely replacement of ventilators that were known to be a problem. Specifically, a ventilator failure of April 12, 2012. Evidence includes the following.

Environment of Care minutes of 6/18/12 noted an item on the agenda about "urgent need to replace ventilators". The action was to "provide updates on the purchase agreement with a target date on 6/30/12

Review of the Patient Safety Committee Minutes of June 29, 2012 ( 3 months after the ventilator failure) noted the existing ventilators were in need of replacement as they had no battery back up in case of failure.

The minutes of the Patient Safety Committee of July 20, 2012 acknowledged the ventilator failure that occurred on April 12, 2012. At the time of the July 20 meeting, the incident report for the April ventilator failure was "not available" and the the minutes recorded the "issue remains". Again, the event occurred in April.

The minutes of the safety committee also noted that ..."availability of risk free ventilators support in the hospital continues to be a major issue. It was promised that ventilators would be a priority and addressed by leadership...ventilators continue to fail and are of great concern ...that any failure poses a great risk and potential of harm to our patients, they have no battery back up capability, they have to be reset manually after any power loss. Concerns of ventilator issues have been strongly communicated to hospital Administration for immediate action."

CMS had ongoing communication regarding the delays of the delivery of the ventilators during the August 22 conference call and were told the ventilators should arrive by the end of August. Delivery was just received prior to the survey in September.

Based upon review of Infection Control Policy- Sharps Safety an interview, the hospital failed to implement their policies and provide the necessary safety devices to ensure the risk of blood borne pathogens was mitigated. Evidence includes the following.

During an interview on 9/22/12 at 1:00 AM with Physician #3, concerns relative to needlestick safety was discussed. It was stated that the hospital does not always have safety syringes/equipment available which increases the risk to patient and staff safety.

The needlestick log was reviewed and noted several needlestick injuries with dirty syringes had occurred and these syringes did not have a safety feature.

Review of the policy on Sharps Safety, indicates that hospital staff would select safe needle devices during the annual review of the exposure control program and Product and Evaluation Standardization Committee would introduce, evaluate and select sharp safety products.

Interview with hospital leadership staff BB verified that the Product Evaluation Committee had never met and no safety sharp devices had been reviewed. Please refer to A0286

Interview on 9/27/12 at 10:45 AM with Physician #1 referenced that there are only a few "new" mattresses in the Emergency Department. If any patient is on "hold" status (waiting for an inpatient bed), they may need to remain on the older thinner mattresses that are not adequate for pressure reduction. Hospital leadership was aware of this concern as verified by an e-mail last April which addressed concerns of the frail elderly who due to staff shortages are on stretchers for "extended periods of time".

Based upon observations, medical record reviews, document reviews and interviews, it was determined that the Medical Staff of the hospital failed to be responsible for the quality of medical care. Evidence includes but is not limited to:

The hospital administration and leadership staff had been made aware over a period of time regarding serious concerns about the quality and standards of medical care to patients. These issues were brought to the attention of key leaders of the hospital by professional staff members both verbally and in writing over an extended period of time. Information was brought to the attention of leadership as far back as January, 2012.

In addition to specific patient index cases that were brought to the attention of leadership, other concerns such as the availability of physicians when on call, lack of effective and professional communication, the timeliness of physician responses to patient concerns, delays in the provision of care, the professional actions/reactions and interactions were also reported to hospital leadership.

The Medical Executive Committee (MEC) had been aware of communication issues, patient care concerns and interpersonal issues back in 3/11 and had not made any effective resolution as the issues and similar concerns continue through 9/12.

Interview with Physician #8 on 9/25/12 at 8:30 AM, provided background on the Mortality and Morbidity (M&M) case reviews including the fact that there is a large back log of cases to be reviewed. It was revealed that there is a problem capturing morbidity and that chiefs of the departments would be asked to capture their own morbidity cases.

This know problem of capturing morbidity was noted in the M&M minutes back in 12/21/11. There it stated that Morbidity data is not being appropriately captured and that there is a need for each department to capture their own morbidity data using specific criteria. Each department should discuss and provide a list of triggers to be reviewed by the M&M Committee as well as a way to capture each departments morbidity.

Interview with Physician # 1 on 9/27/12 at 8:05 AM noted this subject was again brought up about 1 month ago and to date only 1 department had forwarded any triggers. This lack of response demonstrates the continued communication issues and the lack of engagement by some members of the medical staff as previously noted.


Minutes of the Medical Executive Committee of 8/17/12 indicated all departments must review their M&M cases and those cases that fall outside would then go to the M&M Committee. Any cases needed further review would go to back to the Medical Staff Quality Committee (MSQC )and if needed, to the MEC.

Interview with Physician #5 stated the MEC has the final determination of what needs outside review and the results of an outside review go back to the MEC.

The MEC minutes of 8/17/12 also noted that committees need to meet and submit reports to the MEC, that the MEC is not getting reports from some committees and the committees need to be motivated and have a plan for each committee. This known lack of engagement by physicians had been known and documented since 2/15/12.


Upon review of the Mortality and Morbidity Committee (M&M) of 2/15/12, the minutes indicated their committee is scheduled to meet six (6) times per year and as soon as cases are received, they are to be given to the Chief of Services to be reviewed with recommendations made by the Chief of Service. It was noted that the cases that had been submitted to Physician #6 had still not been returned to the Performance Improvement Committee.

Physician #8 wrote a letter dated 2/20/12 to the MSQC and MEC requesting further review of Medical Record # 10. The notes of the review indicated concerns with the lack of follow through in the immediate acute pre-operative management, significant incomplete medical record documentation and delay in treatment. The patient expired within 24 hours of surgery. The case was forwarded to the Medical Staff Quality Committee (MSQC and Medical Executive Committee (MEC).

On 3/6/12, this same medical record was delivered to Physician #7 along with the records of several other patients needing review/oversight. There was no evidence of a review or comments.

On 4/18/12, the M&M Committee requested a response from the MSQC and MEC to acknowledge cases submitted for their review and discussion.

On 8/9/12, a written detailed summary was provided to the MEC, Medical Director and CEO by a member of the medical staff regarding numerous patient care concerns including the case above for which there had been no shared response to the concerns addressed. This patient expired in 12/3/11.

Not until 9/14/12, in Executive Session, did any of the concerns receive attention and responses. Three (3) of nine (9) index cases that had been repeatedly brought to the attention of hospital leadership were to be reviewed by the Chief Medical Officer and sent to the MEC for further review. There was no mention of the other 6 cases.

Interview on 9/22/12 at 1:00 P.M. with Physician # 5 acknowledged problems within the institution including reluctance of physician engagement and information is not readily shared and used for improvement opportunities.


During an interview with Physician #8 on 9/25/12 at 8:30 AM, it was confirmed that for Medical Record #10, the results were still not known, 9 months after the patient expired and the physician would immediately seek out a response.


Medical Record for Patient #24, revealed the patient was admitted to the facility on 6/28/12 with diagnosis that included intra abdominal sepsis. The record was reviewed on 9/26/12. Interview with Physician #2 on 9/26/12 at 9:15 AM indicated concerns with standards of care, specifically delay in treatment, that it was felt that the medical record should be reviewed.

The patient expired 7/4/12 and as of 9/28/12, the case had not been reviewed- again knowing that standards of care had been a reported concern.

Based upon interview and document reviews, the Medical Staff failed to adopt bylaws laws that included transfer agreements to meet Emergency Medical Treatment and Labor Act (EMTALA )obligations. Evidence includes the following.

The hospital leadership was asked to provide copies of the agreements that Governor Juan Luis Hospital has with receiving hospitals pertaining to EMTALA. Several documents were provided but none were signed transferred agreements.

On 9/27/12 during an interview with Physician #2 and Physician #3, it was stated that emergent cases may sometimes be transferred to Roy Schneider Hospital in St Thomas for which there was a signed transfer agreement dated 6/24/11.

The interviews continued where it was also stated that patients have also been transferred sometimes to Centro Medico or HemaHealth, a hospital in Florida or to a hospital in Puerto Rico. The physicians indicated at times there were delays with the receiving hospitals accepting the patients that had been transferred. Transfers were done on a "gentlemen's" agreement and at times the appropriate receiving hospital staff were not aware of the transfer. Interview with CC at approximately 9:30 AM on 9/27/12 confirmed they had no other signed agreements other than the Roy Schneider Hospital transfer agreement.

Based upon interviews and review of the Medical Staff Bylaws revised 10/11 and approved 11/11, the hospital failed to carry out its' responsibilities. Evidence incudes the following.

Section 1. purpose of the medical staff is to "provide oversight of care, treatment and services provided by practioners...medical staff work together as an organized body to promote a unform standard if quality patient care, treatment and services, to offer recommendations and input to the Chief Executive Office and the Board."

On page 14, Evaluation, it indicates that the Medical Staff has the "responsibility of evaluation and improvements of the quality of care rendered in the hospital."

On page 15- triggers are an assessment tool to measure adverse events. A Focused Professional Practice Evaluation (FPPE) may be triggered through data collection that may include but is not limited to:
information obtained from peer review activities other evidenced base suggesting a practioner's performance may not fall within accepted practice guideline of care
specifics or single incidents
other circumstances including those in which patient safety may be compromised

Section 2 of Article V speaks to the Medical Executive Committee who are to "account to the Board and to the Medical Staff for the overall quality and efficiency od professional patient care services...and coordinate the participation of the Medical Staff in organizational performance improvement activities...take reasonable steps...competent clinical performance...including....investigations when warranted.

Hospital Medical Staff had been provided information pertaining to quality services that were in question for some time. Care practice guidelines were questioned, requests for further reviews were requested and the Medical Staff failed to abide by the Bylaws to exercise and discharge their responsibilities timely to improve care and protect patients.







20665

Based upon observations, medical record reviews, document reviews and interviews, it was determined that the hospital failed to meet the Nursing Condition of Participation as evidenced by:

1. The hospital failed to have a well organized nursing service including numbers of staff necessary to provide nursing care. Please refer to A0386.

2. Nursing service failed to demonstrate adequate numbers of nurses and other personnel to meet patient needs. Please refer to A0392.

3. Nurses failed to implement physician orders. Please refer to A0395.

4. Nursing staff failed to follow standards of care and follow their own policy for intravenous therapy. Please refer to A0395.

5. Nursing staff failed to follow their own policy related to pressure ulcers and wound care standards. Please refer to A0395.

6. Nursing staff failed to keep current patient care plans. Please refer to A0396.

Based upon observation, interviews and medical record review, the hospital failed to have a well- organized nursing service department with clear delineation of patient care responsibilities and sufficient numbers of staff to meet patient care needs. Evidence includes the following.

Upon entrance into the hospital on 9/22/12 at 8:00 AM, the receptionist was asked to call the individual in charge of the facility so that the survey could be officially announced. The receptionist then used the overhead page to call for the patient care coordinator to come to the front desk.

With no response from the page, the receptionist then began to call the inpatient units to see if she could locate staff that would be able to come to the lobby as "CMS" was here.

According to the receptionist, no staff could be found to come to the lobby. The response from one nursing unit, according to the receptionist, was they could not come to the lobby, as there was not "sufficient staff" for them to leave the unit. Please refer to A0392.

During an interview with Physician #2 on 9/22/12 at 11:00 AM, it was stated that Emergency Room back up can be severe at times. It was further stated that there are not enough nurses on the units to facilitate the patient discharges timely so patients from the emergency room can be admitted.

Based upon the daily census rosters, the following patients were identified as being on "hold" in the emergency room. On "hold" indicates the patient has been admitted but at the time, there are no beds that are staffed to place the emergency room patients in at the time.

Data from the daily printed hospital roster census revealed:
On 9/21/12, 1 patient was on hold since 9/20/12.
On 9/22/12 , 7 patients were on hold since 9/21 and 1 patient since 9/20/12.
On 9/23/12, 1 patient was on hold since 9/22 and 1 since 9/21/12.
On 9/24/12, 3 patients were on hold since 9/23, 1 patient since 9/22/12 and 1 since 9/21/12.
On 9/25/12, 7 patient were on hold since 9/24/12, 2 patients since 9/23/12 and 1 patient since 9/22/12.
On 9/26/12, 4 patients were on hold since 9/25/12, 4 patients since 9/24/12, 2 patients since 9/23/12 and 1 patient since 9/22/12.

Interviews through out the survey and with nursing administration staff SS and FF, indicated the nursing units are staffed with a 5 to 1 ratio- following a California model and that presently, due to staffing all beds were not in use.

On 9/28/12 at 8:30 AM, interview with staff nurse RR indicated the concern for patient safety in the emergency room when the bed capacity has been exceeded. It was further stated that the previous night, all 16 beds were full, the bed used for OB/GYN patients and 1 bed in the hallway were all in use as well, placing the emergency department over capacity. While the unit was full, an emergent gun shot victim also presented.

It was revealed the patients leave the emergency room without being seen due to the back log and long wait. It was stated that it is difficult to meet patient needs due to the criticality of some while others are in a hold status waiting for the availability of a bed and nursing follow through of discharges.

Nursing services failed to ensure that staffing adequately supports the admission and discharge process.


While conducting a walk through on the Medical Unit on the morning of 9/22/12, Patient #6 was observed lying in bed with head of bed elevated in need of personal hygiene. Noted was a growth of facial hair.

This same patient was observed on 9/23/12, again unshaven with the growth of facial hair still evident. Interview with nursing staff indicated when (they) pulled to do other things, something's just don't get done. Please refer to A0392.

Patient #16 was observed in distress, crying due to failure of staff to respond to the call light requesting help. Nursing staff only responded to the call light after direct intervention by the surveyor. Please refer to A0392.

Patient #6 on 9/27/12 had dressings on the lower extremities with a date of 9/12/12. When staff was interviewed, it was stated that the 9/12/12 date was the last time the treatment had been done and that the staff person was not on duty to do the treatment. Please refer to A0392.

Nursing services failed to ensure that nursing staff was adequate in numbers to meet patient needs. In addition, nursing services failed to provide adequate coverage of staff when other staff were scheduled off to ensure that treatments and intervention were not disrupted.

Based upon observation, interview and medical record review, the hospital failed to ensure that sufficient staff were available to meet and assess patient needs for four (4) patients. Medical Record #1, #6, #11 and #16. Evidence includes the following.

Medical Record #1

During wound care treatment observations with Patient #1 on 9/25/12 at 10:45 AM, the wound care nurse was observed setting up supplies to provide wound care treatment for the patient. As the nurse attempted to peel off the old dressing that had adhered to the patient ' s wounds, the patient was moaning in obvious pain. The nurse continued to spray and peel off the dressing and the patient continued to moan in pain. The nurse did not attempt to do a pain assessment although the patient stated that he was in pain. The nurse was asked by the surveyor when the resident was last medicated for pain. She responded by saying she did not know. The nurse was asked to discontinue the treatment until the patient was assessed and medicated for pain.

Medical Record #6

Medical Record #6 was reviewed on 9/22/12 after observing the patient lying in bed in a semi fowlers position. Patient noted to have an old soiled Band-Aid on right antecubital space which appeared as old blood, a towel folded under the chin of the patient, an intravenous therapy infusion system and a several day growth of facial hair.

Noted on the bedside table at the foot of the bed was a unopened can of Glucerna ( nutritional supplement for those with Diabetes) and a tray with another can on Glucerna unopened. When asked about the unopened can on the bedside table, staff person AB was not sure why it was there. When asked if the patient had been offered the Glucerna s/he indicated she did not know. When asked if during hand off, any information about the patients nutritional status had been discussed, s/he just shrugged. As far as the breakfast can of Glucerna staff person AB stated the patient had not been given any because of his refusal in the past. When asked if this information had been shared with the physician, the response was to shrug the shoulders.

On 9/23/12, Patient #6 was observed lying in bed still unshaven and poorly positioned. Nursing Staff AB was interviewed at 11:45 AM on 9/23/12 and asked about personal hygiene for Patient #6. It was stated that the assignment s/he had was five (5) patients. "Personal hygiene was done by the night staff; s/he would do it only if they had time". It was further stated that s/he "gets pulled to help others, that s/he can not do everything, if I don't have time I don't do it."

Results of the above interview were shared with hospital leadership staff AA and FF at 12:10 PM on 9/23/12.

Observation of 9/26/12 noted Patient #6 with significant bilateral edema both lower extremities at 12:45 PM. While accompanied by hospital staff, it was noted than neither leg was elevated, heels were not off loaded per physician order and that the dressings on both legs were deeply indented into the patients skin due to the edema. Noted on the dressing was the date 9/12/12.


On 9/27/12 at 10:00 AM, staff person GG stated that s/he was sorry but s/he had not done with dressings for Patient #6 as she was not on duty. It was verified that the dressings dated 9/12 reflected the last time the actual dressing had been done.

Medical Record #11


Medical Record review for Patient #11 noted multiple areas of compromised skin integrity. Areas included a stage 3 on the sacrum, a stage 1 on both the left and right trochanter and deep tissue injury to both the left and right heels.

On 9/22/12, observations were made of Patient #11 in the presence of hospital staff of both heels lying directly on the mattress. Review of the physician orders dated 9/21/12 indicated for pressure reduction to keep "heels off loaded with pillows." Staff confirmed that the orders were not followed.


Medical Record #16

During the walk through, Patient #16 was noted lying in bed, in apparent distress. S/he stated s/he had used the call light but no staff responded. The surveyor explained that the surveyor would call the nurse to summon help for the patient. The surveyor was told by the patient "don't bother" they don't come, while sobbing.

The surveyor then used the nurse call light to summon help and stayed in the room waiting for staff to respond. After more than 5 minutes, hospital leadership staff LL who had been accompanying the surveyor, came into the room. The surveyor explained that the patient and I were waiting for the unit staff to answer the call light and asked that LL remain in the room to see how long it took before staff responded.

After more than 9 minutes, the surveyor stood outside the room to see if any of the staff, within view at the nurses station, would respond, which no one did. The surveyor then went to the nurses station to ask staff to note the visible call light and audible sounds of the patient in need of immediate attention.

Nursing Services failed to ensure that staff was sufficient to meet and address patient needs.

Based upon medical record review, observations and interviews, the hospital failed to supervise, assess and evaluate standards of nursing care for patients.

Nursing failed to supervise staff to ensure that physician orders were carried out for six (6) patients. Patient #6, Patient # 8, Patient #9, Patient #12, Patient #15 and Patient #19. Evidence includes the following.

Medical Record #6
During a walk through the morning of 9/23/12, Patient #6 was observed to be lying in bed with oxygen apparatus from the wall via a re-breather mask running at 15 liters. Accompanied by hospital leadership, the liters were confirmed to be set at 15. Review of the physician orders noted an order for oxygen, 3 liters by nasal canula. Hospital staff did not have a physician order for the use of the rebreather or gauge setting of 15 liters. On 9/23 12 at 1715, an order was written for a re-breather mask to be set at 10 liters.

Observation later on 9/24/12 at 10:05 AM, noted the patient to be lying in bed poorly positioned. Oxygen was noted running at 10 liters, and confirmed by hospital leadership AA with the mask inappropriately positioned on the patient.

Observation at 12:45 PM on 9/26/12 noted the patient to be lying in bed with oxygen running at 5 liters. Reconciliation with the physician orders noted on that on 9/24/12 the orders for oxygen was to run at 3 liters via nasal canula. Hospital leadership staff AA and FF confirmed that physician orders for the use of oxygen were not followed.



Medical Record #8

Review of the Medical Record #8 noted an admission date of 8/27/12, surgery on 8/31 for diagnoses that acute renal failure, abdominal sepsis and dehydration.

On 9/14/12, the physician wrote an order for wound care consult. Hospital staff was unable to provide the evidence that the wound consult was done during the interview on 9/26/12.

The physician wrote on 9/15/12 for strict intake and output and record the output in the electronic medical record and restrict fluid intake to 1500 milliliters (ml) per day.

Review of the intake and output documentation noted that the fluid intake for 9/21/12 was 1729 ml- beyond the fluid restrictions ordered by the physician and on 9/25/12 was documented as 1550 ml- also beyond the fluid restrictions. There was no evidence that the physician had been notified that the orders were not followed.

Nursing staff confirmed on 9/26/12 at 10:45 AM, that physician orders were not followed.

Medical Record # 9

Record review for Medical Record #9 noted the patient was admitted on 8/14/12 with diagnoses that included unexplained weight loss. A physicians order of 8/18/12 indicated daily weights were to be recorded. In the presence of hospital staff, there was no evidence that weights were recorded on 8/16; 8/17 and 8/18/12. On 8/25/12, the physician rewrote the order for daily weights which were not followed as ordered on 8/26; 8/27; 8/29; 8/30; 8/31; 9/1; 9/3; 9/4; 9/5; 9/8; 9/10; 9/12 through 9/15.

On 8/16/12, the physician ordered 1 can of Ensure to be provided per meal due to the significant weight loss prior to admission. Hospital staff was unable to provide evidence that the dietary supplement was consistently provided and documented as ordered.

On 8/25/12, the physician also wrote an order for intake and output to be recorded. Review of the medical record documentation found no evidence that the intake and output was recorded by nursing staff from 8/25 through 9/16/12.

The above findings were confirmed in the presence of hospital staff AA while conducting the reviews on 9/23/12 at approximately 2:00 PM.


Medical Record #12

Medical Record for Patient #12 noted a physicians order written on 9/7/12 for wet to dry dressings to left foot and bilateral heels and re-consult with wound care for follow up. The most recent wound consult noted in the record was 9/2/12 which was confirmed in the presence of hospital leadership staff AA, FF and GG on 9/23/12. No wound re-consult was found until staff person GG brought the issue to the attention of the physician and obtained an order on 9/23/12.


Medical Record #15

Review for Medical Record #15 on 9/26/12 revealed a physician's order dated 9/24/12 that read, AFBs, today and daily times 2 days. These sputum cultures were ordered to determine if the patient's sputum cultures remained positive for Tuberculosis.

In reviewing the medical record with the nurse manager it was determined, that the sputum cultures ordered for 9/24/12 and 9/25/12 had not been obtained. There was no documentation in the medical record indicating why the specimens had not been obtained and submitted to the lab for testing.

The nurse acknowledged the absence of documentation and stated during the interview that the specimens had not been obtained because the patient had been uncooperative.

The 9/26/12 sputum specimen was obtained and submitted to the lab on the day of this interview, 9/26/12. When asked if the physician had been notified that the patient had been uncooperative and that the two specimens had not been submitted to the lab for testing, the nurse replied no.

Medical Record #19

Review of medical record #19 noted this patient was admitted to the medical unit from the ED although her principle diagnosis was Acute Psychosis. The patient had a history of additional diagnoses that included Schizophrenia, End Stage Renal Disease, Hypertension, and Diabetes.

In reviewing the medical record it was determined that the patient had refused most of her medications on a daily basis for 9 consecutive days, 9/15/12 through 9/24/12, prior to her discharge from the hospital. On the days the patient refused to take her medications the nurse circled the times and wrote, "patient refused". There was no evidence by the nurse to indicate why the patient refused, and no evidence that the physician had been notified by the nurse of the patient's continual refusal to take her medications. In addition to the patient refused medication note, the nurse sometimes indicated that the patient was in dialysis. There was no documented evidence to indicate if the resident receive her medications while in dialysis.

The patient's daily medications that were refused are as follows: 9/15/12 - Cardizem 360 MG, Phoslo 1, and Seroquel 50 MG. 9/16/12 - Losartan 100 MG, Protonix 40 MG, Nephro Cap 1, Phoslo 1, Norvasc 10 MG, Aricept 10 MG, Seroquel 50 MG, and Zoloft 50 MG. 9/17/12 - Phoslo 1 and Seroquel 50 MG. 9/18/12 - Norvasc 10 MG, Seroquel 50 MG, Losartan 100 MG, Protonix 40 MG, Nephro Cap 1, and Phislo 1. 9/19/12 - All does of medications were circled with a note next to the circle noting "patient in dialysis". 9/20/12 - Cozaar 100 MG, Protonix 40 MG, Nephro Cap 1, Phoslo I, and Aricept 5 MG. (9/21/12 - Nephro 1 Cap, Phoslo 1, Zoloft 50 MG., and Seroquel 50 MG. 9/22/12 - Cozaar 100 MG, Protonix 40 MG, Nephro Cap 1, Phoslo 1, Norvasc 10 MG, Zoloft 50 MG, and Aricept 5 MG. 9/23/12 - Lamictal 25 MG, Seroquel 50 MG, Protonix 40 MG, Phoslo 1, Cozaar 100 MG, Neuro Cap 1, Norvasc 100 MG and Zoloft 50 MG.

During an interview with the patient's primary physician in the conference room on 9/28/12, the physician stated that he was unaware at the time he made the decision to discharge the patient, that the patient had been refusing to take her medications for as many days indicated in the patient's medical record. He stated that the nurses had told him about one day of refusal, and stated that he had not been made aware of the multiple days.


Medical Record #12

Nursing supervision failed to ensure that professional standards of practice were followed for Patient #12, Evidence includes the following:

Hospital staff leadership was asked to provide evidence of the wound dressings being done that described the wound in order to assess and determine how effective the wound treatment was working. Notes provided revealed the only the following limited information to describe the wounds.
9/8... (physician) ordered wet to dry dressing- no new skin break
seen
9/9...wet to dry dressing on both heels are being dressed by ...primary care nurse daily
9/22...heels are on wet to dry dressing done by the PCN
(primary care nurse)

When hospital staff was asked what the wound looks like, staff were not able to describe the wound. Staff person GG was asked how s/he would know the effectiveness of what was being done if the primary care nurse did not document what was seen but the staff person did not have a response.

Medical record documentation for the daily wound treatment was reviewed again on 9/28/12 in the presence of hospital leadership. Once again, staff confirmed that documentation written on 9/27/12 still did not describe the wounds as a standard of practice.


Nursing failed to supervise staff to ensure the hospital policies were followed related to intravenous therapy. Evidence includes the following.

During the walk through on 9/22/12, multiple patients were observed with intravenous therapy. Based upon observations, nursing staff failed to follow a standard of care and their own IV (intravenous) Therapy policy effective May, 2009 and reviewed August 2012, by placing a label on the IV site, including the gauge size, date and time along with the initials of the nurse starting the site.

Interview with hospital leadership staff AA on 9/22/12 at 10:30 AM verified the nursing staff did not consistently follow their policy. During a subsequent walk through on 9/23/12, several IV's still remained without labels/dates/times.

During the walk through on 9/22/12 and 9/23/12 wound dressing were noted not to be dated or labeled.

Patient # 21 was observed at 10:00 AM lying in bed with a dressing on the right foot without a date or time the dressing had been done. The Patient indicated the dressing might have been done last night but was not sure. Nursing staff stated the wound dressing should have identified date/time and initials by the individual who did dressing.

On 9/26/12 at 12:30 PM, Patient # 18 was noted lying in bed both legs wrapped with protective dressings. The dressings had no date or time as to when they were done. Interview with the staff nurse and hospital leadership staff AA confirmed the dressings shown have been identified with date and time.


Nursing Staff failed to supervised and assess patients for pain.

Medical Records #1, #6 and # 3
Review of medical records for three (3) patients observed in what the patient's expressed as severe or excruciating pain, revealed that nurses failed to conduct pain assessments as per the hospital's Pain Management policy. Nursing also failed to ensure that physician's orders for pain medications were carried out as ordered to prevent and minimize pain.

Medical Record #1

During dressing change observations the following observations for Patient #1 were made. When the nurse attempted to peel off the old dressing that had adhered to the patient's ' right leg wounds, he moaned out in pain. The nurse continued to spray and peel off the dressing and the patient continued to moan in pain. The nurse did not attempt to do a pain assessment although the patient stated that he was in severe pain. He described the pain as 12 on a 1/10 scale.

The nurse was asked by the surveyor when the resident was last medicated for pain. She responded by saying she did not know. The nurse was asked to discontinue the treatment until the patient was assessed and medicated for pain.

Review of the patient's medical record revealed that he had not been medicated for pain in over 24 hours. The medical record contained a physician's order for Percocet 5/325 MG 1 by mouth every 6 hours for pain greater than 4/10.

The patient plan of care for pain indicated that the pain assessment scale would be used appropriately to assess for pain. The hospital's Pain Management policy states that the nurse should routinely assess the patient for pain every 4 hours while awake, and that analgesics should be administered as prescribed.

Medical Record #6

Review of the medical record for Patient #6 revealed nursing notes on 9/26/12 indicating that the "intravenous (IV) was infiltrated, tried to reinsert IV x 6 but was not successful and patient was crying already bec (because) of the pain during the needle insertion".

Knowing that the patient was in pain, the nurse failed to assess the level of pain and offer the elder patient the PRN (whenever necessary) pain medication that was available to relieve the patient's obvious pain.

Medical record # 13.

On 9/25/12 at 10 AM during a tour of the Emergency Department (ED) Patient # 13 was observed lying supine on a gurney. The patient's IV pump was beeping and the IV tubing had become dislodged from the IV site. The patient was observed grimacing as if in pain. The patient stated that he came to the ED after falling several floors from a balcony.

When asked by the surveyor if he was in pain, he replied yes and described the pain as excruciating. He stated that he had been given something for the pain earlier but it had worn off. According to the patient he had requested more pain medication but had not received it yet.

During a brief interview with the ED nurse who was taking care of the patient, the nurse stated that she had not given the patient any pain medications. She stated that she had made rounds in the patient's room at 9:00 AM and stated that she had not medicated him for pain as of yet.

Review of the patient's medical record noted that the patient had a comminuted fracture of the distal radius and a non displaced intertrochanteric right hip fracture. The medical record contained a current physician's order that read: Morphine 5 MG IV every 4 hours prn-pain > 5/10. Motrin 600 MG PO every 6 hours prn pain < 5/10. The medical record indicated that the patient was medicated for pain at 0045 with Morphine 5 MG IV (Intravenous), almost 10 hours previously, and had not received any medications for pain since that time.
Nursing services failed to have supervisory staff properly oversee and supervise the unit nursing staff for the delivery of care, ensuring physician orders were implemented, ensure that physicians were notified when orders were not followed and failed to achieve standards of care and follow hospital policy.

Based upon medical record review and interview, the hospital failed to develop and maintain care plans for three (3) patients that were revised, current or noted the patients response to interventions. Evidence includes the following.

Medical Record #7

Review of Medical Record #7 noted the care plan pertaining to pressure ulcers was computer generated which identified impaired skin integrity. The care plan was not revised or edited by using the free text option to personalize and tailor the care plan to note the multiple areas of compromised skin integrity.

Medical Record #9

Record review for Patient #9 noted a diagnosis and past history of weight loss. On 8/16/12, the physician wrote an order for Ensure, a dietary supplement. Nursing staff failed to edit/revised the care plan to reflect the current patient need. The only item on the care plan were canned computer language including "monitor caloric intake, maintain adequate intake and decreased caloric intake" without any individualized approaches as to how this will be done.

Medical Record #12

Record review for Patient #12 noted significant compromised skin integrity. Notes included toe amputation, left and right heel debridement skin, subcutaneous tissue and necrotic tissue...no early granulation... all appear dusky written in medical notes of 9/12/12. Care plan only noted "high risk: impaired skin integrity". The care plan was not revised/edited to reflect the multiple areas of compromised skin integrity.

These findings were confirmed with nursing leadership during the record views.

Based upon medical record review and confirmed by interview hospital staff, all entries were not complete, accurate, dated or signed. Evidence includes the following.

Medical Record #10

Review of the Medical Record #10, noted that the patient was admitted on 11/27/11 and underwent a surgical procedure on 12/2/11 where the patient coded and died on 12/3/11. Review of the surgical operative notes written on 12/4/11 at 1438 hours stated"pt (patient) transported to OR (operating room) via stretcher. PT assisted self onto OR table without any incidents. BL (bilateral) armboards...safety straps applied, PT supported during anesthesia...Pt prep with Chloraprep. Procedure turned into an open case...Pt tolerated procedure well.....PT transferred onto bed and transported to ICU. Report given to ICU nurse".

The entry was written for another patient and included in the Medical Record for #10. This was confirmed during with record review with hospital leadership staff AA

Medical Record #8

Review of the Medical Record #8 included a form for a procedure that was to be done on 8/31/12. The area for the physicians to date and time relative to the time out was left blank. This finding was confirmed with Staff Person AA on 9/26/12 at 10:45 AM

Medical Record #17

Review of Medical Record #17 noted medical entry by the physician on 8/12/12 that was not dated or timed including the time out for the surgical procedure.

20665


Based on review of hospital documents related to Radiology and radiological equipment, interviews conducted with staff physicians who order X-ray services, the Director of the hospital's Radiology Department and the Chief of Radiology, it was determined that equipment preventive maintenance and inspections are not always done timely.

It was further revealed that much of the equipment is outdated compared to current standards, reading and interpreting of X-rays are often delayed, imaging is poor and the need for repeat x-rays are higher than normal, and the department lacks the Quality Assurance Software needed develop, evaluate and monitor a sound Quality Control System.

During interviews with hospital physicians throughout the length of the survey up to the time just prior to the formal exit conference, physicians of varying specialties ranging from surgery to the emergency department complained about the poor quality of X-ray images with special emphasis on C-Spine images. In addition to poor imaging, timeliness of reporting, and the need for repeat X-rays were all common complaints that all of the physicians agreed impacted the quality of care and services being rendered to patients.

The issue with timeliness of reporting had been a known issue as recorded in minutes of the Medical Executive Committee on 9/16/11 yet not integrated through the Quality Assessment and Performance Improvement Program.

During 2 separate interviews with the MD # 11 it was acknowledged that some of the equipment is old and outdated which directly impacts the quality of images. He also acknowledged that C-spine images pose the greatest problem. Review of a report from the Radiology department's contract service provider providing feedback from the radiologist concerning a C-spine image, stated the following: reformats are unreadable thus making recons non-diagnostic.

MD #11 also acknowledged that repeat X-rays are higher than average, X-rays ordered by a physician may be missed and not done, and acknowledged that reading and reporting of X-rays are often late. He stated that because his department lacks the Quality Assurance software such as repeat and reject analysis, the department lacks the scientific evidence to measure and improve overall quality. When asked if he had brought the need for the software to the attention of hospital administration he said he had and stated that the software has not been ordered yet because of the hospital's current financial status.

As of July 2012 the department announced the 24 hour support from a contracted outside vendor service for Radiologist support for reading and reporting X-rays intended to improve turn-around time.

Review of Turn-Around Statistics reports for the months of July and August 2012 revealed the following for in-house reporting and contract reporting: July - Average # of Hours 40.31 (in-house), 0.58 (contract) and for the month of August - Average # of Hours 23.60 (in-house) and 0.83 (contract). According to the Director 45 minutes 1 hour is acceptable with 60 minutes being the department's current goal.

During an interview conducted with the MD #12, when asked about the quality of the equipment, he admitted that some of the radiological equipment is dated compared to todays standards, but stated that with special positioning of the patient adequate imaging can still be done.

When asked about the lack of timeliness with reading and reporting he sated that because he was the only Radiologist in-house and because of his extra involvement in committees there has been delays. He stated that another Radiologist would be returning which will ease the burden and improve turn-around time.

Review of the preventive maintenance reports and interview with MD #11 revealed that preventive maintenance services were due in July 2012. The director stated that the preventive maintenance inspection had been delayed because he was trying to coordinate this with another service in an effort to control cost for the outside service provider.

Based upon interview and document review, the Utilization Review Committee failed to implement their Utilization Review Plan. The hospital failed to review Medicare and Medicaid patients to the medical necessity of admissions to the hospital, duration of stay and professional services provided to the patients.

Evidence includes the following.

1. The Utilization Review Committee failed to review patients admission for medical necessity. Please refer to A0655.

2. The Utilization Review Committee failed to determine that admissions or continued stays were medically necessary. Please refer to A0656.

3. The Utilization Review Committee failed to review cases that were outliers for the threshold based upon their diagnosis. Please refer to A0657.

4. The Utilization Review Committee failed to review professional services provided to patients for medical necessity. Please refer to A0658.

The hospital has failed to implement their Utilization Management Plan- 2012 Utilization and Care Management Plan effective 3/20/12.

Based upon interview and document review, the hospital failed to conduct Utilization Reviews for Medicare and/or Medicaid patients. Evidence includes the following.

An interview was conducted on 9/24/12 at approximately 9:30 AM with Physician #10 of the committee. During this time, it was revealed that the committee had actually only reviewed 1 case and confirmed that the committee needed to receive the appropriate data timely so that the committee could be more efficient.

Although the committee has met, there was no evidence that medical necessity for Medicare and/or Medicaid patients had been reviewed in respect to admissions, duration of stay and the professional services provided to the patients.

At the time of the survey, several patients had been in the facility since 2011 without any evidence of necessary reviews.

Based upon document review and interview, the facility failed to review current inpatients for their admissions or if the continued stay was medically necessary. Evidence includes the following.

During an interview on 9/24/12 at approximately 9:30 AM, it was revealed that the committee had not reviewed cases in accordance with the requirements. At the present time, admissions had not been reviewed for the appropriateness of medical necessity and/or continued stay.

Based upon interview and document review, the hospital failed to review patient case files who exceed the criteria for length of stay based upon the diagnosis. Evidence includes the following:

During an interview on 9/24/12 at 9:30 AM, Physician #10 discussed the Utilization Review of the hospital. Utilization Review Committee combines their meetings with Medical Records Committee.

The prior focus had been on Medical Records and documentation issues rather than actual case reviews and the plan was to review more direct reviews. It was stated that only one (1) case had been reviewed.

Hospital leadership staff BB indicated that during the meeting of September 11, 2012, the committee for Utilization Review had been educated as to the requirements within Utilization Review and case documentation.

At the time of survey, there were four (4) patients presently in the facility with "extended durations". This was confirmed by interview with staff person PP on 9/24/12 at 10:45 AM and again on 9/25/12 at approximately 1:00 PM.

Patient #3 was admitted to the hospital on 2/5/11.

Patient #1 was admitted to the hospital on 5/15/11.

Patient # 20 was admitted to the hospital on 1/2/12.

Patient # 2 was admitted to the hospital on 5/9/12.

The hospital failed to conduct case reviews for extended duration.








20665

Based upon interviews and medical record reviews, the Utilization Review Committee of the hospital failed to perform reviews of professional services rendered to patients. Evidence includes the following.

Interview on 9/24/12 at 9:30 AM with Physician #10, it was stated that the Utilization Review Committee had only discussed one (1) case to date and that the focus had been on Medical Record documentation issues rather than actual case reviews.

Additional interviews with several different staff members during the survey, indicated that serious concerns had repeatedly been brought to the attention of the hospital medical staff concerning professional services, lack of professional services and efficient use of the services of the hospital several times.

These concerns were presented in writing in January, 2012, again in March 2012, and August, 2012 as well as verbally just recently in September, 2012.

Had the hospital Utilization Review Committee met in accordance with the requirements, the concerns raised regarding professional services, the lack of professional dialogue regarding care coordination and scheduling timeliness could have addressed these issues timely so any improvement actions could have been taken.

Although some of the cases brought to the attention of the hospital were reviewed internally and externally, none of the cases were brought through and assessed through the Utilization Review Committee. Please refer to A0338.

Based upon a walk through on 9/22/12 and 9/23/12, interviews with patients, families, staff and review of hospital documents, the hospital has not ensured that supplies and equipment meet patient needs. Evidence includes the following.

In the presence of hospital staff, several patient rooms were noted to have light pulls that would operate their over the bed light that were too short. To address the situation, hospital staff tied several clear plastic bags, similar to the bags used to line waste disposal baskets, together to add the needed length to the light cord and then tied the plastic bags to the side rails.

This adaptation was not only unsafe but was an infection control risk.

During a walk through on the Medical Unit on 9/22/12 at approximately 10:15 AM, the surveyor was approached by a family member concerned about the safety needs of the patient. Both the patient and family member stated that had repeatedly asked for a light bulb for the bathroom since admission to the room without any response from the facility. The family member also stated they also had no wash basin or personal supplies in the bedside table. Through surveyor intervention, hospital leadership staff CC, arranged to have the concerns addressed.

During an interview with DD on 9/27/12 at 10:30 AM, it was acknowledged that three (3) people were aware of the complaint about the light bulb and yet no action had been taken until directed by CMS.

Also noted during the walk through was a bedside table noted to have a cracked and torn edge around the table, peeling off. The patient in the room was at a serious risk for infection due to severely compromised skin integrity. The table was asked to be removed by the surveyor.

Based upon observation and interview, the hospital failed to ensure the operating rooms had visible controls to measure humidity.
Evidence includes the following.

A tour of the operating suites was conducted in the presence of hospital staff. Based upon the 8/22/12 conference call with the hospital staff, it was stated the the HVAC (Heating, Ventilation, Air Conditioning) system was in place and effectively working. Humidity levels could be seen online with the new system and levels were appropriate.

Interview with MM, manager from the surgical arena and observation of the rooms that were not occupied, revealed wall units do not register the humidity in the operating rooms. MM confirmed they can be viewed on line but for staff entering each room, there is no way to visually determine the actual percentage of humidity.

Based on observation, review of hospital documents, policies and procedures, and interview with hospital personnel it was determined that
the infection control coordinator and other responsible staff failed to ensure that the hospital's infection control policies were implemented by staff, failed to ensure that congruency existed between the infection control policies, procedures and monitoring tools, and failed to ensure that staff were aware of, and performed their responsibilities in implementing them timely and consistently.

This was true for the hand washing and hand hygiene policy and procedures during the restart of intravenous fluids for a resident in the emergency department where the nurse failed to wash her hands before donning her gloves and after removing her gloves once the procedure had been completed.

Failing to follow the hospitals hand hygiene and hand washing policy occurred during wound treatment observations where the wound treatment nurse donned gloves to provide wound care to a patient's leg that required removing an old dressing that was adhered to the patient's leg and contained old, dried blood and exudate, and new red blood from the wounds.

The wound care nurse failed to follow the hand hygiene and hand washing policy by not washing her hands before and after donning her gloves, and by contaminating other objects in the patient's environment when she touched multiple surfaces before removing her contaminated gloves. In addition, when the nurse did wash her hands she did so for less than 15 seconds. Facility policy states that hand washing should occur for a minimum of 15 seconds.

Failure to ensure consistent monitoring and recording was observed for the monitoring of differential pressure in negative pressure rooms used for isolation of airborne infections such as Tuberculosis. Policies and procedures as to who would be responsible and when was unclear. The Policy and procedure delegated responsibility to maintenance staff on weekends and holidays, and the monitoring checklist delegated responsibility to the clinical care coordinator on duty.


Please refer to A 0144

Based upon review of Infection Control Policy- Sharps Safety an interview, the hospital failed to implement their policies to ensure the risk to blood borne pathogens was mitigated. Evidence includes the following.

During an interview on 9/22/12 at 1:00 AM with MD #3, concerns relative to needlestick safety was discussed. It was stated that the hospital does not always have safety syringes/equipment available which increases the risk to patient and staff safety.

On 9/22/12, the list of needlestick injuries reported to the hospital was requested. Once received, several events of needlestick's without a safety feature had been reported to hospital staff.

Review of the policy on Sharps Safety, effective August 2011 indicates " GJLH will consider and select safe needle devices during the annual review of the exposure control plan. That the Infection Control staff will work closely with Material Management to secure medical devices (i.e. needles; scalpels; lancets' ect that have sharp safe mechanisms. Through incidences of sharps injury, the Employees Health Nurse will help identify medical devices that do not have safety devices. Through the Product and Evaluation Standardization Committee new sharp safety products will be introduced, evaluated and accepted. Physician and nursing staff will be involved in the evaluation and selection of devices".

Interview with hospital leader Staff Person BB on 9/24/12 stated that the Product and Evaluation Standardization Committee has never met. Please refer to A0286

Based upon interview and medical record review, the hospital failed to adequately prepare Patient # 19 for discharge. Evidence includes the following.

Medical Record #19

Review of medical record #19 noted this patient was admitted to the medical unit from the ED although her principle diagnosis was Acute Psychosis. The patient had a history of additional diagnoses that included Schizophrenia, End Stage Renal Disease, Hypertension, and Diabetes.

During an interview with the patient's physician on 9/24/12 on the medical unit, the physician stated that he admitted the patient to the medical unit rather than the psychiatric unit in consideration of her medical needs. It was stated that staffing on the psychiatric unit was not best prepared to meet the medical needs of the patient.

Record review of 9/28/12 revealed that the patient was discharged home on 9/26/12 by the primary attending physician. Documentation noted that the patient had refused most of her medications on a daily basis for 9 consecutive days, 9/15/12 through 9/24/12, prior to her discharge from the hospital. On the days the patient refused to take her medications the nurse circled the times and wrote, "patient refused". There was no evidence by the nurse to indicate why the patient refused, and no evidence that the physician had been notified by the nurse of the patient's continual refusal to take her medications. In addition to the patient refused medication note, the nurse sometimes indicated that the patient was in dialysis. There was no documented evidence to indicate if the resident receive her medications while in dialysis.

During an interview with the patient's primary physician in the conference room on 9/28/12, the physician stated that he was unaware at the time he made the decision to discharge the patient, that the patient had been refusing to take her medications for as many days indicated in the patient's medical record. He stated that the nurses had told him about one day of refusal, and stated that he had not been made aware of the multiple days.

When asked if he would have made the decision to discharge the patient had he been aware of the patient's refusal to take her medications for multiple days, the physician acknowledged that he had intended initially to keep the patient at least one more day.

It was learned on 9/28/12 that the patient had been brought to the hospital DOA (Dead On Arrival) in the early morning of 9/28/12, less than two days after being discharged cause of death unknown at the time of this report.

Medical Record #11

Record review Patient #11 revealed an admission on 7/30/12 with diagnoses that included Hypoglycemia, Hypertension and Chronic Kidney Disease. Further review of the record indicated the patient was discharged home on 8/18/12 at 1300 hours (1:00 PM).

This same patient returned to the hospital on 8/18/12 via the Emergency Room at 2120 hours (9:20 PM- 8 hours later) with a diagnosis that included sepsis and Urinary Tract Infection.
The discharge plans for Patient #19 and Patient #11 failed to fully assess and evaluate the patient prior to discharge.

Medical Record # 23

Patient #23 was admitted as a trauma patient on 9/15/12 with a vertebral artery injury, brain hemorrhage, low platelets and multiple spine fractures.

Record review revealed on 9/15/12, the patient received 1 dose of a medication ordered by another physician that was contraindicated due to the diagnosis of acute head bleed. The medication was immediately discontinued by the attending physician after the single dose had been administered.

There was no communication or consultation prior to the medication being administered for this patient with a known risk due to the diagnosis. A repeat head CT (Cat Scan) showed expansion of the bleed.

When the attending Physician returned to review the patients on 9/19/12 under his/her care after being away, it was noted that another physician had discharged Patient #23 directly out from ICU to home without any communication with the attending nor the Intensive Care staff.

There was no evidence of discharge planning prior to the patient being sent home that would have addressed the risk factors of further cerebral bleed and high risk of spinal hematoma.

The hospital medical staff failed to communicate and prepare adequate discharge planning for patients patients who may be at risk.

Based upon record review and interviews, the hospital failed to effectively counsel Patient #9 for post hospital care as it relates to the medication regime. Evidence includes the following.

Patient #9 was admitted to the psychiatric unit on 8/14/12 with a significant psychiatric history. The patient was discharged on 9/20/12 without any evidence of an actual discharge plan. The discharge summary under "recommendations" included" medication compliance."

Review of the "Discharge To Home- Medications and Prescriptions" listed the following:

Seroqual 300 mg 2 x daily
Lamictal 50 mg po x 14 days q (every) day
Lamictal 75 mg po x 7 days q day
Lamictal 100 mg po daily q day.

During an interview with the staff nurse on 9/23/12 at 12:50 PM, it was stated that on 9/22/12, the psychiatric unit was closed because the unit had no patients. Since the unit had no patients, staff were floated to other units. With the unit being vacant, any telephone calls went unanswered.

The nurse further stated that the day the unit was closed (9/22) Patient #9 called the psychiatric unit about her prescriptions but no one answered. The patient called the unit again on 9/23/12 concerned about her prescriptions told the nurse how she had been taking the medications.

Based upon the conversation with the patient, the nurse told the patient to come immediately to the hospital. The patient had been taking one pill from each of the three bottles of Lamictal- a 100mg tablet, a 75 mg tablet and one 50 mg tablet each day.

The patient was readmitted to the psychiatric unit, the diagnosis was an unintentional overdose of the medication Lamictal.

When the vials of medication were removed from the patient's personal belongings, there were three (3) medication bottles. One vial marked as 100mg of Lamictal take 1 QD (every day), 1 bottle of 75 mg of Lamictal marked take 1 QD and 1 bottle of 50 mg of Lamictal marked take 1 QD.

No where in the directions for use did the instructions indicate that this was to be a titrating dose of Lamictal; that when the 14 days supply of the 100 mg dose was completed, the patient should start with the 75 mg dose, and when that was completed, the patient should begin to take the 50 mg dose.

A copy of the prescription was requested from the pharmacy responsible for filling the prescription. With the prescription, interviews with hospital staff person TT and AA were asked to describe how they would have interpreted the label for use of the mediations. Both indicated that as written, the order was not clear and that patient followed what was written.

The hospital failed to have clear discharge instruction pertaining to medication explained prior to discharge.