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Based on interview and record review, the governing body failed to ensure the safety and quality of the care provided to the hospital patients because:

1. Patients' rights were not protected and promoted because patients placed in physical restraints were not monitored by qualified personnel at designated intervals, and patients who were to be monitored each 15 minutes were not assured of monitoring while away from their assigned nursing units, and 2 of 6 grievances reviewed received incomplete consideration and written responses (see A-115).

2. The governing body did not ensure the implementation and maintenance of an effective, on-going and hospital wide quality assessment and improvement program because QAPI did not measure, analyze and track processes of care and hospital service, because data was not integrated into the Quality Assurance and Performance Improvement Program for the BH program (A274).

The cumulative effect of these failings meant the governing body did not ensure high quality healthcare in a safe environment for all patients using the facility.


Findings:

1. The hospital policy, Restraint or Seclusion (revised 12/11) was seen on 7/12/12. Section 1.7.2 read, "Assessment will be completed as specified on the currently approved restraint documentation form. The assessment shall include the following, unless it is inappropriate for the type of restrain employed: Signs of any injury associated with applying restrain or seclusion, Nutrition and hydration, Circulation and range of motion of the extremities, vital signs, hygiene and elimination, physical and psychological status and comfort, readiness for discontinuation of restraint." The required assessment outlined in the policy did not include the assessment of the respiratory and general circulatory system required by regulation. The hospital restraint form, "Seclusion and/or Restraint Initial Assessment" referenced in the policy did not include space for documenting an examination, vital signs, the psychological status or comfort of the patient.

In an interview with the Dir Pharm on 7/13/12 at 10:25 AM, she stated that the Seclusion and /or Restraint Initial Assessment form would have been appended to the restraint policy when it was approved by the governing body.

During an interview with the CMS, a member of the governing body, on 7/13/12 at 14:00 hours, he stated that he believed that assessment of patients in restraints was done by the nursing staff, but that he was not aware of the training of the nurses doing the assessments in the BH unit. He stated that he was not aware that the assessments being performed did not meet regulatory requirements.

2. The hospital failed to ensure that the face-to-face assessment of 1 of 23 sampled nursing patients was completed within 1 hour of the initiation of the restraint (involuntary restricting the movement of arms or legs or the whole body) and seclusion (patient place alone in a quiet room being monitored by staff) for patients with violent and self-destructive behaviors, included both a comprehensive physical and behavioral assessment of the patients by qualified practitioners within the scope of their practice. This failure resulted in patients' not receiving a comprehensive physical and behavioral assessment to determine what factors were contributing to the patients' behavior that required the use of restraint and seclusion. This had the potential to negatively affect the health and safety of a universe of 53 patients on the Behavioral Health Units (see A-179 and A-205).
For 3 BH unit patients (Patients 2, 10 and 11), the safety of the patients was not ensured through monitoring checks performed each 15 minutes (see A-144).

In an interview with the Dir Risk on 7/13/12 at 3 PM, she stated that QI monitoring in the BH unit had not been reported through the QI committee, the MEC, the psychiatry section committee or the governing body. She stated that there was a restraints auditing tool, but aggregated data and analysis of the data had not been seen. She stated that the QI program had not addressed the adequacy of the restraint auditing tool. She stated that the tool checked whether the auditing forms had been completed, but did not address the quality of the documentation on the forms. She stated that the Clin Dir BH collected data on the 15 minutes monitoring checks, but the data had not been brought forward to the QI department.









The cumulative effect of these failings meant the governing body did not ensure high quality healthcare in a safe environment for all patients using the facility.

Based on interview and record review, the hospital failed to protect and promote the rights of each patients by failing to:

1. Ensure that the patient's representative was informed of the patient's rights in advance of furnishing patient care for 1 of 23 nursing sampled patients (Patient 41). For Patient 41, admitted to the hospital on 7/10/12 at 6 AM, the facility did not inform the parent of the patient's rights as a hospitalized patient timely. This failure created the risk for all patients that received services to not have their rights protected and promoted. (Refer to A-117).

2. Ensure that the face-to-face assessment conducted within 1 hour of the initiation of the restraint (involuntary restricting the movement of arms or legs or the whole body) and seclusion (patient place alone in a quiet room being monitored by staff) for patients with violent and self-destructive behaviors, included both a physical and behavioral assessment of the patients by qualified practitioners within the scope of their practice. This deficient practice resulted in the patients' not receiving a complete physical and behavioral assessment to determine what factors were contributing to their behavior that required the use of restraint and seclusion. This failure had the potential to result in negative outcomes for a universe of 53 patients on the Behavioral Health Units. (Refer to A-0179).

3. Ensure that the Registered Nurses (RN's) completing the face to face initial assessment within 1 hour of initiation of restraints and seclusion for violent or self-disruptive behaviors; had the training and education necessary to be competent in performing comprehensive physical and psychological assessment of the patients. This deficient practice resulted in the RN's performing incomplete physical and psychological assessments of the patients. This failure had the potential to result in negative outcomes for a universe of 53 patients on the Behavioral Health Units. (Refer to A- 205)

4. Patients' rights were not protected and promoted because patients placed in physical restraints were not monitored by qualified personnel at designated intervals, and patients who were to be monitored each 15 minutes were not assured of monitoring while away from their assigned nursing units, and 2 of 6 grievances reviewed received incomplete consideration and written responses

The cumulative effect of these systemic failures resulted in the hospital not protecting and promoting the rights of each the patient and in compliance with the Condition of Participation for Patient's rights.

Findings:

1. On 7/10/12, Patient 41's medical record was reviewed with a Registered Nurse (RN) 4.
A review of the face sheet for Patient 41 was conducted and showed that the patient was admitted on 7/10/12 at 6 AM, to rule out sepsis (a systemic blood infection).
A review of the medical record failed to show documented evidence that the patient's parent was notified of the patient's rights in advance of furnishing patient care. RN 4 confirmed the finding and stated that the admitting department was responsible for approaching the patient with patient rights information.

On 7/10/12 at 12:10 PM, an interview was conducted with an Admission Representative (AR) 1. AR 1 confirmed that Patient 41's mother was not informed of the patient's rights as a hospitalized patient at the time of interview (6 hours later).

2. On 7/9/12, a review of Patient 48's medical record was reviewed. It noted the patient was admitted to the hospital on 7/6/12, and was placed on a 5150 hold (involuntary placement into the acute psychiatric unit for 72 hours due to danger to self and others). Diagnoses included paranoid schizophrenia (characterized by delusions; symptoms may include anger and anxiety and aloofness and doubts about gender identity; the patients are usually presentable and (if delusions are not acted on) may function in an apparent normal way) and drug and alcohol abuse.

On 7/9/12 at approximately 2:40 PM, an interview was conducted with Registered Nurse (RN) 3. RN 3 stated that Patient 48 was in seclusion (involuntary placement of the patient alone in a room). The patient was on 1:1(a staff was assigned to sit in the room and monitor the patient for 24 hours) following a violent behavior outburst that had occurred at 7:30 AM per RN 3. RN 3 stated that she had just spoken to the Patient 48 in the hallway, turned and was walking away from him, when he hit a patient in the hallway, unprovoked.

RN 3 stated that the patient was placed in 4 points restraint (both arms and legs were placed in leather restraints and secured to the bed frame) and seclusion (placed in a room with a small viewing window and a door to the hallway. A staff was assigned to provide 1:1 observation and monitoring of the patient). RN 3 stated that she completed the initial face-to-face assessment required within 1 hour of initiation of restraints and or seclusion, notified the physician and obtained telephone orders. RN 3 stated that the patient ' s psychiatrist assessed the patient later that morning.

A review was conducted of the initial face to face assessment of Patient 48 conducted within the 1 hour after the initiation of the restraints and seclusion by RN 3. RN 3 stated that she completed the forms titled, "Seclusion and or Restraint RN 1 Hour Initial Assessment", and "Clinical Justification for Restraint".

A review of the form titled, "Seclusion and or Restraint RN 1 Hour Initial Assessment", included the following:
"Initial Assessment: 7/9/12 at 7:30 AM. Hit another patient.
Criteria for release:
Demonstrate calm behavior
Able to follow directions
Able to contract for no self-harm
Able to contract not to harm others
Attending physician contacted
Reason for Restraint and Seclusion explained to patient: Because of unpredictable behavior.
Less restrictive measures attempted: Limit setting.
Patient response: None, patient extremely unpredictable, unprovoked.
Patient debriefing meeting was conducted with the patient and staff and signed by RN 3 on 7/9/12 at 10:05 AM.."

A review of the form titled, "Clinical Justification for Restraint", (a telephone order for the restraint) noted the following:
Behavior Restraints: Behavior posing danger to others.
Type of restraint: Hard locking
Four (4) point-all four (4) limbs restrained.
Time limited order from Date: 7/9/12, Time: 7:30 AM to Date: 7/19/12 (error per nurse, should have been 7/9/12), Time: 10:05 AM.
The following section of the form was completed by RN 3 on 7/9/12 at 2:45 PM during our interview and review of the medical record:
The telephone order for the restraint was signed and dated.
The initial face to face was conducted by a nurse.
Physician Assessment:
Patient assessed, need for restraint and type of restraint reviewed.
Patient care conference held and alternative treatment measures discussed.
Restraint Continues to be Necessary: No
Discontinue date: 7/9/12 at 10:05 AM.."

During the same interview and review of Patient 48's medical record, RN 3 stated that it was the policy and practice of the hospital for the RN's in the Behavioral Health Units, to complete the face to face I hour initial assessment of the patients. RN 3 stated that her training consisted of completing the following forms: "Seclusion and /or Restraint RN 1 Hour Initial Assessment", the "Clinical Justification for Restraint" and the "Seclusion &/or Restraint Q (every) 15 Minutes Evaluation Form" which included: (Sign of injury, circulation, physical/psychological (agitation, verbal aggression, spitting/biting, responding to hallucination/delusions, mumbling, self- harm, asleep, other), Intervention: 1:1 interaction, audio/visual (seclusion only after 1 hour), medication given, decrease stimuli, other, Nutrition/hydration needs addressed, Hygiene/elimination needs addressed, ROM (range of motion): relief from restraint provided, Release criteria communicated to patient, patient understands criteria for release, readiness to discontinue restraint). RN 3 stated that she did not perform a comprehensive physical or psychological assessments of patients during the initial face to face assessment.

An interview was conducted on 7/11/12, at 9:20 AM with RN 6; the charge nurse for the Acute Psychiatric Locked Unit East, regarding the training that was provided to the RN's to complete the face-to-face initial assessment within 1 hour of initiation of restraints and or seclusion. The charge nurse stated that the RN's were trained on how to complete the "Seclusion and /or Restraint RN 1 hour Initial Assessment Form" and that the assessment was completed on the "Seclusion &/or Restraint Q 15 Minutes Evaluation Form.

An interview was conducted on 7/11/12 at approximately 9:25 AM with the Director of Behavioral Health Services (BHS). The Director of BHS was asked what training the RN's received to ensure that they were competent to perform the face-to-face comprehensive physical and psychological assessment within 1 hour of initiation of restraints and or seclusion. The Director of BHS stated, "All of the RN's received training, but it is not that extensive". The Director of BHS confirmed that the RN's were not performing comprehensive physical and psychological assessments of patient during the initial face to face assessment.

An interview was conducted on 7/11/12, at approximately 11:15 AM, with Psychiatrist 1 for the BHS units. Psychiatrist 1 stated that the RN's were responsible for completing the face to face initial assessment within 1 hour of the initiation of restraints and or seclusion. He stated that the assessment included: vital signs, monitoring the patient's behavior and response to the restraints/seclusion, calling the physician for new orders for the restraint and or medication and monitoring the patients' on going need for restraints and or seclusion. Psychiatrist 1 stated that the hospital policy was for the physician to complete a face to face assessment within 24 hours of initiation of restraints or seclusion.

A review of the facility policy titled, "Restraint or Seclusion", reviewed 6/12, and included the following: "Restraint or Seclusion", reviewed 6/12, and included the following:
"Violent/Self Destructive Restraint: One-hour face-to-face assessment- The physician or an appropriately trained Registered Nurse or Physician ' s Assistant will perform a face-to-face assessment of the patient ' s physical and psychological status within one hour of initiation of R/S (restraint/seclusion) ".

An interview was conducted on 7/11/12, at approximately 2:30 PM with the Director of Education and a review was conducted of the RN's competency training received for conducting the 1 hour face-to-face evaluation. Absent from the training were physical (complete review of system assessment) and behavioral assessment; as well as the assessment of the patient's history, drugs and medications interactions, most recent labs, etc.

During the same interview and review of the RN training material, the Director of Education confirmed that the RN training did not include a comprehensive physical and behavioral assessment. The Director of Education stated that the hospital policy was not specific as to the appropriate training necessary for the nurses to be competent in performing the face-to-face initial assessment within 1 hour of initiation of restraint/seclusion for violent or self-destructive behaviors to meet the regulation.

3. On 7/9/12, a review of Patient 48's medical record was reviewed. It noted the patient was admitted to the hospital on 7/6/12, and was placed on a 5150 hold (involuntary placement into the acute psychiatric unit for 72 hours due to danger to self and others). Diagnoses included paranoid schizophrenia (characterized by delusions; symptoms may include anger and anxiety and aloofness and doubts about gender identity; the patients are usually presentable and (if delusions are not acted on) may function in an apparent normal way) and drug and alcohol abuse.

An interview was conducted on 7/11/12 at approximately 9:25 AM with the Director of Behavioral Health Services (BHS). The Director of BHS was asked what training the RN's received to ensure that they were competent to perform the face-to-face comprehensive physical and psychological assessment within 1 hour of initiation of restraints and or seclusion. The Director of BHS stated, " All of the RN's received training, but it is not that extensive".

An interview was conducted on 7/11/12 at approximately 2:30 PM with the Director of Education and RN 3's competency file was reviewed. The Director of Education confirmed that the RN's training was not comprehensive and did not include system assessment (a head to toe system assessment of the patient). RN 3 completed the 18 minute video presentation titled, "Restraints, Seclusion, and the 1 Hour Face-to-Face Evaluation" the required training for all RN's. The power point presentation that accompanied the video included the following RN responsibilities:
"In Behavioral Services, in cases of emergency, an RN's who have completed this training must conduct a face-to-face assessment within 1 hour of application of restraint".
"What happens if the order time limit expires but the patient still needs restraints and/or seclusion and the physician is not available to re-evaluate the patient?"
"A competent RN who performs a face-to-face may conduct the re-evaluation of restraints and/or seclusion for the patient. After the evaluation, the RN must:
Promptly call the physician and discuss the evaluation.
Write a new verbal order for the continued use of restraints and/or seclusion.
Document the assessment in the medical record, including the justification and the continued use of restraints and or seclusion".
Physician's responsibilities:
"Face-to-face evaluations conducted by the Physician must be within 24 hours of initiation of restraint and/ or seclusion if the patient has been released before 8 hours. The evaluation determines whether or not the patient is released within the time frame of the written order. "
"The physician must sign the order for restraints and/or seclusion:
Upon the next visit.
Within 24 hours of the original order, whichever is less".
Restraint/Seclusion: Face-to-face Evaluation:
"A face -to-face assessment requires: Evaluation of the patient ' s safety within 1 hour after the initiation of the restraint(s) and/or seclusion by the physician, or a competent RN to perform a face-to-face assessment".
"A face-to-face assessment also requires:
Evaluation for the continued need for restraint and/or seclusion and patient safety.
Status of patient ' s physical/mental/psychological/behavioral condition.
Presenting issues of immediate situation.
Reaction to the restraint".

A review of the facility policy titled, " Restraint or Seclusion", reviewed 6/12, and included the following:
"Violent/Self Destructive Restraint: One-hour face-to-face assessment- The physician or an appropriately trained Registered Nurse or Physician ' s Assistant will perform a face-to-face assessment of the patient ' s physical and psychological status within one hour of initiation of R/S (restraint/seclusion) ".

During the same interview and review of the RN training material for the face to face initial assessment within 1 hour of initiation of restraint and seclusion, the Director of Education confirmed that the hospital policy was not specific as to the RN training requirements to perform this task. She also confirmed that the RN training was not comprehensive and did not provide the RN's with the appropriate training to be competent in performing the initial face to face assessment within 1 hour of the initiation of restraint and seclusion. The hospital did not provide documented evidence that the RN's were qualified to conduct a comprehensive physical and behavioral assessment of the patients.


4. The hospital policy, Restraint or Seclusion (revised 12/11) was seen on 7/12/12. Section 1.7.2 read, "Assessment will be completed as specified on the currently approved restraint documentation form. The assessment shall include the following, unless it is inappropriate for the type of restrain employed: Signs of any injury associated with applying restrain or seclusion, Nutrition and hydration, Circulation and range of motion of the extremities, vital signs, hygiene and elimination, physical and psychological status and comfort, readiness for discontinuation of restraint." The required assessment outlined in the policy did not include the assessment of the respiratory and general circulatory system required by regulation. The hospital restraint form, "Seclusion and/or Restraint Initial Assessment" referenced in the policy did not include space for documenting an examination, vital signs, the psychological status or comfort of the patient.


In an interview with the Dir Pharm on 7/13/12 at 10:25 AM, she stated that the Seclusion and /or Restraint Initial Assessment form would have been appended to the restraint policy when it was approved by the governing body.


During an interview with the CMS, a member of the governing body, on 7/13/12 at 14:00 hours, he stated that he believed that assessment of patients in restraints was done by the nursing staff, but that he was not aware of the training of the nurses doing the assessments in the BH unit. He stated that he was not aware that the assessments being performed did not meet regulatory requirements.

Based on interview and record review, the hospital failed to inform the patient's representative of the patient's rights in advance of furnishing patient care for 1 of 23 nursing sampled patients (Patient 41). For Patient 41, admitted to the hospital on 7/10/12 at 6 AM, the facility did not inform the parent of the patient's rights as a hospitalized patient timely. This failure created the risk for all patients that received services to not have their rights protected and promoted.

Findings:

On 7/10/12, Patient 41's medical record was reviewed with a Registered Nurse (RN) 4.

A review of the face sheet for Patient 41 was conducted and showed that the patient was admitted on 7/10/12 at 6 AM, to rule out sepsis (a systemic blood infection).

A review of the medical record failed to show documented evidence that the patient's parent was notified of the patient's rights in advance of furnishing patient care. RN 4 confirmed the finding and stated that the admitting department was responsible for approaching the patient with patient rights information.

On 7/10/12 at 12:10 PM, an interview was conducted with an Admission Representative (AR) 1. AR 1 confirmed that Patient 41's mother was not informed of the patient's rights as a hospitalized patient at the time of interview (6 hours later).

Based on interview and record review, for one of six grievances reviewed, the grievance of Patient 14, an allegation regarding physician behavior was not referred to the medical staff and not investigated, creating the risk of substandard care for Patient 14.

Findings:

The hospital policy, Patient Grievance Resolution Process (revised 6/12), read in part, "Purpose: To establish the process for the prompt resolution of a patient and/or family/significant other grievance regarding: Expressed perceptions of unsatisfactory care or service, concerns, conflicts and/or ethical issues related to, including but not limited to the plan of care, treatment of of the patient, interactions with physicians or staff....", and The Grievance Committee will assure that the grievances are investigated."

Six grievances from the hospital's log were randomly selected for review.

Patient 14's grievance dated 1/9/12 started, "Dr was not nice or communicate with me...", and ended, "this doctor was horrible". The patient also complained of continuing symptoms at discharge and not receiving medication.

During an interview with the Dir Risk on 7/10/12 at 1130 hours, she stated that the physician behaviors that were the subject of allegations in Patient 14's grievance were not referred to the medical staff for investigation and review.

In an interview with the Dir MS Services on 7/13/12 at 11:05 AM, she stated that the allegations of Patient 14 regarding physician behavior were not presented at the grievance committee, and if presented would have been sent to the department chair for investigation and sent to the physician for response.

Based on interview and record review, for one grievance, the grievance of Patient 13, there was no written response to the grievance for the date of service referenced in the grievance, creating the risk of substandard healthcare for Patient 13.

Findings:

The hospital policy, Patient Grievance Resolution Process (revised 6/12), read in part, "The Grievance Committee will assure that the grievances are investigated.", and "... the patient will be provided with a written notice of the...results of the investigation and grievance process."

A random selection of 6 grievances were reviewed.

The grievance of Patient 13, dated 2/28/12 and received 2/27/12, discussed the patient's concerns, including that she had been awaiting treatment in the ER from 2:17 PM until 8:20 PM.

The response letter to the patient, dated 3/5/12, did not appear to respond to the same date of service, and referenced different times and events than described in the grievance.

In an interview with the Dir Risk on 7/10/12 at 11 AM, she stated that there was a misunderstanding about the date of service that Patient 13 was complaining about, and that the follow up letter sent to the patient did not reflect the correct date of service. She stated that she discussed the error with the patient by phone, but did not send a corrected written response to the patient.

Based on interview and record review, for 3 behavioral health unit patients requiring tests performed outside of the unit (Patients 2, 10 and 11), the hospital failed to ensure their safety by performing monitoring checks, creating the risk of an unsafe environment for those patients.

Findings:

1.During a review of the medical record of Patient 2 on 7/9/12 at 13:25 hours, the record showed that she was admitted to the hospital after a suicide attempt, and that she was to be observed each 15 minutes.

The Mgr BH stated in an interview on 7/9/12 at 14:30 hours that precautions implemented for Patient 2 included observations each 15 minutes, and that the location and activity of the patient were recorded on the observation sheets.

The observation record for Patient 2 on 7/7/12 was reviewed, and showed that at 15 minute intervals, staff wrote a code that indicated the patient's activity and location. On 7/7/12, the code " 19 " was written at 8:45, 9:00 and 9:15 AM. Opposite code 19 on the observation record was written, " test " .

The physician ' s orders for Patient 2 were reviewed, and an ultrasound of the lower extremity was ordered. There was no order for each 15 minute monitoring to be suspended while the patient had the test.

During a continuing interview with the Mgr BH, she stated that patients left the unit to go to tests. She stated the monitor did not go with the patient to observe each 15 minutes while she was away for a test.

The hospital policy, Levels of Observation and Special Precautions (reviewed 2/12a) was reviewed and read in part, " 15 minute checks (Q15) Presumes that the patient meets criteria for danger to self, danger to others or gravely disabled. This is the minimum observation for all BHS hospitalized patients "

2. During a review of the closed medical record of Patient 10 on 7/12/12, the patient's record contained documentation that he was admitted to the facility on 6/23/12 with homicidal and suicidal ideation. He was to be monitored each 15 minutes. The physician orders included orders for a CT of the head and an EEG. There was no documentation of an order for the patient to go to the tests unmonitored.

The monitoring sheets were reviewed, and showed that Patient 10 had a code " 19 " recorded on his sheets, indicating he was away from the unit for tests from 12 to 1 PM on 6/24/12, and from 6:45 to 7 PM on 6/24/12, and from 11 to 11:45 AM on 6/25/12.

The physician progress note from 6/24 read in part, " The patient currently displays alteration in mood, altered thought processes. The patient still wants to hurt people. The patient currently displays yelling, screaming and cursing behavior. The patient is currently being monitored every 15 minutes for safety. " The progress note from 6/25/12 read in part, " The patient displays agitation and problems managing anger. "

In an interview with the Dir Risk, she stated that patients leaving the unlocked BH unit were escorted by transporters, but that she did not know if the transporters were informed of precautions associated with individual patients, and she did not know if the transported was instructed to stay with the patient. She stated there was no policy on monitoring patients from the unlocked BH unit while they were away from the unit.

In an interview with the Med Dir BH, he stated that he was unsure about hospital policy, and believed that other hospital staff could monitor the patient outside of the unit.

In an interview with Transporter 1 on 7/13/12 at 2:35 PM, he stated that he transported patients from the unlocked BH unit to tests. He stated that the patients were sometimes rowdy, but he had not encountered violence, and that he was trained in the management of assaultive behavior. He stated that if the patient was sent for a quick test he might stay with the patient, but for longer tests, such as an EEG, ultrasound, or CT of the abdomen, he would not stay with the patient. He waited until the radiology personnel performing the test were ready to begin, then left.

The Dir Radiology was interviewed regarding BH unit patients brought for radiologic tests. He stated that his staff was not asked to perform behavioral monitoring during the time that the patient was in radiology, and that the staff was not trained in the management of assaultive behavior.

3. Record review for Patient 11 indicated that on 7/9/12 he was taken off the Behavioral Health unit, to the radiology department, for a head CT (specialized X-Ray) to rule out injury. Review of the Patient Tracking Profile (run on 7/13/12) indicated he was in the radiology suite at 1:27 PM.

Review of the Q 15-Minutes Observation Record-BHS in the medical record of Patient 11 shows that Patient 11 was present and accounted for on the locked Behavioral Health unit at that time. The record indicates that Patient 11 was coded as " 4 " and " 3 " which means in the hall and in the TV room between 1:15 PM and 1:30 PM.

While reviewing Patient 11 ' s medical record with the DBHS on 7/13/12 at 11:45 AM, she stated " the documentation shows they were not aware of his location at that time. There should be documentation on the Q15 he ' s off the unit. "

Based on interview and record review, the hospital failed to ensure that the face-to-face assessment of 1 of 23 sampled nursing patients was completed within 1 hour of the initiation of the restraint (involuntary restricting the movement of arms or legs or the whole body) and seclusion (patient place alone in a quiet room being monitored by staff) for patients with violent and self-destructive behaviors, included both a comprehensive physical and behavioral assessment of the patients by qualified practitioners within the scope of their practice. This failure resulted in patients' not receiving a comprehensive physical and behavioral assessment to determine what factors were contributing to the patients' behavior that required the use of restraint and seclusion. This had the potential to negatively affect a universe of 53 patients on the Behavioral Health Units.

Findings:

On 7/9/12, a review of Patient 48's medical record was reviewed. It noted the patient was admitted to the hospital on 7/6/12, and was placed on a 5150 hold (involuntary placement into the acute psychiatric unit for 72 hours due to danger to self and others). Diagnoses included paranoid schizophrenia (characterized by delusions; symptoms may include anger and anxiety and aloofness and doubts about gender identity; the patients are usually presentable and (if delusions are not acted on) may function in an apparent normal way) and drug and alcohol abuse.

On 7/9/12 at approximately 2:40 PM, an interview was conducted with Registered Nurse (RN) 3. RN 3 stated that Patient 48 was in seclusion (involuntary placement of the patient alone in a room). The patient was on 1:1(a staff was assigned to sit in the room and monitor the patient for 24 hours) following a violent behavior outburst that had occurred at 7:30 AM per RN 3. RN 3 stated that she had just spoken to the Patient 48 in the hallway, turned and was walking away from him, when he hit a patient in the hallway, unprovoked.

RN 3 stated that the patient was placed in 4 points restraint (both arms and legs were placed in leather restraints and secured to the bed frame) and seclusion (placed in a room with a small viewing window and a door to the hallway. A staff was assigned to provide 1:1 observation and monitoring of the patient). RN 3 stated that she completed the initial face-to-face assessment required within 1 hour of initiation of restraints and or seclusion, notified the physician and obtained telephone orders. RN 3 stated that the patient ' s psychiatrist assessed the patient later that morning.

A review was conducted of the initial face to face assessment of Patient 48 conducted within the 1 hour after the initiation of the restraints and seclusion by RN 3. RN 3 stated that she completed the forms titled, "Seclusion and or Restraint RN 1 Hour Initial Assessment", and "Clinical Justification for Restraint".

A review of the form titled, "Seclusion and or Restraint RN 1 Hour Initial Assessment", included the following:

"Initial Assessment: 7/9/12 at 7:30 AM. Hit another patient.
Criteria for release:
Demonstrate calm behavior
Able to follow directions
Able to contract for no self-harm
Able to contract not to harm others
Attending physician contacted
Reason for Restraint and Seclusion explained to patient: Because of unpredictable behavior.
Less restrictive measures attempted: Limit setting.
Patient response: None, patient extremely unpredictable, unprovoked.
Patient debriefing meeting was conducted with the patient and staff and signed by RN 3 on 7/9/12 at 10:05 AM.."

A review of the form titled, "Clinical Justification for Restraint", (a telephone order for the restraint) noted the following:

Behavior Restraints: Behavior posing danger to others.
Type of restraint: Hard locking
Four (4) point-all four (4) limbs restrained.
Time limited order from Date: 7/9/12, Time: 7:30 AM to Date: 7/19/12 (error per nurse, should have been 7/9/12), Time: 10:05 AM.
The following section of the form was completed by RN 3 on 7/9/12 at 2:45 PM during our interview and review of the medical record:
The telephone order for the restraint was signed and dated.
The initial face to face was conducted by a nurse.

Physician Assessment:

Patient assessed, need for restraint and type of restraint reviewed.
Patient care conference held and alternative treatment measures discussed.
Restraint Continues to be Necessary: No
Discontinue date: 7/9/12 at 10:05 AM.."

During the same interview and review of Patient 48's medical record, RN 3 stated that it was the policy and practice of the hospital for the RN's in the Behavioral Health Units, to complete the face to face I hour initial assessment of the patients. RN 3 stated that her training consisted of completing the following forms: "Seclusion and /or Restraint RN 1 Hour Initial Assessment", the "Clinical Justification for Restraint" and the "Seclusion &/or Restraint Q (every) 15 Minutes Evaluation Form" which included: (Sign of injury, circulation, physical/psychological (agitation, verbal aggression, spitting/biting, responding to hallucination/delusions, mumbling, self- harm, asleep, other), Intervention: 1:1 interaction, audio/visual (seclusion only after 1 hour), medication given, decrease stimuli, other, Nutrition/hydration needs addressed, Hygiene/elimination needs addressed, ROM (range of motion): relief from restraint provided, Release criteria communicated to patient, patient understands criteria for release, readiness to discontinue restraint). RN 3 stated that her she did not perform a comprehensive physical or psychological assessments of patients during the initial face to face assessment.

An interview was conducted on 7/11/12, at 9:20 AM with RN 6; the charge nurse for the Acute Psychiatric Locked Unit East, regarding the training that was provided to the RN's to complete the face-to-face initial assessment within 1 hour of initiation of restraints and or seclusion. The charge nurse stated that the RN's were trained on how to complete the "Seclusion and /or Restraint RN 1 hour Initial Assessment Form" and that the assessment was completed on the "Seclusion &/or Restraint Q 15 Minutes Evaluation Form.

An interview was conducted on 7/11/12 at approximately 9:25 AM with the Director of Behavioral Health Services (BHS). The Director of BHS was asked what training the RN's received to ensure that they were competent to perform the face-to-face comprehensive physical and psychological assessment within 1 hour of initiation of restraints and or seclusion. The Director of BHS stated, "All of the RN's received training, but it is not that extensive". The Director of BHS confirmed that the RN's were not performing comprehensive physical and psychological assessments of patient during the initial face to face assessment.

An interview was conducted on 7/11/12, at approximately 11:15 AM, with Psychiatrist 1 for the BHS units. Psychiatrist 1 stated that the RN's were responsible for completing the face to face initial assessment within 1 hour of the initiation of restraints and or seclusion. He stated that the assessment included: vital signs, monitoring the patient's behavior and response to the restraints/seclusion, calling the physician for new orders for the restraint and or medication and monitoring the patients' on going need for restraints and or seclusion. Psychiatrist 1 stated that the hospital policy was for the physician to complete a face to face assessment within 24 hours of initiation of restraints or seclusion.

A review of the facility policy titled, "Restraint or Seclusion", reviewed 6/12, and included the following: "Restraint or Seclusion", reviewed 6/12, and included the following:

"Violent/Self Destructive Restraint: One-hour face-to-face assessment- The physician or an appropriately trained Registered Nurse or Physician ' s Assistant will perform a face-to-face assessment of the patient ' s physical and psychological status within one hour of initiation of R/S (restraint/seclusion) ".

An interview was conducted on 7/11/12, at approximately 2:30 PM with the Director of Education and a review was conducted of the RN's competency training received for conducting the 1 hour face-to-face evaluation. Absent from the training were physical (complete review of system assessment) and behavioral assessment; as well as the assessment of the patient's history, drugs and medications interactions, most recent labs, etc.

During the same interview and review of the RN training material, the Director of Education confirmed that the RN training did not include a comprehensive physical and behavioral assessment. The Director of Education stated that the hospital policy was not specific as to the appropriate training necessary for the nurses to be competent in performing the face-to-face initial assessment within 1 hour of initiation of restraint/seclusion for violent or self-destructive behaviors to meet the regulation.

Based on interview and record review, the hospital failed to ensure that the Registered Nurses (RN) completing the face to face initial assessment, for 1 of 23 sampled nursing patients, within 1 hour of initiation of restraints and seclusion for violent or self-disruptive behaviors; had the training and education necessary to be competent in performing comprehensive physical and psychological assessment of the patients. This failure resulted in the RN's not performing a complete review of systems and assessing what factors were contributing to the patients' violent behavior and had the potential for negative outcomes for a universe of 53 patients on the Behavioral Health Services.

Findings:

On 7/9/12, a review of Patient 48's medical record was reviewed. It noted the patient was admitted to the hospital on 7/6/12, and was placed on a 5150 hold (involuntary placement into the acute psychiatric unit for 72 hours due to danger to self and others). Diagnoses included paranoid schizophrenia (characterized by delusions; symptoms may include anger and anxiety and aloofness and doubts about gender identity; the patients are usually presentable and (if delusions are not acted on) may function in an apparent normal way) and drug and alcohol abuse.

An interview was conducted on 7/11/12 at approximately 9:25 AM with the Director of Behavioral Health Services (BHS). The Director of BHS was asked what training the RN's received to ensure that they were competent to perform the face-to-face comprehensive physical and psychological assessment within 1 hour of initiation of restraints and or seclusion. The Director of BHS stated, " All of the RN's received training, but it is not that extensive".

An interview was conducted on 7/11/12 at approximately 2:30 PM with the Director of Education and RN 3's competency file was reviewed. The Director of Education confirmed that the RN's training was not comprehensive and did not include system assessment (a head to toe system assessment of the patient). RN 3 completed the 18 minute video presentation titled, "Restraints, Seclusion, and the 1 Hour Face-to-Face Evaluation" the required training for all RN's. The power point presentation that accompanied the video included the following RN responsibilities:

"In Behavioral Services, in cases of emergency, an RN's who have completed this training must conduct a face-to-face assessment within 1 hour of application of restraint".
"What happens if the order time limit expires but the patient still needs restraints and/or seclusion and the physician is not available to re-evaluate the patient?"
"A competent RN who performs a face-to-face may conduct the re-evaluation of restraints and/or seclusion for the patient. After the evaluation, the RN must:

Promptly call the physician and discuss the evaluation.
Write a new verbal order for the continued use of restraints and/or seclusion.
Document the assessment in the medical record, including the justification and the continued use of restraints and or seclusion".

Physician's responsibilities:

"Face-to-face evaluations conducted by the Physician must be within 24 hours of initiation of restraint and/ or seclusion if the patient has been released before 8 hours. The evaluation determines whether or not the patient is released within the time frame of the written order. "
"The physician must sign the order for restraints and/or seclusion:

Upon the next visit.
Within 24 hours of the original order, whichever is less".

Restraint/Seclusion: Face-to-face Evaluation:

"A face -to-face assessment requires: Evaluation of the patient ' s safety within 1 hour after the initiation of the restraint(s) and/or seclusion by the physician, or a competent RN to perform a face-to-face assessment".
"A face-to-face assessment also requires:
Evaluation for the continued need for restraint and/or seclusion and patient safety.
Status of patient ' s physical/mental/psychological/behavioral condition.
Presenting issues of immediate situation.
Reaction to the restraint".

A review of the facility policy titled, " Restraint or Seclusion", reviewed 6/12, and included the following:

"Violent/Self Destructive Restraint: One-hour face-to-face assessment- The physician or an appropriately trained Registered Nurse or Physician ' s Assistant will perform a face-to-face assessment of the patient ' s physical and psychological status within one hour of initiation of R/S (restraint/seclusion) ".

During the same interview and review of the RN training material for the face to face initial assessment within 1 hour of initiation of restraint and seclusion, the Director of Education confirmed that the hospital policy was not specific as to the RN training requirements to perform this task. She also confirmed that the RN training was not comprehensive and did not provide the RN's with the appropriate training to be competent in performing the initial face to face assessment within 1 hour of the initiation of restraint and seclusion. The hospital did not provide documented evidence that the RN's were qualified to conduct a comprehensive physical and behavioral assessment of the patients.

Based on observation, interview and record review, The Quality Assessment and Performance Improvement Program:
1. Failed to ensure that the radiology study reporting process resulted in results being available to clinical staff, and did not ensure an accurate and complete medical record that included the results of imaging studies, and did not ensure that a system of abbreviations and colored marker chips used to encode patient conditions was universally understood by the staff and implemented, creating the risk of substandard medical care for all patients using the hospital (A267).

2. Failed to ensure that data collected was used to monitor the quality of care performed in the hospital and as a basis for improvements, creating the risk of substandard care for all patients in the BH unit (A274).

3. Failed to ensure that the Nutritional Services department collected quality data that monitored the effectiveness of care. This occurred when they set up criteria for the dietitian recommendations being carried out to be completed within 4 days. This length of time allowed to carry out dietitian recommendations was not effective at ensuring that the nutrition needs of the patients were being met in a timely manner (A275).

The cumulative effect of these failings meant the Quality Assessment and Performance Improvement Program did not ensure high quality healthcare provided in a safe environment for all patients obtaining services.
Findings:

1. During a review of radiology studies on 7/9/12 through 7/12/12, the results of 6 patients (Patients 2, 8, 16, 17, 18 and 19) were not available because they were "on hold" for up to 14 days pending radiologist review and correction (see A-553).

In an interview with the Dir Radiology on 7/12/12 at 1030 hours, he stated that he was not sure why holds on radiology reports were not being resolved in a timely fashion. He stated that he had not been evaluating how the holds got resolved.

1a. During a review of the closed medical records of Patients 10 and 11, the paper records did not contain evidence of CT scans being performed on the patients-the section of the record for imaging results was empty. The medical record of Patient 10 had attached flags indicating the records had been reviewed by medical records staff, and pages were flagged where physician signatures were required, but the record did not have flags for the missing reports (see A-553).

In an interview with the Dir MR on 7/13/12 at 1045 hours, she reviewed the medical records of Patients 10 and 11 and stated that that there were no imaging results in the records. She stated that the paper record was the legal medical record for the hospital, and should contain all of the results and reports of patient tests. She stated that the medical records were analyzed for physician errors and omissions, but not for accuracy and completeness. She stated there is a breakdown in the system of ensuring that results were placed in the paper medical record. (See also A 553.)

In an interview with the Dir Risk on 7/13/12 at 3 PM, she stated that performance improvement monitoring for the medical records included assessing completeness of the physician's components, not other aspects of the medical record.

1b. During a tour of the 4th floor nursing station on 7/10/12 at 0900 hours, a board with patient information, some of it encoded in abbreviations or colored chips, was seen. During subsequent interviews, some of the staff were aware of the meaning of the colored chips and abbreviations, while others were not. For one patient, Patient 6, a colored marker was used for which he did not have a qualifying condition (see A-392).

In an interview with the Dir QI on 7/10/12 at 1255 hours, she stated that she was unsure if the issue of staff correctly interpreting and using abbreviations and marker chips was the subject of QI review.

The QI department documentation of Performance Improvement Monitoring summaries was reviewed on 7/12/12, and did not contain evidence that the completeness of the medical record, the timeliness of radiology reports and the coding system used in nursing stations were subject to QI review.

2. The hospital failed to ensure that the face-to-face assessment of 1 of 23 sampled nursing patients was completed within 1 hour of the initiation of the restraint (involuntary restricting the movement of arms or legs or the whole body) and seclusion (patient place alone in a quiet room being monitored by staff) for patients with violent and self-destructive behaviors, included both a comprehensive physical and behavioral assessment of the patients by qualified practitioners within the scope of their practice. This failure resulted in patients' not receiving a comprehensive physical and behavioral assessment to determine what factors were contributing to the patients' behavior that required the use of restraint and seclusion. This had the potential to negatively affect the health and safety of a universe of 53 patients on the Behavioral Health Units (see A-179 and A-205).
For 3 BH unit patients (Patients 2, 10 and 11), the safety of the patients was not ensured through monitoring checks performed each 15 minutes (see A-144).

In an interview with the Dir Risk on 7/13/12 at 3 PM, she stated that QI monitoring in the BH unit had not been reported through the QI committee, the MEC, the psychiatry section committee or the governing body. She stated that there was a restraints auditing tool, but aggregated data and analysis of the data had not been seen. She stated that the QI program had not addressed the adequacy of the restraint auditing tool. She stated that the tool checked whether the auditing forms had been completed, but did not address the quality of the documentation on the forms. She stated that the Clin Dir BH collected data on the 15 minutes monitoring checks, but the data had not been brought forward to the QI department.

3. During an interview with the Clinical Nutrition Manager (CNM) on 7/11/12 at 3:15 PM, she stated that the Clinical Nutrition Services department collected data regarding acknowledgement by the physician of the dietitian's recommendation. She stated that a record review met the criteria for appropriate acknowledgement if it occurred within 4 days of the recommendation. She stated that the study indicated that the criteria were met consistently in at least 95% of the records reviewed. The CNM verified that the dietitian recommendations should have been acknowledged and carried out in a timelier manner. She was not sure what the average length of stay for the patients in the hospital was.

During an interview with the Director of Pharmacy (DP) on 7/12/12 at 11:30 AM, she stated that the average length of stay for patients in the hospital was 4.4 days.

A review of the study dated 2012- 2013 revealed that it did not capture data on the timeliness of the dietitian recommendations being implemented, especially in a patient population that only had an average hospital stay of 4.4 days.

Based on observation, interview and record review, the hospital failed to ensure that of radiology study reporting process resulted in results being available to clinical staff, and did not ensure an accurate and complete medical record that included the results of imaging studies, and did not ensure that a system of abbreviations and colored marker chips used to encode patient conditions was universally understood by the staff and implemented, creating the risk of substandard medical care for all patients using the hospital.

Findings:

1.During a review of radiology studies on 7/9/12 through 7/12/12, the results of 6 patients (Patients 2, 8, 16, 17, 18 and 19) were not available because they were "on hold" for up to 14 days pending radiologist review and correction (see A-553).

In an interview with the Dir Radiology on 7/12/12 at 1030 hours, he stated that he was not sure why holds on radiology reports were not being resolved in a timely fashion. He stated that he had not been evaluating how the holds got resolved.

2. During a review of the closed medical records of Patients 10 and 11, the paper records did not contain evidence of CT scans being performed on the patients-the section of the record for imaging results was empty. The medical record of Patient 10 had attached flags indicating the records had been reviewed by medical records staff, and pages were flagged where physician signatures were required, but the record did not have flags for the missing reports (see A-553).

In an interview with the Dir MR on 7/13/12 at 1045 hours, she reviewed the medical records of Patients 10 and 11 and stated that that there were no imaging results in the records. She stated that the paper record was the legal medical record for the hospital, and should contain all of the results and reports of patient tests. She stated that the medical records were analyzed for physician errors and omissions, but not for accuracy and completeness. She stated there is a breakdown in the system of ensuring that results were placed in the paper medical record. (See also A 553.)

In an interview with the Dir Risk on 7/13/12 at 3 PM, she stated that performance improvement monitoring for the medical records included assessing completeness of the physician's components, not other aspects of the medical record.

3. During a tour of the 4th floor nursing station on 7/10/12 at 0900 hours, a board with patient information, some of it encoded in abbreviations or colored chips, was seen. During subsequent interviews, some of the staff were aware of the meaning of the colored chips and abbreviations, while others were not. For one patient, Patient 6, a colored marker was used for which he did not have a qualifying condition (see A-392).

In an interview with the Dir QI on 7/10/12 at 1255 hours, she stated that she was unsure if the issue of staff correctly interpreting and using abbreviations and marker chips was the subject of QI review.

The QI department documentation of Performance Improvement Monitoring summaries was reviewed on 7/12/12, and did not contain evidence that the completeness of the medical record, the timeliness of radiology reports and the coding system used in nursing stations were subject to QI review.

Based on interview and record review, the QI program did not ensure that data collected was used to monitor the quality of care performed in the hospital and as a basis for improvements, creating the risk of substandard care for all patients in the BH unit.

Findings:

The hospital failed to ensure that the face-to-face assessment of 1 of 23 sampled nursing patients was completed within 1 hour of the initiation of the restraint (involuntary restricting the movement of arms or legs or the whole body) and seclusion (patient place alone in a quiet room being monitored by staff) for patients with violent and self-destructive behaviors, included both a comprehensive physical and behavioral assessment of the patients by qualified practitioners within the scope of their practice. This failure resulted in patients' not receiving a comprehensive physical and behavioral assessment to determine what factors were contributing to the patients' behavior that required the use of restraint and seclusion. This had the potential to negatively affect the health and safety of a universe of 53 patients on the Behavioral Health Units (see A-179 and A-205).
For 3 BH unit patients (Patients 2, 10 and 11), the safety of the patients was not ensured through monitoring checks performed each 15 minutes (see A-144).

In an interview with the Dir Risk on 7/13/12 at 3 PM, she stated that QI monitoring in the BH unit had not been reported through the QI committee, the MEC, the psychiatry section committee or the governing body. She stated that there was a restraints auditing tool, but aggregated data and analysis of the data had not been seen. She stated that the QI program had not addressed the adequacy of the restraint auditing tool. She stated that the tool checked whether the auditing forms had been completed, but did not address the quality of the documentation on the forms. She stated that the Clin Dir BH collected data on the 15 minutes monitoring checks, but the data had not been brought forward to the QI department.

Based on interviews and record reviews, the hospital failed to ensure that the Nutritional Services department collected quality data that monitored the effectiveness of care. This occurred when they set up criteria for the dietitian recommendations being carried out to be completed within 4 days. This length of time allowed to carry out dietitian recommendations was not effective at ensuring that the nutrition needs of the patients were being met in a timely manner.

Findings:

During an interview with the Clinical Nutrition Manager (CNM) on 7/11/12 at 3:15 PM, she stated that the Clinical Nutrition Services department collected data regarding acknowledgement by the physician of the dietitian's recommendation. She stated that a record review met the criteria for appropriate acknowledgement if it occurred within 4 days of the recommendation. She stated that the study indicated that the criteria were met consistently in at least 95% of the records reviewed. The CNM verified that the dietitian recommendations should have been acknowledged and carried out in a timelier manner. She was not sure what the average length of stay for the patients in the hospital was.

During an interview with the Director of Pharmacy (DP) on 7/12/12 at 11:30 AM, she stated that the average length of stay for patients in the hospital was 4.4 days.

A review of the study dated 2012- 2013 revealed that it did not capture data on the timeliness of the dietitian recommendations being implemented, especially in a patient population that only had an average hospital stay of 4.4 days.

Based on interview and record review, the hospital failed to ensure that the medical history and physical (H&P) examination for 1 of 23 nursing sampled patient (Patient 62) was completed. For Patient 62, the hospital failed to ensure that the H&P was completed and contained within the patient ' s closed medical record. This failure created the potential for all patients that received services at the hospital to not have their overall medical condition documented, which may contribute to negative health care outcomes for those patients.

Findings:

On 7/13/12, Patient 62's medical record was reviewed.
Patient 62 was admitted to the facility on 5/10/12 and discharged from the hospital on 5/10/12. The patient's diagnoses included pneumonia (a bacterial lung infection).

A review of the patient's medical record failed to show evidence that a medical H&P examination was completed for Patient 62.

On 7/13/12 at 2:40 PM, an interview was conducted with the Director of Medical Record (DMR). She reviewed the patient's closed medical record and confirmed that the H&P was not completed. The DMR stated that it should have been completed and contained within the patient's medical record.

Based on observation, interview and record review, the hospital did not ensure that a system of codes and colored markers used to flag patient conditions was understood and correctly implemented, creating the risk of substandard care for all patients in the hospital.

Findings:

During an observation on 7/10/12 at approximately 0910 hours, of the nursing station on the 4th floor, an informational white board contained written patient information, including codes, such as " dw " , and colored magnetic chips in yellow, green, purple, pink and blue. The patient care team was observed rounding in front of the board and referencing information on the board. There were legends on the board that indicated the meaning of some of the chips (including the yellow and purple chips), but not others (such as the blue or pink chips).

In an interview with RN 7 on 7/10/12 at approximately 0900 hours, she stated that she knew the meaning of some of the color chips, such as yellow chip meaning falls precautions were to be implemented, but not of others, such as the green and blue chips. She was not sure what the meaning of " dw " was.

In an interview with the Dir CM on 7/10/12 at approximately 910 hours, she looked at the board and stated that she did not know what the pink chip meant.

In an interview with RN 8 on 7/10/12 at approximately 0915 hours, she stated that the blue chip meant the patient was not on telemetry and the green chip represented a hemodialysis patient, while a pink chip meant the patient was at increased risk for skin breakdown, and that "dw" meant "daily weights". She stated the pink chip was placed when the patient had a Braden scale score of less than or equal to 18, which signaled an increased risk of skin breakdown.

The chips on the board next to Patient 6's identifying information included a pink chip.

The medical record of Patient 6 was reviewed and the Braden score for 7/9/12 was 20, and there was no new score posted for 7/10/12.

During a continuing interview with RN 8, she reviewed the medical record and stated that Patient 8 had a Braden score of 22 upon admission, and that it had been 20 since admission, so the patient did not appear to qualify for the pink chip on the board.

A policy for the colored chips and abbreviations in use in the nursing station was requested, but in an interview with the Dir Pharm on 7/12/12 at 2 PM, she stated there was no policy specific to the colors. She provided copies of training materials that had been presented to the nurses. The training materials included a legend of the colored markers to be used on the 4th floor. The meaning of blue and pink colors were not included in the legend.

Based on observation, record review and interview, the hospital failed to ensure that the Registered Nurses (RN's) were supervising and evaluating the nursing care/services for 2 of 23 nursing sampled patients (Patient 41, 43) and for 2 or 6 patients reviewed for nutrition care (Patients 21 and 22) when:

1. The hospital failed to ensure that the registered nurse informed 1 of 23 nursing sampled patients (Patient 41) admitting physician of the abnormal blood potassium level result timely. For Patient 41 who was 26 days old, and admitted to the hospital with an abnormal blood potassium (electrolyte) level 5.5 (normal 3.5- 5.0) on 7/10/12 at 6 AM, the physician was not notified of the abnormal potassium until 3 hours after admission. This failure had the potential for all patients that received services at the hospital to not have their abnormal laboratory studies reported to the physician timely, which may contribute to a delay in prompt treatment.

2. The hospital staff failed to follow up on the Registered Dietitian (RD) recommendations for for Patient 43 dated 7/8/12, to change and increase the percutaneous endoscopic gastrostomy (PEG tube, is a surgical incision and the placement of a tube directly into the stomach for long term administration of food, fluids, and medications) formula in a timely manner. This had the potential to cause malnutrition (a medical condition caused by improper or insufficient diet) and delay the healing of the Stage II pressure ulcer (partial thickness loss of the skin) to the sacral area (large bone at the base of the spine).

3. The hospital failed to ensure the Nutrition Screening of patients were completed accurately by the RN for 2 or 6 patients reviewed for nutrition care (Patients 21 and 22) .

These failures had the potential to cause a delay in identifying medical and nutrition problems and a delay in the provision of appropriate medical assessment and nutritional assessment and care.

Findings:

1. On 7/10/12, Patient 41's medical record was reviewed with a Registered Nurse (RN) 4. RN 4 stated that the patient was admitted at 6 AM.

A review of the patient's laboratory results dated 7/10/12 at 2:15 AM was conducted and showed that the potassium level was 5.5 (high). RN 4 stated that the potassium level result was obtained from the transferring hospital.

A review of the admission physicians orders dated 7/10/12 at 6:45 AM was conducted and showed that the patient was admitted to rule out sepsis (a systemic blood infection). The medication orders included intravenous fluids (IVFs via vein), dextrose 5 % in water 0.25 % normal saline with 10 milliequivalents of potassium per liter.

A review of the Nursing Documentation with RN 4 failed to show that the abnormal potassium level was reported to the physician on admission. On 7/10/12 at 10:30 AM, RN 4 confirmed the finding.

On 7/10/12 at 10:40 AM, RN 4 stated that she notified the physician of the abnormal potassium level at 9:50 AM (3 hours and 50 minutes later). She stated at that time she obtained a new physician order for IVFs dextrose 5 % in 0.25 % normal saline. RN 4 stated that the hospital's policy was to notify the physician as soon as the abnormal laboratory result was received.

A review of the hospital's policy and procedure titled, "Critical Test and Critical Result/Value Policy," dated 2/12, was conducted and showed that the purpose for the policy was to establish a process by which critical tests and critical lab values/results are defined and reported to the responsible caregiver so that the patient may be treated promptly. All critical results/values as specified in Appendix B and are first time critical results will be reported to the ordering physician with 15 minutes that the abnormal result is noted.


28068


2. On 7/10/12, Patient 43 s medical record was reviewed. It noted that the patient was admitted to the hospital on 7/7/12. The diagnoses included syncope (partial or complete loss of consciousness with interruption of awareness of oneself and ones surroundings), end stage renal disease (ESRD, the kidneys are no longer able to work at a level needed for day-to-day life) on dialysis (a medical process that is used when a person's kidneys are damaged and can no longer filter toxins from the blood) and stage 2 pressure ulcer (partial thickness loss of dermis, layer under the skin) on the sacral area ( the large bone at the base of the spine).

On 7/10/12 at 9:00 AM, observation was made of Patient 43 in a semi-sitting position in the bed. Glucerna (specialized nutrition with fiber for abnormal glucose tolerance) was infusing at 30 milliliter (ml)/hr (hour) via the PEG tube. A review of the RD consultation completed on 7/8/12 including the following:
"Patient currently on: Glucerna at 30 ml/hr x 24 hours = 720 KCAL (calories), 30.1 GM (gram) protein, 614 ml free water".
"Patient estimated nutritional needs: 1650 - 1925 KCAL, Protein 66-83 GM, fluid per MD (medical doctor)."
"Interventions/recommendations: Recommend switch tube feeding to Nepro (a nutritional product specifically designed to help meet the nutrition needs of people on dialysis) as this is pt ' s home formula rate of 40 ml/hr to provide 1728 KCAL, 78 GM protein and 696 ml free water".

An interview was conducted on 7/10/12 at approximately 10:10 AM with the Manager of the Intensive Care Unit (ICU) and the Senior Director of Clinical Services and Patient 43's medical record was reviewed. The ICU Manager and the Senior Director of Clinical Services were unable to provide documented evidence on the computer or in the medical record that the RD recommendation was carried out. They both confirmed that Patient 43 was still receiving Glucerna at 30 ml/hr and that there was no physician order to change the formula or to add free water. Based on the current Glucerna formula, Patient 43 was receiving less than ? of the daily required calories and protein.

An interview was conducted on 7/10/10 at approximately 2:08 PM with Chief Clinical Dietician and the process for follow up of RD recommendation was reviewed. The Chief Clinical Dietician stated that the RD recommendation was placed in the physician progress notes section of the medical record. Within 2 days if there was no change in orders, the RD could follow-up by written note, face to face or a telephone call. She stated that the RD should have communicated the recommendations with the nursing staff. The Dietician stated that Nutrition Services had up to 4 days to reassessed the high risk patients nutritional needs.

A review of the hospital policy titled, "Assessment and reassessment of Patients", effective 8/97, included the following under "Strategies for Clinical Management and Interdisciplinary Assessment and Reassessment of Patients":
"Nutrition Services: "High risk patients identified to be at high nutritional risk will be assessed by the Dietitian within 1 day of notification".
The following criteria will be used to determine high nutrition risk: Adult
Tube feeding or TPN (total parenteral nutrition is an intravenous feeding that provides nutrition and fluids for someone who cannot take in foods and fluid orally).
Unplanned weight loss
Difficulty chewing /swallowing
Open wound or pressure ulcer
Unable to eat for > (greater) 5 days

"Time frame for re-assessment of high risk: every 2-4 days, based on the patient's nutritional needs and risk status and the patient's response to care and significant change in patient's condition, diagnosis or physicians orders".

An interview was conducted on 7/10/12, at approximately 12:30 PM with Registered Nurse (RN) 5, the charge nurse for Patient 43. RN 5 stated that the physician should have reviewed the dietitian recommendation and the RD should have followed up with a nurse.

An interview was conducted on 7/11/12, at approximately 4:20 PM with RD 1, who completed the nutritional consultation on Patient 43 on 7/8/12. RD 1 stated that usually she would discuss her recommendations with the RN, but one was not available at the time. Also, since she worked part-time, she would leave a note for the other RD to follow-up on her recommendations. RD 1 stated that she could also contact the physician by telephone with her recommendations.


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3. A review of the medical record for Patient 21 revealed that the patient was admitted to the hospital on 7/7/12 with a pressure ulcer (bed sore) on the right hip. The patient's height was 5 foot 7 inches and weight was 109 pounds (80% of ideal body weight). A review of the Nutrition Screening portion of the General Admission the Assessment completed by the RN, dated 7/7/12, inaccurately showed that the patient did not have any open wounds or pressure ulcers. There was no assessment by the RN to indicate the patient's weight was less than desirable.

During an interview with the Clinical Nutrition Manager (CNM) on 7/10/12 at 2:45 PM, she stated that since the patient had a pressure ulcer, the dietitians should have received a consult for a nutrition assessment. She verified that there was no consult.

During an interview with RN 5 on 7/10/12 at 3:00 PM, she verified that the patient had a pressure ulcer and that the Nutrition Screening was not accurate.

A review of the medical record for Patient 22 revealed that the patient was admitted to the hospital on 7/3/12 from the hospital's long term care unit with a long history of requiring a tube feeding (artificial feeding)
for nutrition and a wound. A review of the Nutrition Screening portion of the General Admission Assessment, dated 7/3/12, showed that the RN indicated the patient did not have a tube feeding and did not have a wound.

During an interview with the CNM on 7/10/12 at 3:45 PM, she verified that the Nutrition Screening was not accurate. She also verified that the RN did not consult the dietitian for a nutrition assessment and to evaluate the nutrition plan of care. The CNM verified that there was potential for patients who were at high nutrition risk to not be provided appropriate nutrition care when the RN did not accurately screen the patients for nutrition risk factors.

A delay in appropriate nutrition care for patients can result in further decline in their nutrition and overall medical status.

Based on interview and record review, for 1 of 41 patients, Patients 2, the hospital did not ensure that the need for seizure precautions was addressed with a care plan, and that the care plan was implemented, creating the risk of a poor health outcome for Patient 2 due to unanticipated needs associated with risk of seizures.

Findings:

The Dir Pharm was asked about seizure precautions on 7/13/12 at 10:25 AM, and she stated that there was no policy specific to seizures, but that the hospital referenced Perry and Potter, a nursing text.

According to page 342 of the Perry and Potter text, care planning for seizures includes inspecting the patient's room for hazards and keeping the bed in a low position, with siderails up at the head of the bed, with the patient in a side-lying position when possible.

During a review of the medical record of Patient 2 on 7/9/12 at 1:25 PM, the care plan section of the record indicated that the patient was on seizure precautions and suicide precautions. The binder containing the patient's paper medical record bore a large yellow sticker on which was written, " falls precautions " .

The Mgr BH was interviewed on 7/9/12 at 13:25 hours and 14:30 hours, and she reviewed the medical record of Patient 2 and stated that the patient was not on falls precautions, and that sticker must have been placed on her admission to the hospital, and that it was no longer appropriate. The Mgr BH stated that seizure precautions included padding the bed and placing a yellow armband on the patient, but that there was no policy on seizure precautions.

The Mgr BH reviewed the forms that the hospital used for recording observations of patients each 15 minutes. The forms contained a box to check for " seizure precautions " . The box was not checked on Patient 2's forms.

The Mgr BH stated that the seizure precautions box should have been checked.

Based on interview and record review, for two patients (Patients 10 and 11), the hospital did not ensure a complete and accurate medical record because imaging results had not been filed in the closed medical record, and for one surgical patient (Patient 7), there was omissions from information gathered for the pre-anesthesia evaluation by the nurse, creating the risk of a substandard health outcome for those patients.

Findings:

The hospital policy, Distribution of Department of Medical Imaging Procedural Reports (revised 6/12) read in part, "A copy of the report is printed in the Medical Records department and is permanently maintained in the patient's medical record file."

During a review on 7/12/12 of the closed medical records of Patients 10 and 11, the paper records did not contain evidence of CT scans being performed on the patients-the section of the record for imaging results was empty.

In an interview with the Dir MR on 7/13/12 at 10:45 AM, she reviewed the medical records of Patients 10 and 11 and stated that that there were no imaging results in the records. She stated that the paper record was the legal medical record for the hospital, and should contain all of the results and reports of patient tests. She stated that unless the CT results were specifically requested, a request for a copy of the medical record would be met by copying the paper medical record only. She stated that labs and radiologic study results were to be printed and placed in the record on the unit. She stated that she thought there was an automatic mechanism by which the results were printed, and that the unit secretary was to then file the results in the record.

The Dir Radiology was interviewed on 7/12/12 at approximately 2:30 PM and was unable to state why the CT reports were not in the paper medical records. He stated that the reports were in the computer.

The medical record of Patient 7 was seen on 7/11/12 at approximately 9:30 AM. The patient was admitted to the hospital for surgery on her nasal septum. The record contained a Preanesthesia Questionnaire that had been completed by phone by a nurse on 7/10/12. The portion of the questionnaire for sleep apnea screening had been left blank. The form indicated that the patient used a nerve stimulator unit, but the questions about limitation affecting the motion of arms and legs and handicaps were left blank.

In a concurrent interview with the DOS, she reviewed the form and stated that the blank sections should have been completed.

Based on record review and interview, the hospital failed to ensure that verbal/telephone orders were authenticated (signing and verifying that the orders were accurate) within 48 hours for 2 of 4 nursing discharge records reviewed (Patient 60, 61). This had the potential for the staff to not identify and correct errors timely which could result in negative outcomes for the patients, as evidenced by:

1. The hospital failed to ensure that Resident 60's verbal/telephone orders dated 6/22/12, 6/27/12 and 7/1/12 were authenticated by the physician within 48 hours.

2. The hospital failed to ensure that Resident 61's verbal/telephone orders dated 6/18/12 were authenticated by the physician within 48 hours.

Findings:

1. On 7/12/12, Patient 60's medical record was reviewed. It noted that the patient was admitted to the hospital on 6/22/12 and discharged on 7/2/12. The diagnoses included bipolar disorder (radical emotional changes and mood swings, from manic, restless highs to depressive, listless lows) and, 5150 hold (involuntary placement into the acute psychiatric unit for 72 hours due to danger to self and others).

A review of the physician orders was conducted on 7/12/12. It noted the following telephone orders that were not authenticated:
"6/22/12 at 16:10, Emergency Medications x 24 hours: Zyprexa (antipsychotic medical use to treat behaviors) 10 milligram (mg) PO (by mouth) Q (every) 8 hours PRN (as needed) with Ativan (antianxiety medication) 2 mg PO Q 8 hours PRN severe agitation. May give IM (injection intramuscular) if PO refused. Zyprexa, 10 mg, IM, Q 8 hours PRN with Ativan 2 mg IM Q 8 hours PRN severe agitation " .
"6/27/12, Nicoderm (nicotine replacement therapy to decrease smoking) patch 21 mcg topical (on the skin) Q 24 hours".
"7/1/12, Renew Oxycodone (a narcotic use to treat pain) order: Oxycodone HCL 10 mg PO TID (three times daily) for pain".

A review of the facility policy titled, "Medical Staff General Rules and Regulations 2012" included the following:
" ...All orders dictated over the telephone shall be signed by the person who dictated with the name of the physician per his/her own name. The prescriber shall date and time and countersign medication orders within forty-eight hours. All other orders shall be signed within 14 days of discharge".

An interview was conducted on 7/12/12, at approximately 3:00 PM with the Director of Medical Records. She confirmed that the orders were not authenticated by the physician within 48 hours per the hospital policy.

2. On 7/12/12, Patient 61's medical record was reviewed. It noted that the patient was admitted to the facility on 6/17/12 and discharged on 6/25/12. The diagnoses included bipolar disorder and 5150 hold.

A review of the physician orders noted the following telephone order not authenticated:
"Given 10 mg Haldol (antipsychotic medication use to treat behaviors) IM with 2 mg with 2 mg Ativan IM and 50 mg of Benadryl (antihistamine with sedating effects) IM Q 6 hours PRN agitation as emergency medications for 24 hours".
"Restraints for protection of self and others not exceed 4 hours".

An interview was conducted on 7/12/12, at approximately 3:05 PM with the Director of Medical Records. She confirmed that the orders were not authenticated by the physician within 48 hours per the hospital policy.

Based on interview and record review, the hospital failed to ensure that the pharmacist reviewed the medication for 1 of 23 nursing sampled patients (Patient 41) prior to administration. For Patient 41, the Registered (RN) Nurse administered intravenous (IVFs-via vein) dextrose 5 % in 0.25 % normal saline prior to the pharmacist review and approval for safe medication administration. This failure had the potential for all patients to receive medications that were not reviewed by the pharmacy prior to administration, which may contribute to adverse health outcomes.

Findings:

On 7/10/12, Patient 41's medical record was reviewed with a RN 4.

Patient 41 was admitted to the hospital on 7/10/12 at 6 AM to rule out sepsis.

On 7/10/12 at 10:40 AM, a medication pass administration was conducted with RN 4. She administered IVFs, dextrose 5% in .25 % normal saline to the patient's left hand intravenous catheter.

A review of the electronic medication administration document (EMAD)was conducted with RN 4. There was no documented evidence to show the physician ordered IVFs, dextrose 5% in .25 % normal saline. RN 4 stated that the EMAD did not show the medication, because she did not fax the physician order to the pharmacy prior to administration.

A review of the physician order, dated 7/10/12 at 9:50 AM was conducted and showed intravenous fluids (IVFS) dextrose 5 % in water 0.25 % normal saline.

On 7/10/12 at 11:30 AM, an interview was conducted with RN 4. She stated that the hospital's practice allowed IVFS without additives to be administered to patients prior to the first pharmacist review.

On 7/11/12 at 2 PM, an interview was conducted with the Director of Pharmacy (DP). The DP stated that all medications must be reviewed by the pharmacy prior to the first dose, unless there was an emergency situation.

On 7/12/12 at 3 PM, a review of the Pharmacy Order document was conducted. The documentation showed that the IVFs were approved by the pharmacy to start on 7/10/12 at 11:30 AM, not at 10:40 AM when the RN administered the fluids to Patient 41.

A review of the hospital's policy and procedure titled, "Pharmacist Review of Medication Orders," dated 3/12, was conducted and showed that the purpose of the policy was to ensure the safe and accurate ordering, preparation, dispensing administration, and monitoring of medications.

Policy: Before the drug is dispensed or administered, a pharmacist reviews each prescription or medication order against the medication profile and other relevant patient-specific information and contacts the prescriber or orderer when questions or concerns arise.

Based on observation, interview and document review, the hospital failed to ensure that the anesthesia work drawer in the operating room medication cart was available for review by pharmacy staff, and failed to ensure that the drawer was free of outdated medications, and failed to ensure that intravenous solutions placed in a warmer in the labor and delivery department had been dated, creating the risk of substandard medication administration for patients using the operating rooms, and substandard intravenous fluid administration for patients in labor and delivery, including the increased risk of infection from improperly stored fluid.

Findings:

1. The hospital policy, Outdated Drug Control (revised 3/12), read in part, The Department of Pharmacy will ensure that no outdated medications are dispensed for patient use or allowed to remain the in the dispensing area of the pharmacy. " , and " The pharmacy personnel will routinely check all nursing stations and other area where medications are stored, including all automated dispensing machines...".

During a tour of OR 4 on 7/10/12 at 4:15 PM, with the DOS, the anesthesia cart contents were reviewed and contained diphenhydramine 50mg/ml, 1mg vial expired 4/12.

The cart was opened through the use of a security password, but there was a locked drawer labeled, " Anesthesia work drawer " . When asked, the Mgr Surgical Services did not have a key to the lock. She was able to find an anesthesiologist to open the drawer. The drawer was seen to contain: Atropine sulfate 1 mg expired 1/12, epinephrine 1:10,000, 1 mg vial expired 2/12, metoprolol expired 9/11, oxytocin expired 8/11, biopatch expired 1/12, and metoprolol 5mg that had been opened, and had an illegible discard date marked on it.

During a concurrent interview with the DOS, she witnessed the medications and agreed that they were expired.

During an interview on 7/11/12 at 11:45 AM with the PM, he stated he stated that some pharmacists did not have the key to the anesthesia work drawer. He stated " we ' re working on it " in regards to the locked Anesthesia work drawer which contained expired medications.

2. The facility policy, Warming Cabinet Use For Blankets and Fluids (effective date 5/12) read in part, " Fluids in the warming unit are dated with the date they are to be removed. " The policy also read, " Solutions will be dated upon placement into the warmer and exchanged once they have reached their maximum time period. "

During a tour of Labor & Delivery on 7/11/12 at 10:10 AM, three bottles of 0.9% Saline irrigation fluid (fluid to wash surgical wounds) were observed in the blanket warmer, without documentation of the date they were placed in the warmer or an expiration date.

During a concurrent interview with the Labor & Delivery MLD and RN7, they confirmed the absence of a date on the bottles of irrigation fluid (fluid to wash surgical wounds) found in the blanket warmer.

Based on observation, interview and record review, for 6 patients (Patients 2, 8, 16, 17, 18 and 19), the hospital failed to ensure that radiologic study results were reviewed, corrected and made available to care providers in a timely fashion, and for two patients (Patients 10 and 11) failed to ensure that reports were in the paper medical record, creating the risk of substandard healthcare for patients requiring radiologic studies.

Findings:

1. The hospital policy, Distribution of Department of Medical Imaging Procedural Reports (revised 6/12) read in part, "All procedural reports from the Department of Medical Imaging will be forwarded to the appropriate physicians and/or physician's offices in a timely manner.", and "If a preliminary report is intiated by the interpreting Radiologist, the preliminary report is faxed to the appropriate floor/unit and/or physician immediately following the interpretation."

During a review of the medical record of Patient 2 on 7/9/12 at 1:25 PM, the record showed an order for an ultrasound of the lower extremity dated 7/7/12, but there was no result in the paper record.

The Mgr BH was interviewed on 7/9/12 at 1:30 PM and she checked the paper medical record and stated there was no result. She checked the electronic health record and stated that the test was performed on Saturday (7/7/12).

2. The hospital policy, Distribution of Department of Medical Imaging Procedural Reports (revised 6/12) read in part, "If a report is incorrrect or missing demoraphics: ...A copy of the requisition will be reprinted, assembled with the procedural films and submitted for re-dictation by either the lead technologist or the radiology Clerk. Verification that each procedure has been interpreted and a report transcribed is done each evening by the clirical personnel."

During a review of the medical record of Patient 2 on 7/9/12 at 1325 hours, the record showed an order for an ultrasound of the lower extremity dated 7/7/12, but there was no result in the paper record.

The Mgr BH was interviewed and she checked the paper medical record and stated there was no result. She checked the electronic health record and stated that the test was performed on Saturday (7/7/12), but there was no result available yet. She stated that the result was " on hold " in the computer.

The Dir Radiology was interviewed on 7/9/12 at 14:20 hours, and he stated that if in the review of the voice transcriptions a possible error in a radiology report was detected, the physician must review the report, and this caused a delay. He stated that a copy of Patient 2's initial, unclarified, report should nonetheless have been faxed to the nursing unit. He subsequently checked the fax log and stated that it had not been faxed to the unit. He was able to print a copy of the held report, which had been dictated on 7/7/12 at 10:12 AM. The report showed that the use of one word in the report was being questioned.

The report for a CT scan of the abdomen and pelvis done 7/9/12 for Patient 8, and transcribed on 7/10/12 at 0728 hours. The electronic radiology records were reviewed with the Dir Radiology on 7/12/12 at 1030 hours, and they showed that Patient 8's CT scan of the abdomen and pelvis, performed on 7/9/12, had been on hold, and the report was not available for review from the EMR system used by clinicians. During a concurrent interview with the Dir Radiology, he stated that he was not sure why the CT report had not been corrected and the hold removed.

During a tour of the radiology department on 7/12/12 at 1030 hours, in one of the two radiology viewing rooms (the room adjacent to the large work room), the radiology preliminary reports for an obstetrical ultrasound for Patient 16 from 7/4/12 at 4:19 AM, the ultrasound of the lower extremities for Patient 17 from 6/29/12 at 11:12 AM, the cervical spine x-ray of Patient 18 from 7/7/12 at 9:55 AM, and the abdominal ultrasound of Patient 19 from 7/10/12 at 1:02 AM were seen face down on a desk. Each of the reports bore the notation " the report is on hold " and the print date 7/11/12.

In an interview with the Dir Radiology on 7/12/12 at 1025 hours, he stated that the transcriptionist gave reports needing clarification to the radiologist by handing them to the radiologist or leaving them on a desk to be read.

DR 4, a radiologist, was interviewed on 7/12/12 at 0945 hours, and he stated that there were two reading rooms for the radiologist in the department, and that he preferred to use the room off of the hallway, not the room adjacent to the workroom. He stated that he was not told to check for studies needing correction left in the other reading room. He stated that if there were studies needing correction, either the transcriptionist handed them to him, or he learned of them by a phone call from his group's office.

The hospital policy on radiology reports was reviewed with the Dir Radiology. He confirmed that the policy read that the reports were to be reviewed and presented to the radiologist each morning.

3. The hospital policy, Distribution of Department of Medical Imaging Procedural Reports (revised 6/12) read in part, "A copy of the report is printed in the Medical Records department and is permanently maintained in the patient's medical record file."

During a review on 7/12/12 of the closed medical records of Patients 10 and 11, the paper records did not contain evidence of CT scans being performed on the patients-the section of the record for imaging results was empty.

In an interview with the Dir MR on 7/13/12 at 1045 hours, she reviewed the medical records of Patients 10 and 11 and stated that that there were no imaging results in the records. She stated that the paper record was the legal medical record for the hospital, and should contain all of the results and reports of patient tests. She stated that unless the CT results were specifically requested, a request for a copy of the medical record would be met by copying the paper medical record only. She stated that labs and radiologic study results were to be printed and placed in the record on the unit. She stated that she thought there was an automatic mechanism by which the results were printed, and that the unit secretary was to then file the results in the record.

The Dir Radiology was interviewed on 7/12/12 at approximately 2:30 PM and was unable to state why the CT reports were not in the paper medical records. He stated that the reports were in the computer.

Based on interviews and record reviews, the hospital failed to ensure the nutrition needs of the patients were met when:
1. the nutrition analysis of the menu was not comprehensive;
2. the fiber needs of the patients were not met with the regular diet;
3. the caloric content of the 1800 calorie diabetic diet ranged from 1630 to 2200 calories;
4. patients did not have the ability to make meal selections and were not informed of the menu prior to the arrival of their meal and therefore had delayed meal service when they were unable to eat the food served; and,
5. one of six patients reviewed for nutrition care, who was underweight, was no assessed timely by the registered dietitian.
The effect of these deficient practices had the potential to result in the nutrition needs of the patients not being met in a hospital with a licensed bed capacity of 227.

Findings:

1. A review of the hospital's nutrition analysis of their menus revealed that they had only a limited number of nutrients that had been analyzed. For vitamins, the analysis included only vitamins A and C. For minerals, the analysis included only calcium, sodium, iron and potassium.

During an interview with the Clinical Nutrition Manager (CNM) on 7/11/12 at 3:15 PM, she stated that the hospital did not have an analysis of all the nutrients for their menus. She verified that the analysis did not include all vitamins and minerals that were included in the Recommended Dietary Allowances (RDA) or the Dietary Reference Intakes (DRI) of the Food and Nutrition Board of the National Research Council. She was unable to state how she could evaluate the menus to determine if they met the needs of the patients without a comprehensive nutrition analysis.

2. A review of the hospital's nutrition analysis of their menus revealed that the requirement for fiber content of the regular diet was 25 grams of fiber daily. It further showed that for the regular diet, only one out of 21 days of menus contained 25 grams of fiber. The fiber content of the regular diet ranged from 12.9 grams to 25.2 grams daily. Also, the weekly average fiber content of the regular menus was 18.8 grams, 20.1 grams and 19.4 grams a day for the 3 weeks.

A review of the hospital's policy titled' "Menu Planning, Guidelines and Approval" dated 7/11, revealed that the menu was found to meet the DRI standards for 25 year old male. It further stated that the menus were approved by the Registered Dietitian.

According to the 2002/2005 Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids, the DRI for fiber for a 25 year old male is 38 grams of fiber a day.

During an interview with the CNM on 7/11/12 at 3:15 PM, she verified that the menu did not meet the DRI for dietary fiber. She stated that she understood that fiber in the diet was important, but was unable to state why the hospital's menus did not meet the requirements for fiber.

Including adequate dietary fiber in the diet is important in maintaining bowel health and has been linked to positive effects on weight control, blood glucose control and lowering of blood cholesterol.

3. A review of the hospital's nutrition analysis of their menus revealed that the caloric range for the 1800 calorie diabetic diet for the 3 week menu cycle was 1628 to 2197 calories. In 11 out of 21 days, the menus provided greater than 100 calories more or less than 1800 calories.

During an interview with the CNM on 7/11/12 at 3:15 PM, she verified this range of calories. She stated that she needed to work on ensuring that the 1800 calorie diabetic diet was more consistently closer to 1800 calories.

4. During an interview with the Director of Food and Nutrition Services (DFNS) on 7/9/12 at 9:15 AM, he stated that the hospital utilized a non-select, 3 week cycle menu. He further stated that the diet technicians obtain patient's food preferences and allergy information within 24 - 48 hours of a patient's admission. He verified that the patients do not get a copy of the menu and do not have access to information on what was going to be served before the meal arrived.

During an interview with the CNM on 7/11/12 at 12:00 PM, she verified that since the patients did not have access to the menu before their meal was served, they didn't have an opportunity to order an alternative before the meal arrived if they didn't like (or couldn't eat) what is served. The patients then had to wait for a late-tray which were made after all the other trays were sent out.

During an interview with Patient 23, a 19 year old male, on 7/11/12 at 12:10 PM, he stated that he didn't know what the food was going to be before it was served. He stated that once he got his food, he then had to ask for a substitute if he didn't like it. He stated that he usually got a burger and fries. He further stated that he sometimes had to wait a long time to get his meal when he asked for an alternative.

The patients are a risk for not eating when they are not offered a choice or are required to wait for a meal when they have been served food that they either are unable or don't want to eat.

5. A review of the medical record for Patient 26 revealed that the patient was admitted on 7/6/12 with a height of 5 feet 5 inches and a weight of 106 pounds. The patient's Body Mass Index (BMI) was 17.6, underweight. BMI is calculated from a person's height and weight. It provides an indicator of body fatness and is used as a screen for weight categories that may lead to health problems. A BMI below 18.5 is considered underweight.

Further review of the medical record indicated that the diet technician screened the patient on 7/9/12 and indicated that the patient met the criteria for a nutrition priority level 1 (high) due to poor appetite. The dietitian assessment was not completed until 7/10/12, 4 days after the patient was admitted, even though the patient was a priority level 1.

During an interview with the CNM on 7/12/12 at 10:20 AM, she stated that the diet technician's screen should have been completed within 48 hours (it was done in 3 days). She also stated that the hospital did not use BMI as an indicator of nutrition risk level.
A review of the hospital's policy titled, "Prioritizing Patients for Nutrition Assessment" dated 6/12, revealed that high risk patients (Priority Level 1) will be seen by the Registered Dietitian within 2 days of admission for an in-depth assessment.

During an interview with the Director of Pharmacy (DP) on 7/12/12 at 11:30 AM, she stated that the average length of stay for patients in the hospital was 4.4 days.

If high nutrition risk patients do not receive a nutrition assessment by the dietitian until 4 days after admission, nutrition interventions and care are delayed. They are also likely to occur on or after the last day the patient is in the hospital.

Based on observation, interview and document review, the hospital failed to ensure the availability of emergency supplies because an emergency supply " crash cart " in the emergency department lacked adult defibrillator pads, creating the risk of a delayed treatment and poor patient outcome in the emergency room.

Findings:

The hospital policy, Crash Cart and Resuscitation Supplies Location (revised 3/12), read in part, " Upon use of the Crash Cart or a discovery that supply contents have been compromised: Nursing administration personnel with take a stocked Crash Cart to the department/area for exchange of used/compromised cart. "

During a tour of the emergency room on 7/9/12 at 10:35 hours, the crash cart was seen, and the top of the cart contained a defibrillator machine and a tray containing pediatric defibrillator pads, but no adult defibrillator pads.

In a concurrent interview with the Clin Mgr ER, she stated that the adult pads might be in the cart. However, the cart was opened and contained no defibrillator pads. The Clin Mgr ER stated that the central supply sends the cart with the supplies, and that there was no routine for checking supplies that were not locked in the cart. She stated that the supplies on top might have been used, but the cart not unlocked, so it was not returned to central supply for restocking.

Based on observation, interview, and record review, the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to implement, an active program for prevention, control, and investigation of infections by failing to:


1. Ensure that a mother wore a disposable isolation gown when she was in the room with her 22 months old son who was on contact isolation (to prevent spread of organisms from an infected patient through direct (touching the patient) or indirect (touching surfaces or objects that that been in contact with the patient) per hospital policy (See A749).

2. Ensure that a Registered Nurse (RN) and family members wore eye shield (covering for the eyes) when they were within 3 feet of the patient on droplet isolation (to prevent the spread by droplets or dust particles, such as by coughing, sneezing, or talking or during procedures such as suctioning and bronchoscopy) per facility policy (See A749).

3. Ensure that the patient nourishment refrigerator in the out-patient laboratory department was free of employee drink (See A749).

4. Ensure that blood spill kits were readily available in all of the laboratory departments (A749).

5. Ensure that there were infection control measures in place to prevent the development of food borne illness and cross contamination with regards food service. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services staff (A749).


6. The hospital did not ensure that instruments were sterilized in the open position, creating the increased risk of infection for patients having surgery at the hospital (See A749 and A951).

7. For 1 patient, Patient 1, did not ensure the correct use of the rapid sepsis screening tool in use in the ER, and did not ensure that staff were educated about the correct completion of the screening tool (See A749).

These deficiencies had the potential for cross contamination and the spread of infection to patient and personnel. Also by not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared and distributed under unsafe and unsanitary conditions and there was potential for such continuation in the absence of identification and remediation.

Findings:

1. On 7/9/12, Patient 42 medical record was reviewed. It noted that the patient was admitted to the hospital on 7/6/12 with a diagnosis of an abscess (swelling/lump) to the left buttocks that required incision (surgical cut) and drainage of the abscess.

A review of the wound culture obtained on 7/6/12, noted positive for Staphylococcus Aureus (a bacteria that causes infection).

On 7/9/12, a sign posted on the outside of the room read " Contact Isolation " , with instructions that included wearing a disposable isolation gown when entering the room.

On 7/9/12, at approximately 3:35 PM, upon entering the room, accompanied by Registered Nurse 1, Patient 42 ' s mother was observe in the room not wearing a gown. Patient 42 was running around in the room, wearing a hospital gown and a diaper.

An interview was conducted on 7/9/12 at approximately 3:37 PM with Patient 42 ' s mother. The mom responded that she wore a gown and gloves when she removed the soil top dressing covering the wound. She stated that she knew to wash her hands when she handled her child.

An interview was conducted on 7/9/12, at approximately 3:42 PM with Registered Nurse 1, who was assigned to provide care for the patient. RN 1 confirmed that patient 42 ' s mom was not wearing a disposable isolation gown, and that the mom had been visiting for hours. RN 1 stated that the mom was educated on the isolation precautions and that she knew when to wear a gown. RN 1 did not respond when asked if the Mom was re-educated regarding the isolation precautions. RN 1 was asked the purpose for the contact isolation precaution. RN 1 stated, "Well, I do not see the harm, I do not think that there are other kids in the house. "

A review of the hospital policy titled, " Standard and Isolation Precautions " , revised 6/09, included the following under Contact Isolation:
"Disposable isolation gown will be worn when entering the room if there is a possibility that clothing will have contact with patient, surfaces or patient care items..."

2. On 7/9/12, Patient 45's medical record was reviewed. It noted that the patient was admitted to the facility on 6/26/12 with diagnoses that included bilateral lower extremities (legs/feet) cellulitis (spreading of bacterial infection below the skin), diabetes (elevated blood glucose). The patient was currently on a ventilator (a machine that assist the patient with breathing) and on Droplet Isolation.

A review of the bronchial washing specimen collected on 7/8/12, tested positive for Staphylococcus Aureus and Pseudomonas Aeruginosa (bacteria's that causes infections).

Observation was made of a signed posted on the outside of the patient ' s room that read, "Droplet Isolation". Instructions included: Mask covering eyes, nose and mouth required when you are within 3 feet of the patient..."

On 7/12/12, at approximately 10:20 AM, RN 2 and 2 family members were observed putting on isolation gowns, gloves and face masks. The face mask did not include the eye shield. RN 2 and the 2 family members entered Patient 45's droplet isolation room. RN 2 was later observed having contact with the patient while she was not wearing an eye shield. The 2 family members were observed at the patient's bedside without wearing eye shields.

An interview was conducted with the Manager of the Intensive Care Unit on 7/12/12, at approximately 10:22 AM regarding the isolation precautions. The manager confirmed that RN 2 was within 3 feet of the patient and she was not wearing eye shield. The 2 family members were by the bed and were not wearing eye shields, they wore eye glasses. The Manager stated that the family members wearing glasses did not need to wear eye shields.

An interview was conducted on 7/12/12 at approximately 10:24 AM with the Infection Control Manager (ICM). The ICM confirmed that eye shield was required when within 3 feet of patients on droplet isolation and that eye glasses were not an acceptable substitute for wearing eye shields.

A review of the hospital policy titled, "Standard and Isolation Precautions, revised 6/09, including the following precautions for Droplet Isolation:
"Employees will wear mask that cover eyes, nose and mouth when performing any function within 3 feet of the patient.."
3. During an observation on 7/11/12 at 9:30 AM of the out-patient laboratory department, inside the refrigerator designated for storing nourishments for patients was an employee ' s opened used drinking cup with an uncovered straw.

During an interview on 7/11/12 at 9:30 AM, at the time of the observation, with Lab Assistant 1 (LA1) she stated that the compact size refrigerator was used to store nourishments for patient use; the refrigerator was called the " clean " refrigerator. LA1 stated that she stored her personal drinking cup in the " clean " refrigerator. LA1 further stated that she did not know that personal employee drinking cups should not be stored in the refrigerator with patient nourishments.

During an interview, on 7/12/12 at 9:30 AM, with the Infection Control Manager (IFM), she stated that the employees should not use the refrigerators designated for patient nourishments, " that ' s an infection control issue " .

Record review on 7/12/12, of the facility ' s policy and procedure from the Infection Control Department, titled Refrigerators and Freezers, dated 03/03, noted that " Patient Nourishment Refrigerator - These refrigerators are for patient food and nourishment only. There is to be no employee food or drink items " .

4. On 7/12/12 at 3:15 PM, a tour of the hospital's Clinical Laboratory was conducted. During the tour an interview was conducted with Clinical Laboratory Scientist (CLS) 1 regarding a potential blood spill within the laboratory. The Director of the Clinical Laboratory Services (DCLS) was present during the interview.

CLS 1 was unable to locate a blood spill cleanup kit within the Clinical Laboratory. The DCLS confirmed that a blood spill kit cleanup was not readily accessible to the staff.

On 7/13/12 at 1 PM, an interview was conducted with the Infection Control Manager. She stated that she was unaware that the Clinical Laboratory did not have readily accessible blood spill clean-up kits.

A review of the hospital's policy and procedure titled, "Blood Spill Cleanup," dated 7/11, was reviewed and showed that a blood spill kit was to be located within each department of the Clinical Laboratory.

5. a. During a tour of the kitchen on 7/9/12 at 10:30 AM, a clean paper towel swipe of the interior of the ice machine produced a significant amount of a brown tinged gelatinous material. Also noted was a significant accumulation of a brown tinged lime scale build-up along the chute, inside the ice machine where ice drops into the storage bin.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS) and the Plant Operations Manager (POM), they stated that the Plant Operations department was responsible for cleaning and maintaining the ice machine. The POM stated that the hospital utilized a contract company that serviced the ice machine quarterly and the last service was performed on 6/13/12. He was unable to explain why there was an accumulation of lime scale and gelatinous material inside the ice machine. He confirmed that the accumulation came in contact with the ice that the patients consumed and it was not desirable.

The 2009 Food Code states that in equipment such as ice bins and enclosed components of equipment such as ice machines, surfaces shall be cleaned at a frequency necessary to preclude accumulation of soil or mold.

The Code also states that food contact surfaces are to be smooth and easily cleanable. A significant accumulation of lime scale resulted in the chute of the ice machine to not be smooth and easily cleanable. This allowed for the potential harborage of harmful bacterial that was resistant to cleaning.

Soil, mold and lime scale accumulation on parts of an ice machine have the potential to cause food borne illness in the patients.

b. During a tour of the kitchen on 7/9/12 at 11:15 AM, two pipes were noted without an air gap maintained, draining into a floor drain, under the ice machine. The observation was verified by the Plant Operations Manager (POM).

During a concurrent interview with the POM, he stated that the pipes were draining water from the ice machine. He verified that in the event of negative water pressure, waste water could potentially back up into the ice machine. He confirmed that an air gap should have been maintained at the drain.

According to the 2009 Food Code, an air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment or non-food equipment shall be at least twice the diameter of the water supply inlet and may not be less than one inch.

A backflow of waste water into the ice machine had the potential to contaminate the ice served to patients and cause food borne illness.

c. During a tour of the kitchen on 7/9/12 at 11:00 AM, meat thawing in the walk-in refrigerator was noted to have 2 dates written on each of 4 boxes: 7/5/12 and 7/15/12.

During a concurrent interview with the Executive Chef (EC), he stated that first date is the thaw date, or the date the meat was pulled from the freezer and placed in the refrigerator. He stated the second date was the use-by date. He stated that the 10 day timeframe included 3 days for the meat to thaw, then an additional 7 days the meat could be stored in the refrigerator.

A review of the hospital's policy titled, "HACCP/Infection Control" dated 7/11 revealed that maximum storage period for fresh meats in the refrigerator was 3 days.

During a follow-up interview with the DFNS and the EC on 7/10/12 at 9:30 AM, they were unable to state why a 10 day period was used in labeling the meat. They confirmed 10 days was longer than the shelf life of the fresh meat according to the hospital policy.

Meats and other potentially hazardous foods stored and consumed after their shelf life have the potential to cause food borne illness in an already compromised patient population.

d. During a tour of the kitchen on 7/9/12 at 10:10 AM, the table mounted can opener was noted with the blade surface worn off. A piece of the silver surface of the blade was loose and hanging from the blade . During a concurrent interview with the DFNS, he verified the findings. He stated that the blade should be changed to prevent cross contamination from the blade.

According to the 2009 Food Code, cutting or piercing part of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is open. It further stated that multiuse food contact surfaces shall be smooth and free of crevices. Surfaces which have imperfections such as cracks, chips or pits allow microorganisms to attach and form biofilms that can release pathogens in the food. Biofilms are highly resistant to cleaning and sanitizing efforts.

These biofilms have the potential to cause food borne illness in patient.

e. During a tour of the kitchen on 7/9/12 at 10:20 AM, a container of liquid was observed in the catering refrigerator. During a concurrent interview with the Catering Manager (CM), she verified the observation and stated that the liquid was an employee's ice tea. She further stated that employee food should not be stored in the catering refrigerator. She further stated that there was an employee refrigerator that all employee food was supposed to be stored.

During a concurrent interview with the DFNS, he stated that the employees were provided with a dedicated employee refrigerator where they were supposed to store their food. He stated that employee food should not be stored in the patient or catering refrigerator.

Comingling unapproved food and beverage from employees in patient and retail areas created the potential for unsafe and unsanitary conditions for food that the patients consume.

During an interview with the Infection Control Manager (ICM) on 7/11/12 at 2:10 PM, she verified that she was not aware of the above practices in the kitchen. She stated that infection control rounds (ICR) were conducted monthly in the kitchen but there was no surveillance of the cleanliness of the interior of the ice machine. She also verified that the ICR also didn't monitor to ensure an air gap was maintained between the pipes from the ice machine to the floor drain. She stated that she monitors to ensure perishable food was dated, but did not evaluate if the thawing meat exceeded the required shelf life. She was not aware that employee food was stored in the catering refrigerator. She could not explain why the worn can opener blade had not been detected and changed.

A review of the hospital's Infection Control Plan (ICP), dated January 2012 revealed that the purpose of the plan was to establish, maintain and insure the implementation of an ICP that encompassed all facility departments and involved all employees and care providers. The organizational goal was to prevent the spread of infection in the hospital and to promote a safe environment for all individuals - patients, employees, other care providers and visitors.


6. During a tour of the sterile instrument storage area on 7/11/12 at approximately 11:30 AM, multiple instruments including Mayo scissors were found in the closed position in their steri-packs, (packs used in sterilization method) after going through the sterilization process.

During a concurrent interview, each instrument that appeared closed was confirmed to be closed by the Sup SP and he agreed they were not sterile.

7. During a review of the medical record of Patient 1 in the ER on 7/9/12 at 10 AM, the record showed that the patient, a homeless woman, had come to the hospital with complaints of a draining wound with a maggot, and a cough with shortness of breath. The medical record contained a triage infection screening tool with the question, " Suspected or confirmed infection? " , with the response, " N " for " no " recorded. Subsequently the nursing assessment showed that the patient also had diarrhea, nausea and vomiting.

In a concurrent interview with the Clin Mgr ER, she reviewed the record and stated that the question regarding suspected or confirmed infection had been answered "no" correctly. She stated that the question was only answered " yes " if there was physician referral information (i.e. if the patient was sent from an office with a request to administer antibiotics), or in consultation with a physician. She stated that there was no policy on completing the rapid sepsis screening.

During an interview with RN 10 on 7/19/12 at 10:15 AM, she stated that the question regarding suspected infection should have been answered " yes " , based on the patient's complaints.

During a review of QI department audit documents, the document showed that 1 of 3 sepsis screens was felt to be accurate in May, 2012, and 8 of 10 were found to be accurate in April, 2012.

Based on observation, interview and record review, the hospital infection control staff, failed to ensure that the systems for controlling infections and communicable diseases of patients and personnel were consistently practiced and compliance monitored for all policies, procedures, protocols and other infection control program requirements as evidenced by:

1. The facility failed to ensure that a mother wore a disposable isolation gown when she was in the room with her 22 months old son who was on contact isolation (to prevent spread of organisms from an infected patient through direct (touching the patient) or indirect (touching surfaces or objects that that been in contact with the patient) per hospital policy.

2. The facility failed to ensure that a Registered Nurse (RN) and family members wore eye shield (covering for the eyes) when they were within 3 feet of the patient on droplet isolation (to prevent the spread by droplets or dust particles, such as by coughing, sneezing, or talking or during procedures such as suctioning and bronchoscopy) per facility policy.

3. The facility failed to ensure that the patient nourishment refrigerator in the out-patient laboratory department was free of employee drink.


4. The facility failed to ensure that blood spill kits were readily available in all of the laboratory departments.


5. The hospital failed to ensure that there were infection control measures in place to prevent the development of food borne illness and cross contamination with regards food service. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services staff.


6. The hospital did not ensure that instruments were sterilized in the open position, creating the increased risk of infection for patients having surgery at the hospital (see A-951).

7. For 1 patient, Patient 1, did not ensure the correct use of the rapid sepsis screening tool in use in the ER, and did not ensure that staff were educated about the correct completion of the screening tool.

These deficiencies had the potential for cross contamination and the spread of infection to patient and personnel. Also by not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared and distributed under unsafe and unsanitary conditions and there was potential for such continuation in the absence of identification and remediation.

Findings:

1. On 7/9/12, Patient 42 medical record was reviewed. It noted that the patient was admitted to the hospital on 7/6/12 with a diagnosis of an abscess (swelling/lump) to the left buttocks that required incision (surgical cut) and drainage of the abscess.

A review of the wound culture obtained on 7/6/12, noted positive for Staphylococcus Aureus (a bacteria that causes infection).

On 7/9/12, a sign posted on the outside of the room read " Contact Isolation " , with instructions that included wearing a disposable isolation gown when entering the room.

On 7/9/12, at approximately 3:35 PM, upon entering the room, accompanied by Registered Nurse 1, Patient 42 ' s mother was observe in the room not wearing a gown. Patient 42 was running around in the room, wearing a hospital gown and a diaper.

An interview was conducted on 7/9/12 at approximately 3:37 PM with Patient 42 ' s mother. The mom responded that she wore a gown and gloves when she removed the soil top dressing covering the wound. She stated that she knew to wash her hands when she handled her child.

An interview was conducted on 7/9/12, at approximately 3:42 PM with Registered Nurse 1, who was assigned to provide care for the patient. RN 1 confirmed that patient 42 ' s mom was not wearing a disposable isolation gown, and that the mom had been visiting for hours. RN 1 stated that the mom was educated on the isolation precautions and that she knew when to wear a gown. RN 1 did not respond when asked if the Mom was re-educated regarding the isolation precautions. RN 1 was asked the purpose for the contact isolation precaution. RN 1 stated, "Well, I do not see the harm, I do not think that there are other kids in the house. "

A review of the hospital policy titled, " Standard and Isolation Precautions " , revised 6/09, included the following under Contact Isolation:
"Disposable isolation gown will be worn when entering the room if there is a possibility that clothing will have contact with patient, surfaces or patient care items..."

2. On 7/9/12, Patient 45's medical record was reviewed. It noted that the patient was admitted to the facility on 6/26/12 with diagnoses that included bilateral lower extremities (legs/feet) cellulitis (spreading of bacterial infection below the skin), diabetes (elevated blood glucose). The patient was currently on a ventilator (a machine that assist the patient with breathing) and on Droplet Isolation.

A review of the bronchial washing specimen collected on 7/8/12, tested positive for Staphylococcus Aureus and Pseudomonas Aeruginosa (bacteria's that causes infections).

Observation was made of a signed posted on the outside of the patient ' s room that read, "Droplet Isolation". Instructions included: Mask covering eyes, nose and mouth required when you are within 3 feet of the patient..."

On 7/12/12, at approximately 10:20 AM, RN 2 and 2 family members were observed putting on isolation gowns, gloves and face masks. The face mask did not include the eye shield. RN 2 and the 2 family members entered Patient 45's droplet isolation room. RN 2 was later observed having contact with the patient while she was not wearing eye shield. The 2 family members were observed at the patient's bedside without wearing eye shields.

An interview was conducted with the Manager of the Intensive Care Unit on 7/12/12, at approximately 10:22 AM regarding the isolation precautions. The manager confirmed that RN 2 was within 3 feet of the patient and she was not wearing eye shield. The 2 family members were by the bed and were not wearing eye shields, they wore eye glasses. The Manager stated that the family members wearing glasses did not need to wear eye shields.

An interview was conducted on 7/12/12 at approximately 10:24 AM with the Infection Control Manager (ICM). The ICM confirmed that eye shield was required when within 3 feet of patients on droplet isolation and that eye glasses were not acceptable substitute for wearing eye shields.

A review of the hospital policy titled, "Standard and Isolation Precautions, revised 6/09, including the following precautions for Droplet Isolation:
"Employees will wear mask that cover eyes, nose and mouth when performing any function within 3 feet of the patient.."



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3. During an observation on 7/11/12 at 9:30 AM of the out-patient laboratory department, inside the refrigerator designated for storing nourishments for patients was an employee ' s opened used drinking cup with an uncovered straw.

During an interview on 7/11/12 at 9:30 AM, at the time of the observation, with Lab Assistant 1 (LA1) she stated that the compact size refrigerator was used to store nourishments for patient use; the refrigerator was called the " clean " refrigerator. LA1 stated that she stored her personal drinking cup in the " clean " refrigerator. LA1 further stated that she did not know that personal employee drinking cups should not be stored in the refrigerator with patient nourishments.

During an interview, on 7/12/12 at 9:30 AM, with the Infection Control Manager (IFM), she stated that the employees should not use the refrigerators designated for patient nourishments, " that ' s an infection control issue " .

Record review on 7/12/12, of the facility ' s policy and procedure from the Infection Control Department, titled Refrigerators and Freezers, dated 03/03, noted that " Patient Nourishment Refrigerator - These refrigerators are for patient food and nourishment only. There is to be no employee food or drink items " .


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4. On 7/12/12 at 3:15 PM, a tour of the hospital's Clinical Laboratory was conducted. During the tour an interview was conducted with Clinical Laboratory Scientist (CLS) 1 regarding a potential blood spill within the laboratory. The Director of the Clinical Laboratory Services (DCLS) was present during the interview.

CLS 1 was unable to locate a blood spill cleanup kit within the Clinical Laboratory. The DCLS confirmed that a blood spill kit cleanup was not readily accessible to the staff.

On 7/13/12 at 1 PM, an interview was conducted with the Infection Control Manager. She stated that she was unaware that the Clinical Laboratory did not have readily accessible blood spill clean-up kits.

A review of the hospital's policy and procedure titled, "Blood Spill Cleanup," dated 7/11, was reviewed and showed that a blood spill kit was to be located within each department of the Clinical Laboratory.



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5. a. During a tour of the kitchen on 7/9/12 at 10:30 AM, a clean paper towel swipe of the interior of the ice machine produced a significant amount of a brown tinged gelatinous material. Also noted was a significant accumulation of a brown tinged lime scale build-up along the chute, inside the ice machine where ice drops into the storage bin.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS) and the Plant Operations Manager (POM), they stated that the Plant Operations department was responsible for cleaning and maintaining the ice machine. The POM stated that the hospital utilized a contract company that serviced the ice machine quarterly and the last service was performed on 6/13/12. He was unable to explain why there was an accumulation of lime scale and gelatinous material inside the ice machine. He confirmed that the accumulation came in contact with the ice that the patients consumed and it was not desirable.

The 2009 Food Code states that in equipment such as ice bins and enclosed components of equipment such as ice machines, surfaces shall be cleaned at a frequency necessary to preclude accumulation of soil or mold.

The Code also states that food contact surfaces are to be smooth and easily cleanable. A significant accumulation of lime scale resulted in the chute of the ice machine to not be smooth and easily cleanable. This allowed for the potential harborage of harmful bacterial that was resistant to cleaning.

Soil, mold and lime scale accumulation on parts of an ice machine have the potential to cause food borne illness in the patients.

b. During a tour of the kitchen on 7/9/12 at 11:15 AM, two pipes were noted without an air gap maintained, draining into a floor drain, under the ice machine. The observation was verified by the Plant Operations Manager (POM).

During a concurrent interview with the POM, he stated that the pipes were draining water from the ice machine. He verified that in the event of negative water pressure, waste water could potentially back up into the ice machine. He confirmed that an air gap should have been maintained at the drain.

According to the 2009 Food Code, an air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment or non-food equipment shall be at least twice the diameter of the water supply inlet and may not be less than one inch.

A backflow of waste water into the ice machine had the potential to contaminate the ice served to patients and cause food borne illness.

c. During a tour of the kitchen on 7/9/12 at 11:00 AM, meat thawing in the walk-in refrigerator was noted to have 2 dates written on each of 4 boxes: 7/5/12 and 7/15/12.

During a concurrent interview with the Executive Chef (EC), he stated that first date is the thaw date, or the date the meat was pulled from the freezer and placed in the refrigerator. He stated the second date was the use-by date. He stated that the 10 day timeframe included 3 days for the meat to thaw, then an additional 7 days the meat could be stored in the refrigerator.

A review of the hospital's policy titled, "HACCP/Infection Control" dated 7/11 revealed that maximum storage period for fresh meats in the refrigerator was 3 days.

During a follow-up interview with the DFNS and the EC on 7/10/12 at 9:30 AM, they were unable to state why a 10 day period was used in labeling the meat. They confirmed 10 days was longer than the shelf life of the fresh meat according to the hospital policy.

Meats and other potentially hazardous foods stored and consumed after their shelf life have the potential to cause food borne illness in an already compromised patient population.

d. During a tour of the kitchen on 7/9/12 at 10:10 AM, the table mounted can opener was noted with the blade surface worn off. A piece of the silver surface of the blade was loose and hanging from the blade . During a concurrent interview with the DFNS, he verified the findings. He stated that the blade should be changed to prevent cross contamination from the blade.

According to the 2009 Food Code, cutting or piercing part of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is open. It further stated that multiuse food contact surfaces shall be smooth and free of crevices. Surfaces which have imperfections such as cracks, chips or pits allow microorganisms to attach and form biofilms that can release pathogens in the food. Biofilms are highly resistant to cleaning and sanitizing efforts.

These biofilms have the potential to cause food borne illness in patient.

e. During a tour of the kitchen on 7/9/12 at 10:20 AM, a container of liquid was observed in the catering refrigerator. During a concurrent interview with the Catering Manager (CM), she verified the observation and stated that the liquid was an employee's ice tea. She further stated that employee food should not be stored in the catering refrigerator. She further stated that there was an employee refrigerator that all employee food was supposed to be stored.

During a concurrent interview with the DFNS, he stated that the employees were provided with a dedicated employee refrigerator where they were supposed to store their food. He stated that employee food should not be stored in the patient or catering refrigerator.

Comingling unapproved food and beverage from employees in patient and retail areas created the potential for unsafe and unsanitary conditions for food that the patients consume.

During an interview with the Infection Control Manager (ICM) on 7/11/12 at 2:10 PM, she verified that she was not aware of the above practices in the kitchen. She stated that infection control rounds (ICR) were conducted monthly in the kitchen but there was no surveillance of the cleanliness of the interior of the ice machine. She also verified that the ICR also didn't monitor to ensure an air gap was maintained between the pipes from the ice machine to the floor drain. She stated that she monitors to ensure perishable food was dated, but did not evaluate if the thawing meat exceeded the required shelf life. She was not aware that employee food was stored in the catering refrigerator. She could not explain why the worn can opener blade had not been detected and changed.

A review of the hospital's Infection Control Plan (ICP), dated January 2012 revealed that the purpose of the plan was to establish, maintain and insure the implementation of an ICP that encompassed all facility departments and involved all employees and care providers. The organizational goal was to prevent the spread of infection in the hospital and to promote a safe environment for all individuals - patients, employees, other care providers and visitors.




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6. During a tour of the sterile instrument storage area on 7/11/12 at approximately 11:30 AM, multiple instruments including Mayo scissors were found in the closed position in their steri-packs, (packs used in sterilization method) after going through the sterilization process.

During a concurrent interview, each instrument that appeared closed was confirmed to be closed by the Sup SP and he agreed they were not sterile.

7. During a review of the medical record of Patient 1 in the ER on 7/9/12 at 10 AM, the record showed that the patient, a homeless woman, had come to the hospital with complaints of a draining wound with a maggot, and a cough with shortness of breath. The medical record contained a triage infection screening tool with the question, " Suspected or confirmed infection? " , with the response, " N " for " no " recorded. Subsequently the nursing assessment showed that the patient also had diarrhea, nausea and vomiting.

In a concurrent interview with the Clin Mgr ER, she reviewed the record and stated that the question regarding suspected or confirmed infection had been answered "no" correctly. She stated that the question was only answered " yes " if there was physician referral information (i.e. if the patient was sent from an office with a request to administer antibiotics), or in consultation with a physician. She stated that there was no policy on completing the rapid sepsis screening.

During an interview with RN 10 on 7/19/12 at 10:15 AM, she stated that the question regarding suspected infection should have been answered " yes " , based on the patient's complaints.

During a review of QI department audit documents, the document showed that 1 of 3 sepsis screens was felt to be accurate in May, 2012, and 8 of 10 were found to be accurate in April, 2012.

Based on interview and record review, the hospital failed to ensure that 1 of 4 sampled discharge patients (Patient 41) discharge plan was re-evaluated to ensure that the patient was discharged to a safe home environment. Patient 41 was 26 days old. Patient 41's mother was reported to Child Protective Services (CPS) when her second child was born (11 months ago) and tested positive for methamphetamine (speed is a potent and addictive central nervous system stimulant). The mother also had a history of major depression (a condition of general emotional sadness and withdrawal) for which she stopped taking prescribed antidepressant medications. This failure had the potential to contribute to adverse health consequences (abuse and/or neglect) for all patients that required re-evaluation of their discharge plan to ensure safety upon discharge.

Findings:

On 7/10/12, Patient 41's medical record was reviewed with a Registered Nurse (RN) 4.

A review of the face sheet for Patient 41 was conducted and showed that the patient was admitted on 7/10/12 at 6 AM, to rule out sepsis (a systemic blood infection).

A review of the Pediatric Admit Assessment was conducted. The Social Service Needs section showed a CPS history. RN 4 stated that she was not knowledgeable regarding the circumstances regarding the CPS history. RN 4 stated that the Case Management Department was notified to conduct a consultation related to the CPS high risk trigger.

A review of the Case Management Note, dated 7/10/12 at 11:55 AM, was reviewed and indicated that the hospital reported the mother to CPS when her second child was positive for drugs at birth (child neglect). The notes showed that the mother stated that CPS investigated her case. and she took parenting classes, drug rehabilitation and prenatal classes. The mother also stated that the CPS case was closed after she took voluntary classes (parenting classes, drug rehabilitation and prenatal classes). There was no documented evidence to show that the CM verified the mother's statement to ensure that the patient was not suffer adverse health consequences (abuse and/or neglect).

The CM Notes also showed that Patient 41's mother had a history of major depression (high risk behaviors) for which she stopped taking prescribed antidepressant medications (Paxil and Prozac) to breast feed Patient 41. There was no documented evidence to show that the CM referred the mother to a licensed practitioner while Patient 41 was hospitalized to evaluate the mother's potential for increased depression related to the discontinuation of the Paxil and Prozac, and/or post-partum depression. The documentation showed that the mother was encouraged to seek help if she became depressed.

On 7/12/12 at 1:55 PM, an interview and record review was conducted with the Director of Case Management (DCM). The DCM confirmed that the Case Manager's notes did not reflect that the CPS case closure was verified by the CM. She also confirmed that the mother's history of major depression without the administration of medication was evaluated by a physician to ensure that Patient 41 was discharged to a safe home environment.

On 7/12/12 at 2:10 PM, an interview was conducted with CM 1 that conducted and documented the discharge plan for Patient 41. The DCM was present for the interview. CM 1 stated that he was very familiar with Patient 41's mother, because he reported the mother to CPS when her second child (baby 2) tested positive for "speed" at birth (child neglect). He confirmed that he did not follow-up with the family and/or CPS after he provided CPS with the necessary information after baby 2 was discharged from the hospital (11 months ago). CM 1 stated that the second baby was discharged home prior to CPS investigation. CM 1 confirmed that he did not verify that the CPS case was closed to ensure that there were no ongoing or unresolved concerns.

CM 1 also confirmed that Patient 41's mother had a history of major depression for which she had stopped taking medications to breast feed Patient 41. He stated that the mother denied depression at the time he interviewed her. CM 1 also confirmed that no follow-up was done to address the mother's diagnosis of major depression and the discontinuation of her antidepressant medications. CM 1 stated that he felt comfortable discharging Patient 41 home, because she did not exhibit any inappropriate behaviors during the patient's hospitalization. He stated that there was no other documentation to reflect that the discharge plan for Patient 41 was safe.


A review of the hospital's policy and procedure titled, " Discharge Planning," dated 6/12, was conducted and showed that the policy purpose was to provide consistent guidelines and procedures to meet patient/family or representatives' pre-admission, admission, hospitalization and post-hospitalization needs.


Policy: Discharge planning at hospital name is an interdisciplinary hospital wide process consistent with the philosophy of continuum of care, which promotes continuity at all levels.

Procedure: Admission/Discharge Planning Assessments and Reassessments.

Initiation of discharge planning will begin in a timely manner and is expedited to promote continuity of medical care and other services to meet their identified needs.

High Risk Screening shall be initiated at patient's point of entry into hospital system. Case Management staff shall be notified. See Appendix A.

Appendix A- included, history or diagnosis suggestive of child abuse/neglect. Also, history of behavioral health diagnosis.

Based on interview and record review, for two of 41 patients (Patients 3 and 9), the hospital did not ensure that discharge planning addressed the need for drug abuse treatment, creating the risk of a poor health outcome for those two patients.

Findings:

The hospital policy, Discharge Planning - Role of the Nurse (revised 4/12), read in part, " During the initial admission assessment, it will be the responsibility of the registered nurse (RN) to determine the patient's needs and goals of treatment in order to implement a successful discharge plan. " , and " Discharge plans may be revised as necessary according to the patients or families needs. "

The hospital policy, Discharge Planning (revised 6/12), read in part, " Initiation of discharge planning needs might include but not be limited to the following mechanism(s): Referrals for interdisciplinary or community based services. "

1. The medical record of Patient 3 was reviewed and handwritten notes from the treatment team meeting on the patient's 7/5/12 care plan showed that the patient reported a history of using multiple illicit drugs, " too much drugs, I was ballistic " as a result of drug use, and uses meth (methamphetamines), " I use it all " for 4 years, and last use yesterday. The subsequent care plan was reviewed, and did not include care planning for drug use.

During an interview with the Dir BH on 7/9/12 at 15:05 hours, she stated that the handwritten items were to have been added to the subsequent care plan by the nurse, but that did not occur, and there was no care or discharge planning for drug use.

2. The medical record of Patient 9 was seen on 7/12/12 and included the psychiatric nurse documenting that the patient had a history of alcohol and cocaine abuse. His urine drug screen was positive for benzodiazepines (sedatives that can be abused), and he gave no history of being prescribed benzodiazepines.

In an interview with the Dir BH on 7/12/12 at 2 PM, she reviewed the medical record of Patient 9, and stated that substance abuse had not been added to his care plan concerns, and was not mentioned in his discharge planning documentation. She stated drug use should have been included in Patient 9's care and discharge planning process, with appropriate referrals.

In an interview with the Med Dir BH on 7/12/12 at 1130 hours, he stated that there were no therapy groups that addressed drug problems for the inpatients, but that patients with drug problems were referred for outpatient treatment at discharge.

Based on observation, interview and record review, the facility did not:

1. Ensure that surgical scheduling was consistent with the needs of one of 41 sampled patients (Patient 50), which increased the risk of prolonged discomfort, loss of blood, infection and a poor health outcome, and

2. Ensure surgical instruments such as Mayo Scissors were sterilized in the open position, creating an increased risk of infection in patients requiring those instruments, and

3. Ensure that the oxygen tank in the Labor & Delivery O.R. 2 was refilled after the tank was emptied during prior use, creating an increased risk of a poor health outcome for any patient requiring oxygen in that surgical area, and

4. Did not retire laryngeal mask airways (LMAs-breathing tubes used while patients are sedated) according to the manufacturer ' s warranty use limit, creating the risk of a poor surgical outcome for patients requiring LMAs at the hospital.

Findings:

1. The clinical record for Patient 50 was reviewed on 7/13/12. The Physician Progress Notes written by DR4 dated 7/6/12 at 8:30 PM " An 86 yrs old female, suffers from senile dementia (loss of some brain functions such as memory) and is diabetic (high blood sugar disease). She fell at home ... " The next note written by DR3 dated 7/6/12 at 10:30 PM " Ortho Notes. 86 year old ...Recommend: Repair Fx Proximal Humerus Rt Shoulder " (repair broken right arm/shoulder). Review of the Physician Orders written by DR3 dated 7/6/12 at 10:30 PM " Consent for repair fracture proximal humerus right shoulder " (discuss repair broken right arm/shoulder) and " Type & X match for 2 units PRBC ' s " (have 2 units of blood ready if needed). An order written by DR3 dated 7/6/12 at 2305 " NPO after Midnight " (nothing by mouth after midnight).

Review of the Physician Progress Notes written by DR3 dated 7/7/12 at 11:58 PM " 3-D CT Scan (specialized X-Ray) Right Shoulder could not be done ....Pt. would not cooperate. Pt. needs special equipment for the repair of fx Rt shoulder (broken right shoulder)- this equipment will not be available until Monday- 7/09/12. Will reschedule the surgery for Monday. "
During an interview with the DOS on 7/13/12 at 9:40 AM, she stated there was no documentation of DR3 ' s scheduling request on 7/7/12. The Pending Case List indicated DR3 ' s office called to schedule surgery for Patient 50 on 7/9/12 at 10:30 AM, putting Patient 50 third on the list for that day. According to the Register of Operations dated 7/09/2012, the two cases in front of Patient 50 were performed that day in O.R. one. The DOS indicated that Patient 50 ' s surgery was delayed partly because the equipment had to be ordered and sterilized, which could take up to four hours. Also, an emergent (threatens life or limb) case arrived, which was prioritized ahead of Patient 50, delaying her surgery until the next day (7/10/12).

Review of Physician Progress Notes written by DR3 dated 7/9/12 at 10:10 PM " ...Surgery on Rt shoulder postponed till tomorrow because OR was too crowded the whole day- it was too late to do the surgery this pm. " Review of the Immediate Post- Procedure Note written by DR3 dated 7/10/12 at 7:20 PM indicated " ORIF 3-part fx Prox Humerus Rt Shoulder (repaired broken upper arm /right shoulder) using Prox Humerus locking plate " (specialized arm plate/equipment) was performed.

During an interview on 7/13/12 at 2:05 PM with the DR1, he stated there was a " failure of the chain of command in the O.R. " on 7/7/12. On that date, he observed DR3 attempting to schedule surgery with the O.R. nurse, who stated she could not get in touch with the equipment representative to obtain the required humerus fixator apparatus (specialized equipment needed to repair arm/ shoulder). The DR1 said that on 7/7/12 the O.R. nurse never relayed DR3 ' s request for surgical scheduling to the Nursing House Supervisor (NHS), who was responsible for surgery scheduling and obtaining the necessary equipment.

The facility policy indicates in part, " Scheduling of Operative Procedures. Policy: Surgery is a 24 hour/day, seven days a week service to surgeons, their patients and the community. Elective and emergent (threatens life or limb) surgery scheduling is coordinated within the Department of Perioperative (pertaining to surgery) Services during normal business hours Monday through Friday and through the Nursing House Supervisor after normal business hours, weekends and holidays. " Also Urgent and Emergent (threatens life or limb) Surgical Procedures (Effective Date: 7/93) read in part " Urgent/emergent procedures (threatens life or limb) are accommodated as they occur and placed into the first available room during routine hours of operation and may delay the next case scheduled for that room. "

2. During a tour of the sterile instrument storage area on 7/11/12 at approximately 11:30 AM, multiple instruments including Mayo scissors were found in the closed position in their steri-packs, (packs used in sterilization method) after going through the sterilization process.

During a concurrent interview, each instrument that appeared closed was confirmed to be closed by the Sup SP and he agreed they were not sterile.

3. The hospital policy, E-Cylinders and Regulators (effective 06/91) was reviewed and read in part, " Cardiopulmonary Services, in conjunction with the respective nursing stations and Medical Imaging, will be responsible for the maintenance and change of oxygen E-cylinder. "

During an observation on 7/11/12 at approximately 9:30 AM in the labor and delivery operating room 2, a portable oxygen tank was seen near the door. The dial on the portable tank indicated that it was empty-the arrow was all the way to the base of the red " refill " area.

During a concurrent interview with the Mgr L&D, she stated that the tank would be used when transporting patients from the operating room back to the recovery room after a C-section.

During a concurrent interview with the Dir Clin Services, he observed the tank and stated that respiratory services staff were to make daily rounds and should have checked and replaced the empty oxygen tank.

4. The manufacturer's warranty for the respiratory equipment in use in the hospital was reviewed and read in part, "The above LMA airways are reusable and warranted against manufacturing defects for forty (40) uses or a period of one (1) year from the date of purchase (whichever is earlier)..."

During tours of the ORs in the surgery department and in labor and delivery on 7/9/12, and 7/10/12, anesthesia supply carts were noted to contain LMAs.

During a tour of sterile processing area, the " LMA Record Card " tracking documentation for LMA's was reviewed on 7/11/12 at 1110 hours, and showed most of the LMAs had been in use for over one year, with several being in use since 2008. For example, LMA SECHO5251904 had been in use since 10/17/08, and was last used 9/28/11. LMA ASCBO7310502 was first used 8/12/08 and last used 4/25/11. LMA SECF09120212 was first used 1/6/10 and last used 5/29/12.

In a concurrent interview with the Sup SP on 7/11/12 at 1110 hours, he stated that the use of LMAs was tracked, and that they were retired after 40 uses. He concurred that the LMAs were in use for over one year. He was not aware that the manufacturer ' s recommendations included retiring the LMAs after 40 uses or one year, whichever came first.