HospitalInspections.org

Based on policy and procedure reviews, documentation reviews, open and closed medical record reviews, observations during tour, and staff interviews, the hospital failed to have an effective Governing Body to ensure: the promotion of patient's rights; ensure an effective, data-driven QAPI program; ensure nursing supervision; and to develop and maintain the facilities in a manner to ensure the health and safety of patients, staff, and visitors.

The finding include:

1. The hospital's nursing staff failed to protect and promote patient's rights as evidenced by failing to implement restraints in accordance with safe and appropriate standards of care.

~cross refer to 482.13 Patients' Rights, Condition Tag A0115.

2. The hospital failed to maintain an effective, data-driven QAPI program.

~cross refer to 482.21 QAPI, Condition Tag A0263.

3. The hospital failed to have an effective nursing service providing oversight and supervision of day to day operations by failing to ensure nursing staff implemented restraints in accordance with safe and appropriate standards of practice and to ensure blood transfusions were administered according to hospital policy.

~cross refer to 482.23 Nursing Services, Condition Tag A0385.

4. The hospital staff failed to develop and maintain the facilities in a manner to ensure the health and safety of patients, staff, and visitors.

~cross refer to 482.41 Physical Environment, Condition Tag A0700.

Based on policy and procedure reviews, open and closed medical record reviews, observations and staff interviews, the hospital's nursing staff failed to protect and promote patient's rights as evidenced by failing to implement restraints in accordance with safe and appropriate standards of care.

The findings include:

1. The hospital's nursing staff failed to document alternatives attempted and response to the alternatives prior to the use of restraints for 3 of 8 sampled restrained patients (#69, #70, and #45).

~cross refer to 482.13(e)(2) Patients' Rights Standard: Tag A0164.

2. The nursing staff failed to obtain an order for a Therapeutic Hold for 1 of 1 adolescent patients reviewed that was restrained for violent and self-destructive behaviors (#87).

~cross refer to 482.13(e)(5) Patients' Rights Standard: Tag A0168.

3. The nursing staff failed to obtain a renewal order to restrain an adolescent patient for 1 of 1 adolescent patients reviewed that was restrained for violent and self-destructive behaviors (#87).

~cross refer to 482.13(e)(8) Patients' Rights Standard: Tag A0171.

4. The hospital's nursing staff failed to assess and monitor patients to ensure restraints were discontinued at the earliest possible time for 4 of 8 sampled restrained patients (#69, #70, #62 and #45).

~cross refer to 482.13(e)(9) Patients' Rights Standard: Tag A0174.

5. The hospital's nursing staff failed to monitor restrained patients per policy for 5 of 8 sampled restrained patients (#69, #70, #62, #45, and #88).

~cross refer to 482.13(e)(10) Patients' Rights Standard: Tag A0175.

Based on hospital policy review, medical record review, observation and staff interview, nursing staff failed to document alternatives attempted and response to the alternatives prior to the use of restraints for 3 of 8 sampled restrained patients (#69, #70, and #45).

The findings include:

Review of the "Restraint and Seclusion" policy effective 01/27/2010 revealed "... Restraints are used only when preventive strategies have been attempted and age specific alternative measures are ineffective to protect the patient or others from harm. After a thorough assessment by the Registered Nurse or Licensed Independent Practioner (LIP), interventions must begin with the least restrictive method.... IV.A.1. Use of physical or chemical restraint and/or seclusion is based on a comprehensive assessment of the patient by the RN (registered nurse), physician, or LIP. 2. The use of restraint or seclusion is based on the individual patient's needs and the associated risk of restraint use. The risk to vulnerable patient populations such as emergency, pediatric, and cognitively or physically impaired patients is assessed. 3. Before restraints are used, appropriate preventive strategies are attempted and alternative measures used. 4.... Examples of alternatives may include: Identifying triggers to behavior, maintaining kind, firm, enforceable limits, or conversation or administering PRN (as needed) medications. 5. Strategies and alternatives used or attempted and the patient's response to them will be documented in the patient's record."

1. Closed record review for Patient #69 revealed a 64 year-old female that was admitted on 04/04/2011 with a fractured left humerus with repair done at an outside hospital on 03/26/2011. Record review revealed the patient had complications of respiratory failure following surgery and had been intubated, improved and was weaned off the mechanical ventilator. Review of a physician's order dated 04/12/2011 at 1033 revealed bilateral soft wrist restraints were ordered due to "unable to follow safety instructions." Further review of the order recorded the patient's "current mental status" as "disoriented/confused, agitated, acute delirium." Review of a physician's progress note dated 04/12/2011 at 1507 revealed the patient "continues to be somewhat agitated and has not kept LUE (left upper extremity) in sling for fracture. Restraints this AM to keep left arm stable until Pt (patient) calmed down." Record review revealed no nursing documentation of the type of restraint applied, time applied and released or monitoring of the patient during the use of restraints. Record review revealed no nursing documentation regarding alternatives tried or response to alternatives prior to the use of restraints.

Review of a physician's order dated 04/13/2011 at 1250 revealed a soft right wrist restraint was ordered due to "dislodging of lines or tubes" and "unable to follow safety instructions." Further review of the order recorded the patient's "current mental status" as "disoriented/confused, agitated, acute delirium and unable to follow commands." Record review revealed no nursing documentation that recorded the time the patient was placed in restraints or the type of restraint applied. Review of nursing notes dated 04/13/2011 at 2357 revealed "...restraints bilateral soft to wrists initiated 04/13/2011 status post patient disrupting medical equipment necessary for monitoring and care of this patient. Myself, this RN checked on patient just 10 - 15 minutes prior to 2357 04/13/2011, for a routine safety check. (Patient) was observed in her bed HOB (head of bed) at 45 (degrees), wrist restraints intact and in place. At 2357 patient found pulseless and apneic still in wrist restraints, crossed arms with knees on the floor by her bed. Restraints removed, patient eased to a supine position. CPR (cardiopulmonary resuscitation) immediately begun with a cardiac board placed underneath patient's chest. Code Blue called...." Record review recorded the patient's time of death as 0021 on 04/14/2011. Record review revealed no nursing documentation regarding alternatives tried or response to alternatives prior to the use of restraints.

Interview on 04/28/2011 at 1500 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should document alternatives tried and response to the alternatives prior to applying restraints. Interview confirmed there was no available documentation that nursing staff attempted alternatives as required by policy prior to the application of restraints on 04/12/2011 and 04/13/2011.

2. Closed record review for Patient #70 revealed a 21 year-old male that was admitted from the emergency department on 12/03/2010 with pain in his upper and lower extremities related to sickle cell crisis. Review of physician's progress notes dated 12/03/2010 at 0727 revealed "Pt (patient) acting very strangely this morning, rocking back and forth on bed, kicking out legs and jumping out of bed suddenly. Is not talking at all and will not verbalize what is bothering him." Review revealed a physician's order dated 12/03/2010 at 0725 for a sitter at bedside. Further review revealed a physician's order dated 12/03/2010 at 0915 for a vest restraint due to "Dislodging of lines or tubes, Disrupting medical equipment and Unable to follow safety instructions." Review of a physician's order dated 12/03/2010 at 1026 revealed an order to discontinue the sitter. Review of a "Non-violent Restraint Reassessment" revealed a vest restraint was applied on 12/03/2010 between 1001 and 1100 (no specific time recorded). Review revealed the patient was restrained from 1101 through 1200, 1201 through 1300 and 1301 through 1400. Nursing notes recorded that the patient was confused on 12/03/2010 at 1001 through 1400. Review of nursing notes dated 12/03/2010 at 1215 recorded "unable to obtain vital signs, patient sleeping, has been combative." Review of nursing notes dated 12/03/2010 at 1325 revealed "Nurse checked on patient and was found unresponsive, no pulse and no breathing. Code Blue called and CPR started ...." Review of the Code Blue record dated 12/03/2010 revealed the patient expired at 1349. Review of the restraint documentation revealed no evidence of alternatives tried and no behaviors documented by the nurse that required the application and continued use of the vest restraint on 12/03/2010.

Interview on 04/28/2011 at 1330 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should document alternatives tried and response to the alternatives prior to applying restraints. Interview confirmed there was no available documentation that nursing staff attempted alternatives as required by policy prior to the application of restraints on 12/03/2010.



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3. Observation on 04/27/2011 at 1330 during tour of the Post-Surgical Intensive Care Unit revealed Patient #45 was lying in bed, intubated, and on a mechanical ventilator. Observation revealed bilateral soft wrist restraints were on the patient and were tied to the frame of the bed.

Open record review on 04/27/2011 of Patient #45 revealed a 80 year-old female admitted 03/09/2011 with acute abdomen, pneumonia and respiratory insufficiency. Record review revealed the patient had a tracheostomy on 03/19/2011 and is ventilator dependent. Record review revealed a physician's order dated 04/25/2011 at 1108, 04/26/2011 at 1212 and 04/27/2011 at 1301 for bilateral soft wrist restraints. Review of the electronic medical record form, "Non-Violent Restraint Reassessment," dated 04/25/2011, revealed a check mark beside "Restrained 11:01 - 12:00, 12:01-13:00, 13:01-14:00 and 23:01-24:00. Review of the form revealed no checks in the boxes for "Alternatives Tried and Ineffective." Review of the electronic medical record form, "Non-Violent Restraint Reassessment," dated 04/26/2011, revealed a check mark beside "Restrained 01:01-02:00, 02:01-03:00, 03:01-04:00, 04:01-05:00, 05:01-06:00, 06:00-07:00, 07:01-08:00, 08:01-09:00, 09:01-10:00 ,10:01-11:00, 19:01-20:00, 20:01-21:00, 21:01-22:00 and 22:01-23:00. Review of the form revealed no checks in the boxes for "Alternatives Tried and Ineffective." Review of the electronic medical record form, "Non-Violent Restraint Reassessment," dated 04/27/2011, revealed a check mark beside "Restrained 11:01-12:00, 12:01-13:00 and 13:01- 14:00. Review of the form revealed no checks in the boxes for "Alternatives Tried and Ineffective."

Interview on 04/27/2011 at 1345 with the staff registered nurse assigned to Patient #45 for the 0700 to 1900 shift revealed, "there is no documentation that alternatives were tried before applying restraints". Interview further revealed the hospital's policy for restraints was not followed.

Based on policy and procedure review, closed medical record review and staff interview the nursing staff failed to obtain an order for a Therapeutic Hold for 1 of 1 adolescent patients reviewed that was restrained for violent and self-destructive behaviors (#87).

The finding include:

Review of hospital policy and procedure bulletin for Restraint and Seclusion "PPB-NCBH-42" last revised 1/27/11 revealed "All restraints or seclusion require a physician or LIP order...A. Restraint: any manual method, physical or mechanical...that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely...B. Therapeutic Hold: physically holding a patient for a limited time in a manner that restricts movement against the patient's will. The hold is only used in emergency situations where the immediate safety of the patient or others is compromised."

Medical record review of Patient # 87 revealed a 12 year old presenting to the Emergency Department (ED) on 3/18/2011 with a chief complaint of aggressive behavior and mood disorder. Record review revealed the patient was admitted to the inpatient psychiatric unit on 3/24/2011. Record review revealed on 4/23/2011 the patient "was hyper & started testing limits. Banging on door to children's unit. Age appropriate intervention, firm limits set but pt. ignored & started pulling fire alarms. Security called. Escorted to seclusion. 1600 Patient in seclusion and continues to be combative beating door, kicking and screaming." Further review revealed the patient was secluded from 1520 until 1720 (2 hours). Record review revealed no documentation of a physician's order for a therapeutic hold. Record review revealed at 1830 the "Patient attempted to inflict staff with nasal fluid and debris. Staff used redirection and age appropriate interventions to get patient to change behavior. Patient became more aggressive, started to kick and scream. climbed on table., Pt. continued to be defiant and combative. Placed in seclusion with security assist." Record review revealed no documentation of a physician's order for a therapeutic hold.

Interview with psychiatric nursing staff on 4/28/2011 at 1030 revealed there was no documentation for an order for a therapeutic hold. The interview revealed the staff and security may hold the patient's arms limiting the patient's freedom of movement to escort the patient to seclusion. The interview did not reveal why the staff did not obtain on order for therapeutic holds.

Based on policy and procedure review, medical record review and staff interview the nursing staff failed to obtain a renewal order to restrain an adolescent patient for 1 of 1 adolescent patients reviewed that was restrained for violent and self-destructive behaviors (#87).

The findings include:

Review of hospital policy and procedure bulletin for Restraint and Seclusion "PPB-NCBH-42" last revised 1/27/11 revealed on page 4 of 14 " C. Ordering of Restraints or Seclusion ...Restraints for Seclusion for Violent Reasons...Time limits may not exceed:...Two (2) hours for age 9 to 17."

Medical record review of Patient #87 revealed a 12 year old presenting to the Emergency Department (ED) on 3/18/2011 with a chief complaint of aggressive behavior and mood disorder. Record review revealed on 3/20/2011 a physician's order for restraints for biting, scratching the staff, aggressive and to prevent harm to self. Review of the restraint order form revealed type of restraint was "Soft extremity - Wrist x 2 (Both wrist), Soft Extremity - Ankle x 2 (Both ankles), Twice as Tough cuffs x 2." Further review of the restraint order form revealed "Order Time Limits:...2 hrs (hours) for ages 9 - 17;" and a box checked for 2 hours. Review of the order revealed it was dated 3/20/2011 and timed 1600. Record review revealed the restraints were applied at 1600. Review of the nursing documentation revealed the patient was continuously restrained from 1600 until 1945 (3 hours 45 minutes). Record review did not reveal any documentation of a renewal order obtained by nursing staff at 1800 (end of initial 2 hour time limit) for the the time limited restraints. Record review revealed the patient was restrained for an additional 1 hour and 45 minutes (1800 to 1945)without a physician's (renewal) order for restraint.

Interview with emergency department administrative nursing staff on 4/28/2011 at 1000 revealed there was no documentation for a renewal order to continue to restrain the patient after the 2 hour time limit. The interview revealed the staff did not follow the hospital policy and did not obtain a renewal order to restrain the patient.

Based on hospital policy review, medical record review, observation and staff interview, nursing staff failed to assess and monitor patients to ensure restraints were discontinued at the earliest possible time for 4 of 8 sampled restrained patients (#69, #70, #62 and #45).

The findings include:

Review of the "Restraint and Seclusion" policy effective 01/27/2010 revealed "... D.3. Assessment of the restrained or secluded patient includes documentation of the following: The patient's mental status and behavior before, during and after a restraint episode; ... The need for continuation of restraints or seclusion is reassessed to determine the appropriateness of early release....E. RN Documentation for Restraints or Seclusion: 1. Assessment of the need for restraints or seclusion...is documented on the appropriate restraint or seclusion order. 2. A new assessment is documented when restraints need to be continued due to an expired time limit or an unsuccessful release....G.1. Restraints or seclusion are discontinued as soon as clinical justification verifies that the patient no longer has the potential to harm himself/herself. This may occur before the time-limited order has expired. 3. The RN (registered nurse) may initiate early release based on professional judgment."

1. Closed record review for Patient #69 revealed a 64 year-old female that was admitted on 04/04/2011 with a fractured left humerus with repair done at an outside hospital on 03/26/2011. Record review revealed the patient had complications of respiratory failure following surgery and had been intubated, improved and was weaned off the mechanical ventilator. Review of a physician's order dated 04/04/2011 at 2143 revealed bilateral soft wrist restraints were ordered due to "dislodging of lines or tubes" and the patient was "intubated/receiving continuous sedation." Further review of the order recorded the patient's "current mental status" as "sedated and unable to follow commands." Record review revealed the patient was placed in a soft wrist restraint to the right wrist on 04/04/2011 at 2228. Record review revealed the patient remained in the restraint until 04/05/2011 at 1900 (20 hours and 32 minutes). Review of the restraint monitoring revealed the patient was "arousable" on 04/04/2011 at 2301 through 04/05/2011 at 0700. Review revealed the patient was "confused" on 04/05/2011 at 0701 through 1900. Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no documentation of the need for continuation of restraints.

Review of a physician's order dated 04/06/2011 at 0620 revealed a soft right wrist restraint was ordered due to "dislodging of lines or tubes" and "disrupting medical equipment." Review of the order recorded the patient was "intubated/receiving continuous sedation." Further review of the order recorded the patient's "current mental status" as "disoriented/confused." Record review revealed the patient was placed in a soft wrist restraint to the right wrist on 04/06/2011 between 0701 and 0800 (no specific time recorded). Record review revealed the patient remained in the restraint until 04/07/2011 at 0601 through 0700 (no specific time recorded). Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no documentation of the need for continuation of restraints from 04/06/2011 at 0701 through 0800 through 04/07/2011 at 0601 through 0700 (23 hours and 59 minutes).

Review of a physician's order dated 04/13/2011 at 1250 revealed a soft right wrist restraint was ordered due to "dislodging of lines or tubes" and "unable to follow safety instructions." Further review of the order recorded the patient's "current mental status" as "disoriented/confused, agitated, acute delirium and unable to follow commands." Record review revealed no nursing documentation that recorded the time the patient was placed in restraints or the type of restraint applied. Review of nursing notes dated 04/13/2011 at 2357 revealed "...restraints bilateral soft to wrists initiated 04/13/2011 status post patient disrupting medical equipment necessary for monitoring and care of this patient. Myself, this RN checked on patient just 10 - 15 minutes prior to 2357 04/13/2011, for a routine safety check. (Patient) was observed in her bed HOB (head of bed) at 45 (degrees), wrist restraints intact and in place. At 2357 patient found pulseless and apneic still in wrist restraints, crossed arms with knees on the floor by her bed. Restraints removed, patient eased to a supine position. CPR (cardiopulmonary resuscitation) immediately begun with a cardiac board placed underneath patient's chest. Code Blue called...." Record review recorded the patient's time of death as 0021 on 04/14/2011. Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no documentation of the need for continuation of restraints from 04/13/2011 at 1250 (ordered) through 04/13/2011 at 2357 when the patient was found without a pulse or respirations (11 hours and 7 minutes).

Interview on 04/28/2011 at 1500 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should assess and document the need for continued use of restraints and discontinue restraints at the earliest possible time. Interview confirmed there was no documentation of the need for continued use of restraints on 04/04/2011 through 04/05/2011, 04/06/2011 through 04/07/2011 and 04/13/2011.

2. Closed record review for Patient #70 revealed a 21 year-old male that was admitted from the emergency department on 12/03/2010 with pain in his upper and lower extremities related to sickle cell crisis. Review of physician's progress notes dated 12/03/2010 at 0727 revealed "Pt (patient) acting very strangely this morning, rocking back and forth on bed, kicking out legs and jumping out of bed suddenly. Is not talking at all and will not verbalize what is bothering him." Review revealed a physician's order dated 12/03/2010 at 0725 for a sitter at bedside. Further review revealed a physician's order dated 12/03/2010 at 0915 for a vest restraint due to "Dislodging of lines or tubes, Disrupting medical equipment and Unable to follow safety instructions." Review of a physician's order dated 12/03/2010 at 1026 revealed an order to discontinue the sitter. Review of a "Non-violent Restraint Reassessment" revealed a vest restraint was applied on 12/03/2010 between 1001 and 1100 (no specific time recorded). Review revealed the patient was restrained from 1101 through 1200, 1201 through 1300 and 1301 through 1400. Nursing notes recorded that the patient was confused on 12/03/2010 at 1001 through 1400. Review of nursing notes dated 12/03/2010 at 1215 recorded "unable to obtain vital signs, patient sleeping, has been combative." Review of nursing notes dated 12/03/2010 at 1325 revealed "Nurse checked on patient and was found unresponsive, no pulse and no breathing. Code Blue called and CPR started ...." Review of the Code Blue record dated 12/03/2010 revealed the patient expired at 1349. Review of the restraint documentation revealed no behaviors documented by the nurse that required the application and continued use of the vest restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no documentation of the need for continuation of the vest restraint on 12/03/2010.

Interview on 04/28/2011 at 1330 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should assess and document the need for continued use of restraints and discontinue restraints at the earliest possible time. Interview confirmed there was no documentation of the need for the continued use of the vest restraint on 12/03/2010.


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3. Observation on 04/27/2011 at 1530 during tour of the Neurosurgical Intensive Care Unit revealed Patient #62 was lying in bed, intubated, and on a mechanical ventilator. Observation revealed the patient had his eyes closed and was not moving in bed. Observation revealed bilateral soft wrist restraints were on the patient and were tied to the frame of the bed.

Open record review for Patient #62 revealed an 82 year-old male that was admitted on 04/13/2011 with a subdural hematoma (bleeding around the brain). Review of physician's orders for restraint dated 04/18/2011 at 2104 revealed, "Clinical Justification for NON-VIOLENT Restraint Dislodging of lines or tubes....Unable to follow safety instructions...." Record review revealed the patient was placed in bilateral soft wrist restraints on 04/18/2011 at 2104. Record review revealed the patient had continuously been in restraints from 04/18/2011 at 2104 until 04/27/2011 at 1530 (when the patient was observed). Record review revealed documentation of physician's orders to continue restraints each day from 04/19/2011 through 04/27/2011. Review of nursing documentation on 04/19/2011 at 0707 revealed, "Pt (patient) trying to climb out of bed." Record review revealed no nursing documentation the patient tried to climb out of bed, pull tubes, or failed to follow safety instructions between 04/19/2011 at 0707 and 04/27/2011 at 1530 (8 days).

Interview on 04/28/2011 at 1440 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should assess and document need for continued use of restraints and discontinue restraints at the earliest possible time. Interview confirmed there was no nursing documentation of the need for continued use of restraints between 04/19/2011 at 0707 and 04/27/2011 at 1530 (8 days).


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4. Observation on 04/27/2011 at 1330 during tour of the Post-Surgical Intensive Care Unit revealed Patient #45 was lying in bed, intubated, and on a mechanical ventilator. Observation revealed bilateral soft wrist restraints were on the patient and were tied to the frame of the bed.

Open record review on 04/27/2011 of Patient #45 revealed a 80 year-old female admitted 03/09/2011 with acute abdomen, pneumonia and respiratory insufficiency. Record review revealed the patient had a tracheostomy on 03/19/2011 and is ventilator dependent. Record review revealed a physician's order dated 04/25/2011 at 1108, 04/26/2011 at 1212 and 04/27/2011 at 1301 for bilateral soft wrist restraints due to "dislodging of lines or tubes." Review of the electronic medical record form, "Non-Violent Restraint Reassessment," dated 04/25/2011, revealed a check mark beside "Restrained 11:01 - 12:00, 12:01-13:00, 13:01-14:00 and 23:01-24:00. Review of the electronic medical record form, "Non-Violent Restraint Reassessment," dated 04/26/2011, revealed a check mark beside "Restrained 01:01-02:00, 02:01-03:00, 03:01-04:00, 04:01-05:00, 05:01-06:00, 06:00-07:00, 07:01-08:00, 08:01-09:00, 09:01-10:00 ,10:01-11:00, 19:01-20:00, 20:01-21:00, 21:01-22:00 and 22:01-23:00. Review of the electronic medical record form, "Non-Violent Restraint Reassessment," dated 04/27/2011, revealed a check mark beside "Restrained 11:01-12:00, 12:01-13:00 and 13:01- 14:00. Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no documentation of the need for continuation of restraints.

Interview on 04/27/2011 at 1345 with the staff registered nurse assigned to Patient #45 for the 0700 to 1900 shift revealed nursing staff should assess and document the need for continued use of restraints and discontinue restraints at the earliest possible time. Interview further revealed there is no documentation that the restraints were ended at the earliest possible time. Interview further revealed the hospital's policy for restraints was not followed.

Based on hospital policy review, medical record review, observation and staff interview the hospital's nursing staff failed to monitor restrained patients per policy for 5 of 8 sampled restrained patients (#69, #70, #62, #45 and #88).

The findings include:

Review of the "Restraint and Seclusion" policy effective 01/27/2010 revealed "... D. Assessment and Monitoring Patients in Restraints or Seclusion ... 3. Assessment of the restrained or secluded patient includes documentation of the following: The patient's mental status and behavior before, during and after a restraint episode.... The need for continuation of restraints or seclusion is reassessed to determine the appropriateness of early release. 4. Monitoring of the restrained or secluded patient includes documentation of the following: Limbs are observed for adequate circulation, sensation and movement and signs of injury. Skin integrity is monitored. Food, fluids and toileting are offered at a minimum of every 2 hours as appropriate. When medically appropriate, the patient may perform active range of motion (if safe to remove restraints) or be provided with passive range of motion (if unsafe to remove restraints). Range of motion will be performed every two hours. The patient is repositioned to maintain proper body alignment and comfort. The respiratory status is monitored to assure no compromise due to the restraints and coughing and deep breathing is encouraged as appropriate...." Further review of the policy revealed assessment and monitoring should be completed and documented "at least every two hours" for patients that have restraints applied for nonviolent reasons.

1. Closed record review for Patient #69 revealed a 64 year-old female that was admitted on 04/04/2011 with a fractured left humerus with repair done at an outside hospital on 03/26/2011. Record review revealed the patient had complications of respiratory failure following surgery and had been intubated, improved and was weaned off the mechanical ventilator. Review of a physician's order dated 04/04/2011 at 2143 revealed bilateral soft wrist restraints were ordered due to "dislodging of lines or tubes" and the patient was "intubated/receiving continuous sedation." Further review of the order recorded the patient's "current mental status" as "sedated and unable to follow commands." Record review revealed the patient was placed in a soft wrist restraint to the right wrist on 04/04/2011 at 2228. Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed the patient remained in the restraint until 04/05/2011 at 1900 (20 hours and 32 minutes). Review of the restraint monitoring revealed the patient was "arousable" on 04/04/2011 at 2301 through 04/05/2011 at 0700. Review revealed the patient was "confused" on 04/05/2011 at 0701 through 1900. Record review revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during restraint use from 04/04/2011 at 2228 through 04/05/2011 at 1900 (20 hours and 32 minutes).

Review of a physician's order dated 04/06/2011 at 0620 revealed a soft right wrist restraint was ordered due to "dislodging of lines or tubes" and "disrupting medical equipment." Review of the order recorded the patient was "intubated/receiving continuous sedation." Further review of the order recorded the patient's "current mental status" as "disoriented/confused." Record review revealed the patient was placed in a soft wrist restraint to the right wrist on 04/06/2011 between 0701 and 0800 (no specific time recorded). Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed the patient remained in the restraint until 04/07/2011 at 0601 through 0700 (no specific time recorded). Review of the restraint monitoring revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during restraint use from 04/06/2011 at 0701 through 0800 through 04/07/2011 at 0601 through 0700 (23 hours and 59 minutes).

Review of a physician's order dated 04/12/2011 at 1033 revealed bilateral soft wrist restraints were ordered due to "unable to follow safety instructions." Further review of the order recorded the patient's "current mental status" as "disoriented/confused, agitated, acute delirium." Review of a physician's progress note dated 04/12/2011 at 1507 revealed the patient "continues to be somewhat agitated and has not kept LUE (left upper extremity) in sling for fracture. Restraints this AM to keep left arm stable until Pt (patient) calmed down." Record review revealed no nursing documentation of the type of restraint applied, time applied and released or monitoring of the patient during the use of restraints. Record review revealed no nursing documentation of the time the restraint was ended. Record review revealed no nursing documentation regarding alternatives tried or response to alternatives prior to the use of restraints.

Review of a physician's order dated 04/13/2011 at 1250 revealed a soft right wrist restraint was ordered due to "dislodging of lines or tubes" and "unable to follow safety instructions." Further review of the order recorded the patient's "current mental status" as "disoriented/confused, agitated, acute delirium and unable to follow commands." Record review revealed no nursing documentation that recorded the time the patient was placed in restraints or the type of restraint applied. Review of nursing notes dated 04/13/2011 at 2357 revealed "...restraints bilateral soft to wrists initiated 04/13/2011 status post patient disrupting medical equipment necessary for monitoring and care of this patient. Myself, this RN checked on patient just 10 - 15 minutes prior to 2357 04/13/2011, for a routine safety check. (Patient) was observed in her bed HOB (head of bed) at 45 (degrees), wrist restraints intact and in place. At 2357 patient found pulseless and apneic still in wrist restraints, crossed arms with knees on the floor by her bed. Restraints removed, patient eased to a supine position. CPR (cardiopulmonary resuscitation) immediately begun with a cardiac board placed underneath patient's chest. Code Blue called...." Record review recorded the patient's time of death as 0021 on 04/14/2011. Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during restraint use from 04/13/2011 at 1250 (ordered) through 04/13/2011 at 2357 when the patient was found without a pulse or respirations (11 hours and 7 minutes).

Interview on 04/28/2011 at 1500 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should monitor patients that are in restraints for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity and perform range of motion exercises every two hours. Interview confirmed there was no available documentation that nursing staff monitored Patient #69 for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours as required by policy during the application of restraints on 04/04/2011 through 04/05/2011, 04/06/2011 through 04/07/2011, 04/12/2011 and 04/13/2011.

2. Closed record review for Patient #70 revealed a 21 year-old male that was admitted from the emergency department on 12/03/2010 with pain in his upper and lower extremities related to sickle cell crisis. Review of physician's progress notes dated 12/03/2010 at 0727 revealed "Pt (patient) acting very strangely this morning, rocking back and forth on bed, kicking out legs and jumping out of bed suddenly. Is not talking at all and will not verbalize what is bothering him." Review revealed a physician's order dated 12/03/2010 at 0725 for a sitter at bedside. Further review revealed a physician's order dated 12/03/2010 at 0915 for a vest restraint due to "Dislodging of lines or tubes, Disrupting medical equipment and Unable to follow safety instructions." Review of a physician's order dated 12/03/2010 at 1026 revealed an order to discontinue the sitter. Review of a "Non-violent Restraint Reassessment" revealed a vest restraint was applied on 12/03/2010 between 1001 and 1100 (no specific time recorded). Review revealed the patient was restrained from 1101 through 1200, 1201 through 1300 and 1301 through 1400. Nursing notes recorded that the patient was confused on 12/03/2010 at 1001 through 1400. Review of nursing notes dated 12/03/2010 at 1215 recorded "unable to obtain vital signs, patient sleeping, has been combative." Review of nursing notes dated 12/03/2010 at 1325 revealed "Nurse checked on patient and was found unresponsive, no pulse and no breathing. Code Blue called and CPR started ...." Review of the Code Blue record dated 12/03/2010 revealed the patient expired at 1349. Review of the restraint documentation revealed no evidence of alternatives tried and no behaviors documented by the nurse that required the application and continued use of the vest restraint. Record review revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during the use of restraints on 12/03/2010.

Interview on 04/28/2011 at 1330 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should monitor patients that are in restraints for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity and perform range of motion exercises every two hours. Interview confirmed there was no available documentation that nursing staff monitored Patient #70 for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours on 12/03/2010.


22563

3. Observation on 04/27/2011 at 1530 during tour of the Neurosurgical Intensive Care Unit revealed Patient #62 was lying in bed, intubated, and on a mechanical ventilator. Observation revealed bilateral soft wrist restraints were on the patient and were tied to the frame of the bed.

Open record review for Patient #62 revealed an 82 year-old male that was admitted on 04/13/2011 with a subdural hematoma (bleeding around the brain). Record review revealed the patient was placed in bilateral soft wrist restraints on 04/18/2011 at 2104. Record review revealed the patient had continuously been in restraints from 04/18/2011 at 2104 until 04/27/2011 at 1530 (when the patient was observed). Record review revealed no documentation that nursing staff monitored the patient's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during the following shifts: 7P (1900-0700) on 04/18/2011; 7A (0700-1900) on 04/20/2011; 7A on 04/23/2011; 7A and 7P on 04/25/2011; and 7A and 7P on 04/26/2011 (7 of 18 shifts reviewed).

Interview on 04/28/2011 at 1440 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should monitor the restrained limbs of patients that are in restraints for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity and perform range of motion exercises every two hours. Interview confirmed there was no available documentation that nursing staff monitored Patient #62's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during the following shifts: 7P (1900-0700) on 04/18/2011; 7A (0700-1900) on 04/20/2011; 7A on 04/23/2011; 7A and 7P on 04/25/2011; and 7A and 7P on 04/26/2011 (7 of 18 shifts reviewed).


25021

5. Observation during tour of the 8th North Tower patient care area on 4/27/2011 at 1525 revealed Patient #88 was in bilateral wrist restraints. Observation revealed both restraints were attached to the bedframe. Further observation revealed the patient was on contact isolation (isolation requiring staff to don personal protective equipment, such as gloves and gown, when entering the patient's room and making contact with the patient).

Open medical record review for Patient #88 on 04/28/2011 revealed a 87 year old male admitted on 04/12/2011 for possible cholecystitis, dementia and ESRD (End-Stage Renal Disease). Review revealed a physician's order for bilateral wrist restraints was written on 04/26/2011 at 1000 and on 04/27/2011 at 1000, both for a 24 hour period. Review of restraint monitoring from 04/26/2011 at 1000 through 04/28/2011 at 1000 (24 potential restraint monitoring episodes with monitoring every two (2) hours) failed to reveal documentation of restraint monitoring on 04/26/2011 from 1600-1800 and 2000-2200, on 04/27/2011 from 0100-0300, 0400-0600 and 1600-1800. Review revealed nursing staff failed to monitor the patient for five (5) of 24 total monitoring episodes.

Interview with nursing administrative staff on 04/28/2011 at 1010, during the medical record review for Patient #88, revealed monitoring for patients in non-behavioral, non-self-destructive restraints should occur every two hours. Interview revealed the medical record failed to reveal documentation of restraint monitoring on 04/26/2011 from 1600-1800 and 2000-2200, on 04/27/2011 from 0100-0300, 0400-0600 and 1600-1800. Interview revealed staff failed to follow hospital policy to monitor the patient in restraint every two hours.



22798

4. Observation on 04/27/2011 at 1330 during tour of the Post-Surgical Intensive Care Unit revealed Patient #45 was lying in bed, intubated, and on a mechanical ventilator. Observation revealed bilateral soft wrist restraints were on the patient and were tied to the frame of the bed.

Open record review on 04/27/2011 of Patient #45 revealed an 80 year-old female admitted 03/09/2011 with acute abdomen, pneumonia and respiratory insufficiency. Record review revealed the patient had a tracheostomy on 03/19/2011 and is ventilator dependent. Record review revealed a physician's order dated 04/25/2011 at 1108, 04/26/2011 at 1212 and 04/27/2011 at 1301 for bilateral soft wrist restraints. Review of the electronic medical record form, "Non-Violent Restraint Reassessment," dated 04/25/2011, revealed a check mark beside "Restrained" 11:01 - 12:00, 12:01-13:00, 13:01-14:00 and 23:01-24:00, the 04/26/2011 form revealed a check mark beside "Restrained" 01:01-02:00, 02:01-03:00, 03:01-04:00, 04:01-05:00, 05:01-06:00, 06:00-07:00, 07:01-08:00, 08:01-09:00, 09:01-10:00 ,10:01-11:00, 19:01-20:00, 20:01-21:00, 21:01-22:00 and 22:01-23:00 and the 04/27/2011 form revealed check mark beside "Restrained" 11:01-12:00, 12:01-13:00 and 13:01- 14:00. Record review revealed no documentation that nursing staff monitored the patient's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours per hospital policy for the hours restrained on 04/25/2011, 04/26/2011 and 04/27/2011.

Interview on 04/27/2011 at 1345 with the staff registered nurse assigned to Patient #45 for the 0700 to 1900 shift revealed, "there is no documentation that monitoring was done". Interview further revealed there was no documentation that nursing staff monitored the patient's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours per hospital policy for the hours restrained on 04/25/2011, 04/26/2011 and 04/27/2011. Interview further revealed the hospital's policy for monitoring a patient while in restraints was not followed.

Based on review of hospital policies and procedures, open and closed medical record reviews, Quality Assessment and Performance Improvement (QAPI) data,
QAPI meeting minutes and staff interviews, the hospital failed to maintain an effective, data-driven QAPI program.

Findings include:

1. The hospital failed to monitor the effectiveness and safety of services by failing to ensure restraint education was effective in improving monitoring and reassessment of patients in restraint.

~ Cross refer to 482.21(b)(2) QAPI Quality of Care - Tag A0275.

2. The hospital failed to incorporate data regarding hemodialysis (HD) services into the hospital-wide QAPI program.

~Cross refer to 482.21(b)(1) QAPI Program Data - Tag A0274.

3. The hospital failed to monitor the safe preparation of medication in the utilization of a robot used to prepare medications in the pharmacy department.

~Cross refer to 482.21(c)(2) QAPI Program Data - Tag A0286.

Based on review of hospital policies and procedures, Quality Assessment and Performance Improvement (QAPI) meeting minutes and staff interviews, the hospital failed to incorporate data regarding hemodialysis (HD) services into the hospital-wide QAPI program.

The findings include:

Review of hospital policy "Quality Assessment and Performance Improvement Plan" on 04/27/2011 revised 04/11 revealed "Executive Summary - The Quality Assessment and Performance Improvement Plan details system-wide, ongoing, data-driven efforts to assess quality and enhance performance improvement. The centralized plan coordinates, directs, monitors, and evaluates quality improvement and patient safety activities for patients throughout the [name of hospital]....providing as well for Board participation and oversight." Further review revealed "A. Quality Council - 1. Purpose: The Quality Council (QC) will facilitate and advise the medical center's continuous improvement of health care services to meet the needs of our patients, our community, referring physicians and other stakeholders. 2. Functions: a. In that role, the Council will also be responsive to the [name of hospital] Board's ultimate oversight of institutional quality...B. Quality Management Team - 1. Purpose: Oversee the appropriate deployment and operations of the QAPI Plan of the medical center...c. Collate and review the medical center-wide data on performance indicators."

Interview with HD administrative staff on 04/26/2011 at 1300 revealed performance data for the HD department is reported at the HD Quality Committee monthly. Interview revealed the HD Quality Council is comprised of members of the hemodialysis staff, including the HD medical director and a pharmacist. Interview revealed there is a representative from the HD Quality Committee that sits on the hospital's Quality Council. Interview revealed "I don't believe the hemodialysis data is presented at the Quality Council."

Interview with QAPI administrative staff on 4/27/2011 at 1005 revealed "We have recently revamped our committee reporting structure." Interview revealed HD data should be reported to the Quality Management Team committee. Interview revealed the HD data was not being reported into the QC reporting structure. Interview revealed meeting minutes of the hospital's QAPI committees would not reflect any reporting of HD data into the the hospital-wide QAPI program. Further interview revealed the hospital-wide QAPI program failed to ensure governing body oversight of the performance of the HD service and operation by failing to ensure HD performance data was being reported into the hospital-wide QAPI program.

Based on review of hospital policies and procedures, open and closed medical record reviews, Quality Assessment and Performance Improvement (QAPI) restraint data and staff interviews, the hospital failed to monitor the effectiveness and safety of services by failing to ensure restraint education was effective in improving monitoring and reassessment of patients in restraint.

The findings include:

Review of hospital policy "Quality Assessment and Performance Improvement Plan" on 04/27/2011 revised 04/11 revealed "Executive Summary - The Quality Assessment and Performance Improvement Plan details system-wide, ongoing, data-driven efforts to assess quality and enhance performance improvement. The centralized plan coordinates, directs, monitors, and evaluates quality improvement and patient safety activities for patients throughout the [name of hospital]...providing as well for Board participation and oversight."

Review of the "Restraint and Seclusion" policy effective 01/27/2010 revealed "... J. Performance Improvement: There is a chain for reporting outcomes of the Restraint program to hospital leadership. This results in an organized approach to restraint use that protects the patient's health and safety and preserves his or her dignity, rights and well being. The quality improvement process shall support (hospital name's) commitment to prevent, reduce and when possible, eliminate the use of restraint or seclusion through preventive strategies and innovative alternatives that focus of the patient's well being. Through Quality Performance Improvement Processes, hospital leadership will: assess and monitor the use of restraint or seclusion in their hospital; Implement actions to ensure that restraint or seclusion is used only to ensure the physical safety of the patient, staff and others; and Ensure that the hospital complies with the requirements set forth in this standard as well as those set forth by state law and hospital policy when the use of restraint or seclusion is necessary."

Closed record review for Patient #69 revealed an 64 year-old female that was admitted on 04/04/2011 with a fractured left humerus with repair done at an outside hospital on 03/26/2011. Record review revealed the patient had complications of respiratory failure following surgery and had been intubated, improved and was weaned off the mechanical ventilator. Review of a physician's order dated 04/04/2011 at 2143 revealed bilateral soft wrist restraints were ordered due to "dislodging of lines or tubes" and the patient was "intubated/receiving continuous sedation." Further review of the order recorded the patient's "current mental status" as "sedated and unable to follow commands." Record review revealed the patient was placed in a soft wrist restraint to the right wrist on 04/04/2011 at 2228. Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed the patient remained in the restraint until 04/05/2011 at 1900 (20 hours and 32 minutes). Review of the restraint monitoring revealed the patient was "arousable" on 04/04/2011 at 2301 through 04/05/2011 at 0700. Review revealed the patient was "confused" on 04/05/2011 at 0701 through 1900. Record review revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during restraint use from 04/04/2011 at 2228 through 04/05/2011 at 1900 (20 hours and 32 minutes).

Review of a physician's order for Patient #69 dated 04/06/2011 at 0620 revealed a soft right wrist restraint was ordered due to "dislodging of lines or tubes" and "disrupting medical equipment." Review of the order recorded the patient was "intubated/receiving continuous sedation." Further review of the order recorded the patient's "current mental status" as "disoriented/confused." Record review revealed the patient was placed in a soft wrist restraint to the right wrist on 04/06/2011 between 0701 and 0800 (no specific time recorded). Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed the patient remained in the restraint until 04/07/2011 at 0601 through 0700 (no specific time recorded). Review of the restraint monitoring revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during restraint use from 04/06/2011 at 0701 through 0800 through 04/07/2011 at 0601 through 0700 (23 hours and 59 minutes).

Review of a physician's order Patient #69 dated 04/12/2011 at 1033 revealed bilateral soft wrist restraints were ordered due to "unable to follow safety instructions." Further review of the order recorded the patient's "current mental status" as "disoriented/confused, agitated, acute delirium." Review of a physician's progress note dated 04/12/2011 at 1507 revealed the patient "continues to be somewhat agitated and has not kept LUE (left upper extremity) in sling for fracture. Restraints this AM to keep left arm stable until Pt (patient) calmed down." Record review revealed no nursing documentation of the type of restraint applied, time applied and released or monitoring of the patient during the use of restraints. Record review revealed no nursing documentation regarding alternatives tried or response to alternatives prior to the use of restraints or the time the restraint was ended.

Review of a physician's order Patient #69 dated 04/13/2011 at 1250 revealed a soft right wrist restraint was ordered due to "dislodging of lines or tubes" and "unable to follow safety instructions." Further review of the order recorded the patient's "current mental status" as "disoriented/confused, agitated, acute delirium and unable to follow commands." Record review revealed no nursing documentation that recorded the time the patient was placed in restraints or the type of restraint applied. Review of nursing notes dated 04/13/2011 at 2357 revealed "...restraints bilateral soft to wrists initiated 04/13/2011 status post patient disrupting medical equipment necessary for monitoring and care of this patient. Myself, this RN checked on patient just 10 - 15 minutes prior to 2357 04/13/2011, for a routine safety check. (Patient) was observed in her bed HOB (head of bed) at 45 (degrees), wrist restraints intact and in place. At 2357 patient found pulseless and apneic still in wrist restraints, crossed arms with knees on the floor by her bed. Restraints removed, patient eased to a supine position. CPR (cardiopulmonary resuscitation) immediately begun with a cardiac board placed underneath patient's chest. Code Blue called...." Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during restraint use from 04/13/2011 at 1250 (ordered) through 04/13/2011 at 2357 when the patient was found without a pulse or respirations (11 hours and 7 minutes). Record review revealed no nursing documentation regarding alternatives tried or response to alternatives prior to the use of restraints.

Closed record review for Patient #70 revealed a 21 year-old male that was admitted from the emergency department on 12/03/2010 with pain in his upper and lower extremities related to sickle cell crisis. Review of physician's progress notes dated 12/03/2010 at 0727 revealed "Pt (patient) acting very strangely this morning, rocking back and forth on bed, kicking out legs and jumping out of bed suddenly. Is not talking at all and will not verbalize what is bothering him." Review revealed a physician's order dated 12/03/2010 at 0725 for a sitter at bedside. Further review revealed a physician's order dated 12/03/2010 at 0915 for a vest restraint due to "Dislodging of lines or tubes, Disrupting medical equipment and Unable to follow safety instructions." Review of a physician's order dated 12/03/2010 at 1026 revealed an order to discontinue the sitter. Review of a "Non-violent Restraint Reassessment" revealed a vest restraint was applied on 12/03/2010 between 1001 and 1100 (no specific time recorded). Review revealed the patient was restrained from 1101 through 1200, 1201 through 1300 and 1301 through 1400. Nursing notes recorded that the patient was confused on 12/03/2010 at 1001 through 1400. Review of nursing notes dated 12/03/2010 at 1215 recorded "unable to obtain vital signs, patient sleeping, has been combative." Review of nursing notes dated 12/03/2010 at 1325 revealed "Nurse checked on patient and was found unresponsive, no pulse and no breathing. Code Blue called and CPR started ...." Review of the Code Blue record dated 12/03/2010 revealed the patient expired at 1349. Review of the restraint documentation revealed no evidence of alternatives tried and no behaviors documented by the nurse that required the application and continued use of the vest restraint. Record review revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during the use of restraints on 12/03/2010. Review of the restraint documentation revealed no evidence of alternatives tried and no behaviors documented by the nurse that required the application and continued use of the vest restraint on 12/03/2010.

Open record review on 04/27/2011 of Patient #45 revealed a 80 year-old female admitted 03/09/2011 with acute abdomen, pneumonia and respiratory insufficiency. Record review revealed the patient had a tracheostomy on 03/19/2011 and is ventilator dependent. Record review revealed a physician's order dated 04/25/2011 at 1108, 04/26/2011 at 1212 and 04/27/2011 at 1301 for bilateral soft wrist restraints. Review of the electronic medical record form, "Non-Violent Restraint Reassessment", dated 04/25/2011, revealed a check mark beside "Restrained 11:01 - 12:00, 12:01-13:00, 13:01-14:00 and 23:01-24:00. Review of the form revealed no checks in the boxes for "Alternatives Tried and Ineffective". Review of the electronic medical record form, "Non-Violent Restraint Reassessment", dated 04/26/2011, revealed a check mark beside "Restrained 01:01-02:00, 02:01-03:00, 03:01-04:00, 04:01-05:00, 05:01-06:00, 06:00-07:00, 07:01-08:00, 08:01-09:00, 09:01-10:00 ,10:01-11:00, 19:01-20:00, 20:01-21:00, 21:01-22:00 and 22:01-23:00. Review of the form revealed no checks in the boxes for "Alternatives Tried and Ineffective". Review of the electronic medical record form, "Non-Violent Restraint Reassessment", dated 04/27/2011, revealed a check mark beside "Restrained 11:01-12:00, 12:01-13:00 and 13:01- 14:00. Review of the form revealed no checks in the boxes for "Alternatives Tried and Ineffective". Record review revealed no documentation that nursing staff monitored the patient's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours per hospital policy for the hours restrained on 04/25/2011, 04/26/2011 and 04/27/2011.

Open record review for Patient #62 revealed a 82 year-old male that was admitted on 04/13/2011 with a subdural hematoma (bleeding around the brain). Record review revealed the patient was placed in bilateral soft wrist restraints on 04/18/2011 at 2104. Record review revealed the patient had continuously been in restraints from 04/18/2011 at 2104 until 04/27/2011 at 1530 (when the patient was observed). Record review revealed no documentation that nursing staff monitored the patient's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during the following shifts: 7P (1900-0700) on 04/18/2011; 7A (0700-1900) on 04/20/2011; 7A on 04/23/2011; 7A and 7P on 04/25/2011; and 7A and 7P on 04/26/2011 (7 of 18 shifts reviewed).

Open medical record review for Patient #88 on 04/28/2011 revealed a 87 year old male admitted on 04/12/2011 for possible cholecystitis, dementia and ESRD (End-Stage Renal Disease). Review revealed a physician's order for bilateral wrist restraints was written on 04/26/2011 at 1000 and on 04/27/2011 at 1000, both for a 24 hour period. Review of restraint monitoring from 04/26/2011 at 1000 through 04/28/2011 at 1000 (24 potential restraint monitoring episodes with monitoring every two (2) hours) failed to reveal documentation of restraint monitoring on 04/26/2011 from 1600-1800 and 2000-2200, on 04/27/2011 from 0100-0300, 0400-0600 and 1600-1800. Review revealed nursing staff failed to monitor the patient for five (5) of 24 total monitoring episodes.

Review of Restraint QAPI data on 04/28/2011 revealed data collection regarding restraint use beginning week one in December 2010 through 3/09/2011. Review revealed data for "Reassessment Complete" and "Alternatives Listed" was collected. Review revealed the following findings:

12/2010 Week 1 - 72% (28 of every 100 patients restrained not reassessed)
12/2010 Week 1 - 78% (22 of every 100 patients with no alternatives to restraint listed)

12/2010 Week 2 - 48% (52 of every 100 patients restrained not reassessed)
12/2010 Week 2 - 52% (48 of every 100 patients with no alternatives to restraint listed)

12/2010 Week 3 - 78% (22 of every 100 patients restrained not reassessed)
12/2010 Week 3 - 80% (20 of every 100 patients with no alternatives to restraint listed)

12/2010 Week 4 - 88% (12 of every 100 patients restrained not reassessed)
12/2010 Week 4 - 80% (20 of every 100 patients with no alternatives to restraint listed)

01/2011 Week 5 - 74% (26 of every 100 patients restrained not reassessed)
01/2011 Week 5 - 81% (19 of every 100 patients with no alternatives to restraint listed)

01/2011 Week 6 - 65% (35 of every 100 patients restrained not reassessed)
01/2011 Week 6 - 78% (22 of every 100 patients with no alternatives to restraint listed)

01/2011 Week 7 - 92% (8 of every 100 patients restrained not reassessed)
01/2011 Week 7 - 92% (8 of every 100 patients with no alternatives to restraint listed)

01/2011 Week 8 - 61% (39 of every 100 patients restrained not reassessed)
01/2011 Week 8 - 67% (33 of every 100 patients with no alternatives to restraint listed)

01/2011 Week 9 - 72% (28 of every 100 patients restrained not reassessed)
01/2011 Week 9 - 67% (33 of every 100 patients with no alternatives to restraint listed)

02/07/2011 - 83% (17 of every 100 patients restrained not reassessed)
02/07/2011 - 73% (27 of every 100 patients with no alternatives to restraint listed)

03/09/2011 - 85% (15 of every 100 patients restrained not reassessed)
03/09/2011 - 82% (18 of every 100 patients with no alternatives to restraint listed)

Review on 4/28/2011 of form "Monthly Restraint Prevalence Audit" revealed "Directions for completing the monthly audit:...3) All patients on that census must be included in the audit, 4) If patient is restrained, check all documentation for the past 12 hours...8) Check Nursing Restraint Reassessment documentation...For nonviolent restraints...Does the reassessment include all the hours the patient was restrained, Is the patient's mental status documented at least every 2 hours, Have attempted alternatives to restraints been documented..."

Interview with QAPI staff on 4/28/2011 at 1420 revealed data collection regarding patients being reassessed and monitored while in restraint and alternatives to restraint began December 2010. Interview revealed only the 02/07/11 and 3/09/11 have data to support "100% of the patients restrained were audited." Interview revealed for the other days restraint data was collected "we were close to 100%." Interview revealed data findings regarding reassessment while a patient is restrained and alternatives attempted are currently below the expected level of performance. Interview revealed there have been education opportunities for nursing staff regarding restraint use based on the data collected beginning December 2010. Interview revealed there has been no trend of improvement in the restraint data collected to demonstrate the educational sessions were effective. Interview revealed there has been no monitoring of how many staff have completed the education.

Based on physician and staff interviews the hospital Quality Assessment and Performance Improvement Program (QAPI) failed to monitor the safe preparation of medication in the utilization of a robot used to prepare medications in the pharmacy department.

The findings include:

Interview with the Medical Director of infection control on 4/28/2011 at 0935 revealed in December 2010 he was requested by the pharmacy department to assist with investigating an issue with a robot utilized in the main pharmacy department. The interview revealed a robot was used as a syringe filling apparatus using vials of medications. The interview revealed the pharmacy staff completed quality controls and rarely had a positive result. The interview revealed the first week of December 2010, 3 of 10 control specimens resulted in positive results for contamination. The interview revealed a week later 10 of 10 control specimens were tested positive for contamination. The interview revealed the contamination was a bacteria. The interview revealed the robot was stopped immediately. The interview revealed the investigation indicated in an area where the syringes were rinsed the solution splattered back up onto the syringe. The interview revealed this will be reported to the FDA (Food and Drug Administration) in a the next "weeks".

Interview with the physician chairman of the Pharmacy and Therapeutics committee on 4/27/2011 at 0855 revealed he was aware of the "robot" incident when he heard talk within the hospital staff recently. The interview revealed the P/T committee did not have knowledge of the incident involving the robot.

Interview with QAPI administrative staff on 4/27/2011 at 1005 revealed they had no knowledge of of an incident in December 2010 of a robot used to prepare medications had been stopped immediately due to resulting positive cultures on the syringes.

Based on hospital policy and procedure reviews, open and closed medical record reviews, observations, and staff interviews the hospital failed to have an effective nursing service providing oversight and supervision of day to day operations by failing to ensure nursing staff implemented restraints in accordance with safe and appropriate standards of practice and to ensure blood transfusions were administered according to hospital policy.

The findings include:

1. The hospital's nursing staff failed to assess, monitor, and supervise the safe delivery of care to restrained patients by failing to attempt alternative measures, ensure monitoring and/or discontinue restraints at the earliest time for 5 of 8 sampled restrained patients (#69, #70, #62, #45, and #88).

~cross refer 482.23(b)(3) Nursing Services Standard: Nursing Supervision, Tag A0395.

2. The nursing staff failed to administer blood transfusions according to hospital policy for 2 of 7 sampled patients that received a blood transfusion (#35 and #80).

~cross refer 482.23(c)(3) Nursing Services Standard: Nursing Supervision, Tag A0409.

Based on hospital policy review, medical record review, observation and staff interview nursing staff failed to assess, evaluate and supervise the safe delivery of care to restrained patients by failing to attempt alternative measures, ensure monitoring and/or discontinue restraints at the earliest time for 5 of 8 sampled restrained patients (#69, #70, #62, #45, and #88); failed to obtain an order for a Therapeutic Hold for 1 of 1 adolescent patients reviewed that was restrained for violent and self-destructive behaviors (#87); and failed to obtain a renewal order to restrain an adolescent patient for 1 of 1 adolescent patients reviewed that was restrained for violent and self-destructive behaviors (#87).

The findings include:

Review of the "Restraint and Seclusion" policy effective 01/27/2010 revealed "... IV.A.1. Use of physical or chemical restraint and/or seclusion is based on a comprehensive assessment of the patient by the RN (registered nurse), physician, or LIP. 2. The use of restraint or seclusion is based on the individual patient's needs and the associated risk of restraint use. The risk to vulnerable patient populations such as emergency, pediatric, and cognitively or physically impaired patients is assessed. 3. Before restraints are used, appropriate preventive strategies are attempted and alternative measures used. 5. Strategies and alternatives used or attempted and the patient's response to them will be documented in the patient's record." Further review of the policy revealed "...D.4. Monitoring of the restrained or secluded patient includes documentation of the following: Limbs are observed for adequate circulation, sensation and movement and signs of injury. Skin integrity is monitored. Food, fluids and toileting are offered at a minimum of every 2 hours as appropriate. When medically appropriate, the patient may perform active range of motion (if safe to remove restraints) or be provided with passive range of motion (if unsafe to remove restraints). Range of motion will be performed every two hours. The patient is repositioned to maintain proper body alignment and comfort. The respiratory status is monitored to assure no compromise due to the restraints and coughing and deep breathing is encouraged as appropriate...." Further review of the policy revealed assessment and monitoring should be completed and documented "at least every two hours" for patients that have restraints applied for nonviolent reasons." Policy review revealed "... D.3. Assessment of the restrained or secluded patient includes documentation of the following: The patient's mental status and behavior before, during and after a restraint episode; ... The need for continuation of restraints or seclusion is reassessed to determine the appropriateness of early release....E. RN Documentation for Restraints or Seclusion: 1. Assessment of the need for restraints or seclusion...is documented on the appropriate restraint or seclusion order. 2. A new assessment is documented when restraints need to be continued due to an expired time limit or an unsuccessful release....G.1. Restraints or seclusion are discontinued as soon as clinical justification verifies that the patient no longer has the potential to harm himself/herself. This may occur before the time-limited order has expired. 3. The RN (registered nurse) may initiate early release based on professional judgment...."

1. Closed record review for Patient #69 revealed a 64 year-old female that was admitted on 04/04/2011 with a fractured left humerus with repair done at an outside hospital on 03/26/2011. Record review revealed the patient had complications of respiratory failure following surgery and had been intubated, improved and was weaned off the mechanical ventilator. Review of a physician's order dated 04/04/2011 at 2143 revealed bilateral soft wrist restraints were ordered due to "dislodging of lines or tubes" and the patient was "intubated/receiving continuous sedation." Further review of the order recorded the patient's "current mental status" as "sedated and unable to follow commands." Record review revealed the patient was placed in a soft wrist restraint to the right wrist on 04/04/2011 at 2228 and remained in the restraint through 04/05/2011 at 1900 (20 hours and 32 minutes). Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Review of the restraint monitoring revealed the patient was "arousable" on 04/04/2011 at 2301 through 04/05/2011 at 0700. Review revealed the patient was "confused" on 04/05/2011 at 0701 through 1900. Record review revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during restraint use from 04/04/2011 at 2228 through 04/05/2011 at 1900 (20 hours and 32 minutes). Record review revealed no documentation of the need for continuation of restraints.

Review of a physician's order dated 04/06/2011 at 0620 revealed a soft right wrist restraint was ordered due to "dislodging of lines or tubes" and "disrupting medical equipment." Review of the order recorded the patient was "intubated/receiving continuous sedation." Further review of the order recorded the patient's "current mental status" as "disoriented/confused." Record review revealed the patient was placed in a soft wrist restraint to the right wrist on 04/06/2011 between 0701 and 0800 (no specific time recorded). Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed the patient remained in the restraint until 04/07/2011 at 0601 through 0700 (no specific time recorded). Review of the restraint monitoring revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during restraint use from 04/06/2011 at 0701 through 0800 through 04/07/2011 at 0601 through 0700 (23 hours and 59 minutes). Record review revealed no documentation of the need for continuation of restraints from 04/06/2011 at 0701 through 0800 through 04/07/2011 at 0601 through 0700 (23 hours and 59 minutes).

Review of a physician's order dated 04/12/2011 at 1033 revealed bilateral soft wrist restraints were ordered due to "unable to follow safety instructions." Further review of the order recorded the patient's "current mental status" as "disoriented/confused, agitated, acute delirium." Review of a physician's progress note dated 04/12/2011 at 1507 revealed the patient "continues to be somewhat agitated and has not kept LUE (left upper extremity) in sling for fracture. Restraints this AM to keep left arm stable until Pt (patient) calmed down." Record review revealed no nursing documentation regarding the type of restraint applied, time applied or monitoring of the patient during the use of restraints. Record review revealed no nursing documentation of the time the restraint was ended.

Review of a physician's order dated 04/13/2011 at 1250 revealed a soft right wrist restraint was ordered due to "dislodging of lines or tubes" and "unable to follow safety instructions." Further review of the order recorded the patient's "current mental status" as "disoriented/confused, agitated, acute delirium and unable to follow commands." Record review revealed no nursing documentation that recorded the time the patient was placed in restraints or the type of restraint applied. Review of nursing notes dated 04/13/2011 at 2357 revealed "...restraints bilateral soft to wrists initiated 04/13/2011 status post patient disrupting medical equipment necessary for monitoring and care of this patient. Myself, this RN checked on patient just 10 - 15 minutes prior to 2357 04/13/2011, for a routine safety check. (Patient) was observed in her bed HOB (head of bed) at 45 (degrees), wrist restraints intact and in place. At 2357 patient found pulseless and apneic still in wrist restraints, crossed arms with knees on the floor by her bed. Restraints removed, patient eased to a supine position. CPR (cardiopulmonary resuscitation) immediately begun with a cardiac board placed underneath patient's chest. Code Blue called...." Record review recorded the patient's time of death as 0021 on 04/14/2011. Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no nursing documentation regarding alternatives tried or response to alternatives prior to the use of restraints. Record review revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during restraint use from 04/13/2011 at 1250 (ordered) through 04/13/2011 at 2357 when the patient was found without a pulse or respirations (11 hours and 7 minutes). Record review revealed no documentation of the need for continuation of restraints from 04/13/2011 at 1250 (ordered) through 04/13/2011 at 2357 when the patient was found without a pulse or respirations (11 hours and 7 minutes).

Interview on 04/28/2011 at 1500 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should document alternatives tried and response to the alternatives prior to applying restraints. Interview confirmed there was no available documentation that nursing staff attempted alternatives as required by policy prior to the application of restraints on 04/12/2011 and 04/13/2011. Interview further revealed nursing staff should monitor patients that are in restraints for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity and perform range of motion exercises every two hours. Interview confirmed there was no available documentation that nursing staff monitored Patient #69 for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours as required by policy during the application of restraints on 04/04/2011 through 04/05/2011, 04/06/2011 through 04/07/2011, 04/12/2011 and 04/13/2011. The staff member revealed nursing staff should assess and document the need for continued use of restraints and discontinue restraints at the earliest possible time. Interview confirmed there was no documentation of the need for continued use of restraints on 04/04/2011 through 04/05/2011, 04/06/2011 through 04/07/2011 and 04/13/2011.

2. Closed record review for Patient #70 revealed a 21 year-old male that was admitted from the emergency department on 12/03/2010 with pain in his upper and lower extremities related to sickle cell crisis. Review of physician's progress notes dated 12/03/2010 at 0727 revealed "Pt (patient) acting very strangely this morning, rocking back and forth on bed, kicking out legs and jumping out of bed suddenly. Is not talking at all and will not verbalize what is bothering him." Review revealed a physician's order dated 12/03/2010 at 0725 for a sitter at bedside. Further review revealed a physician's order dated 12/03/2010 at 0915 for a vest restraint due to "Dislodging of lines or tubes, Disrupting medical equipment and Unable to follow safety instructions." Review of a physician's order dated 12/03/2010 at 1026 revealed an order to discontinue the sitter. Review of a "Non-violent Restraint Reassessment" revealed a vest restraint was applied on 12/03/2010 between 1001 and 1100 (no specific time recorded). Review revealed the patient was restrained from 1101 through 1200, 1201 through 1300 and 1301 through 1400. Nursing notes recorded that the patient was confused on 12/03/2010 at 1001 through 1400. Review of nursing notes dated 12/03/2010 at 1215 recorded "unable to obtain vital signs, patient sleeping, has been combative." Review of nursing notes dated 12/03/2010 at 1325 revealed "Nurse checked on patient and was found unresponsive, no pulse and no breathing. Code Blue called and CPR started ...." Review of the Code Blue record dated 12/03/2010 revealed the patient expired at 1349. Review of the restraint documentation revealed no evidence of alternatives tried and no behaviors documented by the nurse that required the application and continued use of the vest restraint on 12/03/2010. Record review revealed no documentation that nursing staff monitored the patient for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during the use of restraints on 12/03/2010. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no documentation of the need for continuation of the vest restraint on 12/03/2010.

Interview on 04/28/2011 at 1330 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should document alternatives tried and response to the alternatives prior to applying restraints. Interview confirmed there was no available documentation that nursing staff attempted alternatives as required by policy prior to the application of restraints on 12/03/2010. Interview revealed nursing staff should assess and document the need for continued use of restraints and discontinue restraints at the earliest possible time. Interview confirmed there was no documentation of the need for the continued use of the vest restraint on 12/03/2010. Interview revealed nursing staff should monitor patients that are in restraints for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity and perform range of motion exercises every two hours. Interview confirmed there was no available documentation that nursing staff monitored Patient #70 for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours on 12/03/2010.


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3. Observation on 04/27/2011 at 1530 during tour of the Neurosurgical Intensive Care Unit revealed Patient #62 was lying in bed, intubated, and on a mechanical ventilator. Observation revealed the patient had his eyes closed and was not moving in bed. Observation revealed bilateral soft wrist restraints were on the patient and were tied to the frame of the bed.

Open record review for Patient #62 revealed an 82 year-old male that was admitted on 04/13/2011 with a subdural hematoma (bleeding around the brain). Review of physician's orders for restraint dated 04/18/2011 at 2104 revealed, "Clinical Justification for NON-VIOLENT Restraint Dislodging of lines or tubes....Unable to follow safety instructions...." Record review revealed the patient was placed in bilateral soft wrist restraints on 04/18/2011 at 2104. Record review revealed the patient had continuously been in restraints from 04/18/2011 at 2104 until 04/27/2011 at 1530 (when the patient was observed). Record review revealed documentation of physician's orders to continue restraints each day from 04/19/2011 through 04/27/2011. Review of nursing documentation on 04/19/2011 at 0707 revealed, "Pt (patient) trying to climb out of bed." Record review revealed no nursing documentation the patient tried to climb out of bed, pull tubes, or failed to follow safety instructions between 04/19/2011 at 0707 and 04/27/2011 at 1530 (8 days). Further record review revealed no documentation that nursing staff monitored the patient's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during the following shifts: 7P (1900-0700) on 04/18/2011; 7A (0700-1900) on 04/20/2011; 7A on 04/23/2011; 7A and 7P on 04/25/2011; and 7A and 7P on 04/26/2011 (7 of 18 shifts reviewed).

Interview on 04/28/2011 at 1440 with a Senior Compliance Analyst from the Nursing Quality and Compliance Department revealed nursing staff should assess and document need for continued use of restraints and discontinue restraints at the earliest possible time. Interview confirmed there was no nursing documentation of the need for continued use of restraints between 04/19/2011 at 0707 and 04/27/2011 at 1530 (8 days). Further interview revealed nursing staff should monitor the restrained limbs of patients that are in restraints for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity and perform range of motion exercises every two hours. Interview confirmed there was no available documentation that nursing staff monitored Patient #62's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours during the following shifts: 7P (1900-0700) on 04/18/2011; 7A (0700-1900) on 04/20/2011; 7A on 04/23/2011; 7A and 7P on 04/25/2011; and 7A and 7P on 04/26/2011 (7 of 18 shifts reviewed).


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4. Observation on 04/27/2011 at 1330 during tour of the Post-Surgical Intensive Care Unit revealed Patient #45 was lying in bed, intubated, and on a mechanical ventilator. Observation revealed bilateral soft wrist restraints were on the patient and were tied to the frame of the bed.

Open record review on 04/27/2011 of Patient #45 revealed an 80 year-old female admitted 03/09/2011 with acute abdomen, pneumonia and respiratory insufficiency. Record review revealed the patient had a tracheostomy on 03/19/2011 and is ventilator dependent. Record review revealed a physician's order dated 04/25/2011 at 1108, 04/26/2011 at 1212 and 04/27/2011 at 1301 for bilateral soft wrist restraints. Review of the electronic medical record form, "Non-Violent Restraint Reassessment," dated 04/25/2011, revealed a check mark beside "Restrained" 11:01 - 12:00, 12:01-13:00, 13:01-14:00 and 23:01-24:00, the 04/26/2011 form revealed a check mark beside "Restrained" 01:01-02:00, 02:01-03:00, 03:01-04:00, 04:01-05:00, 05:01-06:00, 06:00-07:00, 07:01-08:00, 08:01-09:00, 09:01-10:00 ,10:01-11:00, 19:01-20:00, 20:01-21:00, 21:01-22:00 and 22:01-23:00 and the 04/27/2011 form revealed check mark beside "Restrained" 11:01-12:00, 12:01-13:00 and 13:01-14:00. Review of the form revealed no checks in the boxes for "Alternatives Tried and Ineffective." Record review revealed no documentation that nursing staff monitored the patient's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours per hospital policy for the hours restrained on 04/25/2011, 04/26/2011 and 04/27/2011. Review revealed no nursing documentation describing the patient's behaviors that required the use of the restraint. Review of the record revealed no nursing documentation that the patient was pulling at lines or attempting to dislodge tubes. Record review revealed no documentation of the need for continuation of restraints.

Interview on 04/27/2011 at 1345 with the staff registered nurse assigned to Patient #45 for the 0700 to 1900 shift revealed, "there is no documentation that alternatives were tried before applying restraints." Interview revealed, "there is no documentation that monitoring was done." Interview further revealed there was no documentation that nursing staff monitored the patient's wrists for signs of adequate circulation, sensation and movement, signs of injury, and skin integrity or performed passive range of motion exercises every two hours per hospital policy for the hours restrained on 04/25/2011, 04/26/2011 and 04/27/2011. Interview revealed nursing staff should assess and document the need for continued use of restraints and discontinue restraints at the earliest possible time. Interview further revealed there is no documentation that the restraints were ended at the earliest possible time. Interview further revealed the hospital's policy for restraints was not followed.



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5. Observation during tour of the 8th North Tower patient care area on 4/27/2011 at 1525 revealed Patient #88 was in bilateral wrist restraints. Observation revealed both restraints were attached to the bedframe. Further observation revealed the patient was on contact isolation (isolation requiring staff to don personal protective equipment, such as gloves and gown, when entering the patient's room and making contact with the patient).

Open medical record review for Patient #88 on 04/28/2011 revealed a 87 year old male admitted on 04/12/2011 for possible cholecystitis, dementia and ESRD (End-Stage Renal Disease). Review revealed a physician's order for bilateral wrist restraints was written on 04/26/2011 at 1000 and on 04/27/2011 at 1000, both for a 24 hour period. Review of restraint monitoring from 04/26/2011 at 1000 through 04/28/2011 at 1000 (24 potential restraint monitoring episodes with monitoring every two (2) hours) failed to reveal documentation of restraint monitoring on 04/26/2011 from 1600-1800 and 2000-2200, on 04/27/2011 from 0100-0300, 0400-0600 and 1600-1800. Review revealed nursing staff failed to monitor the patient for five (5) of 24 total monitoring episodes.

Interview with nursing administrative staff on 04/28/2011 at 1010, during the medical record review for Patient #88, revealed monitoring for patients in non-behavioral, non-self-destructive restraints should occur every two hours. Interview revealed the medical record failed to reveal documentation of restraint monitoring on 04/26/2011 from 1600-1800 and 2000-2200, on 04/27/2011 from 0100-0300, 0400-0600 and 1600-1800. Interview revealed staff failed to follow hospital policy to monitor the patient in restraint every two hours.


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6. Review of hospital policy and procedure bulletin for Restraint and Seclusion "PPB-NCBH-42" last revised 1/27/11 revealed "All restraints or seclusion require a physician or LIP order...A. Restraint: any manual method, physical or mechanical...that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely...B. Therapeutic Hold: physically holding a patient for a limited time in a manner that restricts movement against the patient's will. The hold is only used in emergency situations where the immediate safety of the patient or others is compromised."

Medical record review of Patient # 87 revealed a 12 year old presenting to the Emergency Department (ED) on 3/18/2011 with a chief complaint of aggressive behavior and mood disorder. Record review revealed the patient was admitted to the inpatient psychiatric unit on 3/24/2011. Record review revealed on 4/23/2011 the patient "was hyper & started testing limits. Banging on door to children's unit. Age appropriate intervention, firm limits set but pt. ignored & started pulling fire alarms. Security called. Escorted to seclusion. 1600 Patient in seclusion and continues to be combative beating door, kicking and screaming." Further review revealed the patient was secluded from 1520 until 1720 (2 hours). Record review revealed no documentation of a physician's order for a therapeutic hold. Record review revealed at 1830 the "Patient attempted to inflict staff with nasal fluid and debris. Staff used redirection and age appropriate interventions to get patient to change behavior. Patient became more aggressive, started to kick and scream. climbed on table., Pt. continued to be defiant and combative. Placed in seclusion with security assist." Record review revealed no documentation of a physician's order for a therapeutic hold.

Interview with psychiatric nursing staff on 4/28/2011 at 1030 revealed there was no documentation for an order for a therapeutic hold. The interview revealed the staff and security may hold the patient's arms limiting the patient's freedom of movement to escort the patient to seclusion. The interview did not reveal why the staff did not obtain on order for therapeutic holds.

7. Review of hospital policy and procedure bulletin for Restraint and Seclusion "PPB-NCBH-42" last revised 1/27/11 revealed on page 4 of 14 " C. Ordering of Restraints or Seclusion ...Restraints for Seclusion for Violent Reasons...Time limits may not exceed:...Two (2) hours for age 9 to 17."

Medical record review of Patient #87 revealed a 12 year old presenting to the Emergency Department (ED) on 3/18/2011 with a chief complaint of aggressive behavior and mood disorder. Record review revealed on 3/20/2011 a physician's order for restraints for biting, scratching the staff, aggressive and to prevent harm to self. Review of the restraint order form revealed type of restraint was "Soft extremity - Wrist x 2 (Both wrist), Soft Extremity - Ankle x 2 (Both ankles), Twice as Tough cuffs x 2." Further review of the restraint order form revealed "Order Time Limits:...2 hrs (hours) for ages 9 - 17;" and a box checked for 2 hours. Review of the order revealed it was dated 3/20/2011 and timed 1600. Record review revealed the restraints were applied at 1600. Review of the nursing documentation revealed the patient was continuously restrained from 1600 until 1945 (3 hours 45 minutes). Record review did not reveal any documentation of a renewal order obtained by nursing staff at 1800 (end of initial 2 hour time limit) for the the time limited restraints. Record review revealed the patient was restrained for an additional 1 hour and 45 minutes (1800 to 1945)without a physician's (renewal) order for restraint.

Interview with emergency department administrative nursing staff on 4/28/2011 at 1000 revealed there was no documentation for a renewal order to continue to restrain the patient after the 2 hour time limit. The interview revealed the staff did not follow the hospital policy and did not obtain a renewal order to restrain the patient.

Based on review of hospital policies and procedures, medical record review and staff interviews the nursing staff failed to administer blood transfusions according to hospital policy for 2 of 7 sampled patients that received a blood transfusion (#35 and #80).

The findings include:

Review of hospital policy "Administration of Blood and Blood Components" (PPB-NCBH-169, Last Revision: 6/09) revealed, "... D. Obtaining Blood Products 1. Verify prior to picking up blood products from the Blood Bank: a) Order to transfuse blood products... E... 14. Rate of infusion: a) Slow infusion rates (2-4 hours) are preferable because they can reduce the incidence of transfusion reactions...Unless otherwise ordered... Blood Component: Packed Red Blood Cells, Infusion Time: 1-2 hours... G. Patient Monitoring and Documentation Standards 1. Vital signs including Temp(erature), BP (Blood Pressure), pulse, and Respiratory rate should be recorded at the following intervals for all transfusions: a) Pre-transfusion (within 20 minutes of start time) b) 15 minutes after initiation c) Hourly during transfusion d) Post transfusion...5. Document the following on the transfusion record: a) Date and time transfusion initiated b) Date and time transfusion ended c) Signature of nurse ending transfusion d) Amount of component infused... 6. Document in the medical record: a) Vital signs b) amount and type of infusion (on patient's intake/output record as well as on transfusion record)..."

1. Closed record review for Patient #35 revealed a 41-year old male admitted on 12/27/2010 with a diagnosis of dissection (to split open) of aortic arch and ascending aorta. Review of a Blood Bank Transfusion form dated 12/30/2010 revealed nursing staff started a transfusion of packed red blood cells (PRBC) at 0930 and did not record the time the transfusion ended on the transfusion form as required by hospital policy. Further record review revealed nursing staff documented the patient's temperature on 12/30/2010 at 0800 and 1200 but did not document the patient's temperature at 0900, 1000, or 1100 (pre-transfusion within 20 minutes of start time, 15-minutes after initiation, hourly during, and post-transfusion as required by hospital policy). Record review revealed the patient received a transfusion of PRBC on 01/11/2011 and the physician's order (dated 01/11/2011 at 0633) specified an infusion rate of "1 units1-2 hours each unit (a minimum transfusion rate of 1 hour per Unit)." Record review revealed the patient received a transfusion on 01/11/2011 starting at 0800 and ending at 0830 (infusion rate 30 minutes). Record review revealed the patient's temperature 15-minutes after initiation of transfusion and the volume infused (375 ml) was not documented on the nurse's flow-sheet as required by hospital policy. Record review revealed the patient received two transfusions of PRBC on 01/14/2011; one infusion started at 1615 and ended at 1700 followed by a second transfusion starting at 1710 and ending at 1800. Record review revealed the patient's temperature was recorded on the nurse's flow-sheet in the 1600 time slot (minute increment unknown) as 98.7° (degrees Fahrenheit) and again in the 1800 time slot (minute increment unknown) as 100°. Record review revealed the patient's post transfusion temperature (transfusion ending at 1615), pre-transfusion (within 20 minutes of start time) and 15-minutes after initiation temperatures (for transfusion beginning at 1700) were not documented. Record review revealed the patient received a transfusion of PRBC on 01/17/2011 starting at 1832 and ending at 1940. Record review revealed no documentation of a pre-transfusion temperature (last recorded temperature prior to transfusion at 1500 on 01/17/2011).

Interview on 04/27/2011 at 1500 with the Nurse Manager of the nursing unit where Patient #35 received the aforementioned transfusions confirmed there was no additional nursing documentation available. Interview confirmed nursing staff failed to document on the nursing flow-sheet the patient's temperature per hospital policy during 4 transfusions and failed to document the blood volume infused during 1 transfusion per hospital policy. Interview further confirmed nursing staff failed to infuse 1 transfusion at the rate ordered by the physician and failed to complete the Blood Transfusion form by omitting the transfusion end time. Interview revealed the unit manager does not review all Blood Bank Transfusion forms for accuracy of completion. Interview revealed six random chart audits are performed bi-monthly, including 3 blood transfusion charts. Interview revealed "... (I'm) not looking at all transfusion records. This is an opportunity to do this and I will begin auditing all transfusion records."

Interview on 04/28/2011 at 0945 with the nursing administration revealed the hospital's administration was "aware of the problem" with nursing documentation of blood administration. Interview revealed the problem was thought to be "an issue with the paper flow sheets" and the mix of electronic and paper documentation. Interview revealed the chart audit tool had been revised in March 2011 to "focus on required elements (blood administration vital signs)."

Interview on 04/28/2011 at 1045 with the Medical Director of the hospital's Blood Bank revealed the Blood Bank does not review Transfusion Records for accuracy of completion. Interview revealed "... Unless there is a blood reaction we are not looking at the slips (Transfusion Records)." Interview revealed the director was not aware of any missed transfusion reactions.

Interview on 04/28/2011 at 1050 with the Blood Safety Officer revealed chart audits of blood administration were conducted on patient charts that had a recorded transfusion reaction or had a reported incident. Interview revealed there was no real-time monitoring of blood administration.


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2. Medical record review of Patient #80 revealed on 4/20/2011 documentation of physician orders for transfusion of two units of packed red blood cells over "1 - 2 hours each unit." Review of the transfusion documentation revealed the first unit was started on 4/20/2011 at 1750. Record review revealed the unit was ended at 1853 (45 minutes infusion time duration ). Record review did not reveal any documentation why the transfusion was not administered per the physician's orders to transfuse over 1 - 2 hours.

Interview with administrative nursing staff on 4/26/2011 at 1110 revealed the blood transfusion was not administered per the physician's order. The interview revealed there was no documentation available why the blood was not administered per the physician's orders. The interview revealed the nurse is to administer blood per the physician's order.

Based on policy and procedure review, review of the Pharmacy and Therapeutics (P/T) Committee meeting minutes and staff interviews the P/T committee failed to ensure safe medication delivery by failing to review adverse drug events, mediation errors, adverse drug reactions and sentinel events per the hospital policy.

The finding include:

Review of policy "PPB-WFBMC - 97 formerly PPB-NCBH-97" last revision 04/07 revealed "There shall be a P/T committee which shall meet at least quarterly. This committee is an advisory committee of the medical staff and serves as the organization line of communication between the medical staff and the pharmacy department. ...It is also a policy recommending body to the medical staff and to the administration of the hospital on all matters related to the use of drugs...The primary purpose of the P/T committee are: A. Advisory: The committee recommends the adoption or assists in the formulation of broad professional polices regarding evaluation, selection, procurement, distribution, use, safe practices, and other matters pertinent to drugs in the hospital...this committee should function according to the following guidelines...8. To review adverse drug events and encourages process improvement initiatives to avoid adverse impacts."

Review of policy "PPB-NCBH-109" last revision 04/11 revealed "It is the policy of xxx (name of hospital) to provide a safe medication use process consistent with all applicable state and federal laws, rules and regulations and consistent with accepted professional standards and regulatory expectations...The P/T Committee will consider indication for use effectiveness, risks (including propensity for medication errors, drug interaction, adverse drug events...sentinel events. and other risks)...Summary reports of actual or potential adverse drug events, adverse drug reactions or medications variances".

Review of the P/T committee meeting minutes from February, 2010 through February, 2011 revealed the P/T committee met monthly except or the month of April 2010 and March 2011. Review of the P/T meeting minutes did not reveal any documentation regarding medication errors, drug interaction, adverse drug events or sentinel events. P/T meeting minutes review did not reveal any documentation of "Summary reports of actual or potential adverse drug events, adverse drug reactions or medications variances." Review of the pending approval of the P/T committee meeting minutes for April 2011 revealed data reported regarding Adverse drug events and medication errors.

Review of the Medication Use Process Improvement Team meeting minutes revealed meetings occurred from January 2010 through March 2011. Review of the June 21, 2010 meeting minutes revealed on the agenda "Medication Errors: Pharmacy report This item was tabled due to time constraints" with the action for a "future meeting."

Interview with administrative pharmacy staff on 4/25/2011 at 1510 revealed medication monitoring reports "ideally should be reported to the P/T committee quarterly." The interview revealed "we did have a lapse in reporting" data for adverse drug events, medications errors and adverse drug reactions for the past year from March 2010 until April 2011. The interview revealed there had been one report to P/T committee in the last year regarding medication data.

Based on review of hospital policies and procedures, medical records and staff interview, the hospital's pharmacist staff failed to ensure the appropriateness of a physician PRN (as needed) medication order prior to approving the PRN order into the patient's medication profile for 1 of 3 hemodialysis patient records reviewed (Patient #50).

The findings include:

Review of the hospital's Pharmacy policy "Medication Use Process" on 04/26/2011 revised 4/11 revealed "...C. Storage and Control...d...Following are examples of medication that may be stored at the patient's bedside as indicated by the physician's order: Topicals for wound care, Eye drops, Oral rinses, Metered dose inhalers...2d. All controlled substances throughout the medical center are stored in securely-locked, substantially-constructed cabinets." Further review revealed "D. Ordering and Prescribing...h. Actions to take when medication orders are incomplete, illegible, or unclear...(2) Pharmacy...(c) the pharmacists should contact the prescriber for clarification of medication orders which may include, but are not limited to...(ii) Dose, route, frequency unclear, missing or incorrect, (iii) Any needed information necessary for safe medication use."

Closed medical record review for Patient #50 on 04/26/2011 revealed a 71 year old male admitted 03/07/2011 for pneumonia and acute renal failure. Review revealed the patient was admitted to a medical floor but was transferred to the medical intensive care unit (MICU) the same day as admission increasing oxygen requirements and difficulty breathing. Review of physician orders for the MICU written 03/07/2011 at 2227 revealed "Etomidate (intravenous anesthetic agent used for sedation) 2 mg/ml (milligrams per milliliter) 20 ml VL (vial), 50 mg, IV (intravenous) PRN, bedside, Inject over 15 to 60 seconds" and "Midazolam (a controlled narcotic sedative) 1 mg/ml, 2 mg, IV, bedside." Record review revealed the PRN orders for the Etomidate and Midazolam were active until 03/11/2011, when the patient was transferred out of the MICU.

Interview with pharmacist administrative staff on 04/26/2011 at 1415 revealed sedative medications such as Etomidate and Midazolam cannot be kept at the bedside. Interview revealed "The pharmacist reviewing the order should have called the prescribing physician to clarify the order." Interview revealed "This order should have never reached the patient's medication profile." Interview revealed the pharmacist staff failed to follow hospital policy for safe medication use by failing to clarify a PRN order with the prescribing physician.

Based on hospital policy and procedure reviews, staff interviews, observations during tours, personnel file reviews, temperature log reviews, manufacturer's recommendations review and observations as referenced in the Life Safety Report of Survey completed April 28, 2011, the hospital staff failed to develop and maintain the facilities in a manner to ensure the health and safety of patients, staff, and visitors.

The findings include:

1. The hospital failed to maintain the environment ensuring the safety and well being of patients as referenced in the Life Safety survey completed 04/28/2011.

~Cross-refer to 482.41(a) Physical Environment Standard Tag A0701.

2. The hospital staff failed to ensure safe water testing of water used for hemodialysis (HD) by failing to ensure staff performing HD water testing for chlorine and chloramine had color-blindness screening (to determine if staff can perform colormetric tests) performed for 1 of 3 HD staff personnel files reviewed (Staff #34); and failed to ensure temperatures were maintained per manufacturer's recommendations for 4 of 6 contrast warmers observed within the radiology department (warmers A, B, C, & D).

~Cross-refer to 482.41(c)(2) Physical Environment Standard Tag A0724.

Based on observations and staff interviews as referenced in the Life Safety Report of Survey completed April 28, 2011, the hospital staff failed to develop and maintain the facilities in a manner to ensure the health and safety of patients, staff, and visitors.

The findings include:

1. Observation of Building four, on April 25, 2011 at approximately 1300 onward: Room # A468, there were penetrations in rated walls that were not properly sealed to maintain the required fire rating of the walls.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0012.

2. Observation of Building two, on April 25, 2011 at approximately 1300 onward: Eighth (8th) Floor, North Tower,- Hemo, Corridor door with self closing device held open with Electro-Magnetic device , did not close upon activation of Fire Alarm as required.
Observation of building four, on April 25, 2011 at approximately 1300 onward: 1. The corridor door to Reception Room at Clerical Room was held open with wooden wedge. 2. Adult ED/ Fast Track - Corridor door to clean utility room held open with rubber glove.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0018.

3. Observation of Building one, on April 25, 2011 at approximately 1300 onward: The fire door to the eight floor diverter shaft 125 is not self-closing and latching.
Observation of Building two, on April 26, 2011 at approximately 0730 onward: The access door to the vertical chase is not a listed self-closing and latching fire door - located in room 4D085.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0020.
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4. Observation of Building three, on April 27, 2011 at approximately 0530 onward: There is a hole in the smoke barrier wall above doors 904A.
Observation of Building seven, on April 28, 2011 at approximately 0800 onward: The combination fire and smoke curtain did not close with activation of ceiling smoke detectors adjacent to the required smoke barrier.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0025.

5. Observation of Building two, on April 25, 2011 at approximately 1300 onward: Eighth (8th) floor, Cross Corridor smoke doors (#8 B 116) and at ICU-4C, 4th floor did not close on activation of Fire Alarm.
Observation of Building four, on April 25, 2011 at approximately 1300 onward: Fourth (4 th) Floor - Cross Corridor smoke doors (#077B) and (#A457) did not close for smoke tight seal when tested.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0027.

6. Observation of Building one, on April 26, 2011 at approximately 0730 onward, There are holes in the door to housekeeping room M055 - the door equipped with a hasp that prevents exiting from inside the room. 2. Electrical rooms R-701 and 702 - 2-hr (hour) rated walls - There was no fire damper in Exhaust duct through walls.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0029.

7. Observation on Building two, on April 26, 2011 at approximately 0730 onward, the special locking arrangements for selected doors are noncompliant based upon the following: a. lack of complete installation in accordance with required building codes - locks at doors 40075C and CCU (Critical Care Unit, 7th floor) are not provided with a master release on/off switch at a supervised nurse's station. b. Sixth (6th) Floor , Stairwell #61, Exit door equipped with Mag- locks did not release with activation of Fire Alarm, the door did release with over ride switch at door.
Observation of Building four, on April 25, 2011 at approximately 1300 onward: the ninth (9th) Floor - 400 A Wing - Panic Hardware would not release door under normal operation. This door is equipped with NC Special (Mag) Locking. Ground Level , Exit door to Cancer Center is equipped with NC Special (Mag) locking - There is no master release switch at manned Nursing Station. The seventh (7th) Floor, Stair #2 , Exit door is equipped with NC Special (Mag) locking - There is no master release switch at manned Nursing Station.
Observation of Building seven, on April 25, 2011 at approximately 1300 onward: the second (2nd) Floor - Exit door next to #214 equipped with magnetic locking device did not release with emergency over ride switch, it did release with FA. Exit door equipped with Mag- locks did not release with activation of Fire Alarm, the door did release with over ride switch at door.
Observation of Building nine, on April 25, 2011 at approximately 1300 onward: Exit discharges from Rehab Center had no hard surface path to public way nor Emergency lighting to safe public way.
Observation of Building sixteen from Monday 4/25/2011 at approximately 1300 onward: K32 - special locking arrangements are incomplete in the following areas:1. exit near second floor elevators - no on/off switches adjacent to doors, no wiring diagram posted at fire alarm control panel, and no master release switch at a supervised station. 2. access controlled locks at cross corridor doors near stair #2 - no sensor is provided in accordance with Life Safety Code. 3. no master release switch for first floor electromagnetic locks near stair #2.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0032.

8. Observation of Building one, on April 26, 2011 at approximately 0730 onward, there is approximately a half inch gap between the meeting edge of fire doors RT01 - the astragal provided is not sufficient to maintain required fire rating.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0033.

9. Observation of Building one, on April 26, 2011 at approximately 0730 onward, the exit access doors require greater than a thirty pound force to set the doors in motion - doors from Chinese garden.
Observation of Building two, on April 27, 2011 at approximately 0530 onward, there is no forty-two inch guardrail between access door and shaftway floor penetration - third floor operating room suite.
Observation of Building Three, on April 27, 2011 at approximately 0530 onward, there is no guardrail provided between exit access door from shaftway room A-874 and floor penetration and the Tenth (10) Floor - Greater than thirty foot plus dead -end corridor at South Corridor, Main Entrance
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0038.

10. Observation of Building one, on April 26, 2011 at approximately 0730 onward, the horizontal sliding door to room R419 is used as an exit access door - the doors to similar rooms are not located within a suite of rooms.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0040.

11. Observation of Building one on Monday , 4/25/2011 at approximately 1300 onward : The ninth (9th) Floor : There was no lighting on Emergency Circuit ( LS Branch) for family waiting room # 90064 2. There was not exit discharge lighting in the exit discharge path from the first floor Reynolds to West and Watlington. (1st floor Reynolds)
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0045.

12. Observation of Building one, on April 26, 2011 at approximately 0730 onward, the emergency lighting serving the exit discharge could not be verified as being connected to the Life Safety Branch of the essential electrical system - located at M213B across from morgue pick-up area.
Observation of Building two, on April 25, 2011 at approximately 1300 onward, There is no lighting identified on the Life Safety Branch of the essential electrical system in the following areas: a. central corridor near the dialysis coordinator office - eight floor; b. corridor near bio-med office - eight floor and c. corridor near eight floor nurse's station.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0046.

13. Observation of Building one on Monday , 4/25/2011 at approximately 1300 onward : There was not exit signage at the first floor old emergency room exit. (1st floor Reynolds)
Observation of Building two, on April 26, 2011 at approximately 0730 onward, there is no exit sign near cross corridor doors to fourth floor Intensive Care Unit (ICU) - door 40075C.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0047.

14. Observation of Building two, on April 27, 2011 at approximately 0530 onward: Staff in operating room suite was not familiar with unlabeled air handler shutdown switch - located at abandoned room in third floor north tower.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0050.

15. Observation of Building one, on April 25, 2011 at approximately 1:1300 onward, there is no smoke detector located within eight floor nurse's station area - near door hold-open device located in required smoke barrier.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0051.

16. Observation of Building one, on April 25, 2011 at approximately 1300 onward: Both IT rooms #s 90067 and 90099 , no sprinkler coverage. The electrical room 1029A, in a building not equipped with a sprinkler system, did not have a smoke head. (1st floor Reynolds) Note: NFPA 13 5-13.11 Electrical Equipment. Sprinkler protection shall be required in electrical equipment rooms. Hoods or Shields installed to protect important electrical equipment from sprinkler discharge shall be noncombustible. Exception: Sprinklers shall not be required where all of the following conditions are met: (a) The room is dedicated to electrical equipment only. (b) Only dry-type electrical equipment is used. (c) Equipment is installed in a 2-hour fire-rated enclosure including protection for penetrations. (d) No combustible storage is permitted to be stored in the room.
Observation of Building two on Monday 4/25/2011 at approximately 1300 onward: AHU #18 mechanical room has sprinkler head that is blocked partially by a duct (9 North). Electrical room next to pharmacy did not have a sprinkler head (3rd floor North room # 3B0006). The Telecommunication room, next to equipment room, did not have a sprinkler head (3rd floor North, room # 3B005)
Observation of Building four, on April 27, 2011 at approximately 0530 onward: There is no sprinklers provided for closets located adjacent to corridors between rooms B-1119 and B-1120 - there are other similar closets on the same floor without sp2. Adult ED/ Fast Track - Room across from FT3 - Storage on shelves blocking sprinkler head coverage.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0056.

17. Observation of Building sixteen on Monday 4/25/2011 at approximately 1300 onward:1. K61 - potter tamper switches with cords are not approved by NFPA standards for monitoring four sprinkler control valves in main mechanical room.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0061.

18. Observation of Building 16 on Monday 4/25/2011 at approximately 1300 onward:1. K62 - green bulb sprinklers rated for 200 degrees Fahrenheit are used in the following rooms: A. environmental services 2H10-1 B. main mechanical room - room does not contain equipment that produces ambient temperatures in excess of 100 degrees Fahrenheit.
Observation of Building 2, on April 26, 2011 at approximately 0800 onward, 1. Sprinkler system components are incomplete in the following areas: a. storage room 4B026 - utilizes green bulb sprinklers rated for 90 degrees Celsius. b. staff lounge hallway sprinkler is cover with lint - near room 4B047. c. room 4D066 - ceiling furring obstructs pendent sprinkler. The sub-basement pump room - Tamper switch when tested did not send alarm.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0062.

19. Observation of Building one, on April 25, 2011 at approximately 1300 onward, the mechanical systems in the following areas are incomplete: a. mechanical room PH019 - duct penetrations of vertical chase are not equipped with service access openings and breakaway connections for fire dampers - could not verify installation a time of survey. b. air handlers #3, and #4 are not equipped with emergency shutdown switch(es) - eight floor.
Observation of Building two, on April 26, 2011 at approximately 0800 onward, The corridor is used as a return air plenum at office 4B087. The office is not equipped with a return air inlet.
Observation of Building three, on April 27, 2011 at approximately 0530 onward: The mechanical systems are noncompliant due to the following: a. no fire damper at duct penetration of two hour rated chase adjacent to eight floor communications room 106A.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0067.

20. Observation of Building three, on April 27, 2011 at approximately 0530 onward: The soiled linen chute door will not self-close and latch - fifth floor soiled utility near A-577.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0071.

21. Observation of Building one, on April 25, 2011 at approximately 1300 onward: There is unattended storage of impediments in the corridor near eight floor elevators - items were not in immediate and continuous use. Note: This condition existed through-out the entire campus in several areas. Flat screen monitors, mounted on corridor walls, extend greater than three and one half inches into required corridor headroom clearance - located in area containing room R-408. The seventh (7th) Floor - Wall mounted charting tables in the corridor that were not self retracting/closing. Linen Closets at room R709 - with Corridor doors not self closing or open 180 degrees.

Observation of Building two, on April 26, 2011 at approximately 0800 onward: There are unattended impediments stored in the corridor near room N-801. Horizontal sliding door, interior courtyard exit access 4B082, will not swing one hundred eighty degrees to prevent corridor obstruction. Observation on Monday 4/25/2011 at approximately 1300 onward: Oxygen/ Med Gas gauges not registering correctly - could not test alarms. Interior courtyard exit access 4B082, will not swing one hundred eighty degrees to prevent corridor obstruction. Observation on Monday 4/25/2011 at approximately 1300 onward: Clean linen doors open into corridor without closure. The doors did not open 180 degrees. (9 North)
Observation of Building four, on April 25, 2011 at approximately 1300 onward: Ground Level, Corridor door to Rest Room GAA018 swings into corridor, this door is not self closing nor swings 180 degrees to clear corridor egress path.
Observation of Building seven, on April 25, 2011 at approximately 1300 onward: Second (2nd) Floor - Corridor Doors to Elec Rooms #283A open into the corridor. These doors do not swing 180 degrees into corridor nor have self closing devices on them.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0072.

22. Observation of Building two, on April 27, 2011 at approximately 0800 onward: There are full and empty oxygen cylinders are intermingled in the same storage racks - north tower, third floor operating room suite, 5th Floor Respiratory Therapy.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0076.

23. Observation of Building one on Monday 4/25/2011 at approximately 1300 onward: Oxygen/ Med Gas gauges not registering correctly - could not test alarms.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0077.

24. Observation of Building one, on April 27, 2011 at approximately 0530 onward, the essential electrical system is noncompliant due to the following: a. during loss of normal power to the life safety branch automatic transfer switch, the system required approximately nineteen seconds to restore power to the emergency systems. b. audible signaling device cannot be tested using generator annunciator test switch. c. low fuel level, when there is approximately a three hour capacity remaining in the main tank, audible and visual indicator is not monitored on the generator annunciator panel(s).
Observation of Building two, on April 26, 2011 at approximately 0800 onward, There is no lighting identified on the Critical Branch of the essential electrical system in the following area: eight floor nurse's station. Fire alarm power supply, circuit #27, is wired to critical branch panelboard CL-4-C - panelboard is located in room 4D068.
Observation of Building three, on April 27, 2011 at approximately 0530 onward: The life safety branch panelboard contains auto doors east and west - located on panelboard LSL8.
Observation of Building six, on April 27, 2011 at approximately 0530 onward: The essential electrical system is noncompliant due to the following: during loss of normal power to the life safety branch transfer switch, the essential electrical system required approximately nineteen seconds to restore power to required systems.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0145.

25. Observation of Building one, on April 25, 2011 at approximately 1300 onward, electrical systems are incomplete in the following areas: a. exposed bulb fluorescent light fixture is used above storage shelf - penthouse floor storage room near cafeteria and b. medication refrigerator in medication preparation room is connected to normal power receptacle - eight floor. c. light in medication preparation room is not connected to the critical branch of the essential electrical system - eight floor.
Observation of Building two, on April 27, 2011 at approximately 0530 onward, There are unlisted relocatable power taps used in patient care areas of the third floor operating room suite. Standard relocatable power taps are not listed for use in patient care areas of health care facilities.
~ Cross refer to Life Safety Code Standard - NFPA 101, Tag K 0147.

Based on hospital policies and procedure reviews, End-Stage Renal Disease (ESRD) Regulations, personnel file reviews, observations during tours, temperature log reviews, and staff interviews, the hospital staff failed to ensure safe water testing of water used for hemodialysis (HD) by failing to ensure staff performing HD water testing for chlorine and chloramine had color-blindness screening (to determine if staff can perform colormetric tests) performed for 1 of 3 HD staff personnel files reviewed (Staff #34); and failed to ensure temperatures were maintained per manufacturer's recommendations for 4 of 6 contrast warmers observed within the radiology department (warmers A, B, C, & D).

The findings include:

1. Review of hospital HD policy "Chlorine testing of Reverse Osmosis System" on 4/28/2011 revised 04/11 revealed "I. Policy: The water purification system is used to provide hemodialysis safely to the patients of NCBH." Further review revealed "IV. Procedure: every 4 hours and end of day - A. Using a WaterCheck2 test strip and a catch basin, allow a stream of water from TP4 to flow over strip for 30 seconds after water has run for 1 minute...C. Result should read 0 or <0.1 ppm (parts per million)." Further review revealed "References:...ESRD Program Interpretive Guidance version 1.1 (2008). Baltimore, Maryland: Center for Medicaid and State Operations/Survey & Certification Group."

Review of "ESRD Program Interpretive Guidance version 1.1 (2008)" on 4/28/2011 revealed "V196 - ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40 (a) 6.2.5 Carbon adsorption: monitoring, testing freq(uency)...Additional Guidance:...The ability to discern colors is an essential job function for persons responsible for reading colormetric tests."

Observation of water testing for chlorine and chloramine on 04/26/2011 at 1000 revealed Staff #34 performing the water testing for the HD inpatient unit. Observation revealed the staff member using the WaterCheck2 test-strip method for determining the presence or absence of chlorine and chloramine in the water being used for HD treatment. Interview during the observation revealed the staff was looking for a color change on the test strip to determine the presence or absence of chlorine and chloramine. Further interview revealed the staff member had been working in the HD unit for approximately 23 years.

Review of personnel file for Staff #34 failed to reveal any color-blindness screening had been performed during the staff's employment at the hospital.

Interview with human resources staff on 04/28/2011 at 1445 revealed only HD employees hired after the year 2000 have had color-blindness screening. Interview revealed Staff #34 had been hired prior to 2000 and had no evidence of color-blindness screening on file. Further interview revealed 32 HD staff may perform water testing. Interview revealed eight (8) of the 32 total staff performing water testing had not been screened for color-blindness. Interview revealed the hospital failed to ensure the safety of water testing for chlorine and chloramine by failing to ensure staff performing water testing were screened for color-blindness if performing colormetric testing.


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2. Review of the contrast media manufacturer's recommendations on 04/26/2011 revealed "Omnipaque Injection in all presentations may be stored in a contrast media warmer for up to one month at 37 (degrees) C (98.6 [degrees] F)."

Observations during tour of the Radiology Department on 04/26/2011 at 1030 revealed contrast media warmers used for storage of contrast media solutions. Observation of warmer A and B revealed the warmers had no visible temperature thermometers inside each warmer. Observation revealed a "green" light on the front of each warmer was used to indicate whether or not the temperature inside the warmer was normal. Review of the temperature logs for the two warmers revealed the staff were recording "N" (normal) for the temperatures. Further observations revealed warmers C and D had a thermometer strip inside each warmer to give a numerical reading. Review of the temperature logs for warmers C and D revealed the temperatures recorded were below the manufacture's recommendations of 37 degrees C (98.6 F). Review of the temperature log for warmer C (scanner #20) revealed the temperature was documented by staff at 90 degrees from 11/22/2010 through 4/21/2011 (150 days out of range). Further review revealed warmer D (scanner #21) had temperatures documented by staff at 90 degrees from 12/10/2010 through 4/21/2011 (132 days out of range). Further review revealed no available documentation in the temperature logs, the temperatures in warmer C and D were identified by staff as being out of range until 4/21/2011 (150 days and 132 days respectively). Interview during tour with the Department manager revealed they (the staff) should be monitoring the actual temperature for accuracy and the temperatures in warmers C and D that read 90 degrees should have been checked when the discrepancy was first noted.

Based on review of hospital policies and procedures, blood and body fluid exposure logs, employee health files and staff interviews, infection control staff failed to ensure blood and body fluid exposure prevention counseling was performed for 7 of 7 employee health files reviewed (Staff #s 57, 63, 59, 60, 61, 62, 58).

The findings include:

Review of hospital policy "Bloodborne Pathogens Exposure Control Plan" on 4/27/2011 dated 4/11 revealed "Purpose - To eliminate or minimize occupational exposure to bloodborne pathogens...I. Post-exposure Evaluation and Follow-up - 1. A post-exposure evaluation and follow-up will be provided to all employees...who sustain inadvertent exposures to OSHA defined blood or other potentially infectious material...5. Immediately following an exposure incident as defined above, the exposed employee will have a confidential medical evaluation and follow-up including at least the following elements:...h) Counseling." Further review revealed "Appendix D - Responsibilities for Bloodborne Pathogens Exposure Control Plan...II. Hospital Infection Control is responsible for:...E. Assisting with compliance evaluation...III. Employee Health is responsible for:...B. Providing post-exposure management, C. Maintaining documentation of exposures and follow-up as required by the most current OSHA final rule, D. Assisting with compliance consultation and evaluation...IV. Risk and Insurance Management are responsible for:...C. Coordinating with Employee Health and Infection Control to assure proper follow-up on all occurrences with an emphasis on prevention...V. Department Directors/Managers, Supervisors are responsible for:...D. Evaluating compliance by:...2. Initiating retraining or education for non-compliance, 3. Initiating and documenting disciplinary action for failure to comply...XI. [University affiliate] School of Medicine is responsible for: A. All faculty, staff, students and volunteers of [University affiliate] who are determined to have occupational exposure to bloodborne pathogens shall comply with the Hospital's Exposure Control Plan during the performance of their duties."

Review of the hospital's log "Blood Body Fluid Exposures" on 4/27/2011 from April 2010 through April 20/2011 revealed the hospital had 424 total exposures during the time period. Review revealed seven staff had three or more exposures during the time period for a total of 30 of the 424 hospital-wide exposures (7% of the hospital-wide exposures).

1. Review of a Risk Management log for blood body fluid exposure follow-up revealed Staff # 57, a house officer, had six exposures from April 2010 through April 20/2011:
6/21/10 - needlestick,
8/23/10 - needlestick,
8/27/10 - needlestick,
12/06/10 - needlestick,
01/25/11 - needlestick, and
01/31/11 - contaminated wire.
Further review of each exposure recorded for Staff #57 revealed "Did employee receive counseling training of safe work habits," for each exposure incident, the answer was "No" or no counseling follow-up addressed in "Follow-up" column.

Employee Health record review for Staff #57 revealed no further documentation of counseling related to blood and body fluid exposure prevention.

2. Review revealed Staff #63, a House Officer, had four exposures from April 2010 through April 20/2011:
5/27/10 - needlestick
5/28/10 - sharp stick
11/05/10 - splashed in eyes with heparinized saline irrigation
11/10/10 - hand pierced by wire with small skin break
11/19/10 - wire pierced hand
Further review of each exposure recorded for Staff #63 revealed "Did employee receive counseling training of safe work habits," the 11/05/10 exposure, the answer was "Yes", for the 11/12/10 exposure, the answer was "Not Sure," for the other two exposure incidents, no counseling follow-up addressed in "Follow-up" column.

Employee Health record review for Staff #63 failed to revealed what counseling was provided to the staff member as recorded for the 11/05/10 exposure. Further review revealed no further documentation of counseling related to blood and body fluid exposure prevention for the other exposure incidents.

3. Review revealed Staff #59, a House Officer, had four exposures from April 2010 through April 20/2011:
11/15/10 - needlestick
02/28/11 - needlestick
3/15/11 - needlestick
3/16/11 - sharp (wire) stick
Further review of each exposure recorded for Staff #59 revealed "Did employee receive counseling training of safe work habits," the 3/15/11/10 exposure, the answer was "Yes", for the other three exposure incidents, no counseling follow-up addressed in "Follow-up" column.

Employee Health record review for Staff #59 revealed for the 3/15/11 exposure, the source patient's Hepatitis C titer was reactive (or positive). Further review failed to reveal what counseling was provided to the staff member as recorded for the 3/15/11 exposure to a Hepatitis C positive patient. Review revealed no further documentation of counseling related to blood and body fluid exposure prevention for the other exposure incidents.

4. Review revealed Staff #60, hospital faculty, had four exposures from April 2010 through April 20/2011:
9/17/10 - blood splashed in eye
10/08/10 - needlestick
02/01/11 - needlestick
03/28/11 - needlestick
Further review of each exposure recorded for Staff #60 revealed "Did employee receive counseling training of safe work habits," for each of the exposure incident, "Follow-up" column revealed "School employee".

Employee Health record review for Staff #60 revealed no further documentation of counseling related to blood and body fluid exposure prevention.

5. Review revealed Staff #61, a operating room nurse, had four exposures from April 2010 through April 20/2011:
4/07/10 - sharp stick
4/27/10 - needlestick
02/28/11 - needlestick from surgeon
3/31/11 - needlestick
Further review of each exposure recorded for Staff #63 revealed "no counseling follow-up addressed in "Follow-up" column for the 02/28/11 and 03/31/11 exposures. Employee Health record review for Staff #61 revealed no further documentation of counseling related to blood and body fluid exposure prevention.

Employee Health record review for Staff #61 revealed no further documentation of counseling related to blood and body fluid exposure prevention.

6. Review revealed Staff #62, a House Officer, had four exposures from April 2010 through April 20/2011:
4/14/10 - needlestick from other surgeon
5/02/10 - needlestick
12/06/10 - needlestick
03/02/11 - needlestick
Further review of each exposure recorded for Staff #62 revealed "Did employee receive counseling training of safe work habits," no counseling follow-up addressed in "Follow-up" column for the 4/14/10, 5/02/10 or 03/02/11 exposures.

Employee Health record review for Staff #62 revealed no further documentation of counseling related to blood and body fluid exposure prevention.

7. Review revealed Staff #58, a House Officer, had three exposures from April 2010 through April 20/2011:
12/01/10 - needlestick from other surgeon
12/02/10 - needlestick
02/21/11 - needlestick
Further review of each exposure recorded for Staff #63 revealed no counseling follow-up addressed in "Follow-up" column for any of the three exposures.

Employee Health record review for Staff #58 revealed no further documentation of counseling related to blood and body fluid exposure prevention.

Interview with the Occupational Health (Employee Health) physician on 04/28/2011 at 0915 revealed Employee Health will provide some of the post-exposure counseling. Interview revealed any additional post-exposure counseling that is not reflected on the blood and body fluid exposures log provided by Risk Management would have been provided by Infection Control.

Interview with Infection Control staff on 4/28/2011 at 1050 revealed there was no other counseling provided to Staff #57, #63, #59, #60, #61, #62, or #58 regarding prevention of multiple blood and body fluid exposures. Interview revealed staff failed to follow the hospital's Exposure Control Plan by failing to ensure staff receive follow-up counseling after multiple blood and body fluid exposures.