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Based on interview, record review and observation it was determined the Governing Body failed to have an effective Governing Body based on the deficiencies cited on the complaint investigation conducted 07-18-12, 07-25-12 and 08-03-12.. This failed practice had the potential to affect all patients admitted to the hosptial. See A117, A131, A144, A173, A175 and A194.

Based on clinical records review, policy and procedure reviews, interviews and observations, it was determined that the facility failed to protect the rights of patients and failed to provide care in a safe setting. Clinical records review revealed 2 (#6 and #11) of 11 (#1-11) patients did not have signed Medicare Important Notices in their clinical records prior to discharge. See Tag A117.

There were 2 (#2 and #6) of 11 (#1-11) clinical records that did not contain consents for care. See Tag A131.

Observations and interviews revealed 1 (#8) of 2 (#7 and 8) current in-patients did not receive care in a safe setting in that the facility failed to ensure that all four side rails were in the up position at all times except when the patient was being transferred to and from the safety enclosure beds as required by the manufacturer's instruction manual. See Tag A144.

Clinical records review, policy and procedure reviews and interviews revealed that the facility failed to ensure that orders for restraints were obtained from the physician per facility Policy and Procedure. See Tag A173.

Review of policy and procedures, interviews and clinical records review revealed that the facility failed to monitor restrained patients as required by facility policy and procedure for 8 (#1-5, #7-8, and #11) of 11 (#1-11) patients. See Tag A175.

Clinical records review and interviews revealed that 1 (#8) current patient of 11 (#1-11) patients was not afforded safe implementation and monitoring of restraints by trained staff. Staff of all levels of nursing at the facility were not knowledgeable in the safe and recommended use of a safety enclosure bed. See Tag A194.

The failed practices pose an Immediate Jeopardy to the health and safety of patients which could lead to harm or potential for harm, serious injury or death. These failed practices had the potential to affect all patients admitted to the Facility.

Based on clinical records review, it was determined that 2 (#6 and #11) of 11 (#1-11) patients did not have signed Medicare Important Notices in their clinical records prior to discharge. Failure to ensure issuance of the Medicare Important Notice did not allow the patients the opportunity to be informed of and aware of their rights as a hospital patient, as well as their discharge and appeal rights. The failed practice affected 2 (#6 and #11) of 11 (#1-11) patients. Findings follow:

1. Review of the clinical records of 2 (#6 and #11) of 11 (#1-11) patients revealed no signed Medicare Important Notice in the clinical record.

2. The lack of a signed consent for care in Patient #6's clinical record was verified by the Medical Surgical Director at 1230 on 07/18/12.

3. The lack of a signed consent for care in Patient #11's clinical record was verified by the 7B Unit Supervisor at 1320 on 07/18/12.

Based on clinical records review, it was determined that 2 (#2 and #6) of 11 (#1-11) clinical records did not contain consents for care. Failure to obtain signed consents for care did not afford the patient or their representative the opportunity to make informed decisions regarding his or her care. The findings affected 2 (#2 and #6) of 11 (#1-11) patients. Findings follow:

1. Review of the clinical records of 2 (#2 and #6) of 11 (#1-11) patients revealed no signed consent for care in the clinical records.

2. The lack of a signed consent for care in Patient #2's clinical record was verified by the Risk Manager at 1530 on 07/16/12.

3. The lack of a signed consent for care in Patient #6's clinical record was verified by the Medical Surgical Director at 1230 on 07/18/12.

Based on observations and interviews, it was determined that one (#8) of two (#7 and 8) current in-patients did not receive care in a safe setting in that the facility failed to ensure that all four side rails were not in the up position at all times except when the patient was being transferred to and from the safety enclosure beds. Failure to ensure that all four side rails were in the up position at all times except during transfer to and from the safety enclosure bed, as required by the Product Operation manual, posed an Immediate Jeopardy to the patient's health and safety since it had the potential to allow Patient #8 to become trapped and/or injured. The failed practice affected Patient #8 on 07/18/12. Findings follow:

1. Review of manufacturer's guidelines, Safe-T Care Manufacturing, Inc., Product Operation Manual (Model LTC) were received from the Critical Care Educator at 1430 on 07/16/12. Review of the manufacturer's guidelines revealed the following on page 2, under "PRECAUTIONS (continued)", #4. Always leave side rails in the "up" position except when moving the patient from the bed." The Critical Care Educator stated these manufacturer's guidelines were placed on each safety enclosure bed by the rental company and were there for the nurses to use as a reference guide.

2. During a tour of the 3B Unit at 0950 on 07/18/12, Patient #8 was observed in Room #355 to be in a safety enclosure bed, with both the right and left lower side rails down. Registered Nurse (RN) #1 was asked if all four side rails were supposed to be in the up position and she stated "No, all four side rails up would require a physician's order." RN #1 was asked if that applied to the safety enclosure beds as well and she stated "Yes". No manufacturer's guidelines or instructions were noted to be present in the room and that was verified by RN #1 at 0950 on 07/18/12.

3. During an interviews with the Assistant Vice President of Nursing and Risk Manager at 1145 on 07/18/12 the Assistant Vice President of nursing stated four side rails up would constitute a second type of restraint. The Risk Manager stated four side rails up on a safety enclosure bed would not constitute a secondary restraint.

4. During a second tour of the 3B Unit at 1410 on 07/18/12, Patient #8 was observed in Room #355 to be in a safety enclosure bed with the left upper side rails, left and right lower side rails in the down position. The 7B Unit Supervisor and the Medical Surgical Director were accompanying the Surveyor during the second tour. The 7B Unit Supervisor raised the side rails on the left side of the bed and the Medical Surgical Director raised the side rails on the right side of the bed. Both were asked if all four side rails were supposed to be in the up position on the safety enclosure bed and both stated yes.

5. Review of Shift Assessment timed and dated 1920 on 07/16/12 and authored by RN #15 revealed "Received patient lying in safety enclosure bed, HOB (Head of Bed) slightly elevated, eyes opened, alert, oriented to self only, no acute distress at this time... Siderails up x (times) 2, bed in lowest/locked position..."

6. Review of Shift Assessment authored by RN #16, untimed and dated 07/17/12 revealed... "Side rails up x 2"... The above was verified by RN #1 at 1405 on 07/18/12.

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Based on clinical records review, policy and procedure reviews and interviews, it was determined that the facility failed to ensure renewal orders for restraints were obtained from the physician per facility Policy and Procedure.

Facility policy and procedure titled Restrains/Seclusion, numbered 545, page 4, number 4 states: "Physician Order for Medical Surgical Care Restraint (non violent or non self-destructive behavior).Use:
4.1. A restraint order is required before each application of restraints except in cases of medical emergency.
4.3. PRN orders are not acceptable.
4.3.1.1. Restraint orders are limited to a maximum 24 hours in acute care and one calendar week from the date of the initial order in recuperative care.
4.3.2. Release of Restraints: Patients must be released from restraints as soon as behavior justifies and no longer meets the criteria. An episode of restraints ends when the patients are released for no longer exhibiting the behavior or no longer meeting the criteria for restraint application. The release and behavior justifying restraint re-application is documented in the patient's medical record. A new order must be received for every new episode of restraint application.

Facility standardized orders titled "BHMC-LR (Baptist Health Medical Center-Little Rock) Non-violent or non-self destructive behavior restraint orders" were generated for patients requiring restraint use but were not timed by the physician, were not specific to the type of restraint, or left blank while patients were in restraints. Failure to ensure current restraint orders were in place for each episode of patient restraint allowed Patients # 1-5 and #11 to be restrained without a physician's order. Findings follow:

1. Review of the clinical record for Patient #1 revealed orders for restraints written at 0908 on 06/29/12, 1015 on 06/30/12, 0805 on 07/01/12, 1724 on 07/02/12 and an order to stop the safety enclosure bed at 1817 on 07/03/12. Review of Patient #1's health assessment reports and patient activity detail reports revealed Patient #1 was in a safety enclosure bed during those times. The above was verified by the Risk Manager at 1255 on 07/16/12.

2. Review of the clinical record for Patient #2 revealed orders for restraints written at 1312 on 06/07/12, 1635 on 06/08/12, 1920 on 06/09/12 and 2300 on 06/10/12. Review of Patient #2's health assessment reports and patient activity detail reports revealed Patient #2 was in a safety enclosure bed during those times. The above findings were verified by the Risk Manager at 1530 on 07/16/12.

3. Review of the clinical records for Patients #3-5 and #11 revealed findings identical to Patients #1 and 2.

4. Review of Patient #5's clinical record revealed one standardized restraint order timed and dated 1902 on 02/19/12 by RN #9 electronically signed by Physician #2 at 0219 PM on 03/15/12. The above findings were verified by the Risk Manager at 1100 on 07/18/12.

5. Review of Patient #11's clinical record revealed two standardized restraint orders dated 05/15/12 and 05/16/12, without a nurse signature, electronically signed by Physician #1 at 0955 on 06/21/12. The above was verified by the Medical Surgical Director at 1345 on 07/18/12.

Based on reviews of policy and procedures, interviews and clinical records review, it was determined that the facility failed to monitor restrained patients as required by facility policy and procedure numbered 545, 6.1 and titled Restraints/Seclusion for eight (#1-5, #7-8, and #11) of eleven (#1-11) patients. Failure to monitor and assess restrained patients every two hours per facility policy and procedure pose an Immediate Jeopardy to the patient's health and safety due to the potential serious injury or death. Further, the staff failed to assess the patient so he/she could be released from restraints as early as safely possible. The failed practice affected two current patients, #7 and 8, on 07/18/12. Findings follow:

1. Review of Patient #1's closed clinical record revealed orders for a safety enclosure bed on 06/29/12 through 07/03/12. Restraint monitoring was not documented from 2030 on 06/29/12 through 0032 on 06/30/12, from 0032 06/30/12 through 0735 on 06/30/12, from 0925 through 1945 on 06/30/12, from 194506/30/12 through 0720 on 07/01/12 and from 1930 on 07/02/12 through 0730 on 07/03/12. The above findings were verified by the Risk Manager at 1255 on 07/16/12. In addition, Licensed Practical Nurse #1 documented at 2200 on 07/03/12 that at 0600 on 07/04/12 restraint (safety enclosure bed) was off. This was verified by the Medical Surgical Director at 1430 on 07/16/12.

2. Review of Patient #2's closed record revealed orders for a safety enclosure bed from 2018 on 06/04/12 through 0920 on 06/11/12. Restraint monitoring was not documented from 0600 on 06/07/12 through 2200 on 06/07/12, from 1200 through 2000 on 06/08/12, from 0600 through 2000 on 06/09/12, from 2000 on 06/09/12 through 0800 on 06/10/12, and from 0800 through 2000 on 06/10/12. The above findings were verified by the Risk Manager at 1530 on 07/16/12.

3. Review of Patient #3's closed record revealed orders for a safety enclosure bed from 06/17/12 through 06/28/12. Restraint monitoring was not documented from 2330 on 06/17/12 through 0800 on 06/18/12, from 0820 through 2000 on 06/18/12, from 0000 through 0800 on 06/19/12, from 0815 through 1928 on 06/19/12, from 2200 on 06/19/12 through 0730 on 06/10/12, from 0900 through 2000 on 06/20/12, from 0000 through 0830 on 06/21/12, from 0830 on 06/21/12 through 0800 on 06/22/12, from 2025 on 06/22/12 through 1000 on 06/23/12, from 1600 on 06/23/12 through 0835 on 06/24/12, from 0835 through 2000 on 06/24/12, from 0830 through 1950 on 06/25/12 and from 1000 on 06/26/12 through 0745 on 06/27/12. The above findings were verified by the Risk Manager at 1530 on 07/16/12.

4. Review of Patient #4's closed clinical record revealed orders for restraints from 05/11/12 through 05/16/12. Restraint monitoring was not documented from 1400 through 2000 on 05/11/12, from 1400 through 2000 on 05/11/12, from 1400 through 2000 on 05/12/12, from 2013 on 05/13/12 through 0800 on 05/14/12, from 1200 through 1950 on 05/14/12, from 1002 through 2000 on 05/15/12. Documentation on 05/13/12 by RN #8 at 1000 and 1200 on 05/13/12 revealed documentation of restraint monitoring but documentation by RN #7 stated at 0750 Patient #4 was taken to surgery via the safety enclosure bed. Documentation by RN #7 at 1400 on 05/13/12 revealed Patient #4 was received back from surgery in the safety enclosure bed at that time.

5. Review of Patients #5's closed clinical record revealed orders for restraints on 02/18/12 through 02/22/12. Restraint monitoring was not documented from 1930 on 02/18/12 through 0700 on 02/19/12, from 0700 until 2055 on 02/19/12, from 2055 02/19/12 through 0800 on 02/20/12, from 0800 until 2045 on 02/20/12, and from 2045 on 02/20/12 through 1300 on 02/21/12. The above findings were verified by the Risk Manager at 1100 on 07/18/12.

6. Review of Patient # 7's current clinical record revealed orders for restraints from 07/16/12 through 07/18/12. Documentation revealed the restraints were applied at 1900 on 07/17/12. Documentation at 2143 on 07/17/12 revealed restraint check. Documentation by Registered Nurse (RN) #2 at 0630 revealed "Patient remained in right soft limb restraint for total of 9 hours this shift. Restraints were removed every 2 hours to assess circulation and to offer patient water, food, toileting. Patient continues to be combative and pulls at tubes and drains." There was no other documentation between 2143 and 0630. The above was verified by the 7B Unit Supervisor at 1420 on 07/18/12.

7. Review of Patient #8's current clinical record revealed orders for safety enclosure bed from 07/16/12 through 07/18/12. Review of documentation by RN #3 at 1920 on 07/16/12 revealed "Received Patient lying in safety enclosure ... Side rails up x (times) 2, bed in lowest/locked position, call light within reach ... " Review of the clinical record of Patient #8 revealed no restraint monitoring documented from 2012 on 07/16/12 through 0800 on 07/17/12 and from 1200 through 2000 on 07/17/12. The above was verified by RN #1 at 1405 on 07/18/12.

8. Review of Patient #11's closed clinical record revealed orders for restraints from 05/14/12 through 05/171/2. Restraint monitoring was not documented from 0200 until 0800 on 05/16/12, from 1000 through 2000 on 05/16/12 and from 0400 through 0800 on 05/17/12. The above was verified by the Medical Surgical Director at 1345 on 07/18/12.

Based on clinical records review, observations and interviews, it was determined that the staff were not familiar and trained in the safe use and implementation of restraint in one current (#8) patient of eleven (#1-11) patients. Staff of all levels of nursing at the facility were not knowledgeable in the safe and recommended use of a safety enclosure bed. Failure to provide patients with effectively trained, knowledgeable staff to initiate, monitor and use restraint safely pose an Immediate Jeopardy to patient's health and safety in that it has the potential to cause harm, serious injury or death. The failed practice affected Patient #8 on 07/18/12 and had the potential to affect all patients admitted to this facility. Findings follow:

1. Review of manufacturer's guidelines, Safe-T Care Manufacturing, Inc., Product Operation Manual (Model LTC) were received from the Critical Care Educator at 1430 on 07/16/12. Review of the manufacturer's guidelines revealed the following on page 2, under "PRECAUTIONS (continued)", #4. Always leave side rails in the "up" position except when moving the patient from the bed." The Critical Care Educator stated these manufacturer's guidelines were placed on each safety enclosure bed by the rental company and were there for the nurses to use as a reference guide.

2. During a tour of the 3B Unit at 0950 on 07/18/12 Patient #8 was observed in Room #355 to be in a safety enclosure bed, with both the right and left lower side rails down. Registered Nurse (RN) #1 was asked if all four side rails were supposed to be up and she stated "No, all four side rails up would require a physician's order." RN #1 was asked if that applied to the safety enclosure beds as well and she stated "Yes". No manufacturer's guidelines or instructions were noted to be present in the room and this was verified by RN #1 at 0950 on 07/18/12.

3. During an interview with the Assistant Vice President of Nursing and Risk Manager at 1145 on 07/18/12 the Assistant Vice President of nursing stated four side rails up would constitute a second type of restraint. The Risk Manager stated four side rails up on a safety enclosure bed would not constitute a secondary restraint.

4. During a second tour of the 3B Unit at 1410 on 07/18/12 Patient #8 was observed in Room #355 to be in a safety enclosure bed, with the left upper, left and right lower side rails down. The 7B Unit Supervisor and the Medical Surgical Director were accompanying the Surveyor during the second tour. The 7B Unit Supervisor raised the side rails on the left of the bed and the Medical Surgical Director raised the side rails on the right side of the bed. Both were asked if all four side rails were supposed to be up on the safety enclosure bed and both stated yes.