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Based on review of medical records, review of policy and procedures and interview, it was determined the facility failed to:

1. Follow their policy for restraint use and monitoring.

2. Follow their policy for obtaining physician orders for restraints.

This had the potential to affect all restrained patients in the facility.

Findings include:

Refer to A 154 and A 168 for findings.

Based on review of medical records, review of policy and procedures and interview, it was determined the facility failed ensure the policy and procedure for restraint use was followed for 1 of 5 medical records reviewed of patients with restraints.

This had the potential to affect all patients served by this facility and did affect Medical Record (MR) # 1.

Findings include:

Policy II Clinical justification Patients admitted to the hospital may require the use of mechanical restraints (soft limb) for the purpose of protecting medical devices that if accidentally removed could negatively affect the patients outcome. Such patients may be in a state of diminished cognition due to the effects of recent anesthesia, medication or overwhelming physiological compromise. If, after a thorough assessment the registered nurse determines the patient is at risk for injury based on his behavior, and the presence of such devices are considered life sustaining, soft limb restraints may be implemented. The patients must meet both the behavioral and device specific physician approved criteria as follows:

1. Restraints used to maintain or deliver treatment associated with medical or surgical condition that if left untreated would compromise the patient.

Example: Pulling at or attempting to remove vital catheters, lines, or tubes such as Foley catheters, NG (nasogastric) tubes and/or IV (intravenous)sustaining infusions that, if interrupted could cause deleterious effects, injury, and/or death. Pulling at endotracheal tube, tracheotomy tube, or other devices for respiratory or airway management. Attempting to remove or dislodge dressing. Picking or disturbing open wound.

2. Unable to follow directions to avoid unintentionally harming him/herself. The patient must have demonstrated an inability to follow directions and/or demonstrated an inability to use appropriate judgement to protect him/herself from harm. The patient is exhibiting signs of diminished cognition, which indicates the patient does not understand the need to have the devices.

Examples: Attempts to get out of bed or chair without assistance after a surgical procedure (as such as hip replacement) or while connected to life sustaining equipment, wandering in rooms or hallways without the strength or cognitive ability to safely do so. Inability to to respond to direct requests or follow instructions to request assistance. Unable to comprehend the need for treatment.

1. Medical Record # 1 was admitted on 10/19/13 with admitting diagnosis of Acute Chronic Respiratory Failure.

A review of the History and Physical dated 10/19/13 revealed a 60 year old black male admitted from acute care hospital with Acute Respiratory Distress. Past medical history included Hypertension, Congestive Heart Failure and Chronic Obstructive Pulmonary Disease. Medications included Digoxin, Cardizem, Lovonox, Flonase, Lasix, Atrovent, Xopenex, Mag-Ox, Zaroxolyn, Mucinex, Solu-Medrol, Polysporin topical, Norco for pain, Morphine 2 mg (milligrams) IV (intravenous) every 2 hours prn (as needed) pain and Zofran 4 mg IV q (every) 4 hrs (hours) prn (as needed) nausea and vomiting. Assessment: In mild respiratory distress. Conversation is understandable Assessment and plan: Acute hypoxemic respiratory failure, pulmonary following continue steroids nebs (nebulizer) oxygen and supportive therapies. 2. HTN (Hypertension). 3. COPD (Chronic Obstructive Pulmonary Disease). 4. Pulmonary fibrosis unstable. 5. Anemia, clinically stable. 6. Epitaxis persistent. 7. ENT (ear, nose and throat) consulted. 8. A-fib (atrial fibrillation) unsuccessful. 9. Cardioversion, 9/30/13 continue Cardizem and Digoxin and Protonix.


A review of the nursing admission assessment dated 10/19/13 revealed pt was alert and oriented to person place and time. Speech unclear Breath sounds: Rhonchi. Character: Deep. Urination: Foley Catheter. Circulatory: Rhythm irregular. Cardiac Monitor. Skin color normal. Respiratory: High flow Nasal Cannula with non-rebreather and Bipap (Bilevel positive airway pressure). Feeding : self. 2 gram sodium diet. Side rails x 2. Fall risk: Moderate. Bed in low position. IV (intravenous) Right PICC (Peripherally inserted central catheter) line.

A review of the nursing narrative notes from 10/19/13 from 1230 to 2200 revealed, "pt talkative and able to make needs known. HFNC (High flow nasal cannula) with non breather and bipap at HS (hour of sleep). SOB (Shortness of breath) noted on exertion. Bilateral rhochi with non productive cough."

A review of the physician orders dated 10/22/13 at 0515, "initial physician notification of (physician name) by ...Registered Nurse (RN) at 0515. Patient need assessment performed by ...RN at 0515." Less restrictive measures have been judged to be ineffective to protect patient: see restraint flowsheet for alternatives attempted. Clinical justification criteria for restraint application: Maintain or deliver treatment associated with a medical or surgical condition that left untreated would compromise the patient. Unable to follow direction to avoid harming him/herself. Type of device: Soft wrist RA (right arm) and LA (left arm). Restraint applied according to manufactures direction by RN at 0515. Form signed by RN and MD (medical doctor) at 1540.

A review of the Restraint flowsheet dated 10/22/13 at 0515 included hazardous items removed least restrictive safe and effective method, procedure explained criteria for release explained and patient respected. Type of restraint: Soft limb right arm, left arm. Behavior: 1. Getting OOB (out of bed). 2. Pull med (medical) devices. Time interval 0515 1, 2. 0600 1,2.

A review of a Narrative note dated 10/22/13 at 0515, "Pt. with repeated attempts to get OOB unassisted. Hx (history) falls. Repeatedly removing Bipap and desating to 70's. Pt (patient) unresponsive in bed at present with bipap removed. Placed back on Bipap Sat 70%. Pulled back up in bed with HOB (head of bed) elevated. Sats (saturation) slowly increased to 93%. Pt responsive as Sats increased. Placed in BL (bilateral) soft wrist restraints for pt's safety. Note signed by RN. Narrative note 10/22/13 at 0645, "Continues to rest comfortably on Bipap with no distress. Report to be given to oncoming staff."

A review of a Restraint flowsheet dated 10/22/13 at 0800. Behavior: 2. Attempting OOB. Time interval: 0700 to 1800 with # 2 behavior documented. Circulation checks: 0700 to 1800. Care: checks were indicated from 0700 to 1800 for fluids and meals offered. Orientation: documented x 1 (oriented to person) from 0700 to 1800. Position change, pulse check distal to restraint, respiratory status, ROM (range of motion)/release/reapply and skin integrity was checked from 0700 to 1800. Toileting offered/FC (foley catheter) was checked from 0700 to 1800. De-escalation/early release was checked from 0700 to 1800. Alternatives: verbal intervention and physical distraction were documented from 0700 to 1800. Justification: wandering/getting out of bed unassisted/unable to be redirected was documented from 0700 to 1800.

There was no clinical justification documented for the use of the soft wrist restraints from 0700 to 1800.

A review of Narrative note addendums dated 10/22/13 at 0800. "Alert at times. Oriented x 1 only at best. On bipap sats 86 to 100%, + 3 pitting edema to B (bilateral) thighs decrease po (by mouth) intake due to being on bipap but doesn't tolerate NRB (non rebreather mask) very well. Will closely assess for needs. Bed in low position. SR x 4. Call light within easy reach. 1630 no change in status. 1702 Code called. See Code sheet for more complete details."

A review of the Mechanical Ventilator Flow Sheets dated 10/22/13 revealed the following:

0800 Vent (ventilation) mode Bipap 18
0745 vent mode Bipap 18
0905 vent mode HFNC (high flow nasal cannula) at 15 liters per minute
0930 vent mode Bipap 18
1110 vent mode Bipap 18
1427 Bipap 18

There was no Respiratory Therapy monitoring of the Bipap or HFNC completed after 1427. A review of a Mechanical Ventilator Flow Sheets Shift summary dated 10/22/13 included, "at 1705 resp (respiratory therapy) entered pts room observed pt not breathing called RN to room. CPR (Cardiopulmonary Resusitation) started."

A review of the code flow sheet dated 10/22/13 revealed at 1702 revealed Location 469. Witnessed arrest: No. Pt found by ... (Respiratory Therapist). Code called at 1703. Code sheet completed and code terminated at 1725 by .. RN."

There was no documentation of a clinical justification for the continued use of the bilateral soft wrist restraints in use on 10/22/13 from 0800 to the time of the patient's death.

A review of the restraint form revealed staff continued to document use of the soft wrist restraints until 1800 (after the patient expired at 1725).

There was no documentation the staff reevaluated this patient following the fall on 10/20/13 to initiate interventions to prevent falls for this patient identified as high risk for falls.

Interviews conducted on 12/5/13 at 12:30 PM with Employee Identifier (EI) # 1, Nurse Manager and EI # 3, RN, confirmed the above findings.

Based on record review, policy and procedure review and physician orders were obtained every 24 hours for the use of physical restraints for 4 of 5 patients. This had the potential to affect all patients served by this facility and did affect Medical Record (MR) #'s 2, 3, 4 and 5.

Findings include:

Policy No:HD-HI
Medical Record Completion; Guidelines for completion, Verbal and Standing Orders, Hand P. 3. ...Exceptions include orders for Do-Not-Resuscitate/code status (which should be authenticated within 24 hours) and restraints which must be signed within one (1) calendar day of order.

Policy No: HD-NUR
Guideline: Restraints; Assessment Documentation and Application Documentation and Application in Medical/Surgical Care. III. Initial Physician Order. If alternatives proved unsuccessful and the application of restraints are clinically justified the nurse will notify the attending physician (or covering physician) of the need to restrain. If the attending physician is not immediately available to give the restraint order, a nurse, trained in restraint use may initiate the restraints. The Restraint Order Sheet should be implemented. A. Written or verbal order must be obtained from the attending physician within 12 hours. B. A written order, based on the assessment of the patient by the attending physician must be documented within 24 hours.


1. Medical Record (MR) # 2 was admitted on 10/30/13 with diagnoses including Acute Respiratory Failure, Perforated Gastric Ulcer and Acute Renal Failure.

A review of the medical record revealed soft wrist restraints to right and left arms for behavior of "pulling out tubes."

A review of the Initiation of Restraints/Renewal Restraint Order forms completed by the Registered Nurse (RN) dated 11/26/13 at 0700, 11/27/13 at 0700, 11/28/13 at 0700, 11/29/13 at 0700, 11/30/13 at 0700 and 12/1/13 at 0700 revealed no physician signature until 12/2/13 at 0945.

Review of the Nurses 24 Hour Assessment and Progress Record Restraint Flowsheets revealed soft wrist restraints were in use from 11/26/13 to 12/1/13.

2. MR # 3 was admitted on 11/6/13 with diagnoses including Acute Respiratory Failure and Septic Shock.

A review of the medical record revealed soft wrist restraints to right and left arms for behaviors of "confusion and pulling out medical devices."

A review of the Initiation of Restraints/Renewal Restraint Order forms completed by the RN dated 11/23/13 at 0700 revealed no physician signature until 11/25/13 at 1343. A restraint order 11/24/13 at 0600 was not signed by the physician until 11/25/13 at 1340. Initiation of Restraints/Renewal Restraint Order forms dated 11/25/13 at 2130, 11/26/13 at 0700, 11/27/13 at 0106, 11/28/13 at 0400 and 11/29/13 at 0600 were not signed by the physician until 12/2/13.

Review of the Nurses 24 Hour Assessment and Progress Record Restraint Flowsheets revealed soft wrist restraints were in use 11/25/13 from 2100 to 0600, 11/26/13 from 0700 to 0600, 11/27/13 from 0700 to 0600, 11/28/13 from 0700 to 0600, 11/29/13 from 0700 to 0600,

3. MR # 4 was admitted on 9/19/13 with diagnoses including Respiratory Failure and Encephalopathy.

A review of the medical record revealed restraint orders and use of restraints for soft wrist restraints due to behaviors of "pulling devices."

A review of the Initiation of Restraints/Renewal Restraint Order forms completed by the RN dated on 11/20/13 at 0700 revealed no physician signature until 11/21/13 at 1415, 11/23/13 at 1100 without a physician signature until 11/25/13 at 1400, 11/26/13 at 0010 without a physician signature, 11/26/13, 11/27/13, 11/28/13, 11/29/13, 11/30/13 and 12/1/13 without a physician signature until 12/2/13 at 0950.

Review of the Nurses 24 Hour Assessment and Progress Record Restraint Flowsheets revealed soft wrist restraints were in use 11/20/13 from 0700 to 0600, 11/21/13 from 0700 to 1200, 11/23/13 from 1100 to 1600, 11/26/13 from 0700 to 0600, 11/27/13 from 0700 to 0600, 11/28/13 from 0700 to 0600, 11/29/13 from 0700 to 0600, 11/30/13 from 0700 to 0600, 12/1/13 from 0700 to 0600 and 12/2/13 from 0700 to 0600.

4. MR # 5 was admitted on 7/30/13 with diagnoses including Acute Respiratory Failure and Left Inguinal Hernia Repair.

A review of the medical record revealed restraint orders and use of restraints for soft wrist restraints due to behaviors of "climbing out of bed and confusion."

Review of the Nurses 24 Hour Assessment and Progress Record Restraint Flowsheets revealed soft wrist restraints were in use and monitored on 8/15/13 from 1800 to 0600. There was no Initiation of Restraints/Renewal Restraint Order form, completed by the RN or signed by the physician on 8/15/13, available for review.

A review of the Initiation of Restraints/Renewal Restraint Order forms completed by the RN dated 8/22/13 at 0700 was not signed by the physician until 8/23/13 at 1600.

Review of the Nurses 24 Hour Assessment and Progress Record revealed soft wrist restraints to right and left arms were in use and monitored on 8/22/13.

An interview on 12/5/13 at 1:00 PM with Employee Identifier (EI) # 1, Nurse Manager and EI # 3 Registered Nurse, confirmed physician orders had not been signed, for the use of soft wrist restraints, as required in their policy.

Based on record review, policy and procedure review and interview, it was determined the facility failed to follow their policy for completion of an event report following a fall. This had the potential to affect all patients and did affect Medical Record (MR) # 1.

Findings include:

Policy No: HD-NUR
Guideline: Fall Prevention

5. Completes an event report and submits it to the Director of Clinical Services.


1. MR # 1 was admitted on 10/19/13 with diagnoses including Acute Respiratory Failure, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure and Hypertension.

On 10/20/13 at 0210 a narrative note revealed, "Bipap (bilevel positive airway pressure) alarming upon entering room found patient lying on floor face down blood noted around mouth. Agonal breathing, code strong called, put back to bed, no neuro (neurological) response. Head of respiratory bagged Bipap replaced. Dr.(doctor) ... called new order for CT (Computerized Tomography) scan of head and call pulmonary. 0220 Family called at this time. And talked with sister."

A case management note dated 10/20/13 at 0257 included, ABG (Arterial Blood Gas) obtained at present. Awake alert and talking with sister and nephew moving all extremities. B/P 105/86. Talked with Dr. ... CT Scan of head canceled per his orders. Informed Dr. ... at this time. Family staying at bedside at this time to ensure safety. 0600 Dr. ... here informed of current status."

An interview on 12/5/13 at 1:00 PM per telephone with Employee Identifier (EI) # 2, Director of Clinical Services, revealed he was unaware of the fall occurring on 10/20/13.

A review of the "Event Report" binder on 12/5/13 at 1:30 PM provided by EI # 1, Nurse Manager, revealed no incident report had been completed on 10/20/13 regarding the fall of MR # 1.