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Based on observation, interview and record review, the hospital failed to safely care and protect four of 33 sampled patients (1, 2, 33, and 27) from harm when:

1. Patients 1 and 2 were not assessed for the continued need for restraints. This failure caused Patients 1 and 2 to be restrained without a physician's order and prevented Patient 1 and 2 to be able to move freely and Patient 1 to be able to feed himself. (Refer to A 154)

2. Patient 1 and 2 did not have appropriate physician orders for restraints which included the clinical indications for the use of restraints, type of restraints to be used and the duration of time the restraints were to be used. These failures caused the patients to be restrained without physicians orders. ( Refer to 168)

3. Patient 33 did not receive staff supervision during meals as ordered by the physician. This failure caused the patient to choke on food which blocked the airway and eventually resulted in death. (Refer to A 144)

4. Patient 27 was not assessed and re-evaluated by licensed staff after the patient consistently verbalized that he was experiencing severe pain. This failure resulted in the patient suffering through unmanaged pain for hours. (Refer to A 144)

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure their patients' rights were honored by not providing a safe environment free of the use of restraints, with adequate supervision and monitoring, and failing to advocate for the patient's welfare.

Based on observation, interview, and record review, the hospital failed to safely care for and protect two of 33 sampled patients (33 and 27) from harm when:

1. Patient 33 did not receive staff supervision during meals as ordered by the physician. This failure caused the patient to choke on food which blocked the airway and eventually resulted in death.

2. Patient 27 was not followed and re-evaluated by licensed staff after the patient consistently verbalized that he was experiencing severe pain. This failure resulted in the patient suffering through unmanaged pain for hours.

Findings:

1. During a concurrent interview and record review with Nurse Manager (NM) 4, on 3/22/16, at 8:50 AM, she stated Patient 33 was admitted to the hospital on 2/29/16 for brain surgery and was placed in the intensive care unit (hospital unit where a patient receives a high level of care). On 3/2/16, Patient 33 was transferred to a medical-surgical telemetry unit (hospital unit where the patient's heart rate and rhythm are continuously monitored), and was ordered to have a regular diet.

During a review of the clinical record for Patient 33, the "Nurses' Notes" written by Registered Nurse (RN) 7, dated 3/7/16, at 12:45 PM, indicated an Occupational Therapist had reported "That PT [Patient 33] was shoveling food into [her] mouth so quickly that [Patient 33] started choking." At 4:52 PM, RN 7 documented Patient 33 "Continues to eat without chewing well and tends to choke... she cont [continues] to shovel food into [her] mouth quickly and without chewing and swallowing at regular intervals and cont [continues] to choke."

The "Nurses' Notes" written by RN 9, dated 3/7/16, at 7:40 PM, indicated Patient 33 was being supervised while eating her snacks "As [the] patient tends to eat too fast. "

The "Physician's Orders", dated 3/8/16, indicated Patient 33 was ordered to have "Supervision during eating."

The "Nurse's Notes" written by RN 10, dated 3/10/16, at 4:34 PM, indicated Patient 33 "Puts more food in [her] mouth than [what she was] able to chew and swallow", and that Patient 33 was at risk for aspirating (accidentally inhaling foreign materials such as food, blocking the airway passage).

During a concurrent interview and record review with Physical Therapist (PT) 1, on 3/22/16, at 10:20 AM, she stated she had participated in Patient 33's therapy treatment and described her as "impulsive" with poor safety awareness. PT 1 stated Patient 33 was noted to fill her mouth with food without swallowing. Patient 33 stopped whenever she was redirected but would ask for food again after a few minutes. PT 1 also stated Patient 33's behavior towards food had increased, and on 3/10/16, she relayed her concerns to the licensed nursing staff and also placed a note for the doctor to be aware.

A review of the "Physician's Orders", dated 3/11/16, indicated Patient 33 was ordered to be evaluated by a speech-language pathologist (trained professional who evaluates and treats patients with communication and swallowing disorders).

During a concurrent interview and record review with the Speech-Language Pathologist (SLP), on 3/22/16, at 3:22 PM, he stated he had evaluated Patient 33 on 3/11/16 as ordered by the doctor. When he offered Patient 33 liquids, he stated she wanted to "drink it all". The SLP verified his evaluation notes which were documented as follows: "Poor control over bolus size" (amount of food to put in mouth at one time), "Took half piece of bread and pushed in [to her] mouth", "Attempts large sips [of liquids]", and "Benefits from cues [signals]/feeder assistance". The SLP also noted Patient 33 had a "Safety awareness deficit" with an elevated risk of aspirating especially with food secondary to "stuffing [food] in [her] mouth". The SLP recommended Patient 33 to have a mechanically soft diet (food is altered into smaller and softer pieces to make it easier to chew and swallow) and indicated he had notified the licensed nursing staff of his recommendations. The SLP stated he had spoken to one of the licensed nurses but could not remember exactly who the person was.

During an interview with Charge Nurse (CN) 3, on 3/22/16, at 4:18 PM, she reviewed Patient 33's clinical records and was unable to find documentation which indicated the doctor was notified of the SLP's recommendations to provide a mechanically-soft diet to the patient. She stated the procedure was the SLP will notify the patient's primary nurse, who will notify the doctor for further orders. She also verified Patient 33 had remained on a regular diet.

During an interview with CN 3, on 3/22/16, at 10:52 AM, she stated Patient 33 was only being fed by staff because "She was just too impulsive." She stated on 3/12/16, at around dinner time, she went to Patient 33's room after RN 6, who was the patient's primary nurse, called the "Code [Blue]" (Code Blue- a hospital-wide emergency alarm that alerts hospital staff a patient was in need of life-saving measures). CN 3 also stated upon arriving at Patient 33's room, the patient was "foaming at the mouth and turning blue." She noted pieces of lettuce on Patient 33's chest area and that "there was food all over." She indicated at that time there were no visitors or family members in the room, and before the code was called, both RN 6 and Certified Nurse Assistant (CNA) 3, the patient's primary CNA, were assisting other patients.

During a concurrent interview with CN 3, CNA 3, and NM 3, on 3/22/16, at 11:06 AM, CNA 3 stated Patient 33 would always ask for food and was hungry all the time. She stated on 3/12/16, during lunch time, she was feeding the patient and she "got scared" so she pushed the emergency button. CN 3 verified the incident and stated she went to Patient 33's room, and she managed to pull out a piece of lettuce from the patient's mouth. CNA 3 also stated she did not feed Patient 33 at dinner time because she was admitting another patient. She was also not aware of who gave the dinner tray to Patient 33. NM 3 stated Patient 33 was brought a regular diet tray for dinner inside the room and she was unable to find out who had placed the food tray within the patient's reach.

During a review of RN 6's "Nurse's Notes", dated 3/12/16, at 6 PM, it indicated she was notified by the telemetry technician (person who electronically monitors a patient's heart rate and rhythm) that Patient 33's heart rate was in the "40s" (beats per minute) and was still dropping. RN 6 noted she found Patient 33 unresponsive and was "light blue in color." She called a "Code Blue" and cardiopulmonary resuscitation (life-saving chest compressions) was initiated after noting Patient 33 had no pulse at 5:23 PM.

During a review of the "Cardiopulmonary Arrest Record", dated 3/12/16, it indicated Patient 33 was "Asystole" (the heart was not beating) from 5:20 PM to 5:33 PM (a total of 13 minutes).

During a review of the clinical record for Patient 33, the "Emergency Room Report" written by Medical Doctor (MD) 2, dated 3/12/16, at 5:51 PM, indicated the patient had a "Cardiopulmonary arrest (sudden stop in the patient's heart function and breathing with loss of consciousness), possibly secondary to aspiration (food enters the lungs)." MD 2 also indicated it was difficult to intubate the patient (insert a tube in the airway to deliver oxygen) because the posterior pharynx (area located behind the throat) was full of food and it was very difficult to excavate (remove) the food in order to even see the larynx (muscular part of the throat which forms an air passage to the lungs). The notes also indicated the food pieces were "just too big to be sucked out." MD 2 eventually used a pair of "forceps" (an instrument that grasps objects resembling tongs) to remove enough food "which allowed for the intubation." MD 2 also indicated "The patient had a lot of food contents coming back up through the endotracheal tube (name of the tube inserted in the airway) and stated it was "all suctioned free."

During a review of the "Progress Record" written by MD 3, dated 3/14/16, at 10:03 AM, it indicated Patient 33 had "Severe Hypoxic Ischemic Encephalopathy" (a brain injury caused by deprivation of oxygen to the brain) with an "extremely poor prognosis" (extremely poor outcome or chances of recovery). On 3/15/16, at 2:40 PM, MD 3's notes indicated Patient 33 was declared brain dead.

2. During a concurrent observation and interview with Patient 27, on 3/29/16, at 9:20 AM, he was lying in bed with his body positioned low and towards the right side of the bed. His right elbow was pressed against the bed siderail. When asked how he would call the staff when he needed assistance, he stated he would push the call button. Patient 27 hesitated to move and stated the call button was "somewhere in here." When asked how he was doing, he only moved his eyes and stated his right elbow was hurting and he was experiencing pain "all over." Patient 27 described his pain at a level 10 on a 0 to 10 pain scale (0 = No pain, 10 = Worse Pain).

During a concurrent observation and interview with CN 2 and NM 1, on 3/29/16, at 9:23 AM, in Patient 27's room, CN 2 and NM 1 repositioned Patient 27 higher and to the center of the bed. After he was repositioned, Patient 27 stated "That's better." CN 2 also stated the patient's call button was located on the inside of the bed siderail.

During a review of the "History and Physical", dated 3/29/16, written by MD 1, it indicated Patient 27 was 80 years old and had fallen landing on his right hip. He presented to the emergency department with a right hip fracture (broken right hip bone). MD 1 indicated Patient 27's treatment plan included pain control and supportive care. A review of the "Physician's Order", dated 3/29/16, at 1:55 AM, indicated Patient 27 was to receive an intravenous (through the vein) pain medication every four hours as needed.

During a review of the clinical record for Patient 27, the "Nurse's Notes" written by RN 5, dated 3/29/16, at 2:55 AM, indicated the patient arrived on the unit from the emergency department and had asked for pain medication. The notes also indicated RN 5 had informed Patient 27 he would be given the pain medication when the "Pharmacy gets him into the system." There was no indication RN 5 had evaluated his pain. A review of the "Medication Administration Record" (MAR), dated 3/29/16, indicated RN 5 had administered the intravenous pain medication to Patient 27 at 5:28 AM (approximately two hours after the patient asked for pain medication) for a pain level of 10 (worse pain).

During an interview with the Pharmacist, on 3/29/16, at 3:01 PM, he reviewed Patient 27's clinical records and stated the intravenous pain medication was already available to licensed staff on the unit at 3:18 AM (approximately 20 minutes after the patient arrived on the floor).

During an interview with the NM 1, on 3/29/16, at 2:02 PM, he reviewed Patient 27's clinical records and stated the last time he received the same intravenous pain medication in the emergency department was on 3/28/16, at 11:09 PM (approximately six and a half hours before the patient received another dose on the unit).

During a review of the "Nurse's Notes" written by RN 4, dated 3/29/16, at 8:24 AM, it indicated Patient 27 had complained of pain to his "right lower extremities." The notes also indicated RN 4 did not give any pain medication because it was already given earlier by the previous shift's nurse and it was not yet due. There was no indication RN 4 had assessed the severity of the patient's pain.

During an interview with CN 2, on 3/29/16, at 2:02 PM, she reviewed Patient 27's MAR and was unable to find documentation that indicated RN 5 re-evaluated the patient's pain after the pain medication was given. There was also no indication that either RN 4 or RN 5 had notified the doctor of the patient's reports of pain. RN 6 also stated when the ordered pain treatment was not effectively managing the pain, the doctor was supposed to be notified.

The hospital policy and procedure titled "Pain Management", dated 9/2014, indicated if pain intensity was rated at 4 or greater, pain-relieving interventions will be implemented, as appropriate, with regular assessment and follow-up. The physician will be notified when a patient consistently has a pain rating of 4 or higher. It also indicated the patient had the right to receive follow-up care during re-evaluation of the patient's pain and the use of further measures to treat pain. Further, the policy indicated the elderly should be considered an at-risk group for the under treatment of pain... therefore, elderly patients require aggressive pain assessment and management. The procedure indicated to assess and document the patient's pain status on the MAR 30 minutes after intravenous administration of pain medications.

Based on observation, interview, and record review, the hospital failed to assess the continued need for restraints for two of 33 sampled patients (1 and 2), and to remove restraints for Patient 1 when the bi-pap machine (a machine used to provide pressurized oxygen to ease breathing) was not in use and to allow him to feed himself.

Findings:

During an observation and concurrent interview with Registered Nurse (RN) 1, on 3/28/16, at 10:25 AM, Patient 1 was sitting up in bed at a 30 degree angle. Both wrists were restrained with soft ties tied to the frame of the bed with a slip knot. Patient 1 had two inches of potential movement with each wrist. His hands were resting on the bed's side rails. The call light was tucked into the mattress and not within reach of the patient's hands. All four of Patient one's siderail were raised. A body belt restraint was tied around his chest and tied to the bed. The body belt restraint afforded Patient 1 no side to side movement. Patient 1 had no oxygen or bipap machine in use and did not appear agitated. The right arm had a dressing above and under the restraint. RN 1 identified the dressing as a covering for a skin tear. She stated he would not be able to use his call light but could shout out if he needed help. Patient 1 stated, "could you please cut me loose". The Chief Nursing Officer (CNO) released his wrist restraints and Patient 1 pulled up his sheet and stated he was cold. The wrist restraints had small red and brown stains where it touched Patient 1's skin.

During an observation and concurrent interview with the CNO and Certified Nursing Assistant (CNA) 1 on 3/29/16 at 9:25 AM, Patient 1 was sitting up in bed at a 30 degree angle. Both wrists were restrained with soft ties tied to the frame of the bed with a slip knot. Patient 1 had two inches of potential movement with each wrist. His hands were resting on the bed's side rails. The call light was tucked into the mattress and not within reach of the patient's hands. All four of Patient 1's siderails were raised. A body belt restraint was tied around his chest and tied to the bed. The body belt restraint afforded Patient 1 no side to side movement. A breakfast tray with food cut into small pieces was on the patient's bedside table. CNA 1 was feeding Patient 1 while his hands and chest were restrained. CNA 1 stated she did not know if Patient 1 was capable of feeding himself.

During a review of the clinical record on 3/29/16 at 10 AM, the "Nursing Assessment" dated 3/28/16 at 6:40 PM, under the category feeding ability indicated "self".

The "Patient Notes" dated 3/25/16 at 5:49 AM, indicated "He [Patient 1] is restless and crying this morning for me to remove his bipap mask. He started to cry and beg and I explained the situation, explained if he doesn't want it he would have to tell the M.D. (medical doctor), he doesn't want everything. He nodded yes. The patient is stress free." At 7:20 AM the note indicated, "The patient is on 5 liters of oxygen ( provided through a tube, not the bi-pap machine) and has bilateral wrist restraints on. Bed alarm is on." The "Physician's Orders" dated 3/24/16 at 3:30 PM, indicated, "can restrain patient if taking bipap off and agitated".

During an observation and concurrent interview with Nurse Manager (NM) 1 and RN 8 on 3/29/16 at AM, Patient 2 was sitting up in bed at a 30 degree angle. Both wrists had untied soft ties. RN 8 stated, "I just untied him to give him a rest". NM 2 stated Patient 2 had restraints on because he has dementia.

The hospital policy and procedure titled "Use of Restraints" dated 3/20/16, indicated when a restraint is necessary, such activity will be undertaken in a manner that protects the patient's health and safety and preserves his rights and well being. The decision to use restraints will not be driven by diagnosis."

Based on observation, interview, and record review, the hospital failed to obtain appropriate physician orders which included the clinical indications for the use of restraints, type of restraints to be used, and the duration of time the restraints were to be used for two of 33 sampled patients (1 and 2). These failures caused the patients to be restrained without physicians' orders and to suffer psycho-social harm.

Findings:

During a concurrent observation and interview with Registered Nurse (RN) 1, on 3/28/16, at 10:25 AM, Patient 1 was sitting up in bed at a 30 degree angle. Both wrists were restrained with soft ties tied to the frame of the bed with a slip knot. Patient 1 had two inches of potential movement with each wrist. His hands were resting on the bed's side rails. The call light was tucked into the mattress and not within reach of the patient's hands. All four of Patient 1's siderails were raised. A second body belt restraint was tied around his chest and tied to the bed. The body belt restraint afforded Patient 1 no side to side movement. Patient 1 had no oxygen or bipap machine (machine used to provide the patient continuous delivery of air while asleep) in use and did not appear agitated. The right arm had a dressing above and under the restraint. RN 1 identified the dressing as a covering for a skin tear. She stated he would not be able to use his call light but could shout out if he needed help. Patient 1 stated "Could you please cut me loose". The Chief Nursing Officer (CNO) released his wrist restraints and Patient 1 pulled up his sheet and stated he was feeling cold.

During a review of the clinical record for Patient 1, with Nurse Manager (NM) 2, on 3/28/16, at 10:25 AM, the "Physician's Orders", dated 3/24/16, at 3:30 PM, indicated "Can restrain patient if taking bipap off and agitated". The order did not indicate what type of restraint was to be used, or the duration of time the restraint was to be used. The "Physician orders: non-violent restraints", dated 3/24/16, at 7:51 PM, indicated RN 2 had obtained a Physician's telephone order for restraints at 6:23 PM but the order was never signed by the Physician. The order form indicated the "Telephone order must be countersigned within 24 hours", and "My face to face assessment of the patient indicates the need for restraints" which was to be completed by the physician. NM 2 was unable to find documentation of a physician assessment for Patient 1 indicating his need for physical restraints. Section 3 of the "Physician orders: non-violent restraints", dated 3/27/16, at 3:40 PM, indicated the type of restraint to be used were soft restraints for both upper extremities. The boxes indicating to use a body belt restraint and four siderails raised were not checked for the restraint orders from 3/24/16 to 3/27/16.

During a concurrent observation and interview with NM 1, and RN 8 on 3/29/16 at AM, Patient 2 was sitting up in bed at a 30 degree angle. Both wrists had untied soft ties. RN 8 stated, "I just untied him to give him a rest". NM 2 stated Patient 2 had restraints on because he has dementia.

During a review of the clinical record for Patient 2, with the NM 2 on 3/29/16 at 9:25 AM, the "Physician orders: non-violent restraints" "dated 3/26/16 at 5 PM, indicated the clinical indication for restraints was dementia.

The "Physician orders: non-violent restraints" dated 3/27/16 at 7:51 PM, indicated a Registered Nurse had obtained a physician's telephone order for restraints at 11 AM but the order was never signed by the physician.

The "Physician orders: non-violent restraints" indicates "THERE MUST BE A NEW ORDER OBTAINED EVERY CALENDAR DAY".

Based on observation, interview, and record review, the hospital failed to individualize and revise care plans for three of 33 sampled patients (4, 15, and 16). This failure had the potential to result in unmet care needs.

Findings:

1. During a concurrent observation and interview with Patient 4, on 3/29/16, at 3:30 PM, she was sitting up in bed with her husband at the bedside. Patient 4 stated, "I still have some difficulty with swallowing and with some movements but I'm getting better."

During a review of the clinical record for Patient 4, the "Multidisciplinary Care Plan", dated 3/27/16, indicated "Dysphasia" (difficulty swallowing) under the heading "Patient Problems". No entries were noted under the columns for interventions and goals. A review of the "Therapy Notes" dated 3/28/16, at 11:15 AM, indicated "Intermittent supervision, meds crushed in puree, no straws, small bites and sips, RN (registered nurse) informed of the above."

During an interview with Speech Therapist (ST) 1, on 3/29/16, at 3:30 PM, she stated, "I talk with the nurse to see how the patient is doing and document the diagnosis, goals and interventions in the therapy notes and the nurses document the interventions and goals in the care plan."

2. During a review of the clinical records for Patient 15, the "Multidisciplinary Care Plan", indicated Patient 15 had a "Foley catheter" (flexible plastic tube inserted into the bladder to provide continuous urine drainage).

During a concurrent interview and record review with the Chief Nursing Officer (CNO), on 3/28/16, at 11:30 AM, she reviewed Patient 15's medical record and stated the Foley catheter was removed on 3/24/16. The CNO acknowledged Patient 15's care plan should have been revised to reflect the Foley catheter was discontinued.

3. During a concurrent interview and record review with Charge Nurse (CN) 1, on 3/29/16, at 2:05 PM, she reviewed Patient 16's medical record and stated there was a physician order for Xanax (a medication used to treat anxiety) on 3/26/16. CN 1 verified a care plan for anxiety was not initiated until 3/28/16. CN 1 stated patient care plans should be reviewed and updated at least every 24 hours, and Patient 16's care plan for anxiety should have been initiated when the problem was initially identified.

The hospital policy and procedure titled "Multidisciplinary Patient Care Plan-Acute Care", dated 3/2015, indicated "The MCP (multidisciplinary care plan) will be utilized to identify patient problems and needs, interventions and goals/outcomes to meet the needs of the patient... As problems are resolved, the date of the resolution will be entered to the left of the identified problem... Upon problem identification, expected goals/outcomes will be established."