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Based on review of hospital policy, job descriptions, closed medical record review, monitor technician log review and staff interview the hospital's leadership failed to provide oversight and have systems in place to ensure the protection of patients' rights and failed to have an organized nursing service to ensure the provision of patient care in a safe environment.

The findings include:

1. The hospital failed to protect and promote patients' rights for a safe environment for patients by failing to ensure care was provided in a safe setting by failing to ensure the nursing staff supervised and evaluated patient care by failing to follow physician orders for continuous cardiac monitoring, failing to recognize signs and symptoms of hypoxia, failing to report a change in patient condition and failing to release the restraint when the patient was resting quietly for 1 of 1 patients with a cardiac arrest (Patient #7).

~cross refer to 482.13 Patient Rights Condition: Tag A0115

2. The hospital's nursing staff failed to have an effective nursing service providing oversight of day to day operations to ensure registered nursing staff supervised and evaluated patient care.

~cross refer to 482.23 Nursing Condition: Tag A0385

Based on review of hospital policy and procedure, job descriptions, closed medical record review, monitor technician log review and staff interview, the hospital failed to protect and promote patients' rights for a safe environment for patients by failing to ensure care was provided in a safe setting by failing to ensure the nursing staff supervised and evaluated patient care by failing to follow physician orders for continuous cardiac monitoring, failing to recognize signs and symptoms of hypoxia, failing to report a change in patient condition and failing to release the restraint when the patient was resting quietly for 1 of 1 patients with a cardiac arrest (Patient #7).

The findings include:

1. The hospital failed to ensure care in a safe setting by failing to ensure the nursing staff supervised and evaluated patient care by failing to follow physician orders for continuous cardiac monitoring, failing to recognize signs and symptoms of hypoxia, and failing to report a change in patient condition for 1 of 1 patients with a cardiac arrest (Patient #7).

~cross refer to 482.13(c)(2) Patient Rights Standard: Tag A0144

2. The nursing staff failed to release a restraint at the earliest possible time by failing to release the restraint when the patient was resting quietly for 1 of 1 patients with a cardiac arrest (Patient #7).

~cross refer to 482.13(e)(9) Patient Rights Standard: Tag A0174

Based on review of hospital policy, job descriptions, closed medical record review, monitor technician log review and staff interview, the hospital failed to ensure care in a safe setting by failing to ensure the nursing staff supervised and evaluated patient care by failing to follow physician orders for continuous cardiac monitoring, failing to recognize signs and symptoms of hypoxia, and failing to report a change in patient condition for 1 of 1 patients with a cardiac arrest (Patient #7).

The findings include:

Review of the hospital's policy, "Physiologic Alarm Settings", revised 07/2011, revealed, "PURPOSE : To provide safe environment through maintenance of monitor alarm settings of patient's physiological data and documentation of data strips....DOCUMENTATION: ECG: A recording of each patient's ECG rhythm strip* will be obtained on admission and at the beginning of each shift and documented on the Rhythm Strip Analysis Sheet."

Review of the hospital's "Cardiac Monitoring Program Guidelines", revised 03/01/2014 revealed "The following are the procedures to follow to communicate patient status for all units that are monitored by the Cardiac Monitoring Program. ..." Review revealed an algorithm for Monitor Techs to follow when monitor leads are off. The algorithm revealed "...If the patient remains off the monitor/ leads remain off/ or battery is not changed after notifying the clinical staff", then the monitor tech is to contact the clinical staff every 15 minutes for two times. If the issue has still not been resolved, the Monitor Tech is to "Contact the Charge Tech". The Charge Tech "will go to the unit and discuss the issue with the Charge Nurse for resolution. Charge Tech will not leave the unit until the issue is resolved."

Review of Hospital Document "(Hospital Initials) ADULT GENERAL CARE UNIT SCOPE OF SERVICE" revealed 3 South (general medical cardiac monitored unit) was "...designated to provide service to the stable young adult to geriatric population requiring continuous cardiac monitoring". Review revealed Vital Sign frequency as every 4 hours or greater.

Review of the hospital's job description for a Staff Nurse I, dated 11/07/2013, revealed, "...Position Summary: Deliver direct, quality patient care, utilizing a basic clinical skill level and knowledge base. Develop, implements and evaluates/revises a plan of care.....Responsibilities. Provides age specific direct patient care according to unit scope of service ....Interprets overt assessment data to determine when patient is at acute physiological and or psychosocial risk....Follows hospital policies and procedures and unit protocols....Demonstrates competency in basic nursing practice and mastery in the use of nursing process. ..."

Review of the hospital's Monitor Technician job description, dated 3/21/2012, revealed "...Responsibilities 1. Observes base station monitors and identifies life threatening arrhythmias of changes in patient's rhythm. 2. Notifies responsible RN of changes in patient's cardiac rhythm. ..."

Closed medical record review of Patient #7 revealed a 26 year old female admitted on 04/16/2014 with a history of systemic lupus erythematosus (SLE - a disease where the body's immune system mistakenly attacks healthy tissue), antiphospholipid syndrome (can cause blood clots to form), rheumatoid arthritis (inflammation and painful swelling of the joints), vasculitis (inflammation of blood vessels), previous left forefoot amputation (removed part of left foot), chronic kidney disease, recurrent perianal abscesses (collection of pus around the anus), anemia (low blood count), and elevated blood pressure. Review revealed Pt #7 was admitted to an intermediate cardiac monitored care unit. Review of physician orders revealed an order on 04/17/2014 for continuous cardiac monitoring and continuous pulse oximeter monitoring "until specified". On 04/20/2014 Pt #7 was transferred to 3 South, a Monitored General Medical Unit. Record review revealed continuous cardiac monitoring was reordered on 05/03/2014 at 1427 to include "...Transport off monitor per Nursing Assessment Guidelines. Documentation of flow sheets on 05/09/2014 at 0800, documented at 1228, revealed Pt #7 was on "room air" with a cardiac rhythm of "Sinus Rhythm". Review of Nursing Progress Notes, dated 05/09/2014 at 1900, revealed "Continues to holler out and cry. When asked if she needs anything. She says 'nothing'. Informed patient that her mother is coming to see her. Patient was in bathroom. Denied needing help, but continues to cry out saying she needs help." Flow sheet review revealed on 05/09/2014 at 2000 Vital Signs were obtained with Pulse 88, Respirations 22, Blood Pressure (BP) 125/89, and SpO2 (pulse oximeter oxygen saturation) 100% (normal 95-100%). Further review revealed RN #1 assessed the patient on 05/09/2014 at 2215 (documented 05/10/2014 at 0226) as "Anxious; Restless, Agitated." Further review revealed at 2215 (documented at 0226) the patient was meeting the "cardiac standard", and was in "Sinus Rhythm". Review of Nursing Progress Notes revealed on 05/09/2014 at 2217 "...Patient had pulled her Foley (urinary catheter) out. 'No, I do not want it.' states patient. MD to be notified." Further review of Nursing Progress Notes revealed at 2241 "(urinary catheter) balloon intact. Informed patient that we can leave the (urinary catheter) out for now. Cardiac leads off of patient. Patient had pulled those off too. ..." Review of flow sheets revealed on 05/09/2014 at 2310 the patient complained of Pain as 10 (excruciating). Medications revealed on 05/09/2014 at 2310 Dilaudid (narcotic pain medication) 2 mg IV and Ativan (anti-anxiety medication) 0.5mg IV were administered for pain and agitation. Record review of a Non-violent/ non-self-destructive restraint flow sheet revealed on 05/10/2014 at 0000, Patient #7 was "Pulling at/Removing Lines/Tubes; Pulling at/Removing Dressings/Equipment; Thrashing leg(s)/compromising treatment modalities; Injury to self/Others; Unable to follow safety instructions...Further review revealed on 05/10/2014 at 0000 the patient was "Agitated; Anxiety: Confused; Delusional; Restless" and "...Attempting to get out of Bed/Chair." Review of Nursing Progress Notes revealed on 05/10/2014 at 0011 "Phone call to MD on-call to get order for restraints. Patient crawling OOB (out of bed) between rails. Mother of patient was in the room and could not hold patient in the bed, patient constantly pulling off cardiac leads, pulled out (urinary catheter) earlier. Patient very agitated. Ativan and Dilaudid given earlier. Patient was stating she was hot and wanted to sleep on the floor, this was when patient crawled out of the bed with all siderails up. (RN #3) Charge Nurse notified and in with patient. Restraint put on due to safety issues... ." Review of Physician Orders revealed an order from NP #1 on 05/10/2014 at 0027 for arterial blood gases. Further review revealed the order was discontinued at 0052. Review did not reveal evidence that a blood gas was drawn. Review of MD Progress Notes on 05/10/2014 revealed NP #1 visited the patient at 0033 because nursing staff reported agitation and confusion. Further review of his Progress Notes revealed Patient #7 was in bilateral wrist restraints and vest restraint, and denied pain. Progress Note review revealed an assessment of "acute agitation" and a plan to keep the patient restrained for patient safety as "she is trying to get up, and does not appear safe to do so unsupervised." Review of Physician Orders revealed an order on 05/10/2014, documented at 0142, to "Restrain for non violent reasons." Restraints ordered were "Upper Soft" and "Vest", with a purpose of "High Risk of Unintended Injury/Trauma to Self" and "Unintentional Interference with Necessary Treatment/Devices". On 05/10/2014, documented at 0151, review of orders revealed an order for Oxygen 2 liters per minute. Record review of Flow Sheets and Nursing Progress Notes did not reveal documentation of oxygen being applied. Further review of Flow Sheets revealed vital signs at 0200, including Pulse 89, BP 131/102, and SpO2 62% (low). Record review did not reveal documentation that RN #1 notified a physician/ provider or the Charge Nurse of the 62% oxygen saturation result. Record review revealed the readings at 0200 were the last validated readings by RN #1 (3 hours, 51 minutes before the cardiac arrest/ code blue was initiated). The last pulse electronically recorded was 88 at 0213. Record review failed to reveal any cardiac monitoring after 0213. Record review did reveal multiple SpO2 readings recorded in the medical record from 0323 to 0354, ranging from 1% at 0336 to 100% at 0341. Record review did not reveal that RN #1 validated any of these readings, instead they were validated by RN # 2 (who responded to the Code Blue) on 05/10/2014 at 0643 (after the code blue was initiated). Review of Flow sheet revealed Pain Assessment at 0317, with pain intensity of 10 (on scale of 0-10). Review of Medications revealed Dilaudid 2 mg IV was administered on 05/10/2014 at 0317. Review of the "Pain Assessments Sedation Scale", revealed at 0354 "...Eyes closed, easy to arouse (acceptable, no action necessary)." Further review revealed SpO2 of 65% (validated by RN #2 at 0643, not validated by RN #1). Review of Nursing Notes and Flow Sheets failed to reveal restraint release or application of monitor leads at this time. Review of Nursing Progress Notes did not reveal any written Nursing Notes documented by RN #1 after 0212 until after the cardiac arrest. Review of Restraint Summary flowsheet on 05/10/2014 at 0400, documented at 0421, revealed the restraint was continued. Further review of Nursing Progress Notes did not reveal documentation to indicate the patient was placed back on cardiac monitoring after restraints were initiated nor did it reveal any additional notification to Charge Nurse or Physician related to cardiac monitoring or change in patient condition. Review of the "Code Blue Note", 05/10/2014 at 0551, revealed "...Responded to code blue, on arrival CPR (Cardiopulmonary Resuscitation) in progress... ." Review of Discharge/ Death Summary revealed "on 5/10/2014 the patient had several episodes of confusion and agitation. She received Ativan and Dilaudid. Patient was also given one dose of Bumex (diuretic) for worsening pulmonary edema. She was later found unresponsive and cold. Code blue was called and patient was found to be in PEA (pulseless electrical activity or cardiac) arrest. She received CPR, epinephrine x 3 (3 times) and was intubated with ROSC (Return of Spontaneous Circulation) after 15 minutes. She was transferred to MICU for further management....Pupils were fixed and dilated, no respiratory effort and pH of 6.9. CT head was obtained which showed changes consistent with global hypoxic ischemic injury. ..." The patient expired on 05/10/2014 at 1302. Continued review of the Death Summary revealed "Principle Diagnosis: Anoxic brain injury secondary to PEA (pulseless electrical activity) arrest."

Review of the "Monitor Technician - Daily Patient Activity Log" revealed Pt #7 was off the monitor (monitor leads off) on 05/09/2014 at 2145. Review revealed RN #1 was notified, with explanation of "will go check on pt (patient) and leads. Review revealed at 2235, monitor leads were off and RN #1 was notified, with explanation "pt refusing monitor orders". Review revealed at 2302 the patient was on the monitor. On 05/10/2014 at 0005, log review revealed the RN was with the patient, the patient had fallen. Further review revealed the CT (Charge Technician) was notified at this time. On 5/10/2014 at 0009, review revealed the patient was on the monitor. At 0044, monitor leads were off. Review revealed at 0044 "CP (Care Partner) not logged in", at 0045 "RN not available", at 0047 "no answer at Sect. (secretary) desk", at 0048 "no answer at CN (Charge Nurse) number", and at 0049 "CT notified". At 0054 review revealed monitor leads were off, the monitor tech spoke with RN #1, and description/explanation documented was "Pt (patient) refusing monitor again, MD is aware of situation and ordered AG's (Arterial Blood Gases)". Further log review revealed on 05/10/2014 at 0200 leads were off, RN #1 was notified, and explanation documented was "OK, pt refusing, pt in restraints". Continued log review revealed on 05/10/2014 at 0300, 0407, and 0537 monitor leads were off, RN # 1 was notified, and the explanation was "pt refusing" each time. Review of the Monitor Log failed to reveal documentation of monitor leads being on or the patient being monitored after 0044. On 05/10/2014 at 0551, log review revealed "Code blue called on pt, pt still off monitor, CT notified."

Review of "Charge Technician Code Blue Report" revealed a description of the events was "Code Blue called @ (at) 0551 prior to code (Monitor Technician #1) was notified by (RN #1) that patient was refusing monitor. Patient started refusing monitor @ 2235 until time of code. Charge Tech check on patient Code Team still working on patient 0605... ."

Interview on 09/30/2014 at 1430 with Administrative Staff #1 revealed Patient #7 was confused and agitated on 05/10/2014. Interview further revealed Patient #7 was not on a cardiac continuous monitor per the physician's order. Interview further revealed that on 05/10/2014 at 0200, RN #1 assessed Patient #7's oxygen saturation as 62% (low) and did not notify the physician of a change in the patient's status. Interview further revealed that RN #1 "did not recognize hypoxia (lack of oxygen). She chose to ignore all the warnings for this patient".
Telephone interview on 10/01/2014 at 1500 with Unit Secretary (US) #1 revealed she remembered Patient #7. Interview revealed, "she was very needy a couple of days prior to her death. She changed. She started falling and getting out of bed. On May 9th, her call bell kept going off. I went down to her room about 11:00 (pm) and she was on the floor. I notified the Charge Nurse (RN #3). She fell at least three times that night". Interview further revealed, "(RN #3) said she had her cardiac leads back on".
Telephone interview on 10/01/2014 at 1655 with Monitor Tech #1 revealed he was monitoring the 3 south cardiac monitors on 05/09/2014 at 1900 until 05/10/2014 at 0700. Interview revealed, "We were very busy that night. (Patient #7) was off the monitor at 1900. I called the Unit Secretary. I called the nurse (RN #1) several times that night. I went down to the room during a bathroom break. She (RN #1) was frustrated that night, maybe because of her patient load. She said the patient refused the monitor. I called (RN #1) hourly to see if the patient was still refusing. I called (Monitor Charge Tech) to let her know the patient was refusing to have her leads on, hoping she would call the nurse about the patient not being on the monitor". Interview further revealed, "Our department is closing because according to (Name of Administrative Staff), the nurses don't trust the monitor techs. A lot of nurses don't know their rhythms".
Telephone interview on 10/01/2014 at 1510 with a Monitor Charge Technician (#1) revealed she was the supervising Monitor Charge Technician on 05/09-10/2014. Interview revealed, "the monitor tech said she (Patient #7) was refusing the monitor. The monitor tech called the nurse and she said she wasn't going to put the patient back on the monitor". Interview revealed Monitor Technician #1 kept calling the Monitor Charge Technician (#1), because he wanted to her to "make the RN put the patient on the monitor" . Interview revealed "I can't make them put them on the monitor". Interview revealed, "I couldn't go down to the unit because I was sitting on 3West monitoring because they had a call out". Interview further revealed, "We didn't have a supervisor to call. We didn't have anybody to call" .
Telephone interview on 10/01/2014 at 1230 with RN #3 revealed she was the Charge Nurse for the 3 South Unit on 05/09/2014 beginning at 1900 until 05/10/2014 at 0700. Interview revealed, "when I was making rounds, the Care Partner told me they were not letting (Patient #7) out of bed because she was falling. She had fell with the nurse in the bathroom and with her Mom. (Patient #7) was real restless. She wanted to lay on the floor. I told her Primary Nurse (RN #1) to call the physician. The nurse practitioner came to see her around midnight. (Patient #7) was placed in restraints because she was agitated and had pulled her Foley out and took her cardiac leads off". Interview further revealed, "she should have been placed back on the cardiac monitor. The monitor tech never called me. He was able to get up with (RN #1). (RN #1) never told me anything about her sats (oxygen) dropping". Interview further revealed, "I made rounds at the beginning of the shift. I went to her room each time she fell. It was a very busy night. We had 38 patients. We were fully staffed". Interview further revealed, "(RN #1) never reported any of her behaviors - anxious, moving about, wanting to be cooler, getting out of bed, to me. They are all signs of decreased oxygen. (RN #1) did not notify me of a change in her (Patient #7's) condition. Both of us should have called the doctor if we knew about it".
Telephone interview on 10/01/2014 at 1530 with Nurse Practitioner #1 revealed he works with the hospitalist service and he remembered Patient #7. Interview revealed, "I got a call from a nurse around midnight (05/10/2014) about (Patient #7) being agitated, impulsive and attempting to get out of bed. I went to see her. She was anxious, trying to get out of bed, wanting to go to the bathroom. She was alert but was fixated on going to the bathroom. A restraint was ordered to keep her in the bed and to keep the monitor (cardiac) on. I initially ordered ABGs (arterial blood gases) but after I went to see her, I didn't see a need. Her chest sounded ok". Interview further revealed, "I expected her to be reconnected to the cardiac monitor. The nurse didn't call me saying it was not reconnected. The nurse didn't call me to let me know her O2 sats (saturation) were dropping. I expected oxygen to be on, too". Further interview revealed, "I expected the nurse to call me if her (Patient #7) condition changed. I did not get a call from the nurse".
Interview on 10/01/2014 at 1005 with Care Partner (CP) #1 revealed the CP was a Nursing Assistant II and was assigned to Patient #7 on 05/09/2014 beginning at 2300 until 05/10/2014 at 0700. Interview revealed, "when I arrived to her room, she was on the floor saying she was hot. She wanted to sleep on the floor. She had taken her (cardiac) leads and her gown off. There were 5 or 6 people in the room with her. I got back to her room around 11:30 to take her vitals. I wasn't able to get them because she was flailing her arms, saying she was hot. I put her back to bed and her skin was cool. I told the nurse (RN #1) and she gave her some Ativan. She (Patient #7) slid out of bed. Her mother was right beside her but her mother couldn't keep her in the bed. She was little and she could slide between the rails. The nurse put her in restraints. She continued to be agitated, even in restraints. She didn't have the pulse ox (oximeter) or the cardiac monitor on after she was restrained. (RN #1) said she wasn't going to put them back on because she had already put 4 sets on her. About 4:30 (am) she calmed down. About 5:45, her mother left the room. She had slid down in the bed so I went to get another Care Partner to help me pull her up. When I got back, her head was turned to the side and I couldn't get her to respond. Her nurse was in the next room. I notified her. A Code was called".
Interview on 10/01/2014 at 0850 with RN #2 revealed the RN was a member of the Emergency Response Team and responded to the Code Blue for Patient #7 on 05/10/2014 around 0600. Interview revealed, "CPR (Cardio-Pulmonary Resuscitation) was in progress, chest compressions were being done and the patient was being bagged without an artificial airway. She was not on the cardiac monitor. She had on a Posey vest. I cut it off. I put the pads (defibrillator) on and she was asystole (no cardiac electrical activity). She was getting ACLS (Advanced Cardiac Life Support) meds (medications) and got a rhythm back without shocking (the heart)". Interview further revealed, "I read the record after she was transported to MICU (medical intensive care unit). She had been showing signs of hypoxia all night - agitated, restless, picking at self, pulling out her Foley (urinary catheter), taking the leads (cardiac) off". Further interview revealed, "Once she was restrained, she should have been hooked back up to the cardiac monitor. I rounded on the unit prior to the event, sometime after midnight, and nobody mentioned this patient to me". Interview further revealed, "I went to the monitor tech room the next night to look at her rhythm and vital signs before the event and there was a lot of missing data". Interview confirmed that the nursing staff caring for Patient #7 on 05/10/2014 failed to evaluate and supervise the care of Patient #7.
Telephone interview on 10/01/2014 at 1630 with Care Partner #2 revealed she remembered Patient #7. Interview revealed, "she was in a lot of pain. I was her Care Partner on 05/09/2014 from 7 o'clock (pm) until 11 o'clock (pm). She wasn't herself. She was up and down, out of bed, fidgeting, agitated and uncomfortable. She told me she was having trouble breathing. She had oxygen but she wouldn't wear it. I put it back on. I can only give her 2 liters of oxygen. I told the nurse (RN #1) she was having trouble breathing. (RN #1) didn't listen to what I was saying. I told the Charge Nurse (RN #3) that she was having trouble breathing". Interview revealed, "she should have been transferred off that floor the first four hours I was there. Something wasn't right".
Consequently, Patient #7 exhibited signs and symptoms of hypoxia (agitation, restlessness, hot, climbing out of bed, difficulty breathing) with oxygen desaturation and was restrained by RN #1 with a vest and upper soft limb restraints in order to reconnect the cardiac monitor and RN #1 did not follow the physician's order for cardiac monitoring, did not reassess the patient's vital signs and did not notify the physician of a change in the patient's condition. Subsequently, Patient #7 was found by a nursing assistant to be unresponsive and in cardiac arrest, suffered global hypoxic ischemic brain injury and died on 05/10/2014 at 1302.

Based on review of hospital policy, job descriptions, closed medical record review, monitor technician log review, and staff interviews, the nursing staff failed to release a restraint at the earliest possible time by failing to release the restraint when the patient was resting quietly for 1 of 1 patients with a cardiac arrest (Patient #7).

The findings include:

Review of the hospital's policy, "Restraint & Seclusion, Non-Violent & Violent, Including Behavioral Health Services, reviewed 02/2014, revealed "POLICY:...Restraint or Seclusion may only be imposed to ensure the immediate physical safety of the patients, a staff member, or others and must be discontinued at the earliest possible time ....If restraints are required they must be used in accordance with the patient's plan of care, and used only when less restrictive interventions have been determined to be ineffective....II. CRITERIA FOR RELEASE OF RESTRAINT The Registered Nurse has the authority to discontinue the restraints at the earliest possible time. It is appropriate to discontinue restraints when the patient's activity (that which jeopardized the immediate physical safety of the patient, a staff member or others) has resolved. ..."

Closed medical record review of Patient #7 revealed a 26 year old female admitted on 04/16/2014 with a history of systemic lupus erythematosus (SRE - a disease where the body's immune system mistakenly attacks healthy tissue), antiphospholipid syndrome (can cause blood clots to form), rheumatoid arthritis (inflammation and painful swelling of the joints), vasculitis (inflammation of blood vessels), previous left forefoot amputation (removed part of left foot), chronic kidney disease, recurrent perianal abscesses (collection of pus around the anus), anemia (low blood count), and elevated blood pressure. Review revealed Patient #7 was admitted to an intermediate, cardiac monitored care unit and was transferred to 3 South, a Monitored (Cardiac) General Medical Unit on 04/20/2014. Record review of a Non-violent/ non-self-destructive restraint flow sheet revealed on 05/10/2014 at 0000, Patient #7 was "Pulling at/Removing Lines/Tubes; Pulling at/Removing Dressings/Equipment; Thrashing leg(s)/compromising treatment modalities; Injury to self/Others; Unable to follow safety instructions..." Further review revealed on 05/10/2014 at 0000 the patient was "Agitated; Anxiety: Confused; Delusional; Restless" and "...Attempting to get out of Bed/Chair." Review of Nursing Progress Notes revealed on 05/10/2014 at 0011 "Phone call to MD on-call to get order for restraints. Patient crawling OOB between rails. Mother of patient was in the room and could not hold patient in the bed, patient constantly pulling off cardiac leads, pulled out (urinary catheter) earlier. Patient very agitated. Ativan (anti-anxiety medication) and Dilaudid (narcotic pain medication) given earlier. Patient was stating she was hot and wanted to sleep on the floor, this was when patient crawled out of the bed with all siderails up. (RN #3) Charge Nurse notified and in with patient. Restraint put on due to safety issues... ." Review of MD Progress Notes on 05/10/2014 revealed NP #1 visited the patient at 0033 because nursing staff reported agitation and confusion. Further review his Progress Notes revealed Patient #7 was in bilateral wrist restraints and vest restraint. Progress Note review revealed an assessment of "acute agitation" and a plan to keep restrained for patient safety as "she is trying to get up, and does not appear safe to do so unsupervised. Review of Physician Orders revealed an order on 05/10/2014, documented at 0142, to "Restrain for non violent reasons." Restraints ordered were "Upper Soft" and "Vest", with a purpose of "High Risk of Unintended Injury/Trauma to Self" and "Unintentional Interference with Necessary Treatment/Devices". Record review of flow sheet of the Pain Assessments Sedation Scale, on 05/10/2014 at 0354, revealed "...Eyes closed, easy to arouse (acceptable, no action necessary)." Review of Nursing Notes and Flow Sheets failed to reveal the restraints were released and that cardiac monitor leads were re-applied as ordered (a reason given for restraints). Review of the Restraint flow sheet documentation on 05/10/2014 at 0400, documented at 0421, revealed soft wrist restraints on the right and left wrists and a vest restraint were continuing. Flow sheet review revealed the patient "remains at risk". Review revealed no further documentation of the restraints until 0700, documented at 1038, when the wrist and vest restraints were documented as discontinued. Review of the "Code Blue Note", 05/10/2014 at 0551, revealed "...Responded to code blue, on arrival CPR (Cardiopulmonary Resuscitation) in progress... ."

Interview on 10/01/2014 at 1005 with Care Partner (CP) #1 revealed the CP was a Nursing Assistant II and was assigned to Patient #7 on 05/09/2014 beginning at 2300 until 05/10/2014 at 0700. About 4:30 (am) she (Patient #7) calmed down". Interview revealed the patient remained in restraints even after she was asleep and calm.
Interview on 10/01/2014 at 0850 with RN #2 revealed the RN was a member of the Emergency Response Team and responded to the Code Blue for Patient #7 on 05/10/2014 around 0600. Interview revealed, "CPR (Cardio-Pulmonary Resuscitation) was in progress, chest compressions were being done and the patient was being bagged without an artificial airway. She was not on the cardiac monitor. She had on a Posey vest. I cut it off. ..."

Based on review of hospital policy, job descriptions, closed medical record review, monitor technician log review, and staff interviews, the hospital's nursing staff failed to have an effective nursing service providing oversight of day to day operations to ensure registered nursing staff supervised and evaluated patient care.

The findings include:

1. The nursing staff failed to supervise and evaluate patient care by failing to follow physician orders for continuous cardiac monitoring, failing to recognize signs and symptoms of hypoxia, and failing to report a change in patient condition for 1 of 1 patients reviewed with a cardiac arrest (Patient #7).

~cross refer to 482.23(b)(3) Nursing Standard: Tag A0395

Based on review of hospital policy, job descriptions, closed medical record review, monitor technician log review, and staff interviews, the nursing staff failed to supervise and evaluate patient care by failing to follow physician orders for continuous cardiac monitoring, failing to recognize signs and symptoms of hypoxia, and failing to report change in patient condition for 1 of 1 patients reviewed with a cardiac arrest (Patient #7).

The findings include:

Review of the hospital's policy, "Physiologic Alarm Settings", revised 07/2011, revealed, "PURPOSE : To provide safe environment through maintenance of monitor alarm settings of patient's physiological data and documentation of data strips ....DOCUMENTATION: ECG: A recording of each patient's ECG rhythm strip* will be obtained on admission and at the beginning of each shift and documented on the Rhythm Strip Analysis Sheet."

Review of the hospital's "Cardiac Monitoring Program Guidelines", revised 03/01/2014 revealed "The following are the procedures to follow to communicate patient status for all units that are monitored by the Cardiac Monitoring Program. ..." Review revealed an algorithm for Monitor Techs to follow when monitor leads are off. The algorithm revealed "...If the patient remains off the monitor/ leads remain off/ or battery is not changed after notifying the clinical staff", then the monitor tech is to contact the clinical staff every 15 minutes for two times. If the issue has still not been resolved, the Monitor Tech is to "Contact the Charge Tech". The Charge Tech "will go to the unit and discuss the issue with the Charge Nurse for resolution. Charge Tech will not leave the unit until the issue is resolved."

Review of Hospital Document "(Hospital Initials) ADULT GENERAL CARE UNIT SCOPE OF SERVICE" revealed 3 South (general medical cardiac monitored unit) was "...designated to provide service to the stable young adult to geriatric population requiring continuous cardiac monitoring". Review revealed Vital Sign frequency as every 4 hours or greater.

Review of the hospital's job description for a Staff Nurse I, dated 11/07/2013, revealed, "...Position Summary: Deliver direct, quality patient care, utilizing a basic clinical skill level and knowledge base. Develop, implements and evaluates/revises a plan of care.....Responsibilities. Provides age specific direct patient care according to unit scope of service....Interprets overt assessment data to determine when patient is at acute physiological and or psychosocial risk....Follows hospital policies and procedures and unit protocols....Demonstrates competency in basic nursing practice and mastery in the use of nursing process. ..."

Review of the hospital's Monitor Technician job description, dated 3/21/2012, revealed "...Responsibilities 1. Observes base station monitors and identifies life threatening arrhythmias of changes in patient's rhythm. 2. Notifies responsible RN of changes in patient's cardiac rhythm. ..."

Closed medical record review of Patient #7 revealed a 26 year old female admitted on 04/16/2014 with a history of systemic lupus erythematosus (SLE - a disease where the body's immune system mistakenly attacks healthy tissue), antiphospholipid syndrome (can cause blood clots to form), rheumatoid arthritis (inflammation and painful swelling of the joints), vasculitis (inflammation of blood vessels), previous left forefoot amputation (removed part of left foot), chronic kidney disease, recurrent perianal abscesses (collection of pus around the anus), anemia (low blood count), and elevated blood pressure. Review revealed Pt #7 was admitted to an intermediate cardiac monitored care unit. Review of physician orders revealed an order on 04/17/2014 for continuous cardiac monitoring and continuous pulse oximeter monitoring "until specified". On 04/20/2014 Pt #7 was transferred to 3 South, a Monitored General Medical Unit. Record review revealed continuous cardiac monitoring was reordered on 05/03/2014 at 1427 to include "...Transport off monitor per Nursing Assessment Guidelines. Documentation of flow sheets on 05/09/2014 at 0800, documented at 1228, revealed Pt #7 was on "room air" with a cardiac rhythm of "Sinus Rhythm". Review of Nursing Progress Notes, dated 05/09/2014 at 1900, revealed "Continues to holler out and cry. When asked if she needs anything. She says 'nothing'. Informed patient that her mother is coming to see her. Patient was in bathroom. Denied needing help, but continues to cry out saying she needs help." Flow sheet review revealed on 05/09/2014 at 2000 Vital Signs were obtained with Pulse 88, Respirations 22, Blood Pressure (BP) 125/89, and SpO2 (pulse oximeter oxygen saturation) 100% (normal 95-100%). Further review revealed RN #1 assessed the patient on 05/09/2014 at 2215 (documented 05/10/2014 at 0226) as "Anxious; Restless, Agitated." Further review revealed at 2215 (documented at 0226) the patient was meeting the "cardiac standard" and was in "Sinus Rhythm". Review of Nursing Progress Notes revealed on 05/09/2014 at 2217 "...Patient had pulled her Foley (urinary catheter) out. 'No, I do not want it.' states patient. MD to be notified." Further review of Nursing Progress Notes revealed at 2241 "(urinary catheter) balloon intact. Informed patient that we can leave the (urinary catheter) out for now. Cardiac leads off of patient. Patient had pulled those off too. ..." Review of flow sheets revealed on 05/09/2014 at 2310 the patient complained of Pain as 10 (excruciating). Medications revealed on 05/09/2014 at 2310 Dilaudid (narcotic pain medication) 2 mg IV and Ativan (anti-anxiety medication) 0.5mg IV were administered for pain and agitation. Record review of a Non-violent/ non-self-destructive restraint flow sheet revealed on 05/10/2014 at 0000, Patient #7 was "Pulling at/Removing Lines/Tubes; Pulling at/Removing Dressings/Equipment; Thrashing leg(s)/compromising treatment modalities; Injury to self/Others; Unable to follow safety instructions...Further review revealed on 05/10/2014 at 0000 the patient was "Agitated; Anxiety: Confused; Delusional; Restless" and "...Attempting to get out of Bed/Chair." Review of Nursing Progress Notes revealed on 05/10/2014 at 0011 "Phone call to MD on-call to get order for restraints. Patient crawling OOB (out of bed) between rails. Mother of patient was in the room and could not hold patient in the bed, patient constantly pulling off cardiac leads, pulled out (urinary catheter) earlier. Patient very agitated. Ativan and Dilaudid given earlier. Patient was stating she was hot and wanted to sleep on the floor, this was when patient crawled out of the bed with all siderails up. (RN #3) Charge Nurse notified and in with patient. Restraint put on due to safety issues... ." Review of Physician Orders revealed an order from NP #1 on 05/10/2014 at 0027 for arterial blood gases. Further review revealed the order was discontinued at 0052. Review did not reveal evidence that a blood gas was drawn. Review of MD Progress Notes on 05/10/2014 revealed NP #1 visited the patient at 0033 because nursing staff reported agitation and confusion. Further review of his Progress Notes revealed Patient #7 was in bilateral wrist restraints and vest restraint, and denied pain. Progress Note review revealed an assessment of "acute agitation" and a plan to keep the patient restrained for patient safety as "she is trying to get up, and does not appear safe to do so unsupervised." Review of Physician Orders revealed an order on 05/10/2014, documented at 0142, to "Restrain for non violent reasons." Restraints ordered were "Upper Soft" and "Vest", with a purpose of "High Risk of Unintended Injury/Trauma to Self" and "Unintentional Interference with Necessary Treatment/Devices". On 05/10/2014, documented at 0151, review of orders revealed an order for Oxygen 2 liters per minute. Record review of Flow Sheets and Nursing Progress Notes did not reveal documentation of oxygen being applied. Further review of Flow Sheets revealed vital signs at 0200, including Pulse 89, BP 131/102, and SpO2 62% (low). Record review did not reveal documentation that RN #1 notified a physician/ provider or the Charge Nurse of the 62% oxygen saturation result. Record review revealed the readings at 0200 were the last validated readings by RN #1 (3 hours, 51 minutes before the cardiac arrest/ code blue was initiated). The last pulse electronically recorded was 88 at 0213. Record review failed to reveal any cardiac monitoring after 0213. Record review did reveal multiple SpO2 readings recorded in the medical record from 0323 to 0354, ranging from 1% at 0336 to 100% at 0341. Record review did not reveal that RN #1 validated any of these readings, instead they were validated by RN # 2 (who responded to the Code Blue) on 05/10/2014 at 0643 (after the code blue was initiated). Review of Flow sheet revealed Pain Assessment at 0317, with pain intensity of 10 (on scale of 0-10). Review of Medications revealed Dilaudid 2 mg IV administered on 05/10/2014 at 0317. Review of the "Pain Assessments Sedation Scale", revealed at 0354 "...Eyes closed, easy to arouse (acceptable, no action necessary)." Further review revealed SpO2 of 65% (validated by RN #2 at 0643, not validated by RN #1). Review of Nursing Notes and Flow Sheets failed to reveal restraint release or application of monitor leads at this time. Review of Nursing Progress Notes did not reveal any written Nursing Notes documented by RN #1 after 0212 until after the cardiac arrest. Review of Restraint Summary flowsheet on 05/10/2014 at 0400, documented at 0421, revealed the restraint was continued. Further review of Nursing Progress Notes did not reveal documentation to indicate the patient was placed back on cardiac monitoring after restraints were initiated nor did it reveal any additional notification to Charge Nurse or Physician related to cardiac monitoring or change in patient condition. Review of the "Code Blue Note", 05/10/2014 at 0551, revealed "...Responded to code blue, on arrival CPR (Cardiopulmonary Resuscitation) in progress... ." Review of Discharge/ Death Summary revealed "on 5/10/2014 the patient had several episodes of confusion and agitation. She received Ativan and Dilaudid. Patient was also given one dose of Bumex (diuretic) for worsening pulmonary edema. She was later found unresponsive and cold. Code blue was called and patient was found to be in PEA (pulseless electrical activity or cardiac) arrest. She received CPR, epinephrine x 3 (3 times) and was intubated with ROSC (Return of Spontaneous Circulation) after 15 minutes. She was transferred to MICU for further management....Pupils were fixed and dilated, no respiratory effort and pH of 6.9. CT head was obtained which showed changes consistent with global hypoxic ischemic injury. ..." The patient expired on 05/10/2014 at 1302. Continued review of the Death Summary revealed "Principle Diagnosis: Anoxic brain injury secondary to PEA (pulseless electrical activity) arrest."

Review of the "Monitor Technician - Daily Patient Activity Log" revealed Pt #7 was off the monitor (monitor leads off) on 05/09/2014 at 2145. Review revealed RN #1 was notified, with explanation of "will go check on pt (patient) and leads. Review revealed at 2235, monitor leads were off and RN #1 was notified, with explanation "pt refusing monitor orders". Review revealed at 2302 the patient was on the monitor. On 05/10/2014 at 0005, log review revealed the RN was with the patient, the patient had fallen. Further review revealed the CT (Charge Technician) was notified at this time. On 5/10/2014 at 0009, review revealed the patient was on the monitor. At 0044, monitor leads were off. Review revealed at 0044 "CP (Care Partner) not logged in", at 0045 "RN not available", at 0047 "no answer at Sect. (secretary) desk", at 0048 "no answer at CN (Charge Nurse) number", and at 0049 "CT notified". At 0054 review revealed monitor leads were off, the monitor tech spoke with RN #1, and description/explanation documented was "Pt (patient) refusing monitor again, MD is aware of situation and ordered ABG's (Arterial Blood Gases)". Further log review revealed on 05/10/2014 at 0200 leads were off, RN #1 was notified, and explanation documented was "OK, pt refusing, pt in restraints". Continued log review revealed on 05/10/2014 at 0300, 0407, and 0537 monitor leads were off, RN #1 was notified, and the explanation was "pt refusing" each time. Review of the Monitor Log failed to reveal documentation of monitor leads being on or the patient being monitored after 0044. On 05/10/2014 at 0551, log review revealed "Code blue called on pt, pt still off monitor, CT notified."

Review of "Charge Technician Code Blue Report" revealed a description of the events was "Code Blue called @ (at) 0551 prior to code (Monitor Technician #1) was notified by (RN #1) that patient was refusing monitor. Patient started refusing monitor @ 2235 until time of code. Charge Tech check on patient Code Team still working on patient 0605... ."

Interview on 09/30/2014 at 1430 with Administrative Staff #1 revealed Patient #7 was confused and agitated on 05/10/2014. Interview further revealed Patient #7 was not on a cardiac continuous monitor per the physician's order. Interview further revealed that on 05/10/2014 at 0200, RN #1 assessed Patient #7's oxygen saturation as 62% (low) and did not notify the physician of a change in the patient's status. Interview further revealed that RN #1 "did not recognize hypoxia (lack of oxygen). She chose to ignore all the warnings for this patient".
Telephone interview on 10/01/2014 at 1500 with Unit Secretary (US) #1 revealed she remembered Patient #7. Interview revealed, "she was very needy a couple of days prior to her death. She changed. She started falling and getting out of bed. On May 9th, her call bell kept going off. I went down to her room about 11:00 (pm) and she was on the floor. I notified the Charge Nurse (RN #3). She fell at least three times that night". Interview further revealed, "(RN #3) said she had her cardiac leads back on".
Telephone interview on 10/01/2014 at 1655 with Monitor Tech #1 revealed he was monitoring the 3 South cardiac monitors on 05/09/2014 at 1900 until 05/10/2014 at 0700. Interview revealed, "We were very busy that night. (Patient #7) was off the monitor at 1900. I called the Unit Secretary. I called the nurse (RN #1) several times that night. I went down to the room during a bathroom break. She (RN #1) was frustrated that night, maybe because of her patient load. She said the patient refused the monitor. I called (RN #1) hourly to see if the patient was still refusing. I called (Monitor Charge Tech) to let her know the patient was refusing to have her leads on, hoping she would call the nurse about the patient not being on the monitor". Interview further revealed, "Our department is closing because according to (Name of Administrative Staff), the nurses don't trust the monitor techs. A lot of nurses don't know their rhythms".
Telephone interview on 10/01/2014 at 1510 with a Monitor Charge Technician (#1) revealed she was the supervising Monitor Charge Technician on 05/09-10/2014. Interview revealed, "the monitor tech said she (Patient #7) was refusing the monitor. The monitor tech called the nurse and she said she wasn't going to put the patient back on the monitor". Interview revealed Monitor Technician #1 kept calling the Monitor Charge Technician (#1), because he wanted to her to "make the RN put the patient on the monitor". Interview revealed "I can't make them put them on the monitor". Interview revealed, "I couldn't go down to the unit because I was sitting on 3West monitoring because they had a call out". Interview further revealed, "We didn't have a supervisor to call. We didn't have anybody to call" .
Telephone interview on 10/01/2014 at 1230 with RN #3 revealed she was the Charge Nurse for the 3 South Unit on 05/09/2014 beginning at 1900 until 05/10/2014 at 0700. Interview revealed, "when I was making rounds, the Care Partner told me they were not letting (Patient #7) out of bed because she was falling. She had fell with the nurse in the bathroom and with her Mom. (Patient #7) was real restless. She wanted to lay on the floor. I told her Primary Nurse (RN #1) to call the physician. The nurse practitioner came to see her around midnight. (Patient #7) was placed in restraints because she was agitated and had pulled her Foley out and took her cardiac leads off". Interview further revealed, "she should have been placed back on the cardiac monitor. The monitor tech never called me. He was able to get up with (RN #1). (RN #1) never told me anything about her sats (oxygen) dropping". Interview further revealed, "I made rounds at the beginning of the shift. I went to her room each time she fell. It was a very busy night. We had 38 patients. We were fully staffed". Interview further revealed, "(RN #1) never reported any of her behaviors - anxious, moving about, wanting to be cooler, getting out of bed, to me. They are all signs of decreased oxygen. (RN #1) did not notify me of a change in her (Patient #7's) condition. Both of us should have called the doctor if we knew about it".
Telephone interview on 10/01/2014 at 1530 with Nurse Practitioner #1 revealed he works with the hospitalist service and he remembered Patient #7. Interview revealed, "I got a call from a nurse around midnight (05/10/2014) about (Patient #7) being agitated, impulsive and attempting to get out of bed. I went to see her. She was anxious, trying to get out of bed, wanting to go to the bathroom. She was alert but was fixated on going to the bathroom. A restraint was ordered to keep her in the bed and to keep the monitor (cardiac) on. I initially ordered ABGs (arterial blood gases) but after I went to see her, I didn't see a need. Her chest sounded ok". Interview further revealed, "I expected her to be reconnected to the cardiac monitor. The nurse didn't call me saying it was not reconnected. The nurse didn't call me to let me know her O2 sats (saturation) were dropping. I expected oxygen to be on, too". Further interview revealed, "I expected the nurse to call me if her (Patient #7) condition changed. I did not get a call from the nurse".
Interview on 10/01/2014 at 1005 with Care Partner (CP) #1 revealed the CP was a Nursing Assistant II and was assigned to Patient #7 on 05/09/2014 beginning at 2300 until 05/10/2014 at 0700. Interview revealed, "when I arrived to her room, she was on the floor saying she was hot. She wanted to sleep on the floor. She had taken her (cardiac) leads and her gown off. There were 5 or 6 people in the room with her. I got back to her room around 11:30 to take her vitals. I wasn't able to get them because she was flailing her arms, saying she was hot. I put her back to bed and her skin was cool. I told the nurse (RN #1) and she gave her some Ativan. She (Patient #7) slid out of bed. Her mother was right beside her but her mother couldn't keep her in the bed. She was little and she could slide between the rails. The nurse put her in restraints. She continued to be agitated, even in restraints. She didn't have the pulse ox (oximeter) or the cardiac monitor on after she was restrained. (RN #1) said she wasn't going to put them back on because she had already put 4 sets on her. About 4:30 (am) she calmed down. About 5:45, her mother left the room. She had slid down in the bed so I went to get another Care Partner to help me pull her up. When I got back, her head was turned to the side and I couldn't get her to respond. Her nurse was in the next room. I notified her. A Code was called".
Interview on 10/01/2014 at 0850 with RN #2 revealed the RN was a member of the Emergency Response Team and responded to the Code Blue for Patient #7 on 05/10/2014 around 0600. Interview revealed, "CPR (Cardio-Pulmonary Resuscitation) was in progress, chest compressions were being done and the patient was being bagged without an artificial airway. She was not on the cardiac monitor. She had on a Posey vest. I cut it off. I put the pads (defibrillator) on and she was asystole (no cardiac electrical activity). She was getting ACLS (Advanced Cardiac Life Support) meds (medications) and got a rhythm back without shocking (the heart)". Interview further revealed, "I read the record after she was transported to MICU (medical intensive care unit). She had been showing signs of hypoxia all night - agitated, restless, picking at self, pulling out her Foley (urinary catheter), taking the leads (cardiac) off". Further interview revealed, "Once she was restrained, she should have been hooked back up to the cardiac monitor. I rounded on the unit prior to the event, sometime after midnight, and nobody mentioned this patient to me". Interview further revealed, "I went to the monitor tech room the next night to look at her rhythm and vital signs before the event and there was a lot of missing data". Interview confirmed that the nursing staff caring for Patient #7 on 05/10/2014 failed to evaluate and supervise the care of Patient #7.
Telephone interview on 10/01/2014 at 1630 with Care Partner #2 revealed she remembered Patient #7. Interview revealed, "she was in a lot of pain. I was her Care Partner on 05/09/2014 from 7 o'clock (pm) until 11 o'clock (pm). She wasn't herself. She was up and down, out of bed, fidgeting, agitated and uncomfortable. She told me she was having trouble breathing. She had oxygen but she wouldn't wear it. I put it back on. I can only give her 2 liters of oxygen. I told the nurse (RN #1) she was having trouble breathing. (RN #1) didn't listen to what I was saying. I told the Charge Nurse (RN #3) that she was having trouble breathing". Interview revealed, "she should have been transferred off that floor the first four hours I was there. Something wasn't right".
Consequently, Patient #7 exhibited signs and symptoms of hypoxia (agitation, restlessness, hot, climbing out of bed, difficulty breathing) with oxygen desaturation and was restrained by RN #1 with a vest and upper soft limb restraints in order to reconnect the cardiac monitor and RN #1 did not follow the physician's order for cardiac monitoring, did not reassess the patient's vital signs and did not notify the physician of a change in the patient's condition. Subsequently, Patient #7 was found by a nursing assistant to be unresponsive and in cardiac arrest, suffered global hypoxic ischemic brain injury and died on 05/10/2014 at 1302.
NC00100627