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Based on interview and record review, the hospital's process improvement program (PIP) failed to identify quality of care concerns regarding proper assessment during patient monitoring by Behavioral Health Associate (BHA), not following the CDC guidelines in the use of Nicotine gum, and inaccurate documentation of medication compliance. This failure resulted in a missed opportunity to improve care and or ensure patient safety.

Findings:

Patient 4 had a physician's order, dated 9/17/24, to observe the patient every 15 minutes for suicide risk. Review of Patient's Behavioral Health - Monitoring Sheet from 9/29/24 at midnight to 10/5/25 at 9:45 a.m. were complete except for five entries. There was multiple coding of AS indicating the patient appeared to be asleep with chest rising/falling.

During an interview on 10/29/24 at 9:19 a.m., BHA F stated he observed the chest fluttering.

During an interview on 11/1/24 at 12:05 p.m., the BHA F stated on the morning of 10/5/24, he checked on Patient 4 multiple times, called his name and he did not respond. BHA F stated he had training for patient monitoring but did not remember what was discussed.

During an interview and viewing of the hospital's mandatory healthstream (web based learning management platform) video on 11/1/24 at 2:13 p.m., indicated observe for the rise and fall of the chest if patient sleeping but it did not offer further guidance on what to do if breathing was not detected.

During the concurrent interview with BHA G, he stated he was to train and educate staff, the snoring or fluttering chest movements was not considered breathing and it was "common sense" for behavioral health assistants (BHAs) to report to nurses for guidance when questions arose. BHA G also stated the training documentation addressing what staff should have done when patients' rise and fall of chest was not observed during sleep was requested and not provided.

Review of the August 2024 PIP documentation addressing patient monitoring indicated there was daily oversight of the monitoring system reported by Nursing Oversite, re-education were completed as needed and there was 99% compliance. The documentation did not identify whether staff were correctly observing patients or if the training material contain sufficient information to enable staff to conduct accurate assessments.

During an interview on 11/1/24 at 5:15 p.m., the Director of Quality Compliance (DOQC) stated the hospital adopted a new system (proximity based monitoring system consisting of a band applied to patients and connected to a tablet) to assist staff to monitor patient whereabout, activity/behavior, and when the next observation was due. The system did not detect human signs of life such as pulse and respiration. The DOQC stated during daily rounds staff randomly watch BHAs monitor patients but did not follow them into rooms when assessing for sleep and there was no audit tool. The DC stated the hospital did not measure the quality of rounds which is a "human factor" and acknowledged the performance improvement project was insufficient.

During an interview on 10/28/24 at 2:55 p.m., the Pharmacy Director (PD) stated the hospital followed the Centers for Disease Control and Prevention(CDC, the nation's leading science-based, data-driven service organization designed to protect public health) guidance for the use of nicotine gum.

According to cdc.gov under nicotine gum, it was indicated nicotine gum was not used like ordinary chewing gum. It instructed to chew it a few times, "park" it between cheek and gums, hold it for about a minute and repeat the chew and park process until the tingling stops (usually about 30 minutes).

Review of 11 of 11 sampled patients who were prescribed nicotine gum (Patient 31, 35, 36, 37, 38, 39, 40, 41, 42, 43, and 44), the physician's order did not follow the CDC guidelines.

During the same interview on 11/1/24 at 5:30 p.m., the DOQC stated the PIP committee did not identify the problem of nicotine gum orders not following CDC guidelines and will address this in the next meeting.

Review of Patient 4's record indicated he was admitted with diagnoses including high blood pressure, history of CABG (coronary artery bypass graft, a major surgery to improve blood flow to the heart) and chronic viral infection. On 9/14/24, 9/15/23, 9/16/24 and 9/24/24, the record indicated Patient 4 refused medications for his heart condition and infection. Nursing notes on those days did not consistently indicate the patient was noncompliant with taking medications and did not notify the physician.

During an interview on 11/1/24 at 5:39 p.m., the DOQC stated the PIP committee did not identify the concern of staff not communicating patient refusal of medications to other nurses and physician.

Review of the Process Improvement Program policy, dated 01/2024, indicated the hospital was dedicated to providing measurement-based, quality of care and services for all patients in a safe, clean and therapeutic environment. The Program emphasized ongoing assessment of performance, including surveillance of health care delivery.

Based on interview and record review, the facility failed to comply with the Conditions of Participation for Nursing Services as evidenced by:

1. Failure to supervise and evaluate the care for one of 26 sampled patients (Patient 4) when the Registered Nurse did not assess the patient's health status and supervise Behavioral Health Associate (BHA) (Refer to A-395).

2. Failure to ensure behavioral health associates (BHAs) received sufficient training to competently assess to determine patients were breathing while asleep for three of five BHA interviews (Refer to A-397).

3. Failure to ensure policies and procedures were followed regarding properly documenting medication refusal, physician noltification, carry-out physician order and patient code blue resuscitation (act of reviving a person from apparent death) for one of one sampled patient (Patient 1). (Refer to A-398).

4. Failure to ensure medications were administered in accordance with the hospital's policy and procedures, or per manufacturer's guidelines, or Centers for Disease Control (CDC) guidelines for 11 of 11 sampled patients (Patient 31, 35, 36, 37, 38, 39, 40, 41, 42, 43 and 44). (Refer to A-405)

The cumulative effects of these systemic problems resulted in the facility's inability to ensure the provision of quality care in a safe environment.

Based on interview and record review, the hospital failed to ensure implementation of safe standards of practice when the Registered Nurse did not assess and evaluate the physical condition of one of 26 sampled patients, and supervise patient monitoring by Behavior Health Associate (BHA).

This failure had the potential to affect patient's health and safety at risk.

Findings:

During a review of Patient 4's facesheet, indicated Patient 4 was admitted to the hospital on 9/13/24 at 11:57 a.m. The "Admission Form" indicated Patient 4 had an admitting diagnosis of unspecified psychosis (a mental disorder characterized by a disconnection from reality) not due to a substance or known physiologic condition.

During a review of Patient 4's "Incident Report Form", dated 10/5/24, the "Incident Report Form" indicated at approximately 9:40 a.m., patient was found by medication nurse unresponsive. Code Blue was called several times. CPR (Cardiopulmonary Resuscitation, emergency procedure consisting of chest compressions often combined with artificial ventilation, or mouth to mouth in an effort to save a life) initiated at approximately 9:40 a.m.. At approximately 9:48 a.m., patient was still unresponsive. At 9:40 a.m., no shock advised. At approximately 9:50 a.m., EMT (Emergency Medical Technicians) arrived and told to stop CPR and took over. Per EMT, "patient looks like he passed away overnight".

During an interview with Registered Nurse (RN) A, on 10/25/24, at 10:03 a.m., RN A was assigned as the Medication Nurse on 10/5/24 dayshift for Patient 4. RN A entered Patient 4's room around 9:40 a.m., called out his name but did not respond. RN A then shook Patient 4 and he felt cold. RN A then checked Patient 4's pulse but no pulse and not breathing. RN A stated he initiated CPR.

During an interview with RN M, on 10/25/24 at 10:12 a.m., RN M worked night shift on 10/4/24 from 11:00 p.m. to 7:30 a.m.. RN M stated she saw Patient 4 at the beginning of the shift asleep. RN M stated she did not go into Patient 4's room for the rest of the shift. RN M stated nurses don't go into the patient's room to check if the patient is breathing.

During an interview with RN B, on 10/25/24, at 10:31 a.m., RN B was working day shift as the charge nurse on 10/5/24 and her shift start at 7:00 a.m.. RN B stated she did not go inside to check Patient 4 until the medication nurse informed her that Patient 4 was not responsive around 9:40 a.m. RN B stated she was supposed to go inside and check their patients at the beginning of the shift. RN B stated she did not do assessment on Patient 4.

During an interview with Behavior Health Associate (BHA) C, on 10/25/24 at 11:08 a.m., BHA C was working night shift from 11:00 p.m. to 7:30 a.m. on 10/4/24. BHA C stated he was told to check for the rise and fall of chest when the patient is sleeping. BHA C stated Patient 4's room was dark, and no light and BHA C went up to the foot of the bed and listen to Patient 4 snoring. BHA C stated he did not see the rise and fall of Patient 4's chest. BHA C stated if Patient 4 was not snoring, he would get up to the side of the patient's bed to check the rise and fall of the chest. BHA C stated he will check the physical condition like skin color if the light was on.

During an interview with BHA D, on 10/25/24 at 11:52 a.m., BHA D stated he was working night shift on 10/4/24. BHA D stated during monitoring, he would listen for snoring and see the moving of chest up and down if patient is sleeping. BHA D stated Patient 4 was asleep with no light in the room, and he did not use flashlight when he went into the room because he did not think using a flashlight in the room was a necessity at that time. BHA D stated he listened for snoring, but he could not tell if Patient 4 was snoring because the roommate was snoring extremely loud.

During an interview with Registered Nurse (RN) H, on 10/28/24 at 10:55 a.m., RN H stated based on P&P, RN should have check the Patient 4 during rounds at the beginning of the shift to make sure the patients are breathing.

During an interview with Chief Nursing Officer (CNO), on 10/28/24, at 3:03 PM, CNO stated after shift report the RN should have visual check on their patients.

During an interview with BHA E, on 10/29/24 at 9:19 a.m., BHA E stated he went to Patient 4's room and saw the back of the patient and documented it as sleeping. BHA E saw a movement on Patient 4's chest and described it as a subtle flutter. BHA E stated Patient 4 was not snoring and he did not try to wake up Patient 4.

During an interview with Nursing Supervisor (NS), on 11/1/24 at 11:00 a.m., NS stated BHA were told to call the patient's name if they can't see the chest rising and they are sleeping. NS stated BHA were instructed to wake up the patient even if they have blanket over them.

During an interview with BHA F, on 11/1/24 at 12:05 p.m., BHA F stated he worked dayshift on 10/5/24 and during rounds Patient 4 has a blanket over him, called Patient 4's name but he didn't respond. BHA F stated if you don't see the respirations, to wake them up or move the blanket. BHA F stated he did not move Patient 4's blanket when he did not see the respirations.

During an interview with BHA G, on 11/1/24 at 2:13 p.m., BHA G stated he trained the BHA and uses a module in Healthstream to train, which indicated "If this check had occurred during sleeping hours, the proper procedure was to ensure that the patient's head is not covered with blankets and observe 3 full breaths before continuing with your rounds." BHA G stated its common sense to investigate more if there was no chest rising. BHA G stated BHA should see the rise and fall of the chest and not just hear the patient snoring.

During a review of the facility's policy and procedure (P&P), titled "Assessment/Reassessment", dated 3/2016, the P&P indicated "Reassessments are completed by the Registered Nurse on day and evening shifts and documented ...Each patient is reassessed as necessary based on the patient's plan for care or change in their condition ..."

During a review of the facility's P&P, titled "Observations, Patient", revised date 4/23, indicated "During the rounds staff are to observe sleeping patients close enough to confirm they are breathing and not in any physical distress ..."

Based on staff interview and record review the hospital failed to ensure behavioral health associates (BHAs) received sufficient training to competently assess to determine patients were breathing while asleep for three of five BHA interviews. This failure led to inaccurate assessments of patient status for Patient 4 who was monitored every 15 minutes for suicide risk and found unresponsive.


Findings:

During an interview on 11/1/24 at 2:36 p.m., registered nurse (RN) B stated when she was performing artificial ventilation for Patient 4 on the morning of 10/5/24 around 9:40 a.m, the patient's arms and leg were cold and rigid. When the emergency medical service team arrived, hospital staff were instructed to stop resuscitation (act of reviving a person from apparent death) because the patient passed away overnight.

Patient 4 had a physician's order dated 9/15/24 to observe the patient every 15 minutes for suicide risk. Review of Patient's Behavioral Health - Monitoring Sheet, dated 10/4/24 at 10:45 p.m. to 10/5/24 6:45 a.m. and 10/5/24 on 7:30 a.m. to 8:15 a.m., was coded AS, indicating the patient appeared to be sleeping with chest rising/falling. On 10/5/24 from 9 a.m. to 9:30 a.m. the same sheet indicated Patient 4 was calm.

During an interview on 10/29/24 at 9:19 a.m., BHA E stated he saw Patient 4's chest fluttering.

During an interview on 11/1/24 at 12:05 p.m., the BHA F stated on 10/5/24 he was assigned to take patient vital signs (temperature, pulse, respiration rate and blood pressure), pass meal trays, and on other days he had assignments to monitor patients. The BHA stated on the morning of 10/5/24, he checked on Patient 4 multiple times, called his name and the patient did not respond. The BHA stated he had orientation training for patient monitoring but did not remember what was discussed.

During viewing of the hospital's mandatory healthstream (web based learning management platform) video on 11/1/24 at 2:13 p.m., it was indicated when performing checks when patients were sleeping was to ensure patient's head was not covered and observe for three full breaths. The video did not offer further guidance on what to do if breathing was not detected.

During the review of the video the BHA G, whose duty included training and orienting staff stated it was mandatory inservice training upon hire for all care staff to view the healthstream for patient observation. The BHA G stated snoring or fluttering chest movements was not confirmation for breathing and it was "common sense" for BHAs to report to nurses for guidance. The BHA G also stated during orientation BHAs in addition to one week orientation had one to one training with an experienced staff for at least five days and there was no written instructions indicating what to do if patient breathing was not observed.

Review of the Training and Development policy, dated 9/1/15, indicated the hospital provided orientation, on-going training, in-service training and other educational training and development opportunities to increase staff knowledge and maintain compliance with regulatory requirements.

Based on interview and record review the hospital failed to ensure policies and procedures were followed regarding properly documenting medication refusal and physician notification, vital signs not taken as ordered by the physician and patient code blue resuscitation (act of reviving a person from apparent death) for one of one sampled patient (Patient 4). This failure resulted in inaccurate documentation of medical record.

Findings:

1. During a review of Patient 4's "Admissions Form", dated 9/13/24, indicated the facility's staff admitted Patient 4, to the hospital on 9/13/24 at 11:57 a.m.. The "Admission Form" indicated Patient 4 had an admitting diagnosis of unspecified psychosis (a mental disorder characterized by a disconnection from reality) not due to a substance or known physiologic condition.

During a review of Patient 4's "Physician Orders", dated 9/13/24, included an order that indicated, " vital signs twice a day".

During a concurrent interview and record review, with the Director of Quality Compliance (DOQC), on 10/24/24 at 12:52 p.m., she reviewed Patient 4's vital signs record. The DOQC stated the vital signs on Patient 4 was not taken on 10/5/24.

During an interview with Registered Nurse H, on 10/28/24 at 10:55 a.m., RN H stated vital signs are taken after the nurse shift report. RN H stated the BHA takes the vital signs.

During an interview with Chief Nursing Officer (CNO), on 10/28/24 at 3:03 p.m., CNO stated vital signs are taken at the beginning of the shift by the BHA.

During an interview with BHA F, on 11/1/24 at 12:05 p.m., BHA F stated he did not take Patient 4's vital signs because he thought patient was in deep sleep.

During an interview with RN B, on 11/1/24 at 2:26 p.m., RN B stated she saw the BHA doing rounds for vital signs but did not ask if the Behavioral Health Associate (BHA) took Patient 4's vital signs.

During a review of the facility's policy and procedure (P&P), titled "Vital Signs and Weights", dated 3/2016, the P&P indicated "vital signs will be taken at the time of admission, as ordered by the practitioner and no less frequently than twice a day."

During a review of Patient 4's Medication Administration Record (MAR), on 10/25/24, indicated Patient 4 refused to take his medications Raltegravir (to treat virus), Atorvastatin (to treat high cholesterol), Metoprolol (Lopressor, to treat high blood pressure), Biktarvy (to treat infection), Aspirin (to treat pain), Gabapentin (to treat anxiety), Clonazepam (Klonopin, to treat anxiety), and Sertraline (Zoloft, to treat depression) on 9/14/24, 9/15/24, 9/1/24, and 9/29/24.

During a review of Patient 4's Medical Consultation Report Form, dated 9/20/24, indicated medical diagnoses including Coronary Artery Disease (CAD, buildup of plaque causing narrowing of coronary arteries), Hypertension (high blood pressure), Hyperlipidemia (high cholesterol in the blood), HIV (Human Immunodeficiency Virus that attacks the body's immune system), History of CABG (Coronary Artery Bypass Grafting, surgical procedure that improves blood flow to the heart).

During an interview with CNO, on 10/29/24 at 10:09 am, CNO stated RN are required to notify the physician if patient refused medication.

During an interview with Medical Doctor (MD), on 10/31/24 at 11:07 a.m., MD stated he does not recall being informed that Patient 4 has refused his medications.

During a concurrent interview and record review with RN I, on 10/31/24 at 12:46 p.m., RN I verified that she documented in the nursing note that Patient 4 was compliant with all his medications and did not indicate if MD was notified on 9/15/24. RN I verified that Patient 4's medications were not given as documented in the MAR.

During a concurrent interview and record review with RN J, on 10/31/24 at 1:03 p.m., RN J verified that she documented in the nursing note, dated 9/16/24, that Patient 4 was compliant with all his medications and did not notify the MD. RN J verified that patient 4's medications were not given as documented in the MAR. RN J stated she did not update the nursing note.

During a concurrent interview and record review with RN K, on 10/31/24 at 3:34 p.m., RN K verified that he documented in the nursing note, dated 9/29/24, that Patient 4 was compliant with all his medications and did not notify the MD. RN K verified that Patient 4's medications were not given as documented in the MAR. RN K stated his documentation must have been based on the information the day before. RN K stated he would have charted differently if he knew that the patient refused his cardiac medications.

During a concurrent interview and record review with RN L, on 10/31/24 at 3:33 p.m., RN L verified that she documented in the nursing note, dated 9/14/24, that Patient 4 was compliant with all medications and MD not notified. RN L verified that Patient 4's medications were not given on 9/14/24 as documented in the MAR. RN L stated she would update the nursing note if she was informed by the medication nurse that the patient refused his medications and notify the MD.

During a review of the facility's P&P, titled "Medication Administration", dated 3/2016,, the P&P indicated "Document all refused drugs on the patient's MAR. Notification of the practitioner is also to be documented in the progress note."

During a review of the facility's P&P, titled "Documentation Protocol", dated 1/24, the P&P indicated "Facility records, reports, charts and documentation are to be accurate, truthful, timely, and complete."


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2. During an interview on 11/1/24 at 11:40 a.m., registered nurse (RN) A stated on the morning of 10/5/24 when he approached Patient 4 to pass medications the patient was in his bed, cold, stiff and did not have a pulse.

Review of Patient 4's Progress Note, dated 10/5/24 at 10:48 a.m. indicated the patient was found unresponsive at 9:40 a.m. and resuscitation (act of reviving a person from apparent death) was started. It did not indicate patient condition other than unresponsiveness, his location, what staff were present and what role they were serving and how the patient left the hospital.

During an interview on 11/1/24 at 10:11 a.m., the chief nursing officer (CNO) stated during code blue (person having life threatening medical emergency) situation one nurse was to perform chest compression, another nurse was to place a rebreathing mask (device used to deliver oxygen to a person), and another staff was to call for help. The code blue documentation was to include how many cycles of chest compressions were performed and list of staff providing intervention.

Review of Patient 4's completed Code Blue Evaluation form, dated 10/5/24 did not include to evaluate for completeness of documentation.

Review of the Code Blue Response - Medical Emergency/Cardiac Arrest policy, dated 01/2017, indicated to document in patient's medical record patient assessment of condition, place found, what was done by staff, patient response to what was done, when and what condition the patient left the facility.

Based on interview and record review, the hospital failed to ensure medications were administered in accordance with the hospital's policy and procedures, or per manufacturer's guidelines, or Centers for Disease Control (CDC) guidelines for 11 of 11 sampled patients (Patient 31, 35, 36, 37, 38, 39, 40, 41, 42, 43 and 44) when:
1. Patient 31 shared the nicotine gum to another patient (Patient 1);
2. Manufacturer's and CDC guidelines were not followed.

This failure had the potential to affect the patients' health and safety.

Findings:

1. During a review of Patient 31's "Admission Form", indicated the facility's staff admitted Patient 31 to the hospital on 6/29/24 at 3:25 pm, with an admitting diagnosis of major depressive disorder (a mental health disorder characterized by persistently depressed mood or loss of interest in activities).

During a review of Patient 31's "Physician Orders", dated 6/29/24, included an order that indicated Nicotine Polacrilex (Nicotine Gum) 2 milligrams (mg, unit of measurement) orally every three hours PRN (as needed).

During a review of Patient 1's "Admission Form", indicated the facility's staff admitted Patient 1 to the hospital on 6/27/24 at 2:21 pm, with an admitting diagnosis of major depressive disorder.

During a review of Patient 31's Omnicell (automated machine for dispensing drugs) transactions report, dated 10/30/24, indicated Nicotine gum was dispensed on 6/30/24 at 8:00 pm.

During a review of Patient 1's "Progress Note", dated 6/30/24, indicated "At 2000 patient was seen in the hallway with another peer. Both redirected to be more visible. Approximately 5 minutes later patient was seen chewing gum. When asked about it, patient spit the gum out and gave it to staff. It was the nicotine gum that was given to another peer."

During a review of Patient 1's "Medication Consent", dated 6/28/24, indicated Patient 1's medications included Fluoxetine HCL (Prozac, used to treat depression) and Guanfacine (Tenex, to treat attention deficit hyperactivity disorder).

During a concurrent interview and record review with Director of Quality Compliance (DOQC), on 10/23/24 at 1:50 PM, DOQC stated Patient 1 got the nicotine gum from another patient and was identified as Patient 31.

During an interview with Chief Nursing Officer (CNO), on 10/23/24 at 1:58 pm, CNO stated they do not check later if patient still have the nicotine gum or not.
During an interview with Registered Nurse (RN) N, on 10/23/24 at 2:58 p.m., RN N stated Patient 31 asked for a nicotine gum. RN N stated she saw Patient 31 and Patient 1 in the hallway close together and saw them move hands that seem like they passed something. RN N stated she realized that Patient 1 was chewing and asked to spit out. RN N stated it was the nicotine gum from the other patient.

According to the manufacturer's guidelines for nicotine gum, revised date 10/2020, indicated a drug warning to "keep out of reach of children. Pieces of nicotine gum may have enough nicotine to make children sick."

During a review of the facility's policy and procedure (P&P), titled "Medication Administration", revised date 8/2022, indicated "No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe."


2. During a review of Patient 31, 35, 36, 37, 38, 39, 40, 41, 42, 43 and 44's Physician order for nicotine gum, on 10/25/24, indicated specific instructions for medication administration was not included.

According to the manufacturer's guidelines for nicotine gum, revised date 10/2020, indicated "Chew the gum slowly until it tingles. Then park it between your cheek and gum, When the tingle is gone, begin chewing again, until the tingle returns. Repeat this process until most of the tingle is gone (about 30 minutes). Wrap the used nicotine gum in paper and throw away."

According to CDC guidelines on how to use nicotine gum, dated 9/2023, indicated "To use it correctly, bite down slowly on the gum until you feel a tingling in your mouth. Then "park" the gum between the inside of your cheek and your gums. Hold it for about a minute to let the nicotine absorb into your body. Then repeat this "chew" and "park" process until the tingling stops (usually about 30 minutes), occasionally changing where you "park" the gum in your mouth."

During an interview with Medical Doctor (MD) P, on 10/25/24 at 11:41 a.m., MD P stated he follows the CDC guidelines when prescribing nicotine gum to patients.

During an interview with RN H, on 10/28/24 at 10:55 a.m., RN H stated she told the patient to chew the nicotine gum for two hours.

During an interview with RN Q, on 10/28/24 at 11:43 a.m., RN Q stated she tell the patient to give the nicotine gum to the nurse once they are done chewing. RN Q stated she does not tell the patient how long they will chew the nicotine gum.

During an interview with RN R, on 10/28/24 at 2:10 p.m., RN R stated she will let the patient chew the nicotine gum until they are done. RN R stated she would not chase the patient for a piece of gum just to check if they still have the nicotine gum in their mouth.

During an interview with the Pharmacy Director (PD), on 10/28/24 at 2:55 p.m., the PD stated there is no specific instructions on how to administer the nicotine gum in the medication order. The PD stated the facility follows the CDC guidelines. The PD stated, "I assumed the nurses know how to administer nicotine gum".