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Based on record review and interview, the hospital failed to maintain and demonstrate evidence of its Quality Assurance Performance Improvement (QAPI) program for surveyor review. The hospital failed to provide the requested information to determine QAPI compliance with the Condition of Participation claiming it was protected Safety Work Product under the Federal Patient and Quality Improvement ACT.

The findings including

1. The hospital failed to provide requested evidence of its QAPI program, data collection for indicators requested, monitoring of interventions and activities and their evaluation of their QAPI process for surveyor review.
Refer to A273, A392 and A405.

Based on record review and interview, the hospital failed to ensure evidence was provided to the surveyor to ensure action plans following the incident on 6/16/18 had been implemented, and sustained; and the QAPI program collected and evaluated data as specified and provided evidence of monitoring action plans for 1 of 1 (Patients #1) patient incidents reviewed.

The findings included:

1. According to the Quality Assessment Performance Improvement (QAPI) plan submitted by email by the Risk Manager on 4/10/19 the plan documented the success of the actions implemented was monitored by absence of similar events. The Risk manager did not provide evidence that QAPI had developed this incident as a quality indicator or evidence of improvement or absence of further incidents of this nature.

The plan documented data was collected by chart audits on a rotating schedule for departments. The Risk Manager did not provide evidence that the data was actually collected in the manner and frequency specified.

2. The QAPI plan documented meetings were held in June 2018 with the Chief Nursing Officer (CNO) and unit managers. The Risk manager did not provide evidence that the hospital instituted interventions through activities or projects to ensure improvement or absence of further incidents of this nature.

3. The QAPI plan documented open chart audits were being completed. The Risk manager did not provide evidence of how many chart audits were being completed, who was completing the audits and the time frame for these audits. The Risk Manager did not provide evidence of data analysis and if there were any areas needing improvement and evidence the hospital instituted interventions such as activities and/or projects to address them.

4. The Risk Manager did not provide evidence of tracking and trending and that an evaluation of any processes put in place were being evaluated over time to ensure patient safety and improved quality of care. The Risk Manager did not provide evidence that its improvement activities focused on areas that were high risk, high volume, or problem-prone.

5. The hospital failed to maintain and demonstrate evidence and document reviewed improvement actions of its QAPI plan related to nursing services for Patient #1.

6. On 4/1/19 at 4:20 PM the Risk Manager was asked for QAPI action plan summary related to the incident with Patient #1 stated," ... what I have is Peer review ..."

On 4/9/19 at 8:10 AM when asked by the surveyor for evidence of QA review related to incidents of this nature that occurred with Patient #1 the Risk Manager stated, ' ...I can share the agenda ...QAPI meets every other month and findings are reported to the MEC [medical executive committee]. This case had already been discussed and MEC was aware of the nursing pieces ...QAPI we talk about opportunities to improve care ...". The Risk Manager failed to provide evidence related to QAPI review, data collection, data review and action plans for quality improvements.

Refer to A392 and A405.

Based on policy review, record review and interview, the hospital failed to ensure nursing services were met by ongoing assessments of patient's needs, communication of patient needs to others providing nursing and medical care, and providing nursing staff to meet those needs for 1 of 4 (Patient #1) sampled patients.

The findings included:

1. Review of the Emergency Medical Services (EMS) report revealed Patient #1 was transported by EMS on 6/16/18 at 10:54 and arrived at the hospital's emergency department (ED) at 11:41. The EMS staff documented the patient had a strong pulse but they were unable to obtain a blood pressure times 8 attempts. The EMS personnel documented they did not give the receiving hospital a report that they were in route to the ED because there was no answer at the ED times several attempts.

2. Review of the ED medical record for Patient #1 revealed the 42 year old female arrived by emergency medical services (EMS) to the hospital's ED on 6/16/18 at 11:45 with complaints of chest pain, right arm weakness and shortness of breath (SOB). Registered Nurse (RN) #1 documented an acuity of level of 2. The hospital's 'Triage Assessment of Patients' policy revealed, "...level 2 = Emergent- (Life Threatening)-MD sees in less than 15 minutes...Level 2 Semi Urgent: Patients with major illness/injury who have a very high risk problem that could worsen and become potentially life threatening without immediate intervention..."

At 12:00 PM, ED RN #1 documented the patient complained of pain at a 9 on a scale of 1 - 10 with 10 being the most severe, right arm radiating pain, SOB and weakness. The patient's pulse oximetry was 74% (pulse ox - measures the function of the heart and lungs and gives a percentage (%) of oxygen in your blood with normal being 95 - 100%), and the patient's blood pressure was low at 71/57. ED RN #1 documented the patient, "appears in no apparent distress". This was contradictory to what ED physician #1 documented on 6/16/18 at 12:14 PM, "The patient appears alert, anxious, obese, in obvious distress, moderately distressed, obviously ill".

The ED RN documented he inserted a saline lock in the patient's right antecubital area to collect a blood specimen. At 12:50 PM, the ED RN documented the ED physician was notified of a critical lab result of potassium (K+) of 6.3, normal being 3.5 - 5.5. The ED RN documented the patient required oxygen administration by nasal cannula at 5 - 6 liters a minute. The ED RN documented the patient's BP was low 9 out of 10 readings while in the ED with BP readings between 60/47 - 82/76, with 82/76 being the last reading prior to leaving the ED.

At 2:00 PM, the ED physician wrote an order for the patient to be on a Cardiac diet. At 2:26 PM, the ED RN documented the patient was given a regular diet meal and the patient was given juice.

At 4:14 PM, ED RN #1 documented report was called to floor nurse #1 and the floor nurse was notified the patient had a saline lock intact, was alert & oriented, and obeyed commands. There was no documentation the patient was transferred to the floor with the oxygen on bi-nasal cannula. The ED RN did not notify floor nurse #1 that the patient's BP had been continuous low, the patient had an elevated K+ level, the patient was experiencing SOB requiring 6 liters of oxygen a minute or any other information was not reported to the floor nurse about the patient. The patient left the ED at 16:16.

There was no documentation what time Patient #1 arrived to the floor. There was no documentation of the patient's status while on the floor unit, an assessment of the patient's vital signs or any other form of nursing documentation involving the patient while on the floor unit.

3. In a telephone interview on 4/9/19 at 11:03 AM Licensed Practical Nurse (LPN) #1 stated Patient #1 was in distress upon arrival to the Medical/Surgical floor. The LPN stated, "...When she [Patient #1] got here I could see she was in distress. I told the ED nurse [ED RN #1 who transported the Patient #1 to the medical/surgical floor] not to leave. He assisted me with getting her into the bed. I told him to call respiratory and to get me a Venturi mask [a type of disposal face mask used to deliver a controlled oxygen concentration to a patient]...She was on 6 liters of oxygen by nasal cannula..."
LPN #1 stated she was told during a telephone report by ED RN #1 that Patient #1's O2 saturation was good, labored breathing, vital signs were good better than they had been and had been given Kayexelate for high Potassium.
LPN #1 stated that Patient #1's IV [intravenous catheter] became stuck in the patient's gown and came out when the patient was being cleaned and turned after having a bowel movement.
LPN #1 verified she had not documented Patient #1's status while the patient was on the medical/surgical floor, or performed an assessment of the patient's vital signs.
There was no documentation in the patient's medical record of the time the patient arrived to the medical/surgical floor, or an assessment of the patient's status, vital signs, complaints and any treatment rendered to Patient #1 while she was a patient on the medical/surgical floor.

4. On 6/16/18 at 6:48 PM a Code Blue (an emergency due to the patient had stopped breathing and didn't have a heart rate) was called to Patient #1's room. The Code Blue record documented the patient did not have an IV access in order to administer emergency medications. An emergency intraosseous catheter (a catheter inserted in the patient's bone marrow to allow access to the patient's blood in order to administer fluids and medications) was inserted by the physician in order to administer medications and fluids. The patient was transferred to Intensive Care Unit (ICU) at 7:20 PM and expired following cardiorespiratory arrest 2 times in ICU and pronounced dead at 11:31 PM. The hospital was unable to provide documentation of the patient's 2nd Code Blue that occurred while in the ICU.

5. Review of Cardiologist #1's note revealed the Cardiologist responded to the Code Blue of Patient #1. Cardiologist #1 documented the patient had been managed in the hospital's ED prior to being coded. The Cardiologists documented he had not been made aware the patient had been transferred to a hospital floor unit. There was no documentation the Cardiologist on-call was notified when the patient arrived to the floor unit.

6. In a telephone interview on 4/2/19 at 1:00 PM with Cardiologist #1 when asked did you treat Patient #1 on 6/16/18 Cardiologist #1 stated, "...yes, my contact with [named Patient #1] began with her during the code [Code Blue], code on 1st floor..."
Cardiologist #1 stated he did not know the patient had gone to the medical/surgical floor from the ED.
Cardiologist #1 stated ED Physician #1 had called initially during his evaluation of the patient in the ED stating, "...I was in the cath lab doing a procedure. He told me this patient had shortness of breath, poor renal function, hypotensive and in heart failure, so I thought he needed some help starting some medications so I advised him if he wanted to stabilize the patient, evaluate, so he was apprehensive with starting IV Lasix, so I said do we have an echo on this patient...he said no...I instructed him to obtain a stat echo which he didn't think could be done so I said request a stat echo for whoever is on call for them to come in and do it, get an echo, get us more information about the patient, what is going on and that will guide the therapy we will do. Also this patient should have an IV central line so we can monitor CVP [Central Venous Pressure], monitor factors aide in treatment of the pt. So that was my only contact, my only conversation with [named ED physician #1]. So he told me he was going to call the echo department and try to get the echo and that was while I was in the procedure. I had just finished when that code was called.."
When asked if there was anything you would have changed in the treatment for Patient #1, Cardiologist #1 stated, "...Yes, Yes I think she should have been in the ICU not a regular floor. When coming to find out what happened to the patient, how she felt according to the nurse's testimony when the patient was brought to the floor that she was very anxious, that she couldn't breathe. They thought it was just anxiety and they were going to give her anti-anxiety medications and no she was in heart failure. Maybe she could have been stabilized somewhat in the ED before being moved out plus moving her out she should have been moved to the ICU not the floor and that was what really surprised me. That she was on the floor, so not knowing everything else that happened prior to her coming to the hospital showed this pt was very sick, she was sick already..."
When asked if the patient was on oxygen Cardiologist #1 stated, "...I don't really know. I came in during the code and I think there was a nasal cannula on her but so much happening at the time when I took over the code. We had to bring her out of the bed to the floor. This woman was over 400 pounds so there was no way to do effective chest compressions in the bed. She didn't have a hard board underneath her. It took enormous effort to get this lady out of the bed onto the floor where we could get her on a hard surface and do chest compressions. So during that time we tried to intubate her while doing chest compressions while rest of the staff was trying to get an airway secured..."
When asked if the patient had an IV access Cardiologist #1 stated, "...So they said she had one, IV access, this lady was 5 foot tall and over 400 lbs, she had lots of adipose sites, lot of tissue. They had IV line but in maneuvering, getting her out of bed, the IV line was lost. So when I got there she didn't have access. We had to use IO [intraosseous] access...that was the only way we were able to give her IV medications until I put a central line after initial code..."
When asked if he felt he provided appropriate care for the patient Cardiologist #1 stated, "...yes under the circumstances, yes not aware of the K+ level. I received information about this patient and when the patient was come to this floor. When I talked to the ER doctor [ED Physician #1] I did not have this patient. That the patient was coming to my service first of all I have to accept the patient. He called me that he had a patient so my advice was for him to get more information, lets know what is going on, sounds like the patient is unstable. You know stabilize the patient, you don't send unstabilized patient to the floor...At the point when he decided to send the patient to the floor he didn't call me. After echo he didn't call me to look at it when it's done. After echo was done by the tech [radiology technician] they need to call me, need to notify me to look at it. I don't know when it's done, when it's finished. He did not call me to say the echo was ready, can you come down and take a look. No, I didn't hear anything. He [ED physician #1] did not call me that he was sending the patient to the floor cause I had not officially accepted the patient yet. That pt was not under me but he put the patient under my name and sent the patient to the floor I think that was a poor move, you don't send. You don't send that type of patient, should come to the ICU, at least ICU not floor. I was really upset he had my name on it and I had not officially accepted the patient. Still unhappy about that..."

Based on policy review and interview, the hospital failed to have essential medications on hand for 1 of 1 (Patient #1) patients requiring emergency medications during intubation.

The findings included:

1. Review of the ED medical record for Patient #1 revealed the 42 year old female arrived by emergency medical services (EMS) to the hospital's ED on 6/16/18 at 11:45 with complaints of chest pain, right arm weakness and shortness of breath (SOB).

2. Review of the hospital's Adult Code Cart Contents' policy revised on 6/2018 revealed there were no Anti-anxiety Agents listed on the contents of the emergency cart.

3. Review of the Clinical Documentation Report for Patient #1 revealed the Respiratory Therapist (RT) documented on 6/16/18 at 6:40 PM, "...rapid response followed by Code Blue [an emergency due to the patient had stopped breathing and didn't have a heart rate]...RT intubated [inserted a tube in the trachea in order for ventilation] patient...intubated on first attempt...tube secured via tube holder...patient became responsive and begun to flail and thrash. patient attempting to bite tube in half. sedation called for, (Named physician #3) requested Versed. No Versed available at the time, other Registered Nurse (RN) attempting to transport to Intensive Care Unit swiftly. (Named physician #3) requested to extubate the patient. RT confirmed x 3 with (name of physician at code blue). patient was extubated and placed on Venturi mask [a type of disposal face mask used to deliver a controlled oxygen concentration a patient]...RT then assisted bed transfer to elevator and up to ICU, pt ceased to be responsive and combative. (Named Physician #3) wanted patient intubated again...RT intubated patient on 1st attempt for the 2nd time. code blue lasted until 8:00 PM. pt then placed on ventilator..."

4. In an interview in the conference room on 4/1/19 at 3:31 PM, the Quality Director stated Versed was not kept in the Medication Dispensing System, or the emergency medication cart on the Medical/Surgical floors. The Quality Director stated it was only in the Emergency room, Intensive Care Unit, Cardiac Catheterization Lab, and Operating Room.

In an interview on in the conference room on 4/2/19 at 9:30 AM, Physician #3 stated Patient #1 had a Code Blue while a patient on the Medical/Surgical floor, and the patient had to be intubated. The physician stated the patient responded and became awake and started thrashing, and attempting to pull the ventilation tube out. The physician stated he then ordered for the patient to receive a medication to relax her which was the medication Versed. The physician stated he was told the medication was not available.