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Based on medical record review, hospital policy review, hospital document review, review of incident reports, and staff interview, it was determined the hospital failed to ensure an effective, ongoing, hospital-wide, data-driven QAPI program focused on improved health outcomes. This resulted in the inability of the hospital to monitor the quality of patient care services and safety. Findings include:

1. Refer to A286 as it relates to the failure of the hospital to ensure adverse patient events were analyzed and actions were taken to prevent further incidents.

2. Refer to A843 as it relates to the failure of the hospital to ensure its discharge planning process was reassessed on an on-going basis.

The cumulative effect of these negative systemic practices prevented the hospital from evaluating the care and services it provided.

Based on medical record review, hospital policy review, hospital document review, review of incident reports, and staff interview, it was determined the hospital failed to ensure adverse patient events were identified, analyzed, and actions were taken to prevent further incidents for 1 of 1 patients (Patient #5) who had an adverse event and whose record was reviewed. This resulted in lack of analysis and evaluation of safe patient care and had the potential for unidentified adverse patient events for all patients receiving care at the hospital. Findings include:

A hospital document "Quality, Risk, and Safety Plan," effective 8/14/18, stated "Duty to Report...All health care providers, agents and employees of the facility have an affirmative duty to report events and close calls to the Patient Safety Director, Risk Manager or to his or her designee." "New-hire and ongoing education...Staff education includes information about the need to report close calls and unanticipated adverse events as well as how to report these events." This plan was not followed.

Patient #5 was a 52 year old female who was admitted to the hospital on 7/26/18 with diagnoses including ESLD, cirrhosis, and history of gastrointestinal bleeding. She was a DNR/DNI and expired in the hospital on 7/29/18.

The Mayo Clinic website, accessed 8/16/18, states "Vomiting blood (hematemesis) refers to significant amounts of blood in your vomit. Blood in vomit may be bright red, or it may appear black or dark brown life coffee grounds." "Bleeding in your upper gastrointestinal tract (mouth, esophagus, stomach and upper small intestine) from peptic (stomach or duodenal) ulcers or torn blood vessels is a common cause of vomiting blood." "...truly vomiting blood usually represents something more serious and requires immediate medical attention."

Additionally, the Mayo Clinic website, accessed 8/16/18, states "Normal blood pressure...120/80." "A blood pressure reading lower than 90 millimeters of mercury (mm Hg) for the top number (systolic) or 60 mm Hg for the bottom number (diastolic) is generally considered low blood pressure." "Conditions that can cause low blood pressure...Blood loss. Losing a lot of blood, such as from a major injury or internal bleeding, reduces the amount of blood in your body, leading to a severe drop in blood pressure."

Further, the Mayo Clinic website, accessed 8/16/18, states "A low hemoglobin count is defined as less than...12 grams per deciliter [of blood] for women." "A low hemoglobin count can also be due to blood loss, which can occur because of...Bleeding in your digestive tract..."

The Cleveland Clinic website, accessed 8/16/18, states "Esophageal varices are enlarged or swollen veins that occur on the lining of the esophagus. Varices can be life-threatening if the break open and bleed. They usually occur in people with cirrhosis of the liver."

Patient #5's medical record included the following nursing notes, dated 7/29/18, signed by her RN:

- 2:10 AM: "Blood pressure 70/35...PATIENT HAS BEEN REPORTING BLACK VOMIT. HOWEVER I HAVE YET TO SEE ANYTHING SINCE THE ONE EVENT OF RED BLOODY EMESIS [vomit] LAST NIGHT."

- 3:11 AM: "Blood pressure 70/41."

- 5:18 AM: "Blood pressure 71/34."

- 6:27 AM: "Hgb [hemoglobin] 4.9...order and transfuse [3 units] PRBC as ordered."

Patient #5's medical record included a discharge summary, dated 7/29/18, signed by the physician, which stated "However, during her stay the patient developed sever hematemesis [vomiting blood] likely secondary to esophageal variceal bleed and passed away on 0918 on 7/29/18."

It was not documented if the RN contacted Patient #5's physician regarding her complaint of "black vomit" or her continuous low blood pressures. It could not be determined by the RN's documentation if Patient #5 received her ordered blood, as there was no blood administration forms in her medical record. Due to lack of RN documentation, it was unclear what events transpired on 7/29/18 between 6:27 AM and 9:18 AM.

The Director of Quality, Risk, and Patient Safety was interviewed on 8/14/18, beginning at 1:46 PM, and Patient #5's medical record was reviewed in her presence. She stated the missing blood administration documentation and subsequent death for Patient #5 had not been identified yet and did not warrant an incident/adverse event report. The Director of Quality, Risk, and Patient Safety stated there had not been a mortality review of Patient #5's chart yet. When asked why a mortality review had not been done, she stated the hospital only had one employee who would do the initial mortality reviews and it would take that person up to 30 days to complete. The Director of Quality, Risk, and Patient Safety stated "it takes time and resources and she [the mortality reviewer] has other duties and responsibilities." She stated there was no written policy or procedure for patient mortality reviews to identify potential adverse events in a timely manner. The Director of Quality, Risk, and Patient Safety confirmed Patient #5's RN failed to document physician notification of her complaints and low blood pressure, and blood administration. She confirmed it was unclear whether Patient #5 received her blood transfusion or not.

An incident/adverse event report regarding Patient #5's blood administration was requested from the Director of Quality, Risk, and Patient Safety on 8/14/18. The report provided, dated 8/01/18, referenced the wasting of unused blood for Patient #5 and stated "Blood Administration...Omission."

The RN who cared for Patient #5 during the night shift of 7/29/18 was interviewed by phone on 8/15/18, beginning at 9:02 AM. When asked if he notified Patient #5's physician regarding her complaint of "black vomit" and low blood pressure, he stated he did, but confirmed he did not document this. When asked if he administered the ordered blood for Patient #5, he stated he started a new peripheral IV in Patient #5's left arm and started the blood administration prior to leaving his shift, but confirmed he did not document this.

The Blood Bank Supervisor was interviewed on 8/15/18, beginning at 9:50 AM. When asked if she could locate blood administration documentation for Patient #5, she stated there was none. She stated Patient #5 did not receive her ordered blood and the blood was returned to the hospital laboratory following her death. The Blood Bank Supervisor stated "[name, Registered Medical Laboratory Scientist] told me the RN spiked the unit of blood, but [Patient #5's] IV was occluded. She [Patient #5] got no blood and died while they were trying to get a new IV."

The Clinical Supervisor who was on shift and assisting when Patient #5 expired, and Director of Quality, Risk, and Patient Safety, were interviewed together on 8/15/18, beginning at 10:39 AM. When asked if Patient #5 received her ordered blood, the Clinical Supervisor stated "no." The Clinical Supervisor stated Patient #5 did not have a working IV to administer the ordered blood and expired "hemorrhaging from the mouth." When asked if she completed an adverse event report regarding Patient #5's blood administration complications and death, the Clinical Supervisor stated "it wasn't needed." When asked what her definition of an adverse event was, the Clinical Supervisor stated "something outside the norm." When asked if the situation preceding Patient #5's death was outside normal expected outcomes, the Clinical Supervisor stated "yes" and confirmed an adverse even form should have been completed. When asked how hospital staff were trained on identifying and reporting adverse events, the Director of Quality, Risk, and Patient Safety stated "only during new-hire orientation." When asked how long she had been an employee of the hospital, the Clinical Supervisor stated "20 years."

The Director of Quality, Risk, and Patient Safety was interviewed on 8/15/18, beginning at 10:51 AM. She confirmed the conflicting stories of events preceding Patient #5's death and confirmed an adverse event form should have been completed.

The hospital failed to ensure adverse patient events were identified, analyzed, and actions were taken to prevent further incidents.

Based on review of policies, procedures, medical records, quality documents, and staff and caregiver interviews, it was determined the hospital failed to ensure the hospital's written policies and procedures addressed all the requirements of 42 CFR 482.43(a) - 482.43(e). The hospital also failed to ensure family members were adequately counseled to prepare them for post-hospital care, that lists of home health agencies were provided to patients/caregivers in accordance with hospital policy, that physicians received necessary medical information post-hospitalization, that a process was established to assess/reassess its discharge planning process. These failures interfered with the implementation of discharge planning and had the potential to result in unmet patient needs. Findings include:

1. Surveyors requested policies and procedures related to discharge planning. The hospital policy "Assessment, Patient - Case Managers/Social Workers/Utilization Review," dated 5/04/15, stated "The hospital's policies and procedures must be specified in writing. This is a mandatory requirement of the Conditions of Participation for Hospitals."

Policies did not address all discharge planning requirements. Examples include:

a. Hospital policy did not address the requirements at 482.43(b)6 (A-811) to discuss the results of the discharge planning evaluation with the patient or the patient's representative (and document the communication in the medical record).

b. Hospital policy did not address the requirements at 482.43.(c)(2) (A-819) specifying in the absence of a finding by the hospital that a patient needs a discharge plan, the patient's physician may request a discharge plan, and in such a case, the hospital must develop a discharge plan for the patient.

c. Hospital policy did not address the requirements at 482.43(d) (A-837) as it relates to providing physician offices with necessary medical information post-hospitalization.

d. Hospital policy did not address the requirement at 482.43(e) (A-843) to have a process to reassess its discharge planning process on an on-going basis, including a review of discharge plans.

2. Refer to A-820 as it relates to the failure of the hospital to ensure family members were adequately counseled to prepare them for post-hospital care.

3. Refer to A-823 as it relates to the failure of the hospital to ensure home health agency lists were provided to patients/caregivers in accordance with hospital policy.

4. Refer to A-837 as it relates to the failure of the hospital to ensure a process was established to inform physicians of necessary medical information post-hospitalization.

5. Refer to A-843 as it relates to the failure of the hospital to ensure a process was established to assess/reassess its discharge planning process on an on-going basis as a part of the hospital's QAPI program.

The cumulative effect of these negative facility practices impeded the hospital's ability to provide adequate discharge planning services to patients.

Based on record review, policy review, and staff interview, and caregiver interview, it was determined the hospital failed to ensure family members were adequately counseled to prepare them for post-hospital care for 2 of 5 patients (#1 and #5) whose medical records were reviewed. This resulted in a lack of preparation and involvement of family members for patient discharges and had the potential to result in unmet patient needs. Findings include:

The hospital policy, "Skilled Nursing/Assisted Living Facility Referrals," dated 5/13/16, was reviewed. It stated "The Social Worker/Case Manager will meet with the patient, family/significant others to: a. Prepare the patient, family/significant others emotionally for the patient's transfer to the appropriate level of post-acute care as determined by the physician."

Family members were not counseled appropriately to prepare them for post-hospital care. Examples follow:

1. Patient #1 was an 86 year old female admitted to the hospital on 7/06/18 for delirium in the setting of Alzheimer-type dementia with overlying urinary tract infection. Her daughter was listed on the initial nursing assessment, dated 7/06/18, as her decision-maker and DPOA. At admission, the daughter indicated a preference for a specific ALF after discharge.

PT daily notes for Patient #1, on 7/06/18, 7/07/18, and 7/08/18, included documentation that PT recommended Patient #1 be discharged to a SNF or LTC.

A physician note, dated 7/08/18, documented a plan for discharge to a SNF.

Patient #1 was discharged on 7/09/18 to the ALF with home health services.

Patient #1's DPOA was interviewed by telephone on 8/15/18 at 7:50 AM. The DPOA stated Patient #1's physician explained to her on 7/08/18 (the day prior to Patient #1's discharge) that the Physical Therapist had recommended Patient # 1 be discharged to a SNF or rehabilitation unit due to her condition and he, the physician, agreed with those recommendations and proposed the plan. The DPOA stated she agreed to the plan and was willing to have Patient #1 go to any of 4 or 5 facilities that were presented to her as options. She stated she received a call later letting her know one of the SNFs was not available. She stated she assumed another one would have been arranged. On 7/09/18, the day of Patient #1's discharge, the DPOA arrived at the hospital, expecting to drive Patient #1 to a SNF or rehabilitation unit. Instead, the discharging nurse told her, the DPOA, that Patient #1 was being discharged to the ALF that was initially discussed upon admit. She expressed surprise at hearing this change of plan but she signed the discharge paperwork anyway. She stated she should have protested. She stated no-one contacted her prior to her arrival at the hospital to inform her the plan for discharge had changed or to discuss it with her.

There were no clinical notes to indicate Patient #1's caregiver had been counseled as to the change in discharge plans.

Patient #1's Case Manager was interviewed. She reviewed Patient #1's medical record and stated she had not considered SNFs, otherwise there would have been a Patient Choice Form in the medical record, and there was not. She stated the family expressed an initial interest in the ALF at admission and she did not recall any other plan. She stated there was not a specific process to coordinate with physical therapy regarding the recommendations of the physical therapists.

During an interview on 8/14/18 at 8:20 PM, the Director of Case Management and Social Services stated that if there had been coordination of care it would have been documented in the Case Management notes.

The hospital did not prepare Patient #1's family ahead of time related to the discharge to the ALF after recommendations for SNF placement.



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2. Patient #3 was a 74 year old female who was admitted to the hospital on 7/07/18 with diagnoses including encephalopathy, altered mentation, and DM Type 2. She was discharged to her sister's home with home health services on 7/10/18.

Patient #3's medical record included a case management report, dated 7/09/18, signed by her case manager, which stated "Physicians asked that we discuss ALF placement with family. Message left for sister [name]."

Patient #3's medical record included a case management note, dated 7/09/18, signed by her case manager, which stated "Spoke with patient's sister on the phone regarding ALF planning and anticipated discharge tomorrow with [name of home health agency]."

Patient #3's medical record included a case management note, dated 7/10/18, signed by her case manager, which stated "Discharge orders sent to [name of home health agency]."

Patient #3's medical record included a discharge summary, dated 7/10/18, signed by her physician, which stated "At discharge she'll be sent home with home health care. The patient and her sister have been provided with information on pursuing placement at an assisted living facility."

It was not documented if Patient #3's sister was counseled to prepare her for post-hospital care at home.

The Director of Case Management and Social Services was interviewed on 8/14/18, beginning at 10:05 AM, and Patient #3's medical record was reviewed in her presence. She confirmed counseling for Patient #3's sister to prepare her for post-hospital care at home was not documented.

The hospital failed to ensure Patient #3's sister was counseled to prepare her for post-hospital care at home.

Based on record review, policy review, and staff interview, it was determined the hospital failed to ensure home health agency lists were provided in accordance with hospital policy for 2 of 2 patients (#1 and #3) who were referred to home health services upon discharge. This had the potential to interfere with patient/caregiver understanding of options for home health services. Findings include:

The hospital policy "Discharge Planning and Referrals of Patients to Post-Discharge, dated 5/04/15, was reviewed. It stated "All patients who have orders to arrange post-hospital home health care ... will be presented with the available options. This includes patients who have come from a facility or who have previously had post hospital services in the home. The patient or patient's representative makes a selection and signs the Patient Choice Form. The form is placed in the chart and becomes a permanent part of the medical record." It also stated "Medicare patients must be presented with a list of available providers, even if the physician or patient already has a preference." "The discharge planning documentation must include that the list was provided and the patient was able to choose their provider of care. (Patient Choice Form)."

The hospital did not provide lists of home health options, in accordance with hospital policy, to patients who had a prior relationship with a home health agency. Examples include:

1. Patient #1 was an 86 year old female admitted on 7/06/18 for delirium in the setting of Alzheimer-type dementia with overlying urinary tract infection. Her daughter was listed on the initial nursing assessment, dated 7/06/18, as her decision-maker and DPOA

She was discharged to an ALF with home health services on 7/09/18.

There was no documentation a list of home health agencies had been provided to Patient #1 and her DPOA.

Patient #1's RN Case Manager was interviewed on 8/15/18 at 9:15 AM. She confirmed a list had not been provided and explained that Patient #1 wanted to return to the same home health agency, so a list was not necessary.

A list of home health agencies was not provided to Patient #1 in accordance with hospital policy, which required the list be presented to the patient/caregiver even if the patient had previous services in the home.



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2. Patient #3 was a 74 year old female who was admitted to the hospital on 7/07/18 with diagnoses including encephalopathy, altered mentation, and DM Type 2. She was discharged to her sister's home with home health services on 7/10/18.

Patient #3's medical record included a case management note, dated 7/09/18, signed by her Case Manager, which stated "Spoke with patient's sister on the phone regarding ALF planning and anticipated discharge tomorrow with [name of home health agency]."

Patient #3's medical record included a discharge summary, dated 7/10/18, signed by her physician, which stated "At discharge she'll be sent home with home health care. The patient and her sister have been provided with information on pursuing placement at an assisted living facility."

Patient #3's medical record did not include documentation the hospital presented Patient #3 with a list of home health agencies she could choose from in her geographic area.

The Director of Case Management and Social Services was interviewed on 8/14/18, beginning at 10:05 AM, and Patient #3's medical record was reviewed in her presence. She confirmed Patient #3's discharge plan did not include a list of home health agencies in her geographic area to choose from.

Patient #3's discharge plan did not include a list of home health agencies in her geographic area to choose from.

Patients who had prior relationships with home health agencies were not provided with lists of options in accordance with hospital policy, which required the list be presented to the patient/caregiver even if the patient had previous services in the home.

Based on record review, policy review, and staff interview, it was determined the hospital failed to ensure a process was established to inform physicians of necessary medical information post-hospitalization. This impacted 2 of 2 patients (#3 and #4) who were referred to physicians for office follow-up and whose records were reviewed. This had the potential to result in patients' physicians being unaware of the outcome of hospital treatment or follow-up care needs and negatively impact the quality of follow-up patient care.

Discharge policies were requested for review. Policies addressed the necessity to send necessary medical information when patients were transferred to another inpatient facility, and for discharge to a SNF, ALF, home health agency, and hospice.

However, discharge policies did not address the necessity to send necessary medical information to physician offices on behalf of patients sent home or to an ALF and asked to follow-up with their physicians with appointments post-hospitalization.

Necessary medical information was not sent to physicians. Examples include:

1. Patient #4 was a 62 year old male admitted to the hospital on 7/10/18 related to an unwitnessed seizure and soft tissue trauma. He was transferred to the inpatient rehabilitation unit on 7/13/18. A "Physician Discharge Summary" included instructions for discharge follow up: "He should follow up with his primary care provider in 1-2 weeks for further monitoring of his blood pressure. He should also follow up with urology and I would like to send him referral to [name of urologist] for further evaluation and management of his urinary retention as he is being discharged home with Foley catheter. he should also follow up with neurology in 2-4 weeks for stroke followup [sic] and continued evaluation and management of probable seizure."

There was no documentation to indicate any clinical information was sent to Patient #4's physicians to inform them regarding the hospitalization.

2. Patient #3 was a 74 year old female who was admitted to the hospital on 7/07/18 with diagnoses including encephalopathy, altered mentation, and DM Type 2. She was discharged to her sister's home with home health services on 7/10/18.

Patient #3's medical record included discharge instructions, dated 7/1018, signed by Patient #3, which stated "Primary Care Physician Follow UP...[practitioner name] in 5 - 7 days [name] Gastroenterology in 1 - 2 weeks."

There was no documentation to indicate any clinical information was sent to Patient #3's physicians to inform them regarding the hospitalization.

During an interview on 8/13/18 at 4:10 PM, The Director of Case Management and Social Services stated the hospital did not routinely send information to physicians when patients were sent home. She stated many physicians can access patient information using the electronic portal. When asked if physicians were alerted to patient discharges so they could access the electronic medical record, she stated, not to her knowledge. When asked how physicians accessed information who were out of the area, she stated there was not a process.

During an interview on 8/14/18 at 2:00 PM, a Social Worker for the inpatient Rehabilitation Department, stated the nurses set up appointments for patients for post-hospital care. She stated she was not aware of any information sent to the physician offices. She stated many doctors can see the records electronically.

The hospital failed to ensure a process was established to inform physicians of necessary medical information post-hospitalization.

Based on review of policies and quality data, and staff interview, it was determined the hospital did not have a process to reassess its discharge planning process on an on-going basis, including a review of discharge plans. This interfered with the identification of problem areas that could be addressed for process improvements. Findings include:

Discharge planning policies were requested. None of the policies provided addressed the necessity for the hospital to reassess its discharge planning processes on an ongoing basis.

The Director of Case Management and Social Services was interviewed on 8/13/18 4:10 PM. She stated she was not aware of any process to reassess the discharge planning processes. She stated the hospital monitored readmission rates, but she was not aware of how that information was used.

The Director of Quality, Risk & Patient Safety was interviewed on 8/14/18 at 11:00 AM. She stated Discharge Planning was not a part of the hospital's quality program.

The hospital did not have a policy or process to reassess its discharge planning process on an on-going basis.