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Based on hospital policy review, contract review, education record review, and staff interview it was determined the hospital failed to ensure a comprehensive agreement with an OPO, failed to ensure organ, tissue, and eye donations were requested by a designated requestor, and failed to work with the OPO to educate staff. This resulted in lack of staff understanding of proper procedure to follow at the time of a patient's death, and had the potential to affect the families of all patients who expired at the hospital. Findings include:

Refer to A886, as it relates to the failure of the hospital to incorporate an agreement with an OPO that included determination of medical suitability for tissue and eye donation.

Refer to A889, as it relates to the failure of the hospital to ensure the individual who initiated a request for organ, tissue, or eye donation to the family of a deceased patient was an organ procurement representative or a designated requestor.

Refer to A891, as it relates to the failure of the hospital to work with the designated OPO to educate the hospital staff on organ, tissue and eye donation issues.

The cumulative effects of these systemic deficient practices significantly impeded the ability of the hospital to ensure proper procedures were followed regarding organ, tissue, and eye donation requests.

Based on grievance/complaint log review, hospital policy review, and staff interview, it was determined the hospital failed to provide written grievance resolutions for 3 of 3 complaints not recognized as grievances. This had the potential for incomplete grievance investigations and resolutions to patient/family concerns. Findings include:

A hospital policy "Incident Reporting," revised March 2019, stated, "All complaints not immediately resolved will be considered a Grievance and will be handled as such..." This policy was not followed.

The hospital's "COMPLAINT/GRIEVANCE LOG," from 1/01/19 to 8/21/19 was reviewed. Complainants were not provided with resolutions to their grievances. Examples include:

1. The complaint/grievance log included an incident, undated, which stated, "pt's [patient's] family states the requested [sic] that they be kept informed of the patient's first blood cultures were negative. The pt's spouse states she spoke with [physician] last week and learned that there were negative blood cultures for the patient and when she asked why she hadn't been informed that [physician] was rude to her and gave her an unprofessional response."

The incident included a section titled "Description of Resolution," which stated, "Incident was sent to the CEO for investigation. CEO had a 1 on 1 [sic] conversation with [physician] regarding proper communication and customer service. YTD provider complaint data with education provided to all providers during June's provider meeting."

The incident included an additional section titled "Written Response Required," with an answer of "N [no]." The complainant's issue was not immediately resolved, nor captured as a grievance.

2. The complaint/grievance log included an incident, dated 3/05/19, which stated, "Patient's wife complained that the patient developed a new wound to R [right] flank area as well at [sic] bilateral feet which she states were caused by inaccurate inflation settings on his bed. She also complained that the patient's catheter site was red and that she'd like him to receive a bath daily."

The incident included a section titled "Description of Resolution," which stated, "[name] DQRM met with patient on 3/06/19. The patient does have a DTI to R flank area which looks to have been caused by the hose which fluidizes [sic] the Clinitron Bed [sic]. Pt was seen by [physician] and he states he's never had an issue with the Clinitron bed but does note the pressure from the hose. Hill-Rom specialist [name] called in to change the settings on the bed. order placed for new bed. Clinical specialist [name] will provide in-service for Clinitron treble [sic] shooting. Hill-Rom will provide an RN inservice [sic] the primary care nurse any time they drop off a bed. Upon visualization of the pt's catheters during the meeting the site was not red, the patient's wife states it may have "just been irritated" but that she'd like the clinical staff to pay close attention to the site. All lines are inspected as part of the shift assessment. The patient's bath schedule was changed to qday [every day]."

The incident included an additional section titled "Written Response Required," with an answer of "N [no]." The complainant's issue was not immediately resolved, nor captured as a grievance.

3. The complaint/grievance log included an incident, dated 2/08/19, which stated, "Pt's niece [name] called the House Supervisor phone to complain that after he [sic] aunt passed (previous NOC shift) the House Sup. [name] was rude to her and her mother (the patient's sister). She states that [name] was defending staff members who she feel mismanaged her aunt's pain medications (RN [name] addressed during Grievance in January). She states that her mother got a pair of scissors in an attempt to cut the patient bands from her aunt's wrist and [name] told them she would escort them out if they could not abide by VHB policy. She also states that [name] told them that if they 'continued to be confrontational' that she would escort them out."

The incident included a section titled "Description of Resolution," which stated, "Family was reached out to be [sic] CMO [name] and CEO [name] in an attempt to open a dialogue about the events surround [sic] the actions of staff and the patient's family after her passing on 2/08/19. House Supervisor [name] was interviewed and she states that the family was being loud and disruptive to other patient at 0300 in the morning. She states that the family was confrontational with her and they were attempting to remove items from the patient's body and room prior to the body being released. She states she did tell them she would have them escorted out if they continued to disrupt other patients."

The incident included an additional section titled "Written Response Required," with an answer of "N [no]." The complainant's issue was not immediately resolved, nor captured as a grievance.

The Director of Quality was interviewed on 8/21/19, beginning at 4:09 PM, and the hospital's complaint/grievance log was reviewed in her presence. She confirmed the complaints were not captured as grievances and the complainants did not receive a resolution to their grievances. The Director of Quality confirmed hospital policy was not followed.

Written resolutions of complainants' grievances were not provided.

Based on policy review, medical record review, and staff interview, it was determined the hospital failed to ensure legal representatives were allowed to make informed decisions regarding the care of the patient for 2 of 2 patients (#4 and #22) who were unable to sign consent forms and did not have a responsible party present at the time of admission. This resulted in care provided by the hospital prior to receiving informed consent. Findings include:

The hospital's policy, "Patient Rights and Consents," revised 12/2010 and last reviewed 3/2019, stated, "Upon admission, the Charge RN and/or admitting RN will obtain signatures on the Consent to Treat form from the patient and/or the patient's legal representative...If patient is unable to sign Consent to Treat and the patient's legal representative are [sic] unavailable for signature upon admission, nursing will document three consecutive attempts to obtain signature." This policy was not followed. Examples include:

1. Patient #4 was a 38 year old male admitted to the hospital on 8/03/19 at 1:36 PM, with a primary diagnosis of respiratory failure. He was a current patient at the time of the survey. His record was reviewed.

Patient #4's record included a "CONSENT TO TREAT" form. The form stated, "Patient is unable to sign above because: medical condition." The form stated consent was received from Patient #4's mother by telephone on 8/04/19 at 2:38 PM, 25 hours after his admission to the hospital. Patient #4's record did not include documentation of prior attempts to obtain consent from his mother.

2. Patient #22 was a 73 year old female admitted to the hospital on 7/18/19 at 4:03 PM, with a primary diagnosis of acute kidney injury. She expired on 7/26/19. Her record was reviewed.

Patient #22's record included a "CONSENT TO TREAT" form. The form stated, "Patient is unable to sign above because: medical condition." The form stated consent was received from Patient #22's daughter by telephone on 7/19/19 at 11:10 AM, 19 hours after his admission to the hospital. Patient #22's record did not include documentation of prior attempts to obtain consent from her daughter.

During an interview on 8/26/19 beginning at 2:00 PM, the CCO stated the responsible parties for Patients #4 and #22 were out of town and telephone consent was required. She stated the admitting nurse was responsible for obtaining consent from the responsible party when a patient was unable to sign consent forms. The CCO confirmed attempts to obtain telephone consents for Patients #4 and #22 were not made until the day after admission to the hospital.

The hospital failed to ensure timely consent for admission was obtained from the responsible parties for Patients #4 and #22.

Based on hospital policy review, Idaho Statutes review, grievance log review, and staff interview, it was determined the hospital failed to ensure patients were free from abuse or harassment for 2 of 2 grievances reviewed which documented potential abuse. This had the potential for unsafe conditions for all patients receiving care at the hospital. Findings include:

"IDAHO STATUTES TITLE 39 HEALTH AND SAFETY CHAPTER 53 ADULT ABUSE, NEGLECT AND EXPLOITATION ACT," updated 7/01/18, states "39-5303. Duty to report cases of abuse, neglect or exploitation of vulnerable adults. (1) Any physician, nurse, employee of a public or private health facility, or a state licensed or certified residential facility serving vulnerable adults, medical examiner, dentist, osteopath, optometrist, chiropractor, podiatrist, social worker, police officer, pharmacist, physical therapist, or home care worker who has reasonable cause to believe that a vulnerable adult is being or has been abused, neglected or exploited shall immediately report such information to the commission. Provided however, that nursing facilities defined in section 39-1301(b), Idaho Code, and employees of such facilities shall make reports required under this chapter to the department. When there is reasonable cause to believe that abuse or sexual assault has resulted in death or serious physical injury jeopardizing the life, health or safety of a vulnerable adult, any person required to report under this section shall also report such information within four (4) hours to the appropriate law enforcement agency." This Statute was not followed.

A hospital policy "Abuse and Neglect," revised 7/2019, stated, "Failure to report immediately a suspected abuse incident or cooperate in the appropriate investigation can result in corrective action." This policy was not followed.

The hospital's "COMPLAINT/GRIEVANCE LOG," from 1/01/19 to 8/21/19 was reviewed. Cases of potential patient abuse were not reported to Idaho APS. Examples include:

1. The complaint/grievance log included an incident, dated 2/28/19, which stated, "Pt disclosed to OT [name] that he was physically abuse [sic] by a staff member during a previous hospitalization."

The incident included a section titled "Description of Resolution," which stated, "Pt met with [name], DQRM on 2/28/19. Pt was interviewed and stated he was 'slammed into a wall by a nurse' during a previous hospitalization. He states that the hospital was SIACH then and not VHB. He states he did not report the abuse when it occurred and that he was not injured. He further stated that the nurse currently works for VHB but will not disclose the name of the name despite multiple efforts to obtain it. He states 'we made up and she apologized to me' so he will not disclose the name. The patient states he feels safe at VHB and he is happy with his clinical care. The patient was given direct contact information for the House Supervisor's phone as well as [name] and given instructions to call with any concerns or complaints. The patient states he understands and will contact someone if needed."

It was not documented if the patient's potential physical abuse was reported to APS.

2. The complaint/grievance log included an incident, dated 5/28/19, which stated, "pt's son reports that the pt's room was messy when he arrived and that she was haying [sic] crooked in her bed upon arrival. He also states she tol [sic] him that she was woken up by 2 people hitting her in face at approx. 0530 in the morning."

The incident included a section titled "Description of Resolution," which stated, "Staff members who cared for the patient were immediately interview [sic] and denied hitting the patient or hurting her in any way. They did state that they positioned the patient around the time she alleged someone hit her and that maybe she was startled by them or confused about what was going on." "The patient states she cannot identify who she thinks hit her. She states there was contact around her head with an open hand at aprox [sic] 5:30 am and that it was dark. She states that she could not see who struck her and that the person did not speak to her."

It was not documented if the patient's potential physical abuse was reported to APS.

The Director of Quality was interviewed on 8/21/19, beginning at 4:09 PM, and the hospital's complaint/grievance log was reviewed in her presence. She confirmed it was not documented if the patient's potential physical abuse was reported to APS as mandated by Idaho state law.

The hospital failed to ensure patients were free from potential physical abuse.

Based on record review, policy review, and staff interview, it was determined the facility failed to ensure policies were followed for appropriate monitoring of a patient in medical restraints for 1 of 3 patients (Patient #28) who had restraints ordered and whose records were reviewed. This had the potential to interfere with the hospital's ability to ensure restraints were implemented in a safe and effective manner. Findings include:

The hospital policy "Restraint Use," revised December 2016, stated under the section "RESTRAINTS USE FOR MEDICAL REASONS (MEDICAL RESTRAINT)," "Patient assessment is ongoing throughout the episode of restraint ... Minimally every 2 hours or more frequently if condition warrants." This policy was not followed. Examples include:

Patient #28 was a 76 year old male admitted to the hospital on 11/17/18, for aspiration pneumonia. His record was reviewed.

Patient #28's record included forms titled, "Restraint Order and Flow Record, Medical," dated from 11/23/18 through 12/08/18. The forms stated soft restraints were applied to Patient #28's right and left arms on 11/23/18 at 9:00 PM and discontinued on 12/08/18. The forms also included assessments of Patient #28's safety and needs which exceeded the 2 hour minimum requirement, as follows:

- An RN documented assessments of Patient #28 on 11/23/18, at 11:00 PM and 2:00 AM.

- An RN documented assessments of Patient #28 on 11/27/18, at 5:15 PM and 8:00 PM.

- An RN documented assessments of Patient #28 on 11/29/18, at 12:30 AM and 3:30 AM.

- An RN documented assessments of Patient #28 on 11/30/18, at 1:15 PM and 4:10 PM.

During an interview on 8/26/19 beginning at 11:09 AM, the hospital CCO reviewed Patient #28's record and confirmed the assessments exceeded the 2 hour minimum requirement by hospital policy.

The hospital failed to ensure policies were followed for appropriate monitoring of Patient #28 while he was in medical restraints.

Based on hospital policy review, medical record review, and staff interview, it was determined the facility failed to ensure restraints were discontinued at the earliest possible time for 1 of 3 patients (Patient #20), who were restrained and whose records were reviewed. This resulted in Patient #20 being restrained longer than was necessary to ensure his safety. Findings include:

The hospital's policy "Restraint Use," revised December 2016, stated, "Every attempt is made to remove the patient from restraint as soon as possible. Based on the assessment of patient's behavior/risk, the RN contacts the physician for an order to discontinue restraints. Appropriateness of removal of restraint I [sic] should include an evaluation of the patient's ability to appreciate the potential outcome of his/her behavior and the observation that there has been a reduction of the behavior(s) warranting restraint use."

Patient #20 was a 76 year old male admitted to the hospital on 7/10/19, with a primary diagnosis of abnormal liver function. He was discharged on 7/16/19. His record was reviewed.

Patient #20's record included 3 forms titled "Restraint Order and Flow Record, Medical," dated 7/12/19, 7/13/19, and 7/14/19. The forms stated soft restraints were applied to Patient #20's right and left arms on 7/12/19 at 6:45 PM, and discontinued on 7/14/19 at 7:29 PM.

Patient #20's restraints were not discontinued at the earliest possible time, as evidenced by the following documentation:

- A "Patient Care Note" dated 7/13/19 at 10:13 AM, signed by an RN stated, "Narcan IVP given as ordered due to lack of arrousability [sic]...No significant change noted. Patient still only remains arrousable [sic] for a few seconds with sternal rubs and to pain."

- A "Patient Care Note" dated 7/13/19 at 8:07 PM, signed by an LPN stated, "Patient remains non-arousable...Patient in soft-restraints. Not currently a danger to himself."

- A "Patient Care Note" dated 7/14/19 at 2:06 AM, signed by an LPN stated, "Patient responds only to painful stimuli. Pupils remain fixed and 2mm."

- A "Patient Care Note" dated 7/14/19 at 8:30 AM, signed by an RN stated, "PO medications misdosed due to inability to arrouse. [sic]"

- A "Patient Care Note" dated 7/14/19 at 9:53 AM, signed by an RN stated, "PATIENT ASLEEP"

During an interview on 8/26/19 at 9:40 AM, the CCO reviewed Patient #20's record and confirmed restraints were continued when documentation by nursing staff stated he was unresponsive and not a danger to himself.

The hospital failed to ensure Patient #20's restraints were removed at the earliest possible time.

Based on pre-admission paperwork review, hospital policy review, website review, and staff interview, it was determined the hospital failed to ensure adverse events were identified and analyzed for 1 of 11 pre-admission screenings reviewed. This resulted in lack of identifying adverse events for individuals presenting to the hospital for potential admission. Findings include:

The hospital failed to identify and analyze adverse events. An example includes:

A hospital policy "EMTALA," revised 3/2018, stated "Persons requiring...services outside the scope of those provided by this hospital will be transferred to the nearest emergency room via an emergency transport service. The hospital will provide care treatment within its scope of services to stabilize the condition until appropriate transfer can be arranged. This policy applies to current inpatients, outpatients, visitors, employees and staff of the hospital." This policy was not followed.

A hospital "Pre-Admission Screening," dated 8/16/19, was reviewed. It included a section titled "Primary Acute Hospital Diagnosis" which stated, "ALCOHOL DEPENDENCE." The form also included a section titled "Additional Notes/ Discussion" which stated, "PATIENT IS A 52 YEAR OLD MALE WITH A PAST MEDICAL HISTORY THAT INCLUDES ALCOHOL DEPENDENCE, ANXIETY, DEPRESSION, AND HSV-2 [Herpes simplex virus- type 2]. PATIENT PRESENTED TO THE ED ON 8/14 SEEKING HELP AND STATING THAT HE 'HAS BEEN DRINKING A LOT [sic] AND EATING VERY LITTLE.' PATIENT THEN PRESENTED TO URGENT CARE ON 8/15, CONTINUING TO SEEK HELP WITH ALCOHOL DETOX. PATIENT WAS REFERRED TO VIBRA HOSPITAL TO BE MEDICALLY MONITORED WHILE UNDERGOING ALCOHOL DETOXIFICATION." Additionally, the form included a section titled "Admission Disposition" which stated, "Medical Director Denied."

The Clinical Liaison who completed the pre-admission screening was interviewed on 8/22/19, beginning at 11:56 AM. She stated she did not remember this patient. The Clinical Liaison stated alcohol detoxification was "not a normal diagnosis to take."

The Chief Marketing Officer was interviewed on 8/22/19, beginning at 2:11 PM, and the pre-admission screening completed by the Clinical Liaison was reviewed in her presence. She stated the patient was referred to Vibra by his primary care physician. The Chief Marketing Officer stated 2 local psychiatric hospitals declined the patient admission previously. She stated she informed the CEO of the admission as she was unsure if the hospital would be able to admit him. The Chief Marketing Officer stated the CEO told her the hospital could accept the patient. However, once the patient's condition was relayed to the Medical Director, the Chief Marketing Officer stated the admission was declined.

The Chief Marketing Officer stated that same day, 8/16/19, the patient whose admission was declined, was driven to the hospital by his significant other. She stated the patient's primary care provider called the patient at home and informed him to go to Vibra hospital for admission. The Chief Marketing Officer stated a physician-to-physician conversation regarding the admission did not happen. She stated the patient was "so intoxicated he could not talk." The Chief Marketing Officer stated she informed the patient and his significant other that the admission was declined. She stated she arranged for the patient to be seen at a local acute care hospital ED. The Chief Marketing Officer stated the patient and his significant other left Vibra hospital and headed to the local acute care ED in their personal vehicle.

The Healthline website, accessed 8/28/19, stated:

"What are the symptoms of alcohol intoxication?...

5. Stupor

At this stage, a person no longer responds to the things happening around or to them.

A person won't be able to stand or walk. They may completely pass out or lose control over their bodily functions, becoming incontinent or vomiting uncontrollably.

They may also experience seizures or have blue-tinged or pale skin. Their breathing and gag reflexes will likely be impaired.

This stage can be very dangerous and even fatal if a person chokes on their vomit or becomes critically injured.

Any of these symptoms are signs that immediate medical attention is necessary. At this stage, a person's BAC will range from 0.25 to 0.4 percent.

6. Coma

This stage is extremely dangerous. A person's breathing and blood circulation will be extremely slowed. Their motor responses and gag reflexes are nonfunctional, and their body temperature drops. A person at this stage is at risk of death.

Their BAC will measure in at 0.35 to 0.45 percent. Emergency medical attention is necessary at this point to avoid death and severe health problems.

7. Death

At a BAC of 0.45 percent or above, a person is likely to die from alcohol intoxication."

When asked if the intoxicated patient's clinical presentation was referred to the hospital's medical or nursing staff, the Chief Marketing Officer stated, "no." When asked if the patient was given a basic MSE or assessment to ensure he was safe to leave the property, the Chief Marketing Officer stated, "no." When asked if the patient's significant other was offered EMS transport to the local acute care ED to ensure his safety, the Chief Marketing Officer stated, "no." When asked if she filed an adverse event report regarding the situation, the Chief Marketing Officer stated, "no."

The Director of Quality was interviewed on 8/22/19, beginning at 2:27 PM. She stated the intoxicated patient's arrival to, and departure from, the hospital should have been captured in an incident report.

The Medical Director was interviewed on 8/23/19, beginning at 9:23 AM. When asked if he was familiar with the pre-admission patient and his potential admitting diagnosis, he stated, "yes." The Medical Director stated the hospital did not currently have the protocol and staff training to care for alcohol detoxification patients. When asked if he was aware the patient arrived at the hospital per instructions from his primary care provider, the Medical Director stated, "no." He stated, "I had no idea the patient was on site and was intoxicated; I was not informed." The Medical Director stated the patient should have been medically evaluated and should have been offered EMS for transport to the local acute care hospital ED.

The CEO was interviewed on 8/23/19, beginning at 1:58 PM. He stated he spoke to the Medical Director regarding the pre-admission screening and was informed the hospital could not accept the patient. The CEO stated he had not been aware the hospital could not accept alcohol detoxification patients due to lack of protocol and staff training.

The hospital failed to identify and analyze adverse events for individuals presenting to the hospital for potential admission.

Based on QAPI document review and staff interview, it was determined the Governing Body failed to ensure the hospital's quality program involved all departments. This resulted in the inability of the hospital to evaluate the effectiveness and safety of its radiologic services. Findings include:

The hospital's "2019 PERFORMANCE IMPROVEMENT PLAN" was reviewed. It included a section titled "2019 Departmental Reporting Schedule" which documented all departments of the hospital, including "Radiology." Next to "Radiology" were 12 "X" marks representing each month for 2019. The marks did not elaborate what was being reported, by whom, for what purpose, and what analysis or patient outcomes were extrapolated. It was unclear what was being measured for the hospital's radiology department.

Additionally, the plan included 47 quality indicators being tracked by the hospital, such as patient safety, emergency preparedness, respiratory services, case management, medical record auditing, and employee performance. The plan did not include quality indicators for radiology services. It could not be determined if radiology services were monitored.

The Director of Quality was interviewed on 8/23/19, beginning at 2:19 PM, and the hospital's quality data was reviewed in her presence. She confirmed the hospital's radiology department had not submitted quality data for review or analysis. The Director of Quality confirmed the radiology department was not involved in the hospital's QAPI program.

The Governing Body failed to ensure the hospital's quality program involved all departments.

Based on organizational chart review, observation, and staff interview, it was determined the hospital failed to ensure administrative authority and delineation of responsibilities were documented for all nursing service lines. This had the potential to negatively impact the quality of care provided to patients. Findings include:

A tour of the hospital was conducted in the presence of the Director of Quality on 8/22/19, beginning at 8:44 AM. During the tour, a space labeled "Dialysis Room" was noted. The room included hemodialysis supplies, computers, a crash cart, and 2 hemodialysis machines. The Director of Quality stated hemodialysis treatments were provided by hospital RN's.

The hospital's organizational chart, undated, was reviewed. The chart did not include hemodialysis services. It could not be determined who was responsible for the service line and to whom the hemodialysis RN's reported to.

The VP of Compliance was interviewed on 8/26/19, beginning at 1:45 PM, and the hospital's organizational chart was reviewed in her presence. She confirmed the hospital's hemodialysis service was not included on its organizational chart.

The hospital failed to ensure administrative authority and delineation of responsibilities were documented for hemodialysis services.

Based on review of medical records, and staff interview, it was determined the facility failed to ensure comprehensive POCs were developed for 2 of 28 patients (#1 and #21) whose records were reviewed. This resulted in a lack of direction to staff caring for these patients and had the potential to result in unmet patient needs. Findings include:

1. Patient #1 was a 75 year old male admitted to the hospital on 8/02/19, with a primary diagnosis of stage 3 pressure ulcer on his sacrum. He was a current patient at the time of the survey. His record, including his nursing care plan, was reviewed.

Patient #1's record included a history and physical report, dated 8/02/19, signed by a physician. The report stated he was admitted to the hospital for aggressive treatment of his sacral wound.

Patient #1's record included a consult note, dated 8/04/19, signed by the wound care physician. The note contained a plan which included wound care, and prevention of additional skin breakdown by offloading weight with a low air loss mattress and chair cushion, turning in bed, and keeping the head of his bed less than 30 degrees at all time.

Patient #1's record included a case management admission note, dated 8/05/19, signed by the Case Manager. The note stated he was admitted to the hospital for wound care, IV therapy, physical therapy, and overall management of conditions.

Patient #1's record include a care plan, created on 8/02/19. The care plan included a diagnosis of stage 3 pressure ulcer of sacral region. It included the following problems, with interventions, and objectives:

- decreased self care
- pain management
- safety
- nutrition
- functional mobility deficits

Patient #1's care plan did not include problems, interventions or objectives to address his primary diagnosis of sacral wound, or to prevent further skin breakdown.

During an interview on 8/26/19 at 10:15 AM, the CCO reviewed Patient #1's record and confirmed his care plan did not address his primary diagnosis of sacral wound or prevention of further skin breakdown.

The hospital failed to ensure a nursing care plan was developed to address care of Patient #1's wound and prevent additional skin breakdown.

2. Patient #21 was a 47 year old female admitted to the hospital on 7/10/19, with a primary diagnosis of cellulitis of left lower limb. She was discharged on 7/20/19. Her record was reviewed.

Patient #21's record included progress notes, signed by the PA, with entries as follows:

- 7/12/19 "She did not sleep well last night."

- 7/14/19 "[Patient] was unable to get comfortable last night and ended up sleeping the reclining chair in her room."

- 7/15/19 "She does not feel she is sleeping well and the melatonin is ineffective...She has nonspecific pain and aching to her hips and legs..."

- 7/17/19 "[Patient] still with a [complaint of]restless night."

- 7/18/19 "Pt states she was awoken by pain last night..."

Patient #21's record include a care plan, created on 7/10/19. The care plan included a diagnosis of cellulitis of left lower limb. It included the following problems, with interventions, and objectives:

- Alteration in ventilatory status

- Airway resistance

- Cellulitis, impaired physical mobility

- Impaired skin integrity

- Safety

- Nutrition

- Decreased self care

- Functional mobility deficits

Patient #21's care plan did not include problems, interventions or objectives to address her pain and sleep issues.

During an interview on 8/26/19 at 9:55 AM, the CCO reviewed Patient #21's record and confirmed her care plan did not include problems, interventions or objectives to address her pain and sleep issues.

The hospital failed to ensure a nursing care plan was developed to address Patient #21's pain and sleep issues.

Based on medical record review and staff interview, it was determined the hospital failed to ensure medical record entries were properly authenticated for 4 of 28 patients (#11, #13, #18, and #28) whose records were reviewed. This resulted in improperly executed patient admission consents and physician's orders. Findings include:

1. Patient #18 was a 56 year old male who was admitted to the hospital on 6/01/19, with a primary diagnosis of acute respiratory failure.

a. Patient #18's medical record included a "CONSENT TO TREAT" form, dated 6/01/19, and signed by him. However, the form did not include a time for Patient #18's signature. It could not be determined if Patient #18 signed his consent prior to receiving treatment.

b. Patient #18's medical record included an "ADMISSIONS AGREEMENT/ CONDITIONS OF TREATMENT" form, dated 6/01/19, signed by him. However, the form did not include a time for Patient #18's signature. It could not be determined if Patient #18 signed his consent prior to receiving treatment.

c. Patient #18's medical record included an "ACKNOWLEDGEMENT OF RECEIPT OF HEALTH CARE INFORMATION AND CONSENT TO TEXT MESSAGING COMMUNICATIONS" form, dated 6/01/19, signed by him. However, the form did not include a time for Patient #18's signature. It could not be determined if Patient #18 signed his consent prior to receiving treatment.

The CCO was interviewed on 8/26/19, beginning at 10:23 AM, and Patient #18's medical record was reviewed in her presence. She confirmed Patient #18's 3 consent forms were not timed. Additionally, she confirmed it was unclear if Patient #18 signed his forms before or after treatment was provided.

Patient #18's consents were improperly authenticated.

2. Patient #13 was a 68 year old male who was admitted to the hospital on 5/24/19, with a primary diagnosis of toxic encephalopathy.

Patient #13's medical record included an "ACKNOWLEDGEMENT OF RECEIPT OF HEALTH CARE INFORMATION AND CONSENT TO TEXT MESSAGING COMMUNICATIONS" form, dated 5/25/19, signed by him. However, the form did not include a time for Patient #13's signature and it was unclear why the form was signed one day after he was admitted.

The CCO was interviewed on 8/26/19, beginning at 10:23 AM, and Patient #13's medical record was reviewed in her presence. She confirmed Patient #13's consent form was not timed. Additionally, she confirmed it was not clear why Patient #13 signed his consent a day after he was admitted.

Patient #13's consents were improperly authenticated.



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3. Patient #11 was an 84 year old male who was admitted to the hospital on 5/29/19, with a primary diagnosis of acute respiratory failure.

a. Patient #11's medical record included a "CONSENT TO TREAT" form, dated 5/29/19, and signed by him. However, the form did not include a time for Patient #11's signature. It could not be determined if Patient #11 signed his consent prior to receiving treatment.

b. Patient #11's medical record included an "ADMISSIONS AGREEMENT/ CONDITIONS OF TREATMENT" form, dated 5/29/19, signed by him. However, the form did not include a time for Patient #11's signature. It could not be determined if Patient #11 signed his consent prior to receiving treatment.

c. Patient #11's medical record included an "ACKNOWLEDGEMENT OF RECEIPT OF HEALTH CARE INFORMATION AND CONSENT TO TEXT MESSAGING COMMUNICATIONS" form, dated 5/29/19, signed by him. However, the form did not include a time for Patient #11's signature. It could not be determined if Patient #11 signed his consent prior to receiving treatment.

The CCO was interviewed on 8/26/19, beginning at 11:09 AM, and Patient #11's medical record was reviewed in her presence. She confirmed Patient #11's 3 consent forms were not timed. Additionally, she confirmed it was unclear if Patient #11 signed his forms before or after treatment was provided.

Patient #11's consents were improperly authenticated.

4. Patient #28 was a 76 year old male admitted to the hospital on 11/17/18, for aspiration pneumonia.

Patient #28's medical record included forms titled "Restraint Order and Flow Record," dated 11/23/18, 11/27/19, 11/28/19, 11/30/19, 12/02/19, 12/03/19, 12/04/19, and 12/06/19, and signed by a physician. However, the forms did not include a time for the physicians' signatures. It could not be determined if Patient #28's physicians signed the order before the initiation/continuation of restraint use for Patient #28.

The CCO was interviewed on 8/26/19, beginning at 11:09 AM, and Patient #28's medical record was reviewed in her presence. She confirmed the Patient #28's 8 restraint order forms were not timed.

Patient #28's physician's orders were improperly authenticated.

Based on medical record review, observation, review of CDC website and guidelines, and staff interview, it was determined the hospital failed to ensure staff followed effective infection prevention practices, including hand hygiene and sanitation of equipment. This directly affected 1 of 2 patients (Patient #4) whose wound care was observed, and had the potential to affect all patients. Findings include:

1. Patient #4 was a 38 year old male admitted to the hospital on 8/03/19, with a primary diagnosis of respiratory failure. He was a current patient at the time of the survey. His record was reviewed.

The Director of Quality was interviewed on 8/26/19, beginning at 2:15 PM. When asked what nationally recognized infection control guidelines the hospital followed, she stated, "CDC guidelines."

The CDC website, accessed 8/27/19, included a guideline for when to perform hand hygiene in a healthcare setting. It stated:

"Use an Alcohol-Based Hand Sanitizer:

- Immediately before touching a patient

- Before performing an aseptic task (e.g., placing an indwelling device) or handling invasive medical devices

- Before moving from work on a soiled body site to a clean body site on the same patient

- After touching a patient or the patient's immediate environment

- After contact with blood, body fluids or contaminated surfaces

- Immediately after glove removal"

Patient #4's care was observed in his room on 8/21/19, beginning at 11:30 AM. Following wound care provided by the wound care RN and LPN, the RN assigned to Patient #4's care for the day entered his room. She donned gloves and assisted the wound care nurses to change his sheets. She then provided oral suctioning and tracheal suctioning through his tracheotomy tube without changing her gloves. The RN straightened Patient #4's sheets and discarded the disposable pad on his bed. She then discarded her gloves and did not complete hand hygiene. The RN made an adjustment to Patient #4's IV pump and documented on a clipboard. She donned gloves, made an adjustment to Patient #4's urinary catheter bag, and removed her gloves. Without performing hand hygiene, she repositioned Patient #4's head. She then went to the sink and washed her hands.

During an interview on 8/21/19 at 11:47 AM, the RN assigned to Patient #4's care confirmed she did not perform hand hygiene when moving from 1 body part to another and after removing her gloves.

Patient #4's RN failed to perform hand hygiene as required by CDC guidelines.



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2. A tour of the hospital's kitchen was conducted in the presence of the Director of Quality on 8/22/19, beginning at 8:21 AM. During the tour, sanitation issues were identified. Examples include:

a. The hospital's food tray line, available to staff and patients/visitors was observed. The entirety of the food tray line area did not have a hand gel sanitizer dispenser. The food tray line had a single sink with an automatic soap dispenser, however, the dispenser did not work. It was unclear how staff working the food tray line would sanitize their hands.

b. Behind the food tray line were 2 Delfield food warmers/coolers. The tops of these 2 units had a large accumulation of dust, debris, and grease on elevated horizontal surfaces. It could not be determined the last time the 2 units were cleaned.

c. A large amount of dust, debris, and food particles were noted underneath the food tray line and 2 Delfield food warmers/coolers. It could not be determined the last time these areas were cleaned.

d. A Delfield food warmer/cooler inside the hospital's main kitchen had a large accumulation of dust, debris, and grease on elevated horizontal surfaces. It could not be determined the last time this unit was cleaned.

e. A Vulcan oven inside the hospital's main kitchen had a large accumulation of dust, debris, and grease on elevated horizontal surfaces. It could not be determined the last time this unit was cleaned.

f. A large amount of dust, debris, and food particles were noted underneath food preparation stations, ovens, and fryer inside the hospital's main kitchen. It could not be determined the last these areas were cleaned.

The Director of Quality was interviewed during the tour on 8/22/19, beginning at 8:39 AM, and confirmed the hospital kitchen's sanitation issues.

Sanitation of the hospital's kitchen was not maintained.

Based on hospital policy review, contract review, and staff interview, it was determined the hospital failed to incorporate an agreement with an OPO that included determination of medical suitability for tissue and eye donation. This had the potential to affect the determination of suitability for tissue and eye donation of all patient who expired at the hospital. Findings include:

The hospital's policy, "Organ Tissue Donation," effective 3/2018, stated, "This hospital will report all imminent deaths and deaths to the designated Organ Procurement Organization."

The hospital's contract with the OPO was reviewed. The responsibilities of the organ procurement organization stated:

- "includes twenty-four (24) hour organ procurement services including evaluation of every potential donor for medical suitability, clinical management of the potential donor to ensure optimal organ viability, coordination of organ recovery processes, organ allocation, and organ recovery."

- "[OPO] shall collaborate with entity as needed to assist them in the development of organ donation protocols, policies and practices, including Donation after Cardiac Death (DCD), as required by CMS rules."

The responsibilities of the hospital stated:

- "ENTITY shall adopt and implement a protocol, policy or practice for DCD to allow for the recovery of organs after the withdrawal of life sustaining therapies."

- "ENTITY shall provide staff and services to assess and maintain organ viability and assist with organ recovery in the operating room on a 23/7 basis."

The hospital's contract with the OPO did not include evaluation of potential donors for suitability for eye or tissue donation.

During an interview on 8/26/19 at 1:15 PM, the Director of Quality stated when a patient expired, the House Supervisor called the OPO. She stated no additional call was made to a tissue or eye bank. The Director of Quality confirmed the contract with the OPO did not state how eligibility for eye and tissue donation would be determined.

The hospital failed to ensure its agreement with the OPO included determination of medical eligibility for eye and tissue donation.

Based on record review and staff interview, it was determined the hospital failed to ensure the individual who initiated a request for organ, tissue, or eye donation to the family of a deceased patient was an organ procurement representative or a designated requestor. This affected the family of 1 of 3 patients (Patient #23) whose records were reviewed for organ/tissue/eye donation requests, and had the potential to affect possible organ, tissue, and eye donation for all patients who expired at the hospital. Findings include:

Patient #23 was a 66 year old male admitted to the hospital on 7/17/19, with a terminal diagnosis of pulmonary fibrosis. He expired on 7/30/19. His record was reviewed.

Patient #23's record included a "Record of Death," dated 7/30/19 at 1:26 AM. The form included a section titled "EYE/TISSUE/ORGAN DONATION." It included the name of the OPO contact person. It stated, "Medically unsuitable for donation Reason: Family declined donation." The line titled "Approached by:" was blank. It could not be determined who approached Patient #23's family regarding donation.

During an interview on 8/26/19 at 9:50 AM, the CCO reviewed the "Record of Death" form and confirmed it could not be determined who approached Patient #23's family regarding donation.

The night shift House Supervisor on duty on 7/30/19 was interviewed by telephone on 8/26/19 at 10:25 AM. She stated she spoke to Patient #23's family and asked them about donation prior to calling the OPO. The House Supervisor stated the family declined donation and she passed that information on to the OPO representative when she called the OPO. The House Supervisor stated she did not receive formal training on organ/tissue/eye donation and was not trained to be a designated requester. She stated when she was being trained as a House Supervisor, she was told by another House Supervisor she should talk to the patient's family before the death, and before calling the OPO.

Another House Supervisor was interviewed on 8/24/19 at 3:50 PM. She stated when a death occurred, she called the OPO donation hotline to report the death and answered questions used to determine eligibility. She stated if the OPO representative stated the patient qualified for donation, she would approach the family to ask if they were interested in donation, then call the OPO back to report the family's decision. The House Supervisor stated she did not receive formal training on organ/tissue/eye donation and was not trained to be a designated requester. She stated another House Supervisor told her it was the responsibility of the House Supervisors to ask families about donation when a patient expired.

The CCO was interviewed on 8/26/19 at 1:45 PM. She confirmed the House Supervisors should not talk to families about organ/tissue/eye donation. The CCO stated the hospital did not have staff trained as designated requestors, and all requests for donation were to be made by the OPO representative.

The hospital failed to ensure requests for organ/tissue/eye donations were made only by an OPO representative or a trained designated requester.

Based on medical record review, education record review, and staff interview it was determined the hospital failed to work with the designated OPO to educate the hospital staff on organ, tissue and eye donation issues. This resulted in failure of hospital employees to follow the proper protocol related to organ/tissue/eye donation which directly affected 1 of 3 patients (Patient #23) whose records were reviewed for organ/tissue/eye donation requests and had the potential to affect all patients who expire at the hospital. Findings include:

Patient #23 was a 66 year old male admitted to the hospital on 7/17/19, with a terminal diagnosis of pulmonary fibrosis. He expired on 7/30/19. His record was reviewed.

Patient #23's record included a "Record of Death," dated 7/30/19 at 1:26 AM. The form included a section titled "EYE/TISSUE/ORGAN DONATION." It included the name of the OPO contact person. It stated, "Medically unsuitable for donation Reason: Family declined donation." The line titled "Approached by:" was blank. It could not be determined who approached Patient #23's family regarding donation.

The night shift House Supervisor on duty on 7/30/19 was interviewed by telephone on 8/26/19 at 10:25 AM. She stated she spoke to Patient #23's family and asked them about donation prior to calling the OPO. The House Supervisor stated the family declined donation and she passed that information on to the OPO representative when she called the OPO. The House Supervisor stated she did not receive formal training on organ/tissue/eye donation and was not trained to be a designated requester. She stated when she was being trained as a House Supervisor, she was told by another House Supervisor she should talk to the patient's family before the death, and before calling the OPO.

Another House Supervisor was interviewed on 8/24/19 at 3:50 PM. She stated when a death occurred, she called the OPO donation hotline to report the death and answered questions used to determine eligibility. She stated if the OPO representative stated the patient qualified for donation, she would approach the family to ask if they were interested in donation, then call the OPO back to report the family's decision. The House Supervisor stated she did not receive formal training on organ/tissue/eye donation and was not trained to be a designated requester. She stated another House Supervisor told her it was the responsibility of the House Supervisors to ask families about donation when a patient expired.

The CCO was interviewed on 8/26/19 at 1:45 PM. She confirmed the House Supervisors should not talk to families about organ/tissue/eye donation. The CCO stated the hospital did not have staff trained as designated requestors, and all requests for donation were to be made by the OPO representative.

The hospital's Professional Development Coordinator was interviewed on 8/26/19 at 8:40 AM. He stated employees received about 15 minutes of training on organ/tissue/eye donation during new employee education. The content of the training was requested. The Professional Development Coordinator provided 1 page of training titled "Organ Tissue Donation Highlights." He stated he believed training was provided to hospital employees by the OPO and eye bank "about 2 years ago" before he was employed at the hospital, but he was unable to provide documentation of the training.

An email was received from the hospital's Director of Quality on 8/27/19 at 2:54 PM. It included documentation of training provided by the local eye bank, dated 5/02/18, titled "NURSE ORIENTATION FOR TISSUE DONATION." During a telephone call on 8/27/19 at approximately 3:30 PM, the Director of Quality stated the hospital was unable to provide documentation of who attended the training. No documentation of training from the OPO was provided by the hospital.

The hospital failed to work with their designated OPO to educate staff on donation issues.