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Based on the nature of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT, was out of compliance.

A-0286 - Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. The facility failed to ensure the quality assessment and performance improvement (QAPI) program prioritized the investigation of patient deaths in the facility, categorized as unanticipated, in 3 of 3 incident reports categorized by the facility as unanticipated patient deaths (Patients #2, #3, and #8). The failure resulted in a lack of performance improvement activities affecting health outcomes, patient safety, and quality of care following cases of unanticipated patient deaths in the facility.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES was out of compliance.

A-0395 - A registered nurse must supervise and evaluate the nursing care for each patient. The facility failed to ensure nursing staff adequately assessed, intervened, and notified the appropriate interdisciplinary team members of the patient's clinical change in condition. The failure was identified in 1 of 3 patient deaths that occurred in the facility and were categorized as an unanticipated outcome (Patient #3). The failure resulted in the patient experiencing a change in clinical condition without the appropriate interventions, reassessments, and notification to the appropriate interdisciplinary team members.

Based on record review and interviews the facility failed to ensure the quality assessment and performance improvement (QAPI) program prioritized the investigation of patient deaths in the facility categorized as unanticipated, in 3 of 3 incident reports categorized by the facility as unanticipated patient deaths (Patients #2, #3, and #8).

The failure resulted in a lack of performance improvement activities affecting health outcomes, patient safety, and quality of care following cases of unanticipated patient deaths in the facility.

Findings include:

Facility policy:

According to the Performance Improvement Plan, the mission of the hospital was to establish a formal, organizational-wide system to monitor and continuously improve patient outcomes, patient safety, and hospital services. The plan will be used by each employee of the hospital to continually monitor and improve the quality of care, and provide safe environment for patients. Also, the program strives to assess and improve those governance, managerial, clinical, and support processes that most affect patient outcomes and place patients at serious risk.

According to the policy, Sentinel Event/Root Cause Analysis, events that do not meet the definition of Sentinel will be evaluated for the need for a root cause analysis.

According to the policy, Unanticipated Outcomes Communications, a root cause analysis may be performed for educational and improvement process for any unanticipated outcomes, whether a sentinel event or not.

1. The facility failed to ensure the quality assessment and performance improvement program prioritized the investigation of patient deaths in the facility categorized as unanticipated.

a. Document review of the facility's incident reports revealed three reports of patient deaths documented as "unanticipated."

According to the incident report documenting Patient #2's death, the facility determined "all appropriate paperwork and process followed." The investigation description noted the patient was not feeling well that day and was hallucinating. There was no additional investigation noted.

According to the incident report for Patient #3, the facility determined "proper procedure [was] followed."

According to the incident report for Patient #8, the facility determined the "death process [was] followed."

On 6/20/18 at 3:39 p.m., an interview was conducted with the director of compliance (Director #5). According to Director # 5 the facility had not completed an investigation regarding the three incident reports documented as unanticipated patient deaths. Director #5 stated the facility had not identified the need to complete a "root cause analysis" investigation regarding the three deaths. According to Director #5, the facility only reviewed the medical records to assess if the Death of a Patient/Record of Death documentation was completed, if the coroner was contacted, and if the physician was notified of the death.

Director #5 stated a "root cause analysis" investigation of unanticipated patient deaths was important in order to assess the quality of care those patients received while admitted. She stated it was important to perform an investigation in order to identify the need for any potential performance improvement activities.

Director #5 stated the facility should have performed a root cause analysis in order to audit the care Patient #3 received. She confirmed the facility had not previously identified the opportunity for performance improvement following the "unanticipated death" of Patient #3.

b. A review of Patient #3's medical record was conducted. Patient #3 was admitted on 12/19/17 with the chief complaints of peripheral vascular disease (a circulatory condition in which narrowed blood vessels reduce blood flow to the limbs), a new left above-knee amputation, left-sided ischemic stroke, aphasia (loss of ability to understand or express speech, caused by brain damage), dysphagia (difficulty swallowing), deep vein thrombosis (a blood clot in a deep vein), and right-sided hemiparesis (the medical term for weakness on half of the body). Patient #3 had an "unanticipated death" in the facility at 10:32 p.m. on 1/28/18.

Record review of the medical record's Diet/Texture Order section revealed the patient was placed on a specialized diet on 12/19/17 because of the dysphagia. Due to difficulty swallowing, the physician ordered a Level 2-Mechanical Soft/Ground texture diet with ground meat and added "gravy/moisture."

However, on 1/28/18 the patient began having clinical changes in his ability to swallow. On 1/28/18 at 5:30 p.m. the patient's registered nurse (RN #6) documented the patient was "having difficulty swallowing solid foods, [gags], and chokes." Review of nursing notes prior to 1/28/18 found no other documented evidence the patient was having difficulty tolerating the mechanical soft/ground food. Review of the nursing documentation revealed there was no notification to the physician and speech language pathologists regarding the patient's increased difficulty swallowing on 1/28/18.

A review of the nursing documentation for 1/28/18 revealed the patient exhibited atypical symptoms earlier in the day as well, prior to the 5:30 p.m. assessment. At 9:00 a.m., RN #6 documented an assessment of Patient #3 which noted he had taken his medication crushed in pudding, but also experienced a vomiting episode. Review of the documentation revealed no further intervention was performed in regard to the patient's vomiting episode. The patient was not assessed for nausea, the patient was not provided his ordered antiemetic medication (a drug that is effective against vomiting and nausea), and the patient's physician was not notified of the event.

Further record review continued to identify atypical assessments documented by the RN on 1/28/18. At 7:50 p.m., RN #7 documented the patient vomited a "small amount" and oral medications would be held. Review of RN #7's documentation revealed a lack of interventions related to the patient's symptoms. There was no documented evidence the patient's nausea was assessed, no evidence the physician was notified of the clinical changes, and no evidence the ordered antiemetic medication was administered to the patient.

Despite repeated assessments of the patient vomiting throughout the day, and the documented increase in swallowing difficulty, RN #7 continued to provide oral medications to Patient #3 at 8:45 p.m. However, there was no documentation the nurse notified the physician of the patient's change in condition.

Approximately an hour later, at 9:50 p.m., nursing documentation revealed the patient was found in the room sitting upright in the bed slumped over with a large amount of brown vomit, and in respiratory arrest. Due to the respiratory arrest, cardiopulmonary resuscitation (CPR) was initiated. The patient was ultimately pronounced dead at 10:32 p.m..

According to the Discharge Summary, completed by the attending physician (Physician #1), it was "most likely that the patient suffered cardiac arrest secondary to acute hypoxic respiratory failure from emesis [the action or process of vomiting] with aspiration."

c. On 6/19/18 at 12:05 p.m. an interview was conducted with RN #6. RN #6 reviewed the medical record for Patient #3 and confirmed she was the primary nurse during the day shift on 1/28/18. RN #6 confirmed the 9:00 a.m. and 5:30 p.m. documentation revealed the patient was having increased difficulty swallowing and vomiting. RN #6 stated there was no documentation the physician or SLP were notified of the patient's change in condition that day. RN #6 stated the attending physician should have been notified and possible changes to the treatment plan discussed. RN #6 stated the physician should be notified if any patient was having difficulty swallowing, coughing on liquids, having trouble finishing meals, or having trouble taking oral medications.

RN #6 stated after the patient's death, the facility had not provided any re-education or performance improvement plans following the case.

d. On 6/20/18 at 9:35 a.m., an interview was conducted with the attending physician (Physician #1). Physician #1 documented the discharge summary for Patient #3 and was able to review the patient's medical record during the interview. Physician #1 reviewed the nursing documentation from days prior to 1/28/18 and stated the increased difficulty swallowing and repeated vomiting was a change from the patient's previous assessments. Additionally, Physician #1 confirmed the documentation revealed no evidence the patient's attending physician was notified of the change in condition and that any ordered antiemetic medication was administered on 1/28/18 in order to treat the patient's episodes of vomiting.

According to the interview, the attending physician should have been notified in order to perform a physical assessment and address the possible need to alter the treatment plan. Physician #1 stated there could be a concern for aspiration pneumonia due to the vomiting episodes. Therefore x-ray imaging, and oxygen saturation monitoring could have been indicated as well.

Physician #1 stated communication between the interdisciplinary team could have been better in order to ensure the physician and SLP were aware of the patient's change in condition on 1/28/18.

e. During the interview with Director #5, on 6/20/18 at 3:39 p.m., she was able to review the medical record for Patient #3 and confirmed the facility had not audited the record for quality of care following the patient's death. Director #5 reviewed the nursing notes documented on 1/28/18 (the day of the patient's death) and stated there was a lack of communication and intervention between the interdisciplinary team. Specifically, Director #5 stated the physician should have been notified of Patient #3's change of condition on 1/28/18. Director #5 stated the facility had not completed a formal investigation into the unanticipated death.

Director #5 stated the facility should have performed a root cause analysis in order to audit the care Patient #3 received. She confirmed the facility had not previously identified the opportunity for performance improvement following the "unanticipated death" of Patient #3.

Director #5 also stated that a root cause analysis was not conducted for the "unanticipated" deaths of Patient #2 and #8 as documented in the incident reports.

f. Record review for Patient #2 revealed he was admitted to the facility on 1/10/18 with the chief problem of hypoxemic respiratory failure. According to the Discharge Summary, the patient successfully recovered from his hypoxemic respiratory failure and was on supplemental oxygen. Further review of the discharge summary revealed that on 2/12/18 the patient had completed his dialysis therapy Monday afternoon, and "at 6:45 p.m. the patient was on the phone speaking with his daughter." According to the Discharge Summary, at 7:05 p.m. the nurse entered the room to administer the patient's antibiotics and found him "unresponsive, pale, and without a pulse." The patient was ultimately pronounced deceased at 7:20 p.m.

According to the incident report, completed by the facility regarding the death of Patient #2, the patient's death was categorized as an "unanticipated death." The facility was unable to provide any evidence the quality of care and cause of death were analyzed or investigated.

g. Record review was conducted for Patient #8. Patient #8 was admitted 6/29/18 after new left below the knee amputation. The patient was admitted for dialysis and antibiotic therapy for sepsis and necrotizing fascitis. While at the facility, the patient started exhibiting signs of absence seizures. An EEG was obtained and the patient was started on Keppra. During the seizure workup, the patient was also found to have elevated ammonia levels and was treated with Lactulose which helped.

On 7/17/18, the patient became hypotensive during dialysis, and afterwards, exhibited a fever and an acute decline. A chest x-ray was completed, antibiotics were restarted, and the physician spoke with the family. They determined if the patient started having more difficulty breathing or any further decline, the facility would transfer her to an acute care hospital.

Document review of Patient #8's incident report following her death was reviewed. According to the incident report completed on 7/21/18, the patient reported to her family that "her side hurt, then fell asleep and did not wake up." On 7/21/18 the patient was ultimately pronounced dead at 11:22 p.m. According to the incident report, the patient's death was categorized as "unanticipated."

The facility was unable to provide documentation that quality of care and cause of death were analyzed or investigated.

(Cross-reference A-0395)

Based on document review and interviews the facility failed to ensure nursing staff adequately assessed, intervened, and notified the appropriate interdisciplinary team members of the patient's clinical change in condition. The failure was identified in 1 of 3 patient deaths that occurred in the facility and were categorized as an unanticipated outcome (Patient #3).

The failure resulted in the patient experiencing a change in clinical condition without the appropriate interventions, reassessments, and notification to the appropriate interdisciplinary team members.

Findings include:

According to the policy, Reassessment, the registered nurse will perform reassessments and will direct patient care through a variety of mechanisms including notifications of the change to the physician, change to the plan of care, and other interventions based on the patient need.

1. The facility failed to ensure nursing staff adequately assessed, intervened, and notified the appropriate interdisciplinary team members of the patient's clinical change in condition.

a. A review of Patient #3's medical record was conducted. Patient #3 was admitted on 12/19/17 with the chief complaints of peripheral vascular disease (a circulatory condition in which narrowed blood vessels reduce blood flow to the limbs), a new left above-knee amputation, left-sided ischemic stroke, aphasia (loss of ability to understand or express speech, caused by brain damage), dysphagia (difficulty swallowing), deep vein thrombosis (a blood clot in a deep vein), and right-sided hemiparesis (the medical term for weakness on half of the body). Patient #3 had an "unanticipated death" in the facility at 10:32 p.m. on 1/28/18.

Prior to the patient's death, review of the medical record's Diet/Texture Order section revealed the patient was placed on a specialized diet on 12/19/17 because of the dysphagia. Due to difficulty swallowing, the physician ordered a Level 2-Mechanical Soft/Ground texture diet with ground meat and added "gravy/moisture."

However, on 1/28/18 the patient began having clinical changes in his ability to swallow. On 1/28/18 at 5:30 p.m. the patient's registered nurse (RN #6) documented the patient was "having difficulty swallowing solid foods, [gags], and chokes." Review of nursing notes prior to 1/28/18 found no other documented evidence the patient was having difficulty tolerating the mechanical soft/ground food per the Diet/Texture order. Review of the nursing documentation revealed there was no notification to the physician and speech language pathologists regarding the patient's increased difficulty swallowing on 1/28/18.

A review of the nursing documentation for 1/28/18 revealed the patient exhibited atypical symptoms earlier in the day as well, prior to the 5:30 p.m. assessment. At 9:00 a.m., RN #6 documented an assessment of Patient #3 which noted he had taken his medication crushed in pudding, but also experienced a vomiting episode. Review of the documentation revealed no further intervention was performed in regard to the patient's vomiting episode. The patient was not assessed for nausea, the patient was not provided his ordered antiemetic medication (a drug that is effective against vomiting and nausea), and the patient's physician was not notified of the event.

Further record review continued to identify atypical assessments documented by the patient's registered nurse on 1/28/18. At 7:50 p.m., RN #7 documented the patient vomited a "small amount" and oral medications would be held. Review of RN #7's documentation revealed a lack of interventions related to the patient's symptoms. There was no documented evidence the patient's nausea was assessed, no evidence the physician was notified of the clinical changes, and no evidence the ordered antiemetic medication was administered to the patient.

Despite repeated assessments of the patient vomiting throughout the day, and the documented increase in swallowing difficulty, RN #7 continued to provide oral medications to Patient #3 at 8:45 p.m. However, according to the documentation there was no documented evidence the nurse notified the physician of the patient's change in condition.

Approximately an hour later, at 9:50 p.m., nursing documentation revealed the patient was found in the room sitting upright in the bed slumped over with a large amount of brown vomit, and in respiratory arrest. Due to the respiratory arrest, cardiopulmonary resuscitation (CPR) was initiated. The patient was ultimately pronounced dead at 10:32 p.m..

According to the Discharge Summary, completed by the attending physician (Physician #1), it was "most likely that the patient suffered cardiac arrest secondary to acute hypoxic respiratory failure from emesis [the action or process of vomiting] with aspiration."

b. On 6/20/18 at 9:35 a.m., an interview was conducted with the attending physician (Physician #1). Physician #1 documented the discharge summary for Patient #3 and was able to review the patient's medical record during the interview. Physician #1 reviewed the nursing documentation from days prior to 1/28/18 and stated the increased difficulty swallowing and repeated vomiting was a change from the patient's previous assessments. Additionally, Physician #1 confirmed the documentation revealed no evidence the patient's attending physician was notified of the change in condition and that any ordered antiemetic medication was administered on 1/28/18 in order to treat the patient's episodes of vomiting.

According to the interview, the attending physician should have been notified in order to perform a physical assessment and address the possible need to alter the treatment plan. Physician #1 stated, if notified, the physician could assess the cause of the patient's nausea, stop the oral route medications if necessary, perform a physical assessment, consult the speech language pathologist (SLP) to re-evaluate the patient's swallowing deficits, and possibly hold all meals until the patient's swallowing was re-evaluated. He also stated there could be a concern for aspiration pneumonia due to the vomiting episodes. Therefore X-Ray imaging, and oxygen saturation monitoring could have been indicated as well.

Physician #1 stated communication between the interdisciplinary team could have been better in order to ensure the physician and SLP were aware of the patient's change in condition on 1/28/18.

c. On 6/19/18 at 1:14 p.m., an interview was conducted with a speech language pathologist (SLP #8). SLP #8 stated one of her roles in the facility was to assess a patient's ability to swallow safely and recommend to the physician any specialized diets the patient would be able to safely tolerate. SLP #8 stated she should be notified if a patient had a change in condition that included trouble swallowing, "holding food in mouth", or signs the patient was not eating safely.

SLP #8 reviewed the record for Patient #3, and confirmed there was no documented evidence the registered nurse attempted to contact a physician or SLP #8 on 1/28/18, when the patient began exhibiting signs of increased difficulty swallowing. After review of the patient's Diet/Texture order and SLP documentation, SLP #8 confirmed the 1/28/18 assessments documented by the nurse were a change in the patient's clinical condition and should have been reported to the physician and SLP in order to re-evaluate the patient.

d. On 6/19/18 at 12:05 p.m. an interview was conducted with RN #6. RN #6 reviewed the medical record for Patient #3 and confirmed she was the primary nurse during the day shift on 1/28/18. RN #6 confirmed the 9:00 a.m. and 5:30 p.m. documentation revealed the patient was having increased difficulty swallowing and vomiting. RN #6 also reviewed the Diet section documentation and confirmed the patient was having difficulty with his meals on 1/28/18, eating only 25% of breakfast and "[two] bites" at supper. RN #6 stated there was no documentation the physician or SLP were notified of the patient's condition that day. RN #6 stated the attending physician should have been notified of the patient's condition and discuss possible changes to the treatment plan. RN #6 stated the physician should be notified if any patient was having difficulty swallowing, coughing on liquids, having trouble finishing meals, or having trouble taking oral medications.

RN #6 stated earlier communication with the attending physician should have been initiated when the patient was exhibiting increased difficulty swallowing and decrease in appetite. RN #6 stated after the patient's death, the facility had not provided any re-education or performance improvement plans following the case.

e. On 6/19/18 at 6:21 p.m., an interview was conducted with RN #7 who cared for Patient #3 on the evening of 1/28/18. RN #7 reviewed the medical record for Patient #3 and confirmed the patient had an episode of vomiting at 7:50 p.m. RN #7 stated she was told the patient "did not want to eat" and the handoff report, from the day shift nursing, did not detail the previous shifts' findings for 9:00 a.m., of the patient vomiting, and at 5:30 p.m., when the patient was gagging and choking on solid foods. RN #7 stated she would not routinely continue to provide food or oral medications to the patient if they were already assessed as choking and coughing on solid foods. However, RN #7 repeated she was not made aware of the 5:30 p.m. assessment during nursing handoff report.

According to RN #7, changes in the patient's ability to safely swallow would be considered a change in condition. RN #7 stated if a patient was having increased difficulty swallowing the physician and speech language pathologist should be notified and oral intake could be held until the patient was re-evaluated. RN #7 stated she was unsure, from reviewing the record, if Patient #3's symptoms were related to difficulty swallowing or symptoms of nausea.

However, review of the medical record for Patient #3 found no documented evidence the patient was assessed for nausea and provided any doses of the ordered antiemetic medication. Further, there was no documentation the physician or SLP were notified of the patient's change in assessments throughout the day.

RN #7 stated the facility had not provided any re-education or process improvement recommendations following Patient #3's death in the facility.

f. On 6/20/18 at 3:39 p.m., an interview was conducted with the director of compliance (Director #5). Director #5 was also functioning as the director of nursing at the time of the survey. Director #5 stated Patient #3's death was documented as "unanticipated" in the incident report. According to the interview, the facility reviewed the patient's case following the death but had not identified any performance improvement opportunities. Director #5 stated the review of Patient #3's death was an informal process, and not as detailed as a root cause analysis review.

However, Director #5 was able to review the medical record for Patient #3, during the interview, and stated there were missed opportunities for improved communication between the interdisciplinary team based on the assessments documented throughout the day on 1/28/18. Director #5 confirmed there was no documented evidence the patient was assessed for nausea, received the ordered antiemetic medication after episodes of vomiting, no documentation the physician was notified of the repeated vomiting and difficulty swallowing, and no documented evidence the SLP was notified of the patient's swallowing changes.

Director #5 stated the facility should have performed a root cause analysis in order to audit the care Patient #3 received. She confirmed the facility had not previously identified the opportunity for performance improvement following the "unanticipated death" of Patient #3.

Based on observations and interviews, the facility failed to maintain appropriate infection control processes and follow infection control standards in the areas of hand hygiene and glove changing practice. The failure was identified in 2 of 2 observations of patient care.

Findings Include:

Policy:

The facility policy Hand Hygiene read, personnel should wash hands prior to starting work, before and after direct patient contact (including administration of medications), before eating, after toileting, after handling contaminated articles, when hands are obviously soiled, and before leaving work at the end of the shift.

The facility policy Standard Precautions read, gloves will be changed between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms.

Reference:

According to the World Health Organization (WHO), Five Moments of Hand Hygiene, 2017: the 5 Moments for Hand Hygiene approach defines the key moments when health-care workers should perform hand hygiene.
This approach recommends health-care workers clean their hands before touching a patient, before clean/aseptic procedures, after body fluid exposure/risk, after touching a patient, and after touching patient surroundings.

1. The facility failed to ensure patient care staff performed hand hygiene and glove changes according to established infection control guidelines.

a. On 6/19/18 at 9:55 a.m., Physician #1 was observed entering a patient's room to discuss a blood transfusion and to obtain informed consent. No hand hygiene was observed prior to Physician #1 entering or exiting the patient room.

b. On 6/19/18 at 10:00 a.m., Registered Nurse (RN) #2 was observed entering the same patient's room. She was wearing gloves and carrying a unit of blood. She was then observed opening and accessing intravenous (IV) fluids with spiked IV tubing. She did not perform hand hygiene prior to donning gloves, nor did she change gloves after entering the room. No hand hygiene or glove change was observed prior to her accessing the IV fluid.

c. On 6/19/18 at 10:07 a.m., RN #3 was observed repositioning the same patient. She took vital signs and then administered an IV medication. She failed to change gloves or perform hand hygiene in between these tasks.

d. On 6/19/18 at 10:35 a.m., RN #2 was observed entering a different patient's room after the patient had pressed their call bell. RN #2 did not perform hand hygiene prior to entering the patient's room or prior to flushing the IV catheter with saline.

e. On 6/18/18 at 11:30 a.m., RN #4 was observed opening and preparing supplies for a non-sterile dressing change while wearing gloves. Prior to starting the dressing change, she was observed reaching into the right pocket of her scrub top with a gloved hand to remove a pen. She then proceeded with the dressing change without performing hand hygiene or changing her gloves.

f. On 6/18/18 at 3:39 p.m., an interview was conducted with RN #2. She stated hand hygiene should be performed before and after care of all patients. She stated this included before going into a patient's room, after touching something in the room, before any procedures, or doing anything with a patient. She also stated performing hand hygiene was important before putting on gloves or administering medication. RN #2 stated it was important to wear new gloves prior to starting a dressing change or cleaning a wound.

f. An interview was conducted with Physician #1 on 6/20/18 at 9:30 a.m. He stated hand hygiene should be performed before entering and after exiting the patient's room. He stated the risk of not performing hand hygiene at these times would be the potential transmission of infection from one patient to another.

g. On 6/20/18 at 2:07 p.m., an interview was conducted with the director of compliance (Director #5), who also served as the facility's infection preventionist. She stated she expected staff to perform hand hygiene before and after entering a patient's room, after contact with bodily fluids, before any invasive procedures, and after eating or drinking. Director #5 stated she expected staff to put on new gloves after entering a patient's room. She also stated staff should change gloves after reaching into their pockets during procedures, as pockets are frequently accessed throughout the day and could have a high microbial count.