The Medical Center of Aurora

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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation º482.13 PATIENT RIGHTS was out of compliance.

A-0144 The patient has the right to receive care in a safe setting. Based on interviews and document review the facility failed to ensure patients in the facility, who were at risk for harm to self were consistently observed in a safe environment. Specifically the facility failed to ensure patient belongings were safeguarded from patients on mental health holds in order to ensure patients did not access items which could be used for harm to self or others and did not maintain continuous monitoring of patients who were on high risk mental health holds.

Based on interviews and document review the facility failed to ensure patients who were at risk for harm to self or others were consistently observed in a safe environment. Specifically, the facility failed to ensure patient belongings were safeguarded from patients on mental health holds in order to ensure patients did not have access to items which could be used for harm to self or others and did not maintain continuous monitoring of patients who were on mental health holds.

Findings Include:

Facility Policies:

The Suicide Precautions Policy read, all patients over the age of ten must be assessed for risk of suicide. The assessment was to be completed in the emergency department (ED), perioperative area and all inpatient units, to include any change in a patient's behavior which would lead staff to believe the patient was at risk of self-harm. The policy further stated safety precautions were the responsibility of all staff, in an effort to provide a safe environment of care for all patients, at all times. This included but was not limited to searching the patient's room for harmful objects (some examples include: scissors, razors, lighters, belts, scarves, pocket knives etc., if found should be taken by security), removing all items to be sent home or labeled and secured safely apart from the patient. The patient was expected to remove personal clothing to be placed in a patient safe green hospital gown without ties. The patient room will be checked again at the beginning of each shift or when an increase in observation was needed due to patient behavioral change. These safety precautions should be documented in the patient record at intervals requested by the order.

The Safety Attendant and Protective Observation policy read, patients under the care of a one to one, personal safety attendant (PSA) or through a virtual safety attendant (VSA) via video monitoring, patient safety should always come first. The patient at risk for harm must always remain under observation. A VSA observing a patient on the video monitor must use the facility escalation plan to alert a Registered Nurse (RN) or other nursing staff to immediately respond to the room of a patient at risk of harm through the safety alert notification plan. A patient under the care of a PSA for a high risk mental health hold was to be continually visualized by the PSA regardless of whether the patient had family or visitors in the room. The PSA or VSA must document observations every 15 minutes or per order, and minimize any distractions for example use of a personal phone, reading/studying or watching television while working as a PSA or VSA.

The Allied Universal Security Services Violent/Combative Patient Guidelines for Security Officers procedure read, security will be notified when a behavioral health patient was in the ED. Security will verify the patient had been processed and all personal clothing and personal effects were removed. Security will inspect the room and remove anything the patient can use as a weapon to harm the patient or others. Once security monitoring had begun, it would not stop until the patient was released, transferred or security was informed by clinical staff the monitoring had been discontinued. Security must maintain monitoring at all times, unless relieved by another security officer or clinical staff member.

1. The facility failed to ensure patient rooms and personal belongings had been searched for patients in the ED on a mental health holds and were continually visually monitored to maintain patient safety.

a. On 11/18/2020 at 1:14 p.m., an interview with RN #4 was conducted. RN #4 stated when a mental health hold was initiated the RN would immediately notify security and the RN would stay with the patient until the VSA had started monitoring the patient or the PSA, if ordered, had arrived. He stated the patient would not be left alone with their belongings. RN #4 stated the security team would ensure the patient changed out of their clothing and into the patient safe green gown. RN #4 stated the clothing and belongings would then be searched for items which the patient could use for self-harm and these items would be removed from the patient room for patient and staff safety.

b. Review of Patient #2 medical record, who was admitted for an overdose of narcotics, revealed Physician #2 at 4:36 p.m., placed the patient on a mental health hold which required both a PSA and VSA. The record showed the VSA started monitoring the patient at 4:44 p.m. The RN notes showed the RN noticed blood on the patient's clothing at 5:00 p.m. When the RN asked Patient #2 what had happened, the patient stated she had self-harmed with a razor from her belongings. The wound repair required sutures. The RN had paged security to secure Patient #2's belongings, however a search of the patient room and belongings had not occurred, belongings had not been secured and the patient was still in her own clothing. Suicide Precautions policy read the patient with suicidal ideation required a personal, room and belonging search, and belongings would be removed from the patient.

i. On 11/18/20 at 5:12 p.m., an interview was conducted with RN #8. RN #8 stated Patient #2, who had scored as high risk on the physician's assessment, was monitored on video by a VSA. He stated security had been paged to secure the patient's belongings, however the patient was left alone with only video monitoring. A PSA had not yet arrived. RN #8 stated when he returned to the room he saw blood on Patient #2 and the patient told RN #8 she had self-harmed with the razor. RN #8 stated the ED staff and security as a team did not follow facility process for Patient #2.

ii. On 11/18/20 at 4:05 p.m., an interview was conducted with Supervisor #7. Supervisor #7 stated all patients were screened for suicide risk. She stated the assessment scored the patients with a low, medium or high risk, and interventions were then initiated to meet the level of risk. Supervisor #7 stated when a patient was changed to high risk, security was primarily responsible to get the patient into a patient safe green gown, secure the patient belongings, inventory them and search for any potential objects of harm. Supervisor #7 stated an RN accompanied by another RN could perform a search of the patient's belongings, remove the patient's clothing and place them in a patient safe green gown if security were unavailable. Supervisor #7 stated security would still need to be involved to inventory and securely lock up the patient's belongings. Supervisor #7 stated she was aware Patient #2 injured herself with a razor from her belongings. Supervisor #7 stated the situation brought to light disconnects in their process, security and nursing had not searched the patient, her belongings, placed her in a patient safe green gown and the VSA did not notify the RN of patient activity when Patient #2 was able to cut herself with the razor.

iii. On 11/18/20 at 2:19 p.m., an interview was conducted with Director of Hospital Security (Director #5). Director #5 stated security officers in the ED who were assigned the role of VSA were expected to remain at the monitors at all times. He stated the security officer assigned as the roving security officer would be responsible to conduct patient and belonging searches and place the patient in a patient safe green gown. Director #5 stated the roving security officer was responsible to search and gown the patient if they were available, however if security was not available the clinical staff was responsible to complete these actions. Director #5 stated a patient who scored as high risk for their mental health hold would need a PSA, the VSA would then become a second set of eyes to monitor the patient. Director #5 stated the security team was a support role for the clinical team, and he stated if security was not available the clinical team was responsible to keep the patient safe by gowning, searching and securing patient belongings away from the patient. Director #5 stated patients who scored as high risk on mental health holds were all placed in a patient safety green gown, and either clinical staff or security officers could get a patient into a patient safe green gown.

Director #5 stated was informed Patient #2 harmed herself in the ED. He stated the roving security officer was engaged elsewhere and unable to respond to the RN's request for security to search Patient #2. When asked who was ultimately responsible for patient safety, Director #5 stated clinical staff were in care of the patient, security supports the care. However the Allied Universal Security Services Violent/Combative Patient Guidelines for Security Officers procedure read after security was notified of a mental health hold patient in the ED, security would verify the patient personal clothing and effects had been processed and removed.

iv. On 11/18/20 at 10:02 a.m., an interview was conducted with Physician #2. Physician #2 stated the ED physician placed any patient admitted with suicidal, homicidal or psychotic tendencies on a mental health hold. Physician #2 stated once the patient was placed on a mental health hold and assessed at high risk the patient was immediately put on video with a VSA, placed in a green gown, and a PSA was established. She stated security would secure and search the patient's clothing and belongings. Physician #2 stated the purpose of the high risk score assessment and mental health hold was specifically to keep patients and staff safe.

Physician #2 stated she was the physician for Patient #2 when the patient self-harmed in the ED. Physician #2 stated she assessed Patient #2 at high risk and placed Patient #2 on a mental health hold when she had received collateral information from Patient #2's family regarding the overdose of narcotics. She stated she informed the patient's clinical staff of the need for a mental health hold at 4:36 p.m. Physician #2 stated in the time between the initiation of the mental health hold order and 5:00 p.m. when the patient's self-inflicted injury was observed by staff, the patient was left alone with her belongings and had remained in her own clothing. Physician #2 stated Patient #2 was moved to the higher acuity area of the ED after the event, belongings were searched and she was placed in a patient safe green gown. Physician #2 was unaware of any follow up on the event.

c. Review of facility documents revealed Patient #6 was in the ED on 10/2/20. Patient #6 was on a mental health hold and scored as high risk for suicidal ideation she had a PSA. The document revealed Patient #6 walked to the bathroom and the PSA did not immediately follow the patient. The patient's nurse observed the delay and went to check on the patient approximately 1 minute later. The patient's nurse found Patient #6 on the bathroom floor with a pulse oximetry (POX) cord held around her neck. The nurse immediately removed the cord from around the patient's neck, assessed the patient and returned Patient #6 to her room. No injury or ligature marks were noted on the patient. The charge RN, Physician and ED supervisor were informed.

i. On 11/19/20 at 11:15 a.m., an interview was conducted with RN #9. RN #9 stated green gowns signified to staff the patient had been assessed as high risk and was on a mental health hold. She stated the purpose of the gown was to ensure the patient was not able to hide harmful objects. RN #9 stated when she arrived for her shift Patient #6 was in the higher acuity area of the ED and was still in her personal clothing. She stated this was not normal, as the patient was supposed to be in the patient safe green gown. RN #9 stated after she had removed the cord from Patient #6's neck, she and the PSA changed the patient into the patient safe green gown and removed her belongings.

RN #9 stated she did not know how Patient #6 acquired the POX cord. RN #9 stated the patient rooms in the higher acuity area of the ED were already free of harmful objects, however staff needed to check the rooms prior to patients entering the rooms. RN #9 stated Patient #6 was sleeping upon her arrival to her shift, and she observed the patient but did not uncover Patient #6 to search her at the time. This was in contrast to facility policy, which stated a patient was to be searched at the beginning of each shift. RN #9 stated she had had conversations with Supervisor #7 about the event, but she had not noted any changes to procedure or staff education after the event.

d. Review of facility documents revealed Patient #5 was in the ED on 10/29/20. Patient #5 was on a mental health hold, assessed as high risk and had a PSA. The document revealed RN #9 assumed care of Patient #5 at 5:00 p.m.. At 5:45 p.m. the RN discovered Patient #5 was in her personal clothing and her belongings had not been secured. When RN# 9 inquired why Patient #5 had not been gowned and her belongings were not secured, the security officer replied the information had not been passed to them during the change of shift report.

i. On 11/19/20 at 11:15 a.m., an interview was conducted with RN #9. RN #9 stated Patient #5 had returned to the ED from the high acuity area of the ED in her personal clothes and with her belongings because she needed to be medically stabilized. RN #9 stated the patient was on a mental health hold and assessed as high risk, which required her to be placed in the patient safe green gown, and required her belongings to be secured and searched. RN#9 stated removing patient clothing decreased the risk of harm to patients and staff.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation º482.13 QAPI was out of compliance.

A-0286 The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will identify and reduce medical errors. The hospital must measure, analyze, and track adverse patient events. Program Activities. 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. Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: That clear expectations for safety are established. Based on document or record review and interviews, the facility's quality department failed to analyze reported patient occurrences in order to identify contributing factors and implement preventative actions in three of six patients admitted to the Emergency Department (ED) or Progressive Care Unit (PCU), either on a high risk mental health hold or placed on a high risk mental health hold while in the ED (Patient #2, Patient #5 and Patient #6).

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on documents, record review and interviews, the facility's quality department failed to analyze reported patient safety events in order to identify contributing factors and implement preventative actions in three of ten patient safety events reviewed for patients on a mental health hold. (Patient #2, Patient #5 and Patient #6)

Findings Include:

Facility Policy:

The Facility Event and Close Call Reporting policy read, the policy was intended to minimize risks to patients, non-patients, visitors and staff by implementing a close call reporting system based upon the affirmative duty of all health care providers and all agents and employees of the licensed healthcare facility to report occurrences and close calls to the risk manager, patient safety director, or to his or her designee.

The data was supplied by all employees and referred to managers after being entered. Facility managers were given 15 business days to review, document and provide actions. The managers were given 60 calendar days for the investigation to be finalized and provided to the risk manager. The risk manager was given 60 calendar days to finalize their review of actions and disposition. The risk manager was to ensure the Federal, State and local requirements for event and close call reporting, review and response was met.

The policy defined an event as a discrete, auditable and clearly defined occurrence. An adverse event was described as any deviation from standard medical care causing risk of harm or actual injury to the patient resulting in an undesirable outcome to the patient. Close calls were listed as any events or situations which may result in an adverse event. Harm was considered to be any disruption in structure or function of the person's body requiring intervention, including disease, injury or disability, up to and including death. Occurrence, event or incident were considered interchangeable.

The responsibility of reporting would fall to any staff member who was aware of an occurrence, without fear of disciplinary action. The policy stated the facility culture would encourage the use of the reporting system with ease of access, leadership support and shared learning to improve quality of patient care.

1. The facility failed to investigate patient safety events reported to the quality department for patients on a mental health hold in order to identify causes and contributing factors to prevent reoccurrence. Specifically, the quality department failed to investigate and analyze events involving patient self-harm, suicide attempts and lapses in monitoring for patients who required suicide precautions.

a. Patient #2's medical record was reviewed. The record revealed Patient #2 was admitted on [DATE] for an overdose of narcotic pain medication and was on a mental health hold. The record revealed the patient had a history of multiple self-inflicted wounds to her left forearm and was able to use a razor from her belongings to cut herself which resulted in the need for additional medical services while in the Emergency Department (ED). A personal safety attendant (PSA) or one to one sitter was not present, she had only a virtual safety attendant (VSA) watching her on video.

b. Review of facility documents revealed a report of the event in which Patient #2 injured herself with a razor was sent to the ED director and was reviewed within the policy timeline. The patient safety event filed for the incident revealed Security had been paged up to three times to search the patient and had not responded to the pages. An initial meeting was held with the ED director (Director #11), Security director (Director #5), Chief Nursing Officer, Assistant Chief Nursing Officer, and the Chief Operating Officer within four days of the occurrence. No further information was provided regarding the investigation of the event or actions taken to prevent reoccurrence.

i. On 11/18/20 at 5:12 p.m., RN #8 was interviewed. RN#8, who was in care of the patient stated security had been paged to secure the patients belongings and place her in a patient safe green gown and had not responded. Patient #2 admitted to cutting herself when staff returned to the room, Patient #2 surrendered the weapon to staff. In regards to the investigation of the patient safety event with Patient #2, RN #8 stated security had not followed the process, he had discussions with the Nurse Supervisor (Supervisor #7) and some reminders were put into pre-shift huddles to double check procedures. RN #8 was not aware of any changes made to prevent these safety events in the future.

ii. On 11/18/20 at 4:05 p.m. Nursing Supervisor (Supervisor) #7 was interviewed. Supervisor #7 stated she met with Director #11 and Director #5 to follow up on the event in which Patient #2 harmed herself with a razor in her belongings. Supervisor #7 stated the VSA monitoring Patient #2, had not notified the RN of Patient #2's actions. Supervisor #7 stated they discussed ways to increase communications between ED and Security staff for patient safety. Supervisor #7 stated she had informed staff through pre-shift huddles of communication changes with the security department. No documentation was provided of the information in the pre-shift huddles. Supervisor #7 stated the patient safety event with Patient #2 brought to light the disconnects in their process. Supervisor #7 did not mention any follow up with the quality department.

iii. In an interview with Director #11 on 11/19/20 at 1:35 p.m., Director #11 stated all reported events were reviewed daily and investigations were handled by Supervisor #7 and himself. He stated the ED staff educator and the Quality and Safety department were also involved. Director #11 stated medical records for patients involved in reported safety events were reviewed within 24 hours, however he stated no formal timeframe existed to complete investigations. Director #11 stated the follow up for the event involving Patient #2 had taken longer than usual and had not yet been entered into the computer to be reviewed by the quality department. Director #11 stated he and Supervisor #7 were unable to attend either of the two most recent Safety meetings to report on their investigational findings from Patient #2's event. These meeting were overseen by the Director of Patient Safety and Risk Management (Director #12) who followed up on the occurrences. Director #11 stated investigation of safety events was important in order to fix problems in facility processes.

c. Review of facility documents revealed Patient #6 who was admitted on [DATE] and was on a mental health hold in the high acuity area of the ED. The document revealed Patient #6 remained in her personal clothing with her belongings with her. The patient was found by the RN with a pulse oximetry (POX) cord held around her neck.

The event report revealed the investigation was pending. A note entered by Director #12 had requested further information regarding the follow up. No further information was filed regarding the event involving Patient #6.

i. On 11/19/20 at 11:15 a.m. an interview was conducted with RN #9. RN #9 stated Patient #6 was sleeping when she first arrived for her shift. RN #9 did not uncover and search Patient #6 as required by facility policy. Patient #6 later got up to use the restroom and was found by RN #9 with the POX cord around her neck. RN #9 stated POX cords were not kept in the high acuity area of the ED and she did not know how the patient had the cord. RN #9 stated she had a meeting with the ED charge RN and Supervisor #7 to review and discuss the event. RN #9 stated to her awareness no other follow-up or changes had occurred after the event involving Patient #6.

ii. On 11/19/20 at 1:35 p.m. an interview was conducted with Director #11. Director #11 stated after the event involving Patient #6, RN #9 and the other RN who cared for the patient were provided with re-education regarding process in the high acuity area of the ED. Supervisor #7 provided information in a pre-shift huddle to other staff members, however she stated there was no formal education provided to staff on procedures in the high acuity area of the ED. No further information was provided to show follow-up with the quality department.

d. Review of facility documents revealed Patient #5 admitted on [DATE] was on a mental health hold in the ED. The document revealed Patient #5 was not placed on VSA for video monitoring, her belongings were not searched, and she was not placed in a patient safe green gown. The security officer informed the RN they were unaware Patient #5 required a VSA, belongings search or green gown.

The event report revealed the ED educator followed up and performed coaching with all parties involved in the event. No further information was provided on the follow-up for the event with the quality department.

e. Staff interviews revealed staff changes or actions were not taken to prevent reoccurrence of patient safety issues which were reported to facility leadership.

i. On 11/18/20 at 10:58 a.m., an interview was conducted with ED Charge Nurse (CN) #3. CN #3 stated environmental checks or room searches were important to keep patients and staff safe. CN #3 stated security was responsible to inventory and secure all patient belongings. CN #3 stated the security delays were a patient safety issue. CN #3 stated he had filed patient safety event reports and discussed his concerns with ED leadership. CN #3 stated he had not received feedback or observed changes in response to the event reports he had filed.

ii. On 11/18/20 at 1:14 p.m. an interview was conducted with Registered Nurse (RN) #4. RN#4 stated the delayed security response had made him feel unsafe and he felt security staffing was inadequate. RN #4 stated staff had expressed concerns to leadership. In regards to the event involving Patient #2, RN #4 stated he had not been part of any debriefing after the event.

f. Interviews with facility leadership revealed the patient safety events involving Patients #2, #5 and #6 were not investigated according to facility policy, nor were preventive actions implemented to prevent re-occurrence of similar events.

i. An interview was conducted on 11/19/20 at 2:23 p.m., with the Director of Patient Safety and Risk Management (Director #12). Director #12 stated reported patient safety events were reviewed daily. She stated the reports were then sent to unit directors, who were responsible for investigations and follow-up actions. Director #12 stated unit directors reported the results of investigations back to her, and she would assist with implementing changes, send the report back to the unit director requesting more information, give guidance or close the report if she determined the investigation was complete.. Director #12 stated information from patient safety events were shared in daily huddles. Director #12 stated when trends were identified it assists with quality improvement projects.

Director #12 stated she had requested information regarding the event involving Patient #2, in which the patient was able to harm herself with a razor. She stated she had not received the requested information from the unit manager. Director #12 stated she had no knowledge of any investigation of the event or changes implemented as a result of the event, as she had not received the additional information requested.

Director #12 stated she remembered the event involving Patient #6, in which the patient was found in the bathroom with a cord wrapped around her neck. Director #12 stated she had not received any follow-up investigation from the unit director, and she was not aware of any investigation or preventive actions initiated as a result of the event.

Director #12 stated the unit directors were responsible to investigate patient safety events which occurred on their units, however she stated she was ultimately responsible to ensure investigations occurred and necessary preventive actions were implemented.

ii. On 11/19/20 at 4:18 p.m., an interview was conducted with the Vice President of Quality (VP) #6. VP #6 stated the unit directors were responsible to investigate and implement corrective action for reported patient safety events. She stated the quality and safety departments had oversight of the process. VP #6 stated the quality and safety departments supported the unit directors in the process of investigating safety events.

VP #6 stated Director #12 was responsible to close the loop with unit directors to ensure a thorough response had been received after an investigation.. VP#6 stated the reported patient safety events and investigations of the events told the facility's story of what happened and what was done to correct it. VP #6 stated the facility improved on patient care and safety through reported patient safety events.

2. Facility staff failed to report a serious safety event to the quality department according to facility policy.

a. Interviews conducted on 11/18/20 and 11/19/20 revealed an event involving Patient #2 during the patient's admission on 9/30/20 to the Progressive Care Unit (PCU).Two staff who cared for Patient #2 on the PCU stated she had two razor blades in her phone case. There was no documentation of the event in the facility reporting system or in Patient #2's medical record.

b. On 11/18/20 at 7:38 a.m., an interview was conducted with Certified Nursing Assistant (CNA) #1. CNA #1 stated she worked on the PCU as both a CNA and a PSA. CNA #1 stated if patients were on suicide precautions, the patients were allowed to keep their cell phone if the phone had been searched. When asked why a phone would need to be searched, CNA #1 stated she had previously cared for a patient on a mental health hold who had surrendered two razor blades she had hidden in her phone case to staff on the previous shift. CNA #1 stated she was informed of this during the shift change report.

CNA #1 stated she did not file a patient safety event report because the event occurred on a different shift and she assumed the previous shift made a report. CNA #1 stated there were no meetings or follow-up as a result of the event and she was not informed of any changes to procedure regarding patient searches.

b. On 11/19/20 at 12:43 p.m. an interview was conducted with CNA #10. CNA #10 stated she had cared for Patient #2 on previous admissions due to suicide attempts. CNA #10 stated when she cared for Patient #2 on the PCU, the patient surrendered two razors from her phone case.

CNA #10 stated she notified the RN and the charge RN on PCU of the razors being surrendered. CNA #10 stated she did not file a patient safety event report as she had not been trained on how to file a report.. CNA #10 stated the event should have been reported because it would ensure future patients remained safe and other staff could learn from the event. CNA #10 stated she had not received any follow-up regarding the event.

Facility Event and Close Call Reporting policy stated the responsibility of reporting patient safety events was the responsibility of all staff members who were aware of a patient safety event. Reporting of the events was encouraged by leadership to support shared learning and improve processes.

c. On 11/19/20 at 2:23 p.m. Director #12 was interviewed. Director #12 stated she was not aware of an event involving a patient on PCU who had razors in her belongings. She stated there was no event filed to report this event, and therefore no follow-up or investigation had occurred. Director #12 stated due to the safety risk to both patient and staff, facility staff should have reported the event.

Based on document reviews and interviews, the facility failed to ensure patients who experienced a fall event received follow-up nursing care. The failure was identified in 2 of 2 medical records, (Patients #1 and #5) for patients who experienced a fall event. Specifically, the facility failed to ensure staff provided follow-up care and monitored the patient's condition for subsequent injuries.

Findings include:

Facility policy:

According to the Fall Risk Prevention policy, the following nursing care procedures are required upon the discovery of a patient who has experienced a fall. When a patient falls, the facility staff engages the overhead paging system to announce a Code Yellow. This process alerts staff and supervisory staff of the patient room number where the patient fall occurred. This call initiates a response team including the Nursing House Supervisor, the Nursing Unit Manager, the Nursing Unit Director, the Charge Nurse, any Physical Therapy and Occupational Therapy staff available, the Registered Nurse and the Certified Nursing Assistant providing care for the patient.

Upon finding a patient who has experienced a fall, an assessment of the patient is conducted including vitals signs. After the assessment, the patient is transferred to the bed or chair as indicated. The response team conducts a fall debrief using the Code Yellow Form. This debrief process includes the patient and family as appropriate. A Code Yellow Debrief form is sent to the nursing unit manager or nursing unit director.

The patient is reassessed for a fall risk. The post fall assessment is documented in the patient's electronic health record. The facility staff notifies the patient's physician. With the patient's permission, the facility staff notify the patient's family members unless the patient is non-decisional. The facility will notify the Medical Durable Power of Attorney (MDPOA) as indicated. The facility staff will then complete the Risk Management Notification in the patient's electronic health record.

1. The facility failed to ensure nursing staff assessed, evaluated, and managed patient injuries after patients experienced a fall according to facility policies.

a. Review of documentation dated 9/15/20 at 5:16 a.m. revealed Patient #5 experienced a witnessed assisted fall when the patient rolled sideways out of bed and hit his back. The report revealed the patient injured his back and a small abrasion was noted. Two nurses assisted Patient #5 back to his bed.

i. Patient #5's medical record was reviewed. Patient #5's medical record lacked a nursing assessment, location of the abrasion, or documentation of follow-up care for the injury to the patient's back and abrasion following his witnessed fall on 9/15/20.

ii. On 11/4/20 at 1:12 p.m., an interview was conducted with Nurse Manager #5 (NM #5). NM #5 reviewed Patient #5' s medical record. NM #5 was unable to locate documentation regarding the location and characteristics of the patient's injury after the patient fell . NM#5 acknowledged nursing assessment and follow-up care for Patient #5's injuries were not conducted.

b. Review of a report dated 8/10/2020 revealed, Patient #1 fell two days earlier on 08/08/2020. The staff member who entered the report documented she assessed Patient #1 and the patient had a bruise on her buttocks.

i. Review of Patient #1's medical record revealed the patient had a change in mental status following a back surgery. Patient #1 became impulsive and frequently got out of bed without staff assistance, and she was noted to be high risk for falls.

ii. Review of a nursing note entered on 8/10/20 revealed Patient #1 and the patient's family member informed the nurse Patient #1 fell and was injured on 8/8/20. The nurse subsequently assessed Patient #1 and found the patient had a bruise on her inner buttocks. The nurse documented there were no previous notes regarding Patient #1's fall and bruise.

iii. Review of Patient #1's medical record revealed nursing staff who cared for Patient #1 on 8/8/20 did not document the patient's fall or bruise. There was no evidence in the medical record of nursing assessment of the bruise or follow-up evaluation and interventions between 8/8/20 when the fall occurred and 8/10/20 when the patient and family member reported the fall to the nurse. Additionally, the medical record did not show evidence of coordination with the patient's physician or family after the patient fell .

iv. On 11/03/2020 at 4:00 p.m., an interview was conducted with Registered Nurse (RN) #2, who cared for Patient #1 on 8/8/20. RN #2 stated Patient #1 fell out of bed onto the protective floor mat. She stated the charge nurse told her since the patient fell on the protective floor mat it was not necessary to activate the Code Yellow alert system. RN #2 stated the patient did get a bruise on her buttocks. RN #2 stated she did not write a patient assessment in the medical record because she did not think a patient falling on a floor mat was considered a fall. She stated she did not document a skin assessment for the same reason.

This was in contrast to the facility Fall Risk Prevention policy, which read if a patient fell , staff were to announce a Code Yellow, conduct an assessment of the patient's condition, reassess the patient's fall risk, complete a post-fall debrief, and complete a Risk Management notification.

2. The facility failed to consistently provide nursing care for patients who experienced a fall. The facility failed to ensure follow-up nursing assessment, care and evaluation for patients subsequent to fall injuries according to facility policy.

a. An interview with nursing leadership revealed nursing staff were required to complete specific actions in response to a patient fall.

i. On 11/4/20 at 1:12 p.m., an interview was conducted with Nurse Manager #5 (NM #5). NM #5 stated a fall was defined as any patient found on the ground. NM #5 stated this definition included falls which were witnessed or unwitnessed, and also included falls on the protective mat or on the bare floor. According to NM #5, when a patient fell the nurse completed an assessment of the patient's condition and documented any injuries or abrasions in the electronic medical record. NM #5 stated when a patient fell , nursing staff were to activate a Code Yellow, notify the patient's physician and family of the fall, complete a fall debrief form, and enter a report for follow up and tracking.

b. Nursing interviews conducted between the dates of 11/2/2020 and 11/4/2020 revealed nursing staff lacked understanding of what constituted a patient fall, and of the care and follow-up actions which were required after a patient experienced a fall.

i. On 11/2/20 at 1:39 p.m., an interview was conducted with RN #1. RN #1 stated the Code Yellow facility alert system was used if a patient experienced a fall event. RN #1 stated the Code Yellow alert was used throughout the facility to notify the nursing supervisor, the physician and other staff members if a fall occurred.

ii. On 11/3/20 at 4:00 p.m., an interview conducted with RN #2 revealed when a patient fell , staff did not always activate the Code Yellow facility alert system. RN #2 stated if a patient fell on the protective floor mat or if the patient did not sustain an injury, the nurse did not have to activate the Code Yellow alert system. She stated if staff did not activate a Code Yellow alert, the patient's physician or the patient's family were not notified if a patient fell .

iii. On 11/3/20 at 7:44 a.m., an interview was conducted with RN #3. RN #3 stated if a patient fell on a protective floor mat, it was not deemed as a fall. She stated since she did not consider this to be a fall, she did not activate the Code Yellow alert system or file an report if a patient fell on the floor mat.

iv. On 11/4/20 08:19 a.m., an interview was conducted with RN #4. RN #4 stated if a patient fell on their knees or their buttocks, then a Code Yellow alert was activated. She stated when a patient experienced a fall, the nurse performed a post-fall physical assessment, and noted any new bruises or abrasions. RN #4 stated the assessment was documented in the patient's medical record, and the staff would notify the nursing supervisor of the patient's fall.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review and interviews the facility failed to ensure a reassessment of the patient's post-discharge needs was completed after a change was made to the discharge plan and reflected in the discharge documentation provided to the patient. This failure was identified in 1 of 1 patients who had a change in discharge plans upon discharge (Patient #2).

Findings include:

Facility policy:

The Discharge Planning policy read, the purpose was to identify patients with additional needs after discharge in order to provide patients and caregivers adequate time to ensure the patient and family were aware of the continued needs and support for discharge. Reassessment of the discharge plan was to occur throughout the hospitalization as needs were identified or with change in condition. The nurse was responsible for documentation of the discharge plan within the medical record. For the patient to return home, the home care needs would be identified through assessment by nursing or other disciplines. The case manager was to communicate with the home care agency and coordinate the delivery of services and provide referral information.

1. The facility failed to ensure the patients discharge needs were reassessed and reflected within the discharge packet given to the patient, after a change to the discharge plan was identified.

a. Review of the discharge packet provided to Patient #2 at the time of discharge, on 1/10/20 at 2:12 p.m. revealed the documentation provided to the patient did not reflect the change in the discharge plan. Specifically, the patient received a document, at discharge, which specified the discharge plan was to go to a nursing facility. Patient #2 was discharged home with home health services and was not provided with the contact information for the home health agency selected to provide services. Additionally, there was no evidence in the discharge packet the patient was provided any medical equipment, or resources to obtain equipment had it been recommended.

The facility was not able to provide evidence the contact information for the home health agency was provided at the time of discharge and reviewed in the discharge packet.

b. Medical record review for Patient #2 was conducted. Patient #2 was admitted to the facility on [DATE] with altered mental status (AMS) and a past medical history to include pulmonary embolism (PE) (blood clot in the lungs), hypertension (high blood pressure), sleep apnea (decreased oxygenation with sleep) and type II diabetes (a condition which required medications to control blood sugar levels).

i. The medical record review revealed the patient was evaluated by Physical Therapy (PT) and Occupational Therapy (OT), on 12/29/19, to determine his functional status and therapy services needed in the hospital as well as potential needs at discharge. Both the OT and PT evaluations revealed recommendations for discharge to a rehabilitation center when ready. The OT evaluation revealed the equipment needed for discharge would continue to be assessed throughout the hospitalization and would be obtained as needed. Similarly, the PT evaluation specified equipment needed for discharge was to be determined and it was unknown if Patient #2 had equipment available for use at home.

On 1/9/20 at 2:37 p.m., the medical record revealed a PT note which identified concerns about safety related to altered cognition, but Patient #2 was safe to discharge home with family. Additionally, the patient ambulated with a walker with PT. No equipment was obtained for the patient at discharge and it was unknown what equipment the patient owned.

The OT note on 1/9/20 at 4:39 p.m. revealed the recommendation for discharge continued to be to a rehabilitation facility and equipment recommended would continue to be assessed and obtained as needed.

ii. Review of the Case Management (CM) Discharge Planning Evaluation on 12/29/19 at 6:02 p.m. revealed Patient #2 lived at home with his spouse and had limitations in his ability to toilet himself. Additionally, the patient had home health services prior to admission and had barriers to discharge related to a significant medical condition. CM noted they would continue to follow the patient for discharge needs.

The CM notes revealed on 1/6/20 at 11:46, Patient #2, continued to have barriers to discharge and recommendations were to be determined and discussed with the family as needed.

On 1/10/20 at 10:41 a.m., a note from CM revealed the anticipated discharge was home with home health care and there were no additional recommendations from other members of the care team (PT or OT).

On 1/10/20 at 1:58 p.m. a note from CM revealed PT recommended Patient #2 be discharged to a rehabilitation facility, however, Patient #2 refused and requested to be discharged home with home health care. Per the note, the family agreed with the new discharge plan. The CM note revealed the patient was accepted to receive home health services upon discharge, but no follow up was noted for Patient #2's post discharge needs due to the new discharge plan.

iii. The Discharge Summary completed by the physician on 1/10/20 at 5:12 p.m. revealed the disposition plan was for Patient #2 to go home with home health services which was discussed with the patient and his family. The Discharge Summary noted CM was to arrange the home health as well as medical equipment needed.

Throughout the duration of the hospitalization , and upon discharge, there was no evidence of assessment for the need of medical equipment completed by OT, PT, CM or nursing staff. Furthermore, there was no evidence the patient or family was provided resources in order to obtain medical equipment for use at home.

c. An interview was conducted with Registered Nurse (RN) #1 on 2/18/20 at 8:59 a.m. She stated the information provided to the patient upon discharge differed based on where the patient was discharged to. RN #1 said if a patient was discharged home they would receive a packet which included information about the reason they were hospitalized , the follow up recommendations and plan, recommended diet and activity level, medications and possible side effects as well as general information about stroke and safety after discharge. She stated the discharge packet was her responsibility to compile and review with the patient and families.

Upon review of the discharge packet and information provided to Patient #2, RN #1 identified a discrepancy in the discharge plan. She revealed the discharge packet noted the patient went to a nursing facility, but the note she entered into the record reflected Patient #2 went home with home health. RN #1 was unable to recall if she provided the patient the contact information for the home health agency upon discharge and was unable to provide evidence of the updated information within the discharge packet provided to the patient. Furthermore, RN #1 stated she thought CM provided patients with home health agency contact information.

d. An interview was conducted with CM #2 on 2/18/20 at 9:40 a.m. She stated her role was to assist and coordinate the discharge process to ensure the patients were discharged to a safe environment. She said the discharge planning process included a review of the medical record and conversations with the medical team (OT, PT, nursing and physicians) to determine a patient's post discharge needs. She stated medical equipment needed for discharge was determined by OT and PT recommendations which was then reviewed with the patient and family by CM.

Upon review of Patient #2's record, CM #2 stated she recalled the decision for the patient to return home with home health occurred the same day of discharge. CM #2 said she thought there was an assessment which reflected what the patient needed at home, however was unable to provide evidence of the assessment. CM #2 stated Patient #2's medical equipment needs were identified by OT and PT, however, she was unable to identify any specific recommendations. Furthermore, she was unable to provide evidence this information was reviewed or reassessed with the patient and family after the discharge plan was changed to go home with home health services versus a skilled nursing facility.

CM #2 stated upon selection of an agency prior to discharge, the patient would receive a yellow sheet with the name of the agency the patient was referred to for follow-up. The document was not found in the medical record. CM #2 stated she was unsure if the contact information for the selected agency was included in the discharge packet provided by the RN.

e. An interview was conducted with PT #3 on 2/18/20 at 11:00 a.m. She stated the role of the OT and PT was to make an initial discharge recommendation based on the patient's functional status and needs. She said an evaluation of possible medical equipment needs or equipment a patient had available was completed during the initial evaluation. PT #3 stated recommendations were then relayed to the CM for further coordination.

Upon review of Patient #2's medical record, PT #3 was unable to identify medical equipment recommendations for discharge, nor an assessment of equipment the patient had access to. PT #3 was unable to identify a reassessment of medical equipment needs upon change of the discharge plan. PT #3 stated there was no evidence as to what the patient needed or resources provided to the family. PT #3 stated the risk of discharging a patient without appropriate medical equipment was an unsafe discharge which could ultimately result in a fall.

Based on interviews and document reviews the facility failed to ensure patient staffing assignments were made based on the patient's needs and the competence of the nursing staff. This failure resulted in patients receiving Continuous Renal Replacement Therapy (CRRT) from staff with no evidence of training or competency in the use of the equipment in 1 of 3 medical records reviewed (Patient #6).

Findings include:

1. The facility failed to ensure nursing personnel were trained, and had demonstrated competency, before independently managing and treating a patient requiring CRRT (Patient #6).

a. On 7/22/19 at 1:02 p.m. an interview was conducted with the Clinical Development Educator (Educator #1) for the Progressive and Intensive Care Units (PCU and ICU). Educator #1 stated CRRT was used to provide dialysis (the process of removing fluid and waste from the body when the kidneys no longer function independently) for patients who were medically unstable and was a process which could last from 24-72 hours in duration.

Educator #1 stated in order for a nurse to care for a patient undergoing CRRT they were required to complete an education module and pass a test, attend an in-service and complete one to two orientation shifts with another experienced nurse qualified to do CRRT. She further explained for a traveling nurse to do CRRT, they would need to be able to verbalize the process during orientation. Additionally, there was an outside company which managed competencies for traveling nurses and they would hold any certifications the nurses had.

b. An interview was conducted on 7/22/19 at 1:48 p.m. with Interim ICU Nursing Supervisor #2 (Supervisor #2). Supervisor #2 explained there could be different complications while a patient was undergoing CRRT including lowered blood pressure, too much fluid loss for the body to compensate for, infections within the lines of the equipment if not handled properly and ultimately cardiac arrest (when the heart stops beating). Supervisor #2 stated because of the hourly monitoring of the amount of fluid being taken out or replaced by CRRT and the high risk of complications, the patient was assigned a trained nurse with experience and was to be the only patient the nurse would be responsible for that day.

Supervisor #2 verified in order for a nurse to care for a patient receiving CRRT, nursing staff was required to take the education module and pass the associated test, attend the in-service class and complete one to two orientation shifts with a nurse previously deemed competent with CRRT.

c. An interview was conducted on 7/23/19 at 8:55 a.m. with Relief Charge Nurse #3 (RN #3). RN #3 stated one of his roles as charge nurse was to make nursing assignments for the next shift. He explained he would take into consideration the acuity of the patients as well as the skills and training of the oncoming nurses. RN #3 stated there was a reference book which identified the nurses who were competent in higher level skills such as CRRT which he could reference while making assignments.

RN #3 stated if he was unable to find evidence of competency for a particular nurse, he would talk to his supervisor or manager for further guidance. Furthermore, he explained traveling nurses competencies were not kept in the reference book and he would talk to his manager prior to making any assignments for traveling nurses.

d. Review of Patient #6's medical record revealed on 4/3/19 the patient was receiving CRRT treatment. The nurse identified caring for Patient #6 was a traveling nurse and was the only patient the nurse was assigned to for the shift. The facility was unable to provide any evidence the nurse was competent to care for a patient receiving CRRT.

Supervisor #2 stated the manager had contacted the nurse prior to the start of the shift, who verbalized he was able to do CRRT. Supervisor #2 stated the facility took his word for it because there was no other nurses trained in CRRT to care for the patient on that shift.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document review, the facility failed to provide patient specific discharge instructions for post-hospital care in 2 of 2 patients with a history of Intravenous Drug Use (IVDU) (Patients #2 and #3).

This failure created the potential for increased infection risk and readmission.

FINDINGS

POLICY

According to the policy, Patient Discharge to Home or to Facility for Less Acute Care, assure patient has received appropriate teaching for post-hospital self-care and follow up care.

According to the policy, Transfer/Discharge Documentation, when a patient is discharged from the hospital, the registered nurse documents referrals and/or consultations with resource persons during stay and evidence of patient/family comprehension of instructions.

According to the policy, Discharge planning, all patients shall receive education regarding self-care after discharge. This is considered a routine ongoing component of care.

According to the policy, Insertion, Maintenance and Care for Central Venous Catheter/ PICC TX, all patients receiving a central line will be given home care instructions at the time of catheter insertion or upon discharge. The patient care or the PICC line nurse will go over the PICC line discharge instructions when the patient is discharged home.

According to the policy, Patient/Family Education, as a standard of practice, all patients will receive patient education via Care Notes or an appropriate educational substitute for their relevant diagnosis, which will be reviewed with them. A copy of what was provided is maintained in the record.

REFERENCE

How to Care for Your Peripherally Inserted Central Catheter (PICC) Discharge Instructions include: when to contact a health care provider, when to seek care immediately, how to prevent a bloodstream infection, patient signature of instructions.

1. The facility failed to ensure Patient #2 was given instructions regarding post-hospitalization PICC care and wound care prior to discharge.

a) Review of Patient #2's medical record revealed s/he was admitted on [DATE]. On 09/22/17 at 4:55 p.m., Physician Assistant (PA) #2 documented in the Discharge Summary, Patient #2 had a right axilla (armpit) abscess which required an I&D (a surgical procedure to release pus or pressure) and daily wound care. According to the discharge summary, Patient #2 had a history of IVDU. PA #2 also documented the patient required a PICC due to poor venous access. PA #2 documented the discharge plan for Patient #2 would include daily intravenous (IV) antibiotics at an outpatient infusion center and s/he would need to follow up at the outpatient wound clinic for daily dressing changes of the axilla wound.

On 09/22/17 at 9:43 a.m., Physician (MD) #3 documented in the Progress Notes that Patient #2 was to be discharged home with the PICC line and go to the outpatient infusion center daily for IV antibiotic therapy. MD #3 also documented the discharge plan was to include continued wound care.

b) A Review of Patient #2's medical record revealed an order by MD #4 for Physical Therapy (PT) to evaluate and treat the axilla wound. The PT Discharge Summary included wound care instructions for daily wound care to the axilla to include: cleanse the wound with sterile water, pack the wound with + inch packing strip, and cover the wound with 2 layers of aquacel and finally mepilex.

c) On 01/04/18 at 8:11 a.m., an interview was conducted with Wound Ostomy Continence Nurse (WOCN) #7 who stated the facility's normal process for wound care discharge instructions were wound care recommendations were to be put into the electronic health record (EHR). The patient's nurse would print the instructions and give them to the patient at the time of discharge. WOCN #7 stated the Case Manager (CM) would arrange outpatient wound care at the wound clinic and send the wound care instructions to the clinic. WOCN #7 reviewed Patient #2's medical record and reported s/he did not see documentation from physical therapy that Patient #2 had received wound care education prior to discharge.

d) On 01/03/18 at 3:11 p.m., an interview with CM #1 was conducted. CM #1 stated the WOCN should have ordered outpatient wound care at a wound care clinic. This was in contrast to the WOCN's interview. S/he reported case management should have arranged outpatient antibiotic therapy and PICC line care at an infusion center.

CM #1 reviewed Patient #2's medical record which revealed CM #8 had documented the patient was not a candidate for outpatient IV antibiotic therapy due to a history of IVDU. S/he wrote the patient would be discharged with no home needs. This was in contrast to provider orders and documentation. CM #1 reported the patient did not need PICC line education at discharge because s/he would be seen at the outpatient infusion center and the center would have provided care instructions.

e) On 01/04/17 at 9:59 a.m., an interview with RN #9 was conducted. RN #9 stated education should have been given to the patient during discharge which would include how to monitor and manage wound care and PICC line care. Wound care instructions would be entered in the EHR by the WOCN and then printed and given to the patient. According to RN #9, all nurses had access to a printed PICC education sheet to give to patients at the time of discharge.

f) RN #10 documented a discharge nurses note on 09/22/17 at 7:36 p.m. RN #10 documented Patient #2 had an axilla wound which required daily dressing changes and a PICC line for outpatient antibiotic therapy. RN #10 also documented dressing changes could be performed at the outpatient infusion clinic.

Review of RN #10's documentation of discharge instructions revealed Patient #2 did not receive specific instructions on how to care for the PICC or wound at home. Discharge instructions read keep wound clean and dry and follow up with outpatient infusion clinic tomorrow.

CM #1 reported the infusion center only managed PICC dressing changes, and did not manage wound care dressing changes. CM #1 stated the patient would need to be seen at the wound care clinic for daily dressing changes or perform dressing changes at home independently. CM #1 further stated case management had not arranged any outpatient service for Patient #2.

g) Subsequently, on 09/25/17 at 1:41 a.m., MD #5 documented in the Emergency Provider Report that Patient #2 returned to the Emergency Department (ED) with an issue regarding wound care. Patient #2 stated the packing had fallen out of his/her axilla wound at an unknown time. MD #5 documented wound care was provided as well as discharge instructions.

Two days later, on 09/27/17 at 7:54 p.m., MD #6 documented in the Emergency Provider Report that Patient #2 returned a second time to the ED with a complaint the PICC line was bleeding, painful, and was coming out. MD #6 documented the PICC dressing was changed and discharge instructions were given to Patient #2.

2. The facility failed to ensure Patient #11 was given instructions regarding post-hospitalization peripheral IV care prior to discharge.

a) Review of Patient #11's medical record revealed MD #11 documented in the Emergency Provider Report the patient (MDS) dated [DATE] with multiple resolving abscesses in the right arm, as well as an abscess that had appeared on the left forearm that morning. MD #11 further stated Patient #11 had a known history of intravenous drug use (IVDU) and had admitted to injecting IV drugs on 07/25/17 prior to arrival to the ED. An I&D of the new abscess was performed by Physician Assistant (PA) #12 while Patient #11 was still in the ED. Patient #11 was then admitted as an inpatient for medical treatment and IV antibiotics with a diagnosis of cellulitis (a bacterial skin infection) and an abscess (a confined pocket of pus) of the left arm. The Clinical Documentation Record showed the patient had an IV placed in the left antecubital (area anterior to the elbow) area on 07/25/17 at 11:50 a.m.

On 7/26/17 at 6:17 p.m., PA #2 documented in the hospitalist progress note that Patient #11's cellulitis of the left arm was due to IVDU. S/he also documented the discharge plan would be for the patient to go to the outpatient infusion center for daily peripheral IV for antibiotics. It was also recorded the patient was not to have a PICC line placed due to history of IVDU.

A Review of Patient #11's medical record showed discharge planning documentation by CM #1 on 07/27/17 at 11:03 a.m. which showed the patient would require a peripheral IV to be placed daily for IV antibiotics at the outpatient infusion clinic.

Patient #11 was discharged from the facility on 07/27/17. However, there was no documentation in Patient #11's medical record stating the peripheral IV had been removed or how to manage a peripheral IV during his/her post hospital phase.

b) On 01/03/18 at 3:11 p.m., an interview was conducted with Case Manager (CM) #1 who reviewed Patient #11's medical record. CM #1 stated Patient #11's discharge plan was to go to the outpatient infusion center on a daily basis to receive a peripheral IV so s/he could be administered daily antibiotics. CM #1 stated there was no documentation that Patient #11's IV had been removed prior to discharge.

c) On 01/04/17 at 9:59 a.m., an interview with RN #9 was conducted. RN #9 stated the risk of being discharged home with a peripheral IV (PIV) would be the possibility of developing an infection or an access to inject drugs. RN #9 went on to state it was facility policy to document the removal of PIVs prior to discharging a patient. RN #9 further stated there was no way to know if the PIV was removed if there was no documentation of removal.

d) Record review revealed Patient #11 was readmitted to the facility on [DATE] for a right antecubital abscess.

Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes and follow infection control standards in the areas of medication storage, preparation, and administration.

These failures created the potential for the transmission of healthcare associated infections to patients receiving care in the facility.

FINDINGS

POLICY

According to policy, Common MDI Canister Application (CCA), the following patient populations will be excluded from the application of this policy. These patients will receive MDIs dispensed from the pharmacy with a patient-specific label: NICU, Pediatrics, Oncology, Isolation, ICU, and Tracheostomy patients.

REFERENCE

According to the Clinical Services Group's Common/Shared Metered Dose Inhaler (MDI) Canister Minimum Guidance Statement, CMS's intent in stating that a multi-dose vial being used for more than one patient should not enter the patient treatment area is to prevent inadvertent contamination of the medication container that could then lead to infections in subsequent patients This process results in the MDI entering multiple treatment areas with a potential risk of contamination and subsequent hospital acquired infections.

Gains from employing a common/shared MDI canister will be quickly lost if cross contamination occurs resulting in healthcare associated infections. If staff is not always compliant with hand hygiene between patients, how compliant will they be with cleaning the MDI after every patient use?

The following high-risk populations should be excluded: patients in isolation, ICU, BMT patients, oncology, pediatrics, neonates and all other immunologically compromised patients.

According to the APIC Position Paper, Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016), aseptic technique includes, in part, to disinfect the rubber stopper of medication vials and the neck of glass ampoules with sterile 70% alcohol before inserting a needle or breaking the ampoule.

1. The facility utilized a practice where Metered Dose Inhaler (MDI) canisters entered immediate patient treatment areas and were then used for more than one patient in 4 of 4 patient care unit medication rooms observed (a telemetry, orthopedic, neurology and oncology unit).

a) A tour of the facility was conducted on multiple occasions during the survey. On 08/14/17 at 11:35 a.m., a tour of the 4th floor telemetry unit medication room revealed a green plastic bin with 7 MDIs including 1 Asmanex canister, 1 Atrovent canister, and 5 Dulera canisters.

At 4:05 p.m., in the medication room on the 4th floor Orthopedic Unit, a green bin was observed and contained 6 MDIs; specifically, 3 Dulera canisters, 1 Atrovent canister, 1 Proventil, and 1 Asmanex canister.

At 4:28 p.m., observation of the 4th floor Neurology Unit front medication room revealed a common canister respiratory bin which contained 1 Asmanex canister.

At 4:43 p.m., an interview with the Charge Respiratory Therapist (RRT #1) was conducted. S/he stated the facility employed a common canister Metered Dose Inhaler (MDI) program. S/he stated the MDIs were stored in a common bin in the unit's medication room. In order to administer the medication to a patient, the MDI was taken into the patient's room and used with a patient-specific spacer. After the administration of the MDI, the spacer was returned to a plastic bag which stayed in the patient's room, and the MDI was wiped down and returned to the common bin in the medication room.

RRT #1 stated common canisters were typically used for Dulera 100, Dulera 200, Proventil, Symbicort, and Spiriva medications. S/he stated the canisters were typically cleaned after, but not before they were used by patients. RRT #1 stated this practice was appropriate because the MDI had been cleaned by the Respiratory Therapist who last used the MDI. RRT #1 stated the common canister MDIs were used, instead of patient-specific inhalers, to minimize waste of the medications.

On 08/16/17 at 9:34 a.m., an observation was conducted of a respiratory therapy treatment for Patient #14. RRT #1 looked in the green common respiratory bin located in the back medication room of the Oncology Unit on the 5th floor. S/he stated the correct medication was not in the bin, so s/he had to go to another floor to get the inhaler. S/he then checked the automated medication dispensing system (Pyxis) in the same medication room, but the correct medication was not available in the Pyxis.

Next, RRT #1 decided to look in the Pyxis located in the front medication room on the same oncology unit. At 9:38 a.m., s/he removed a canister of Dulera 100 from the front medication room Pyxis. S/he did not clean the MDI canister. The Dulera canister was then taken into Patient #14's room and set on the table next to the computer while RRT #1 conducted other patient care activities. At 9:42 a.m., the spacer was removed from a plastic bag, not cleaned, and attached to the Dulera canister. The canister was then handed to the patient who activated the inhaler with his/her bare hands, without performing any hand hygiene. RRT #1 then took the canister, removed the spacer, and returned the spacer to the plastic bag. The Dulera canister was placed on the patient's tray table while other patient care activities were performed. RRT #1 then picked up the Dulera canister, scanned it, and placed it again on the table next to the computer, without the cap. A nebulizer treatment was completed with Patient #14. After washing his/her hands, RRT #1 picked up the Dulera canister and returned to the back medication room, where s/he wiped the Dulera canister with an alcohol wipe and returned the canister to the green common respiratory bin.

On 08/16/17 at 9:54 a.m., a second interview was conducted with RRT #1. S/he stated the common canister was safe to use with multiple patients because it was used with the spacer which had a one way valve to prevent cross contamination. S/he confirmed Patient #14 had activated the MDI himself, touching the canister with his uncleaned bare hands.

b) A review of Patient #14's medical record indicated the patient had recently been diagnosed with stage 3 colon cancer. The use of a common canister MDI with the oncology patient was in contrast to facility policy.

c) On 08/16/17 at 2:11 p.m., an interview was conducted with the Respiratory Director (Director #2) who stated the reason for using a common canister program was to minimize cost. S/he was not able to speak to how the facility would have dispensed medication in common canister MDIs without having taken the inhalers into patient rooms. S/he thought this requirement may have applied only to patients in isolation or a circumstance where the canister was not cleaned properly. Director #2 stated as long as the canister was cleaned correctly before and after patient use, common canisters would have been safe for use by patients who were not specifically excluded.

A second interview was conducted on 08/17/17 at 9:45 a.m. with Director #2. S/he stated the Respiratory Department had not conducted any training regarding infection control practices when using common canister MDIs. Director #2 also stated no respiratory specific competencies had been established, and no audits of common canister MDI use had been conducted during the previous two years.

d) An interview was conducted with the Infection Prevention Manager (Manager #3) on 08/16/17 at 4:30 p.m. Manager #3 stated s/he was unaware there was regulatory guidance which required multi-dose vials for aerosolized medications used for more than one patient to not enter the immediate patient treatment areas. S/he stated s/he was aware of studies which concluded compliance with common canister MDIs implementation recommendations was important for infection control. Manager #3 stated it was not his/her responsibility to monitor medication management, and s/he did not conduct any training or auditing of common canister use. S/he was unaware whether any training or auditing had been done by the Respiratory Department. Manager #3 stated s/he did not like all the MDIs stored in a common bin because that may have presented a contamination risk. Manager #3 stated the facility had talked about changing to nebulizers as a best practice but no specific plans had been finalized.

2. The facility failed to ensure staff disinfected the rubber septums of IV medication vials prior to inserting the needle in 1 of 2 IV medication administration observations.

a) On 08/16/17 at 10:00 a.m., an IV medication administration observation was conducted on the 4th floor telemetry unit for Patient A. The Registered Nurse (RN #4) was observed removing the plastic cap from a 40 milligram (mg) vial of Lasix (used to treat fluid retention). RN #4 then inserted a needle through the rubber septum and removed the medication. RN #4 did not disinfect the top of the vial. This medication was then administered through Patient A's intravenous (IV) catheter.

b) An interview was conducted on 08/16/17 at 10:10 a.m. with RN #4. S/he stated the vial of Lasix was closed, not open; therefore, RN #4 understood s/he was not required to disinfect the rubber septum. RN #4 said s/he had been taught to disinfect the vial only if it was already open.

On 08/16/17 at 4:30 p.m., an interview was conducted with the Infection Prevention Manager #3 (Manager #3). S/he stated s/he was told by newly graduated nurses they had been taught in nursing school it was unnecessary to disinfect the rubber septum of single use vials after removing the plastic top. Manager #3 stated the facility did not have a policy which specified how to open a vial properly. S/he acknowledged there was a possible contamination risk if the staff did not perform hand hygiene or gloving properly.

On 08/17/17 at 8:58 a.m., Manager #3 returned for a second interview. S/he provided a 2016 guideline from APIC, referenced above, which recommended disinfecting the rubber stopper of medication vials with sterile 70% alcohol before inserting a needle. Manager #3 indicated the facility would have to change their practice.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document review, the facility failed to provide ongoing nursing care based on standards of nursing practice and facility policy. In addition, the facility failed to ensure appropriate staff and a physician were notified of changes in the patient's condition in 1 of 10 records reviewed (Patient #4).

This failure created the potential for patients' physical needs not being addressed or monitored.

FINDINGS

POLICY:

According to the Rapid Response/Code Blue (Cardiopulmonary Resuscitation) Response, a patient that has an adverse change in condition and the caregiver feels there is a need for assistance in the treatment or diagnosis of [DIAGNOSES REDACTED]

According to Plan for Patient Care Services, each patient's assessment includes physical, functional, psychological and social status. A plan for patient's care/treatment needs is developed based on analysis of data collected. A Registered Nurse assesses the patient's need for care in all settings where nursing care is provided. Nursing reassessment continues throughout the patient's stay.

According to Chain of Command/ Communication, Patient Care, for clinical issues, the staff member needs to determine the urgency of the issue and move rapidly to the appropriate level or resource person in order to ensure patient safety and an optimal outcome. If unable to reach a physician to address a patient care concern, any of the medical staff leaders have the authority and responsibility to enlist a substitute provider to resolve the immediate problem.

According to Critical Alarms and Patient Safety Guidelines, full assessments in the Progressive Care Unit are expected to be completed every 12 hours, focused system reassessment PRN as condition warrants.

According to Centralized Telemetry Monitoring, telemetry monitoring will not be interrupted unless otherwise ordered by a physician, NP or PA. RN will answer phone calls from the centralized telemetry monitoring station immediately. If the RN does not answer immediately, the Telemetry Technician (TT) will escalate the phone call to next in chain of command (ex: CNC, Manager, Director, Hospital Supervisor, OR TT will call Rapid Response).

RN or nursing designee will respond immediately to the patients' room to assess patient based on information shared by TT on phone call.

Yellow Alarms include non-sustained [DIAGNOSES REDACTED] (VTach) greater than 10 beats, leads becoming detached or loss of tracing for any reason. In the event of a Yellow Alarm, the TT will call the RN, then the Charge RN. If no response within 2 minutes, Call Manager or Director of the unit patient is located. If no answer, immediately call Hospital Supervisor to come immediately to the unit and assess the situation. If the patient has not been placed back on telemetry within 6 minutes, call for Rapid Response.

Green Alarms involve changes that require nurse and physician notification, such as non-sustained VTach less than 10 beats.

1. The facility failed to ensure appropriate staff and medical personnel were notified of abnormal assessment patient findings.

a) A review of Patient #4's Discharge Summary, dated 10/27/16 at 11:06 p.m., revealed the patient was admitted on [DATE] for a presumed Non ST Elevation Myocardial Infarction (Non STEMI). Patient #4 underwent a cardiac catheterization and a balloon angioplasty on 10/07/16.

On 10/17/16 at 8:10 a.m., and at 10:20 p.m. Shift Assessment documentation reported Patient #4 had frequent liquid stools, a tender abdomen at palpation and hypoactive bowel sounds.

Review of Nurse Notes showed the following documentation:

On 10/19/16 at 9:00 a.m., Patient #4 had difficulty swallowing pills and that a physician was paged in order to place a speech therapy order.

At 10:28 a.m. the note stated there was no call back from the physician but that an order for speech therapy had been placed.

At 11:15 a.m. a note entry stated the Registered Nurse (RN) was called by the Certified Nursing Assistant (CNA) and was informed the patient had abdominal discomfort and an increased respiration rate of 24-26 breaths per minute. The physician was paged again at that time.

At 12:00 p.m. a Nurse Notes entry stated there was no call back from the physician about the abdominal distention and that s/he was paged again.

There was no further documentation regarding notification to the Charge Nurse or other medical staff leaders after the physician did not respond to being paged 3 times within a 3 hour period. This was in contrast to facility policy which stated if unable to reach a physician to address a patient care concern any of the medical staff leaders had the authority and responsibility to enlist a substitute provider to resolve the immediate problem.

On 10/19/16 at 1:00 p.m., a Nurse Notes entry stated the RN received call from a physician (a different than the physician previously paged) stating the patient had passed away. The RN went to the room and the patient was unresponsive, cyanotic and no pulses were found. No heart beat was auscultated apically.

b) On 11/02/16 at 9:49 a.m., an interview with RN #4 was conducted who stated s/he recalled caring for Patient #4 on 10/19/16. RN #4 stated the patient was not in pain at first but reported abdominal discomfort to the CNA at around 11:00 a.m. RN #4 stated s/he went into Patient #4's room about 15 minutes later and the patient looked uncomfortable. RN #4 stated s/he thought s/he paged Patient #4's physician between 3 to 4 times that morning with no results.

RN #4 then stated s/he had heard a lot of overhead pages for the same physician that day and that s/he had received a call from pharmacy staff who stated they were also trying to page the physician regarding an unrelated issue. RN #4 further stated s/he did not page anyone else regarding Patient #4's abdominal discomfort.

c) On 11/02/16 at 1:04 p.m., an interview with the Manager of the Progressive Care Unit (Manager #9) was conducted. When asked how long staff were expected to wait for a physician to respond to a page from staff regarding a patient concern, Manager #9 stated it would depend on the severity of the page but generally around 15 minutes would be acceptable. If there was no response, Manager #9 stated staff were expected to repage the physician and notify the charge nurse.

d) On 11/02/16 at 2:32 p.m., an interview with the Chief Nursing Officer (CNO #3) was conducted. CNO #3 stated s/he was not aware of a policy offering guidance on how long staff were expected to wait for a physician to respond to a page before notifying their manager. CNO #3 further stated s/he would expect staff to escalate patient concerns to their manager after paging the physician once or twice and not receiving a response in 15 minutes.

2. The facility did not ensure when policy defined alarms were identified for patients on telemetry monitors that the incidents were being documented by Telemetry Technicians (TT) per facility expectation.

a) Review of the History and Physical (H&P) for Patient #2 revealed the patient was admitted on [DATE] with a chief complaint of progressive generalized swelling and shortness of breath. The H&P reported Patient #2 was markedly hypertensive upon presentation to the emergency room (ER) with a blood pressure of 223/127 millimeters of mercury (mmHg). Patient #2 was admitted for concern of possible nephroti[DIAGNOSES REDACTED].

Review of Patient #2's Nurse Notes dated 10/31/16 revealed Patient #2 experienced 16 beats of [DIAGNOSES REDACTED] (VTach - a very fast heart rate which can lead to negative outcomes for patients) at 7:21 p.m. and 7 beats of VTach at 11:10 p.m.

b) Review of the Daily Worksheet Log used by TTs to document telemetry alarms and communication with staff regarding those alarms revealed no evidence of documentation of the 2 episodes of VTach experienced by Patient #2 on 10/31/16.

c) On 11/02/16 at 10:26 a.m., an interview was conducted with TT #5, who stated s/he worked as a technician in the centralized telemetry unit. TT #5 stated his/her job responsibilities included notifying staff of any telemetry alarms initiated for each patient being monitored and to document the notification on the Log.

TT #5 then stated s/he was recently made aware of a new version of the log but s/he did not receive any education on the expectations for completing the new log.

d) On 11/2/16 at 1:04 p.m., an interview was conducted with the Manager of the Telemetry Technicians (Manager #9). Manager #9 stated a change in the documentation process for the TTs was recently implemented after an event occurred where a patient's heart rhythm was not being displayed on the telemetry monitor for more than 40 minutes due to the battery needing to be changed. During the lapse of monitoring, the patient had died .

After this event occurred, Manager #9 stated a new form was implemented and TTs were expected to document every phone call made to staff notifying them of a telemetry alarm. Manager #9 then reviewed the 2 incidents of VTach that occurred with Patient #2 and verified that the phone calls to notify staff of the irregular heart rhythm were not documented on the form but should have been.

Based on observations and interviews, the facility failed to ensure patient care supplies were stored in a manner to avoid diversion or tampering with from unauthorized personnel.

This failure created the potential for unauthorized staff, patients, and visitors to divert or tamper with supplies intended for patient use.

FINDINGS:

1. The facility did not ensure medications and supplies used for the administration of medications were secured in a manner to avoid diversion or tampering.

a) On 10/31/16 at 2:05 p.m., a tour of patient rooms in the Intensive Care Unit (ICU) was conducted and revealed the following unsecured patient medications and supplies:

ICU Room 5 revealed a mobile supplies cart with no ability to be locked. Two sets of Intravenous (IV) tubing were observed on top of the cart. The first drawer of the cart revealed several blunt tipped needles, 5 prefilled syringes of normal saline, IV caps, and alcohol cleansing wipes. The second drawer of the cart revealed several syringes of various sizes. The third drawer of the cart revealed patient gowns and linens.

ICU Room 40 revealed a mobile supplies cart with no ability to be locked. The first drawer of the cart revealed several alcohol cleansing wipes, IV caps and electrocardiogram (EKG) electrodes. The second drawer of the cart revealed several syringes of various sizes. The third drawer of the cart revealed patient gowns and linens.

b) On 10/31/16 at 2:30 p.m. a tour of the Emergency Department (ED) was conducted. During the tour, an unlocked mobile supplies cart was located in a hallway outside of the triage room. Inspection of the drawers of the cart revealed blunt IV needles, angio catheters, band aids, 5 IV starter kits and dressings, 7 1000 milliliter (ml) IV bags of normal saline, and 17 prefilled syringes of normal saline.

c) On 11/01/16 at 9:28 a.m., an interview was conducted with a Registered Nurse (RN #1), who stated s/he worked in the ICU. RN #1 stated the facility was in the process of working on obtaining supplies carts for each patient room that could be locked. RN #1 then stated there was no way to ensure supplies stored in the current supplies cart were free from being diverted or tampered with.

d) On 11/02/16 at 1:57 p.m., an interview was conducted with RN #2 who stated s/he worked as a charge nurse in the ED. RN #2 stated the supplies cart located outside of the triage room was expected to be locked at all times. RN #2 then stated s/he was unaware of why the cart had been observed unlocked but that staff knew it was supposed to be locked.

e) On 11/02/16 at 2:32 p.m., an interview with the Chief Nursing Officer (CNO #3) was conducted. CNO #3 stated it had been common practice to have unlocked supplies carts located in each ICU patient room. CNO #3 then stated the expectation was to empty and discard all supplies in the carts after patients were discharged ; however, there did not seem to be a consistent practice for ensuring this was done.

Based on interviews and document review, the facility failed to provide nursing staff to meet patients' needs and care. The facility failed to ensure nursing care was provided in accordance with acceptable standards of practice during medication administration.

This failure created delays in medications administration which could change or impact the intended therapeutic or pharmacological effect of the prescribed medication.

FINDINGS:

POLICY

According to the policy, Medication Management: Administration, non-time-critical medications will be administered within 1 hour before or after the scheduled dosing time, for a total window of 2 hours. These are medications for which a longer or shorter interval of time since the prior dose does not significantly change the medication's therapeutic effect.

Time-critical medications will be administered within 30 minutes before or after the scheduled dosing time, for a total window of 1 hour. These are medications for which an early or late administration of greater than thirty minutes may have significant impact on the therapeutic or pharmacological effect. Medications/medication classes that apply include: any medication prescribed more frequently than every 4 hours, anticonvulsant's (scheduled), immune agents (scheduled), pain medication (scheduled).

1. The facility failed to ensure patients received their scheduled medications within the appropriate time frame.

a) On 06/02/16 at 7:48 a.m., an interview was conducted with Registered Nurse (RN) #1 who stated the RN to patient ratio on the East unit of the Adult Behavioral Unit was high at nights. RN #1 stated the prior week, s/he was assigned to 14 patients, which resulted in patients receiving his/her medications after the scheduled time frame.

b) On 06/02/16 at 9:40 a.m., an interview was conducted with RN #2 who worked in the Adult Behavioral Unit during the day shift. RN #2 stated, although s/he worked the day shift, s/he noticed the night shift was frequently short staffed RNs, specifically the east unit.

c) Review of staffing for the night shift on 05/23/16, revealed RN #1 was assigned for the care of 13 patients on the East Unit. Two of the 13 patients' Medication Administration Records (MARs) were reviewed and showed scheduled medications were given outside of the time frame allowed per policy. Patient A was scheduled to be given 2 non-time-critical medications at bedtime, 09:00 p.m. Both medications were documented as given by another RN assigned to the West Unit, approximately 28 minutes past the 1 hour time frame allowed by policy. Patient B was scheduled 3 medications at 9:00 p.m. One of the medications was a time-critical medication, Lamictal, which was an antiseizure medication. RN #1 documented the medication was given 1 hour and 30 minutes after the scheduled time frame. This was in contrast to policy.

d) Review of staffing for the night shift on 05/26/16, revealed Registered Nurse (RN #3) was assigned for the care of 14 patients on the East Unit. Two of the 14 patients Medication Administration Records (MARs) dated 05/26/16 were reviewed and showed scheduled medications were given outside of the time frame allowed per policy. Patient A was scheduled to have been given a non-time-critical medication at bedtime, 9:00 p.m. RN #3 documented the medication was given at 10:28 p.m., which was 28 minutes after the 1 hour time frame allowed. Patient B was scheduled to have been given 2 non-time-critical medications and 1 time-critical medication at bedtime. All 3 medications were given outside of the time allowed according to policy. The time-critical medication, Depakote, which was given to prevent seizures, should have been given within 30 minutes prior to or after 9:00 p.m. RN # 3 documented the medication was given at 10:05 p.m.

e) Review of staffing for the night shift on 05/27/16, revealed RN #4 was assigned for the care of 11 patients on the East Unit. Two of the 11 patients' MARs were reviewed and showed Patient B was scheduled to be given 1 non-time-critical medication at 9:00 p.m.. RN #4 documented the medication was given at 10:19 p.m. This was in contrast to policy.

f) On 06/02/16 at 3:14 p.m., an interview was conducted with the Chief Nursing Officer (CNO #5) who stated if an RN was assigned to 14 patients: the timeliness of medication administration could have been impacted. CNO #5 stated s/he was not aware of patient medications being given late per facility policy.

Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 484.13, PATIENT RIGHTS, was out of compliance.

A0118 - Standard: Notice of Rights: The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The facility failed to inform the patient who to contact to file a grievance and failed to initiate the grievance procedure on the patient's behalf.

A0143 - Standard: Patient Rights: Personal Privacy. The patient has the right to personal privacy. The facility failed to ensure the personal privacy of patients who received care while placed in hall beds located in the emergency department's corridors.

A0144 - Standard: Patient Rights: Care in a Safe Setting. The patient has the right to receive care in a safe setting. The facility failed to ensure the safety of patients in the Emergency Department (ED) by allowing hall beds, equipment, and patient visitors to obstruct the emergency department corridors. Furthermore, the facility failed to ensure the safety of hall bed patients by neglecting to provide a nurse-call signal system at every hall bed.

Based on interviews and document review, the facility failed to inform the patient who to contact to file a grievance and failed to initiate the grievance procedure on the patient's behalf.

The failures resulted in the patient's grievance not being reported, investigated, and resolved and created the potential for other patient grievances to not be reported, investigated, and resolved.

FINDINGS:

POLICY

According to the facility grievance process, every effort will be made to resolve patient grievances promptly. If concerns cannot be resolved, the director of the appropriate department will attempt a resolution. If a patient remains dissatisfied with the initial attempts at resolution, s/he may initiate a grievance procedure by contacting the Patient Advocate.

1. The facility failed to inform Patient #2 who to contact to file a grievance, failed to initiate the grievance procedure on the patient's behalf, and took away the patient's means to escalate and report the grievance on his/her own.

a) Medical record review revealed Patient #2 received services at the Emergency Department (ED) beginning on 04/14/15.

Review of the Case Management Report, dated 04/17/15, revealed Social Worker #15 (SW) documented the patient stated s/he was being starved, and was being physically abused by a staff member. The patient was initially provided a phone, but the patient's phone privileges were taken away when the patient called the hospital operator and asked to be transferred to the Charge RN so s/he could report the alleged abuse.

b) On 05/06/15 at 9:31 a.m., a telephone interview was conducted with SW #15 who was assigned to the patient when the allegation of abuse occurred. The patient informed SW #15 that s/he was being abused. According to SW #15 the patient stated s/he had food withheld and that she was physically abused by a staff member. SW #15 stated s/he did not consult his/her supervisor regarding this particular patient's abuse allegations because his/her supervisor knew broadly the difficult nature of the patient who was alleging abuse and why the patient was in the Medical Decision Unit for the duration s/he was. SW #15 did not initiate the grievance procedure on the patient ' s behalf and the patient ' s complaint was not investigated and resolved.

c) On 05/06/15 at 9:46 a.m., an interview with the Vice President (VP) of Quality and Performance Improvement confirmed the grievance procedure was not initiated for Patient #2 ' s allegation of abuse, and s/he had no knowledge of the allegation..

Based on observations, interviews, and document review, the facility failed to have a process in place to ensure the personal privacy of patients who received care while placed in hall beds located in the Emergency Department (ED) corridors.

This failure created instances in which patients were asked personal questions, received physical assessments, nursing care, diagnostics, education, and discharge instructions while in open corridors within the Emergency Department without processes in place to ensure their privacy.

FINDINGS:

Policy

According to facility policy, Patient Rights, all patients are to be treated in a manner that preserves their dignity, autonomy, self-esteem, civil rights, and involvement in their own care.

1. The ED staff provided care to patients in hall beds without ensuring the use of screens, curtains, or other measures to ensure patients' personal privacy and confidentiality of sensitive patient-staff conversations.

a) On 05/04/15 at 9:20 a.m., a tour of the ED was conducted with the Quality Manager, Chief Nursing Officer (CNO), ED Medical Director, ED Manager and Registered Nurse #6 (RN). RN #6 stated the ED was divided into 6 areas: West Wing, East Wing, Pediatric area, Medical Decision Unit, North Wing, and Triage area. In total, the ED had 50 beds which included the triage area.

The hall beds were located in open corridors in the West Wing and East Wing of the ED. Hall bed patients, patients admitted to ED rooms, and visitors to the ED had access to and were moved through the ED corridors. Patients admitted to hall beds were visible to other patients and visitors to the ED.

On 05/04/15 at 3:40 p.m., an additional tour of the ED was conducted. Upon entry to the ED, observation revealed Patient #3 and Patient #4 placed in hall beds in the West Wing of the ED. Patient #4 was observed in hall bed B in street clothes sitting on the edge of the bed. Hall bed B was located across from room 6. Directly down the line of beds, on the same side of the hall, Patient #3 was observed in Hall bed C. Hall bed C was located across from room 5. No privacy screen or curtain was present for either patient. The patients were receiving care in open corridors in which other patients and visitors to the ED also had access.

b) On 05/04/15 at 4:30 p.m., an interview was conducted with RN #8 who stated when all ED rooms were full the patient would be placed in a hall bed so care could be initiated. The care could include a head-to-toe assessment, x-rays, and insertion of an intravenous (IV) catheter while in a hall bed. RN #8 stated s/he would maintain an appropriate level of voice when speaking about care with the patient as a way to ensure privacy.

On 05/05/15 at 2:15 p.m., an interview with RN #13 was conducted. RN #13 stated maintaining privacy was a difficult one for patients in hall beds. RN #13 stated s/he would try to use a low tone of voice as a way to ensure patient privacy while in a hall bed. RN #13 stated patients were placed in hall beds every single day because the ED was busy.

c) During a tour of the ED on 05/04/15 at 9:20 a.m., RN #6 stated the normal flow of patients through the ED would be to check in at the front desk and the RN at the desk would determine if the patient would be immediately bedded, in the case of an emergent situation. In the case of a less emergent situation, the patient would go through the Rapid Medical Examination area. The patient could be placed in a hall bed if no ED rooms were available.

During the same ED tour, the ED Medical Director stated the patient's treatment could get started and a Medical Screening Exam (MSE) could be initiated while the patient was in a hall bed.

Also on the same ED tour, the CNO added that the facility would not go on divert if the ED was full, instead they would do a lot of shuffling of patients. This meant a patient could be assigned to a hall bed to initiate assessment and treatment, then relocated to an ED room, then relocated back to a hall bed to receive education, discharge instructions, and complete their ED visit.

d) ED medical records and Patient Audit Trail reports were reviewed for 7 patients who received care while in hall beds (Patients #1, #3, #4, #5, #7, #8, and #9). Each of the patients admitted to a hall bed received nursing assessments, which included detailed personal questions. Additionally, patients received medical screening exams, had blood and urine collected, initiation of an IV, and received education and discharge instructions, including a review of home medications. The medical records did not reflect how patient privacy was ensured while sensitive patient information was discussed with the patient in the hallway.

e) Review of the Patient Audit Trail report, dated 05/05/15, revealed Patient #9 arrived at the ED, on 03/24/15, with a chief complaint of abdominal pain, was admitted to the hospital's ED at 11:40 a.m. and was not admitted to an ED room until 3:23 p.m. (more than 3 1/2 hours later). There was no documentation to show where the patient was located while services were provided during the 3 1/2 hours s/he was not assigned an ED room.

According to Emergency Patient Record review, dated 03/24/15, the patient had the following treatments and assessments performed prior to assignment of an ED room: an ED RN inserted a 20 gauge single lumen peripheral catheter, blood and urine were collected and results were posted by the Laboratory Department.

Patient #9 remained in an ED room, from 3:23 p.m., until being relocated to Hall Bed E at 7:07 p.m. and subsequently discharged at 7:30 p.m. According to the Emergency Patient Record, RN #18 provided wound care to the patient's abdomen and provided discharge instructions and teaching to Patient #9 at 7:19 p.m., while the patient was located in Hall Bed E with no means to ensure his/her privacy.

f) Review of the Patient Audit Trail report, dated 05/05/15, revealed pediatric Patient #4 arrived at the ED, on 05/04/15, with a chief complaint of headache, was admitted to the hospital's ED at 1:41 p.m. and was admitted to Hall Bed C at 2:02 p.m. The patient's entire course of ED assessment, treatment, discharge instructions, and teaching occurred while the patient was in Hall Bed C until s/he was discharged home at 3:58 p.m. (more than two hours later).

Per the Emergency Provider Report, dated 05/04/15, a Medical Screening Exam (MSE) was performed, and medications were ordered and administered while the patient was in Hall Bed C.

According to Emergency Patient Record review, dated 05/05/15, the patient had the following treatments, assessments, and teaching performed while assigned to a hall bed: vital signs and urine were collected, subjective patient assessments including questions about pain and details of the chief complaint were asked, fall risk education was completed, focused physical assessments that included the patient's gastrointestinal system, mucous membranes, and cardiovascular system (including assessment of capillary refill and pedal pulses) were conducted. The ED RN asked the patient questions of abuse, being bullied, medical history, surgical history, immunization history, time and content of last nutritional intake, vomiting episodes in previous 24 hours, and inquired if the patient had recent appetite or feeding changes.

Per Emergency Patient Record review, the patient was diagnosed with UTI/Cystitis, given discharge instructions, discharge education, and received a discharge prescription while s/he was in Hall Bed C.

g) Review of the Patient Audit Trail report, dated 05/05/15, revealed pediatric Patient #3 arrived at the ED, on 05/04/15, with a chief complaint of abdominal pain, vomiting, diarrhea, and headache, was admitted to the hospital's ED at 1:08 p.m. and was assigned Hall Bed B at 2:14 p.m. until s/he was relocated to ED Room 8 at 3:52 p.m. (more than 1 1/2 hours later).

According to Emergency Patient Record, dated 05/04/15, a detailed physical assessment, which included neurological, musculoskeletal, eye, gastrointestinal, genitourinary, respiratory, integumentary, cardiovascular, psychosocial, and circulatory assessments and subjective assessments including pain, chief complaint onset, and frequency of signs and symptoms, was conducted while Patient #3 and family were in Hall Bed B and not assigned to an ED room. The parent received education regarding medications, disease process, safety, discharge planning, procedures, and ED after care.

Additionally, as part of the detailed assessment, Patient #3's parent was asked questions pertaining to his/her child while not assigned to an ED room, such as if s/he was being bullied, if s/he was being threatened by anyone, medical history, surgical history, immunization history, if there were cultural, religious, language, developmental, or behavioral factors to consider in planning the patient's care, if the patient had attempted suicide in the past year, if the patient had any behavioral related complaints, if the patient had any weakness, dizziness, syncope, seizure history, history falling within the last 30 days, inability to bear weight, and if the patient had used medications that cause drowsiness.

h) Review of the Patient Audit Trail report, dated 05/05/15, revealed Patient #1 arrived at the ED, on 03/05/15, with a chief complaint of headache, was admitted to the hospital's ED at 6:19 p.m., was assigned Hall Bed B and not relocated to an ED Room 6 until 9:33 p.m. (more than 3 hours later).

According to Emergency Patient Record, dated 03/05/15, the patient received a detailed physical assessment, insertion of a peripheral catheter and assessments and reassessments of the patient's head pain.

The patient was asked questions including if s/he thought his/her safety was being threatened by anyone, medical history, surgical history, home medication reconciliation, nutritional assessment, functional assessment, tobacco history, alcohol history, drug use history, cultural, religious, language, developmental, and behavioral factors the staff should consider while providing care to the patient, if s/he experienced weakness, dizziness, syncope or seizure, history of falling in the last 30 days, moderate to severe brain injury, altered loss of consciousness - including drug &/or alcohol impairment, lower extremity neurovascular impairment or inability to bear weight, use of medication causing drowsiness or sedation, any behavioral related complaints (anxiety, depression, aggression, or thoughts of suicide), and if the patient used assistive devices.

According to Emergency Patient Record review, the patient received education and verbalized understanding of the following subject items while in a hall bed and not assigned to an ED room: medications, disease process, pain management, and fall risk education. The patient was encouraged to verbalize anxieties and reassurance was given. The patient was informed of his/her condition and treatment plan, and the patient was encouraged to give input and participate in treatment.

i) Review of the Patient Audit Trail report, dated 05/05/15, revealed Patient #7 arrived at the ED, on 08/11/14, with a chief complaint of multiple injuries secondary to an assault and was admitted to the hospital's ED at 10:52 a.m. The patient was assigned Hall Bed 1 at 10:59 a.m. until s/he was relocated to ED Room 12 at 11:21 a.m.

According to the Emergency Patient Record, dated 08/11/14, the patient received a detailed assessment and was asked questions regarding if s/he thought her/his safety was being threatened by anyone s/he knew, previous medical history, alcohol history, and drug use history while assigned to a hall bed.

j) Review of the Patient Audit Trail report, dated 05/05/15, revealed Patient #8 arrived at the ED with a chief complaint of abdominal pain, was admitted to the hospital's ED on 10/21/14 at 11:41 a.m. and was not admitted to an ED room until 2:00 p.m. (over two hours later).

According to Emergency Patient Record review, dated 10/23/14, the patient had the following treatments and assessments performed prior to assignment of an ED room: an ED RN inserted a 20 gauge single lumen peripheral catheter, blood and urine were collected and results were posted by the Laboratory Department. Additionally, the patient was asked personal sensitive questions before s/he was assigned an ED room.

k) Review of the Patient Audit Trail report, dated 05/05/15, revealed Patient #5 arrived at the ED with a chief complaint of hip pain and was admitted to Hall Bed A on 05/04/15 at 1:05 p.m. until s/he was relocated to ED Room 1 at 1:35 p.m.

According to Emergency Patient Record, dated 05/04/15, the patient received a rapid initial assessment which included questions regarding his/her medical history, surgical history, functional assessment, living arrangements, tobacco history, alcohol history, and drug use history while located in a hall bad with no privacy.

Based on observations, interviews, and document review, the facility failed to ensure the safety of hall bed patients by neglecting to provide a call system for hall beds.

The failure created the potential for an increased risk to patient safety and negative patient outcomes.

FINDINGS:

POLICY

According to the facility policy, Patient Rights and Responsibilities, the patient has a right to reasonable and safe practices and environment.

1. The facility failed to provide a call system for all hall beds in the Emergency Department (ED) for patient use and safety.

a) On 05/04/15 at 9:20 a.m., a tour of the ED with the Quality Manager, Chief Nursing Officer (CNO), ED Medical Director, ED Manager, and Registered Nurse #6 (RN) was conducted. During the ED tour, the ED Medical Director stated every hall bed had a call system. Observations of the ED revealed call systems were not present at 8 of the 8 hall beds (Hall beds A, B, C, D, and 4 unlabeled beds).

In the West Wing hall, across from Exam Rooms 5 and 6, five patient beds were observed in a line against the wall. These beds were labeled Hall A, Hall B, Hall C, Hall D, and one bed without identification. All five beds had a fitted sheet, draw sheet, folded blanket and a patient gown placed on top. Two vital sign machines were observed plugged into the wall between the first two and the last two beds.

During the same ED tour, the ED Medical Director consulted RN #7 regarding call systems for ED hall beds. RN #7 stated none of the hall beds were equipped with a call system. The CNO added the hall beds were used as more of a staging area.

In the East Wing of the ED, 2 unlabeled beds were observed in the hall. There was 1 bed outside of Room 13 and 1 against the wall between Rooms 17 and 18. Neither of these beds was noted to have a call system. The ED Medical Director stated this was a true staging area and patients would not be in the beds very long.

b) On 05/04/15 at 3:40 p.m., an additional tour of the ED was conducted. Observation in the West Hall revealed Hall B had a female patient in street clothes sitting on the bed without a call system and Hall D had an adult male, a young child and Patient #4 holding a white bag for emesis with no access to a call system

During an interview with RN #7 at 3:45 p.m. on 05/04/15, s/he stated hall beds would be in constant vision of the ED staff and a patient could call out if they needed anything. The patients could be on heart monitors and would be able to have vital signs performed. However, RN #7 stated none of the patients in hall beds would have a call system.

Further observation revealed, six of the eight hall beds (A, B, C, and D plus two additional unlabeled hall beds) were not visible by or in close proximity to either of the two nursing stations or either of the two unit secretaries who answered the call system in the ED.

c) On 05/04/15 at 4:20 p.m., an interview with the parent of Patient #3 was conducted in Room 8. The parent stated s/he was in the hall bed for about one hour and was not provided a call system. The parent stated, the nurse said to grab me if you need me.

Review of Patient #3's Patient Audit Trail report, dated 05/05/15, revealed the patient was placed in Hall C from 2:02 p.m. until 4:06 p.m. (more than two hours without access to a call system) before being moved to Room 8.

d) On 05/05/15 at 2:20 p.m., an interview with RN #13 was conducted in the ED. RN #13 stated if a patient needed something while in a hall bed they could just tell us since they are only 3 feet away, so it is actually an ideal situation. S/he further stated the unit clerk would ask the patient what they needed and the unit clerk would tell the nurse responsible for the patient. According to RN #13, some assessments would be delayed if a patient was in a hall bed. As example, s/he would wait to call for an ultrasound or electrocardiogram (EKG) if a patient was in a hall bed.

Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 482.41, PHYSICAL ENVIRONMENT, was out of compliance.

A0725 - Standard: Physical Environment: The extent and complexity of facilities must be determined by the services offered. The facility failed to ensure the Emergency Department was designed to accommodate the volume of patients who presented to and were treated in the Emergency Department (ED).

Based on observations, interviews, and document review the facility failed to ensure the Emergency Department (ED) was designed to accommodate the extent and volume of patients who presented to and were treated in the ED. Furthermore, the facility failed to ensure the safety of hall bed patients by neglecting to provide a call system for hall beds.

The failure created the potential for an increased risk to patient safety related to patients receiving treatment in the emergency department corridors. Additionally, the lack of a call system created the potential for negative patient outcomes.

FINDINGS:

1. The facility was not appropriately designed and equipped for the volume of patients who presented to the Emergency Department.

a) On 05/04/15 at 9:20 a.m., a tour of the ED was conducted with the Quality Manager, Chief Nursing Officer (CNO), ED Medical Director, ED Manager and Registered Nurse #6 (RN). RN #6 stated the ED was divided into 6 areas: West Wing, East Wing, Pediatric area, Medical Decision Unit, North Wing, and Triage area. In total, the ED had 50 beds which included the triage area. Hall beds A, B, C, D were located in the West Wing of the ED. Two unidentified hall beds were located in the East Wing of the ED. The hall beds were positioned in the corridors of the ED.

Observation during the ED tour in the West Wing revealed 5 patient beds in line against the wall across from ED Rooms 5, 6, and 7. These beds were labeled Hall A, Hall B, Hall C, Hall D, and one bed without identification. All five beds had a fitted sheet, draw sheet, folded blanket and a patient gown placed on top. Two vital sign machines on wheels were observed plugged into the wall between the first two and the last two beds. Directly around the corner from Hall D, across from the EMS Lounge, was an unlabeled patient bed. Two additional unlabeled beds were observed in the East Wing. One placed outside of ED Room 17 and one placed outside of ED Room 13. The unlabeled beds had fitted sheets, draw sheets, folded blankets and patient gowns on top of each.

During the same tour, the CNO stated the ED could see over 200 patients a day with 50 beds and would not go on divert when at capacity. The CNO stated last year there were only 10 hours of divert time related to equipment not working. Further, s/he stated the facility had to meet the needs of the community, so there was a lot of shuffling to accommodate their volume.

b) On 05/04/15 at 3:40 p.m., an additional tour of the ED was conducted. Observation in the West Wing revealed Hall B, across from ED Room 6, had a female patient in street clothes sitting on the bed without a call system. Hall D, across from ED Room 5, had an adult male, young child, and Patient #4 holding a white emesis bag without a call system. An additional unlabeled bed was observed during this ED tour, in the hall across from the EMS Lounge.

During an interview with RN #7 at 3:45 p.m. on 05/04/15, s/he stated hall beds would be in constant vision of the ED staff and a patient could call out if they needed anything. The patients could be on heart monitors and would be able to have vital signs performed. RN #7 stated none of the patients in hall beds would have a call system.

However, observation revealed 6/8 hall beds (A, B, C, and D plus two additional unlabeled hall beds) were not visible from or in close proximity to either of the two nursing stations or either of the two unit secretaries who answered the call system in the ED.

c) On 05/04/15 at 4:30 p.m., an interview was conducted with RN #8. S/he stated if all the ED rooms were full, a patient would be placed in a hall bed so treatment could be initiated. RN #8 stated a head-to-toe assessment could be performed in a hall bed and an intravenous (IV) catheter could be inserted. The ED staff would have to rely on the patient to flag down a staff member who would find the nurse by checking the RN assignment board, before the patient could receive assistance.

d) On 05/05/15 at 2:20 p.m., during an interview with RN #13, s/he stated some assessments could be delayed if a patient was in a hall bed. RN #13 stated s/he would wait to call for an ultrasound or electrocardiogram (EKG) if a patient was in a hall bed.

e) On 05/05/15 at 2:50 p.m., an interview with RN #7 revealed if a hall bed patient had an emergency s/he would ask the ED staff which patient could be moved from an ED room into the hall so the emergent hall bed patient could have a room. RN #7 stated they constantly shuffled patients in and out of rooms to accommodate their volume of patients.

RN #7 stated if a patient was sick enough to need a room we would do a shuffle and take another patient out of an ED room and place them in a hall bed so the sick patient could have the room. RN #7 acknowledged a patient could be placed in a hall bed, moved to a room, than placed again in a hall bed because higher acuity and sicker patients received the ED rooms.

f) Review of the Patient Audit Trail report, dated 05/05/15, revealed Patient #1 arrived at the ED, on 03/05/15, with a chief complaint of headache, was admitted to the hospital's ED at 6:19 p.m., was assigned Hall Bed B and not relocated to an ED room until 9:33 p.m. (more than 3 hours later).

g) On 05/04/15 at 4:20 p.m., an interview with the parent of Patient #3 was conducted in Room 8. The parent stated s/he was in the hall bed for over one hour until provided an ED room, and was not provided a call system. The parent stated, the nurse said to grab me if you need me. Review of Patient #3's medical record revealed the patient was placed in Hall C from 2:02 p.m. until 4:06 p.m. (more than 2 hours), before being moved to Room 8.

h) On 05/05/15 at 10:57 a.m., an interview with the Patient Representative (PR) was conducted. The PR stated the facility received multiple patient grievances in the past year related to patients being placed in hall beds. S/he stated patients usually felt the ED was so busy that they did not get their basic needs met.

The PR stated Patient #1 was in an ED hall bed for way too long (more than 3 hours). While in the hall bed, the patient was not offered water or pillows for several hours. The PR stated that was inhumane treatment and the patient was very upset.

2. The facility failed to provide a call system for all hall beds in the Emergency Department (ED) for patient use and safety.

a) During the tour, on 05/04/15 at 9:20 a.m., the ED Medical Director stated every hall bed had a call system. Observations of the ED revealed call systems were not present at 8 of the 8 hall beds (Hall beds A, B, C, D, and 4 unlabeled beds).

During the same ED tour, the ED Medical Director consulted RN #7 regarding call systems for ED hall beds. RN #7 stated none of the hall beds were equipped with a call system. The CNO added the hall beds were used as more of a staging area.

In the East Wing of the ED, 2 unlabeled beds were observed in the hall. There was 1 bed outside of Room 13 and 1 against the wall between Rooms 17 and 18. Neither of these beds was noted to have a call system. The ED Medical Director stated this was a true staging area and patients would not be in the beds very long.

b) On 05/04/15 at 3:40 p.m., an additional tour of the ED was conducted. Observation in the West Hall revealed Hall B had a female patient in street clothes sitting on the bed without a call system and Hall D had an adult male, a young child and Patient #4 holding a white bag for emesis with no access to a call system

During the interview with RN #7, at 3:45 p.m. on 05/04/15, s/he stated hall beds would be in constant vision of the ED staff but none of the patients in hall beds would have a call system.

Further observation revealed, six of the eight hall beds (A, B, C, and D plus two additional unlabeled hall beds) were not visible by or in close proximity to either of the two nursing stations or either of the two unit secretaries who answer the call system in the ED.

c) On 05/05/15 at 2:20 p.m., an interview with RN #13 was conducted in the ED. RN #13 stated if a patient needed something while in a hall bed they could just tell us since they were only 3 feet away, so it is actually an ideal situation. S/he further stated the unit clerk would ask the patient what they needed and the unit clerk would tell the nurse responsible for the patient and acknowledged the patient did not have access to a call system.

Building A4-South Campus-Cardiac Tower

Through observation during the survey, March 18 through March 26, 2014, it was determined that the facility failed to install the Alcohol Based Hand Rub (ABHR) dispensers correctly.

During the walkthrough of the facility, with the Director of Plant Operations, four (4) sets of ABHR's were installed within six (6') of each other on the third (3rd) floor ICU floor.

Note: Corrected during the survey

This deficiency effecetd 1 of 8 smoke compartments

Based on the onsite validation survey, completed between Mrch 18 through March 26, 2014, the facility failed to comply with the regulations set forth for Life Safety and, therefore, deficiencies were cited under Life Safety Code tags K0018, K0025, K0027, K0038, K0046, K0052, 0062, K0069, K0072, K0078, K0144, K-0154 and K0211. See survey event ID #A11X21 for full details of the cited deficiencies.

Based on record review, staff interview, and review of the facility's policies/procedures the facility failed to ensure that emergency services were integrated with other departments of the hospital.

Findings:

1. The facility failed to ensure that the Nuclear Medicine Department was integrated with the Emergency Department. The technician for the Nuclear Medicine department failed to respond timely to a request for a STAT Nuclear Medicine study to be performed on Sample patient #2.

a. Policies/Procedure Review

A review of the facility's policy, Provisions for 'On Call' Exams revealed:

After normal business hours technologists are on call for Nuclear Medicine...Upon notification of procedure required the on call technologist will be paged and/or called by the Imaging Department Staff...

The technologist on call must respond to the page within 10 minutes. They must arrive at the facility to perform the procedure within 45 minutes at all campuses.

b. Medical Record Review

A review of Sample patient #2's record revealed that the patient presented to the facility's Emergency Department with a complaint of shortness of breath on 03/05/12 at 3:39 p.m. The physician's assistant ordered a nuclear medicine study STAT at 5:37 p.m. A nursing notation at 5:44 p.m. stated that the patient was waiting for the nuclear medicine study to be performed. A notation from the nurse at 7:45 p.m. stated that the patient was informed that the facility was awaiting the nuclear medicine study to be performed. The patient left against medical advice at 9:20 p.m. after being informed that the department was awaiting the nuclear medicine technologist.

c. Facility Document Review

A review of the time clock entry in the presence of the facility's Compliance Manager revealed that the nuclear medicine technologist arrived at the facility at 9:00 p.m. The facility did not maintain documentation of when the technologist had been called by either the radiology department or the emergency department.

d. Staff Interview

An interview with the facility's Compliance Manger conducted on 06/28/12 at 9:22 a.m. revealed that the Nuclear Medicine department closed at 4:30 p.m. each day. S/he stated that the person entering the order for a nuclear medicine study would need to call the main radiology department to have the technologist called. A subsequent interview on 06/28/12 at 12:06 p.m. revealed that the Nuclear Medicine department did not keep any type of log to track when technicians were called or responded to pages. S/he stated that the technician had clocked in at 9:00 p.m. and had checked the computer order at 9:41 p.m. A subsequent interview on 06/28/12 at 1:59 p.m. revealed that after s/he had a discussion with the Director of the Radiology department was that there was no documentation or indication that the radiology department was aware of the issue with the delayed response of the Nuclear Medicine technician. S/he stated that no changes had been made as the department was not aware of any issue.

Based on staff interviews and review of medical records and policies and procedures, the facility failed to comply with the Medicare provider agreement as defined in 489.20 and 489.24 related to EMTALA (Emergency Medical Labor and Treatment Act) requirements.

The facility failed to meet the following requirements under the EMTALA regulations.

Reference Tag A2406 Appropriate Medical Screening Examination. The facility's Bylaws and Medical Staff Rules/Regulations did not state that Physician Assistants were Qualified Medical Personnel appropriate to conduct Medical Screening Exams.

Based on review of facility documents, credential files, and staff interviews, the facility failed to ensure that each individual who conducted Medical Screening Exams within the facility was determined qualified by hospital Bylaws or Rules and Regulations. Specifically, the facility's Bylaws and Medical Staff Rules/Regulations did not state that Physician Assistants were Qualified Medical Personnel appropriate to conduct Medical Screening Exams. This failure created the potential for a negative outcome.

The findings were:

The facility's Medical Staff Bylaws were reviewed on 7/5/11 and stated the following, in pertinent part: Qualified Medical Person or Personnel: In addition to a Physician, Qualified Medical Person may perform a medical screening examination. Individuals in the following professional categories who have demonstrated current competence in the performance of medical screening examinations, and who are functioning within the scope of his or her license and policies of the Hospital, have been approved by the Board as Qualified Medical Personnel: Registered Nurse in Perinatal Services, Psychiatric Social Worker, Registered Nurse in Psychiatric Services, or Psychologist.

The facility provided the policy titled EMTALA- Definitions and General Requirements, which was labeled as their corporate policy and not a policy adopted and approved by the facility. Although the policy stated that a Physician Assistant was an example of a professional that may be approved by the hospital's governing board as qualified to administer one or more types of initial MSEs, the policy was not facility specific. Regardless, the facility's governing board did not state in its Bylaws or Rules and Regulations that Physician Assistants had been approved to perform MSEs.

Two Physician Assistant Credential files (samples #1 & #2) were reviewed on 7/5/11. The privileging section stated that each were approved to perform medical screening exams... and that additional documentation related to such included ...physician must contemporaneously review and co-sign ED record (by end of shift.) Review of twenty medical records revealed that, in the cases where Physician Assistants were utilized to provide Medical Screening Exams, the documentation was co-signed by a physician.

An interview with the interim Chief Nursing Officer was conducted, on 7/5/11 at approximately 1:40 p.m. S/he referenced the above excerpt from the Medical Staff Bylaws and stated, This is the only place in the bylaws that says who can do the MSE... S/he stated that with Physician Assistants, it would be part of the credentialing process. It wouldn't be in a specific policy and procedure. On 7/5/11 at approximately 3:15 p.m., the Assistant Vice President of Quality and Performance Improvement confirmed that the Medical Staff Bylaws/Rules and Regulations stated other License Independent Practitioners could perform Medical Screenings Exams, but did not state that Physician Assistants were approved to do so.