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Based on document review and interviews, the facility failed to maintain a log or other system to document deaths which occurred when patients were in any type of restraints.

Findings include:

Facility policy:

The Patient Restraint policy read, the hospital must report deaths associated with the use of a restraint. With the exception of deaths described under paragraph (11)(2) of this section, the hospital must report the following information to Centers for Medicare and Medicaid Services (CMS) no later than the close of business on the next business day following knowledge of the patient's death for: Each death that occurs while a patient is in a restraint. Each death that occurs within 24 hours after the patient has been removed from restraint. Each death known to the hospital that occurs within 1 week after restraints where it is reasonable to assume that use of restraint contributed directly or indirectly to a patient's death, regardless of the type(s) of restraint used on the patient during this time. "Reasonable to assume" in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing, or asphyxiation.

When the only restraints used on the patient are those applied exclusively to the patient's wrist(s), and which are composed solely of soft, non-rigid, cloth-like materials, the hospital staff must record in an internal log the following information: Any death that occurs while a patient is in such restraints. Any death that occurs within 24 hours after a patient has been removed from such restraints.

The staff must document in the patient's medical record the date and time the death is reported to CMS for deaths described in paragraph (11)(1) of this section in the internal log for deaths described in paragraph (11)(2) of this section.

For deaths described in paragraph (11)(2) of this section, entries into the internal log or other system must be documented as follows: Each entry must be made not later than seven days after the date of death of the patient. (ii) Each entry must document the patient's name, date of birth, date of death, name of attending physician or other licensed independent practitioner who is responsible for the care of the patient, medical record number, and primary diagnosis(es).(iii) The information must be made available in either written or electronic form to CMS immediately upon request.

1. The facility did not maintain a log or other system to document the death of a patient which occurred while the patient was in restraints.

a. The facility provided restraint audits performed monthly as their restraint log. Review of the restraint audits revealed no documentation if the patient expired in restraints, or whether the patient expired within 24 hours of restraint use or within one week if the death was associated with the restraint.

b. Interviews with staff revealed the facility did not monitor or report any patient deaths which occurred while in restraints.

i. On 9/21/21 at 2:58 p.m., Director #9 was interviewed as she provided a restraint report. Director #9 stated she was asked to provide a report of patients who had died in restraints. Director #9 stated she was able to run two reports. The first report was all the patients who had expired in the facility from 10/1/20. The second report was all the patients from the same time frame who had restraint ordered while the patients were in the facility. She stated she did not have a report specifically for patients who expired at the facility while in restraints or patients who expired after they had recently been in restraints. She stated in order to determine if any patient had expired while in restraints, she would have to go through the report of patients who expired in the facility and correlate it with the report of patients who had restraint ordered.. Director #9 stated that as the director of the Emergency Department (ED), she was not tracking any patients who expired while in restraints.

ii. On 9/22/21 at 9:57 a.m., Director of Compliance (Director) #11 was interviewed. She stated if a patient died while in restraint it would be reported to the state. Director #11 stated the facility did not have an internal log for tracking deaths in restraints. She stated the facility would be triggered to report any such deaths because front line staff would enter a patient event which would then be reviewed by the quality department. Director #11 stated the Director of Quality was responsible to report a death in restraints to CMS.

iii. On 9/22/21 at 11:22 a.m., Registered Nurse (RN) #12 was interviewed. RN #12 stated he was a RN on the medical surgical unit and had cared for patients who were in restraints. He stated if a patient expired while in restraints he was unaware if he was required to report this to anyone. He stated he had not been trained to fill out a patient event if a patient expired while in restraints. He stated maybe the Manager or Director of the unit knew if a report was required.

iv. On 9/28/21 at 9:32 a.m., an interview with the Director of Quality and Safety (Director) #19 was conducted. Director #19 stated she had been in the role at the facility for four weeks. She stated she oversaw quality tracking and supported staff and departments within the facility for quality and patient safety. Director #19 stated she did not have a log related to patients who expired while in restraints, expired within 24 hours of being in restraints or expired within one week of being in restraints if restraints were a causative factor. She stated she did not audit restraint deaths. Director #19 stated the facility process was for staff to report a patient event if a patient expired, then a chart review would be completed by a manager or director on the unit to determine if further actions were needed. She stated she was uncertain of the exact process to report a death in restraint and would reach out to her Chief Operating Officer (COO) for guidance.

v. On 9/28/21 at 3:01 p.m., an interview was conducted with the charge nurse and Manager of the Medical Surgical Unit and the Intensive Care Unit (Manager) #6. Manager #6 stated she did not perform any audits related to restraints. Manager #6 stated deaths which involved the coroner were reported through the event reporting system, however not all deaths were reported and therefore not all deaths were investigated. This was in conflict with Director #11 and Director #19's interviews, as the directors stated front line staff were to enter a patient event report if a patient expired and this would trigger further review to determine whether the death constituted a death in restraints and required reporting to CMS.

The facility was unable to provide evidence of an internal log tracking patient deaths in restraints or identify the personnel responsible for reporting a death as required.

Based on the manner and degree of the standard-level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QAPI was out of compliance.

A-0286: (a) Standard: Program Scope (1) 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. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) 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. (e) 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: ...(3) That clear expectations for safety are established. Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program implemented, measured and tracked performance improvement activities related to problem-prone areas. Specifically, the facility's QAPI program failed to review and investigate patient safety events to identify causative factors and implement preventive measures.

A-0308: The hospital ' s governing body must ensure that the program reflects the complexity of the hospital ' s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement) ... The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. Based on interviews and document review, the facility's Governing Body (Board) failed to ensure patient safety events were investigated and preventive measures were implemented. Additionally, the Board failed to ensure measures implemented in response to patient safety events were tracked and trended to ensure effectiveness and sustainability. (Cross Reference A-0286).

Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program implemented, measured and tracked performance improvement activities related to problem-prone areas. Specifically, the facility's QAPI program failed to review and investigate patient safety events to identify causative factors and implement preventive measures.

Findings include:

Facility policies:

The Event Reporting policy, reviewed 3/16/21, read, event reports are used to document unexpected events and to monitor and evaluate improvement activities related to patient safety. An event is defined as a situation that is not consistent with routine care of the particular patient. Examples include: patient abuse and neglect, compliance violations, falls, infection control, medication errors, patient management, radiology, skin integrity and surgical complications.

Incident investigation and follow up is required in the timeframes listed below: SSE5-SSE1 events should be investigated and immediate actions documented by close of the business day or close of next business day; PSE4-PSE1 must have investigation completed within seven business days; NME3-NME1 events must have the investigation completed and corrective actions identified within a period of 14 business days. A complete investigation with identification of causal factors and corrective actions is due for every event within 14 business days of submission of the event.

The Clinical Quality Assessment, Patient Safety, and Process Improvement Plan for Fiscal Year 2020 read, the purpose of the plan is to provide a framework for improvement in the safe delivery of care.

The structure includes but is not limited to: The Board of Trustees (the Board) has overall responsibility and accountability for the quality and safety of patient care. The Directors and managers are responsible to inform and operationalize the improvement initiatives and activities of patient care and provide feedback to the Clinical Excellence Committee (CEC) to guide additional improvements and maintain improved performance. The CEC is chaired by the Director of Quality and Patient Safety. The committee has the overall responsibility to monitor quality improvement and patient safety initiatives.

The clinical excellence department maintains an integrated performance improvement program to maintain high quality patient care and improve clinical outcomes. The department collects and analyzes data for the identification of opportunities for improvement.

The goals of the quality department are to identify and analyze high-risk processes for improvement opportunities, proactively reduce risk of harm to patients and provide an optimal level of care through reduction of unnecessary risks.

The MRI Safety policy read, the following steps are to be taken to assure safety in the MRI room: The technologist is to review the screening tool filled out by the patient to ensure the patient is safe to receive an MRI. The screening tool is sent along to medical records to become part of the permanent medical record.

The Informed Consent policy read, a technologist must ensure the patient gives informed consent for all radiologic special procedures.

References:

The Nursing Matrix read, one CNA for up to 10 patients, two CNAs for 11-18 patients and three CNAs for 19-26 patients.

1. The facility's QAPI program failed to implement and monitor performance improvement activities in response to patient safety events related to inadequate staffing and inappropriate placement of intensive care unit (ICU) patients on the medical surgical unit.

A. Medical Record Review

a. Review of Patient #38's medical record revealed on 7/8/21, the patient was admitted to the newborn nursery at 1:30 p.m. Patient #38 required continuous oxygen adjustments and increased respiratory support. The patient was transferred to another facility's neonatal intensive care unit.

b. Review of Patient #39's medical record revealed on 7/8/21, the patient was admitted to the Labor and Delivery unit (L&D) at 1:00 p.m. The patient received Oxytocin (a medication used to induce labor) infused at a low rate and was not increased until 6:38 p.m. Patient #39 went into labor shortly after the medication rated was increased at 11:45 p.m.

c. Review of Patient #40's medical record revealed on 8/20/21, the patient admitted to the medical surgical unit with new onset of heart failure. Patient #40 required treatments which included aggressive IV diuretics (medication used to expel water from the body as urine), thoracentesis (procedure to remove fluid from around the lungs) and oxygen support. Patient #40 remained in an Intensive Care Unit (ICU) status for five days.

d. Review of Patient #41's medical record revealed on 7/2/21, staff documented the patient had a history of chronic dementia and had several episodes of severe confusion at night. Multiple physician notes read Patient #41 was found in different rooms at night.

B. Patient Safety Events

Review of the patient safety events revealed the events were not investigated and preventive measures were not implemented according to facility policy.

a. On 7/8/21 a patient safety event related to Patient #38 was entered. The event read the staff had concerns with the lack of available staff at the facility to care for patients. The event further read an infant was brought to the Emergency Department (ED) in critical condition. The staff who cared for the infant on obstetrical (OB) unit did not receive assistance from the house supervisor or the ED nurse who was supposed to assist on the floor. According to Patient #38's medical record, the patient subsequently required transfer to the ICU at a different facility for a higher level of care.

i. Follow up for the patient safety event was documented on the event log. The follow-up read the facility was busy in all departments. There was no corrective action identified nor were preventive measures put in place to prevent reoccurrence.

b. A patient safety event was entered on the same day 7/8/21 in reference to Patient #39's medical record. The patient safety event read, the L&D department was not appropriately staffed to care for the number of patients at the facility.

i. Review of the follow-up for the patient safety event indicated the facility's QAPI department did not identify corrective actions and implement preventive measures in order to prevent reoccurrence and address the reported lack of staffing.

ii. The patient safety events regarding Patient #38 and Patient #39 were reviewed with the Quality Specialist (Specialist) #20 on 9/28/21 at 1:24 p.m. Specialist #20 stated the unit managers or directors reviewed the events, but the quality department had not reviewed either patient safety event and had not implemented measures to prevent reoccurrence of the events.

c. A patient safety event was entered on 8/20/21 in reference to Patient #40's medical record. The event report read, Patient #40's level of care changed from a medical surgical unit status to an ICU status at 1:51 p.m. However, Patient #40 was not transferred to the ICU until after shift change on 8/20/21 at 6:10 p.m.

i. The follow-up for the incident entered 8/31/21 read, there was a current review being conducted with all team members involved. There were no corrective actions or preventative measures implemented to prevent reoccurrence of the event.

ii. The incident in reference to Patient #40 was reviewed with Specialist #20. Specialist #20 stated Patient #40 should have been transferred out to another facility if sufficient ICU staff were not present to care for the patient. Specialist #20 stated the event was still open and under investigation. Specialist #20 stated there currently were no preventive measures to ensure an ICU patient was not cared for on the medical surgical unit by non-ICU trained staff. Specialist #20 stated she believed the facility was previously cited in February for the same concern, and further stated nothing had changed and the same concerns still occurred.

d. A patient safety event was entered on 7/2/21 in reference to Patient #41's medical record. The event report read, staff was notified by housekeeping Patient #41 was in the lobby. Patient #41 had a history of dementia and was trying to find her car.

i. The follow-up for the incident read the unit census was high and there was only one patient care technician (PCT) for 17 patients. According to the facility's nursing staffing matrix, this exceeded the specified ratio of one PCT for every ten patients. The follow up read on 7/2/21 there was a census of 17 patients, with three RNs and one Charge nurse. Each RN had five patients, the charge nurse had two patients, and only one patient care technician (PCT) was present on the floor. The corrective action read appropriate nursing interventions were done and the patient frequently needed redirection. There were no preventive actions implemented to prevent reoccurrence of the event or address the documented lack of staffing

ii. On 9/28/21 at 3:01 p.m., an interview was conducted with one of the nurse managers for the Medical Surgical Unit and ICU (Manager) #23. The patient safety event referenced to Patient #41 was reviewed with Manager #23. Manager #23 stated Patient #41 was ambulatory and would often get dressed and blend into crowds. Manager #23 stated the unit was short staffed on the shift Patient #41 was found in the lobby. Manager #23 stated as there was a high patient census on the day of the event staff could have called the house supervisor to see if the unit could get more staff or a security sitter for the patient. However she stated she was unsure if staff had contacted the house supervisor. Manager #23 stated it was hard to determine if a similar event could be prevented in the future.

C. Leadership Interviews

a. On 9/28/21 at 9:32 a.m., an interview was conducted with the Director of Quality and Safety (Director) #19. Director #19 stated she had been in her current role at the facility for four weeks but had prior experience in QAPI at other facilities. Director #19 stated Specialist #20 oversaw the incident reports and dispersed the events to the leadership team for review. Director #19 stated the quality department functioned as a support system to assist leadership of the department with setting up debriefs or assisting with chart reviews.

The interview was in contrast to the facility's QAPI plan which read, the goals of the quality department were to identify and analyze high-risk processes for improvement opportunities, proactively reduce risk of harm to patients and provide an optimal level of care through reduction of unnecessary risks.

2. The facility's QAPI program failed to track and monitor performance improvement activities in response to multiple patient safety events which occurred in the radiology department.

A. Document review revealed on numerous occasions patients received a magnetic resonance imaging (MRI) scan without proper screening or safety measures implemented and patient's who received a computed tomography (CT) scan without the proper consent obtained for IV contrast (a medication used to differentiate between different bodily issues).

a. Review of the medical record for Patient #26 revealed on 2/2/21, the patient underwent a computer tomography (CT) scan. According to facility policy, patient consent was needed for a portion of the procedure in which intravenous (IV) contrast was administered if ordered by a physician. The consent for the IV contrast in Patient #26's medical record did not have the patient's or the technician's signature.

b. Review of Patient #29's medical record revealed on 3/11/21, the patient underwent a CT scan procedure. The consent for IV contrast administration did not have the physician's signature. On 3/13/21 an MRI procedure was done. The MRI screening form was not present in the medical record.

i. A patient safety event was entered on 3/13/21 in reference to Patient #29's medical record. The event report read, Patient #29 had a CT scan of the head on 3/11/21. The scan showed a metal artifact which was determined to be from a prior brain procedure. On 3/13/21 a MRI of the head was ordered. The event report read, metal artifact in a patient was a contraindication for a MRI scan.

c. Meeting minutes from the Quality and Safety Department regarding MRI safety from 3/30/21 were reviewed. The committee determined through their investigation of previous MRI safety events the radiology staff did not have access to the patient's electronic medical record (EMR) and additionally staff did not document known implanted devices in the patient's EMR. Preventative measures included providing radiology staff access patient's EMR and determining a way to alert staff if a patient had an implantable device.

The facility was unable to provide evidence the actions implemented were tracked or monitored to determine if they were sustained. Document review revealed continued events in which screening and safety protocols were not implemented for patients who underwent MRI scans.

d. Review of the medical record for Patient #13 revealed on 6/11/21, the patient underwent a CT scan and an MRI scan to rule out a stroke diagnosis. The MRI screening form was not found in the medical record.

e. Review of Patient #30's medical record revealed on 7/7/21, the patient underwent an MRI scan. The MRI screening form was not found in the medical record.

i. A patient safety event was entered on 7/7/21 in reference to Patient #30's medical record. The event report read, Patient #30 had an MRI scan done on 7/7/21. After the MRI scan was completed the technician forgot the patient on the MRI table and the patient crawled out of the MRI scanner.

ii. Follow-up for the incident revealed a discussion occurred with the staff member regarding not leaving a patient alone on the MRI table. However, the facility did not identify the missing MRI screening form and did not implement any further actions to prevent reoccurrence.

B. Interviews

a. On 9/28/21 at 9:32 a.m., an interview was conducted with the Director of Quality and Safety (Director) #19. Director #19 stated the department directors reached out to the quality department to ask for guidance on investigating patient safety events and implementing preventive measures. Director #19 further stated she was not familiar enough with the radiology department and was unaware of the recurrence of patient safety events involving the radiology department.

b. On 9/28/21 at 8:30 a.m., an interview was conducted with the Director of Radiology (Director) #24. Director #24 stated staff were to fill out MRI screening forms and the MRI technician was to review the form prior to the scan. Director #24 stated the completion of the MRI screening form was imperative and if not completed could cause patient harm, specifically if a patient had a metal implanted device. Director #24 stated there were no audits done by her department to track and trend whether MRI screening forms were completed according to facility policy.

Based on interviews and document review, the facility's Governing Body (Board) failed to ensure patient safety events were investigated and preventive measures were implemented. Additionally, the Board failed to ensure measures implemented in response to patient safety events were tracked and trended to ensure effectiveness and sustainability. (Cross Reference A-0286).

Findings include:

Facility policy:

The Clinical Quality Assessment, Patient Safety, and Process Improvement Plan for Fiscal Year 2020 read, the purpose of the plan is to provide a framework for improvement in the safe delivery of care.

The structure includes but is not limited to: The Board of Trustees (the Board) has overall responsibility and accountability for the quality and safety of patient care. The Directors and managers are responsible to inform and operationalize the improvement initiatives and activities of patient care and provide feedback to the Clinical Excellence Committee (CEC) to guide additional improvements and maintain improved performance. The CEC is chaired by the Director of Quality and Patient Safety. The committee has the overall responsibility to monitor quality improvement and patient safety initiatives.

References:

The Governing Board Bylaws, reviewed 6/21 read, duties of the board included to assure the quality and safety of medical services provided in facilities. Two members of the board shall be appointed as representatives to the quality and safety committee. The quality and safety committee is responsible for process and procedures, education and innovations to support improvement in clinical quality and patient safety.

The Nursing Matrix read, one CNA for up to 10 patients, two CNAs for 11-18 patients and three CNAs for 19-26 patients.

1. The facility's governing body failed to ensure the quality department investigated patient safety events, implemented preventive measures and tracked and trended measures to ensure effectiveness to prevent reoccurrence.

A. Review of medical records and patient safety events revealed the events were not investigated thoroughly to identify causative factors and preventative measures were not implemented to prevent reoccurrence. (Cross Reference A-0286).

a. Review of Patient #38's medical record revealed on 7/8/21, the patient was admitted to the newborn nursery at 1:30 p.m. Patient #38 needed continuous oxygen adjustments and increased respiratory support. The patient was transferred to another facility's neonatal intensive care unit.

i. On 7/8/21 a patient safety event related to Patient #38 was entered. The event read, the staff had concerns with the lack of available staff at the facility to care for patients The event further read an infant was brought to the Emergency Department (ED) in critical condition. The staff who care for the infant on the medical surgical unit did not receive assistance from the house supervisor or the ED nurse who was supposed to assist on the floor.

ii. Follow up for the incident was documented on the event log. The follow up read the facility was busy in all departments. There was no corrective action identified nor were preventive measures put in place to prevent reoccurrence.

b. Review of Patient #39's medical record revealed on 7/8/21, the patient was admitted to the Labor and Delivery unit (L&D) at 1:00 p.m. The patient received Oxytocin (a medication used to induce labor) infused at a low rate and was not increased until 6:38 p.m. Patient #39 went into labor shortly after the medication rated was increased at 11:45 p.m.

i. A patient safety event was entered on the same day in reference to Patient #39's medical record. The patient safety event read, the L&D department was not appropriately staffed to care for the amount of patients at the facility.

ii. Review of the follow-up for the patient safety event indicated the facility's QAPI department did not identify corrective actions and implement preventive measures in order to prevent reoccurrence or address the reported lack of staffing.

c. Review of Patient #40's medical record revealed on 8/20/21, the patient admitted to the medical surgical unit with new onset of heart failure. Patient #40 required treatments which included aggressive IV diuretics (medication used to expel water from the body as urine), thoracentesis (procedure to remove fluid from around the lungs) and oxygen support. Patient #40 remained in an Intensive Care Unit (ICU) status for five days.

i. A patient safety event was entered on 8/20/21 in reference to Patient #40's medical record. The event report read, Patient #40's level of care changed from a medical surgical unit status to an ICU status at 1:51 p.m. However, Patient #40 was not transferred to the ICU until after shift change on 8/20/21 at 6:10 p.m.

ii. The follow-up for the incident entered 8/31/21 read, there was a current review being conducted with all team members involved. There were no corrective actions or preventive measures implemented to prevent reoccurrence of the event.

d. Review of Patient #41's medical record revealed on 7/2/21, staff documented the patient had a history of chronic dementia and had several episodes of severe confusion at night. Multiple physician notes read Patient #41 was found in different rooms at night.

i. A patient safety event was entered on 7/2/21 in reference to Patient #41's medical record. The event report read, staff was notified by housekeeping Patient #41 was in the lobby. Patient #41 had a history of dementia and was trying to find her car.

ii. The follow-up for the incident read the unit census was high and there was only one patient care technician (PCT) for 17 patients. According to the facility's nursing staffing matrix, this exceeded the specified ratio of one PCT for every ten patients. The follow up read on 7/2/21 there was a census of 17 patients, with three RNs and one Charge nurse. Each RN had five patients, the charge nurse had two patients, and only one patient care technician (PCT) was present on the floor. The corrective action read appropriate nursing interventions were done and the patient frequently needed redirection. There were no preventive actions implemented to prevent reoccurrence of the event or address the documented lack of staffing

e. Review of the medical record for Patient #26 revealed on 2/2/21, the patient underwent a computer tomography (CT) scan. According to facility policy, patient consent was needed for a portion of the procedure in which intravenous (IV) contrast was administered if ordered by a physician. The consent for the IV contrast in Patient #26's medical record did not have the patient's or the technician's signature.

f. Review of Patient #29's medical record revealed on 3/11/21, the patient underwent a CT scan. The consent for IV contrast administration did not have the physician's signature. On 3/13/21 an MRI procedure was done. The MRI screening form was not found in the medical record.

i. A patient safety event was entered on 3/13/21 in reference to Patient #29's medical record. The event report read, Patient #29 had a CT scan of the head on 3/11/21. The scan showed a metal artifact which was determined to be from a prior brain procedure. On 3/13/21 a MRI of the head was ordered. The event report read, metal artifact in a patient was a contraindication for a MRI scan.

g. Meeting minutes from the Quality and Safety Department regarding MRI safety from 3/30/21 were reviewed. The committee determined through their investigation of previous MRI safety events the radiology staff did not have access to the patient's electronic medical record (EMR) and additionally staff did not document known implanted devices in the patient's EMR. Preventative measures included providing radiology staff access patient's EMR and determining a way to alert staff if a patient had an implantable device.

The facility was unable to provide evidence the actions implemented were tracked or monitored to determine if they were sustained. Document review revealed continued events in which screening and safety protocols were not implemented for patients who underwent MRI scans.

h. Review of the medical record for Patient #13 revealed on 6/11/21, the patient underwent a CT scan and an MRI scan to rule out a stroke diagnosis. The MRI screening form was not found in the medical record.

j. Review of Patient #30's medical record revealed on 7/7/21, the patient underwent an MRI scan. The MRI screening form was not found in the medical record.

i. A patient safety event was entered on 7/7/21 in reference to Patient #30's medical record. The event report read, Patient #30 had an MRI scan done on 7/7/21. After the MRI scan was completed the technician forgot the patient on the MRI table and the patient crawled out of the MRI scanner.

ii. Follow-up for the incident revealed a discussion occurred with the staff member regarding not leaving a patient alone on the MRI table. However, the facility did not identify the missing MRI screening form and did not implement any further actions to prevent reoccurrence.

B. Interviews with staff revealed a lack of investigation of patient safety events by the quality department and a lack of preventive measures to prevent reoccurrence.

a. On 9/28/21 at 1:29 p.m., an interview was conducted with Quality Specialist (Specialist) #20. Specialist #20 stated she oversaw the patient safety event reporting system. Specialist #20 stated she was responsible to ensure the appropriate people were included in the follow-up for a patient safety event and the follow-up was completed within the facility's specified timeframe.

i. The patient safety events regarding Patient #38 and Patient #39 were reviewed with Specialist #20. Specialist #20 stated the unit managers or directors performed their reviews, but the quality department had not reviewed either patient safety events and had not implemented measures to prevent reoccurrence of the events.

ii. The patient safety event in reference to Patient #40 was reviewed with Specialist #20. Specialist #20 stated Patient #40 should have been transferred out to another facility if sufficient ICU staff were not present to care for the patient. Specialist #20 stated the event was still open and still under investigation. Specialist #20 stated there currently were no preventive measures to ensure an ICU patient was not cared for on the medical surgical unit by non-ICU trained staff. Specialist #20 stated she believed the facility was previously cited in February for the same concern and further stated nothing had changed and the same concerns still occurred.

b. On 9/28/21 at 3:01 p.m., an interview was conducted with one of the nurse managers for the Medical Surgical Unit and ICU (Manager) #23. The patient safety event referenced to Patient #41 was reviewed with Manager #23. Manager #23 stated Patient #41 was ambulatory and would often get dressed and blend into crowds. Manager #23 stated the unit was short staffed on the shift Patient #41 was found in the lobby. Manager #23 stated as there was a high patient census on the day of the event staff could have called the house supervisor to see if the unit could get more staff or a security sitter for the patient. However she stated she was unsure if staff had contacted the house supervisor. Manager #23 stated it was hard to determine if a similar event could be prevented in the future.

C. Interviews with facility leadership revealed a lack of oversight and follow-up on investigation of patient safety events and a lack of ensuring preventative measures were implemented to prevent reoccurrence.

a. On 9/28/21 at 9:32 a.m., an interview was conducted with the Director of Quality and Safety (Director) #19. Director #19 stated she had been in her current role at the facility for four weeks but had prior experience with QAPI at other facilities. Director #19 stated Specialist #20 oversaw the patient safety event reports and dispersed the events to the leadership team for review. Director #19 stated the quality department functioned as a support system to assist leadership of the department with setting up debriefs or assisting with chart reviews. Director #19 stated the department directors reached out to the quality department to ask for guidance on improving patient safety events and implementing preventative measures. Director #19 stated she was not familiar enough with the radiology department and was unaware of the recurrence of patient safety events involving the radiology department.

The interview was in contrast to the facility's QAPI plan which read, the goals of the quality department were to identify and analyze high-risk processes for improvement opportunities, proactively reduce risk of harm to patients and provide an optimal level of care through reduction of unnecessary risks.

b. On 9/29/21 at 11:01 a.m., an interview was conducted with the Chief Nursing Officer (CNO) #4. CNO #4 stated she attended Board meetings and presented reports and information related to nursing staff to the Board. CNO #4 stated it was important for facility leadership to be integrated into the quality department and program. CNO #4 further stated it was important to discuss any gaps in patient care and trends identified in patient safety events.

CNO #4 stated the Board received information on any significant patient concerns from the quality department. Additionally, CNO #4 stated the Board oversaw the functions of the facility and signed off on the QAPI plan yearly. CNO #4 stated it was important for the Board to be involved with the facility's quality department in order to maintain a safe patient environment and approve needed purchases to prevent patient safety events.

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

A-0392: The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. Based on interviews and document reviews, the facility failed to ensure there was an adequate number of staff to meet the needs of patients. Specifically, the facility failed to ensure the nursing staffing matrix was adhered to when making unit staffing assignments.

Based on interviews and document reviews, the facility failed to ensure there was an adequate number of staff to meet the needs of patients. Specifically, the facility failed to ensure the nursing staffing matrix was adhered to when making unit staffing assignments.

Findings include:

Facility policies:

The Assignment of Patient Care Policy read, the purpose of this policy is to ensure an adequate number of staff members with appropriate experience and training that supports delivery of care. The policy further read that the staff required for each shift is based upon the use of a staffing matrix that takes into consideration the nursing care needs and acuity of the patient population on the unit. The staffing matrix specifies the number and mix of staff required, based on the acuity and staffing ratios.

References:

The Nursing Matrix read, one CNA for up to 10 patients, two CNAs for 11-18 patients and three CNAs for 19-26 patients.

The Medical Surgical Certified Nursing Assistant (CNA) Job Description read, some but not all responsibilities include: answers call light, bells or intercom to determine patient needs. Bathes, dresses and undresses patients. Services and collects food trays and feeds patients who require help. Turns and repositions bedfast patients, alone or with assistance to prevent bedsores. Changes bed linens, runs errands and answers the telephone. Takes and records temperature, blood pressure, pulse, oxygen saturation and respiration rates. Records fluid and meal intake and output as directed.

1. The facility failed to follow their own staffing matrix to ensure an adequate number of staff, specifically CNAs, were available to perform patient care needs.

A. Document Review

a. According to the staffing matrix provided by the facility, staffing was to consist of one CNA for up to 10 patients, two CNAs for 11-18 patients and three CNAs for 19-26 patients. Review of the staffing assignments revealed for 13 shifts in July 2021, 16 shifts in August 2021 as well as 20 shifts in September 2021 units were staffed one CNA short of what the matrix called for.

b. Review of patient safety events revealed Patient #41, who had dementia (loss of memory, language, problem-solving and other thinking abilities that are severe enough to interfere with daily life) was found in the facility lobby on 7/14/21 or 7/15/21 by the housekeeping staff. Staffing schedules revealed the facility was short staffed on both 7/14/21 and 7/15/21.

B. Interviews

a. An interview was conducted on 9/29/21 at 10:31 a.m. with CNA #22. CNA #22 stated her role was to assist Registered Nurses (RNs) with patient care such as vital signs and assisting with meals and patient safety. She stated she assisted patients to the bathroom and to transfer to chairs, gave baths, answered call lights, turned patients in the bed and performed hygiene for patients who could not perform hygiene on their own. CNA #22 stated the facility had been short staffed of CNAs. She stated on 9/29/21, the day of the interview, the CNA to patient ratio was one CNA for 17 patients. This exceeded the CNA to patient ratio as specified in the nursing staffing matrix, which defined the ratio as one CNA for up to 10 patients.

CNA #22 stated when the facility was short-staffed there was a risk patient care would be limited, such as hygiene and baths, as well as call light response times would be increased.

b. An interview was conducted on 9/29/21 at 1:42 p.m. with RN #25. RN #25 stated she worked on the medical surgical unit. She stated the facility had experienced longer response times to answer patient call lights due to staffing and lack of scheduled CNAs. RN #25 stated the facility had a lack of accountability with answering call lights. She stated sometimes staff thought someone else was going to answer the call light, and sometimes staff were too busy with their own patient to answer the call light immediately. RN #25 stated staff were expected to answer call lights within two minutes. She stated an increase in call light response times could lead to patient safety issues such as patient falls.

c. An interview was conducted with Patient #3 on 9/20/21 at 1:00 p.m. Patient #3 stated staff responded slowly to her call lights and it had on one occasion taken 30 minutes for staff to respond. She stated there were times staff turned off the call light assistance light and never responded to her room to assist with her needs.

d. An interview was conducted on 9/28/21 at 3:01 p.m. with the Nurse Medical Surgical Unit Manager (Manager) #6. Manager #6 stated the facility experienced a decrease in staff in March 2021. Manager #6 stated CNA ratios were supposed to be 10 patients to one CNA, but were consistently 17 to 20 patients to one CNA in recent months. Manager #6 stated there had been some shifts when no CNA was scheduled. Manager #6 stated there was a risk to patient safety when no CNA was available to assist the nurses with patient care. She stated this caused a delay in responding to call lights in a timely manner. Manager #6 stated it also increased the risk of patient falls. She stated she recently had to respond to a patient removing his oxygen at the same time she assisted another patient to the restroom. Manager #6 stated she had to leave the patient in the restroom which increased his risk of falling to assist the other patient with his oxygen need.

e. An interview was conducted on 9/29/21 at 11:24 a.m. with RN House Supervisor (Supervisor) #21. Supervisor #21 stated the facility had been short-staffed of both RNs and CNAs. He stated the ratio of 10 patients to one CNA did not occur often. Manager #21 stated on 9/29/21, the day of the interview, the Medical/Surgical unit had 16 patients and one CNA.

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation, §482.24: Medical Record Services was out of compliance.

A-0441 - Protecting Patient Records. Based on observations, interviews and record review the facility failed to ensure paper medical records were secured and monitored to prevent unauthorized access.

Based on observations, interviews and record review the facility failed to ensure paper medical records were secured and monitored to prevent unauthorized access.

Findings include:

Facility policy:

According to the policy, 026 General Policy, all records shall be kept in a secure area to assure maximum protection of records and to assure confidentiality of the records contents. Directors of each area will be responsible for the security of medical records in their possession. All patients who are seen in this hospital have the right to assume that the information contained in their medical record will not be divulged without their expressed consent and only those individuals to whom they have designated as being allowed to have their medical information. It is the responsibility of the HIM personnel to maintain the confidentiality of each patient's medical information in accordance with hospital policy and state and federal regulations including HIPAA.

According to the policy, Access Key Control, controlling access to building, departments, cabinets, files and desks is a continuing function to assure safety and concern or persons and property.

1. The facility failed to ensure patients' medical records were secured from unauthorized individuals.

A. Observations and Document Review

a. On 9/21/21 at 11:30 a.m., observations revealed unsecured and unmonitored medical records in the Health Information Management (HIM) oncology overflow area. The door to the area was unlocked and no staff were present during the observation. Observations revealed visitors and other facility staff had access to the hallway unaccompanied. The overflow area contained 16 filing cabinets, one four shelf open rack and multiple boxes of patient medical records.

Review of the medical records in the area revealed protected health information to include the patient name, date of birth, social security number, address, insurance information, and medical information such as diagnosis, current medications, labs, medical history, physician orders and oncology treatments.

b. Further observations of another medical record office revealed multiple shelves with unsecured medical records.

According to staff interviews housekeeping had access to this area unsupervised along with anyone with a master key. The master key was observed sitting on the desk.

c. Continued observations of a third storage area for patient medical records revealed an outside shed with 1000's of paper medical records. Noted in the shed were windows, ceiling tiles, a grill, bags of concrete and a ladder.

Review of the medical records in the outside shed area revealed confidential patient information to include the patient name, date of birth, social security number, address, insurance information, and medical information such as diagnosis, current medications, labs, medical history, and physician orders.

d. On 9/21/21 at 4:45 p.m., an observation of the outpatient infusion/oncology center revealed unsecured and unmonitored Protected Health Information (PHI). The observation revealed a small room with an unlocked clear glass door next to a patient exam room with no staff member. The room had PHI hanging from the wall organizers.

B. Interviews

a. On 9/21/21 at 12:00 p.m., an interview was conducted with the Facilities Manager (Manager #7) Manager #7 stated maintenance staff used the medical records shed for storage of windows, ceiling tiles, a grill and concrete. Manager #7 stated his maintenance crew members all had master keys which worked all three areas where medical records were located to include the shed. Manager #7 stated the maintenance staff did not need access to medical records to perform their daily functions of work.

Interviews with Manager #7 revealed the facility leadership was unsure of everyone who had a master key to include current and past employees. Manager #7 was unable to provide a current list of staff who had master keys.

b. On 9/21/21 at 11:50 p.m., an interview with Health Information Management Director (Director #10) was conducted. Director #10 stated she was responsible for patient medical records at the facility.

Director #10 who toured and observed the unsecured patient medical records on 9/21/21 at 11:00 a.m., stated unauthorized staff should not have access to patient medical records, to include maintenance staff. Director #10 stated she was unaware the shed was used by maintenance staff and was also unaware the door to the Oncology overflow medical records storage area was unlocked. Director #10 stated unauthorized access could lead to patient risk to include identity theft.

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation, §482.25: Pharmaceutical Services was out of compliance.

A- 0494 - Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. Based on interviews and document review, the facility failed to ensure nursing staff followed policy and procedures intended to minimize scheduled drug diversion.

Based on interviews and document review, the facility failed to ensure nursing staff followed policy and procedures intended to minimize scheduled drug diversion.

Findings include:

Facility policies:

According to the policy, Controlled Drugs: Administration read, the purpose of this policy is to provide guidance for staff relating to the administration of controlled substances within the facility. Controlled drugs shall be administered in accordance with medical staff rules and regulations relating to administration of medications and the facility's policies and procedures relating to administration of medications.

According to the policy, Controlled Drug Inventories read, a complete and accurate inventory of all controlled drugs located within the facility shall be taken as required by the DEA and the State of Colorado. Discrepancies shall be investigated within the shift in which they occur and the resolution shall be reported to the pharmacy and the nursing supervisor. If a reasonable resolution is not made or the medication is not accounted for, it shall be reported immediately to the Director of Pharmacy, if available and to a pharmacist if the director is not available.

According to the policy, Controlled Substance Diversion Monitoring and Reporting read, the facility will perform routine surveillance of controlled substance activity in order to detect and mitigate possible threatens to patients and employee safety.

1. The facility failed to ensure all drug records were in order and maintained in a manner to minimize potential loss or diversion of a scheduled drug.

A. Discrepancies resolved per policy

a. On 9/20/21 at 11:30 a.m., observations of the Intensive Care Unit Pyxis (machine which dispensed medications) revealed a discrepancy had been created on 9/18/21 (two days prior) for Lorazepam (a controlled medication commonly used to relieve anxiety) by a Registered Nurse (RN).

b. According to the policy, the discrepancy must be resolved on the shift they occur and the resolution shall be reported to the pharmacy and nursing supervisor. If a reasonable resolution was not made or the medication was not accounted for, it shall be reported immediately to the Director of Pharmacy, if available and to a pharmacist if the director is not available.

c. Review of the Discrepancy Audit Detail Report from 6/24/21 to 9/22/21 revealed 40 discrepancies of controlled medications.

Examples included:

-On 6/29/21 Morphine (a controlled medication to treat pain) 2 milligram (mg) 1 milliliter (ml) - the expected count was 14 and the actual count was 13. There was no reason noted for the missing Morphine.

-On 7/19/21 Patients own narcotic medication - the expected count was 13 and the actual count was 0. The reason listed was no medication was found in the drawer.

-On 7/23/21 Fentanyl (a controlled pain medication) 100 micrograms (mcg) Patch - the expected count was 2 and the actual count was 1. The reason listed was inventory out medication.

- On 8/7/21 Hydrocodone/Tylenol (a controlled pain medication) 5/325 mg tablet - the expected count was 15 and the actual count was 14. The reason listed was "only 14 in drawer".

- On 8/16/21 Morphine 2 mg - the expected count was 12 and the actual count was 9. The reason listed was "all counts correct". There was no explanation in the reason listed how the RN determined the count was correct.

- On 8/18/21 Lorazepam 2 mg 1 ml vial - the expected count was 4 and the actual count was 3. The reason listed "inventory is okay". There was no explanation in the reason listed how the RN determined the inventory was okay.

- On 8/19/21 Diazepam (a controlled medication to treat anxiety and muscle spasms) 2 mg tablet - the expected count was 6 and actual count was 5. The reason listed was the "user with prior access selected 1, actually withdrew 2".

- On 9/12/21 Oxycodone/Tylenol (a controlled medication to treat pain) 5/325 mg - the expected count was 15 and the actual count was 12. The reason listed "I don't know why the count was off".

- On 9/14/21 Methadone (a controlled medication to treat pain or addiction to heroin or pain medication) 5 mg - the expected count was 20 and the actual count was 19. The reason listed was "I do not know what caused this discrepancy".

As of 9/23/21 the facility was unable to provide any evidence any of the discrepancies from 6/29/21 had been resolved per policy.

d. On 9/20/21 at 1:00 p.m., an interviews with the Charge RN (RN #6) for the inpatient unit was conducted during the tour. RN #6 stated any discrepancy for controlled substance had to be cleared immediately by the RN involved, but no later than the end of the RN's shift. RN #6 stated this was to prevent the loss or diversion of controlled drugs. RN #6 reviewed the discrepancy identified on tour of the Pyxis which had occurred two days prior. RN #6 stated the discrepancy should have been resolved prior to the RN being able to leave his shift. RN #6 was unable to answer why that had not occurred per policy.

e. On 9/22/21 at 4:24 p.m., an interview was conducted with the Director of Pharmacy (Director #5). A review of the Discrepancy Audit Detail Report was conducted with Director #5. Director #5 stated she was unaware of the discrepancies and had not reviewed the audit report. Director #5 stated it was the RN's responsibility to resolve any discrepancies and did not get involved unless an "event" was submitted or an RN emailed her. Director #5 stated she was unable to account for the missing controlled substances identified from the Discrepancy Report.

B. Leadership failed to follow discrepancy policies

a. According to the policy, controlled substance diversion monitoring and reporting, the chief nursing officer (CNO) would review the proactive diversion report audits each month and each user above three standard deviations above the mean would be subject to four patient chart audits (done timely) using the Diversion Prevention Audit Nursing Unit tool.

b. Review of the proactive diversion report from 5/5/21 to 9/1/21, revealed three users who were above three standard deviations above the mean. One for June and two for August.

i. Review of an email from the CNO on 8/3/21 to RN #6 requested the audits were conducted sooner than later due to other issues with the user.

ii. The facility was unable to provide any chart audits which had occurred for the two August users.

C. Leadership failed to follow workforce drug testing per policy.

a. According to the policy, the facility recognized the need to protect the health, safety and well-being of all patients and employees and provide a safe environment from the risk and dangers created with drug and alcohol abuse. Employees may be subject to drug testing on reasonable suspicion events as part of drug diversion investigations. The standard for reasonable suspicion testing did not require an overwhelming burden of proof. Hunches and "gut feelings" were not valid in making a reasonable suspicion determination. Factors which may be considered reasonable suspicion included: careless disposal of infectious/hazardous waste (medications).

b. Review of an event which occurred on 7/14/21, revealed upon entering the pharmacy the morning of 7/17/21, a small amount of controlled substances (two Oxycodone/acetaminophen 5/325 mg and an ampule of Fentanyl taped to a syringe with a small volume of fluid inside) were found on the center island of the main dispensing area. A note signed by RN #13 and a House Supervisor accompanied the medications. The note read RN #13 accidentally took medications home and the Fentanyl was found in the dryer after washing work clothing, and the Percocet was found in a scrub pocket prior to washing. The patient involved with the incident was Patient #28.

i. The follow up from the event read:

-On 7/20/21, CNO #4 was to conduct an investigation.

-On 7/22/21, CNO #4 documented education and process issues were to be cleared up and worked on collaboration with pharmacy. CNO #4 then documented she needed to interview both RN #13 and the House Supervisor.

-On 7/26/21, the report read, an internal investigation report was done by CNO #4 and would be reviewed for casual and contributing factors and next steps.

- On 8/2/21, CNO #4 stated she had no concerns about diversion after the interviews, but did have a need for education around expectations with narcotics.

ii. Review of the internal investigation done by CNO #4 revealed two emails. Review of the emails revealed:

-On 7/20/21 at 3:06 p.m., CNO #4 emailed Human Resource Director (Director #14) identifying the event and read the Manager for the inpatient unit, CNO #4 and Director #5 all "see a potential need for a drug screen" for RN #13 and requested Director #14 to provide the next steps.

-On 7/20/21 at 4:56 p.m., Director #14 responded to CNO #4 and requested RN interviews to be performed and instructed CNO #4 to make a decision on reasonable suspicion testing based on "what they report and how you feel about it".

c. On 7/25/21 (11 days after the possible diversion event occurred) RN #13 submitted her resignation.

d. On 9/22/21 at 5:23 p.m., an interview was conducted with CNO #4. CNO #4 reviewed the emails she had provided along with the proactive discrepancy report. Stated she had not reviewed the discrepancy report prior to the interview and was unaware of the amount of discrepancies reported. CNO #4 also stated she had not conducted a chart audit for Patient #29 or any chart audits for RN #13. CNO #4 stated with the information provided she would have "handled the investigation differently" and stated the facility had a lack of taking diversion incidents seriously.

e. As of 9/28/21, the facility was unable to provide any further investigation or education which had been provided to staff related to expectations with narcotics.

Based on observation, interviews and document review, the facility failed to ensure outdated medications were removed from stock according to the manufacturer's expiration date. This failure created the potential for patients to receive expired medications and created a delay in patient care. This failure was identified in two of two patient care units in the facility.

Findings include:

Facility policies:

The Medication Administration and Documentation policy read, medications in clearly labeled containers will be used. Medications that do not appear cloudy, have changed color or have expired will not be used and will be returned to the Pharmacy.

The Outdates/Dated Items policy read, all items maintained in inventory will be rotated on a first-in first-out basis to prevent stock from deterioration, contribute to better patient care, and fully utilize the merchandise purchased. Any of these items with an expiration date of one month or less will be identified with the using department for immediate use. In the event the item cannot be used, it will be returned to the Purchasing Section of Materials Management.

The Crash Cart policy and procedure read, all crash carts and their contents are accurately stocked, in-date, and secured at all times. The crash cart shall be inspected once daily.

References:

The Novolog Insulin vials manufacturer's instruction for use (IFU) read, after initial use a vial may be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or light. Opened vials may be refrigerated. Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.

The Lantus Insulin vials manufacturer's IFU read, after initial use a vial may be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or light. Opened vials may be refrigerated. Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.

A. Observations

a. On 9/20/21 at 1:30 p.m., an observation of the medical surgical unit was conducted. Upon observation of the medical surgical unit expired emergency medications were found in the adult crash cart (movable cart carrying supplies and medication for emergency use). Naloxone/Narcan (an opioid reversal medication) vials were found with an expiration date of 1/1/21. This was in contrast to facility policy, which read crash carts contents were to be inspected daily.

b. On 9/20/21 at 2:00 p.m., an observation of the intensive care unit (ICU) was conducted. Observation of the ICU Pyxis machine (automated medication dispensing system) revealed the machine contained Novolog and Lantus insulin vials. Both vials were opened ( plastic cover removed), however the vials were not labeled with the date when the vials were opened. According to the Novolog and Lantus manufacturer's IFUs, an opened vial expired 28 days after it was opened.

B. Document review

a. A patient safety event was entered on 7/19/21 at 7:00 a.m., a patient experienced chest pain and pressure and severe jaw pain. An order for sublingual nitroglycerin (medication used for active chest pain) was ordered to be administered immediately. When staff attempted to remove medication from the ICU Pyxis machine, there were no sublingual nitroglycerin tablets available. When staff attempted to remove the medication from the third floor Pyxis machine the nitroglycerin vial expired on 04/27/21. On the third attempt, the nitroglycerin medication was found in the Emergency Department Pyxis machine which contained a current nitroglycerin vial. The delay in treatment caused the patient to self-administer her own nitroglycerin sublingual tablets to alleviate her chest pain.

C. Interviews

a. On 9/21/21 at 1:35 p.m., an interview with Charge Registered Nurse (RN) #6 was conducted. RN #6 stated expired medication may not be as effective. She stated the effectiveness of a medication could not be guaranteed after the expiration date. She stated the effectiveness of medications ultimately affected patient care and patient safety.

b. On 9/21/21 at 1:40 p.m., an interview with Chief Nursing Officer (CNO) #4 was conducted. CNO #4 stated expired medication had the potential to cause harm to the patient. She stated in general, if staff had to search for medications in an emergency it could delay patient care. CNO #4 stated RNs were to check the crash carts on a monthly basis for expired supplies and medications.

Based on the manner and degree of the standard-level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

A-0749: The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, interviews and document review, the facility failed to implement methods to prevent and control the transmission of infections within the hospital. Specifically, the facility failed to maintain appropriate infection control processes when serving and storing food to prevent exposure to food borne pathogens. Additionally, the facility failed to perform standard precautions which consisted of the use of single-dose vial as a multi-dose vial in the surgical perioperative area for multiple patients. The failure was identified in one of one patient tracer observations (Patient #19).

Based on observations, interviews and document review, the facility failed to implement methods to prevent and control the transmission of infections within the hospital. Specifically, the facility failed to maintain appropriate infection control processes when serving and storing food to prevent exposure to food borne pathogens. Additionally, the facility failed to perform standard precautions which consisted of the use of single-dose vial as a multi-dose vial in the surgical perioperative area for multiple patients. The failure was identified in one of one patient tracer observations (Patient #19).

Findings include:

Facility policies:

The Food Safety and Sanitation policy read, for food safety and sanitation: All leftovers are labeled, covered, and dated when stored, see Appendix A. Foods with expiration dates are used prior to the date on the package. Canned and dry foods without expiration dates are used within one year of delivery or according to the manufacturer's guidelines

The Food Safety-Food Service Director/Supervisor Responsibility policy read, the food service director/supervisor is responsible for providing safe foods to all individuals. The food service director/supervisor assures all of the following:. All refrigerated and frozen foods are stored and handled properly. All dry and staple food items are stored properly. Regular inspections are made by the food service director/supervisor to assure food safety. Labels and dates are to be inspected in accordance with Appendix A, and cleanliness of kitchen/ cafeteria.

Appendix A: Open Food/Leftover Policy read, guidelines: Ready-to-Eat, Potentially Hazardous Food (Time/Temperature Control for Safety Food) Served in facilities providing food to highly susceptible populations shall adhere to the following date marking requirements: The day the original container is opened in the food establishment shall be counted as Day 1; (Except for items with remainder shelf life listed.) The day or date marked by the food establishment may not exceed a Manufacturer's use-by date if the manufacturer determined the use-by date based on food safety.

The Food Temperatures policy read, the temperatures of the food items will be taken and properly recorded for each meal. All hot food items must be cooked to appropriate internal temperatures, held and served at a temperature of at least 135° F. Take temperatures often to monitor for safe temperature ranges of at or below 41 ° F for cold foods and at or above 135° F for hot foods. Cooking temperatures must be reached and maintained according to regulations, and laws. Hot food items may not fall below 135° F after cooking, unless it is an item which is to be rapidly cooled to below 41 ° F and reheated to at least 165° F prior to serving. 2. All cold food items must be maintained and served at a temperature of 41 ° or below. Temperatures should be taken periodically to ensure hot foods stay above 135° F and cold
foods stay below 41 ° F during the portioning, transporting and delivery process until received by the individual recipient.

The General HACCP Guidelines policy read, educate and monitor staff on the temperature danger zone (TDZ). Food must be held >135 degree or <41 degrees. Prevent cross contamination and employee contamination by: hot holding >135 degrees. Cover and stir often. If food drops <135 degrees, reheat to 165 degrees F for a minimum of 15 seconds. Receiving: label and date foods and put foods away promptly.

The Label and Dating policy read, to provide guidance and safety in the department, and the organization on all food products. To make sure proper food handling and information on all products when opened, and Use by date. All items must be stamped with a label gun when it is received by food/paper suppliers. Freezer items must be stamped and rotated. Any products opened will have a food label on the product or be stored in a Ziploc storage bag with use by the date of one month. Unopened Canned products will be dated with a single label if the manufacturer expiration date is stamped on the can. Canned products with no manufacturer expiration date must be stamped with double label showing when product was received and expiration date of one year. All dry products (pastas, beans, etc.) unopened will be dated for one year, unless opened. When opened they will be dated for one month and are required to be stored in a Ziploc bag or storage container with a lid. Cooking wines, vinegars etc. must follow the same procedure as dry products. (Watch products with manufacturer's expiration date.) All individual products such as applesauce, juices, individual soups, etc. will be stamped individually and rotated. (Watch products with manufacturer's expiration date.) Fresh produce items must be stored in containers other than cardboard boxes, and must be labeled and dated according to Appendix A. Single date stamp when manufacture use by date is present. Use double date stamp, when there is no manufacture use by date present.

The Receiving and Storage Safety policy read, safety precautions should be followed when crates, or boxes are opened, and when food and supply items are stored. All containers shall be clearly labeled.

The Medication Administration and Documentation policy read, unit dose packages will be taken to the patient unopened unless partial doses are being administered.

The Use of Multiple Dose Vials Policy read, the expiration date for multi-dose vials (MDV) will be the manufacturer's recommended date listed on the vial, providing that there is no obvious contamination. The Pharmacy Department and Perioperative Services shall verify that MDVs are stored and labeled correctly when medication storage areas are inspected.

References:

The Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2020: Guidelines of Medication Safety, pp. 464-465 read, single-dose/single-use vials should be used on only one patient. The contamination of single-use and multi-dose vials has been demonstrated in laboratory studies. Multi-dose vials should be used for only one patient when medications are prepared at the point of use. Multi-dose vials should be stored outside the immediate patient treatment area when possible.

The Bupivacaine with Epinephrine (local anesthetic medication) manufacturer's instruction for use (IFU) read, products which include epinephrine in 30 ml vial are single-dose vials. Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use.

1. The facility failed to ensure food was maintained at temperatures required for reducing bacterial growth.

a. Observations revealed food was not maintained at temperatures to prevent bacterial growth.

i. On 9/21/21 at 8:57 a.m., a tour of the cafeteria was conducted with the Director of Dietary (Director) #1 and Infection Preventionist (IP) #2. Observed in the dining area were staff and visitors obtaining food from the buffet. The buffet food warmer revealed a metal container of uncovered ham, eggs and potatoes. Director #1 obtained the temperature of the food which read: ham was 89 degrees, the egg temperature was 125 degrees and the potatoes were 125 degrees. The cold bar had cheese which was 45 degrees.

b. Document review revealed the facility staff did not monitor or maintain temperatures of food according to their policy.

i. According to the Food Temperatures policy, the temperatures of food items would be taken and properly recorded for each meal and periodically to ensure hot foods stayed above 135° F and cold foods stayed below 41 ° F.

ii. Review of the Food Temperature Quality Control Log from 5/26/21-9/21/21 revealed the staff only measured the temperature of food one time per meal at 8:00 a.m. for breakfast and 11:00 a.m. for lunch. The log and temperature had not been completed for breakfast on 9/21/21 at 8:57 a.m. (the day of the observation).

The log revealed missing temperature checks on at least one meal or some food items on 24 days: 5/26/21, 6/1/21, 6/2/21, 6/3/21, 6/4/21, 6/15/21, 6/16/21, 6/18/21, 6/23/21, 7/7/21-7/27/21, 8/3/21, 8/12/21, 8/25/21, 9/2/21, 9/3/21.

Additionally, the log revealed food items logged with temperatures below the safe 135 degrees with no description whether the food was served at the incorrect temperature or if an intervention took place such as reheating the food on 15 separate occasions.

Examples:
- On 5/27/21 the sausage and egg burrito was 128.5
- On 5/28/21 the bean burrito was 130 degrees
- On 6/3/21 the fish was 131 degrees
- On 6/7/21 the pancakes were 125 degrees, and the country potatoes were 130 degrees
- On 6/23/21 the quiche was 120 degrees

There were 15 additional similar examples noted.

iii. An email from Director of Compliance (Director) #11 read, the facility was not able to provide logs in which cold food temperatures were obtained for the cafeteria food.

c. Interviews revealed staff did not maintain safe temperature monitoring of food.

i. On 9/21/21 at 8:59 a.m., an interview was conducted with Food Service Worker (FSW) #3. FSW #3 stated she had not taken the temperature of the food at 8:00 a.m. because she forgot. She stated she only had to take the temperature of the food once per meal. FSW #3 stated that if food was not maintained at the correct temperature, the food would poison people and not be safe to eat.

ii. On 9/21/21 at 9:00 a.m., Director #1 was interviewed during the observation. Director #1 stated after obtaining the temperatures, the hot food should be 135 degrees or above to prevent food borne illnesses and the cold food should be 40 degrees or below for safety.

iii. On 9/21/21 at 9:00 a.m., Infection Preventionist (IP) #2 was interviewed during the observation. IP #2 stated food temperature must be monitored and maintained to prevent food borne illnesses.

2. The facility failed to ensure food was stored according to the policy to prevent serving expired food to patients.

a. According to facility policies, food with no manufacturer expiration date should be labeled when it was received and used within one year. Foods with a manufacturer expiration date should be used prior to expiration. Food that had been opened should be labeled with the date opened and the date it expired.

b. On 9/21/21 at 9:10 a.m. an observation of the kitchen and food storage areas was conducted. Observations revealed food was not stored according to the policies as listed below:

i. In the dry storage area, there were large cans and bottles with no manufacturer's expiration dates and no labels when the facility received the items. Examples:
Multiple large cans on the can rack which included green beans, applesauce, and corn. Six bottles of mayonnaise, six bottles of slaw sauce, two cans of coconut milk

ii. Opened food items with no label when they were opened or when they expired in the dry storage, bread rack and the freezer.

Examples:
Box of pancake mix, container of mashed potatoes, bag of mashed potatoes, bag of raisins, bag of low sodium country style gravy, two large packages of hamburger buns, one large package of hot dog buns, english muffins, biscuits

iii. Refrigerated foods opened with no expiration dates.

Examples:
Ranch dressing, dijon mustard, chili sauce, blackberries, blueberries, rice dream, vanilla yogurt

iv. Opened foods which had expired in the dry storage and refrigerator.

Examples:
Two bottles of skim milk expired 9/20/21
Thick and easy expired 9/11/21
Spanish rice use by 7/20/21
Pecans use by 7/21/21

v. Prepared food in the refrigerator with no label when they were prepared or when they expired. 11 containers of cheesecake, three containers of carrot cake, multiple small containers of fruit for patients such as mixed fruit and strawberries

vi. Employee food opened and stored in the patient food refrigerator.

Examples:
Smoothie and green tea

vii. Food in the freezer with no date received or expiration date.

Examples:
Three packs of meat, eggplant, sweet potatoes, french fries, sliced potatoes, breakfast potatoes, garlic cheese bread, danishes, three packs of bagels, four packages of bread, three packages of buns.

c. Interviews with staff revealed food storage should be performed in a manner to ensure staff knew when food expired.

i. On 9/21/21 at 9:00 a.m., during the tour of the food storage and food preparation area, Director #1 was interviewed. Director #1 stated he did not know how to determine the expiration of food if it did not have a manufacture expiration date and if staff did not label when they received it. Director #1 stated there were quite a few cans which were missing expiration dates. He stated food should be labeled once it was received with the date it was received and an expiration date of one year if there was no manufacturer expiration date for dry and canned goods and six months if it was frozen. He stated without an expiration date he was unable to determine if the food was expired or safe to consume. Director #1 stated food which had been opened should be labeled with the date it was opened and an expiration date of seven days after it was opened. He stated if an item was not labeled he was unable to determine when it was opened and if it was safe to consume. Director #1 stated prepared refrigerated food should be labeled with an expiration date of seven days after preparation. He stated employees should not store their personal food items with patient food items in the refrigerator. Director #1 stated it was the staff's duty to ensure food was safe to eat without any mold or contaminants.

ii. On 9/21/21 at 9:10 a.m., Infection Preventionist (IP) #2 was interviewed during the observation. IP #2 stated food should not be prepared and served past the expiration dates to prevent food borne illnesses.

d. Review of the Health Food Safety and Sanitation Checklist revealed facility staff had not completed a safety walk-through for most of 2021. There were no safety walk-through from January to July of 2021. The safety checklist had prompts to ensure proper labeling and storage of food.

Director #1 performed a safety walk through on 8/18/21 and 9/15/21 which identified food was not properly labeled yet did not with no identified plan to correct the issues.




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2. The facility failed to ensure medication vials were accessed and prepared according to the medication IFUs. Specifically, staff accessed and used single-dose vials of a medication for multiple patients.

A. Observations

a. On 9/21/21 at 7:42 a.m., a surgical case tracer for Patient #19 was conducted in the operating room (OR). Registered nurse (RN) #16 was observed as she removed a vial of Bupivacaine with Epinephrine (a local anesthetic) from the Pyxis machine (automated medication dispensing system). RN #16 took the vial into the OR and opened it for the Surgical Technician (ST) #18 to aspirate the contents of the vial with a new needle and syringe. RN #16 then placed the open vial inside an OR cabinet.

b. On 9/21/21 at 8:30 a.m., the OR turnover process was observed following Patient #19's procedure. The OR custodians cleaned the OR and prepared the OR for the next patient's case. The Bupivacaine with Epinephrine vial which was opened and used during Patient #19's procedure was still in the OR cabinet.

This was in contrast to AORN guidelines and the manufacturer's IFUs, which read single-use vials were to be discarded after initial use, not saved for additional uses.

B. Medical records

a. Review of Patient #19's medical record revealed on 9/21/21 at 7:54 a.m., a Bupivacaine with Epinephrine 30 ml vial was removed from the Pyxis machine. On 9/21/21 at 8:22 a.m., RN #16 documented 18 ml was administered to Patient #19. RN #16 documented the remaining 12 ml of the Bupivacaine with Epinephrine was to be wasted. However, on observation of Patient #19 it was observed the Bupivacaine with Epinephrine vial was not wasted following Patient #19's case and instead was placed back into the OR cabinet.

C. Interviews

a. On 9/22/21 at 11:45 a.m., an interview with ST #18 was conducted. He stated the RNs and STs made sure medications were drawn in a sterile process to minimize contamination. However, ST #18 stated staff used MDV in the OR while the patient was in the OR and the reuse of Bupivacaine with Epinephrine vials for multiple patients.

b. On 9/22/21 at 11:55 a.m., an interview with RN #16 was conducted. RN #16 stated staff used Bupivacaine with Epinephrine as a MDV in the OR when supplies were low. She stated there were steps taken to lower the risk of contaminating the vial contents, such as rubbing the rubber top with alcohol and using a new syringe and needle for each medication draw. RN #16 stated open vials were stored in the OR cabinet instead in an open area to lower the risk of vial cross-contamination. She confirmed the facility used AORN guidelines, however she stated she did not think the reuse of Bupivacaine with Epinephrine vials in the OR put a patient at risk for infection.

RN #16's interview was in contrast to the manufacturer's IFUs, which read products which included epinephrine in 30 ml vial were single-dose vials. Discard unused portions of solution. Additionally, RN #16's interview was in contrast to AORN guidelines, which read single-dose vials should be used for only one patient.

c. On 9/22/21 at 11:35 a.m., an interview with the Director of the OR (Director) #15 was conducted. Director #15 stated she was aware staff used MDV in the OR. She stated MDV was used due to low supply of local anesthetic medications, specifically Bupivacaine with Epinephrine. The facility was unable to provide evidence of a low supply of anesthetic medications. This was in contrast to the manufacturer's IFU for the medication, which read manufacturer's IFUs, which read single-use vials were to be discarded after initial use, not saved for additional uses.

Director #15's interview was in contrast to AORN guidelines and the manufacturer's IFUs, which read single-use vials to be discarded after initial use. If MDV were used AORN guidelines read, MDV should be used for only one patient when medications are prepared at the point of use.

Based on observations, interviews and document reviews, the facility failed to integrate support services to ensure a safe management of patients' medical conditions. Specifically, the facility failed to ensure supplies were not expired and ready for use in crash carts.

Findings includes:

Facility policies:

The Crash Cart policy and procedure read, all crash carts and their contents are accurately stocked, in-date, and secured at all times. All crash carts are to be locked and secured, with a red seal or blue seal, if not in use. After a used crash cart, the nurse or technician in the area will restock the supplies used during the emergency and place a blue seal on the cart immediately, which alerts Pharmacy to check the cart.

The crash cart shall be inspected once daily. Check all laryngoscopes blades (device used to visualize throat) and Ambu bags (hand held device used to provide ventilation to patients who are not breathing) once daily. The inspection record shall include date, signature and the color of seal securing the cart. Pharmacy will make rounds daily, check and restock all carts that have blue seals and replace the blue seal with a red seal. A current month's checklist will remain on the crash cart while the previous months' checklist will be secured in the director's office or on SharePoint for three years.

The Stock Rotation policy read, all dated items must be checked on packages by warehouse personnel during the rotation procedure to ensure that the item with the earliest expiration date got issued first. A surveillance check at least monthly must be done to verify compliance with the stock rotation procedure.

1. The facility failed to ensure supplies were not expired and available for use in the crash carts.

A. Observations

a. On 9/20/21 at 1:30 p.m., an observation of the medical surgical unit was conducted.

i. Expired emergency medications were found in the adult crash cart (a movable cart carrying supplies and medication for emergency use). Multiple expired supplies were found which included: blue top laboratory blood tubes with an expiration date of 8/27/21 and yellow intravenous 24 gauge needles with an expiration date of 7/31/21.

ii. Expired emergency supplies were found in the pediatric crash cart. The pediatric crash cart contained pediatric combo pads (pads used to defibrillate and/or cardioversion) with an expiration date on 8/23/21. Upon review of the monthly checklist on the pediatric crash cart, it revealed staff had not checked the contents of the cart since 4/16/21. This was in contrast to facility policy which read crash carts were to be inspected daily.

B. Document review

a. A patient safety event was entered on 08/23/2021 at 4:51 a.m., a Code Blue (hospital emergency code for a patient in a critical status) was activated by staff. Upon document review it revealed the crash cart was opened and multiple items were missing. Some of the items included: 10 ml syringes, saline flush syringes, blunt needles and blood tube lines were not readily available in a Code Blue.

b. A patient safety event was entered on 7/19/21 at 7:00 a.m., a patient experienced chest pain and pressure and severe jaw pain. An order for sublingual nitroglycerin (medication used for active chest pain) was ordered to be administered immediately. When staff attempted to remove medication from the ICU Pyxis machine, there were no sublingual nitroglycerin tablets available. When staff attempted to remove the medication from the third floor Pyxis machine, the nitroglycerin vial expired on 04/27/21. On the third attempt, the nitroglycerin medication was found in the Emergency Department Pyxis machine which contained a current nitroglycerin vial. The delay in treatment caused the patient to self-administer her own nitroglycerin sublingual tablets to alleviate her chest pain.

C. Interview

a. On 9/21/21 at 1:40 p.m., an interview with Chief Nursing Officer (CNO) #4 was conducted. CNO #4 stated in general if staff had to search for supplies and medications in an emergency it could delay patient care. CNO #4 stated RNs were to check the crash carts on a monthly basis for expired supplies and medications.

CNO #4's interview was in contrast to facility policy, which read, all crash carts and their contents were accurately stocked, in-date, and secured at all times.