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Based on observation, interview, record review and policy review, the facility's Governing Body failed to effectively provide oversight in the conduct of the facility when:
- The facility failed to provide an approved annual budget for 2019. (A-0073)
- Patients were not provided information about their patient's rights. (A-0116)
- All facility departments were not included in the facility-wide Quality Assessment and Performance Improvement (QAPI) Program to provide patients with quality care and safety. (A-0283)
- Nursing staff failed to notify the on-call physician, respiratory therapy (RT), or call a rapid response when a patient displayed a change of condition. (A-0395)
- Infection control practices to prevent infections and communicable diseases were not safe. (A-0749)
- Expired medical equipment and supplies were not removed, and medical equipment had not been inspected prior to use on patients. (A-0724)
- Nursing leadership failed to ensure that a person was designated as an infection control officer who implemented policies governing control of infections and communicable diseases. (A-0748)
- Operating Room (OR) staff failed to ensure that the temperature and humidity logs were completed. (A-0940)
- OR staff failed to ensure that the OR log was completed. (A-0958)
- Nursing staff failed to ensure that a History and Physical (H&P) examination was completed and documented prior to the day of surgery. (A-0952)
The facility census was one.

The severity and cumulative effect of these systemic practices resulted in the facility being out of compliance with 42 CFR 482.12 Condition of Participation: Governing Body and resulted in the facility's failure to ensure quality health care and safety.

Based on interview and record review, the facility failed to have systemic practices in place to ensure that all facility departments were included in the facility-wide Quality Assessment and Performance Improvement (QAPI) Program in order to assess and evaluate, track and trend, and perform other projects evidencing active integration to provide patients with quality care and safety and to identify areas for improvement. (A-0283). The facility also failed to ensure the Governing Body had established an ongoing program for improved health outcomes to maintain quality improvement. (A-0309). The facility census was one.

The severity and cumulative effect of these systemic practices resulted in the facility being out of compliance with 42 CFR 482.21 Condition of Participation: QAPI, and resulted in the facility's failure to ensure quality health care and safety.

Based on observation, interview, record review and policy review, the facility failed to ensure that staff:
- Notified the on-call physician in a timely manner when a patient experienced a significant change in respiratory function that resulted in his death.
- Notified the in-house respiratory therapist when a patient experienced a significant change in respiratory function that required increased oxygen demands and suctioning.
- Provided oxygen per the correct device for a patient who experienced a significant change in respiratory function.
- Followed up with the emergency department (ED) physician when the electronic system failed to show admission orders for a patient when he was admitted to Inpatient Care Unit (IPCU) services.
The facility census was one.

As a result of the survey, §482.23 Condition of Participation: Nursing Services, was found to be out of compliance. Refer to A-0395 for additional information.

Additionally, after the discovery of an unsafe patient care environment and limited recognition of the potential for negative patient outcomes the situation constituted an Immediate Jeopardy (IJ) and placed all patients at the facility at increased risk. The facility submitted a document to remove the IJ on 12/05/19 and provided an acceptable plan of correction (POC) to prevent further risk to patients.

The POC dated 12/05/19 submitted by the facility showed that they implemented the following action plan to remove the IJ:
- The facility's Medical-Surgical Scope of Practice and Notification of Changes in Patient Status policies/procedures were updated.
- All nursing staff would receive education on the updated policy/procedure prior to working their next scheduled shift.
- All direct contact information for providers and respiratory therapy (cell numbers) would be posted at the ED Nursing Station and at the IPCU (Medical-Surgical Unit) Nursing Station in "Contact" Binders.
- On-call provider lists were posted at both Nursing Stations.
- Mock Code Blue (drills to simulate an emergency situation where a patient's heart or breathing has stopped and the emergency care/responses needed to restore function or breathing) and/or Patient Decline Scenarios would be conducted on the IPCU twice per month (once per 12 hour shift), unannounced.
- The next Skills Fair would include station(s) related to physical assessment skills and mock scenarios, and escalation up the chain of command if further assistance was needed.

Based on observation, interview, and policy review, the hospital failed to:
- Ensure that sterilized materials and surgical instruments are packaged, handled, labeled, and stored in a moisture, temperature and dust controlled environment that ensured sterility; (A-0749)
- Ensure the cleanliness of one refrigerator in the preoperative area; (A-0749)
- Ensure the cleanliness of the floor in the storage room in the Operating Room (OR) area; (A-0749)
- Ensure that spices and frozen foods were labeled with a use by date; (A-0749)
- Ensure that the coils on the reach in cooler were free of dust collection; (A-0749)
- Ensure that outdated milk was removed from a refrigerator on the inpatient unit; (A-0749)
- Ensure the cleanliness of the Workstations on Wheels (WOW, mobile computer station that can easily be transported between patient rooms and around the hospital); (A-0749) and
- Ensure that a person was designated as an infection control officer who implemented policies governing control of infections and communicable diseases. (A-0748)

These failures increased the risk of infections for all patients admitted to the hospital. The facility census was one.

As a result of the survey, 482.42 Condition of Participation: Infection Control was found to be out of compliance.

Additionally, after the discovery of an unsafe patient care environment and limited recognition of the potential for negative patient outcomes, the situation constituted an Immediate Jeopardy (IJ) and placed all patients at the facility at increased risk. The facility submitted a document to remove the IJ on 12/05/19 and provided an acceptable plan of correction (POC) to prevent further risk to patients.

The POC dated 12/05/19, submitted by the facility, showed that they implemented the following action plan to remove the IJ:
- A third-party, contracted sterilization service would assume responsibility of sterilization for the hospital until the Sterile Processing Department standards met or exceeded minimum expectations for sterile processing.
- Once the Sterile Processing Department met minimum standards, a deep clean would be conducted of the department and all sterile instrumentation would be re-sterilized.
- Portable air conditioning units were removed immediately from Sterile Processing.
- An outside vendor arrived and immediately installed a metal plate to cover the door that was cut and covered by saran wrap.
- An outside vendor was contacted to provide a revised quote for installation of a new heat, vacuum, and air conditioning (HVAC) system specific for the Sterile Processing Department.
- A back up vendor would be utilized for other HVAC needs specific to sterile processing.
- A daily cleaning schedule and log book was implemented.
- The log book would be maintained within the Sterile Processing Department and monitored for compliance.
- An outside vendor was engaged to perform air flow test in Sterile Processing.




39563

Based on interview, record review, and policy review, the facility failed to:
- Ensure that the temperature and humidity logs were completed in the operating room (OR). (A-0940)
- Ensure that a History and Physical (H&P) examination of the patient was completed and documented prior to the day of surgery. (A-0952)
- Ensure that the operating log was completed. (A-0958)
These failed practices had the potential to compromise the safety and health of all patients undergoing procedures at the facility. The facility performed approximately 45 procedures per month. The facility census was one.

The cumulative effect of these failures resulted in non-compliance with 42 CFR 482.51 Condition of Participation: Surgical Services.

Findings included:

1. Review of the facility's policy titled, "Temperature and Humidity in the OR and Recovery Room," revised 02/2014 showed direction for staff to check humidity levels periodically and record on a monthly basis.

Although requested, the facility failed to provide completed temperature and humidity logs for the OR, for the months of May, June, September, and October.

During an interview on 12/02/19 at 2:35 PM, Staff B, Registered Nurse, Manager of Surgical Services, stated that the temperature and humidity logs were incomplete.

During an interview on 12/04/19 at 5:25 PM, Staff F, Chief Nursing Officer, stated that the OR temperature and humidity logs should be up to date.

Based on observation, interview, record review, and policy review, the Governing Body failed to ensure the Chief Executive Officer (CEO) was responsible for management of the entire hospital which included accountability for the effective oversight of the staff to comply with the requirements under the Conditions of Participation (COP) for Governing Board, Patient's Rights, Quality Assurance Performance Improvement (QAPI), Nursing Services, Infection Control and Surgical Services. This failure had the potential to affect the quality of care and safety of all patients. The facility census was one.

Findings included:

1. Review of the hospital's document titled, "Governing Board (Board of Directors) Bylaws," amended 12/06/16, showed the Governing Board appoints a CEO who would be the individual that served as the administrative officer responsible for and managed the hospital. This individual would be responsible to the Board of Directors. This individual would also be responsible to implement policies and procedures the Governing Board approved and act as a liaison between the Governing Board and the Medical Staff.

The CEO failed to ensure compliance when:
- The hospital failed to approved an annual budget for 2019. (A-0073)
- Patients were not provided information about their patient's rights. (A-0116)
- All hospital departments were not included in the hospital-wide QAPI Program. (A-0283)
- Nursing staff failed to notify the on-call physician, respiratory therapy (RT), or call a rapid response when a patient displayed a change of condition. (A-0395)
- Infection control practices to prevent infections and communicable diseases were not safe. (A-0749)
- Expired medical equipment and supplies were not removed from potential use on patients. (A-0724)
- Nursing leadership failed to ensure that a person was designated as an infection control officer. (A-0748)
- Operating Room (OR) staff failed to ensure that the temperature and humidity logs were completed. (A-0940)
- OR staff failed to ensure that the OR log was completed. (A-0958)
- Nursing staff failed to ensure that a History and Physical (H&P) examination was completed and documented prior to the day of surgery. (A-0952)

During an interview on 12/04/19 at 4:30 PM, Staff E, CEO, stated that:
- The hospital did not have an annual operating budget.
- He was not aware of the problems in the Sterile Processing Department (SPD, area designated to clean and sterilize [process that eliminates viruses and bacterial] instruments or equipment that are used in procedures) area.
- The Chief Nursing Officer (CNO) would be responsible for the duties of the Infection Control Nurse and he did not realize there were problems.
- He was not aware of the departments that did not have active QAPI projects integrated into the hospital-wide QAPI program.

During an interview on 12/06/19 at 6:00 PM, Staff LL, Chairman of the Board, stated that the hospital did not have a budget, that he was not aware of any problems in the SPD, and was unaware of passive or inactive house-wide QAPI programs.

During an interview on 12/09/19 at 2:28 PM, Staff MM, owner, stated there was no annual budget for the hospital, he was not aware of any problems in the SPD, and was unaware of the departments that did not have active QAPI projects integrated into the house-wide QAPI program.

Based on interview and record review the facility failed to provide an approved annual operating budget for 2019. This failure could prevent the facility from identifying sources of financing and anticipated expenditures, and result in inadequate hospital finances. The facility census was one.

Findings included:

1. Review of the facility's document titled, "Governing Board (Board of Directors) Bylaws," amended 12/06/16, showed the Governing Board would approve an annual operating budget prepared in a manner that meets the "Generally Accepted Accounting Principles." They would annually meet to review current year income and expenses to determine shortages and overages and formulate short term and long term plans to assist the development of the hospital. The fiscal year for the facility is January 1 through December 31.

During an interview on 12/04/19 at 4:30 PM, Staff E, Chief Executive Officer (CEO), stated that the hospital did not have an annual operating budget.

During an interview on 12/06/19 at 3:40 PM, Staff KK, Chief Medical Officer, stated that the hospital did not have an annual operating budget.

During an interview on 12/06/19 at 6:00 PM, Staff LL, Chairman of the Board, stated that the hospital did not have a budget.

During an interview on 12/09/19 at 2:28 PM, Staff MM, owner, stated there was no annual budget.

During an interview on 12/09/19 at 4:40 PM, Staff NN, Chief Financial Officer (CFO), stated there was no annual budget.

Based on interview, record review, and policy review, the facility failed to provide information about patient's rights to 12 patients (#4, #5, #6, #7, #8, #9, #21, #38, #39, #40, #41, and #42) of 12 patients reviewed. These failures increased the potential for all patients admitted to the facility to be unable to exercise their rights as a patient. The facility census was one.

Findings included:

1. Review of the facility's policy titled, "Patient Rights and Responsibilities," dated 02/2014, showed that patients would be made aware of their rights at the time of admission. This information would be located in the admission packet, located in the bedside drawer, and would be the responsibility of the nurse admitting the patient to give them the packet, explain its contents, and document that such information had been given, on the admission assessment form.

Review of Patients #4, #5, #6, #7, #8, #9, #21, #38, #39, #40, #41, and #42's medical records, showed that no Patient Rights and Responsibilities were given to the patients, it was not marked on the admission assessment that such information had been given.

During an interview on 12/03/19 at 2:47 PM, Patient #21 stated that:
- She was not sure what staff she should report concerns related to care/treatment while an inpatient.
- She did not have knowledge about the facility's grievance process that included reporting a concern/grievance or the investigative process after a concern/grievance had been reported to staff.
- To her knowledge the facility did not provide her with information on how she could contact the State Agency to report concerns/grievances.

During an interview and concurrent observation on 12/05/19 at 10:55 AM, Patient #42 stated that he had not received a copy of the Patient Rights and Responsibilities. There was no packet of information located in the patient's bedside drawer.

During an interview on 12/02/19 at 3:01 PM, Staff H, Social Service Director, stated the patients did not receive the Patient Bill of Rights and Responsibilities anymore.

During an interview on 12/05/19 at 11:00 AM, Staff R, Registered Nurse (RN), stated that they no longer gave the patient's rights information to the patients.

During an interview on 12/04/19 at 4:30 PM, Staff E, Chief Executive Officer (CEO), stated that the patients should be given the Patient Rights and Responsibilities packet on admission, and that he was not aware they were not.

During an interview on 12/05/19 at 11:15 AM, Staff F, Chief Nursing Officer (CNO), stated that all patients should receive the Patient Rights and Responsibilities packet upon admission.



18018

Based on interview and record review, the facility failed to have systemic practices in place to ensure that all facility departments were included in the hospital-wide Quality Assessment and Performance Improvement (QAPI) Program in order to assess and evaluate; track and trend; and perform other projects that evidenced active integration to provide patients with quality care and safety and to identify areas for improvement. 10 of 21 departments failed to have active integration in the QAPI program to measure the effectiveness and safety of services to patients. These failures had the potential to put all patients at risk for sub-standard quality of health care and adverse outcomes. The facility census was one.

Findings included:

1. Review of the facility's undated document titled, "Quality and Patient Safety," showed:
- It was to provide a comprehensive framework for the organization's Performance Improvement (PI) and patient safety initiatives.
- All areas of the hospital operations and populations served are included in the scope of PI and patient safety plan.
- Organizational leaders support QAPI and patient safety through effective planning and priority setting.
- The top focus of organizational QAPI would be to eliminate events that resulted in patient harm.
- The Department Directors and managers were responsible for the functions of their departments and services, to maintain ongoing essential quality control.
- All hospital employees were responsible to promote a safe and engaged culture and actively participate in patient safety and QAPI activities.

Review of the list of services provided by the hospital, showed the following departments that were not actively involved in QAPI:
- Nursing Services;
- Medical Record Services;
- Radiological Services;
- Laundry and Central Supply in the Physical Environment Department;
- Infection Control;
- Surgical Services;
- Anesthesia Services;
- Rehabilitation Services; and
- Respiratory Services.

During an interview on 12/02/19 at 2:00 PM, Staff F, Chief Nursing Officer (CNO), stated that he led QAPI and was aware that it needed improvement. He stated that there was no active QAPI program from every department.

During an interview on 12/02/19 at 2:17 PM, Staff A, Director of Respiratory Services, stated that he did not have any current data collected for the department's QAPI indicators.

During an interview on 12/04/19 at 4:30 PM, Staff E, Chief Executive Officer (CEO), stated that he was aware there should be an active QAPI program.

During an interview on 12/06/19 at 3:50 PM, Staff KK, Chief Medical Officer (CMO), stated that he knew there were no active QAPI projects and had discussed with the Governing Board that it needed to be corrected.

During an interview on 12/06/19 at 6:00 PM, Staff LL, Chairman of the Governing Board, stated that he was not aware of the passive or inactive QAPI program.







18018

Based on interview and record review, the facility's Governing Body failed to effectively provide oversight in the conduct of the facility when the facility failed to have systemic practices in place to ensure that all hospital departments were included in the hospital-wide Quality Assessment and Performance Improvement (QAPI) Program. This had the potential to put all patients at risk for substandard quality care and compromise their health and safety. The facility census was one.

Findings included:

1 Review of the facility undated document titled, "Quality and Patient Safety," showed that:
- Organizational leaders would support PI and patient safety through effective planning and priority setting.
- The Governing Board had overall responsibility for determining the scope and nature of organizational improvement activities.
- The Governing Board used a variety of data and committee reports to review organizational performance and ensure the quality of care and services provided meet the standard of care and community expectations.
- It was the responsibility of the Governing Board to review organization-wide performance measures.
- Ongoing organizational QAPI activities would include findings and recommendations of the QAPI teams and provide recommendations based on available information.

Review of the list of services provided by the hospital, showed the following departments that were not actively involved in QAPI:
- Nursing Services;
- Medical Record Services;
- Radiological Services;
- Laundry and Central Supply in the Physical Environment Department;
- Infection Control;
- Surgical Services;
- Anesthesia Services;
- Rehabilitation Services; and
- Respiratory Services.

During an interview on 12/02/19 at 2:00 PM, Staff F, Chief Nursing Officer (CNO), stated that he led QAPI and was aware that QAPI needed improvement. He stated there was no active QAPI program.

During an interview on 12/04/19 at 4:30 PM, Staff E, Chief Executive Officer (CEO), stated that he was aware there should be an active QAPI program.

During an interview on 12/06/19 at 3:50 PM, Staff KK, Chief Medical Officer (CMO), stated that he knew there were no active QAPI projects and had discussed with the Governing Board that it needed to be corrected.

During an interview on 12/06/19 at 6:00 PM, Staff LL, Chairman of the Governing Board, stated that he was not aware of the passive or inactive QAPI program.

Based on observation, interview, record review and policy review, the facility failed to ensure that staff:
- Notified the on-call physician in a timely manner when one discharged patient (#11) of one discharged patient reviewed, experienced a significant change in respiratory function that resulted in his death.
- Notified the respiratory therapist (RT) when one discharged patient (#11) of one discharged patient reviewed, experienced a significant change in respiratory function that required increased oxygen demands and suctioning.
- Provided appropriate amounts of oxygen per the correct device for optimal oxygen delivery, for one discharged patient (#11) of one discharged patient reviewed, who experienced a significant change in respiratory function and required supplemental oxygen.
- Followed up with the emergency department (ED) physician when the electronic system failed to process admission orders for the patient when he was admitted to Inpatient Care Unit (IPCU) services. These failures had the potential to lead to negative outcome for all patients who were cared for in the facility. The facility census was one.

Findings included:

1. Review of the facility's policy titled, "Notification of Changes in Patient Status," dated 04/2010, showed directives for nursing staff to notify the patient's physician and other responsible persons in the event of significant changes in the patient's physical, mental or emotional status.

Review of the facility's policy titled, "Emergency Oxygen Set-Up," dated 011/2019, showed the oxygen is considered a drug and can only be prescribed by a physician. In the event that a situation arises where a patient needs oxygen and it is not ordered, then the respiratory therapist, nurse, or paramedic should use the following guidelines:
- Decide whether Nasal Cannula (NC, a tube placed into the nostrils used to deliver oxygen) up to six liters or mask (placed over the nose and mouth to deliver oxygen) in any style no less than six liters (NO less than 10 liters for Non-Rebreather Masks [mask that has the capability of delivering a higher level of oxygen concentration]) was the best to use;
- Hook up the oxygen device;
- Contact the patient's physician;
- Monitor the patient's SaO2 (oxygen saturation, a red protein in blood responsible for transporting oxygen)/draw arterial blood gases (ABG, a blood test that measures the amount of oxygen and carbon dioxide in the blood) if ordered; and
- Adjust oxygen accordingly.
- If it is suspected that a patient needs oxygen, call their doctor and get an order for arterial blood gases prior to placing the patient on oxygen. The arterial blood gas results will show what the patient's oxygen level is and will help in determining what oxygen device is needed, how many liters or what percentage to place the patient on and then document the treatment into the electronic medical record (EMR).

Review of the facility's policy titled, "Sentinel Event," dated 09/2005, showed:
- A sentinel event is a patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, permanent harm or severe temporary harm.
- An "Event Report" will be completed by the person with the most knowledge of the current facts and this will be submitted to the Risk Manager or designee.
- A Root Cause Analysis (RCA, a systematic process for identifying "root causes" of problems/events and an approach for responding to them) should be conducted.

Review of Patient #11's ED EMR showed:
- The patient presented to the facility's ED on 11/25/19 at 2:18 AM by ambulance from a nearby nursing home, with complaints of nausea, vomiting and a low oxygen level of 86% (normal range is 95 - 100%).
- At 2:18 AM, Staff BB, ED Registered Nurse (RN), documented that the patient's SaO2 was 93% on room air.
- At 3:30 AM, Staff BB documented that the patient experienced four episodes of vomiting since his arrival to the ED.
- At 3:39 AM, Staff X, ED Physician, documented that the patient experienced dysphagia (difficulty swallowing) and may have been an aspiration (breathing foreign objects into the lungs) risk. The patient's breath sounds are normal and without respiratory distress. The patient's chest x-ray showed a large hiatal hernia (area of the stomach that bulges into the chest area), right costophrenic sulcus blunting (fluid that pushes the lungs upward) and minimal right bibasilar atelectasis (lower lung collapse) or scar was observed.
- At 5:15 AM, Staff BB documented that the patient was transferred and admitted to the facility's Inpatient Care Unit (IPCU). The patient's SaO2 was 91% and was in stable condition at the time of his transfer.

Review of the patient's admission orders dated 11/25/19 at 4:46 AM showed Staff X, ED Physician, wrote an order for "Inpatient Telemetry (electrical monitoring of the heart) NOW".

Staff failed to follow-up with Staff X, ED Physician, when admission orders failed to process through the electronic system. Staff failed to obtain telephone, verbal or written admission orders when they did not receive the orders from the electronic system. Therefore, the patient was not placed on the ordered telemetry monitoring from the time of his admission to the IPCU on 11/25/19 at 5:15 AM until the time of his death on 11/25/19 at 9:50 AM (approximately four and a half hours).

2. Review of the IPCU assessment note documented on 11/25/19 by Staff OO, RN, showed:
- At 5:40 AM, the patient had a non-productive cough, experienced difficulty clearing secretions, lung sounds were coarse, respiratory effort labored, and tachypnea (abnormally rapid breathing greater than 20 breaths per minute) at 26 breaths per minute.
- Oxygen was administered at three liters per nasal cannula with pulse oximetry reading of 92% with supplemental oxygen.
- Aspiration precautions (head of bed elevated up) was initiated.

Staff failed to contact either Staff X, ED Physician, or Staff DD, (on-call) Physician, with the patient's change in respiratory status and the need for supplemental oxygen.

3. Review of the IPCU Assessment note documented on 11/25/19 at 10:38 AM by Staff Y, RN, showed:
- At 7:00 AM, Staff Y, received care of the patient from Staff AA, RN.
- At the beginning of the shift, the patient was unresponsive and his status remained unchanged.
- When Staff Y went into the patient's room, she noticed he was having respiratory difficulty, breathing heavy and making "gurgling (hollow bubbling sound)" sounds.
- Staff Y suctioned the patient's mouth, using an oral suction tool and a moderate amount of yellowish sputum (mixture of saliva and mucus) was returned. After being suctioned, the patient continued to experience a lot of "gurgling".
- At 7:45 AM, Staff Y called the clinic for Staff DD, Physician (on-call), and was informed that Staff DD was not in yet but the office assistant would inform him as soon as he arrived to the clinic to come and see the patient (Staff Y failed to contact Staff DD by his contact number and caused a delay in the patient being assessed for his significant change in respiratory status and demand for supplemental oxygen).
- At 8:45 AM, Staff Y informed the house supervisor that she needed orders for the patient because he had been admitted from the ED earlier (the electronic system failed to process the admission orders that had been entered by Staff X, ED Physician, and staff failed to follow-up in a timely manner for the orders).
- The house supervisor informed Staff Y to call Staff DD for orders.
- Staff Y suctioned the patient several more times and a large amount of yellowish sputum was returned.
- When the patient was turned, a moderate amount of yellowish liquid came out of his mouth.
- The patient's pulse oximetry dropped down to 84% and Staff Y turned up the oxygen to nine liters per nasal cannula (nasal cannula can deliver oxygen up to six liters, nine liters per nasal cannula is three liters over the recommended delivery rate).
- The patient continued to experience difficulty maintaining his oxygen saturations within normal levels, so Staff Y turned up the oxygen to 10 liters per nasal cannula (four liters over the recommended delivery rate).
- The patient's fingernails were cyanotic (blue color) and Staff Y converted the patient from the nasal cannula to a mask.
- At 9:15 AM, Staff Y phoned Staff DD, Physician (on-call), and reported to him the change in the patient's condition (a two hour and 15 minute delay from the patient's first signs and symptoms of respiratory distress at 7:00 AM). Staff DD informed Staff Y to call Staff X, ED Physician, to have him come and see the patient.
- Staff Y called the ED and was informed that they had an emergency and that Staff X, ED Physician, could not come see the patient yet (Staff Y failed to notify Staff DD that Staff X was unavailable to see the patient).
- At 9:45 AM, the patient stopped breathing and no heart rate was detected.
- At 9:50 AM, Staff X, ED Physician, came and pronounced the patient's death.

Staff failed to:
- Follow-up in a timely manner to obtain admission orders when the electronic system failed to process the orders.
- Notify the on-call physician (Staff DD) in a timely manner of the patient's significant change in his respiratory status and the need for supplemental oxygen.
- Notify RT of the patient's increased need for oxygen and suctioning.
- Notify Staff DD that Staff X was unavailable to come and assess the patient due to an emergency in the ED.
- Deliver oxygen with the correct device when higher levels were required by the patient.

These failed practices placed all patients with respiratory needs at increased risk for their safety and health.

Review of a note documented on 11/25/19 at 1:13 PM, by Staff X, ED Physician, showed:
- He was called to the patient's bedside at 9:45 AM from the ED where he had been involved in another emergency.
- When the day shift nurse had checked on the patient, she found him with increased respirations and required suctioning related to possible aspiration.
- The patient's oxygen saturation level had dropped down to 84% and oxygen therapy was administered per mask.
- The nurse noticed that the patient's respiratory effort had ceased at 9:45 AM and Staff X was called to the bedside from the ED where he was involved in another emergency that was in progress.
- At the time of the assessment, the patient's pupils were fixed, dilated and he had no respiratory effort or pulse.
- The patient's time of death was called at 9:50 AM.

During an interview on 12/04/19 at 8:00 AM and 8:43 AM, Staff F, RN, Chief Nursing Officer (CNO), stated that:
- The facility had not investigated or started an investigation for the unexpected death of Patient #11.
- Since the patient's death just happened on 11/25/19, he had not had time to do an investigation or RCA into the unexpected death of the patient.
- The patient was a do not resuscitate (DNR, an order written by a medical doctor that instructs healthcare providers not to provide cardiopulmonary resuscitation if a person stops breathing or the heart stops beating) and questioned since he was a DNR if his death was considered a sentinel event.

The patient expired approximately four and a half hours after being admitted to inpatient services and his death was an unexpected death.

4. During an interview on 12/04/19 at 9:15 AM, Staff X, ED Physician, stated that:
- When the patient presented to the ED and when he examined the patient, his respiratory status was within normal limits.
- When the patient was discharged from the ED his respiratory status remained unchanged and he was in stable condition when he was transported to the inpatient unit.
- He was surprised when the patient expired and his death was unexpected.
- He was unaware of how much respiratory distress the patient was in when the patient was on the IPCU.
- Inpatient care staff did not inform him that they did not receive orders for the patient when he was admitted from the ED to the IPCU.
- If the patient was decompensating in his respiratory effort, staff should have either notified him or RT.

During an interview on 12/04/19 at 9:49 AM, Staff Y, RN, stated that:
- She was the patient's primary care nurse on 11/25/19 during the day shift and began care for the patient at 7:00 AM.
- She received report from the night nurse that the patient was from a nearby nursing home and was seen in the ED for nausea/vomiting, that he might have aspirated but he did not have any signs/symptoms of respiratory distress when he was admitted from the ED.
- At approximately 7:30 AM, when she performed her morning assessments, the patient was "gurgling" so loudly that the sound could be heard from the patient's doorway and his respirations were labored.
- She notified the house supervisor that the patient did not have any floor orders (admission orders to the IPCU) from the ED physician and the house supervisor reported that the ED physician stated that he had placed floor orders in the EMR.
- The patient's oxygen saturation started to decrease for the first time around 9:28 AM.
- She called Staff DD, Physician (on-call), to inform him that the patient was admitted without orders, and provide an update on the patient's respiratory status.
- Staff DD informed her to contact Staff X, ED Physician, to obtain orders and to check on the patient because he (Staff DD) was not in the facility yet.
- She contacted the ED and was informed that the ED was busy with patients and that Staff X, ED Physician, was unable to leave the ED to come to the IPCU at that time.
- She contacted Staff DD a second time approximately 30 minutes after her first contact with him.
- She felt like the patient needed to be seen by a provider and that was why she kept making attempts to get a provider to come see the patient.
- She suctioned the patient and increased his oxygen delivery in an attempt to keep his oxygen saturations at 90%.
- She did not have a physician order to increase the patient's oxygen level.
- The patient was receiving oxygen per nasal cannula and she increased the oxygen to nine and 10 liters by nasal cannula.
- She acknowledged that providing oxygen at either nine or 10 liters per nasal cannula was not the standard of practice and she did convert the patient from the nasal cannula to a mask later.
- She did not call or page for RT because RT only worked on Mondays and Tuesdays (11/25/19 was on a Monday and RT was in the facility at 7:00 AM) and she was not aware if RT was available on-call.
- If RT was in the facility on the morning of 11/25/19, she was not aware they were available.
- She was not aware if another physician was on-call or available that she could have contacted for assistance with the patient's decreased respiratory efforts.
- From 7:45 AM until 9:45 AM, no provider responded to requests to come and assess the patient and he had a "death rattle" (death rattle, sounds often made when a person is dying, caused by fluids accumulated in the mouth and upper chest).
- The facility had not provided any education or training related to this event to date (12/04/19).

During an interview on 12/04/19 at 1:45 PM, Staff PP, Certified Nursing Assistant, stated that she did not know where the contact information for RT was located on the IPCU, and she did not know how to get a hold of RT when they were not in the hospital.

During an interview and observation on 12/04/19 at 1:45 PM, Staff Y, RN, stated that the facility had a notebook with "contact information" at the nurses station on the IPCU. When Staff Y looked in the notebook, RT's contact information was not included.

Observation on 12/04/19 at 1:45 PM showed that on a memo board located on the IPCU nurse's station had a list of the on-call providers for the month.

Review of the on-call providers' calendar dated November 2019, showed that Staff DD, Physician, was on-call on 11/24/19 and 11/25/19.

During a telephone interview on 12/04/19 at 1:47 PM, Staff AA, RN, stated that:
- She was the nurse that received the patient from the ED and she was his primary care nurse for the rest of the night shift until 7:00 AM on 11/25/19, and cared for the patient approximately one and a half hours.
- She received report from the ED nurse that the patient was from a nearby nursing home and presented with nausea and vomiting. His chest x-ray showed he had a hernia and his laboratory results were off (abnormal)
- She did not have any concerns with the patient's respiratory efforts during her care.
- When she assessed the patient, his lung sounds were "coarse" which she attributed to possible aspiration from vomiting.
- During her care of the patient, he did not experience any "rattling" or "gurgling" from his lungs/throat.
- The patient's pulse oximetry did drop down into the 80's and she applied supplemental oxygen without a physician's order because staff have oxygen protocols they can follow if a patient required oxygen.
- She did not notify Staff X, ED Physician, or Staff DD, Physician (on-call), when she initiated supplemental oxygen at three liters per nasal cannula.
- She denied any deterioration in the patient's respiratory status during her care, and his respiratory status was stable at the end of her shift.
- She initiated aspiration precautions and elevated the patient's head of the bed approximately 45 degrees.
- She did not expect the patient to die two hours later.

During a telephone interview on 12/04/19 at 2:06 PM, Staff A, RT Director, stated that:
- He worked from 7:00 AM to 7:00 PM on Monday and Tuesday and was available on-call per phone the rest of the time.
- His contact information was located at the ED nurse's station but he was not sure if the information was also located at the IPCU nurse's station.
- The house supervisor had his contact information for when he was on-call.
- Increasing oxygen up to nine and 10 liters per nasal cannula was not an appropriate level of oxygen delivery for that device.
- The RT department policy and procedure for oxygen delivery per nasal cannula directed that oxygen could be delivered up to six liters by that device.
- Staff did not contact or notify him that a patient on the IPCU was experiencing respiratory distress.
- He was on the IPCU on the morning on 11/25/19 and no staff asked for his assistance with the patient's respiratory distress or suctioning demands.

During a telephone interview on 12/10/19 at 10:56 AM, Staff DD, Physician (on-call), stated that:
- He was on-call for 24 hours from 6:00 AM to 6:00 AM on 11/24/19 and 11/25/19.
- He was available on 11/25/19 by his contact information, but staff never called his cell phone number.
- He was unsure why staff had called the clinic and not his cell phone on the morning of 11/25/19.

Based on observation and interview, the facility failed to ensure that:
- Staff removed outdated/expired medical supplies from one emergency cart.
- Staff removed outdated/expired medical supplies from one procedure room.
- Staff removed outdated/expired medical supplies from outpatient rooms.
- Medical equipment had been inspected prior to patient use.
These failed practices had the potential to allow ineffective or harmful medical supplies and equipment to be used for patient care. The facility census was one.

Findings included:

1. Although requested, the facility failed to provide a policy addressing expired supplies and outdated medical equipment.

Observation on 12/02/19 at 3:10 PM, in the procedure room where pain injection procedures and endoscopies (procedure to examine the interior of a hollow organ or cavity of the body with a lighted tube with a camera) were performed, the following expired supplies were found:
- Three polyp (abnormal tissue growths) forceps expired on 07/21/19;
- Three polyp forceps expired on 09/29/19;
- One polyp forceps expired on 08/26/19;
- One hot biopsy forceps expired on 10/13/19; and
- There were four pieces of equipment in the procedure room with biomedical tags that expired on 09/2019 and one that expired on 05/2019.

Observation on 12/02/19 at 3:25 PM, in an outpatient room, the following expired supplies were found with no sterilization or expiration date:
- Two packages of green towels;
- Two packages of cotton tip applicators;
- One package of two by two gauze; and
- Three tourniquets.

Observation on 12/02/19 at 3:30 PM, in an outpatient room, the following outdated supplies were found:
- Two packages of adhesive expired 11/28/19;
- Four catheter stabilization devices expired 10/2019;
- One container of adhesive expired 10/2018;
- One tube of ointment expired 10/2019;
- One bottle of normal saline expired 11/20/19; and
- One opened bottle of peroxide with no use by date.

Observation on 12/03/19 at 4:52 PM, on the emergency cart on the medical unit, there were two pair of size eight sterile gloves expired 09/2019 and one pair of size seven and one half sterile gloves expired 10/2019.

During an interview on 12/03/19 at 4:56 PM, Staff Q, Licensed Practical Nurse, confirmed that the gloves on the emergency cart were expired.

During an interview on 12/02/19 at 3:25 PM, Staff B, Registered Nurse, Manager of Surgical Services, stated that the expired supplies and equipment should not be available for use.

During an interview on 12/04/19 at 5:25 PM, Staff F, Chief Nursing Officer, stated that expired supplies should not be available for use and equipment should have current inspection stickers.

During an interview on 12/04/19 at 4:56 PM, Staff E, Chief Executive Officer, stated that expired supplies should not be available and inspection stickers should be current.

Based on interview the facility failed to ensure that a person was designated as an infection control officer who implemented policies governing control of infections and communicable diseases. This failure had the potential to affect all patients receiving care in the facility, when infections were not tracked and there was no oversight of infection control practices. The facility census was one.

Findings included:

1. During an interview on 12/03/19 at 3:05 PM, Staff F, Chief Nursing Officer, stated that there was no infection control nurse and no one tracked infections.

During an interview on 12/04/19 at 4:56 PM, Staff E, Chief Executive Officer, stated that the infection control program did not have a person in charge.

Based on observation, interview, record review and policy review, the facility failed to:
- Ensure that sterilized material and surgical instruments were packaged, handled, labeled, and stored in a moisture, temperature and dust controlled environment that ensured sterility;
- Ensure the cleanliness of one refrigerator in the preoperative area;
- Ensure the cleanliness of the floor in the storage room in the Operating Room (OR) area;
- Ensure that spices and frozen foods were labeled with a use by date;
- Ensure that the coils on the reach in cooler were free of dust collection;
- Ensure that outdated milk was removed from a refrigerator on the inpatient unit.
- Ensure the cleanliness of the Workstations on Wheels (WOW, mobile computer station that can easily be transported between patient rooms and around the hospital).
These failures had the potential to cause harm and increased risk of infections to all patients in the facility. The facility census was one.

Findings included:

1. Observation on 12/02/19 at 2:45 PM in Sterile Processing Department (SPD, area designated to clean and sterilize [process that eliminates viruses and bacterial] instruments or equipment that are used in procedures) showed that:
- There was dust and debris clearly visible on the shelves that contained clean equipment for processing sterile instruments, and the stainless steel table used to put instruments into packages prior to sterilization.
- The old sterilizer (a machine that uses high heat and steam to kill harmful organisms) had been replaced with a new one, and a door was cut into the wall so the old one could be removed and the new one installed. This left a large room behind the sterilizer exposed. Located in this room were the water intake and waste drains to the sterilizer. The door was covered with a saran like wrap that was taped along the edges. The tape had failed and allowed dust and debris to be pulled out into the sterile space of the SPD.
- There were two portable air conditioning units in use that were vented to the outside with make shift holes in both sides of a large window. These holes were not sealed properly which allowed outside air to come into the SPD area.
- The filters inside both air conditioning units were covered in heavy dust.
- Ceiling tiles were dirty, the smooth cover had peeled off, and hung down into the room.
- The light fixtures were a metal, fluorescent type, that hung down from the ceiling. These were dirty and rusty.
- Floor tiles around the sterilizer were water and rust stained.
- A fan in the ceiling of the sterile instrument storage area did not fit the hole and the added aluminum backed tape used to seal off the rest of the hole hung down and exposed the area above the ceiling tiles.
- The positive pressure (air pressure inside the room is greater than the pressure outside of it keeping contaminates and germs out by moving air out of the room when doors are opened or not sealed properly) in the area was compromised. Air moved from the hallway into SPD.

Review of the temperature and humidity logs for SPD on 12/02/19 at 3:08 PM, showed temperatures had been higher than normal 24 days over a period of nine months, when the department was opened. The current temperature in the SPD was 77 degrees (normal range is 68 to 73 degrees for proper wrapping of clean instruments to be sterilized).

Review of the hospital's policy titled, "Packaging," dated 11/28/11, showed that packaging systems should ensure sterility of package contents until opened for use.

During an interview on 12/02/19 at 3:15 PM, Staff D, Lead SPD Technician, stated that the hospital's administrative staff were aware of the temperature and unclean conditions in the department. She explained she had to wipe the area down numerous times in the day as she processed instruments and supplies.

During an interview on 12/02/19 at 3:25 PM, Staff U, Maintenance Manager, stated that a positive pressure test had not been done since 01/2019, and he was unaware there was an issue with the air pressure. He also stated he cleaned the filters on the portable air conditioner units frequently. He did not think the hole that was too large for the ceiling fan would cause an issue with the positive pressure.

During an interview on 12/02/19 at 4:15 PM, Staff F, Chief Nursing Officer (CNO), stated that he did not realize SPD was out of compliance with sterile regulations. He knew there were issues with temperatures, but assumed those had been fixed, with the addition of the two portable air conditioning units. Staff F added that he did not track surgical patient infections.

During an interview on 12/04/19 at 4:30 PM, Staff E, Chief Executive Officer (CEO), stated he was not aware of the problems in SPD.

During an interview on 12/06/19 at 3:40 PM, Staff KK, Chief Medical Officer, stated he was not aware of any problems in SPD, and if he knew there were possible sterilization problems, he would have stopped all surgeries himself.

During an interview on 12/06/19 at 6:00 PM, Staff LL, Chairman of the Board, stated he was not aware of any problems in the SPD.

During an interview on 12/09/19 at 2:28 PM, Staff MM, owner, stated he was not aware of any problems in the SPD.

2. Review of the facility's policy titled, "Refrigerators Food," dated 11/2007, showed that the refrigerators should be cleaned monthly or as needed with a diluted bleach solution, and cleaning of the refrigerators should be documented in the log book.

Observation on 12/02/19 at 3:05 PM, showed the inside of the patient nutrition refrigerator had an area on the bottom shelf that was sticky and had hair present.

During an interview on 12/02/19 at 3:05 PM, Staff B, Registered Nurse (RN), Surgical Services Manager, stated that the refrigerator was not clean on the inside and that the nurses or housekeeping were to clean the refrigerator when it was dirty.

3. Although requested, the facility failed to provide a policy for cleaning of the storage room in the OR.

Observation on 12/02/19 at 2:35 PM, showed dried mud and other black particles on the floor in the storage room in the OR.

During an interview on 12/02/19 at 2:35 PM, Staff B, RN, Surgical Services Manager, stated that she was not sure the last time the floor had been mopped.

4. Although requested, the facility failed to provide a policy regarding the shelf life for spices and frozen foods.

Observation on 12/03/19 at 9:35 AM, showed:
- 33 bottles of dry spices on the shelf with no opened or use by date on the containers;
- One bag of opened almonds with no use by date;
- One container of mixed spices with no use by date;
- One bag of meatballs in the freezer with no use by date;
- One pie crust in the freezer with no use by date;
- One bag of chicken patties in the freezer with no use by date;
- One bag of shells in the freezer with no use by date;
- One bag of pork chops in the freezer with no use by date; and
- Two bags of hash browns in the freezer with no use by date.

During an interview on 12/03/19 at 10:14 AM, Staff I, Dietary Manager, stated that she was not sure how long the spices or frozen items were good for and that there was no policy related to frozen food or spices shelf life.

During an interview on 12/03/19 at 10:15 AM, Staff F, CNO, stated that he was unsure how long the spices or frozen items could be used.

5. Observation on 12/03/19 at 9:55 AM, showed that the coils on the back of the reach in cooler were caked with dust accumulation.

During an interview on 12/03/19 at 9:55 AM, Staff J, Cook, stated that he was unsure who cleaned the back of the reach in cooler, but it was not listed on their cleaning logs.

During an interview on 12/03/19 at 10:14 AM, Staff I, Dietary Manager, stated that the coils were very dusty on the back of the reach in cooler and that the kitchen staff had not been responsible for cleaning the coils.

6. Observation on 12/02/19 at 2:15 PM, showed that there were three milk cartons that were expired on 11/26/19 in the refrigerator on the inpatient unit.

During an interview on 12/02/19 at 2:15 PM, Staff F, CNO, stated that the dietary department staff were responsible to check for expiration dates and clean the refrigerator.

7. Review of the facility's Infection Control policies showed the facility did not have a policy related to cleaning WOW's.

Observation on 12/03/19 showed:
- At 2:45 PM, Staff P, RN, entered Patient #21's room with a WOW to administer afternoon medications.
- Staff P did not clean the WOW before she entered or exited the patient's room.
- At 3:06 PM, Staff P entered Patient #22's room with the WOW, to administer afternoon medications.
- Staff P did not clean the WOW before she entered or exited the patient's room.

During an interview on 12/03/19 at 3:42 PM, Staff P, RN, stated that:
- Staff were expected to clean the WOW at least one time during their shift.
- If the WOW became soiled during use, for example, spilled liquids or medications, then staff were expected to clean the surfaces.
- Typically the WOW was cleaned by staff at the end of their shift.
- If a patient was on isolation precautions then she would not take the WOW into that room.
- She did not believe the facility had a policy related to expectations for cleaning the WOW between patient use.

During an interview on 12/03/19 at 4:36 PM, Staff F, CNO stated that he expected staff to clean WOW's between each patient use.


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Based on interview, record review and policy review, the facility failed to ensure that a History and Physical (H&P) examination was completed and documented prior to the day of surgery for one current patient (#19) and four discharged patients (#20, #25, #30, and #32) of 11 patient records reviewed. This failure had the potential to cause surgical patients harm or injury, related to patient needs and/or risks unidentified by the physician on the day of surgery. The facility census was one.

Findings included:

1. Review of the facility's policy titled, "History and Physical," revised 05/2014, showed that when a H&P examination as not present on the record at the time stated for the operation, the operation should be canceled unless the attending physician stated in writing that such a delay would constitute a hazard to the patient.

Review of Patient #19's medical record showed no H&P was present for the patient's date of surgery on 12/03/19.

Review of Patient #20's medical record showed no H&P was present for the patient's date of surgery on 12/03/19.

Review of Patient #25's medical record showed no H&P was present for the patient's date of surgery on 12/03/19.

Review of Patient #30's medical record showed no H&P was present for the patient's date of surgery on 12/03/19.

Review of Patient #32's medical record showed no H&P was present for the patient's date of surgery on 12/03/19.

During an interview on 12/04/19 at 9:00 AM, Staff B, Registered Nurse, Surgical Services Manager, stated that all patients should have an H&P in their medical record prior to any procedure.

During an interview on 12/04/19 at 5:25 PM, Staff F, Chief Nursing Officer, stated that an H&P was required before any procedure.

During an interview on 12/04/19 at 4:56 PM, Staff E, Chief Executive Officer, stated that an H&P should be in the patient's medical record prior to the procedure.

Based on interview and record review, the facility failed to ensure that the Operating Room (OR) log was completed. This failure had the potential to affect the safety of all patients that underwent a surgical procedure in the facility's OR. The facility census was one.

Findings included:

1. Although requested, the facility failed to provide a policy regarding documentation in an OR log.

Review of the OR log book on 12/02/19 at 3:40 PM, showed it was incomplete. The log was reviewed for 164 entries from 08/09/19 through 12/02/19. The age of the patient was not documented for 11 of the entries, the hospital identification number was not recorded for 21 of the entries and there were no assistants recorded for any of the 164 entries.

During an interview on 12/02/19 at 3:40 PM, Staff B, Registered Nurse, Surgical Services Manager, stated that the OR log was incomplete.

During an interview on 12/04/19 at 5:25 PM, Staff F, Chief Nursing Officer, stated that the OR log should be complete.

Based on interview, record review, and policy review the hospital failed to notify four of four discharged Swing Bed (a status of admission that provides skilled care and receives a special reimbursement rate) patients (#38, #39, #40, and #41) their Rights, Services and Responsibilities. This had the potential to cause all Swing Bed patients financial hardship and to deny them quality and safe care. The hospital Swing Bed census was zero current patients.

Findings included:

1. Review of the hospital's policy titled, "Social Services Responsibilities to SNF/NF Program," dated 10/22/14, showed:
- Explain the Skilled Nursing Facility/Nursing Facility (SNF/NF/Swing Bed) program to the patient and/or their family, and give them informational material.
- Read and explain Resident Rights and Responsibilities and obtain a signature verifying completion.
- Give information that pertained to Advance Directives (written statement of a person's wishes regarding medical treatment), and Durable Power of Attorney (DPOA, a person legally appointed to take care of financial and health decisions when a patient is incapacitated).
- Give information regarding the hospital's grievance policy
- Inform residents and their family of the possibility for non-coverage by Medicare for care, supplies and treatments.
-Deliver notice of Medicare Provider Non-coverage (a notice to alert patient's that providers' services are coming to an end) to patient and their family.
- All information and signed forms become a part of the patient's medical record.

Review of Patient's #38, #39, #40, and #41's discharged medical records on 12/04/19 at 3:00 PM, showed:
- All four patients were Medicare beneficiaries.
- The patients were admitted to the hospital as Swing Bed patients.
- There was no documented evidence that initial patient rights and responsibilities were provided to these four patients or their representative(s) upon admission.

During a telephone interview on 12/04/19 at 4:00 PM, Staff H, Social Services Director, stated that:
- She was the one responsible for the Swing Bed Program.
- She did not have any information to give to patients related to their rights and responsibilities.
- She was unaware that the patient rights for the Swing Bed Program were any different than the overall hospital rights.
- She was unaware she should have given patients their rights and responsibilities.

During an interview on 12/04/19 at 4:01 PM, Staff G, Registered Nurse (RN), In-Patient Department Manager, stated that:
- She assisted Staff H with the swing bed patients and completed some of the paperwork.
- She was unaware that the patient rights for the Swing Bed Program were any different than the overall hospital rights the patients received from the Admissions Department when they were admitted.
- She had never seen the Swing Bed patient rights.
- The Swing Bed patient rights would not be in the medical record.

During an interview on 12/04/19 at 3:45 PM, Staff R, Medical Record Specialist, stated that she was unaware of different and separate paperwork for Swing Bed patient rights and responsibilities. The hospital did not have Swing Bed patient rights.