HospitalInspections.org

The CONDITION OF PARTICIPATION (COP) is not met when the Governing Body (GB) failed to ensure :

1.The contracted services provided in the hospital followed a process for a monitored, tracking and securely documented Covid -19 vaccination status to ensure compliance vaccination requirements with the Centers of Medicaid and Medicare Services (CMS) Infection Control COP requirements. This failure created the increased risk of contracted staff not being monitored for COVID vaccines compliance. (Cross Reference A-0083, A-0792).

2. The hospital's established policy and procedures for expectations of patient safety, when facility documents lacked demonstration of governing board oversight were followed. (Cross Reference A-0263).

3. The Quality Assessment and Performance Improvement Program (QAPI) reflected the facility's complex organization and its services for their unique patients, which involved all the departments and services, when the hospital failed to have unique QAPI activities in infection control activities. This deficient practice has the potential of not ensuring that the services, equipment, staff and/or facilities are adequate and in accordance with acceptable standards of care. (Cross Reference A-0308)

4. An ongoing quality program that showed measurable improvement indicators for infection prevention and control. This failure resulted in unsafe infection control practices and the inability to monitor the effectiveness and safety of patient care and identify opportunities for improvement. (Cross reference 0750).

5. Frequency and detail of data collection for the quality assessment and performance improvement program (QAPI) were specified. (Cross reference A-0273).

6.The hospital demonstrated the GB appointed an infection preventionist responsible for the infection control program based off the recommendations of the medical staff leadership and nursing leadership. This governing body failure had the potential for an unqualified infection prevention manager to lead the hospitals infection prevention and control program. (Cross Reference A-0748)

7.The hospital staff and contracted staff followed hospital policy and procedures and standards of practice within the infection prevention and control program, including surveillance, prevention, and control of hospital acquired infections (HAIs), maintaining a clean and sanitary environment and tracking all required vaccinations in order to avoid sources and transmission of infection. (Cross-Reference A-0750, A0792)

8. The hospital acquired infections as well as antibiotic use issues were addressed in collaboration with the hospital QAPI leadership. (Cross Reference A-0771).

9. Nursing policy and procedures for patient care and patient care ratio was enacted when a patient was on a cardiac monitor continuously, assessed, monitored, and care for by the emergency department (ED) nursing staff according to the direct observation unit (DOU) admission status and failed to adjust the patient-to-nurse ratio from the ED to the DOU ratio to provide closer monitoring of patient thus preventing patient's fall and death while being cared for in the ED and failed to notify family patient fell while in the ED. (Cross-Reference A-0395 and A-0385)

The cumulative effects of these systemic sub-standard care practices resulted in the failure of the hospital to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the governing body (GB) failed to ensure the contracted services provided in the hospital were evaluated to ensure compliance with the CMS Infection Control COP requirements and the hospital followed a process for tracking and securely documenting the COVID-19 vaccination status of all contracted student staff.

This failure created the increased risk of contracted staff not being monitored for COVID vaccine compliance.


Findings:


During a interview and concurrent record review on 3/16/22, starting at 9 a.m., with the manager of education (MED1), MED1 indicated having the responsibility to oversee the vaccination status for three college student programs (health programs with direct patient contact). MED1 was unable to present or demonstrate a tracking document that securely documents 68 students vaccination status in one of the programs. MED1 stated, "We are currently looking at a process improvement opportunity to get this (tracking) into a updated spread sheet to include vaccines first and second ones, we currently don't have one."

The CONDITION OF PARTICIPATION is not met when the hospital's Governing Body failed to:


1. Specify frequency and detail of data collection for the quality assessment and performance improvement program (QAPI). The hospital failed to ensure an ongoing quality program that showed measurable improvement indicators for infection prevention and control. This failure resulted in unsafe infection control practices and the inability to monitor the effectiveness and safety of patient care and identify opportunities for improvement. (Cross reference 0273, 0750).

2. Ensure that the quality assurance and performance improvement (QAPI) program reflected the complexity of the hospital's services and involved all hospital departments and services (including those services furnished under contract or arrangement).
(Cross-Reference A-0308, A-0792)

3. The hospital acquired infections (HAI) as well as antibiotic use issues were addressed in collaboration with the hospital QAPI leadership. This failure has the risk of the QAPI leadership not being involved in a integral aspect of the hospitals ongoing support, participation and compliance with the infection prevention program.(Cross Reference A-0771)

The cumulative effects of these systemic problems resulted in the facility's inability to ensure an effective system-wide infection control program thus failing to provide a safe environment free of transmission sources of infections and communicable disease.

Based on interview and record review, the hospital governing body (GB) failed to specify frequency and detail of data collection for the quality assessment and performance improvement program (QAPI) and failed to ensure an ongoing quality program that showed measurable improvement indicators for infection prevention and control.

This failure resulted in unsafe infection control practices and the inability to monitor the effectiveness and safety of patient care and identify opportunities for improvement. (Cross reference 0750).


Findings:

Review of the hospital document titled, "Quality and Performance Improvement Plan," dated, " February 2, 2020", indicated in part... page 2/7, "Program Scope... As patient care is a coordinated and collaborative effort, the approach to improving performance involves multiple departments and disciplines in establishing plans, processes, and mechanisms that comprise performance improvement activities.." further document review on page 3/7 " Relevant information developed from the following activities into performance improvement activities... 5. Infection Prevention and Control."

During an interview and concurrent record review of the Quality and Performance Improvement Plan," dated, " February 2, 2020", on 3/17/22, starting at 8:15 a.m., with the director of QAPI program (QMD), the QMD was asked about infection control findings unique to hospital , and if the governing body was apprised of 2021 infection control/QAPI detail data collection. The QMD stated, "Did not occur in 2021 but is set up for 2022." When the QMD was asked if the governing board specified the frequency and detail of data collection that will monitor the effectiveness and safety of services for 2022 plan, the QMD stated , "Not yet approved, will plan to go to Board in April of 2022."

Based on interview and record review the hospital's governing body failed to ensure the quality assurance and performance improvement (QAPI) program reflected the complexity of the hospital's services and involved all hospital departments and services (including those services furnished under contract or arrangement).

This failure had the potential for non cohesiveness of all departments and services involved in patient care to render quality care to patirnts.

Findings:

1. Review of hospital document titled, "Quality and Performance Improvement Plan," dated, " February 2, 2020", indicated in part... page 2/7, "Program Scope... As patient care is a coordinated and collaborative effort, the approach to improving performance involves multiple departments and disciplines in establishing plans, processes, and mechanisms that comprise performance improvement activities.." further document review on page 3/7 " Relevant information developed from the following activities into performance improvement activities... 5. Infection Prevention and Control."

During an interview and concurrent record review of the Quality and Performance Improvement Plan," dated, " February 2, 2020", on 3/17/22, starting at 8:15 a.m., with director of QAPI program (QMD), the QMD was asked about infection control findings unique to hospital , and if the governing body was apprised of 2021 infection control/QAPI detail data collection, the QMD stated, "Did not occur in 2021 but is set up for 2022." When the QMD was asked when the governing board specified the frequency and detail of data collection that will monitor the effectiveness and safety of services for 2022 plan ? QMD stated , "Not yet approved, will plan to go to Board in April of 2022."

2. Review of hospital document titled "Infection Prevention and Contol Plan", dated 4/1/06, indicated in part...
"Program Evaluation X...C. Findings, conclusions, actions and follow up evidence of results are routinely presented to the ICC, MEC, Quality Committee of the Board and Board of Directors..."

During a interview on 3/16/22, starting at 3:15 p.m., with the Infection Preventionist manager (IP), when asked if the 2021 Infection Control goals and findings were presented to the governing board, the IP stated, "No, 2021 goals were only presented to the ICC (Infection Control Committee) in Febuary, because I could only find data for 3 out of the 10 goals."

3. During an interview and concurrent record review on 3/16/22, starting at 9 a.m., with the manager of education (MED1), the MED1 indicated having the responsibility to oversee the vaccination status for three colleges student programs (health programs with direct patient contact). The MED1 was unable to present or demonstrate a tracking document that securely documents the vaccination status of 68 students in one of the programs. MED1 stated, "We are currently looking at a process improvement opportunity to get this (tracking) into a updated spread sheet to include vaccines first and second ones, we currently don't have one."

The CONDITION OF PARTICIPATION is not met when the hospital failed to ensure:


1.a.Patient N110 with an order for a continous cardiac monitor (CM- pocket device with wires attached to the patient to measure heart rate and rythm with results transmitted to a central monitor either located at the nurses station or separate room managed by specified personnels ) was assessed and monitored for continous connectivity to the heart monitor while at the care of the emergency department (ED) staff. The patient's wirings got disconnected from the CM for hours, not detected by staff, resulting to the patient falling down to the floor and found expired.
b.Patient to nurse ratio (staffing care assignment) was adjusted when the Patient N110 admission status was changed from ED to direct observation unit (DOU) level while remaining at the ED. No direct observation and monitoring was implemented on the patient's care.
c. Family of Patient N110 was informed the patient fell at the ED.(Cross-Reference A-0395)

2. Nursing staff checked patient history and physical (H & P) was completed during pre-op.

3. Staff adhered to the hospital's policies and procedures when sequential compression device were applied without an order, a defibrillator was not inspected, multiply intravenous (IV) sites and tubings were not labeled, and multiply phlebotomy supply carts were observed unlocked/unsecured. (Cross-Reference A-0398)

4.Nursing staff followed safe medication administration, preparation and storage practices when medications were administered without an order, medication was left unattended, no safe medication administration practice were implemented, pain assessments and re-assessments were not performed, and unsafe transferring of medication to the sterile field were observed. (Cross-Reference A-0405)

The cumulative effects of these systemic problems resulted in the facility's inability to ensure an effective system-wide nursing services program thus failing to provide a safe and high quality patient care environment.

Based on observation, interview and record review, the facility failed to ensure:

1. Patient N110 with an order for a continous cardiac monitor (CM- pocket device with wires attached to the patient to measure heart rate and rythm with results transmitted to a central monitor either located at the nurses station or separate room managed by specified personnels ) was assessed and monitored for continous connectivity to the heart monitor while at the care of the emergency department (ED) staff. The patient's wirings got disconnected from the CM for hours, not detected by staff, resulting to the patient falling down to the floor and found expired.
b.Patient to nurse ratio (staffing care assignment) was adjusted when the Patient N110 admission status was changed from ED to direct observation unit (DOU) level while remaining at the ED. No direct observation and monitoring was implemented on the patient's care.
c. Family of Patient N110 was informed the patient fell at the ED.


2. Ensure nursing staff checked patient N401 and N402's history and physical (H & P) was complete during pre-op.


These failures resulted in patient N-110 found on the floor, unresponsive subsequently expiring and place other patients at risk of their care not being supervised and evaluated according to accepted standards of nursing practice and policies and procedures.


Findings:


1.Review of Patient N110 clinical record on 3/15/22 indicated the patient was evaluated in the emergency department (ED) on 1/15/22 at 9:21 p.m., with complaints of weakness and hypoxia (low oxygen), tested positive for COVID-19 virus (contagious infection), and was place in isolation (strict separation from others). Patient N110 was admitted to the direct observation unit (DOU) and orders for treatment were written. Patient remained in the ED until an in-patient DOU bed became available. On 1/16/22 at 6:25 p.m., registered nurse (RN 1) found patient on the floor unresponsive, subsequently patient expired on 1/16/22 at 7:28 p.m.

A physician's order, dated 1/15/22 at 9:03 p.m., indicated "Continuous cardiac monitor" for this patient.

A review of Patient N110 [manufacturer name] central station monitoring system report from 1/15/22 at 8:59 p.m., to 1/16/22 at 7:26 p.m., and concurrent interview with RN 1 on 3/15/22 at 11:38 a.m., the report indicated the heart monitor was suspended and patient was off the continuous heart monitor on 1/16/22 from 2:01 p.m., until 6:28 p.m., when patient was found on the floor unresponsive. RN 1 stated "I don't know what happen. I don't know the reason the monitor did not record his cardiac rhythm to the central station. I don't know what to tell you ..." RN 1 was asked if patient's bedside monitor was alarming at all. RN 1 stated "His bedside alarm was alarming all the time. The patient's oxygen saturation was low most of the time and patient was moving a lot, so the alarms were going off all the time." RN 1 was asked if s/he suspended or turned off patient's bedside monitor. RN 1 replied "No".

The central monitoring system is a monitoring management system that connects a series of patient monitors (patient bedside device that continuously monitors and records blood pressure, heart rate, respirations, and oximetry-oxygen level) together and back to a central monitor.

During an ED room bedside heart monitor demonstration and concurrent interview with the Bio-Med engineer (BME) on 3/16/22 at 9:05 a.m., the BME explained the bedside heart monitor alarms cannot be suspended permanently. The alarms could only be suspended for five minutes then it will resume to alarm unless the monitor is turned off completely. The BME was asked what the reason would be a cardiac rhythm would not be captured and recorded by the central monitoring system. The BME stated "there is no reason why the monitor would stop monitoring and recording. The only reason is if the patient is disconnected from the monitor, or the monitor is turned off. "The BME was asked if the bedside monitor in ED room 15 was functioning well or had any problems in January 2022. The BME went to his department to check his records to confirm if there had been any work orders for the monitor in room 15. The BME confirmed the ED bedside monitor in room 15 have not had any work orders for repairs, was checked for functionality back in January (after patient death incident), and it was found to be functioning well without any problems.

A review of the DOU Consult Note, dated 1/16/22 at 12:17 a.m., indicated Patient N 110 was evaluated by the hospitalist and admitted to DOU care status.

The facility policy and procedure entitled "DOU/Telemetry ...Unit Services", 2021, in the sub-section titled, Methods Used To Assess Patient Needs And Services, indicated "DOU patients are assessed head to toe once a shift and every two (2) hours for focused assessments ...".

Patient N110 assessments documentation was reviewed with RN 1 on 3/15/22 at 11:38 a.m., RN 1 confirmed not performing a head-to-toe patient assessment on 1/16/22 day shift. Furthermore, RN 1 stated "I assisted patient to the bedside commode at around 6:05 p.m. on 1/16/22. Then, the charge nurse asked me to help with patient who was in distress in room 16. At around 6:25 p.m., I came out of room 16 and went into room 15, the patient (Patient N110) fell and was found on the floor unresponsive ..." Subsequently, RN 1 confirmed not performing a fall risk assessment during the day shift on 1/16/22.

The facility policy and procedure entitled "Fall Prevention and Management Policy", dated 12/13/17, in the PROCEDURE part indicated "The RN will assess each patient's fall risk at the time of initial physical assessment, at the time of admission, every shift, upon transfer to another level of care ..."

During the same interview with RN 1 on 3/15/22 at 11:38 a.m., RN assigned to care for Patient N110 on 1/16/22. RN 1 reported that on 1/16/22 it was a very busy day. RN 1 stated "On that date (1/16/22) I was out of ratio. I was assigned to care for four (4) patients ... Patient in room 15 was an in-patient with order for direct observation unit (DOU) status. I should have had three (3) patients instead of four (4), the regular ED nurse-to-patient ratio. The DOU nurse-to-patient ratio is one-to three (1:3) and I had four patients on that date."

The facility's policy and procedure entitled "DOU/Telemetry ...Unit Services", 2021, indicated in page three (3), "Usual nurse-to-patient ratio for the ...DOU is 1:3."

The facility's policy and procedure titled "Patient Safety Event Reporting and Management", dated 2/27/19, in part 111, indicated "Event- situation or event that is not consistent with routine patient care or operations of the care setting and results in, or has the potential to result in injury to a person ... examples of events .... a. Patient fall, with or without harm (injury)". In part V. (B) (7) indicated "Patient Events with Harm or Injury- d. Notify the patient's family/significant other/guardian."

During the same interview with RN 1 on 3/15/22 at 11:38 a.m., RN 1 confirmed that on 1/16/22 at 6:25 p.m., Patient N110 fell inside his ED room and was found on the floor unresponsive. RN 1 confirmed not notifying patient's family of the fall or patient being found on the floor.

During an interview with patient safety manager (PSM 1) on 3/16/22 at 4:01 p.m., PSM 1 confirmed Patient N110 family was not notified by any facility staff or physician that patient fell and was found on the floor inside the ED room.

During an interview with the chief nurse officer (CNO) on 3/16/22 at 3:19 p.m., Patient N110 concerns were discussed with the CNO. The CNO agreed the ED nurse should have assess, monitor, document, and care for Patient N110 as per the DOU admission status and the nurse-to-patient ratio should have been adjusted.


40678

2. During a record review and concurrent interview on 3/17/22, at 10:22 pm, with periop service director (PSD 1), PSD 1 reviewed H&P (history and physical) for 2 patients (Patient N401 and N402) updated on 3/15/22, H&P's indicated, multiple areas were left blank. Review of Pre-op Intake for patient N401 and N402 indicated, yes for current and updated H&P. Confirmed with PSD 1 H&Ps for Patient N401 and N402 are incomplete. PSD 1 stated the nurses in pre-op should be checking that the H&P is complete.

According to AORN guidelines for perioperative practice titled: "Information Management" dated 20112 - 2021, indicated in part ... "Perioperative nursing documentation must correspond to health care accreditation organization requirements. Compliance with state or national health care accreditation agency criteria is mandatory for organizations seeking CMS reimbursement or striving to meet established patient safety goals ... elements of performance ... include evidence of the presence of a current history and physical... In the nursing assessment, include a review of the patient's medical history (eg, history and physical."

Based on observation, interview, record review the hospital failed to ensure staff adhered to the hospital's policies and procedures when:

1. A sequential compression device (SCD-stocking with alternating pressure to prevent blood clots) was implemented without an order for one of 30 sampled patients (Patient N500).

2. A defibrillator (a device used to restore a normal heartbeat) on the crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) was not inspected for use.

3. The intravenous (IV) dressings, tubings and IV fluid bags were not labeled with date and time when started for nine unsampled patients (Patients N502, N503, N504, N505, N506, N605, N606, N607, N608), and three sampled patients (Patient N302, N112, N602).

4. A feeding tube was not labeled with date and time for one unsampled patient (Patient N506).

5.Phlebotomy ( IV, blood draw) supply carts were observed unlocked/unsecured in the emergency department hallway and inside patient care rooms.

6. Critical lab values was not reported to the physician for one sampled patient (N601)

These failures placed patients at risk for inconsistent or inadequate care.

Findings:

1. The facility policy titled "Venous Thromboembolism VTE Prophylaxis" reviewed 7/2020 indicated, " ...Order the appropriate pharmacological and/or mechanical VTE prevention based on the patient's risk level and known contraindications ..."

During an observation in Definitive Observation Unit (DOU) on 3/16/22 at 10:15 AM, Patient N500 was observed connected to an SCD.

During concurrent interview and record review, the Nurse Manager (NM) reviewed Patient N500's record. NM explained and acknowledged there is no order for the SCD and the SCD was contraindicated for Patient N500 because another means of preventing blood clots was instituted (blood thinners).

During a concurrent review and interview, Patient N500's record was discussed with the primary registered nurse (RN5) indicated, the nursing staff recorded in their charting that SCD was used and applied to Patient N500's bilateral lower extremities. Review of the doctor's order did not have evidence of SCD being ordered. However, Patient N500 had been receiving an anticoagulant (blood thinners) since 2/28/22. RN5 confirmed the SCD was used and should not have been used because the Patient has been receiving blood thinners.


2. The facility policy titled "Crash Cart" revised 8/20 indicated, " ...Each day the department is open, and upon receipt of a new cart, the crash cart will be inspected by lead of the shift or designee for the following items: 1. Defibrillator in place, plugged in and tested on battery daily ...2 Pacer module checked daily ..."

During an observation on 3/16/22 at 2:51 PM and review of the defibrillator/crash cart check log sheets for March 2022 in the telemetry unit (3S) indicated the nursing staff inspecting the crash cart had documented on the equipment check record, showing the check was done, however the cardiac strips (paper record) did not prove the recorder test, defibrillator mode and pacer mod test were completed to verify if the cardiac defibrillator is functioning properly and ready for use.

Concurrent interview with the charge nurse (CN) on 3/16/22 at 2:51 PM, the CN acknowledged the finding and explained she forgot to run record test and indicated the day shift charge nurse is to check and run the strips every morning.


3a. The facility policy titled "Peripheral Intravenous Catheter Insertion and Maintenance (Adult)" dated 10/24/18 indicated, " ...Dressings will be labeled with time, date and clinical staff's initials to identify when the dressing was placed. All IV tubing will be labeled with time, date and clinical's staff's initials to identify when the tubing was hung ..."

During a tour of the definitive observation unit (DOU) on 3/16/22 at 9:30 AM, the following unsampled patients were observed:

a.Patient (N502) in room 2118 had an IV catheter in her left hand. There was no label on the IV dressing.

b. Patient (N503) in room 2128 had an IV access in his left arm midline and low line without a label.

c.Patient (N504) in room 2108 had an IV dressing in her right antecubital without a label.

Concurrent interview with the nurse manager (NM) confirmed the findings and concurred it should be labeled.

3b. During a tour of the telemetry unit (2S) on 3/16/22 at 3:10 PM the following unsampled patients were observed:

a.Patient (N505) in room 2209 had an IV solution and tubing not labeled. The nurse manager (2SNM) concurrently confirmed the IV tubing was not labeled and should be labeled.

b. Patient (N506) in room 2214 had an IV dressing in her right antecubital with no label. The 2SNM confirmed the IV dressing was not labeled and should be labeled.


4. During an observation inside room 2214 and concurrent interview with registered nurse (RN4) on 3/16/22 at 3:20 PM, an unlabeled feeding tube attached to a feeding bottle with liquid nutrition was hanging from the IV (intravenous) pole at the head of the Patient N502 bed. RN4 was asked why the remaining used and unlabeled GT formula and tubing were still hanging at the patient's bedside and not connected to the patient. RN 4 explained the patient's GT feeding was held from last night. RN4 acknowledged the GT formula and tubing should have been discarded and it was not.



39520

3c. During an observation and concurrent interview on 3/15/22, at 1:03 p.m., with patient (N302), in Room 1205, on the mother infant unit (MIU), patient N302 was observed to have an IV (a catheter threaded into the vein to give medications or fluids through) in the right forearm. The dressing on the IV site did not have date or label. When asked how long the IV had been in her arm, patient N302 verbalized since admission.

During an observation and concurrent interview on 3/15/22, at 1:05 p.m., with licensed nurse (RN 6), in Room 1205, in MIU, RN 6 acknowledged patient N302 IV site had no label, and no date or time when it was started. RN 6 verbalized the IV was started in labor and delivery on 3/14/22 and the IV should have been labeled.

During a review of the facility's policy and procedure titled, "Peripheral Intravenous Catheter Insertion and Maintenance (Adult)", dated 10/24/18, indicated in part ... "Dressings: 1. Peripheral IV dressings are to be changed every seven days and PRN (as needed) for soiled, loosened and/or contaminated equipment ...3. Dressings will be labeled with time, date, and clinical staff's initials to identify when the dressing was placed.


35399

3d. The facilities policy and procedure title "Peripheral Intravenous Catheter Insertion and Maintenance", dated 10/24/18, in part D, indicated "peripheral IV dressings are changed every seven (7) days and PRN for soil. 3. Dressings will be labeled with time, date and clinical staff's initials to identify when the dressing was placed."

During a tour of the emergency room (ED) and concurrent interview with the infection preventionists (IP) on 3/15/22 at 3:41 p.m., in room 7 patient N111 was observed with a peripheral intravenous catheter (PIV) on right arm without a date or label ask to when the PIV was inserted. During the same observation patient N111 was observed with the intravenous tubing not labeled as to when the IV fluid was hung. The IP acknowledged the observation and stated "Yes, I do not see a label or date."

During the same tour of the emergency room (ED) and concurrent interview with the infection preventionists (IP) on 3/15/22 at 4:07 p.m., in room 30 patient N112 was observed with a peripheral intravenous catheter (PIV) on right arm without a date or label ask to when the PIV was inserted. During the same observation patient was observed with the intravenous tubing not labeled as to when the IV fluid was hung. The IP acknowledged the observation and stated, "I do not see a label on either of them (PIV and tubing)."

5. During a tour of the ED and concurrent interview with the ED manager (EDM) on 3/15/22 at 3:50 p.m., In a heavy traffic ED hallway, a cart was observed unlocked/unsecured, code to open the cart was taped to the front of the cart. Inside the cart supplies i.e. needles, syringes, blood specimen collection tubes, Chlorhexidine swabs, tourniquets, IV fluids... were observed inside the cart. The EDM indicated "it is the policy of the ED to keep those carts locked at all times, nurses have access to those carts, and it is the nurses' responsibility to maintain those carts locked, this is the standard process in the ED.

During a tour of the ED and concurrent interview with the ED manager (EDM) on 3/15/22 from 4:00 p.m., to 4:30 p.m., supplies carts were observed inside patient rooms. The carts contain supplies such as needles, syringes, IV fluid, Chlorhexidine swabs, alcohol swabs ... Three of three sampled ED rooms (7, 29, 32) supply carts were observed unlocked or unsecured even when patient and family member were inside the room. The ED manager indicated "It is the ED policy to maintain those supply carts secure at all times, it is the responsibility of the nurses to secure the carts"

During an observation of the ED trauma room and concurrent interview with the ED manager (EDM) on 3/16/22 at 9:41 a.m., an unsecured drawer was observed with syringes inside the drawer. During the same observation another unsecured drawer was observed with two arterial blood gas kits (syringes inside kit) inside the drawer. The EDM acknowledged the observation and stated "I agree those syringes should not be there if the drawer is unlocked. It's the ED policy to secured syringes."






39912


3e. The facility policy and procedure title "Peripheral Intravenous Catheter Insertion and Maintenance", dated 10/24/18, in part D, indicated "peripheral IV dressings are changed every seven (7) days and PRN for soil. 3. Dressings will be labeled with time, date and clinical staff's initials to identify when the dressing was placed."

According to Fundamentals of Nursing by Potter And Parry 9th edition 2017, on chapter 42 Fluid, Electrolyte, and Acid Base Balance, skill 42-3 Maintenance Of Intravenous System, page 983 indicates " J. Attach piece of tape or label to IV fluid container with date and time of container change. If using a polyvinylchloride (PVC) container, mark only on the label and not the container."

During an observation and concurrent interview with the director of patient experience (DPE) on 3/16/22 at 9:19 AM, patient N605 in room 4122 was observed to have an intravenous catheter on the left forearm. The IV site does not have a date on the dressing. The DPE acknowledged the IV site does not have a date written on it.

During an observation and concurrent interview with the charge nurse (CN2) on 3/16/22 at 9:28 AM, patient N606 in room 4106 was observed to be receiving IV fluids. The IV fluid is lactated ringers, the IV fluid bag does not have a label with date and time. CN2 indicated in our practice, we should put a label on the IV bag.

During an observation and concurrent interview with the tele manager (TM) on 3/16/22 at 10:35 AM, patient N602 in room 3129 was observed to have an IV lactated ringers solution infusing. The IV bag does not have a label with the date and time, TM acknowledge the IV bag was not dated.

During an observation and concurrent interview with the TM on 3/16/22 at 10:40 AM, patient N607 in room 3121 was observed to have an IV normal saline solution infusing. The IV bag does not have a label with the date and time. TM acknowledge the IV bag was not dated.

During an observation and concurrent interview with the TM on 3/16/22 at 10:52 AM, patient N608 in room 3108 was observed to have a IV catheter access on the left forearm with no time and date on the dressing. N608 had normal saline IV fluid infusing. The IV bag does not have a label with the date and time. TM acknowledged both IV site and IV fluid bag was not dated.

6. During an interview and concurrent interview with the manager of patient safety (MPS) on 3/16/22 at 2:52 PM, patient N601's health records indicates the patient had a critical laboratory value for Tobramycin through of 5.5. No notification of the physician was located. MPS acknowledge the physician was not notified.

The facility policy and procedure titled "Critical Results/Values Reporting and Documentation" dated 7/2020 indicates "C. the physician will be called within 30 minutes of the receipt of the critical result and with the 30 minute time frame for call back, should be receiving notification witin 60 minutes - sooner as indicated by patient acuity."

Based on observation, interview and record review, the hospital failed to ensure nursing staff were following safe medication administration, preparation and storage practices when:

1. Pain medication was administered not following the physician's order for Patient N602

2.An eye medication was left unattended in a heavy traffic hallway in the Emergency Department

3 No pain assessment before and after pain medication administration was done for Patient N302 and N304.

4 Nursing staff did not follow safe medication transfer and administration practice during operating room setup for Patient N300

5. No post pain assessment for two Patients, N305 and N306 after pain medication administration.

6. Nursing staff did not follow safe medication administration for patient N400 in the post anesthesia care unit (PACU)

These facility failures had the potential for loss or diversion of medications, inadequate or excessive dosages and inadequate monitoring for medication effectiveness..

Findings:

1. During a concurrent interview and record review with the manager of patient safety (MPS) on 3/16/22 at 3:37 PM, patient N602's health record indicated N602 has an order for :

a. Acetaminophen-oxycodone (Percocet) 325/5 mg (narcotic medication to treat pain) 1 tab every 4 hours, priority: routine, an needed for moderate pain and

b. Acetaminophen-oxycodone (Percocet) 325/5 mg, 2 tabs every 4 hours, priority: routine, as needed for severe pain.

Record review indicated Patient N602 was given 1 tab of Percocet on 3/16/22 at 2:10 AM and 2 tabs of Percocet on 5:18 AM (about 3 hours after the first Percocet was given). The MPS acknowledged the medication was given too early.

The facility policy and procedure titled "Medication Administration" dated 6/2014 indicates in part ... "Before administration, the individual administering the medication does the following: ... 8. Verifies the medication is being administered to the correct patient, at the proper time, in the prescribed dose and the correct route."


35399

2. During a tour of the ED and concurrent interview with the infection preventionist (IP) on 3/15/22 at 4:05 p.m., in the busy ED hallway a Proparacaine eye medication was observed sitting on a table unattended. The IP acknowledged the observation and agreed the medication should not have been left there unattended. IP stated, "I agree the medication should not be here in the hallway."

The facilities policy and procedure title "Medication Administration", dated 6/14, indicated "Medications are to be pulled for one patient at a time. Only retrieve the amount needed for the most current due time ..."


39520

3. During a concurrent interview and record review on 3/16/22, at 3:36 p.m., with the quality managers (QM) & (QM 2), Patient N302's "OB Flowsheet & Pain assessment flowsheet" dated 3/14/22, were reviewed. The "OB flowsheet" indicated Patient N302 was requesting an epidural (a procedure when an anesthetic medication is injected into your lower back to control pain during childbirth) at 2:45 p.m. The "Pain assessment flowsheet" was blank. QM & QM 2 both acknowledged the pain assessment was missing, and not documented in Patient N302's medical record, before the epidural was placed. The "OB flowsheet" indicated Patient N302's epidural was placed at 3:16 p.m. The "Pain assessment flowsheet" post epidural was blank. QM & QM 2 both acknowledged the pain assessment after the epidural was missing, and not documented in the medical record. QM & QM 2 both verbalized the pain assessments before and after the pain intervention should have been documented. Patient N302's "Pain assessment flowsheet" was further reviewed. The next pain assessment that was documented was about 4 hours after the epidural was placed, at 7:00 p.m., on the next shift. Patient N302's pain at 7:00 p.m. was 0/10.

During a concurrent interview and record review on 3/17/22, at 11:30 a.m., with the QM & QM 2, Patient N304's "OB Flowsheet & Pain assessment flowsheet" dated 3/15/22, were reviewed. The "OB flowsheet" indicated Patient N304 was requesting an epidural at 11:17 a.m. The "Pain assessment flowsheet" was blank. QM & QM 2 both acknowledged the pain assessment was missing, and not documented in Patient N304's medical record, before the epidural was placed. The "OB flowsheet" indicated Patient N304's epidural was placed at 11:18 a.m. The "Pain assessment flowsheet" post epidural was blank. QM & QM 2 both acknowledged the pain assessment after the epidural was missing, and not documented in the medical record. QM & QM 2 both verbalized the pain assessments before and after the pain intervention should have been documented. Patient N304's "Pain assessment flowsheet" was further reviewed. The next pain assessment that was documented was about 8 hours after the epidural was placed, at 7:00 p.m., on the next shift. Patient N304's pain at 7:00 p.m. was 5/10.

During a review of the facility's policy and procedure titled, "Pain Management", dated 2/96, indicated in part ... "Each patient has the right to have his/her pain managed across the continuum of care ...1 a. initial assessments: patients admitted to an inpatient care setting will receive an initial screen within 2 hours of admission to identify the presence of pain ...1 b. routine reassessments: inpatients will be reassessed for the presence of pain no less frequently than the minimum requirements for the taking of vital signs (5th vital sign) in the care setting ...at a minimum, this reassessment shall consist of noting the intensity of the patient's pain ...1 c. treatment of pain: in general, inpatients should receive treatment for any active pain issue (acute or chronic), when intensity exceeds their acceptable level ...1 d. reassessments following treatment for pain: if a treatment intervention for pain is provided, the response to that intervention should be assessed ...reassessment is to occur within 60 minutes following treatment."

4. According to AORN (Association of peri-Operative Nurses) guidelines for Perioperative practice titled: "Medication Safety" dated 2021, indicated in part... "Take precautions to mitigate the risk for errors during transfer of medications to the sterile field and handling of medications on the sterile field ...transfer only one medication at a time to the sterile field and apply a label immediately before another medication or solution is transferred ...label containers and syringes on the sterile field that contain medications, solutions, chemicals, and reagents immediately after they are received ...with the medication name, strength, dilution and diluent if used, date, and time accepted on to the sterile field."

During an observation and concurrent interview on 3/16/22, at 9:55 a.m., with licensed nurse (RN 8), in the operating room (OR 2) in surgical services, RN 8 was observed preparing medications to be transferred to the sterile field, during OR room set up for Patient N300 surgical case. RN 8 drew up 1000 units of Heparin into a syringe and injected the Heparin into a 1000 ml bag of normal saline. RN 8 did not label the normal saline bag with the added Heparin. RN 8 then turned away from the medication prep table and went to discard the syringe into the sharps container across the room. RN 8 came back to the medication prep table and was looking around the table. RN 8 then proceeds to draw up another 1000 units of Heparin into a syringe and was about to inject a second dose into the 1000 ml normal saline bag when she was stopped by the quality manager (QM 2) and the surveyor (39520). Both QM 2 & the surveyor (39520) informed RN 8 that she had already put the 1000 units of Heparin into the normal saline bag. RN 8 acknowledged she should discard the normal saline bag and start over. RN 8 acknowledged that this was almost a medication error (near miss) and the patient would have been given a double dose of Heparin. RN 8 further acknowledged the normal saline bag should have been labeled right away.

During a review of Patient N300's "Medication Orders" dated 3/16/22, indicated to add Heparin 1000 units into 1000 ml of normal saline irrigation bag.

During an interview on 3/16/22, at 10:20 a.m., with the surgical directors (PSD 1) & (PSD 2), PSD 1 & PSD 2 both acknowledged RN 8 should have labeled the 1000 ml normal saline bag immediately after adding the 1000 units of Heparin and further acknowledged the near miss medication error.



33720

5. During a concurrent interview and record review on 3/16/22, starting at 11:35 a.m., with licensed nurse (RN10), record of medication administration for Patient N305 and N306, Record revealed Patient N305 was administered Toradol (anti-inflammatory medication utilized for pain) 30 mg (milligrams) IV (intravenous) on 3/16/22, at 6:47 a.m. further record review that pain reassessment had not occurred. Patient N305 also received Oxycodone (a narcotic analgesic used to treat moderate to severe pain) 15 mg by mouth on 3/16/22, at 8:09 a.m.Patient N305's record review indicated that pain reassessment had not occurred, RN10 acknowledged both records were not reassessed within 30 minutes of administration of pain medications stating, "Yes this is late, that is why there is a red trigger box (highlighted area on the medication administration record) indicating the patient had not been reassessed".
Record review of Patient N306, revealed Patient 306 received Percocet (a opioid and non opioid mediation to treat moderate to severe pain) 325/7.5 mg by mouth, for severe pain, on 3/16/22, at 7:14 a.m., there was no record of reassessment of Patient N306 pain level. RN10 acknowledging lack of recorded reassessment stated," The assessment is missing."

Review of facility policy and procedure titled, "(Name of facility) Pain Management" effective date "02/96" pg 5/15 indicated in part..."10. Documentation a. Document pain assessment and re-assessments, medications/non-medication interventions provided the patient/resident/family education, efficacy, and notifications to physician and adverse effects in the electronic health record."

During a interview on 3/16/22, starting at 12:30 p.m., with director of QAPI program (QMD), while concurrently reviewing facility policy and procedure titled "Pain Management", QMD acknowledged a 30 min reassessment policy post pain medication administration stating, "If a red box is on, the mediation record is declaring med response (reassessment) is 30 minutes post pain medication."



40678

6. During an observation, interview, and record review on 3/15/22, at 12:35 pm, in PACU, anesthioligist (ANS) brought 2 syringes of Labetalol and placed them on the patient bedside table. ANS gave 1 syringe to registered nurse (RN 13), ANS told RN 13 to give patient N400 medication. RN 13 went to computer to scan medication and ANS stated I already documented that I gave it in PACU just give it. RN 13 gave medication and did not document it. Review of the Anesthia Record dated, 3/15/22 for patient N400 indicated, PACU Labetalol 5 mg, 5 mg. Review of the MAR and nursing notes for patient N400 indicated, no documentation of first dose of Labetalol 5mg. RN 13 stated I know I shouldn't have given the medication without documenting it . Confirmed with periop service director (PSD 1) RN 13 should not have given medication without documenting it.

Review of Potter and Perry, 9th Edition, Elsevier Fundamentals of Nursing, page 683 in the section titled, "Medication Administration" indicated in part ..., "The six rights of medication administration are the right medication, right dose, right patient, right route, right time, and right documentation ...nurses administer only medications they prepare ...document medications immediately after administration."

The CONDITION OF PARTICIPATION is not met as evidenced by:

1. The Governing body failed to appoint an infection preventionist responsible for the infection control program based off the recommendations of the medical staff leadership and nursing leadership. (Cross Reference A-0748).

2. The Governing body failed to monitor the implementation of infection control activities to prevent the transmission of communicable diseases. (Cross Reference A-0770).

3. The Governing body failed to ensure that hospital acquired infections as well as antibiotic use issues were addressed in collaboration with the hospital QAPI leadership. (Cross Reference A-0771).

4. The hospital failed to ensure communication and collaboration occurred between the infection control and quality programs to ensure the current infection prevention and control issues and activities were addressed, monitored, and modified as needed for effectiveness of their performance improvement. (Cross Reference A-0774).

5. The hospital failed to maintain infection control practices and processes when:

a. Hand hygiene was not performed by staff.
b. Cleaning of the operating rooms (OR's) between patients (room turn over) was not done according to The Association of Peri-Operative Registered Nurses (AORN) guidelines in surgical services and labor and delivery.
c. Gloves were not removed when going from dirty to clean.
d. Terminal cleaning logs were not complete.
e. Unable to determine if movable equiptment was clean or dirty.
f. Surgical instruments not being stored in a temperature and humidity controlled environment.
g. Cleaning of a patient room, on mother infant unit (MIU), environmental services staff did not know contact time of the floor disinfectant.
h. Soiled instruments in biohazard container were not sprayed with an enzymatic in the neonatal intensive care unit (NICU)
i. Suction tubing was on top of a soiled linen container.
j. IV tubing and used IV fluid bag in patient bathroom basket.
k. Not maintaining aseptic technique when stating an IV.
l. Dirty equipment left in clean room.
m. Patient care items were on the floor.
n. Specimen in heavy traffic area left unattended.
o. Heat and Moisture Exchanger (HME) filters not changed according to the manufacture's information for use.
p. Nursing staff left an uncovered linen cart in the hallway.
q. Isolation cart not removed after use.
r. Opened single use milk carton in refreshment refrigerator.
(Cross Reference A-0750)

6. The hospital failed to maintain infection control practices and processes (See A-0750) and failed to monitor the adherence to the Infection Control policies and procedures by hospital personnel which had the potential to result in cross-contamination (the transfer of harmful bacteria) that could impact patients' health and safety and cause preventable healthcare associated infections (HAI) for patients in an already compromised condition.
(Cross Reference A-0776)

7. The hospital failed to operationalize a process for tracking and securely documenting the COVID-19 vaccination status of all contracted student staff to ensure 100% of student/trainees staff were fully vaccinated for COVID-19, except for those staff who had been granted exemptions to the vaccination. (Cross Reference A-0792)

The cumulative effects of these systemic problems resulted in the facility's inability to ensure an effective infection control program that provides quality health care in a safe and sanitary patient environment.

Based on interview, and record review, the facility failed to demonstrate the governing body appointed an infection prevention manager responsible for the infection control program based off the recommendations of the medical staff leadership and nursing leadership.

This facility failure had the potential for an unqualified infection prevention manager to lead the hospitals infection prevention and control program.

Findings:

During a interview on 3/16/22, starting at 3:15 p.m., with Infection prevention manager (IP), IP gives history of being identified by the hospital as IP in 12/21. IP gives further history of no prior employment as a infection prevention position and having no formal certification as a IP. IP was not aware of governing body approval of her into the position.

During a interview with QAPI (Quality and Performance Improvement ) Director (QMD) on 3/17/22, at 3:45 p.m., QMD acknowledged the governing body had not appointed the current infection prevention manger (IP) based off the recommendations of medical staff and nursing leadership.QMD further verbalized the governing body would address the issue soon and that the hospital was aware of the deficient practice. QMD confirmed no documentation could be provided indicating the governing body had appointed IP based on medical staff leadership and nursing leadership recommendations.

Based on observation, interview, and record review, the facility failed to maintain infection control practices and processes when:

1. Hand hygiene was not performed by staff at the Outpatient Pre-op and PACU area ,Cleaning of the operating rooms (OR's) between patients (room turn over) was not done according to The Association of Peri-Operative Registered Nurses (AORN) guidelines in surgical services and labor and delivery.

3. Gloves were not removed when going from dirty to clean. (Dana & Claire- 3 b)

4. Terminal cleaning logs were not complete. (Dana)

5. Unable to determine if movable equiment was clean or dirty. (JEN-5 a, Marianne, Elvira, Claire- 5 f)

6. Surgical instruments not being stored in a temperature and humidity controlled environment. (JEN)

7. Cleaning of a patient room, on mother infant unit (MIU), environmental services staff did not know contact time of the floor disinfectant. (JEN)

8. Soiled instruments in biohazard container were not sprayed with an enzymatic in the neonatal intensive care unit (NICU) (JEN)

9. Suction tubing was on top of a soiled linen container. (Marianne)

10. IV tubing and used IV fluid bag in patient bathroom basket. (Marianne)

11. Not maintaining aseptic technique when stating an IV. (Elvira)

12. Dirty equipment left in clean room. (Elvira)

13. Patient care items were on the floor. (Elvira & Felix - 13 b)

14. Specimen in heavy traffic area left unattended. (Elvira)

15. Heat and Moisture Exchanger (HME) filters not changed according to the manufacture's information for use. (Elvira)

16. the staff left an uncovered linen cart in the hallway. (Claire)

17. the unattended isolation cart was left indefinitely in the telemetry unit (3S) corridor. (Claire)

18. an opened single use milk carton was left inside the refreshment refrigerator in the emergency department (ED)(Claire)

These facility failures had the potential to result in cross-contamination (the transfer of harmful bacteria) that could impact patients' health and safety and cause preventable healthcare associated infections (HAI) for patients in an already compromised condition.

Findings:

1 a. During an observation and concurrent interview on 3/15/22, at 10:30 am, in Outpatient Pre-op, registered nurse (RN 9) performed patient care, removed gloves, got supplies out of the IV start cart, but did not perform hand hygiene. Confirmed with quality manager (QM) RN 9 should be performing hand hygiene after glove removal.

During an observation and concurrent interview on 3/16/22, at 12:15 pm, in PACU (Post-Anesthesia Care Unit), registered nurse (RN 12) placed soiled linen in hamper, removed gloves, handed patient tissues, and charted on computer workstation but did not perform hand hygiene. Confirmed with periop service director (PSD 1) RN 12 should be performing hand hygiene after glove removal.

During a review of the facility policy titled, "Hand Hygiene", revised 11/17, indicated in part ... "Staff must perform hand hygiene ... after removing personal protective equipment (e.g., gloves, gown, facemask)."

2 a. During an observation and concurrent interview on 3/16/22, at 9:50 am, in OR 3, during room turn over, environmental services staff (EVS 4 and EVS 5) cleaned from top to bottom then back to top. EVS 5 cleaned half of the cushions on bed then cleaned the base of the bed near the floor and then continued with the other half of the bed cushions. Confirmed with periop service director (PSD 2) EVS should be cleaning from top to bottom.

According to AORN guidelines for perioperative practice titled: "Environmental Cleaning" dated 20112 - 2021, indicated in part ... "When cleaning and damp dusting, progress from top to bottom. The room may be cleaned in a clockwise or counter-clockwise direction in conjunction with clean-to-dirty and top-to-bottom methods."

3 a. During an observation and concurrent interview on 3/16/22, at 12:01 pm, in PACU (Post-Anesthesia Care Unit), registered nurse (RN 11) donned gloves, provided patient care, went to ice machine, and returned to patient care arear without removing gloves. Confirmed with quality manager (QM 2) RN 11 should be removing gloves after patient care before going to clean ice machine.

Review of the APIC website, https://infectionpreventionandyou.org/infographic/ppe-dos-and-donts/
accessed on 3/22/2022, indicated "Do clean hands and change gloves between each task."

4. During a record review and concurrent interview on 3/17/22, at 11:42 pm, with environmental services staff director (EVSD), reviewed terminal cleaning logs dated 3/7/22 - 3/15/22 that indicated multiple tasks on multiple days were not marked as done. EVSD stated "I don't know why these are not marked." EVSD confirmed there is no way to determine if the terminal cleaning tasks that were not marked were performed.

During a review of the facility policy titled, "Surgical Suite Terminal Cleaning", undated, indicated in part ... "Environmental Services shall provide for end of day terminal cleaning of all surgical suites (C-section Rooms, Cath Labs and O.R. Suites), to assure a complete disinfecting of all surfaces in the surgery suite and to maintain an Aseptic environment. S per facility policy a terminal cleaning log sheet will be filled out for documentation of Terminal cleaning."









39520

1 b. During a review of the facility's policy and procedure titled, "Hand Hygiene", dated 5/25/20, indicated in part ... "Hand Hygiene is performed to remove dirt, organic material and transient microorganisms from the hands of health care workers ...appropriate hand hygiene is a critical component in preventing the transmission of microorganisms between personnel and patients in health care settings ...the center for disease control (CDC) states that hand hygiene is the single most important procedure for preventing health care acquired infections ...health care workers shall decontaminate hands using alcohol-based hand rub or washing with soap and water under the following circumstances: a. before and after patient contact ...b. before donning sterile gloves ...i. after removing gloves."

During an observation and concurrent interview on 3/15/22, at 12:20 p.m., environmental services staff (EVS 1) and environmental services staff (EVS 2), was observed cleaning patient room (Rm 1213) on the mother infant unit (MIU). EVS 2 was removing trash bags from the room. The trash bags were discarded. EVS 2 took off dirty gloves, threw them away, and donned on a new pair of gloves without performing hand hygiene, and continued to assist with cleaning the room. When asked EVS 1 and EVS 2 about hand hygiene, both acknowledged that hand hygiene should be done every time gloves are changed.

During an observation and concurrent interview on 3/16/22, at 11:05 a.m., environmental services staff (EVS 2) and environmental services staff (EVS 3), was observed cleaning of the cesarean section operating room (OR 1), during room turnover, on labor and delivery. EVS 2 was removing trash bags out of OR 1. The trash bags were discarded. EVS 2 took off dirty gloves, threw them away, and donned on a new pair of gloves without performing hand hygiene, and went back into OR 1 to assist with cleaning.

Review of the APIC (Association for Professionals in Infection Control and Epidemiology) website, https://infectionpreventionandyou.org/infographic/ppe-dos-and-donts/
accessed on 3/22/2022, indicated "Do clean hands and change gloves between each task (e.g., after contact with a contaminated surface or environment)."

2 b. According to AORN (Association of peri-Operative Nurses) guidelines for Perioperative practice titled: "Environmental Cleaning" dated 2021, indicated in part... "All personnel should take precautionary measures to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ..perform cleaning activities in a methodical pattern that limits transmission of microorganisms...the method for cleaning may limit transmission of microorganisms and reduce the risk of cross contamination of environmental surfaces...cleaning should progress from clean to dirty areas...cleaning should progress from top to bottom areas...clockwise or counter-clockwise cleaning may be performed when used in conjunction with clean-to-dirty and top-to-bottom methods...always consider floors in the Perioperative practice setting to be contaminated."

During an observation on 3/16/22, at 11:10 a.m., in the operating room (OR 1), in labor and delivery, EVS 2 and EVS 3 were cleaning OR 1 between patients. EVS 3 proceeded to clean the periphery of the room. EVS 3 was observed cleaning counter tops, back tables, and equipment. EVS 3's cleaning pattern went from top-to-bottom then back to top several times without changing gloves and cleaning cloths. EVS 3 cleaned a step stool that was on the floor then proceeded to clean the cautery machine without changing gloves and cleaning cloths. EVS 3 proceeded to clean the OR bed (the most dirty, in the center of room) then cleaned IV pumps and then the anesthesia machine. EVS 3's cleaning pattern went from clean to dirty and back to clean several times. EVS 3 was observed cleaning a kick bucket, then came out of OR 1, discarded the dirty cleaning cloths, then with dirty gloves took out clean cloths and continued to clean the OR.

According to AORN (Association of peri-Operative Nurses) guidelines for Perioperative practice titled: "Environmental Cleaning" dated 2021, indicated in part... "When cleaning with the same cleaning material (eg, cloth, wipe, mop head), progress from clean to dirty areas ...cleaning the least soiled areas before moving to the most soiled areas diminishes the likelihood of spreading contaminants from dirtier areas to cleaner surfaces."

During an interview on 3/16/22, at 11:25 a.m., with the perinatal unit manager (PM 1), PM 1 acknowledged the cleaning sequence was incorrect and not following AORN guidelines. PM 1 verbalized she would call the director of EVS to come and observe the room turnover and further verbalized she would have EVS 3 reclean the room.

During an interview on 3/16/22, at 11:35 a.m. with the director of environmental services (EVSD) and EVS 3 both acknowledged the improper sequence of cleaning (clean to dirty then back to clean). EVSD was informed of the improper cleaning sequence in surgical services as well. EVSD verbalized the staff will need more education and training.

5 a. According to the centers for disease control (CDC), revised 4/20/20, indicated in part..."Re-useable equipment quickly becomes contaminated during their use. All reusable equipment should be well maintained, clean, and in good repair. Regularly inspect and replace or repair all reusable equipment when needed. Develop a facility monitoring and maintenance schedule that clearly documents reusable equipment, frequency of inspection, and responsible staff."

During a concurrent observation and interview on 3/15/22, at 10:30 a.m., with the perinatal unit manager (PM 1), in a clean, empty patient room (LDR 3), an IV pump was observed and was not covered with a bag. When asked how you know if the IV pump was clean or dirty, PM 1 verbalized most equipment stays in the room and is cleaned when the room is cleaned. PM 1 verbalized sometimes equipment needs to be shared with other rooms, like IV pumps, and further verbalized putting a plastic bag over the IV pump indicates the equipment is clean. PM 1 acknowledged the IV pump should have been covered with a plastic bag and was unable to determine the pump was clean or dirty.

During a concurrent observation and interview on 3/15/22, at 11:20 a.m., with PM 1, in the hallway between the labor and delivery operating rooms, a baby radiant warmer and a baby transport isolette were observed and not covered with a plastic bag. PM 1 acknowledged was unable to tell if the equipment were clean or dirty and verbalized they should be covered with plastic bag.

During a concurrent observation and interview on 3/15/22, at 11:30 a.m., with PM 1 in a clean, empty patient room (LDR 10), in the storage closet, a positioning ball (used in between patients legs during labor) was uncovered and located on top of a shelf. In the same closet, a mattress overlay was uncovered and laying on the floor. PM 1 acknowledged she did not know if these reusable equipment items were clean or dirty and verbalized they should be covered.

During a review of the facility's policy and procedure titled, "Isolation Precautions" dated 8/10, indicated in part ... "Standard Precautions: this is the primary strategy for successful prevention of transmission of communicable disease ... standard precautions are designed to reduce the risk of transmission of microorganism from both recognized and unrecognized sources of potential infection in hospitals ...patient care equipment: any patient equipment that is used for more than one patient must be cleaned after use ...generally, the users will clean equipment after use and store the equipment as "clean", ready for next use." Further review of the policy does not specify what identifies the equipment as "clean" (i.e. clean sticker or a plastic bag).

During an interview on 3/17/22, at 10:40 a.m., with the infection preventionist (IP), the IP verbalized the current policy for patient care equipment does not address a process for determining if the equipment is clean or dirty. The IP further verbalized moving forward the policy needs to be improved as well as the cleaning process.

6. According to AORN (Association of peri-Operative Nurses) guidelines for Perioperative practice titled: "Storage of Sterile Items" dated 2021, indicated in part ... "Store sterile items in a controlled environment ...limiting exposure to moisture, dust, direct sunlight, handling, temperature, and humidity extremes, decreases the potential for contamination and degradation of sterile items ..."

During a review of the facility's policy and procedure titled, "Humidity &Temperature Control/Monitoring", dated 8/20, indicated in part ... "The purpose of this policy is to provide appropriate methods of monitoring, documenting and adjusting the temperature and relative humidity levels in sensitive areas or rooms which include in all operating suite procedural rooms, neonatal ICU, ICU, CCU, Endoscopy lab, Cathlab, labor and delivery, and newborn nursery ...a relative humidity that is too high can result in damp or moist supplies with added opportunity for mold and microbial growth ...it can also contribute to excess perspiration and occasional "sweat through" when combined with high temperatures ...the temperature and humidity in all operating rooms, cardiac cath labs, labor and delivery, newborn nursery, endoscopy rooms, ICU, CCU, NICU, and sterile processing department shall be maintained within acceptable standards in order to inhibit bacterial growth and prevent infections, as well as promote patient comfort and safety ...current temperature and humidity requirements are as follows: ... delivery room and cesarean operating room temperature range 68-75° F ...relative humidity 20-60%...temperature and humidity levels in the affected departments as listed in the policy will document the temperature and humidity daily for each affected room."

During a concurrent observation and interview on 3/15/22, at 11:25 a.m., with the perinatal unit manager (PM 1), in a labor room (LDR 8), it was observed that sterile delivery instruments were being stored in the room. When asked if temperature and humidity were being monitored in this room, PM 1 acknowledged the instruments were not in a temperature and humidity-controlled room and further acknowledged temperature and humidity was not monitored daily in the delivery rooms.

During a review of the facility's policy and procedure titled, "Event related Sterility and Shelf Life" dated 4/14, indicated in part ... "All sterilized items should be stored on shelves, bins, or in drawers with a physical design aimed at protecting the items from wetness or damage ...the areas are temperature and humidity controlled and cleanliness is maintained."

7. During an observation and concurrent interview, on 3/15/22, at 12:15 p.m., with environmental service staff (EVS 1), on the mother infant unit (MIU), EVS 1 was preparing to clean the patient room (Rm 1213). When asked about the products used for cleaning, EVS 1 verbalized 3M disinfectant cleaner is used for cleaning counter tops and multitouch surfaces. When asked about the floor product used for cleaning, EVS 1 verbalized 3M 40A disinfectant cleaner is used for cleaning the floor. EVS 1 verbalized the floor product comes from the automated dispenser in the EVS closet. When asked how long the dwell time (wet contact time) was for the floor product, EVS 1 verbalized she did not know and stated, "The floor stays wet until it dries."

During a review of the manufacturer's instructions for use (MFU's) for the "3M Disinfectant Cleaner 40A" indicated in part ... "Disinfection/Virucidal/Fungicidal/Mold and Mildew Control Directions: ...treated surfaces must remain visibly wet for 3 minutes."

During a review of the facility policy titled, "Discharges and Transfer Patient Room Cleaning", dated 2/2014, indicated in part ... "It is the policy of the environmental services department to maintain a clean and sanitary environment in all patient rooms ...Sanitize the Floor: products manufactures dwell time is to be followed at all times, if at any time the area becomes dry prior to the manufacturers recommended dwell time, the area is to be re-wiped down to allow for the dwell time."

8. According to AORN (Association of peri-Operative Nurses) guidelines for Perioperative practice titled: "Instrument Cleaning" dated 2021, indicated in part ... "Keeping instruments moist until they are cleaned by using either saturation with an enzymatic or a towel moistened with water placed over the instruments ...keeping instruments moist helps prevent soil (e.g. blood, body fluids) from drying and adhering to the instruments ...dried soil can make instruments more difficult to clean and potentially lead to the formation of dry surface biofilm (an accumulated biomass of bacteria and extracellular material that is tightly adhered to a surface making it difficult to remove) ...treating instruments with an enzymatic pretreatment at the point of use can help prevent rusting and corrosion, prevent blood and organic materials, and debris from drying on the instruments; and inhibit dry-surface biofilm formation."

During a concurrent observation and interview on 3/15/22, at 3:30 p.m., with the NICU charge nurse (CN 2) and the perinatal director (PD), during a tour of the NICU, a red biohazard container labeled eye tray was observed in the soiled utility room. CN 2 verbalized the instruments are used during eye exams that are performed on the babies. CN 2 verbalized the eye tray instruments are picked up from sterile processing staff (SPD) to be sterilized. When asked if the instruments were sprayed with an enzymatic, CN 2 verbalized she did not know about using an enzymatic on the instruments. The PD acknowledged the instruments should be sprayed while awaiting to be picked up by SPD.

During a review of the facility's policy and procedure titled, "Cleaning and Processing Instruments", dated 5/14, indicated in part ... "All surgical instruments will be subject to a system for handling during the surgical procedure, decontamination, cleaning, and processing ...B. instruments used during the case are to be opened and placed in a rigid transport container containing enzymatic cleaner and water, covering the instruments as much as possible."





33720

During a concurrent observation and interview on 3/16/22, starting at 10 a.m., with rehabilitation manager (RM) on the rehab unit 4th floor of hospital, the following observations occurred:

5 b. In patient shower room located in hallway on rehab floor, a room multiple rehab patients use for showers, was observed to have a shower gurney and multiple shower chairs, within the shower room space. RM indicated all equipment in the shower room is utilized by the occupational therapy staff who are responsible for cleaning all equipment after use. Laying on shower gurney was a shower chair removable commode bucket . Bucket was observed to have dark film along inside of bucket, and small dark solid particles in the floor of the bucket. RM stated, "This is not what I call clean, the OT staff (occupational staff) should have cleaned this."

5 c. Located in the Rehab floor hallway, was observed a movable bladder scanner (portable ultrasound devise which provides a non-invasive scan of the bladder). RM indicated device stored in the hallway was "clean." When asked how a staff member would know the scanner had been cleaned, RM stated,"It should have a (adhesive) dot on it after cleaning." No observed "dot" was located on devise. RM unable to confirm bladder scanner had been cleaned.

5 d. Located on the Rehab floor hallway, observed 2 "comfort air glider" (device used to power air into mattress overlays) movable equipment. RM was unable to determine if equipment had been cleaned prior to placement in the hallway for next patient use.

9. In patient room 4, observed packaged tubing laying on top of soiled linen container, RM picked up tubing and indicated it was for,"suctioning". RM stated, "Not OK placing tubing on top of soiled linebacker."

10. IV tubing and used IV fluid bag observed in patient bathroom basket. RM stated,"Should not be here, should be in a blue canister."

Review of hospital's document titled," Infection Prevention and Control Plan 2022" effective date "4/11/2006" with no approval date, indicated in part..."pg3/9" ... "11. Program Design... B. Standardized practices are implemented to minimize infection risks related to medical equipment, devises and supplies..." pg4/9..." Program Elements... B. Environmental rounds are done in all areas of the facilities to ensure continuous compliance with regulations, and to identify areas requiring follow up attention."


35399

5 e. During a tour of the emergency department (ED) and concurrent interview with the ED manager (EDM) on 3/15/22 at 12:30 p.m., a glidescope (videolaryngoscope that helps to achieve a good view of the laryngeal inlet and the vocal cords effective with difficult endotracheal intubation) was observed in a heavy traffic hallway of the ED, uncovered and unable to determine if it was clean or dirty. The EDM explained the Glidescope is clean by the user which are the physicians. EDM was asked how we know this glidescope was clean. EDM was not able to provide evidence the scope had been cleaned.

During a concurrent observation of the glidescope and interview with the infection preventionists (IP) on 3/15/22 at 12:33 p.m., the IP acknowledged and confirmed there is no evidence the glidescope had been cleaned and sanitized. IP stated, "I agree we do not know if this scope is clean or dirty, it's not cover with plastic like the ventilator."

In the same hallway on 3/15/22 at 12:30 p.m., a C pap machine (use mild air pressure to keep the airways open, and are used by patients who have breathing problems during sleep), and vapo-therm machine (high velocity therapy delivers optimally humidified medical grade vapor that help mobilize secretions present in respiratory infections, such as pneumonia) were observed uncovered next to a ventilator which was covered with a plastic bag indicating the ventilator was clean.

During an interview with respiratory therapy manager (RTM) on 3/15/22 at 12:55 p.m., The RTM stated "the C-pap and Vapo-therm machines are taken down to the respiratory department to get cleaned and bagged to indicate equipment is clean and ready to be use with the next patient." RTM acknowledged the C-pap and Vapo-therm machines had been left uncover indicating they were not clean.

11. During an intravenous (IV) access observation and concurrent interview with the infection preventionist (IP) on 3/15/22 at 3:15 p.m., inside ED room 17 a registered nurse (RN) was observed starting an IV access on patient's right arm. RN scrubbed the area with chlorohexidine then RN palpated the vein with finger before inserting the needle. IP witnessed the observation and stated "I agreed that once the area is scrubbed it should not be palpated."

12. During an observation of ED RN 1 cleaning ED room 32 and concurrent interview with the infection preventionist (IP) on 3/15/22 at 4:00 p.m., RN 1 was observed cleaning the gurney, tables ...but did not clean the IV pump (device that controls the intravenous fluid flow rate) inside the room. RN 1 indicated room cleaning was complete and stated, "the room was ready for new patient." Minutes later a new patient was observed going into this room. The IP acknowledged the observation and stated, "The IV pump should have been clean as well before the next patient."

13 a. During an observation of the ED clean storage room and concurrent interview with the infection preventionists (IP) on 3/15/22 at 4:15 p.m., four evacuation containers (containers use to drain fluid from body e.i. thoracenthesis and paracenthesis procedures were observed on the floor. IP acknowledged the observation and agreed the "containers should not be on the floor due to infection control purposes."

14. During an observation and concurrent interview with the infection control (IP) on 3/15/22 at 3:58 p.m., in a busy ED hallway, a specimen with dark orange substance inside the container was sitting on top of a table unattended. The table also had a chux with dark color stains on top. IP acknowledge the observation and stated, "I agree this specimen should not be sitting here. Its dirty"

15. During a tour of the intensive care unit (ICU) and coronary care unit (CCU) on 3/16/22 from 10:00 a.m., to 11:00 a.m., eight patients (N100, N101, N102, N103, N104, N105, N106, N107), were observed connected to a ventilator. The Heat and Moisture Exchanger (HME) filter for these eight patients were observed without any date, time or any indication as to when the filters were placed on the in-line circuit or when the filters need to be change. The HME filter enhance the protection against airborne microbes to help to reduce the transfer of viruses and bacteria.

During an interview with respiratory therapist (RT) on 3/16/22 at 10:15 a.m., RT explained (HMEs) filters should have the date and time as to when the filter was changed. Filters are change every 3 days or if soiled (as needed PRN).

The manufacture's information for use (MIFUs) for the HME filter use on the ventilator was reviewed on 3/16/22. The MIFUs indicated "Replace the ...HME bypass every 72 hours or as needed to prevent accumulation of secretions."

Record review for Patient N103 was conducted and concurrent interview with respiratory therapy manager (RTM) on 3/16/22 at 10:20 a.m., record indicated the HME filter was placed on 3/12/22 at 5:00 p.m. and was not changed thereafter. RTM acknowledged the finding and stated, "I agree the HME should have been changed and documented as to when this occurred."

Record review for Patient N100 was conducted and concurrent interview with respiratory therapy manager (RTM) on 3/16/22 at 10:30 a.m., record indicated the HME filter was changed on 3/13/22 at 5:00 a.m. and was not changed thereafter and patient remains on ventilator. RTM acknowledged the finding and stated, "I agree the HME should have been changed and documented ..."

Record review for Patient N102 was conducted and concurrent interview with respiratory therapy manager (RTM) on 3/16/22 at 11:30 a.m., record indicated the HME filter was changed on 3/13/22 at 5:10 a.m. and was not changed thereafter and patient remains on ventilator. RTM acknowledged the finding and stated, "I agree the HME should have been changed and documented ..."

During a review of the policy and procedure titled "Routine Equipment Discard or Change Schedule", dated 11/18/21, and concurrent interview with the respiratory therapy manager (RTM) on 3/16/22 at 12:05 p.m., in part 1 (a) the policy indicated "All of the following equipment will be changed on the ventilator every seven (7) days with a heated wire circuit, or as needed with a circuit using a heat moisture exchanger (HME)." The RTM acknowledged that the policy does not reflect the HMEs manufacturers instruction for use (MIFUs) or their current practice. RTM stated, "I agree this policy needs to be updated."














37886

1c. During a tour of the Cath lab and concurrent interview on 3/15/22 at 12:05 PM, the x-ray scrub tech (XRT) was observed touching and moving the trash can with his both hands. XRT did not perform hand hygiene, proceeded to get a blanket, and placed the blanket on the surgery bed, then touched their mask, no hand hygiene observed. XRT confirmed and concurred the finding.

3b. During a tour of the Cath lab and concurrent interview on 3/15/22 at 11:41 AM, the x-ray coordinator (XRC) was observed sitting in the computer area wearing gloves on both hands. The XRC confirmed she wore gloves and should not. XRC concurred gloves are to be removed after caring for a patient.

5f. The facility policy titled "Cleaning of Portable Equipment and Lead Aprons" revised 1/2021 indicated in part, "Lead aprons are clean after any exposure blood borne pathogens or body fluids with germicidal wipes." The policy did not address the proper storage and did not assign the responsibility for the task.

During a tour of the Cath lab department on 3/15/22 at 11:41 AM, multiple lead aprons (a personal protective equipment worn to minimize radiation exposure) were observed hanging on the rack, and one apron was laying on the chair. Another rack of aprons was observed in the hallway outside the door of the Cath lab.

During concurrent interview the circulator nurse (CLCN) explained it's a joint effort among operating room (OR) staff to clean the lead apron after each use and staff do not log the cleaning of the lead apron. CLCN could not confirm nor refute whether the lead aprons inside and outside the Cath lab were all cleaned.

During an interview on 3/17/22 at 11:05 AM with the infection preventionist (IP), the IP explained the cleaning of the lead aprons are not logged and the end user is to clean the lead apron after each use.

5g. During a tour of the intensive care unit (ICU) on 3/15/22 at 12:35 PM revealed an equipment storage room housed multiple movable equipments including but not limited to bear hugger, bladder scanner, IV polls, ultrasound machine, EKG monitor, blood warmer, SCD, respiratory equipment.

Concurrent interview with the ICU charge nurse (CN4) explained ICU staff cleans the equipment after use. CN4 could not provide the process for ensuring clean equipment was sanitized prior to return to the clean storage. CN4 confirmed the findings.

5h. During a tour of the telemetry (3S) on 3/16/22 at 3:00 PM, a clean storage was observed with multiple patient equipment on the floor and shelving. There was no indication that the equipment had been sanitized after patient use and prior to return to clean room.

Concurrent interview with telemetry charge nurse (CN) explained few equipments with label sticker serviced by environmental services are considered cleaned, however CN could not explain the process other than they wipe the equipment with Sani wipes prior to storage.

16. The facility policy titled "Linen Handling Procedures" reviewed 02/5/14, indicated, " ...Clean linen is delivered to the linen room completely wrapped or in plastic lined carts ...The closets are then stocked by the linen room personnel by transporting the clean linen in exchange carts, or a transportation cart, which are covered or wrapped in plastic to insure proper handling ..."

During the tour of the telemetry 2 South on 3/16/22 at 3:29 PM, the linen cart was observed stored in the corridor outside the patient room. This cart contained bedsheets, patient gowns and bath towels. The linen cart was left unattended and uncovered.

Concurrent interview with the registered nurse (RN4) acknowledged the clean linen cart was left uncovered and not protected from contamination while being parked in the hallway and should be covered.

17. During an observation on 3/16/22 at 2:55 PM indicated, the wheeled infection control isolation cart was left unattended in the corridor of the telemetry (3S) unit.

Concurrent interview with the 3S charge nurse (CN) explained the contact isolation has been de-activated for a patient the previous day. CN concurred the isolatio

Based on interview and record review, the hospital governing body failed to:

1. Specify frequency and detail of data collection for the quality assessment and performance improvement program (QAPI). The hospital failed to ensure an ongoing quality program that showed measurable improvement indicators for infection prevention and control.

2. The hospital failed to follow a process for tracking and securely documenting the COVID-19 vaccination status of all contracted student staff.

This failure resulted in unsafe infection control practices and the inability to monitor the effectiveness and safety of patient care and identify opportunities for improvement. (Cross reference 0750).

Findings:

1. Review of hospital document titled "Infection Prevention and Contol Plan", dated 4/1/06, indicated in part..."Program Evaluation X...C. Findings, conclusions, actions and follow up evidence of results are routinely presented to the ICC, MEC, Quality Committee of the Board and Board of Directors..."

During a interview on 3/16/22, starting at 3:15 p.m., with Infection Preventinist manager (IP), when asked if the 2021 Infection Control goals and findings were presented to the governing board, IP stated, "No, 2021 goals were only presented to the ICC (Infection Control Committee) in Febuary, because I could only find data for 3 out of the 10 goals."


2. During a interview and concurrent record review on 3/16/22, starting at 9 a.m., with manager of education (MED1), MED1 explained MED1 responsibility to oversee the vaccination status for 3 college student programs (health programs with direct patient contact). MED1 was unable to demonstrate a tracking document that securely documents 68 students in one of the programs. MED1 stated, "We are currently looking at a process improvement opportunity to get this (tracking) into a updated spread sheet to include vaccines first and second ones, we currently don't have one."

Based on record review and interview, the Governing Board failed to ensure that hospital acquired infections as well as antibiotic use issues were addressed in collaboration with the hospital Quality and Performance Improvement (QAPI) leadership.

This failure has the risk of the QAPI leadership not being involved in a integral aspect of the hospitals ongoing support, participation and compliance with the infection prevention program.

Findings:

Review of hospital document titled, " Quality and Performance Improvement Plan," dated "2/2020, (hospital identified as current 2021 plan) indicated in part,... "pg. 3/7... Actions... E. Relevant information developed from the following activities is integrated into performance improvement initiatives. This occurs in a way consistent with hospital policies or procedures intended to preserve confidentiality and privilege of information established by applicable law. ....5 Infection Prevention and Control..."

During an interview on 3/17/22, starting at 8:15 a.m., with QAPI director (QMD), when asked how the infection control program issues may have interfaced with the QAPI program,QMD stated, "For 2021 they were not interfaced withe the QAPI program, for the future I have plans to create." QMD further offered the programs did not have any shared data metrics between QAPI and IC programs for 2021, stating, "We will, going forward."

Based on record review and interview the hospital failed to ensure communication and collaboration occurred between the infection control and quality programs to ensure the current infection prevention and control issues and activities were addressed, monitor and modified as needed for effectiveness of their performance improvement.

This failure resulted in the infection control and prevention program activities lacking ongoing monitoring, modification and measuring of metrics appropriately to meet their targeted quality goal.

Findings:

Review of facility document titled,"Infection Prevention and Control Plan," "effective date 4/1/26, pg."7/9"... indicated in part..."C.Findings, conclusions, actions and follow-up evidence of results are routinely presented to the ICC, MEC, Quality Committee of the board and the Board of Directors....."

During a interview on 3/17/22, starting at 8:15 a.m., with QAPI director (QMD), QMD was asked how infection control activities interfaced with hospital QAPI program ? QMD stated, "For 2021 there was no communication/collaboration with QAPI, for the future there will be." QMD was unable to provide agenda items, minutes or IC metrics/data into QAPI meetings. QMD stated, "Not for 2021 but we will going forward."

Based on observation, interview, and record review, the facility failed to maintain infection control practices and processes when (See 0750):

1. Hand hygiene was not performed by staff.

2. Cleaning of the operating rooms (OR's) between patients (room turn over) was not done according to policy and procedure and The Association of Peri-Operative Registered Nurses (AORN) guidelines in labor and delivery and surgical services.

3. Gloves were not removed when going from dirty to clean.

4. Terminal cleaning logs were not complete.


These facility failures in auditing and adherence to the IC policies and procedures has the potential to result in cross-contamination (the transfer of harmful bacteria) that could impact patients' health and safety and cause preventable healthcare associated infections (HAI) for patients in an already compromised condition.

During an interview on 3/17/22, starting at 10:40 a.m., with the infection preventionist manager (IP), when asked about the observed hand hygiene not being performed correctly by staff, IP indicated "room for improvement." When asked about environmental staff not cleaning OR rooms per hospital policy and procedures, IP indicated that moving forward she needed to be more involved. IP was asked about moveable patient medical equipment being stored in the hallways, without a process to indicate if the equipment was clean, IP stated, "The current process does not address this, moving forward we need to improve cleaning process and improve policy."

Based on interview and record review, the facility failed to operationalize a process for ensuring that 100% of student/trainee staff were fully vaccinated for COVID-19, except for those staff who had been granted exemptions to the vaccination requirements, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

This failure resulted in student/trainee staff not being monitored for COVID vaccine compliance.

Findings:

During a interview and concurrent record review on 3/16/22, starting at 9 a.m., with manager of education (MED1), MED1 explained MED1 responsibility to oversee the vaccination status for 3 college student programs (health programs with direct patient contact). MED1 was unable to demonstrate a tracking document that securely documents 68 students in one of the programs. MED1 stated, "We are currently looking at a process improvement opportunity to get this (tracking) into a updated spread sheet to include vaccines first and second ones, we currently don't have one."