HospitalInspections.org

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


1. The governing board failed to follow hospital's established policy and procedures for expectations of patient safety, when facility documents lacked demonstration of governing board oversight.
(Cross Reference A-0286).

2. The facility's governing body failed to ensure 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 Operating Room/Surgical Services and Outpatients Services. 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)

3. The facility failed to demonstrate the governing body 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)

4. The governing body failed to ensure the hospital staff followed hospital policy and procedures and standards of practice within the surgical services of the hospital. These failures had the potential to result in negative patient care outcomes, cross contamination of equipment, the potential to spread harmful microorganisms to patients and staff, with the potential to result in procedural and surgical site infections. (Cross Reference A-0749 and A-0750).

5. The hospital failed to ensure the governing body monitored the implementation of infection control activities to prevent the transmission of communicable diseases. This deficient practice had the potential for the spread of hospital acquired infections among patients and staff members. (Cross Reference A-0770).

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 facility failed to assess pain on two of 35 sampled patients, (Patient N506 and N605).

This facility failure had the potential for inadequate pain control for Patients N506 and N605.

Findings:

The facility policy and procedure titled "Range orders And Multiple PRN Medication Order of Use" dated 06/2021 indicated, reassess patient when the drug approximately reaches peak effect:
1. 15-45 minute after Intravenous administration.
2. 45-75 minutes after PO/IM/SQ/Rectal administration.

Review of Patient N506 health records on 6/16/2021 at 10:15 a.m., Patient N506 was given pain medication on 6/16/2021 at 6:32 a.m. Post pain assessment was done on 6/16/21 at 8:43 a.m., two hours after being given pain medication.

During an interview on 6/16/2021 at 10:20 a.m., the charge nurse (LN15), LN15 indicated post pain assessment should be done one hour after oral pain medication is given and was not.




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Review of the facility policy titled, "Addendum A: Nursing Institute Clinical Standards Committee", revised 4/2015, indicated in part ... "Pain assessment ... Pain rating with - prior to administering pain medication ... following administration of pain medication to assess effect."

During a record review and concurrent interview, on 6/6/21, at 10:40 a.m., with clinical educator (CE 2), Patient N605 medical record indicated, Tylenol 650 mg po prn every 4 hrs for pain, Tylenol was given at 2141 on 12/26/20. Flow sheet for pain assessment dated 12/26/20 indicted no pain assessment performed, confirmed with CE 2. CE 2 acknowledged pain assessment should have been performed.

Based on an observation, interview, and record review, the hospital failed to honor patient rights when private health information was found in the ICU for transferred and discharged patients.

This facility failure had the potential for unauthorized people to access private health information.

Findings:

Review of the hospital document titled, "Notice of Privacy Practices", dated 6/1/21, indicated in part ... "Our Responsibilities: We are required by law to maintain the privacy and security of your protected health information."

During an observation (tour of ICU) and concurrent interview, on 6/14/21, between 11:45 a.m., and 12:16 p.m., with critical care unit manager (CCUM), CCUM confirmed multiple pages of hand written private health information for patients that had been transferred and/or discharged were found in various locations in the ICU. CCUM acknowledged private health information should only be available to authorized persons.

Based on observation, interview and record review, the facility failed to ensure safe care was delivered to patients' when their rights were not honored as evidenced by:
1. Ensuring Patients 103, 104 and 107's hospital acquired pressure injury (HAPI) prevention measures were
implemented as per the Wound Nurse recommendations and/or physician's orders.
2. Ensuring expired items use during a central line insertion procedure were removed from inside the Central Line cart
in the critical care unit (CCU).
3. Ensuring an emergency department (ED) nurse inverted blood tubes therefore mixing blood properly to produce the correct test results.
4. Ensuring patients' identity was verified by an arm band attached to the patients' wrist.
These failures place the patients at risk for negative outcome and/or harm.

Findings:

The facility's Patient's Rights/Responsibilities document indicated "A patients' right shall include but not limited to: 13. Receive care in a safe setting ..."

1. A. The facility's policy and procedure entitled "LA Region Pressure Injury Prevention", dated 06/17, In part 10. INTERVENTIONS FOR PREVENTION, (A) Universal for All Patients, (D) Mobility Number 1, indicated "Regular and frequent turning and repositioning for bed and chair-bound individuals will be performed ..."

During an observation of Patient 103 on 6/14/21 at 11:25 a.m., patient was observed intubated ventilator dependent (breathing via a tube connected to breathing machine), sedated, with restraints (secured devices) on both wrists thus unable to self-turn from side to side to prevent HAPI's.

During a review of Patient 103's record and concurrent interview with licensed nurse (LN 1) on 6/16/21 at 9:47 a.m., LN 1 indicated dependent care patients (like Patient 103) need to be turn every 2 hours to prevent pressure injury. The positioning flow-sheet documentation was reviewed. On 6/8/21 the patient was not repositioned from 2:00 p.m., to 8:00 p.m., (6 hours). On 6/9/21 no repositioning occurred from 10:00 p.m., to 6/10/21 at 2:00 a.m., (4 hours). Then, from 4:00 p.m., to 8:00 p.m., (4 hours). On 6/11/21 no repositioning occurred from 12:00 p.m., to 4:00 p.m., (4 hours). On 6/13/21 no repositioning occurred from 4:00 a.m., to 8:00 a.m., (4 hours).

The Wound/Ostomy Care Nurse Progress Note, dated 6/15/21 at 11:00 a.m., indicated patient developed a HAPI to Right outer ear deep tissue pressure injury (DTPI). Recommendations: Utilize foam headrest to position head. Turn patient every two (2) hours.

B. The facility's policy and procedure entitled "LA Region Pressure Injury Prevention", dated 06/17, In part 10. INTERVENTIONS FOR PREVENTION, (A) Universal for All Patients, Number 1, indicated "Continue preventive measures even when a patient has pressure injury to prevent additional pressure areas from developing."

During a review of Patient 104's record and concurrent interview with licensed nurse (LN 1) on 6/16/21 at 9:05 a.m. The Wound/Ostomy Care Nurse Progress Note, dated 6/11/21 at 2:00 p.m., indicated patient was admitted with a stage 1 on sacrum. Pressure Ulcer Prevention measure was to "Turn patient every (2) two hours, left and right side lying only." Patient's physician's orders, dated 6/11/21 at 5:24 p.m., indicated for Pressure Ulcer Prevention to "Turn patient every (2) two hours, left and right side lying only." The positioning flow-sheet documentation was reviewed. The documentation indicated patient was turn supine on back numerous times. Therefore, not following the Wound/Ostomy care Nurse recommendations or the physician's orders. LN 1 acknowledged and confirmed that according to the positioning flowsheet documentation the patient was still position on the back, even thought orders and recommendations indicated not to lay patient on back.

During an interview with the critical care unit manager (CCUM) on 6/16/21 at 9:38 a.m., CCUM acknowledged and agreed the patient should not have been positioned supine on back.

C. A review of Patient 107's clinical record was conducted on 6/15/21. Patient was admitted to facility on 5/14/21. The Wound/Ostomy Care Nurse Progress Note, dated 5/31/21 at 4:52 p.m., indicated patient develop a deep tissue pressure injury (DTPI) on coccyx (tailbone). Wound Interventions were to off-load coccyx and to turn patient every two (2) hours. Patient's physician's orders, dated 6/2/21 at 12:57 p.m., indicated for Pressure Ulcer Prevention to "Turn patient every (2) two hours, avoid supine, if possible." On 6/5/21 a stage 2 pressure ulcer on coccyx was documented. On 6/9/21 an unstageable pressure ulcer on coccyx was documented. On 6/12/21 an unstageable pressure ulcer on coccyx was documented. The positioning flow-sheet documentation was reviewed. On 6/4/21 patient repositioning did not occur from 12:00 p.m., to 7:30 p.m., (7 ½ hours). On 6/6/21 repositioning did not occur form 9:30 p.m., to 1:00 a.m., (3 ½ hours). On 6/11/21 repositioning did not occur from 4:00 p.m., to 8:00 p.m., (4 hours). On 6/12/21 repositioning did not occur from 6:00 a.m., to 10:00 a.m., (same position for 4 hours). On 6/14/21 repositioning did not occur from 2:00 a.m., to 6:00 a.m., (same position for 4 hours).

During record review of Patient 107's record and concurrent interview with licensed nurse (LN 2) on 6/15/21 at 4:40 p.m., LN 2 acknowledged and agreed patient was not repositioned every two hours which was not good.

2. During a tour of the CCU, accompany by the critical care unit director (CCUD) on 6/15/21 at 9:38 a.m., the CCUD explained the Central Line Cart contains items use during a central line insertion procedure. Unclear as to who and when this cart is checked. Inside one of the cart's drawer two bottle of Providence Iodine Topical solution (skin disinfectant) with expire date 11/2020, two bottles of Chlorhexidine Gluconate solution (skin antiseptic) with expire date 08/2020, and one bottle of Hydrogen Peroxide solution (skin antiseptic) with expire date 09/2020, were observed inside the cart. These solutions inside the cart were ready to be use during a central line insertion procedure. The CCUD acknowledged the observation and stated "Yes, I agree these expired solutions should not be inside the cart, someone could have used them, and they are not good."

The facility's policy and procedure entitled "Medication Management", dated 02/18, in part 6. (a) indicated "Medications are dispensed in the most ready-to administer forms available from the manufacturer ... Unused, expired, discontinued, or contaminated medications are returned to the pharmacy."



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3. Review of the facility policy titled, "Specimen Collection and Identification", revised 12/8/20, indicated in part ... "Serious consequences may result from any deviations from this procedure ... Gently invert tubes containing anticoagulant or gel 5 to 10 times for proper mixing."

Review of the hospital document titled, "Laboratory Tube Collection Quick Reference Guide", revised 11/2/20, indicated in part ... "Light Green Tube - 8 tube inversions ensure mixing of anticoagulant with blood to prevent clotting ... Purple Tube - 8 tube inversions required to ensure mixing of anticoagulant with blood."

During an observation, on 6/15/21, at 11:25 a.m., with licensed nurse (LN 6), LN 6 did not invert tubes after blood draw from Patient (N602) in ED.

4. Review of the hospital document titled, "IV Tubing Extensions for Distance IV Pump Placement", dated 4/6/20, indicated in part ... "Potential Safety Issues ... Verification of the patient and the bar coding process is impacted when the IV pump is outside of the patient's room ... If a hospital's clinical leadership evaluates this recommendation and is in a position to begin or continue the practice of distant IV Pump Placement, the following mitigation strategies should be addressed: Describe the process for barcoding scanning of the medication/solution/pump, and how the patient will be verified."

During an interview, on 6/14/21, at 3:50 p.m., with licensed nurse (LN 1), LN 1 verbalized we put the IV pumps outside the patient's rooms in the ICU. Patient identification bands were taped to the glass doors and were also placed on computers that could be wheeled around the unit. Additionally LN 1 verbalized that the staff would go by room number and memory for verifying patient identity. LN 1 acknowledged these practices were not the normal practice for us but we did it.

During an interview, on 6/15/21, at 8:50 a.m., with LN 4, LN 4 verbalized we put the IV pumps outside the patient's rooms in the ICU, a lot of the staff were afraid to go into the patient's rooms. Additionally LN 4 verbalized that the staff taped the patient's identification band to the glass doors or put on the computers so we didn't have to go into the rooms. LN 4 stated, that she wasn't sure who initial told them to move IV pumps outside patient's rooms, she remembers the practice started shortly after COVID began and was in place until 1/21. LN 4 confirmed they were told to stop placing the IV pumps outside patient rooms because the practice was not recommended.

During an interview, on 6/15/21, at 9:25 a.m., with critical care unit manager (CCUM), CCUM confirmed we put the IV pumps outside the patient's rooms in the ICU; also the patient's identification bands were taped to the patient doors, put on computers, and there was a folder at the front desk in the ICU that had all the identification bands - these practices were put in place so staff did not have to go into the patient's rooms. Additionally CCUM verbalized that she wasn't sure who initial told them to move IV pumps outside patient's rooms, she remembers the practice started when COVID began and was in place until February or March of 2021. CCUM stated clinical leadership provided no guidance for IV poles outside patient rooms or patient identification bands (barcodes).

Based on observation, interview and record review, the facility failed to ensure critical care unit (CCU) staff performed physical restraints management (assessments and obtained daily physician's order) for five of 35 sampled patients (Patients 100, 103, 105, N104, N105), as per their policy and procedure.

These failures placed the patients at risk of being restraint unnecessarily.

Findings:

The facility policy and procedure entitled "Restraints/Seclusion for NON-VIOLENT/Non-Self-Destructive Behavior", dated 7/18, in Part 4 (D) indicated "Each calendar day, the patient will be reassessed by the RN to continue the restraint episode. If patient meets ongoing criteria, update the restraint order in electronic health record (EHR) using the order mode "per signed order." In Part 6 (A) indicated "The RN assesses on initiation and reassesses the patient's status and response to restraints at interval not greater than two (2) hours ..."

1. During a tour of the CCU on 6/14/21 at 11:10 a.m., Patient 100 was observed with bilateral wrist soft restraints (devices use in hospitals to safely secure a patient to avoid hurting self or others).

A review of Patient 100's clinical record was conducted on 6/15/21. The record indicated bilateral wrist restraints were applied on patient on 5/22/21 at 8:00 p.m. No nursing restraints assessments were performed on the following dates and times. On 5/28/21 from 10:00 a.m., to 6:00 p.m. On 5/29/21 from midnight to 6:00 a.m., from 10:00 a.m., to 10:00 p.m. On 5/30/21 from midnight to 6:00 p.m., from 9:00 p.m., to midnight. On 5/31/21 from midnight to 6:00 a.m. On 6/1/21 from midnight to 6:00 p.m., from 9:00 p.m., to midnight. On 6/2/21 from midnight to 11:00 p.m. On 6/3/21 from midnight to 6:00 a.m., from 9:00 p.m., to 11:00 p.m. On 6/4/21 from midnight to 8:00 a.m. from 6:00 pm, to midnight. On 6/5/21 from midnight to 8:00 a.m. on 6/6/21 from 10:00 a.m., to 6:00 p.m. On 6/8/21 from midnight to 8:00 a.m., from 10:00 p.m., to midnight. On 6/9/21 from midnight to 8:00 a.m. On 6/12/21 from 8:00 p.m., to midnight. On 6/13/21 from midnight to 8:00 a.m. On 6/14/21 from 8:00 p.m., to midnight. On 6/15/21 from midnight to 6:00 a.m.

Further review of the same record indicated Patient 100 had bilateral wrist restraint from 5/22/21 until 6/14/21 (24 days). However, there were only (6) six (5/28/21, 5/29/21, 6/1/21, 6/11/21, 6/13/21, 6/14/21) physician's restraints orders documented in the record.

During record review of Patient 100 and concurrent interview with licensed nurse (LN2) on 6/15/21 at 12:50 p.m., LN 2 acknowledged and confirmed several restraints assessments were not performed and that out of 24 days of patient being on restraints only six (6) days had physician's orders for the use of the restraints. LN 2 stated "Yes, I agree no assessments were done and there are 18 restraints physician's orders missing."

2. During a tour of the CCU on 6/14/21 at 11:25 a.m., Patient 103 was observed with bilateral wrist soft restraints.
A review of Patient 103's clinical record was conducted on 6/15/21. The record indicated bilateral wrist restraints were applied on patient on 5/31/21 at 6:00 a.m. No nursing restraints assessments were performed on the following dates and times. On 6/4/21 from 12:00 p.m., to 6:00 p.m. On 6/5/21 from 6:00 p.m., to midnight. On 6/6/21 from midnight to 11:00 p.m. On 6/8/21 from 8:00 a.m., to 8:00 p.m. On 6/9/21 from 10:00 a.m., to midnight. On 6/10/21 from 6:00 a.m., to 11:00 a.m., from 12:00 p.m., to 6:00 p.m., from 8:00 p.m., to midnight. On 6/11/21 midnight to 6:00 p.m.

Further review of the same record indicated Patient 103 had bilateral wrist restraint from 5/31/21 until 6/14/21 (15 days). However, there were only (8) eight (5/31/21, 6/2/21, 6/3/21, 6/5/21, 6/7/21, 6/12/21, 6/13/21, 6/14/21) physician's restraints orders documented in the record.

During record review of Patient 103 and concurrent interview with licensed nurse (LN2) on 6/15/21 at 4:25 p.m., LN 2 acknowledged and confirmed several restraints assessments were not performed and that out of 15 days of patient being on restraints only eight (8) days had physician's orders for the use of the restraints. LN 2 stated "Yes, I agree several assessments were not done and there are seven (7) restraints physician's orders missing."

3. During a tour of the CCU on 6/14/21 at 11:39 a.m., Patient 105 was observed with bilateral wrist soft restraints.

A review of Patient 105's clinical record was conducted on 6/15/21. The record indicated bilateral wrist restraints were applied on patient on 6/13/21 at 12:00 p.m. No nursing restraints assessments were performed on the following dates and times. On 6/13/21 from 12:00 p.m., to 8:00 p.m., from 9:00 p.m., to midnight. On 6/14/21 from midnight to 8:00 a.m., from 10:00 a.m., to 6:00pm., from 9:00 p.m., to midnight. On 6/15/21 from midnight to 8:00 a.m.

During record review of Patient 105 and concurrent interview with licensed nurse (LN2) on 6/15/21 at 4:38 p.m., LN 2 acknowledged and confirmed several restraints assessments were not performed. LN 2 stated "Yes, I agree several assessments were not done."




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4. During a record review and concurrent interview on 6/16/21, at 11:04 am, with clinical educator (CE 2), Patient (N604's) clinical record indicated order for restraint for non-violent behavior started on 1/11/21 and expired on 1/12/21 at 1058. Further review of Patient N604's clinical record indicated, flow sheet for assessment - non-violent restraints had no assessments on 1/12/21 from 0800 until documentation of discontinued at 2000. Additionally the order for restraints was not renewed after it had expired. CE 2 confirmed assessments were missing and order for restraints was not renewed.

5. During a record review and concurrent interview on 6/16/21, at 1250 pm, with CE 2. Patient N605's clinical record indicated, order for restraint for non-violent behavior started on 2/3/21 and expired on 2/4/21 at 1445. Further review of Patient N605's clinical record indicated, flow sheet for assessment - non-violent restraints had assessments after order expired and continued use of restraints until after 0600 on 2/5/21. CE 2 confirmed assessments were missing and order for restraints was not renewed.

Based on interview with hospital employees and review of records, the governing board failed to follow hospital's established policy and procedures for expectations of patient safety, when facility documents lacked demonstration of governing board oversight.

Findings:

During a concurrent document review and interview on 6/15/21, starting at 10:45 a.m., with Quality Manager (QM1) and facility document titled, "Improving Organizational Performance and Patient safety Plan," dated "2020," QM1 confirmed 2020 plan most recent plan. Document revealed in part, on page 13 of 25 ... ... ... ....
"XIV. Governing Board "
"The service area Governing Boards provide leadership and oversight of each organization's performance improvement priorities, quality assurance, patient safety, medication safety, infection prevention, and medical staff credentialing/privileging. Board responsibilities include:
A. Set clear direction and regularly monitor organization performance.
B. Focus on performance improvement/patient safety at every board meeting ... ...
I Approve measurement indicators and timelines for data collection and reporting.

Further review of plan document indicated in part on page 1 of 25 ...
I. Authority/Accountability/Structure .....
Regular reports from units/departments, performance improvement/safety committees and Medical Executive Committees are coordinated through ministry quality meetings and reported to the Governing Board ...."

During an interview and concurrent document review on 6/17/21, starting at 11:04 a.m., with risk management director (RMD) review of last 6 months of 2020, governing board meeting agendas and minutes dated, 6/18/20, 8/20/20, 9/16/20, 10/15/20, 12/17/20. RMD acknowledged that minutes did not include agenda items or minutes reflective of performance improvement activities, medical errors or adverse events, RMD stated, " I report safety events to Medical Executive, but I do not see these referenced at the Governing Board."

Based on observations, record review and interview, the facility's governing body failed to ensure 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. The hospital failed to have unique QAPI activities in Operating Room/Surgical Services and Outpatients Services. 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.

Findings:

During a concurrent document review and interview on 6/15/21, starting at 10:45 a.m., with Quality Manager (QM1) and facility document titled, "Improving Organizational Performance and Patient safety Plan," dated "2020," QM1 confirmed 2020 plan most recent plan.
Document revealed in part, on page 13 of 25 ... ... ... ....
"XIV. Governing Board "
"The service area Governing Boards provide leadership and oversight of each organization's performance improvement priorities, quality assurance, patient safety, medication safety, infection prevention, and medical staff credentialing/privileging. Board responsibilities include:
A. Set clear direction and regularly monitor organization performance.
B. Focus on performance improvement/patient safety at every board meeting ... ...
I Approve measurement indicators and timelines for data collection and reporting.

Further review of plan document indicated in part on page 1 of 25 ...
I. Authority/Accountability/Structure .....
Regular reports from units/departments, performance improvement/safety committees and Medical Executive Committees are coordinated through ministry quality meetings and reported to the Governing Board ...."


1. According to the Association of Perioperative Registered Nurses (AORN) guidelines for Perioperative Practice titled: "Design and Maintenance (2012-2019)" indicated in part ... "The health care organization should create and implement a systematic process for monitoring and maintaining structural surfaces and HVAC (Heating, ventilation and air conditioning-HVAC the technology of indoor and vehicular environmental comfort. Its goal is to provide thermal comfort and acceptable indoor air quality) performance ...heating, ventilation, and air conditioning systems, control room air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas ... the HVAC system reduces the amount of environmental contaminants ... the healthcare organization should develop a method for reporting a variance on HVAC system parameters ...personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the healthcare organization's policy and procedures ..."

During a concurrent observation, and interview, on 6/14/21, at 3:35 p.m., with the manager of the mother/baby unit (MOMB), in the newborn nursery procedure room, it was observed that sterile instrument trays were stored in the room. MOMB verbalized circumcisions (the surgical removal of foreskin from a baby's penis) are done in this room. When asked if temperature and humidity were being monitored in this room, MOMB could not locate the thermostat and stated, "There used to be a thermostat in here." MOMB acknowledged temperature and humidity were not being monitored in the room and should be.

During an interview on 6/16/21, at 3:50 p.m., with the director of facilities (DOF), DOF acknowledged sterile circumcision instrument trays were stored in the newborn nursery and acknowledged temperature and humidity were not being monitored. DOF verbalized the temperature and humidity should be monitored in the nursery.

During a review of the facility's policy and procedure titled, "Temperature Humidity and Air Relationships," dated 12/20, indicated in part ... "The objective of the policy is to provide a safe and reliable environment appropriate for anesthetizing locations, sterile processing, sterile storage and clean work areas by maintaining temperature, humidity, and air pressure relationships ...in sterile storage, clean work rooms including processing-processing personnel in each work area are responsible for monitoring and recording the temperature and humidity to ensure that the correct requirements are achieved ...sterile storage relative humidity range %-max 60%...temperature range 72-78° F."

According to AORN guidelines for guidelines for Perioperative Practice titled: "Conditions for Storage of Sterile Supplies (2012-2021)" indicated in part ..."Sterile items should be contained in a US Food and Drug Administration-approved sterile barrier system and stored under environmentally controlled conditions, which include a maximum temperature 75°F, a maximum relative humidity of 60%, positive air pressure in relation to adjacent area and a minimum of our air exchanges per hour."

2. According to the CDC (centers for disease control and prevention) guidelines titled " Disinfection and Sterilization in Healthcare Facilities" updated 2019, indicated ..."once items are cleaned dried and inspected those requiring sterilization must be wrapped or placed in rigid containers and should be arranged instrument tray/baskets" ..."hinged instruments should be opened" ..." the packaging must allow for the penetration of the sterilant."

During a concurrent observation and interview on 6/15/21, at 10:00 a.m., with the manager of surgical services (MOSS), in the sterile storage instrumentation room, a sterilized minor instrument tray (basic set of instruments of a minor surgery) was opened. MOSS acknowledged four towel clamps were sterilized in the closed position. MOSS confirmed these items should be reprocessed in the open position.

According to AORN guidelines for guidelines for Perioperative Practice titled: "Selection and Use of Packaging Systems for Sterilization" (2013) indicated in part ..."Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces ...items to be sterilized should be placed in the package or tray in an open or unlocked position ...the open or unlocked position facilitates sterilant contact of all surfaces of the item ...racks or stringers designed and intended for sterilization can be used to maintain instruments in their open position."

During a review of the facility's policy and procedure titled "Instrument Cleaning and Processing," dated 8/18, indicated in part ... "The patient's safety is maintained by proper cleaning and processing of the surgical instruments ...all instruments with box locks including scissors are opened and strung ...instruments that come apart should be loosened and/or taken apart."

3. According to the Association of Perioperative Registered Nurses (AORN) guidelines for Perioperative Practice titled: "Sterilization" (2012-2021)" indicated in part ... "Area for sterilization Processes ...establish traffic patterns that define requirements for access, movement of personnel, and attire ...control of traffic patterns is intended to protect personnel, equipment supplies, and instrumentation from sources of potential contamination ...establish functional workflow patterns to create and maintain physical separation between decontamination and sterilization areas ...establish functional workflow patterns from areas with high contamination potential to clean areas in the following order:

1. cleaning and decontamination area,
2. preparation and packing,
3. sterilization processing, and
4. sterile storage or the point of use ...

...a workflow pattern that begins in the decontamination area and flows to the storage area or the point of use can help prevent clean or sterile items from reentering a contaminated area where they may become recontaminated."

During a concurrent observation and interview on 6/15/21, at 11:15 a.m., with the manager of the sterile processing department (MSPD) and MOSS, the path of travel for surgical instruments from the decontamination room to the clean room (room where surgical instruments are prepped and packaged for sterilization) was observed. After the surgical instruments are cleaned (not disinfected or sterilized), they are pushed on a cart from the decontamination area (dirty), through a sterile storage room passing by sterilized instruments drying on a rack, through another door into the clean room, where the instruments are to be sterilized.

Both the MSPD and the MOSS acknowledged the separation between the dirty/clean instruments and sterilized instruments is not ideal along this path of travel. MSPD and MOSS acknowledged AORN guidelines and acknowledged there is potential for cross-contamination between dirty/clean instruments and sterilized instruments.

4. During a concurrent observation and interview on 6/15/21, at 11:20 a.m., with the MSPD, the Autoclaves in SPD were observed. Autoclave #1 preventative maintenance sticker for chamber cleaning had been performed on 9/19 and the next cleaning was due 3/20. Autoclave #2 preventative maintenance sticker for chamber cleaning had been performed been performed on 9/19 and the next cleaning was due 3/20. Autoclave #5 preventative maintenance sticker for chamber cleaning had been performed on 9/19 and the next cleaning was due 3/20. When asked if 9/19 was the last chamber cleaning, MSPD was unsure. MSPD verbalized the Instrument Management Service (IMS) stopped coming to the facility for Autoclave maintenance.

During a concurrent observation, and interview, on 6/16/21, at 9:15 a.m., with the infection preventionist (IPM), the director of risk management (RMD), and the MSPD, the routine checklist posted next to Autoclave #1 was reviewed. The routine checklist indicated in part ... to clean the chamber as needed ...turn off the sterilizer power, water, steam supply, following manufacturer instructions in the sterilizers operating manual ...following instructions for chamber cleaning provided in the AMSCO Steam Sterilizer Cleaning Procedure ...professional chamber cleaning is recommended annually or as required to maintain original chamber appearance. MSPD verbalized could not find documentation of when the last chamber cleaning occurred since 9/19. The IPM and RMD acknowledged not following preventative maintenance (PM's) for the chamber cleaning per manufacturer instructions.

During an interview on 6/16/21, at 3:20 p.m., with RMD, RMD verbalized the biomedical contract for the autoclaves had changed and IMS did not come to the facility anymore. RMD verbalized the last chamber cleaning was done on 3/19. RMD acknowledged it had been two years since the last chamber cleaning and is overdue.

During a review of the Steris Operating Manual dated 7/16/07, indicated in part ..."Preventative maintenance schedule: regularly scheduled preventative maintenance is required for safe and reliable operation of this equipment ...maintenance procedures in sections 7 and 9 must be performed regularly at the indicated intervals using the maintenance schedule in table 7-1 as a guide ...customers should maintain a record of all maintenance procedures performed on the sterilizer ...section 7-1.2: clean chamber ...the entire chamber should be wiped down and rinsed following any spills or other soiling ...professional cleaning of the chamber on a yearly basis."

5. According to AORN guidelines for guidelines for Perioperative Practice titled: "Flexible Endoscopes" (2012-2021), indicated in part ... "Store flexible endoscopes in a drying cabinet ...optimal storage of flexible endoscopes facilitates drying, decreases the potential for contamination, and provides protection from environmental contaminants ...drying cabinets include a drying system that circulates hepa-filtered air through the cabinet while filtered air under pressure is forced though the endoscope channels ...the internal and external surfaces of the endoscope are continuously dried, suppressing bacterial growth ...if a drying cabinet is not available, store flexible endoscopes in a closed cabinet with heap-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes ...ventilation promotes continued drying of the endoscope ... using hepa-filtered air may help prevent bacterial growth in the endoscope ...positive pressure may help prevent contamination of the stored endoscopes."

During a concurrent observation and interview on 6/15/21, at 11:55 a.m., with the gastrointestinal (GI) lab manager (GILM), the endoscope storage cabinet was observed and contained nine endoscopes hanging vertically, inside the cabinet. Upon further observation, the storage cabinet did not have any heap-filter or any air-flow system throughout the cabinet. The GILM acknowledged the storage cabinets were incorrect and acknowledged AORN guidelines. The GILM verbalized the facility is aware and has been waiting on new storage cabinets.

During an interview on 6/15/21, at 4:20 p.m., with the IPM, the IPM acknowledged the endoscope storage cabinet is incorrect and needs updating. The IPM acknowledges the cabinet does not have an air-filter and/or positive pressure airflow. The IPM verbalized the facility is aware and the new endoscope cabinets are coming however they are back ordered. The IPM further verbalized the facility has a mitigation risk plan in action and moving forward can come up with a short-term action plan until the new cabinets are installed.

6. During a concurrent observation and interview on 6/15/21, at 12:30 p.m., with GI licensed nurse (LN 7), the medivators (an automated endoscope reprocessor machine that kills microorganisms by cleaning and disinfecting) were observed. LN 7 verbalized the high-level disinfectant (HDL) used in the medivator is Rapicide. The medivator cabinet was opened and the container of Rapicide connected to the medivator was observed. The container was opened and undated. When asked how long the Rapicide is good for after opening, LN 7 verbalized 3 weeks. When asked if the container is open and undated, how do you know when the Rapicide was last changed last, LN 7 verbalized she did not know. LN 7 verbalized they use the Rapicide faster than 3 weeks. When asked if there is a logbook that documents when the Rapicide was changed last, LN 7 verbalized no.

During an interview on 6/15/21, at 12:32 p.m., with the GILM, the manufacturer instruction for use label on the Rapicide container was reviewed. The instructions indicated the product may be used for 21 days after the containers are opened and do not use after that time has expired. The GILM acknowledged the Rapicide container should be dated when opened and changed out after 21 days.


During concurrent interview and document review with QM1, on 6/14/21, at 3:28 p.m., while reviewing quality assessment and performance improvement projects for 2020/2021, QM1 acknowledged hospital does have operating rooms, and surgical services. QM1 also acknowledged that the facility had no tracking, trending QA or PIP activity in this unique setting, QM1 stated ,"Leaders determine what to track based on regional dashboard ."


7. During a concurrent interview on 6/16/21, starting at 4 p.m., with out-patient manager (OPM1), in hospital licensed physical therapy out-patient center, OPM1 indicated she had been employed at out-patient center for approximately 10 years. OPM1 acknowledged that the out-patient program is not integrated into the hospital wide QAPI (quality assurance performance improvement) program, OPM1 stated, "We do with the physical therapy program in the in-patient services but not in the out-patient services."

During an interview with the QAPI Manager on 6/16/21, starting at 4:47 p.m., QAPI manager confirmed out-patient services are not integrated into the hospitals QAPI program, QAPI manager stated, "They (out-patient services ) are not going to the hospital QAPI Program ." Further review of Hospital State license indicates hospital has three separate approved licensed outpatient centers with multiple service types.

Based on observation, interview, and record review, the hospital failed to ensure drug storage areas were administered in accordance with hospital policy and procedures, and accepted professional principles when:

1. Patients' home medications kept in pharmacy storage were not disposed in a timely manner

2. Hospital did not regulate the temperature of the Operating Room (OR) anesthesia workroom (room in operating suites used to store supplies for surgeries) used to store medications

3. Emergency Department (ED) refrigerator storing medications was unsanitary

These failures had the potential to result in serous patient harm from ineffective drug treatment, contaminated treatment, and loss of control of the drug supply.

Findings:

1. During a concurrent observation and interview on 6/14/21, at 11:24 a.m., with Accreditation and Medication Safety Coordinator (AMSC) in the pharmacy, ASMC opened the storage area for patients' home medications brought to the hospital and stored by the pharmacy. The pharmacy log indicated that on 7/18/2020, one medication brought from home was deposited in the pharmacy medication storage area for Patient N204, and on 2/26/21, 14 medications brought from home were deposited in the pharmacy medication storage area for Patient N205.

During an interview on 6/17/21, at 10:16 a.m. with LN 10, LN 10 stated medications brought from home for patients are taken to pharmacy for verification. If the medications were not used or taken home upon patient discharge, it was pharmacy's responsibility to take care of the medications.

During a concurrent interview and record review on 6/17/21, at 12:13 p.m., with Pharmacy Manager (PM), the hospital's policy and procedure (P&P) titled, "Medication Management", dated 2/2018, was reviewed. The P&P indicated, "Medications brought to the Medical Center by the patient are sent home with patient/family whenever possible. If not possible, medications are placed in a patient valuables envelope and sent to the main pharmacy where they are stored in the narcotic room until the patient is discharged, or up to 3 months after patient is discharged. After 3 months, the medications are destroyed." PM acknowledged the pharmacy was not following the hospital policy.

2. During a concurrent observation and interview on 6/15/21, at 10:48 a.m. with Surgery and Cardiovascular Executive Director (SCED) and AMSC, in the OR anesthesia work room, 21 1-liter bags of Plasma-Lyte A Injection (solution to provide water and calories), 6 100-ml bags of normal saline (NS- hydration and electrolyte fluid), 1 500-ml bag of NS were observed in a corner of the anesthesia work room. SCED and AMSC stated they did not know if the temperature of the OR anesthesia work room was regulated.

During an interview on 6/17/21, at 12:17 p.m., PM acknowledged the temperature of the OR anesthesia work worm was not regulated by the hospital. PM stated, "You want medications to be at temperature they are supposed to be, it affects stability. It's not an area we are supposed to keep medications ..."

A review of the manufacturer's package inserts for Plasma-Lyte A Injection, and Sodium Chloride injections provided by the hospital, indicated, "exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25 C [centigrade- unit of measure])..."

During a review of the facility's P&P titled, "Medication Storage Area Inspections", dated 6/1/2019, the P&P indicated, "Ensure medications are stored in appropriate conditions."

3. During a concurrent observation and interview on 6/14/21, at 12:33 p.m., with Emergency Department Manager (EDM) and AMSC in the ED medication room, the refrigerator storing medications was observed to have brown substance throughout the inside of the refrigerator. EDM and AMSC acknowledged the inside of the refrigerator was not clean. EDM stated the refrigerator should be cleaned because of infection control issues.

During an interview on 6/17/21, at 12:12 p.m., PM acknowledged the refrigerator should have been clean. PM stated, "Based on unit inspection, fridge should be clean and neat, it is an infection control issue."

During a review of the facility's P&P titled, "Medication Storage Area Inspections", dated 6/1/2019, the P&P indicated, "Inspections include, but are not limited to: storage cabinets, refrigerators ..."

During a review of American Society of Hospital Pharmacy (ASHP- a nationally recognized organization that sets standards of practice for hospital pharmacies) Standard IV, Section "Medication Storage", dated 2013, the "Medication Storage" section indicated, "Medications shall be received, stored, and prepared under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security to ensure medication integrity and personnel safety."

Based on interview and record review, the hospital failed to

1. Implement an effective system for reconciliation of all controlled drug losses for all controlled drugs including samples for Patients N208, N209, and N210

2. Implement an effective controlled drug diversion system to identify and prevent possible drug diversion in the Anesthesiology Department as per hospital policy and procedure.

These hospital failures had the potential to result in hospital staff diverting controlled drugs, which could place patients at risk for potential adverse outcomes including inadequate pain and anxiety relief, as well as the potential for hospital staff to abuse controlled controls drugs.


Findings:

1. During a concurrent interview and record review, on 6/16/21, at 3:10 p.m., Accreditation and Medication Safety Coordinator (AMSC), Intensive Care Unit (ICU) Unreconciled Pyxis (automatic dispensing secure cabinet use to store medications outside of the pharmacy closer to point of patient need) Dispense Records, corresponding Medication Administration Records (MAR), and Pyxis Waste Documentation Records," were reviewed. The ICU Unreconciled Pyxis Dispense Records indicated:

On 12/14/2020 at 2:43 p.m., 1 vial of Hydromorphone (controlled medication for pain) 1 milligram (mg- unit of measure) per milliliter (ml- unit of measure) injection was dispensed by LN 11 for Patient N208. There was no documentation in the MAR, LN 11 administered the medication to Patient N208 or wasted the medication in the Pyxis Waste Documentation Records.

On 2/8/2021 at 9:34 p.m., 1 tablet of Alprazolam (controlled medication for anxiety) 0.5 mg was dispensed by LN 12 for Patient N209. There was no documentation in the MAR, LN 12 administered the medication to Patient N209 or wasted the medication in the Pyxis Waste Documentation Records.

AMSC stated ICU management filed an Unusual Occurrence Report (UOR) for each unreconciled discrepancy for LN 11 and LN 12; however, ICU management closed both discrepancies because LN 11 and LN 12 were both traveling nurses no longer employed by the hospital. AMSC stated ICU management did not notify pharmacy of the unresolved discrepancies, and pharmacy was unaware of the controlled drug losses.

During an interview on 6/17/21 at 9:44 a.m., with LN 14, LN 14 stated after a nurse dispensed a medication from Pyxis, the nurse is expected to scan the medication and the patient identification barcode; the administration of the medication is recorded electronically when administered to the patient. If the nurse did not administer the medication to the patient, the nurse is expected to return medication to Pyxis and document as not given or waste the medication with another nurse and document in Pyxis as waste.

During a concurrent interview and record review on 6/17/21 at 2:33 p.m., with AMSC, Pharmacy Manager (PM), and Critical Care Unit Manager (CCUM), Intensive Care Unit (ICU) Unreconciled Pyxis Dispense Records, corresponding Medication Administration Records (MAR), and Pyxis Waste Documentation Records," were reviewed. The ICU Unreconciled Pyxis Dispense Records indicated:
On 3/4/2021 at 8:22 a.m., 1 capsule of Chlordiazepoxide (controlled medication for anxiety) was dispensed by LN 13 for Patient N210. There was no documentation in the MAR, LN 13 administered the medication to Patient N210 or wasted the medication in the Pyxis Waste Documentation Records.
CCUM stated ICU management had asked LN 13 to correct the discrepancy before end of shift but the nurse did not correct the discrepancy, and LN 11 and LN 12 were traveling nurses no longer employed by the hospital. CCUM also stated, " ...I thought that documenting an unusual occurrence report, I was ok, now I know I need to notify pharmacy. For Chlordiazepoxide, I don't know where breakdown occurred and I was unaware that it wasn't reconciled." PM and AMSC acknowledged the system for reconciling controlled drug losses was ineffective. PM stated, "Discrepancies should be resolved timely so we can watch for diversion; the longer it stays out, the harder it is to resolve."

During a review of the hospital's policy and procedure (P&P) titled, "Medication, Controlled Substances", dated 6/2021, the P&P indicated, "Controlled Substances Discrepancy Report: In the event of controlled drug count discrepancy, a thorough investigation must first be performed to attempt to resolve the discrepancy ... When a discrepancy cannot be reconciled after an investigation is completed, a UOR is initiated ... UOR is routed to Pharmacy director/designee and Critical Care Unit Managers for timely review and resolution of UOR's."

2. During a review of the hospital's P&P titled, "Inpatient Controlled Substance Management", dated 9/2020, the P&P indicated, "Discrepancy Monitoring and Systematic Diversion Monitoring: Proactive Diversion Report (e.g. Rx Auditor [a report that prints out list of drugs and the names of persons who removed drug from Pyxis and categorizes drugs and users with number of dispenses over a period of time]).

During a concurrent interview and record review on 6/16/21, at 11:29 a.m., with AMSC, AMSC was unable to provide documentation for the proactive monitoring and identification of drug diversion for the Anesthesiology Department of the hospital. AMSC stated, "Yes, Anesthesiologists retrieve controlled medications from Pyxis but are not monitored for drug diversion. They are not evaluated on Rx Auditor, no monitoring for diversion prevention."

During an interview on 6/16/21, at 12:30 p.m. with PM, PM acknowledged the hospital had not implemented a controlled drug diversion system to identify and prevent possible drug diversion in the Anesthesiology Department as per the hospital's policy and procedure.

Based on observation, interview, and record review, the hospital failed to ensure all unusable or expired medications were segregated and not available for patient use in medication storage areas of the Pharmacy and Emergency Department (ED) stock room as evidenced by:

1. A 2.5-liter (unit of measure) bag of discontinued Total Parental Nutrition (TPN- IV solution to provide nutrients and calories) for Patient N206 in the pharmacy refrigerator was available for patient use

2. A 1-liter bag of Plasma-Lyte A Injection (solution to provide water and calories) for Patient N207 was observed in Operating Room (OR) Room 2

3. A 1-liter bag of Sodium Chloride Irrigation bag with partially torn overwrap in the OR fluid warmer available for patient use

4. A punctured multi-dose vial of Cyclophosphamide (medication for cancer treatment) in the infusion pharmacy refrigerator was expired but available for patient use

These failures had the potential to result in patient harm due to exposure to potentially sub-therapeutic (ineffective) medications.

Findings:

1. During a concurrent observation and interview on 6/14/21 at 11 a.m., with Accreditation and Medication Safety Coordinator (AMSC) in the hospital pharmacy, a bag TPN for Patient N206 with a beyond used date of 6/7/21, was observed in the pharmacy refrigerator. AMSC acknowledged the TPN was expired and should have been segregated and not available for patient use.

During an interview on 6/17/21 at 12:06 p.m., with Pharmacy Manager (PM), PM stated, "We shouldn't have expired medications on the shelf. We get stability of drugs and beyond use date [BUD- date after which medication cannot be used] on compounded drugs from manufacturer so you don't know stability of drug and you don't know its potency after manufacturer recommended date."

2. During a concurrent observation and interview on 6/15/21 at 10:34 a.m., with Surgery and Cardiovascular Executive Director (SCED) and AMSC in the hospital OR, a 1-liter bag of Plasma-Lyte A injection bag with a label for Patient N207 was observed in OR Room 2. SCED acknowledged the medication for Patient N207 was discontinued, and discontinued medications should be discarded appropriately and not left hanging in the OR room. AMSC stated nursing should discard discontinued medications immediately to prevent medication errors.

3. During a concurrent observation and interview on 6/15/21 at 11:10 a.m., with SCED and AMSC in the hospital OR, a 1-liter bag of Sodium Chloride irrigation bag with a partially torn overwrap was observed in the fluid warmer. SCED stated her expectation was for staff to remove bags from the fluid warmer if the overwrap was not intact. AMSC stated the BUD would be different since overwrap was torn and should have been removed.

During an interview on 6/17/21 at 12:11 p.m., with PM, PM stated, "If medication is out of overwrap, it shouldn't be used. Expiration date is different from date given when it's in overwrap."

A review of the manufacturer's stability information for 1-liter bag of Sodium Chloride irrigation bag with overwrap provided by the hospital indicated, "When products in VIAFLEX [special plastic] containers are stored as recommended and not removed from the overwrap, the volume of the solvent [liquid] and the concentration of the drug will remain within acceptable compendial [standard] limits through the labeled expiry of the product. Baxter [manufacturer] recommends removing products packaged in VIAFLEX plastic containers from the overwrap immediately prior to product use.

4. During a concurrent observation and interview on 6/16/21 at 9:10 a.m., with AMSC, in the infusion pharmacy, a punctured and expired single dose vial of Cyclophosphamide 500 milligram (mg-unit of measure) dated 6/8/21 was observed in the pharmacy refrigerator not segregated from other medications available for patient use. AMSC acknowledged the medication should have been removed and stated it could result in ineffective therapy if administered to a patient.

During a review of the hospital's policy and procedure (P&P) titled, "Medication Management", dated 2/2018, the P&P indicated, "Single Dose/Single use injectable Vials: If a single-dose/single-use vials opened in ISO Class 5 air quality (Pharmacy barrier isolator/hood) can be used up to six hours. Do not combine or pool leftover contents of single-dose /single-use vials. Do not store used single-dose/single-use vials for later use, no matter what the size of the vial."

According to American Society of Health-System Pharmacy (ASHP), a nationally recognized organization that sets standards of practice for hospital pharmacies, "All stocks of medications shall be inspected routinely to ensure the absence of outdated, unusable, recalled, or mislabeled products."

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. a. In newborn nursery unit temperature and humidity not monitored where sterile instrument trays were stored.
b. Surgical instruments were sterilized in the closed position.
c. No separation between dirty to clean pathway in sterile processing department.
d. Autoclave (a steam sterilizer machine that uses steam under pressure to kill harmful microorganisms during the sterilization of surgical instruments) preventative maintenance not performed according to manufactures instruction for use in the sterile processing department.
e. Endoscope (elongated thin instrument with attached camera to view the intestines) storage not adhering to the association of perioperative registered nurses (AORN) guidelines.
f. Manufactures instruction for use not followed for high-level disinfectant used in the processing of endoscopes.
g. Blood draw and IV (intravenous-in the vein) supplies and emergency water were expired.
h. A package of sterile forceps had a tear in the packaging. (Cross Reference A-0749).

3. a. A surgical mask was worn on top of an N95 mask (a safety device that filters out hazardous substances in the air) and was not doffed between patients.
b. IV (intra venous - within the vein) pumps were placed outside patient's rooms in the intensive care unit.
c. Hand hygiene not performed by nursing staff.
d. Sinks were not disinfected.
e. Two oral airways were found uncovered/unwrapped inside a difficult intubation cart in the intensive care unit.
f. No surveillance monitoring for improper use of personal protective equipment during the Covid-19 Pandemic. (Cross reference A-0750).

4. a. The governing body failed to have oversight over the infection prevention and control program to prevent the transmission of communicable diseases. (Cross reference A-0770).

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 preventionist 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.

During a concurrent interview, and record review, on 6/16/21, at 3:24 p.m., with risk management director (RMD), RMD acknowledged the governing body had not appointed the current infection prevention manger (IPM) based off the recommendations of medical staff and nursing leadership. IPM further verbalized the governing body would address the issue soon and that the hospital was aware of the deficient practice. IPM confirmed no documentation could be provided indicating the governing body had appointed IPM based on medical staff leadership and nursing leadership recommendations.

Based on observation, interview, and record review, the hospital staff failed to follow hospital policy and procedures and standards of practice when:

1. Temperature and humidity were not monitored in the newborn nursery where sterile instrument trays were stored.

2. Instruments were sterilized in the closed position.

3. No separation between dirty to clean pathway in sterile processing department (SPD).

4. Preventative maintenance for chamber cleaning not performed according to Manufacturers instruction for use on the Autoclaves (a steam sterilizer machine that uses steam under pressure to kill harmful microorganisms during the sterilization of surgical instruments) in SPD.

5. AORN (Association of perioperative Registered Nurses) guidelines were not followed in the storage of endoscopes (elongated thin instrument with attached camera to view the intestines).

6. Manufacturer instruction for use not followed for the high-level disinfectant (HDL) used in the processing of endoscopes.

7. Blood draw and IV (intravenous-in the vein) supplies and emergency water were expired.

8. A package of sterile forceps had a tear in the packaging.

These failures had the potential to result in negative patient care outcomes, cross contamination of equipment, the potential to spread harmful microorganisms to patients and staff, with the potential to result in procedural and surgical site infections.

Findings:

1. According to the Association of perioperative Registered Nurses (AORN) guidelines for Perioperative Practice titled: "Design and Maintenance (2012-2019)" indicated in part ... "The health care organization should create and implement a systematic process for monitoring and maintaining structural surfaces and HVAC (Heating, ventilation and air conditioning-HVAC the technology of indoor and vehicular environmental comfort. Its goal is to provide thermal comfort and acceptable indoor air quality) performance ...heating, ventilation, and air conditioning systems, control room air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas ... the HVAC system reduces the amount of environmental contaminants ... the healthcare organization should develop a method for reporting a variance on HVAC system parameters ...personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the healthcare organization's policy and procedures ..."

During a concurrent observation, and interview, on 6/14/21, at 3:35 p.m., with the manager of the mother/baby unit (MOMB), in the newborn nursery procedure room, it was observed that sterile instrument trays were stored in the room. MOMB verbalized circumcisions (the surgical removal of foreskin from a baby's penis) are done in this room. When asked if temperature and humidity were being monitored in this room, MOMB could not locate the thermostat and stated, "There used to be a thermostat in here." MOMB acknowledged temperature and humidity were not being monitored in the room and should be.

During an interview on 6/16/21, at 3:50 p.m., with the director of facilities (DOF), DOF acknowledged sterile circumcision instrument trays were stored in the newborn nursery and acknowledged temperature and humidity were not being monitored. DOF verbalized the temperature and humidity should be monitored in the nursery.

During a review of the facility's policy and procedure titled, "Temperature Humidity and Air Relationships," dated 12/20, indicated in part ... "The objective of the policy is to provide a safe and reliable environment appropriate for anesthetizing locations, sterile processing, sterile storage and clean work areas by maintaining temperature, humidity, and air pressure relationships ...in sterile storage, clean work rooms including processing-processing personnel in each work area are responsible for monitoring and recording the temperature and humidity to ensure that the correct requirements are achieved ...sterile storage relative humidity range %-max 60%...temperature range 72-78° F."

According to AORN guidelines for guidelines for Perioperative Practice titled: "Conditions for Storage of Sterile Supplies (2012-2021)" indicated in part ..."Sterile items should be contained in a US Food and Drug Administration-approved sterile barrier system and stored under environmentally controlled conditions, which include a maximum temperature 75°F, a maximum relative humidity of 60%, positive air pressure in relation to adjacent area and a minimum of our air exchanges per hour."

2. According to the CDC (centers for disease control and prevention) guidelines titled " Disinfection and Sterilization in Healthcare Facilities" updated 2019, indicated ..."once items are cleaned dried and inspected those requiring sterilization must be wrapped or placed in rigid containers and should be arranged instrument tray/baskets" ..."hinged instruments should be opened" ..." the packaging must allow for the penetration of the sterilant."

During a concurrent observation, and interview, on 6/15/21, at 10:00 a.m., with the manager of surgical services (MOSS), in the sterile storage instrumentation room, a sterilized minor instrument tray (basic set of instruments of a minor surgery) was opened. MOSS acknowledged four towel clamps were sterilized in the closed position. MOSS confirmed these items should be reprocessed in the open position.

According to AORN guidelines for guidelines for Perioperative Practice titled: "Selection and Use of Packaging Systems for Sterilization" (2013) indicated in part ..."Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces ...items to be sterilized should be placed in the package or tray in an open or unlocked position ...the open or unlocked position facilitates sterilant contact of all surfaces of the item ...racks or stringers designed and intended for sterilization can be used to maintain instruments in their open position."

During a review of the facility's policy and procedure titled "Instrument Cleaning and Processing," dated 8/18, indicated in part ... "The patient's safety is maintained by proper cleaning and processing of the surgical instruments ...all instruments with box locks including scissors are opened and strung ...instruments that come apart should be loosened and/or taken apart."

3. According to the Association of perioperative Registered Nurses (AORN) guidelines for Perioperative Practice titled: "Sterilization" (2012-2021)" indicated in part ... "Area for sterilization Processes ...establish traffic patterns that define requirements for access, movement of personnel, and attire ...control of traffic patterns is intended to protect personnel, equipment supplies, and instrumentation from sources of potential contamination ...establish functional workflow patterns to create and maintain physical separation between decontamination and sterilization areas ...establish functional workflow patterns from areas with high contamination potential to clean areas in the following order:

1. cleaning and decontamination area,
2. preparation and packing,
3. sterilization processing, and
4. sterile storage or the point of use ...

...a workflow pattern that begins in the decontamination area and flows to the storage area or the point of use can help prevent clean or sterile items from reentering a contaminated area where they may become recontaminated."

During a concurrent observation, and interview, on 6/15/21, at 11:15 a.m., with the manager of the sterile processing department (MSPD) and MOSS, the path of travel for surgical instruments from the decontamination room to the clean room (room where surgical instruments are prepped and packaged for sterilization) was observed. After the surgical instruments are cleaned (not disinfected or sterilized), they are pushed on a cart from the decontamination area (dirty), through a sterile storage room passing by sterilized instruments drying on a rack, through another door into the clean room, where the instruments are to be sterilized. Both the MSPD and the MOSS acknowledged the separation between the dirty/clean instruments and sterilized instruments is not ideal along this path of travel. MSPD and MOSS acknowledged AORN guidelines and acknowledged there is potential for cross-contamination between dirty/clean instruments and sterilized instruments.

4. During a concurrent observation, and interview, on 6/15/21, at 11:20 a.m., with the MSPD, the Autoclaves in SPD were observed. Autoclave #1 preventative maintenance sticker for chamber cleaning had been performed on 9/19 and the next cleaning was due 3/20. Autoclave #2 preventative maintenance sticker for chamber cleaning had been performed been performed on 9/19 and the next cleaning was due 3/20. Autoclave #5 preventative maintenance sticker for chamber cleaning had been performed on 9/19 and the next cleaning was due 3/20. When asked if 9/19 was the last chamber cleaning, MSPD was unsure. MSPD verbalized the Instrument Management Service (IMS) stopped coming to the facility for Autoclave maintenance.

During a concurrent observation, and interview, on 6/16/21, at 9:15 a.m., with the infection preventionist (IPM), the director of risk management (RMD), and the MSPD, the routine checklist posted next to Autoclave #1 was reviewed. The routine checklist indicated in part ... to clean the chamber as needed ...turn off the sterilizer power, water, steam supply, following manufacturer instructions in the sterilizers operating manual ...following instructions for chamber cleaning provided in the AMSCO Steam Sterilizer Cleaning Procedure ...professional chamber cleaning is recommended annually or as required to maintain original chamber appearance. MSPD verbalized could not find documentation of when the last chamber cleaning occurred since 9/19. The IPM and RMD acknowledged not following preventative maintenance (PM's) for the chamber cleaning per manufacturer instructions.

During an interview on 6/16/21, at 3:20 p.m., with RMD, RMD verbalized the biomedical contract for the autoclaves had changed and IMS did not come to the facility anymore. RMD verbalized the last chamber cleaning was done on 3/19. RMD acknowledged it had been two years since the last chamber cleaning and is overdue.

During a review of the Steris Operating Manual dated 7/16/07, indicated in part ..."Preventative maintenance schedule: regularly scheduled preventative maintenance is required for safe and reliable operation of this equipment ...maintenance procedures in sections 7 and 9 must be performed regularly at the indicated intervals using the maintenance schedule in table 7-1 as a guide ...customers should maintain a record of all maintenance procedures performed on the sterilizer ...section 7-1.2: clean chamber ...the entire chamber should be wiped down and rinsed following any spills or other soiling ...professional cleaning of the chamber on a yearly basis."

5. According to AORN guidelines for guidelines for Perioperative Practice titled: "Flexible Endoscopes" (2012-2021), indicated in part ... "Store flexible endoscopes in a drying cabinet ...optimal storage of flexible endoscopes facilitates drying, decreases the potential for contamination, and provides protection from environmental contaminants ...drying cabinets include a drying system that circulates hepa-filtered air through the cabinet while filtered air under pressure is forced though the endoscope channels ...the internal and external surfaces of the endoscope are continuously dried, suppressing bacterial growth ...if a drying cabinet is not available, store flexible endoscopes in a closed cabinet with heap-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes ...ventilation promotes continued drying of the endoscope ... using hepa-filtered air may help prevent bacterial growth in the endoscope ...positive pressure may help prevent contamination of the stored endoscopes."

During a concurrent observation, and interview, on 6/15/21, at 11:55 a.m., with the gastrointestinal (GI) lab manager (GILM), the endoscope storage cabinet was observed. Inside the cabinet, nine endoscopes were hanging vertically. The storage cabinet did not have a hepa-filter or any air-flow filtration system thru the cabinet. The GILM acknowledged the storage cabinet was incorrect and acknowledged AORN guidelines. The GILM further verbalized the facility was aware they were using the incorrect cabinet and have been waiting on new storage cabinets.

During an interview on 6/15/21, at 4:20 p.m., with the IPM, IPM acknowledged the endoscope storage cabinet was incorrect and needed updating. The IPM acknowledged the cabinet did not have an air-filter and/or positive pressure airflow. The IPM verbalized the facility is aware of the incorrect storage cabinet.

6. During a concurrent observation, and interview, on 6/15/21, at 12:30 p.m., with GI licensed nurse (LN 7), the medivators (an automated endoscope reprocessor machine that kills microorganisms by cleaning and disinfecting) were observed. LN 7 verbalized the high-level disinfectant (HDL) used in the medivator was Rapicide. The medivator cabinet was opened and the container of Rapicide connected to the medivator was observed. The container was opened and undated. When asked how long the Rapicide was good for after opening, LN 7 verbalized three weeks. When asked if the container was open and undated, how do you know when the Rapicide was last changed last, LN 7 verbalized she did not know. LN 7 verbalized they use the Rapicide faster than three weeks. When asked if there was a logbook that documents when the Rapicide was last changed out, LN 7 verbalized no.

During an interview on 6/15/21, at 12:32 p.m., with the GILM, the manufacturer instructions for use label on the Rapicide container was reviewed. The instructions indicated the product may be used for 21 days after the containers are opened and do not use after that time has expired. GILM acknowledged the Rapicide container should be dated when opened and changed out after 21 days.




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8. During an observation of the Respiratory Therapy Difficulty Intubation cart and concurrent interview with the respiratory therapy manager (RTM) on 6/16/21 at 12:20 p.m., inside one of the cart's drawer a sterile forceps (pair of pincers or tweezers used in surgery) instrument package was observed with a tear on the top side of the package. The RTM acknowledged the observation and stated, "I agree, the package's integrity is not there, it has a tear."

The facility's policy and procedure entitled "Sterile Supplies (Event Related Outdating System), dated 12/18, indicated "All items sterilized ... will be considered sterile unless the package integrity has been damaged." In part B, indicated "Events that may damage package integrity include, but not limited to, holes or tears, excessive wrinkling, brittleness discoloration ...or open that is not tightly sealed."




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7. Review of the facility policy titled, "Expired Product - Procedure", revised 11/2016, indicated in part ... "Product found on or past the manufacturer expiration date must be removed from department/patient access areas, PAR areas and discontinued from immediate use."

During an observation and concurrent interview, on 6/14/21, at 1153 am, with critical care unit manager (CCUM), CCUM confirmed multiple blood draw test tubes and blood culture bottles had expired and were found in ICU cabinet ready for patient use. CCUM verbalized expired supplies should be discarded.

During an observation and concurrent interview, on 6/14/21, at 1233 pm, with CCUM, CCUM confirmed 4 cases of drinking water in the ICU disaster storage room had expired and were ready for patient use. CCUM verbalized expired supplies should be discarded.

During an observation and concurrent interview, on 6/15/21, at 1016 am, with emergency department manager (EDM), EDM confirmed multiple blood draw supplies had expired and were found in ED clean supply room ready for patient use. EDM verbalized expired supplies should be discarded.

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

1. A surgical mask was worn on top of an N95 (a filtering face piece used to provide respiratory protection) and N95 was not doffed between patients.

2. IV pumps were placed outside patient's rooms.

3. Hand hygiene was not performed.

4. Sinks were not disinfected.

5. Two oral airways were found uncovered/unwrapped inside a Difficult Intubation Cart.

6. When the Infection Prevention Department identified, " Improper Use of PPE (personal protective equipment)," as a hospital prioritized risk and it's 2020 goal to reduce, but failed to identify surveillance monitoring and review of performance indicators, despite being significantly impacted by increased Covid-19 hospitalized patients..

7. Intravenous (IV) bags not labeled for patients in the medical/surgical (Med/Surg) unit (Patients N505, N517, N518 & N519)

8 IV catheter site does not have a date for 3 patients in the Med/Surg unit (Patients N520, N521 & N522)

9. Ensure intravenous (IV- into the vein) tubing connected to three IV fluid bags were labeled with changed date, in accordance with hospital policy and procedure

10. A 1 liter (unit of measure) bag of Plasma-Lyte A Injection (solution to provide water and calories) was labeled with a patient identifier and expiration date, in accordance with hospital policy and procedure

These facility failures in practices and processes had the potential to result in cross-contamination (the transfer of harmful bacteria) that could impact patients' health and safety and cause preventable HAIs (Healthcare Associated Infections) for patients in an already compromised condition.
Findings:


1. According to the CDC guidelines, "Considerations for Covering N95s to Extend Use", updated 12/2/2020, indicated in part ... "When protection against surface contamination is needed, CDC recommends wearing a cleanable face shield over an N95 ... wearing a surgical mask or cloth covering over an FFR, such as an N95, is not approved or recommended by NIOSH because it is not consistent with the conditions of the approval, therefore voiding the certification."

Review of the facility policy titled, "Respiratory Protection: PAPR and N95", revised 1/2018, indicated in part ... "N95 respirators are designed for one time use."

During an observation and concurrent interview, on 6/14/21, at 10:52 a.m., with licensed nurse (LN 3), asked LN 3 the practice used for N95's with surgical mask. LN 3 stated, "I use the N95 all day and change the surgical mask on top between patients."

During an observation and concurrent interview, on 6/14/21, at 10:54 a.m., with clinical educator (CE 2), CE 2 confirmed LN 3 should not have a surgical mask on top of N95 and N95 should be discarded between patients.


2. Review of the hospital document titled, "IV Tubing Extensions for Distance IV Pump Placement", dated 4/6/2020, indicated in part ... "Potential Safety Issues ... extravasation and infiltration are relatively common, and significant, complications of Peripheral IV Therapy. They cannot be adequately assessed from a significant distance. Additional tubing adds to these potential safety risks: Tubing on the floor increases risk of infection, multiple luer connections increase the risk of ... infection ... delayed response to indications of complications including ... numbness, redness, tenderness, change of temperature or color at the infusion site or associated extremity ... Recommendation - The ID-CDT and the (Name of hospital) Nursing Institute strongly recommend following the guidelines of the ISMP, the INS, and B-D. Taken together, the process of attaching extension sets in order to place an IV infusion pump outside of the patients' room should be avoided."

Review of the hospital document titled, "2020 - 2021 CLABSI Prevention", undated, indicated in part ... "What: Get the Lines off the Floor/Getting the IV pumps back in the room/Shortening IV tubing; WHO: (name of Infection Prevention Manager) ... FOLLOW UP ... IV pumps went back into the rooms on 2/17/21 and the IV tubing is being shortened and will no longer touch the floor."

Review of the hospital document titled, "HUDDLE WEEK OF FEBRUARY 15TH, 2021", undated, indicated in part ... "IV Pumps in COVID units: Please start to phase moving IV pumps back into the rooms ... we ... have had ... tubing ripping, tubing occlusions, and of course many CLABSIs."

During an interview, on 6/14/21, at 3:50 p.m., with licensed nurse (LN 1), LN 1 verbalized we put the IV pumps outside the patient's rooms in the ICU, the ICU started getting more CLABSIs (a bloodstream infection that develops in a patient with a central line [an IV line that is inserted into a large vein in the neck or near the heart to administer fluids or medications] that is not related to infection at another site) and they thought it might be due to the tubing extensions. Additionally LN 1 verbalized that the staff tried to lay tubing across chairs and tape it but it would fall and be laying on the floor. LN 1 acknowledged these practices were not the normal practice for us but we did it.

During an interview, on 6/15/21, at 8:50 a.m., with LN 4, LN 4 verbalized we put the IV pumps outside the patient's rooms in the ICU, a lot of the staff were afraid to go into the patient's rooms. Additionally LN 4 verbalized that the staff tried to keep the tubing off the floor but we couldn't. LN 4 stated, that she wasn't sure who initial told them to move IV pumps outside patient's rooms, she remembers the practice started shortly after COVID began and was in place until 1/2021. LN 4 confirmed they were told to stop placing the IV pumps outside patient rooms because the practice was not recommended.

During an interview, on 6/15/21, at 9:25 a.m., with critical care unit manager (CCUM), CCUM confirmed we put the IV pumps outside the patient's rooms in the ICU. Additionally CCUM verbalized that she wasn't sure who initial told them to move IV pumps outside patient's rooms, she remembers the practice started when COVID began and was in place until February or March of 2021. CCUM stated they put the IV pumps back into the patient rooms because CLABSI spiked in 1/2021.

During an interview, on 6/16/21, at 10:10 a.m., with infection prevention manager (IPM), IPM verbalized that there was a change in practice in the ICU, that they were doing some stuff IPM didn't agree with, IV poles outside the room and the tubing was touching the floor. Additionally IPM stated that these were not normally accepted practices that were implemented and that our practices contributed to the increase in CLABSIs in the ICU.

3. Review of the facility policy titled, "Hand Hygiene Policy", revised 9/2019, indicated in part ... "Purpose: To provide evidence-based guidelines for effective and safe hand hygiene in the healthcare setting ... Indications for Hand Hygiene: Hand hygiene will be performed before and after the following activities: Before putting on gloves ... After taking off gloves."

During an observation, on 6/15/21, at 10:32 a.m., with technician (Tech), Tech did not perform hand hygiene before putting on gloves and assisting Patient (N601) out of triage area.

During an observation, on 6/15/21, at 11:25 a.m., with licensed nurse (LN 5), LN 5 did not perform hand hygiene after removing gloves and putting on new gloves while assisting Patient (N602).

During an interview, on 6/15/21, at 11:25 a.m., with emergency department manager (EDM), EDM confirmed Tech and LN 5 did not perform hand hygiene.

4. Review of the facility policy titled, "Environmental Department Procedure", dated 9/9/2003, indicated in part ... "Purpose: To provide a standard routing for cleaning; to ensure correct and effective cleaning techniques while maintaining infection control in designated area ... Wash down sink with germicidal cleaner and wipe dry ... after use of acid, general cleaner or abrasive, rinse sink with germicidal cleaner."

Review of the facility policy titled, "Environmental Department Chemical List/Use Chart", undated, indicated in part ... "Product Type: Cream Cleanser; Product Name: Emeral."


During an observation and concurrent interview, on 6/15/21, at 12:02 p.m., with environmental service tech (EVS 1), asked EVS 1 process and products used for cleaning, EVS 1 stated, "I only use Emeral to clean sinks." Confirmed with EVS 1 that another product is not used after Emeral to disinfect the sinks and EVS 1 stated, "No".

During an observation and concurrent interview, on 6/15/21, at 12:45 p.m., with EVS 2, asked EVS 2 process and products used for cleaning, EVS 2 stated, "I use Emeral by itself to clean sinks." Confirmed with EVS 2 this is only a cleaner and sinks should be cleaned then disinfected.

During an interview, on 6/15/21, at 12:55 p.m., with EVS 3, EVS 3 confirmed staff are using Emeral to clean sinks, EVS 3 was not aware that product was not a cleaner/disinfectant. EVS 3 acknowledged that a disinfectant should be used after Emeral.




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5. During an observation of the Respiratory Therapy Difficulty Intubation cart and concurrent interview with the respiratory therapy manager (RTM) on 6/15/21 at 10:30 a.m., inside one of the cart's drawer two (2) oral airways (a medical device used to maintain or open the patient's airway by preventing the tongue from covering the epiglottis) were observed uncovered/unpackaged or free flowing inside the cart's drawer. The RTM acknowledged the observation and agreed the airways should be packaged individually to prevent cross-contamination and for infection control concerns. RTM stated "I agree the airways must be covered or inside a package ..."


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6. During a concurrent document review and interview on 6/16/21, starting at 10:03 a.m., with Infection Prevention Manager (IPM), review of hospital document titled, "(Name of hospital) Department of Infection Prevention & Epidemiology 2021 Plan and Goals." Document indicated in part ... pg. 8 of 10 ...
"Risk Assessment Process: The infection Control Risk assessment tool is used to define areas of risk based on geographic location, population, care, treatment services, surveillance activities, environment of care. New risks or priorities are identified through surveillance monitoring and review of performance improvement indicators. The risk score is used to identify highest areas of opportunity for department focus in the following year. The relative risk score of 40% or above indicates the need for improvement focused activities to improve patient outcomes, reduce the rate of infection as reported, and ultimately improve the year end risk score ...."
Further review of document revealed that," Improper Use of PPE (personal protective equipment) was listed as scoring 44%, the second highest hospital prioritized risk and a 2020 goal to reduce. On the same document indicated for year end and 2021 review, "2020 data" section, "PPE compliance data unavailable for 2020. Based on rounding observations, PPE was both over and underutilized during COVID-19 pandemic."

IPM manager was asked what the number one IP concern the hospital risked in year 2020, IPM stated, "Corvid." When asked where the performance metrics for this 2020 goal for PPE was, IPM stated , " I don't know, I have only been here (employed) since December 2020, I don't know if the last person who managed the IP department had the PPE data, when I got here we saw we didn't have the information or tools in place (to measure)." IPM further described that IC reports to the Medical Staff Committee and QA committee. Further review of "Infection Control Committee" minutes for 6/17/20 and 12/14/20 did not reveal any updates or adjustments on this prioritized 2020 goal .





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7. During observation and concurrent interview in the Med/Surg unit on 6/16/21 at 9:52 a.m., patient N511 was observed to be receiving IV fluids. The IV bag on the IV pump does not have a date. The Med/Surg manager(MSB) acknowledged IV bag not having a date.

During observation and concurrent interview in the Med/Surg unit on 6/16/21 at 10:15 a.m., patient N505 was observed to be receiving IV fluids. The IV bag on the IV pump does not have a date. The (MSB) acknowledged IV bag not having a date.

During observation and concurrent interview in the Med/Surg unit on 6/16/21 at 11:40 a.m., patient N512 was observed to be receiving IV fluids. The IV bag on the IV pump does not have a date. The Ortho/Vascular manager (MOV) acknowledged IV bag not having a date.
During observation and concurrent interview in the Med/Surg unit on 6/16/21 at 11:52 a.m., patient N513 was observed to be receiving IV fluids. The IV bag on the IV pump does not have a date. The MOV acknowledged IV bag not having a date.

The facility policy and procedures titled "Lippincott Procedures - IV bag preparation" dated May 15, 2020 indicated "label IV bag with the patient's name and identification number, and date and time, the bag number(if applicable) the order rate and duration and your initials.

8. During observation and concurrent interview in the Oncology unit on 6/16/21 at 11:14 a.m., patient N514's IV insertion site was observed not dated. The Charge Nurse (LN16) acknowledged IV insertion site not having a date.

During observation and concurrent interview in the Oncology unit on 6/16/21 at 11:18 a.m., patient N515's IV insertion site was observed not dated. LN16 acknowledged IV insertion site no

During observation and concurrent interview in the Oncology unit on 6/16/21 at 11:35 a.m., patient N516's IV insertion site was observed not dated. The Oncology Manager (MONC) acknowledged IV insertion site not having a date.

The facility policy and procedure titled "Comprehensive Access Management (IV Therapy)" dated 07/2020 indicated in part "IV sites are maintained as clinically indicated, until IV therapy is completed or unless signs of complication arise ... The dressing will be labeled, including the date of insertion."


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9. During a concurrent observation and interview on 6/15/21 at 8:57 a.m., with Licensed Nurse (LN) 8, in Unit 5NE, during medication pass (nurse distributes medication to patients), an undated IV tubing connected to a 50-milliliter (ml- unit of measure) bag of Cefazolin (antibiotic to treat infection) 1 gram (unit of measure) was identified hanging in Patient N202's room as the medication was being administered. LN 8 acknowledged the IV tubing was undated and stated the IV tubing should have been dated when it was hung.

During a concurrent observation and interview on 6/15/21 at 9:19 a.m., with LN 9 in Unit 5NE during medication pass, an undated IV tubing connected to a 50-ml bag of Cefazolin 1 gram and 1-liter bag of Plasma-Lyte A Injection were observed hanging at bedside in Patient N203's room. LN 9 acknowledged the IV tubing for the medications were undated and stated the tubing should have been dated at the time the medications were hung so nursing would know when to change the tubing.

During an interview on 6/15/21, at 10:10 a.m. with Lead Licensed Nurse (LLN) 1, LLN 1 stated all IV tubing should be dated at the time they are hung so nursing would know when to replace the IV tubing. LLN 1 stated if nurses did not change an IV tubing timely, there would be a concern for infection.

During an interview on 6/17/21, at 10:12 a.m., with LN 10, LN 10 stated, "all tubing should be dated as soon as its put up, policy for 72 hours, Propofol [medication for sedation] is different, its 12 hours."

10. During a concurrent observation and interview on 6/15/21 at 9:19 a.m., with LN 9 in Unit 5NE during medication pass, a 1 liter bag of Plasma-Lyte A Injection were observed hanging at Patient N203's bedside without a label identifying the patient, or date of when the bag was hung. LN 9 acknowledged the IV medication should have been labeled with a patient identifier, date and time.

During an interview on 6/15/21, at 10:10 a.m., with LLN 1, LLN 1 stated, " ...item [IV medication bag] should be patient labeled. I am not sure why there was not a sticker. Will remind nurse to put sticker and confirm that it belongs to patient." LLN 1 acknowledged if nurses did not know how long an IV medication hanging was being administered to a patient, it could affect the effectiveness of the medication as well be a concern for infection control.

During an interview on 6/17/21, at 10:14 a.m., with LN 10, LN 10 stated, "expectation is to put a patient label on it [IV medication bag], time and date on it ... we move patient around from room to room so good idea not to give patient wrong medication .... If you leave it [IV medication bag] too long, more likely things can grow and drug can expire ..."

During an interview on 6/17/21, at 10:32 a.m., with Critical Care Unit Manager (CCUM), CCUM stated, "we have policy on IV tubing and we have appropriate stickers so when nurse grabs tubing, they grab sticker at the same time; important to change tubing so it doesn't compromise inside of tubing, its infection prevention and per manufacturer recommendation."

During a review of the facility's P&P titled, "Medication Management", dated 2/2018, the P&P indicated, "all medications are correctly labeled with the following: b. expiration date when not used within 24 hours c. expiration time when expiration occurs in less than 24 hours"

Based on observation, record review and interview, the hospital failed to ensure the governing body monitored the implementation of infection control activities to prevent the transmission of communicable diseases.

This deficient practice had the potential for the spread of hospital acquired infections among patients and staff members.

Findings:

1. During a concurrent document review and interview on 6/16/21, starting at 10:03 a.m., with Infection Prevention Manager (IPM), review of hospital document titled, "(Name of hospital) Department of Infection Prevention & Epidemiology 2021 Plan and Goals." Document indicated in part ... pg. 8 of 10 ...
"Risk Assessment Process: The infection Control Risk assessment tool is used to define areas of risk based on geographic location, population, care, treatment services, surveillance activities, environment of care. New risks or priorities are identified through surveillance monitoring and review of performance improvement indicators. The risk score is used to identify highest areas of opportunity for department focus in the following year. The relative risk score of 40% or above indicates the need for improvement focused activities to improve patient outcomes, reduce the rate of infection as reported, and ultimately improve the year end risk score ...."
Further review of document revealed that," Improper Use of PPE (personal protective equipment) was listed as scoring 44%, the second highest hospital prioritized risk and a 2020 goal to reduce. On the same document indicated "2020 data" section, "PPE compliance data unavailable for 2020. Based on rounding observations, PPE was both over and underutilized during COVID-19 pandemic."

IPM manager was asked what the number one IP concern the hospital risked in year 2020, IPM stated, "Corvid." When asked where the performance metrics for this 2020 goal for PPE was , IPM stated , " I don't know, I have only been here (employed) since December 2020, I don't know if the last person who managed the IP department had the PPE data, when I got here we saw we didn't have the information or tools in place (to measure)." IPM further described that Infection Control and prevention within the organization reports to the Medical Staff Committee and QA committee. Further review of "Infection Control Committee" minutes for 6/17/20 and 12/14/20 did not reveal any updates, explanations or adjustments on this hospital identified prioritized 2020 goal .

2. Review of the hospital document titled, "IV Tubing Extensions for Distance IV Pump Placement", dated 4/6/2020, indicated in part ... "Potential Safety Issues ... extravasation and infiltration are relatively common, and significant, complications of Peripheral IV Therapy. They cannot be adequately assessed from a significant distance. Additional tubing adds to these potential safety risks: Tubing on the floor increases risk of infection, multiple luer connections increase the risk of ... infection ... delayed response to indications of complications including ... numbness, redness, tenderness, change of temperature or color at the infusion site or associated extremity ... Recommendation - The ID-CDT and the (Name of hospital) Nursing Institute strongly recommend following the guidelines of the ISMP, the INS, and B-D. Taken together, the process of attaching extension sets in order to place an IV infusion pump outside of the patients' room should be avoided."

Review of the hospital document titled, "2020 - 2021 CLABSI Prevention", undated, indicated in part ... "What: Get the Lines off the Floor/Getting the IV pumps back in the room/Shortening IV tubing; WHO: (name of Infection Prevention Manager) ... FOLLOW UP ... IV pumps went back into the rooms on 2/17/21 and the IV tubing is being shortened and will no longer touch the floor."

Review of the hospital document titled, "HUDDLE WEEK OF FEBRUARY 15TH, 2021", undated, indicated in part ... "IV Pumps in COVID units: Please start to phase moving IV pumps back into the rooms ... we ... have had ... tubing ripping, tubing occlusions, and of course many CLABSIs."

During an interview, on 6/14/21, at 3:50 p.m., with licensed nurse (LN 1), LN 1 verbalized we put the IV pumps outside the patient's rooms in the ICU, the ICU started getting more CLABSIs (a bloodstream infection that develops in a patient with a central line [an IV line that is inserted into a large vein in the neck or near the heart to administer fluids or medications] that is not related to infection at another site) and they thought it might be due to the tubing extensions. Additionally LN 1 verbalized that the staff tried to lay tubing across chairs and tape it but it would fall and be laying on the floor. LN 1 acknowledged these practices were not the normal practice for us but we did it.

During an interview, on 6/15/21, at 8:50 a.m., with LN 4, LN 4 verbalized we put the IV pumps outside the patient's rooms in the ICU, a lot of the staff were afraid to go into the patient's rooms. Additionally LN 4 verbalized that the staff tried to keep the tubing off the floor but we couldn't. LN 4 stated, that she wasn't sure who initial told them to move IV pumps outside patient's rooms, she remembers the practice started shortly after COVID began and was in place until 1/2021. LN 4 confirmed they were told to stop placing the IV pumps outside patient rooms because the practice was not recommended.

During an interview, on 6/15/21, at 9:25 a.m., with critical care unit manager (CCUM), CCUM confirmed we put the IV pumps outside the patient's rooms in the ICU. Additionally CCUM verbalized that she wasn't sure who initial told them to move IV pumps outside patient's rooms, she remembers the practice started when COVID began and was in place until February or March of 2021. CCUM stated they put the IV pumps back into the patient rooms because CLABSI spiked in 1/2021.

During an interview, on 6/16/21, at 10:10 a.m., with infection prevention manager (IPM), IPM verbalized that there was a change in practice in the ICU, that they were doing some stuff IPM didn't agree with, IV poles outside the room and the tubing was touching the floor. Additionally IPM stated that these were not normally accepted practices that were implemented and that our practices contributed to the increase in CLABSIs in the ICU.

Based on record review and interview the hospital failed to produce a medical staff adopted policy for referrals to outpatient services from practitioners who do not hold hospital privileges. The hospital was unable verify that Patient 201's referring practitioner (MD1) was appropriately licensed and is practicing within scope of law to prescribe orders.

Findings:

During a concurrent record review and interview on 6/16/21, starting at 4:00 p.m., with out-patient manager (OPM1), in hospital licensed physical therapy out-patient center, OPM1 indicated she had been employed at out-patient center for approximately 10 years. Clinical record review of Patient 201, record revealed referring MD 1, on 4/6/21, made a referral for "Physical Therapy Evaluation vs continue and treat therapeutic exercise twice a week for 6 weeks." OPM1 explained process for post evaluation, in that the PT (physical therapist) providing the services sends a progress note to referring doctor and if appropriate doctor may request further treatment. OPM1 was not aware if MD 5 was credentialed by medical staff, or if MD1 license has been verified.

During interview on 6/17/21, starting at 11:00 a.m., with Risk Management Director (RMD), acknowledged that the governing body had not approved MD1 to order the applicable outpatient services.

Based on hospital document review and interview, the hospital failed to integrate its outpatient services into the hospital wide QAPI program. This failure has the potential of not ensuring that the outpatient services, equipment, staff and facilities are adequate to provide the outpatient services offered at each location in accordance with acceptable standards of care.

Findings:


During a concurrent observation and interview on 6/16/21, starting at 4:00 p.m., with out-patient manager (OPM1), in hospital licensed physical therapy out-patient center, OPM1 indicated she had been employed at out-patient center for approximately 10 years. OPM1 acknowledged that the out-patient program is not integrated into the hospital wide QAPI (quality assurance performance improvement) program, OPM1 stated, "We do with the physical therapy program in the in-patient services but not in the out-patient services."

During a interview with the QAPI Manager on 6/16/21, starting at 4:47 p.m., QAPI manager confirmed out-patient services are not integrated into the hospitals QAPI program, QAPI manager stated, "They (out-patient services ) are not going into the hospital QAPI Program ."