HospitalInspections.org

Based on observation, staff interview, clinical record review, and review of facility documents, the facility staff failed to ensure a care plan was developed regarding the use of CPAP (continuous positive airway pressure) for one (1) of three (3) patients included in the survey sample for whom CPAP was ordered (Patient #6).

Findings included:

While making observations on 5E (Pulmonary Unit) on 7/29/19 at 4:20 p.m., the surveyor interviewed Patient #6, who was admitted to the facility on 7/27/19 with diagnoses including, but not limited to Chronic CHF (congestive heart failure), chronic respiratory failure, pleural effusion, dysuria, and NSTEMI (non-ST segment elevation myocardial infarction). Patient #6 had oxygen at four (4) LPM (liters per minute) via NC (nasal cannula) in use, and stated to the surveyor that "I didn't get my CPAP on, I haven't had it on since I came in on Friday".

Staff Member #23, an RN (registered nurse) was outside the room with a computer on wheels when the surveyor exited the room. SM #23 told the surveyor that he/she was familiar with Patient #6, and was interviewed related to the CPAP. SM #23 confirmed by looking at the EMR (electronic medical record) that Patient #6 had an order for Bi-pap (bi-level positive airway pressure, which is equipment used to get more air into the lungs), per RT (respiratory therapy) protocol. The record also evidenced the following information related to Bipap: An ED (emergency department) note from 7/27/19 at 6:24 p.m. documented that Bipap was trialed for 20 minutes before the patient self-removed, and the ED H&P (history and physical) dated 7/27/19 documented "...OSA (obstructive sleep apnea), non-compliant with CPAP/Bipap at home...".

Respiratory Therapy documented the following related to Bi-pap use 7/27/19 through 7/29/19: 1) Bipap initiated on 7/27/29 at 8:20 p.m. 2) restarted 7/27/19 at 9:58 p.m. 3) 7/27/19 at
11:55 p.m. "on standby", refused 4) 7/28/19 at 7:41 a.m., 5) 7/28/19 at 9:44 p.m. "on standby", 6) 7/29/19 at 12:06 a.m. "on standby", refused, 7) 7/29/19 at 9:09 a.m. "on standby".
SM #23 stated "there is documentation that (patient) was wearing oxygen, so (patient) wouldn't have had Bipap on at the same time".

When the surveyor asked SM #23 to see the plan of care to determine if Bipap was included on the plan of care (POC), it was noted that the POC initiated on 7/27/19 included impaired gas exchange, but did not include goals and interventions related to Bipap.

On 7/30/19 at 9:50 a.m., the surveyor conducted an interview with SM #22, Director of Respiratory, who stated, "When Bipap or CPAP are ordered, the RT brings the unit to the floor, unless the patient has brought a home unit to the hospital. The RT puts the equipment on the correct settings (for hospital supplied equipment), which for LGH (Lynchburg General Hospital), is autotitrate. Throughout the night, the nurse may take the Bipap/CPAP off and on, depending on the patient's level of comfort. RT documents when they start therapy, not nursing, by going into the flowsheet under "non-invasive mode", but nursing knows there is an order. In our process we've had a lot of things we've changed, and have worked with the builders of (computer system). When we find barriers, they will add things. It is the expectation that refusals would be documented and that the doctor would be notified of refusals".

The surveyor was given and reviewed the facility's policy/procedure/protocol titled "Patient Care Plan (ORG.01.01.32)", last reviewed 12/7/16, effective 12/7/16, and revealed the following in part:
"...3. Plan of Care: Based on the initial and ongoing needs assessment of the patient, an appropriate inter-disciplinary Plan of Care is collaboratively developed and maintained by the clinical disciplines and is documented in the medical record. The Registered Nurse (RN) will enter the Plan of Care into the medical record at the time of admission. Patient problems are identified by all disciplines involved in the Plan of Care. All Plans of Care are in writing and must be included in the patient's chart. Interdisciplinary care planning priorities for care are determined and documented...".
The policy titled "Nursing-Data Base and Patient Admission History (CLIN.02.05.01), last reviewed 10/11/17, effective 10/11/17, was also given to and reviewed by the surveyor, and evidenced the following: "...5. The plan of care will be initiated within 8 hours of patient arrival on the patient care unit. Each plan of care will be individualized to reflect unique patient need {sic} as well as interdisciplinary (as applicable). Care plans will reflect measureable{sic}goals...".

At 11:45 a.m. on 7/30/19, SM #2 advised the surveyor that "What we've tried to tell our staff is that each problem should be addressed on the Plan of Care. This is all we have on care plans (referring to the aforementioned policy/procedure/protocol Patient Care Plan and Nursing-Data Base and Patient Admission History). These two policies are all we can find related to care plans to give you. If you talk to different people, you will get different answers about how care plans are supposed to be done...".

Concerns related to lack of documentation for Bipap on Patient #6's plan of care were discussed with SM's #2 as noted above, and again on 8/9/19 at 2:55 p.m. with SM's #1, #51, and #52.

Based on observations, staff interviews, and document review, it was determined facility staff failed to implement a system of infection reducing behaviors to ensure patients were protected from exposure to infectious processes, resulting in the identification of Immediate Jeopardy (IJ). These findings are now cited at the Condition of Participation level as the Immediate Jeopardy was abated on August 9, 2019, prior to the end of the survey.

Findings included:

During the survey conducted 7/18/19 through 8/9/19, the survey team identified areas of concern in infection control as a result of observations, interviews, and the review of facility documents. The observations occurred in the following areas: general medical unit (GMU), diabetic renal medical unit (DRMU), medical/surgical intensive care unit (MsICU), 5 East Pulmonary unit, the Emergency Department (ED), and Central Sterile (CS) facility departments.

Observations were made in the MSICU on 7/30/19 at 2:20 p.m., the GMU, DRMU, 5E Pulmonary unit on 7/31/19 between 1:45 p.m. and 3:30 p.m. on 7/31/19. Observations were made in the ED on 8/4/19 between 1:00 p.m. and 1:30 p.m. Observations were made in the CS department on 8/5/19 between 4:20 p.m. and 5:15 p.m., and again on 8/6/19 between 11:15 a.m. and 11:45 a.m.

The facility staff was unable to determine how point of care pre-cleaning of semi-critical equipment requiring high level disinfection was being performed for ENT scopes (ear, nose, throat scope inserted into the nose, throat, or larynx) and Cystoscopes (inserted into the bladder to examine the bladder). The ENT scopes are located on three (3) ENT carts, one (1) of which is maintained in the ED and two (2) in CS; the Cysto scopes are located on 2 carts, both kept in CS. The carts have the potential for use in multiple departments of the facility.

Surveyors observed that Central Sterile department staff were re-stocking supplies, which had been released for specific patients, but had not been used during that patient's hospitalization. There was no evidence available to determine whether the supplies had been in the patient room; Central Sterile staff who accepted supply returns did not investigate whether the unused supplies had been in the patient's room prior to accepting the supplies for restocking.

Surveyors learned that an item observed being re-stocked in Central Sterile, had been in the room of a patient that had been on contact isolation precautions for MRSA (Methacillin Resistant Staphylococcus Aureus).

Surveyors observed a phlebotomist obtain blood samples on a patient who was on contact isolation. The phlebotomist failed to follow contact isolation procedures during the specimen collection in the MICU.

Staff on the GMU failed to properly clean equipment taken into a patient room, to prevent spread of infection between patients.

On the MSICU, GMU and 5E units, surveyors observed improper hand hygiene and glove use during and after care of patients who were on contact isolation, as well as patients who were not on isolation precautions.

The Infection Control program showed evidence of identified issues with high level disinfection, and the development of corrective interventions, and investigation of infections and communicable diseases; however, the program failed to show an ongoing evaluation was implemented to ensure sustained compliance.

There was a lack of evidence of training and oversight of laboratory staff, to ensure the reduction in the risk to patients requiring lab services.

Findings as noted above, as well as multiple observations made during the survey resulted in a finding of IMMEDIATE JEOPARDY for the facility. After consultation with the State Agency, the survey team met with facility staff on 8/6/19 at 2:25 p.m. to inform them of the Immediate Jeopardy findings and to request a Plan of Removal for the IJ.

An initial Plan of Removal was presented to the survey team on 8/8/19. A final Plan of Removal was presented to the survey team on 8/9/19 at 1:00 p.m., and evidenced the following:

-The following verbiage was added to the Infection Prevention: Disposable Patient Care Items Policy on 8.8.2019: "Disposable unused patient care items are not to be returned to Central Supply or any other supply storage areas to prevent use on other patients." COMPLETED 8.8.2019.

-Staff in Central Supply were educated to use of a scripting message developed by the Director of Infection Prevention for use in reminding staff they will not be able to return any unused items when they pick up supplies from Central Supply: Note that disposable patient care supplies released from CS cannot be returned. COMPLETED 8.7.2019.

-Engraved signage was developed by Plant Engineering and posted at the entry of Central Supply: Disposable Patient Care Items are Not To Be Returned To Central Supply. COMPLETED 8.6.2019.

-Huddle points developed by the Director of Infection Prevention and placed in a PowerPoint slide to facilitate communication to educate staff in the following departments on the revision to the disposable patient care items policy: Oncology, Cardiology, Wound Center, Urology, Pain, Emergency Services, Therapy, Respiratory, Nursing, Radiology, and Lab. Huddle points included:
*Unused disposable patient care items in patient rooms are not to be redistributed to other
patients.
*Patient care items placed in patient rooms are for single patient use.
*Contamination of patient care supplies can occur in the patient's environment.
*Removing disposable items that cannot be cleaned or disinfected from patient rooms for other patient use increases risk for healthcare associated infections ("HAI's").
Huddle points were shared in the organization's daily safety huddle on 8.7.2019 and 8.8.2019 and distributed to all attendees. COMPLETED 8.8.2019.

-On 8.8.2019 a mandatory CBL was developed containing the huddle points, which shall be distributed to all clinical staff on 8.9.2019. ALL CLINICAL STAFF WILL HAVE COMPLETED THE MANDATORY CBL BY 8.16.2019. STAFF WHO ARE OUT ON LEAVE AND CANNOT COMPLETE THE CBL BY 8.16.2019 WILL BE REQUIRED TO COMPLETE THE CBL BEFORE WORKING A SHIFT WHERE THE COMPETENCY WILL BE REQUIRED.

-SVP/CNO sent communication to all Centra Leadership with general update on surveyor findings (patient safety emphasis, central supply, portable scopes, infection prevention, etc.) and prompt action planning/policy work being accomplished and deployed across Centra. COMPLETED 8.7.2019.

-CMO sent ED Medical Director and Associate Medical Director a message detailing action planning and policy changes pertaining to managing unused disposable patient use items. The Director of ED Services is verifying daily that all providers have received and understand the communication from the SVP of Medical Affairs. COMPLETED 8.7.2019.

-Compliance will be sustained through use of exemption documentation by Central Supply staff to identify any department that attempts to return supplies. An Attempted Return Template was developed by the Director of Infection Prevention for Central Supply staff to use to document attempts to return.

-Attempted returns will be reported in real time by Central Supply Staff to the manager of the unit and documented on the Attempted Return Template. The template will be forwarded to the Director of Infection Prevention in real time as it occurs. Upon receipt, the Director of Infection Prevention will contact the unit manager to immediately arrange for education of the unit staff to ensure their understanding and compliance. Any occurrences will also be reported to the Perpetual Readiness Committee.

-Compliance will also be sustained by continuing education in annual CBLs, which are to be completed by the end of each calendar year, and new hire general orientation.

-Verbiage was added to the facility policy High Level Disinfection to designate "trained staff" eligible to perform post-produce precleaning of scopes on mobile carts as RNs, LPNs, Surgical Technicians, and Emergency Department Technicians who work in the surgical, intensive care, emergency department, and/or medical surgical units who have completed the in-service education entitled "Use of the First Step Pre-cleanse Kit" provided by endoscopy and/or infection prevention staff. COMPLETED 8.8.2019.

-Job aid on the process for performing post procedure pre-cleaning of soiled scopes was developed by Infection Prevention Team and placed on all mobile endo and cysto carts. COMPLETED 8.7.2019.

-Log sheet was developed by Director, Infection Prevention to document pre-cleaning of scope performed after each use, using First Step Pre-Clean Kit. The log sheet will be reviewed by Sterile Processing Department ("SPD") for complete documentation and maintained in a binder in SPD. Director, SPD will immediately report instances of non-compliance to the Director of Infection Prevention and to the Unit Manager (or designee, e.g., Charge Nurse) of the non-compliant unit/department. Upon receipt of such notification, the Director of Infection Prevention will contact the appropriate unit manager to immediately arrange for education of the unit staff to ensure their understanding and compliance. The Director of Infection Prevention will also report data on any trends to the Perpetual Readiness Committee. COMPLETED 8.6.2019.

-Format of scope tag was standardized by the Director of the SPD to address all elements related to month, date of cleaning, as well as expiration date. Appropriate expiration tags were placed on endo and cysto scopes on all mobile carts. COMPLETED 8.6.2019.

-Education on the procedure for processing mobile carts was provided by the Educator for the Sterile Processing Department to SPD Staff and included: *Process for reviewing the log sheet to look for timeframe since precleaning performed: 1 hour or less OR over 1 hour, OR unknown. *Procedure for completing clean tags after medivation that includes day of cleaning (month/day black circle on tag; expiration date on end of tag in red). COMPLETED 8.7.2019.

-A team comprised of the Director of Infection Prevention, and Infection Preventionist, the Manager and two staff members from Endoscopy delivered roving education to the ED and all other LGH clinical areas throughout the day and evening shift on 8.6.2019 and in VBH clinical areas on the evening of 8.7.2019 to educate and establish users qualified to train other users on each unit in the management of pre-cleaning scopes on mobile carts using FIRST STEP. A roster of trained staff will be maintained on each unit and updated as more users are trained in the procedure. Should a scope be used on the unit, only those who have been trained in the precleaning process will be allowed to perform the pre-cleaning. COMPLETED 8.7.2019.

-CMO sent ED Medical Director and Associate Medical Director a message detailing action planning and policy changes pertaining to the process for post procedure pre-cleaning of ENT/cysto scopes unused disposable patient use items. The Director of ED Services is verifying daily that all providers have received and understand the communication from the CMO. COMPLETED 8.7.2019.

-Communication from the SVP/CNO to nursing staff leadership evening of 8.6.2019 and 8.7.2019 to ensure coverage of all inpatient areas (acute, intermediate, critical care) on use of First Step. Train staff to serve as staff educators. This "train-the-trainer" training began on the evening on 8.6.2019 and has continued on subsequent shifts. COMPLETED 8.7.2019.

-CMO sent ED Medical Director and Associate Medical Director a message detailing action planning and policy changes pertaining to central sterile and portable scopes. COMPLETED 8.7.2019.

-SVP/CNO sent communication to all Centra Leadership with general update on on surveyor findings (patient safety emphasis, central sterile, portable scopes infection prevention) and prompt action planning/policy work being accomplished and deployed across Centra. COMPLETED 8.7.2019.

-A huddle point was developed by the Managing Director of Acute Care Nursing and distributed to staff on 8.7.2019. COMPLETED 8.7.2019.

-On 8.8.2019 a mandatory CBL was developed containing the huddle points, which shall be distributed to all clinical staff on 8.9.2019. ALL CLINICAL STAFF WILL HAVE COMPLETED THE MANDATORY CBL BY 8.16.19. STAFF WHO ARE OUT ON LEAVE AND CANNOT COMPLETE THE CBL BY 8.6.2019 WILL BE REQUIRED TO COMPLETE THE CBL BEFORE WORKING A SHIFT WHERE THE COMPETENCY WILL BE REQUIRED.

-Compliance will also be sustained by continuing education in annual CBLs, which are to be completed by the end of each calendar year, and new hire general orientation.

-Finding 3.1., Phlebotomist/Isolation: A phlebotomist contaminated the isolation cart after exiting an isolated patient's room. Other patients who encountered the phlebotomist or other staff the phlebotomist encountered could have been harmed.

-Interventions on Finding 3.1.:
*Phlebotomy Supervisor, Phlebotomy Educator, Managing Director of Laboratory Services, and Director of Infection Prevention developed, tested, and validated step-by-step instructions for phlebotomist care of/interface with patients under isolation precautions. COMPLETED 8.6.2019.

*All phlebotomists trained in the validated procedure and training documented on sign-in roster with trainer's initials; will be documented in laboratory QA meeting minutes. COMPLETED 8.7.2019.

*Validated process added as an addendum to Laboratory Infection Prevention policy, under specimen collection for isolated patients. COMPLETED 8.7.2019.

*Lab Phlebotomy: Centra Phlebotomy Training Program was revised to remove the work "new" from the Principle section. COMPLETED 8.9.2019.

*Compliance will be sustained by continuing education in annual CBLs, which are to be completed by the end of each calendar year. As of 8.7.2019 this education has been added to the current year's CBLs.

-Finding 3.2.: Multiple observations related to beverages on Computer on Wheels ("COWS"). Staff consuming those beverages in areas where they could have been contaminated by infectious materials, along with any patients they encountered, could have been harmed by this practice.

-Interventions on finding 3.2.:
*Plant Engineering validated with IT there are 400 COWs on the Lynchburg campuses. COMPLETED 8.7.2019.

*"No Food or Drinks" labels created and are being placed on the 400 computers at the Lynchburg campuses. COMPLETED 8.7.2019.

*IT identified 30 non-electrical carts in the Lynchburg campuses. COMPLETED 8.8.2019.

*"No Food or Drinks" labels created and are being placed on the non-electrical carts on the Lynchburg campuses. COMPLETED 8.8.2019.

*The "No Food or Drinks" labelling {sic} will be added to the process for onboarding a new COWs or a non-electrical carts. COMPLETED 8.8.2019.

*Compliance will be sustained by continuing education in annual CBLs, which are to be completed by the end of each calendar year.

-Finding 3.3: Surveyor noted single use sterile water bottles in patient room. Patients who received solutions from pre-used single use solutions containers could have been harmed.

-Interventions on Finding 3.3:

*Section I. E. 1. of the Infection Prevention Ch 05: Disposable Patient Care Items policy was modified on 8.8.2019 to state the following: "Solutions labeled sterile single patient use are to be used once with a single patient and any remaining solutions discarded after such single use." COMPLETED 8.8.2019.

*Section .E. of the Infection Prevention Ch. 05: Disposable Patient Care Items policy was modified on 8.9.2019 as follows:

-Section 1, "Solutions" at the beginning of the section was replaced with "Solutions that do not contain antimicrobial/antibacterial properties and are".

-Section 2 was modified to state: "Disposable solutions with antimicrobial/antibacterial properties may be used for 28 days, unless otherwise specified by the manufacturer. At the time such disposable solutions with antimicrobial/antibacterial properties are opened, they will be dated and timed noting the date opened and the expiration date."

-Section 3 was deleted.
COMPLETED 8.9.2019.

*Huddle Point developed for communication to all nursing staff during shift changes. COMPLETED 8.7.2019.

-Normal Saline and Sterile Water bottles ARE single use ONLY

-When using for Trach care, dressing changes, tube flushes, Respiratory machines, etc., ...USE A SINGLE TIME, THEN DISCARD

-Each unit will use rosters to document attendance at huddles.

*Compliance will also be sustained by continuing education in annual CBLs, which are to be completed by the end of each calendar year, and new hire general orientiation {sic}.

On 8.8.2019 a mandatory CBL was developed containing the huddle points, which shall be distributed to all clinical staff on 8.9.2019. ALL CLINICAL STAFF WILL HAVE COMPLETED THE MANDATORY CBL BY 8.16.19 STAFF WHO ARE OUT ON LEAVE AND CANNOT COMPLETE THE CBL BY 8.16.19 WILL BE REQUIRED TO COMPLETE THE CBL BEFORE WORKING A SHIFT WHERE THE COMPETENCY WILL BE REQUIRED.

The survey team reviewed the Plan of Removal and verified the facility actions were completed as documented on the Plan of Removal. The verification included observations, interviews and document review. The Immediate Jeopardy was abated on 8/9/19 at 2:11 p.m.

The findings are now cited at the Condition of Participation level. Please see citations 0749 and 0756 for further detailed information regarding the observations and concerns identified related to infection control.

Based on observations, staff interviews, and facility document reviews, the facility staff failed to ensure that infection control policies and procedures were implemented throughout the hospital, which contributed to the finding of Immediate Jeopardy (IJ), as evidenced by the following:

A. Issues related to high level disinfection
B. Restocking supplies in the Central Sterile Department which had been released for specific patients for use on other patients.
C. Failure to provide oversight and evaluation of new and ongoing employee infection control training for laboratory personnel, to ensure reduction of risk to patients requiring lab services.
D. Multiple observations of infection control concerns on several different units within the facility.

The findings include:

A: The surveyor reviewed the March 2019, April 2019, and May 2019 High Level Disinfection/Sterilization Meeting Agendas, which included discussions, decisions, planned date of follow-up and staff responsible for follow up.

The March 20, 2019 high level disinfection/sterilization meeting agenda included the following information under "Old Business: A. Point of Care Pre-Cleaning and ENT and Urology Carts: Discussion: First Step and biohazard rigid containers are included on all carts. Flexible scopes should be cleaned at point of use before being transported to CS. Scopes are not always returned in a rigid container...Decisions /Outcomes/Next Steps: Item closed. Need to clarify and make recommendations on responsibility of pre-cleaning at point of use; Person/Target Date (SM's #30 and #84's names) April 3, 2019.

The May 1, 2019 agenda documented that "...there is a sporadic use of the carts throughout the hospital. There is a high use of the ENT cart in the ED. CS is responsible for the carts...First Step is on the cart when it goes to the unit...it has been recommended that a laminated sheet of instructions for pre-cleaning the scopes be included with each cart. The sheet will have a place to write the time First Step was used with a dry erase marker. The scope is to be returned in the biohazard box with the wrapper so that SPD (sterile processing department) knows the scope was used. When a scope is returned to CS it will undergo an extended soak time with the assumption it has been more than an hour since it was used...The laminated sheets will be sent to PND for distribution and education. Also, a huddle point will be presented to staff"; no target date was specified.

The surveyor was provided with a document titled, ENT & Urology Cart Log in/out Sheet, which evidenced that for the dates between 6/29/19 and 7/29/19 the ENT cart was signed out seven (7) times, three (3) times to the ED (emergency department), once to the OR (operating room), and three (3) times to various units throughout the hospital. The document was incomplete; some boxes were blank for the following areas: ordering physician, date/time cart was returned, and "cart checked by".

On 7/31/19 at 2:45 p.m. in an interview with SM #30, the Infection Prevention (IP) Director stated "There is a group that meets periodically to look at high level disinfection/sterilization, and we try to make sure pre-cleaning is done on equipment. A one step solution is used. I'd have to check with sterile processing to see if it's being done, I haven't heard that it's not. We've had some other things come up, the director of Central Sterile is (SM #81's name). Everyone was pulled in who does high level disinfection; the only carts we use are ENT, Urology, and Bronchoscopy.

A discussion was held with SM #30, IP Director, on 8/5/19 at 1:05 p.m. related to high level disinfection and pre-cleaning of scopes. SM #30 told the surveyor that "A nursing bulletin alert was issued in August 2018 about the change in process to notify SPD to come do cleaning ongoing with high level disinfection. We decided SPD would take ownership of precleaning. Alerts are sent out via email and go to managers and nursing leadership, then all staff are made aware".

The surveyor was given an email written by SM #30, dated August 30, 2018, and sent to multiple recipients with the subject "Urology and ENT Cart Process Change", with an attachment titled "Nurse Alert-Effective Immediately: Point of Care pre-cleaning requirement ENT and urology carts. The email, in part stated "In addition to the sign on the carts, to help with nursing staff communication, see attached nurse alert that can be sent out to LGH/VBH nursing staff so they are aware prior to need of the cart. If you want to draft something different, please do so. I just wanted to lend a helping hand".

The Nurse Alert included the following information: 1. The Sterile Processing Department (SPD) will be responsible for delivery and pick-up of all ENT and Urology Carts. 2. All endoscopes are to undergo point of care pre-cleaning immediately after use: *Cystoscope requires flushing of the channel and external wipe down at the end of the procedure *ENT scope requires external wipe down at the end of the procedure *First Step kit of enzymatic detergent and water will be used to perform pre-cleaning at the point of use. 3. SPD staff will be responsible for point of care pre-cleaning after use. 4. Nursing staff responsible for notifying SPD at the end of the beside {sic} procedure. Immediately after use of ENT or Urology Carts notify SPD at (phone number) for proper pre-cleaning at point of use".

SM #30 told the surveyor that the email went to Unit Directors who were responsible for disseminating information to their employees. Then it (the process) changed, I'm not sure when it changed. I think it changed due to a handoff in leadership and I'm not sure who knew what and when.

SM #30 stated "I have been working on high level disinfection for years. I pulled the ad-hock team together to standardize treatment across the system. When we were meeting, the ad-hock team, it came to my attention that the pre-cleaning was not documented. The carts can go anywhere, but probably the ED (emergency department) would be the most prevalent place. We are in the process of trying to make sure every cart is "owned". I do my rounding on those areas that do high level audits. The way it is designed, we have the pouch, the item is put in the pouch, water is added, and scope is cleaned with the sponge. The scope is left in the red container on the cart. When I do my rounding, it's in the SPD because they do the high level disinfection, SPD verifies that cleaning was done. When I round and look at the ED ENT cart, I just glance at the side, I just kind of look and see what's on the cart, but I don't have a check list that I can show you. All supplies are on the cart. There was a leadership change in Central Sterile (CS) around September; the process didn't flow, so now there is a sign out sheet with a note on the cart to call CS to get the cart at the point of care. I will have to ask (SM #81's name) how far back that goes. They may still have had that piece, but I don't know if it was being done".

The surveyor audited the ENT cart located in the ED on 8/5/19 at 1:05 p.m., and noted a tag attached to the scope, which had pre-printed months January through December, days Sunday through Saturday, and numbers 01 through 31. "25" was circled on the tag, but no month or day was circled. The surveyor asked what the tag was used for during an interview with SM #80 on 8/5/19 at 1:25 p.m., and he/she stated "The month, day, and number date should each be circled in order to tell when the scope was processed".

SM #80, Director of Supply Chain Logistics, was interviewed 8/5/19 at 1:25 p.m., and stated "The cart goes to the floor, and we loose visibility of the cart, so we don't know what happens to it once it leaves the SPD. The ED is the only unit that maintains a ENT cart. When they use the cart and need a new one, they call. The ED monitors the cart; after seven (7) days from the day the scope was processed, they bring the cart back, and get a new one. The scopes have a 7 day hang time. Pharmacy keeps up with the drug box". The surveyor asked SM #80 about the tag observed on the scope which was on the ED ENT cart as described above. SM #80 stated that he/she was unable to tell the surveyor when the scope on the ED ENT cart with the tag circled "25" had been processed, or how long it had been hanging, based on the way that tag was documented.

SM #81, Director of Central Sterile, was interviewed 8/5/19 at 1:30 p.m., and stated "When they take the biohazard container in CS, we look to see if we see liquid in the bin. We know it's been pre-cleaned if there's liquid in the red bin. We do not track dry bins and wet bins. Something we need to incorporate for sure. Right now internally, extended soak is being done on all items because we can't be sure of whether pre-cleaning has been done, so we just do one (1) hour extended soak on all scopes. I don't remember the frequency of meetings for sterilization. From my point of view, I became aware of the problem and the extended processing was instituted related to the wet loads from the sterilizer. The sterilization team discusses items we can improve on. Sheets were added for sign in/out, and laminated instructions are on each cart. There is a log sheet when units pick up the cysto and ENT carts. The wet loads were due to a steam trap not functioning properly, and it was fixed in late June or early July. From April 30 to May 11, the sterilizer worked off and on; when we got wet loads, we transferred instruments to another hospital to be processed. We are not tracking dry bins and wet bins returned to CS. Something we need to incorporate for sure is tracking wet and dry bins regarding whether pre-cleaning was done. SPD rounds each shift on units to pick up dirty equipment. The nursing staff puts the dirty equipment into red bins".

The surveyors toured the Central Sterile department and interviewed SM #82, who was performing disinfection and sterilization of equipment at 4:50 p.m. on 8/5/19. The surveyors asked SM #82 how he/she knew the process for cleaning scopes, and he/she stated "I have been given steps by our manager. When I started in 2017 the manager was different, and said to put scopes in the medivator, but when I got certified in 2018, we learned that wasn't a good method. We used to have poster boards on the wall that told us how to clean different scopes, but the walls just got painted, and we can't put posters back up until the second coat of paint goes on.

The surveyors then asked how SM #82 knew the directions for use (DFU) for cleaning the different scopes . SM's #81 and #83 were also present. SM #81 stated "Our role is to read through the DFU's, that happens to the best of our ability. SM #83 added "There are basic cleaning methods, our education gives us any deviations from usual". The surveyor asked SM #82 to explain the process of cleaning/disinfection/sterilization of the scopes; he/she stated "Pre-Klenz is pretty evident, because it's wet. I have to act as if I actually don't know if it was cleaned it it doesn't look wet. There is a 3 washer method: the scope goes into water to remove gross matter, and is manually cleaned if necessary, then to the enzymatic to soak from 3 to 6 minutes; the scope then goes into RO (reverse osmosis) water to rinse off the enzymatic. The scope then goes through a 6 minute sonic cycle, it is loaded onto a rack and through a washer. The Wolfe scope is manually cleaned, it doesn't go into the medivator. It has to be leak tested under water, the biopsy port is flushed with enzymes, brush, if clean, then move to the next step, which is rinse with RO water, alcohol flush, RO water, alcohol, push air through a syringe, then the scope is placed back into it's container. If I knew the scope hadn't been precleaned, I'd treat it the same as if I knew it had been. The Wolfe scope sits for 40 minutes because I know how long it's been out".

The surveyor inquired as to whether the facility had a policy which addressed extended soaking of scopes, and was given an email from SM #81, Director of CS dated 8/5/19, which stated "The extended soak time is a process and not a policy. We do not have it {sic} current policy, but it is current process".

SM #30 provided the surveyor information related to pre-cleaning of scopes on the ENT and urology carts which SM #30 said was provided to facility staff in May 2019; SM #80 also gave the surveyor a copy of a "Safety Break", which he/she stated went out to all departments and nursing leadership as a reminder. The two documents mirrored one another, except that the safety break included some illustrations, which were not on the document provided by SM #30, and included the following information: "ATTENTION USER: Pre-cleaning of Scope Required. Please ensure pre-cleaning of scope is done at end of procedure at point of use (bedside). Follow these simple instructions: 1) Tear open the First Step pouch located in the bottom drawer. 2) Add 500 ml of tap water using the fill line on the pouch. 3) Squeeze the cleaning pad inside the pouch to release the enzymatic detergent and mix with the water. 4) Use the cleaning pad to wipe down the insertion tube. 5) Place the scope in the red biohazard label rigid container located in the bottom drawer. 6) Immediately transport the scope to the reprocessing area. 7) Empty the used First Step package and place in the container with the scope. 8) Return cart immediately to Sterile Processing decontamination area.

On 8/5/19 at 1:55 p.m., the surveyor conducted an interview with SM #36, RN, ED Charge Nurse, related to the ENT cart stationed in the ED, and he/she stated "When the information about pre-cleaning came out, we had inservices. We usually spray the scope down pretty good, we put it into the red bin, and spray it down". The surveyor asked about the use of "First Step" flexible endoscope bedside pre-clean kit/pouches for pre-cleaning, and SM #36 stated "I haven't seen that, we use Pre-Klenz spray".

SM #30 presented the surveyor with the Policy "Infection Prevention Ch 05: Guidelines for High-Level Disinfection of Semi-Critical Patient Care Equipment on 8/6/19 at 2:00 p.m. The policy, which did not have an effective or review date documented, stated in part: "...Centra Health Staff will follow manufacturer's instructions for use or published evidence-based guidelines for pre-cleaning, cleaning, decontamination, and high-level disinfection or sterilization of semi-critical devices. Only FDA approved high-level disinfectants or chemical sterilants will be used for the purpose of high-level disinfection...Responsibility: 1. Infection Prevention has the responsibility for the implementation of this policy...4. Precleaning/Cleaning/Disinfection: b. Precleaning is performed at the point of use to prevent bioburden from drying making decontamination more difficult...5. Extended Soak Time: a. When there is excessive bleeding and/or delayed reprocessing, follow the manufacturer's instructions for extended soak time. Soak the endoscope one (1) hour in detergent solution at the temperature and concentration recommended by the detergent manufacturer...".

After giving the surveyor the policy noted above, at 2:00 p.m. on 8/6/19, SM #30 told the surveyor "I have to be honest, we talked about this when we had the sterilization adhock committee meetings, but did not think they needed to educate or do competencies, because the carts are seldom used, and we thought clear guidance was enough. The policy gives guidance; details come in the department, they then ensure staff has the training to complete these tasks. The policy doesn't always identify who does something. Instructions were put on the cart last week, but staff were not educated. Putting instructions on the cart was not sufficient education; this was when First Step kits were implemented. Those had been on the carts longer than I realized, I don't know when that started. There's a gap in education, we do have to do a better job of disseminating the information. We are trying to pull all these pieces together. Are we doing a good job, no, there's a gap".

The surveyor was given an email written by SM #30, dated August 30, 2018, and sent to multiple recipients with the subject "Urology and ENT Cart Process Change", with an attachment titled "Nurse Alert-Effective Immediately: Point of Care pre-cleaning requirement ENT and urology carts. The email, in part stated "In addition to the sign on the carts, to help with nursing staff communication, see attached nurse alert that can be sent out to LGH/VBH nursing staff so they are aware prior to need of the cart. If you want to draft something different, please do so. I just wanted to lend a helping hand".

The Nurse Alert included the following information: 1. The Sterile Processing Department (SPD) will be responsible for delivery and pick-up of all ENT and Urology Carts. 2. All endoscopes are to undergo point of care pre-cleaning immediately after use: *Cystoscope requires flushing of the channel and external wipe down at the end of the procedure *ENT scope requires external wipe down at the end of the procedure *First Step kit of enzymatic detergent and water will be used to perform pre-cleaning at the point of use. 3. SPD staff will be responsible for point of care pre-cleaning after use. 4. Nursing staff responsible for notifying SPD at the end of the beside {sic} procedure. Immediately after use of ENT or Urology Carts notify SPD at 200-3200 for proper pre-cleaning at point of use".

SM #30 told the surveyor that the email went to Unit Directors who were responsible for disseminating information to their employees.

Review of facility documents evidenced that designated IP staff were aware of and discussed issues related to the pre-cleaning process for ENT (Ear, Nose, and Throat) and Cysto (Cystoscopes) in the High Level Disinfection/Sterilization Meetings on 3/6/19, 3/20/19, 4/6/19, and 5/1/19; however, committee meeting minutes dated May 13, 2019 and June 10, 2019 lacked evidence that issues related to high level disinfection were discussed.

Documentation of the Infection Prevention Update dated June 20, 2019 included information related to hand hygiene and several types of infections, but lacked evidence that high level disinfection and sterilization were discussed.

B: On 8/5/19 between 4:30 and 5:10 p.m. SM #80, Director of Supply Chain Logistics, was interviewed regarding the observation of a staff member returning wound vac dressing supplies, which were labeled with a patient's room number, for re-stocking in the CS department. SM #80 stated "We do re-stock supplies. I'm not sure there is a policy which addresses that, but we look for package integrity, and if there is no damage, items are re-stocked. We wouldn't have any way of knowing if that item had been in a patient's room, or what it had been in contact with. We have had a conversation with IP regarding whether to throw away everything on the isolation cart, and we do not. I have an email about that". Surveyors learned that the patient for whom the wound vac supplies had been released, had been on Contact isolation precautions for MRSA (Methacillin Resistant Staphylococcus Aureus) while an in-patient at the facility.

The surveyor was presented with an email dated 6/1/18 at 11:47 a.m. from SM #80, Director of SPD to SM #30, IP Director, which stated "When the staff issues a new isolation cart, they are discarding the opened packages of disposable products such as the gowns, alcohol and hand sanitizer, boxes of gloves and masks. My concern is that since these products are not sterile and do not come into contact with the patient (they sit outside the room) they should not be considered to be contaminated. We are throwing away a large amount of products, is this necessary? Your thoughts?". On 6/1/18 at 11:54 a.m. SM #30 an email chain was forwarded to SM #80, which included the following information: "We consider the isolation cart as a clean supply cart and the disposable items do not need to be discarded just because the package is opened. If staff are using the carts as designed, it should not be necessary to discard the unused items, unless they are visibly soiled".

The facility did not have a policy which addressed restocking of supplies which could not be cleaned and disinfected after leaving Central Sterile for a dedicated patient.

C: On 7/30/19 at 2:20 p.m. while making observations in the MSICU, the surveyor observed SM #53, a phlebotomist, in ICU Room #13. The patient was on contact isolation precautions. There was a rolling cart, which contained items including lab supplies, a label printer, computer, and keyboard, just outside the glass doors to the room, beside the isolation cart. The surveyor observed SM #53, during the process of drawing blood cultures on the patient. SM #53, while wearing the contaminated gloves used to draw the blood, turned and accessed supplies, keyboard, label printer, and other items on the rolling cart. SM #53 was observed reaching around the isolation gown to get an ink pen out of his/her pocket in order to write information on the label of the blood sample, also while wearing contaminated gloves.

SM #53 placed blood samples into a plastic pouch, removed the isolation gown and gloves, went outside the door of Room #13 without washing or sanitizing his/her hands, took gloves out of the box which was setting on top of the isolation cart, donned gloves, and removed sanitizer wipes from a container sitting on the cart. While standing at the entrance to Room #13, SM #53 swiped the sanitizing wipe across the top of the cart without picking up and cleaning under the boxes of supplies on the top of the cart, and wiped off the hand held scanner. No other areas of the cart were cleaned. SM #53 exited the room, sanitized his/her hands, and rolled the cart down the hall and off the unit.
While SM #53 was preparing to exit the patient's room, another lab technician entered ICU Room #13. The second lab technician did not touch the patient; however he/she did not wash or sanitize his/her hands upon entering or exiting the room, and did not don PPE prior to entering the room.

SM #30, Director of IP was interviewed on 7/31/19 at 2:45 p.m. related to observations described above, IP audits, and staff training. SM #30 stated "Lab staff have the same general orientation as all new employees, then they get more training in their department. I have asked educator to bring information as far as onboarding. There's still that gap to help prevent cross contamination. I come from a place where there were phlebotomy trained people, not what we have here. Certainly we do surveillance rounds; most is environmental-hand hygiene, contact precautions most of what we're looking at is evidence of those things. If we see lack of proper hand hygiene or PPE (personal protective equipment), we address it on the spot. Non-nursing direct care staff do not have a skills fair. Skills fairs are non global, they don't apply to all areas. Physicians are able to get some information to providers through the medical staff office. I asked if there was something we could get out there, and we probably can".

SM #29, Phlebotomy supervisor, was interviewed 7/31/19 at 10:00 a.m., and stated "Currently we are working with (name of a local community college) and they now have a program for phlebotomy. Two (2) to three (3) years ago we didn't hire anybody without phlebotomy experience. Now, one (1) of fifteen applicants might have phlebotomy experience, so we have been forced to start taking people with no phlebotomy experience. We don't go over isolation precautions. We cover hand washing and show them isolation precautions as we go into isolation rooms. Full time phlebotomists have to have six (6) hours of CEU's (certified education units) a year, and part time have to have 3 CEU's a year. I don't know who put that into place, it's just always been a requirement".

The educator for the laboratory (lab), SM #32, was interviewed on 7/31/19 between 3:15 p.m. and 3:45 p.m., and stated "When we hire phlebotomists, we teach them how to stick with different needles, teach them about different tests. We have competencies to do every year on every person. There is no check off for new employees. There is no check list or competency for isolation procedures. We educate them about how to handle patients. There are four (4) weeks of training for phlebotomy, some up to 6 weeks. We go over hand hygiene, wearing gloves. Initially, they start with me for their first couple of days, then they work with other staff. They put an educator in place to make sure everybody gets trained. The last few days I try to follow them to make sure they are doing things right. I do randomly go talk to patients to see how they are doing, the patient will tell you".

The surveyor was given documents provided on new employee orientation training regarding what information was provided, and to whom, for the first and second days of orientation. Day 1 is general orientation, for all new employees, including laboratory personnel, and covers the OSHA (Occupational Safety and Health Administration) Bloodborne Pathogen (BBP) Standard 29 CFR 1910.1030 Universal/Standard Precautions. The stated purpose documented on the information provided was "To provide OSHA requirements for employers and employees to protect staff from occupational exposure to blood and other potentially infectious material".

The OSHA BBP training includes information related to hand hygiene, PPE related to body parts protected by the use of gown, gloves, face protection, cleaning of equipment, regulated medical waste, non-regulated waste, standard precautions, respiratory etiquette, handling laundry, vaccinations, safe injection practice, exposure and post-exposure follow-up, types of and PPE requirements for Contact, Airborne, and Droplet isolation.

The information for Day 2 orientation documented that it was provided for all CNA's (certified nursing assistants, LPN's (licensed practical nurses), and RN's (registered nurses). This included IP policies and procedures; Standard precautions, and Transmission Based Precautions for Contact, Droplet, Airborne, and reviewed PPE required for each type of isolation. Lab personnel do not attend Day 2 of general orientation.

The surveyor reviewed the facility's policy titled "Infection Prevention Ch 10: Laboratory Infection Prevention Policy", last review 1/29/19, and revealed the following, in part:

"...IV. Policy: The Laboratory will follow Centra's Infection Prevention policies as outlined in Chapter 7 of the Infection Prevention Manual and evidence-based guidelines to prevent the spread of infection and maintain a safe environment for patients, healthcare workers, staff, and visitors. To prevent occupational exposure to bloodborne pathogens, all laboratory healthcare workers must routinely use appropriate barrier precautions to prevent skin and mucous membrane exposure when contact with blood or other body fluids is anticipated. Tasks, procedures, or groups of closely related tasks in which occupational exposure occurs in the laboratory: ...4. Contact with patients on blood or body fluid precautions".
"...V. Work Practice Controls: 4. Handwashing. Hands should be washed immediately or as soon as feasible after removing gloves or other protective barriers. Hands and any other skin must be washed immediately or as soon as feasible following contact with blood or other potentially infectious materials. Telephones, computer terminals, printers, etc., in the work area must be considered contaminated and hands should always be washed when leaving the work area, especially before a break, snack, or meal...".

7. The facility's policy titled "Infection Prevention Ch 02: Isolation Precautions" was reviewed, and revealed the following, in part:
"Scope: This policy applies to all facilities and staff within Centra Health including the in-patient and out-patient setting. All employees, licensed independent practitioners, volunteers, students, and contract workers are required to follow this policy in the health care setting...
Purpose: To provide guidance for employees, physicians, volunteers, students and contract workers in the appropriate use of isolation precautions to prevent the spread of communicable diseases...
C. Rationale for Isolation Precautions:
Transmission:
1. Contact transmission. The most important and frequent mode of transmission of nosocomial infections, is divided into 2 subgroups: direct contact transmission and indirect contact transmission.
a. Direct contact transmission involves a direct body surface-to-body surface contact and physical transfer of microorganisms between a susceptible host and an infected or colonized person, such as occurs when a person turns a patient, gives a patient a bath, or performs other patient-care activities that require direct personal contact. Direct contact transmission can also occur between two patients, with one serving as the source of infectious microorganisms and the other as a susceptible host.

b. Indirect contact transmission involves contact of a susceptible host with a contaminated intermediate object, usually inanimate, such as contaminated needles, instruments, or dressings, or contaminated hands that are not washed and gloves that are not changed between patients...".
D. Responsibility
...4. All staff have responsibility to maintain appropriate isolation precautions.

II. Standard Precautions-Use Standard Precautions for the care of all patients.
B. Gloves
...3. Change gloves and perform hand hygiene between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms.
4. Remove gloves promptly after use, before touching non-contaminated items and environmental surfaces, and before going to another patient, and wash hands immediately to avoid transfer of microorganisms to other patients or environments...".

D: During a tour of the facility by the surveyor on 7/31/19, observations were made on the General Medical Unit (GMU) between 1:45 p.m. and 2:30 p.m. Between 2:40 p.m. and 3:15 p.m. observations were made on the Diabetic Renal Medical Unit (DRMU), and between 3:15 p.m. and 3:30 p.m. observations were made on 5E, the Pulmonary unit. On 8/5/19 observations were made in the Emergency Department (ED) between 2:15 p.m. and 2:30 p.m. Concerns were identified regarding staff following proper infection control procedures, which included:

Between 1:50 p.m. and 2:15 p.m., SM #5, a CNA (certified nursing assistant), was observed during the following tasks: exiting Room N333 wearing gloves, walking to and entering the medication/clean room of the GMU to retrieve linens. SM #5 continued to wear the gloves worn in the patient room. SM #54 returned to Room N333, put clean linens on the bed while wearing the same gloves; exited the room and filled the patient's water container with ice and water. After setting the water down on the table, SM #54 removed his/her gloves, moved papers on top of a rolling computer cart which was in the room, wrote something on a piece of paper, used the mouse and keyboard, then pushed the computer cart to, and entered another patient room, Room N334. SM #54 did not wash or sanitize his/her hands prior to or after entering room N334. SM #54 picked up the water container, left the room, and filled the container with ice and water, and returned it to room N334 and sat it down.

At 2:25 p.m. the surveyor observed SM #54 perform a glucose test for the patient in Room N345. SM #54 gathered supplies, went into room N345, sat the glucometer and a green plastic box of supplies on the bedside table. After donning gloves, SM #54 wiped the patient's finger with alcohol, and retrieved a glucose strip from the green box wearing the same gloves. After obtaining the result, SM #54 removed the gloves, sanitized hands, donned clean gloves, and carried glucometer and green box to the computer on wheels near the isolation car outside room N342. SM #54 cleaned the glucometer with sanitizing wipes from the isolation cart, but failed to wipe off the green plastic supply box.

The facility's policy titled "Point of Care Testing: Glucose Meter Accu-Chek II Systems Procedure Hypoglycemial POC 7095.A.002" , last reviewed 1

Based on observations, interviews and review of facility documentation, it was determined the facility staff failed to show an ongoing evaluation of developed and implemented corrective interventions to ensure success, sustainability and reduction of risk to patients in affected problems areas of Infection Control, and that designated infection prevention staff failed to identify the high risk practice of returning supplies to the Central Sterile (CS) department, after they had been released for use.

Findings included:

The hospital developed and enacted a corrective action plan related to pre-cleaning of ENT and cystocope high level disinfection prior to the start of the survey on 7/18/19; however, surveyor observations and interviews indicated improper infection control practices were present.

During the survey conducted 7/18/19 through 8/9/19, the survey team identified multiple areas of concern in infection control during observations in the following areas/units: Emergency Department (ED), Medical/Surgical Intensive Care Unit (MSICU), Central Sterile (CS) department, General Medical Unit (GMU), Diabetic Renal Medical Unit (DRMU), and 5E, Pulmonary unit.

A tour in MSICU was conducted by the surveyor on 7/30/19 at 2:20 p.m., and the the following observations were made:
While collecting blood samples from a patient on Contact isolation, laboratory (lab) staff failed to 1) use proper hand hygiene, 2) properly used PPE (personal protective equipment), 3) clean and disinfect equipment to prevent the spread of infection between patients. (Please see citation 0749 regarding the observations and concerns identified relating to Infection Control).

A tour by the surveyor was conducted in the GMU on 7/31/19 between 1:45 p.m. and approximately 2:30 p.m., and the following observations were made:
a.) While providing ADL (activities of daily living) to patients, a CNA (Certified Nursing Assistant) failed to practice proper hand hygiene and glove changes while providing care to patients who were not on isolation precautions, 2) failed to clean and disinfect equipment used while performing blood glucose monitoring, which was taken into the room of a patient who was not on isolation precautions. (Please see citation 0749 regarding the observations and concerns identified relating to Infection Control).

The surveyor conducted a tour by in the DRMU on 7/31/19 between 2:40 p.m. and 3:00 p.m., and the following observations were made:
1) Open "single use only" solutions available for use in a patient room, 2) Open beverage in undesignated area. (Please see citation 0749 regarding the observations and concerns identified relating to Infection Control).

A tour was conducted by the surveyor on 5E, the Pulmonary unit, on 7/31/19 between 3:15 p.m. and approximately 3:30 p.m., and the surveyor observed improper use of PPE by a CNA while providing care to a patient in Contact isolation. (Please see citation 0749 regarding the observations and concerns identified relating to Infection Control).

Tours of the ED on 8/4/19 at 1:05 p.m., and on 8/5/19 between 1:35 p.m. and 2:15 p.m., interviews with nursing staff , and an audit of the Cysto cart housed in the ED, revealed that staff were not familiar with the pre-cleaning processes put into place as a result of the High Level/Disinfection/Sterilization meetings. The surveyor also observed open beverages setting on top of two (2) computer on wheels, in work areas. The open containers were pointed out to SM #30, who stated "Yes, we see that on our rounds, we report it, then it keeps coming up again and again". (Please see citation 0749 regarding the observations and concerns identified relating to Infection Control).

Observations and interviews conducted in the CS department on 8/5/19 between 4:20 p.m. and 4:50 p.m. revealed that supplies which had been released for use by inpatients were being returned and re-stocked if they were not used during the patient's hospital stay. (Please see citation 0749 regarding the observations and concerns identified relating to Infection Control).

SM #31, RN ( Registered Nurse) IP was interviewed on 8/1/19 at 10:30 a.m., and was asked how and to whom the results of the IP audits are reported, he/she stated "We report our audit findings quarterly at the infection prevention meetings".

A discussion was held with SM #30, IP Director, on 8/5/19 at 1:15 p.m. related to high level disinfection and pre-cleaning of scopes; SM #30 stated "I have been working on high level disinfection for years. I pulled an ad-hock team together to standardize treatment across the system. When we were meeting, the ad-hock team, it came to my attention that the pre-cleaning was not documented. The carts can go anywhere, but probably the ED (emergency department) would be the most prevalent place. A nursing bulletin alert was issued in August 2018 about the change in process to notify SPD (sterile processing department) to come do cleaning ongoing with high level disinfection. In August 2018 we decided SPD would take ownership of precleaning, then it changed, I'm not sure when it changed. I think it changed due to a handoff in leadership and I'm not sure who knew what and when...".

The surveyor was given an email written by SM #30, dated August 30, 2018, and sent to multiple recipients with the subject "Urology and ENT Cart Process Change", with an attachment titled, "Nurse Alert-Effective Immediately: Point of Care pre-cleaning requirement ENT and urology carts. The email, in part stated, "In addition to the sign on the carts, to help with nursing staff communication, see attached nurse alert that can be sent out to LGH/VBH nursing staff so they are aware prior to need of the cart. If you want to draft something different, please do so. I just wanted to lend a helping hand".

The Nurse Alert included the following information: 1. The Sterile Processing Department (SPD) will be responsible for delivery and pick-up of all ENT and Urology Carts. 2. All endoscopes are to undergo point of care pre-cleaning immediately after use: *Cystocope requires flushing of the channel and external wipe down at the end of the procedure *ENT scope requires external wipe down at the end of the procedure *First Step kit of enzymatic detergent and water will be used to perform pre-cleaning at the point of use. 3. SPD staff will be responsible for point of care pre-cleaning after use. 4. Nursing staff responsible for notifying SPD at the end of the beside {sic} procedure. Immediately after use of ENT or Urology Carts notify SPD at 200-3200 for proper pre-cleaning at point of use".

SM #30 informed the surveyor that the email went to Unit Directors who were responsible for disseminating information to their employees.

Review of facility documents evidenced that designated IP staff were aware of and discussed issues related to the pre-cleaning process for ENT (Ear, Nose, and Throat) and Cysto (Cystoscopes) in the High Level Disinfection/Sterilization Meetings on 3/6/19, 3/20/19, 4/6/19, and 5/1/19. However, committee meeting minutes dated 5/13/19 and 6/10/19 lacked evidence that issues related to high level disinfection were discussed.

Documentation of the Infection Prevention Update dated 6/20/19 included information related to hand hygiene and several types of infection, but lacked evidence that high level disinfection and sterilization were discussed.

On 7/31/19 at 2:45 p.m. SM #30 told the surveyor " I can't say that Infection Prevention (IP) is mandated by the MEC (med-exec committee)...". On 8/6/19 at 2:00 p.m., SM #30, Director of IP advised the surveyor that the "IP team does try to do audits at least quarterly, but the policy is not specific for timeframe".

On 8/5/19 SM #80, Director of Supply Chain Logistics was interviewed related to restocking supplies, and stated "We do restock supplies. I'm not sure there is a policy. We look for damage. We would not know if things brought back had been in a patient's room, but if the nurse brings something back and says it wasn't used, we restock. I'd have to look at our infection control policy regarding restocking. I discussed with infection prevention, and I think there's an email about it, I can get it for you".

The surveyor was given an email dated June 1, 2018 which was from SM #80 to SM #30, the IP Director. The email referenced the practice of restocking open, non-sterile supplies such as isolation gowns, masks, and gloves. The response from SM #30 was that "We consider the isolation cart as a clean supply cart and the disposable items do not need to be discarded just because the package is opened. If staff are using the carts as designed, it should not be necessary to discard the unused items, unless they are visibly soiled". The email did not address supplies for individual patients.

The facility's 2019 Infection Prevention Plan was reviewed, and evidenced that the plan was developed by the Infection Prevention Work Group "with input and collaboration from: Administrative leaders, Nursing Clinical Quality Council, Behavioral Health, Surgical Services, Employee Health, Medical Staff, Pharmacy, and Microbiology Lab. A risk assessment is a component of the plan that provides guidance on the priority focus areas for the department. The plan and risk assessment are reviewed at least annually and/or whenever significant changes occur in elements that affect risk. The intent of the risk assessment is to identify risks that pose the greatest threat to patients and the community. Goals are established for prioritized risks with consideration given to preventing transmission of infections associated with procedures, equipment, devices, and supplies. Surveillance data is reviewed quarterly to evaluate the effectiveness of the plan...Findings are reported back to the service leaders in these areas and included in our quarterly report to the Infection Prevention Work Group".

The risk assessment rated the following (in part) as a "priority focus area" based on how each scored in the risk assessment: lack of hand hygiene; inconsistent disinfection of equipment/high touch surfaces; and high level disinfection non-compliance-Central Services. (Please see citation 0749 regarding the observations and concerns identified relating to Infection Control).

The facility's "Organizational Performance Improvement Plan" was reviewed, and stated the following, in part: "...II. Governance, Leadership, and Organizational Structure: ...The Centra Council has local responsibility for all clinical services across the full continuum of care for the service area not governed by the Board of (facility name) or the Board of (facility name)...the Centra Council,,,,set clinical and operational goals, monitor performance regarding clinical quality, patient safety, patient satisfaction, quality data analytics, process improvement....The Medical Executive Committee shares responsibility with the CEO, SMO, VP Medical Affairs, and Administration for developing and reviewing clinically appropriate policies and recommending standards for other Centra staff. Department chairpersons, in coordination with medical directors and service line leaders, are responsible for the quality of patient care provided to patients within their departments. ...Performance Improvement: Performance Improvement (PI) is responsible for oversight and coordination of the Organizational Performance Improvement Plan and the incorporation of ongoing PI activities to continually improve and sustain quality of patient care and related processes...

Concerns were discussed with SM's #1, #2, #7, #30, #80, #81, at multiple times throughout the survey. Concerns were again discussed on 8/9/19 at 9:00 a.m. with SM's #1, #2, and #52