HospitalInspections.org

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


1. Disinfection and sanitation practice in critical areas, procedural units, high touch areas and equipment was implemented according to policy and procedures, Association of Operating Room Nurses (AORN) guidelines, Environmental Protection Agency (EPA) guidelines, and manufacturer's instruction for use (MFU). The hospital used a common cleaning solution in place of the disnfecting solution authorized by EPA and per hospital's policy and procedure. On 4/27/21, at 5:38 p.m., the survey team called an Immediate Jeopardy (IJ) (Refer to A-0000, A0750, Item 1)

2.Automated Endoscope Reprocessor (AER) machine located in the Gastrointestinal Laboratory (GI Lab) was in a negative pressure room /patient care area. This practice exposed patients and staff to harmful chemical vapors , microorganisms and possible infection. On 4/28/21, at 1:35 p.m. the survey team called the second IJ (Cross Refernce A-0000, A0750, Items 3&4)

3 Infection prevention and control program (IPCP) was with oversight, coordinated to all hospital department/services for implementation and evaluated for effectiveness. The lack of oversight resulted in lack of direction on disinfection and sanitation in various hospital critical areas, patient care areas (Refer to A0750) and all equipment used during the COVID-19 pandemic were without evidenced of being checked for proper working condition and appropriate storage . (Cross Reference to A-0749).

4. Demonstrated adherence to nationally recognized standards in infection prevention and control when AORN guidelines were not followed during reprocessing and storage of endoscopes (Cross Reference A-0750).

5. Focused on improving patient outcomes and providing quality patient care services (Cross Reference A-0749, A-0750, A-0770, A-0773, A-0775, A-0780, and A-0781).

6. Effectively maintain a systematic infection control program that tracks and documents infection surveillance, prevention, and control of transmissible diseases, and hospital acquired infections (HAIs) (Cross Reference A- 0770 and A-0773).

7. Ongoing departmental education and competency was done with personnel on current infection control guidelines, during the COVID-19 pandemic (Cross Reference A-0775).

8. Make use of best practice guidelines for improving and optimizing the antibiotic stewardship program when older
versions were used instead of more recent standards (Cross Reference A-0770, A-0780, A-0781).

9. Have the leaders of the antibiotic stewardship program collaborate and communicate effectively with the different
branches of the facility in creating an updated and improved program (Cross Reference A-0770, A-0780).

10.Have competency-based training and education of facility personnel with the guidelines, policies, and procedures of the antibiotic stewardship program (Cross Reference A-0781).

11. Developed a quality assurance and performance improvement (QAPI) plan in a timely manner or to use the hospital's QAPI program to follow high-risk areas of concern in the infection control and prevention (Cross Reference A-0263, A-0283, A-0309, A-0315).

12. Prioritize its performance improvement activities : Focus on high-risk, high-volume, or problem prone areas; consider the incidence, prevalence, and severity of problems in those areas and affect health outcome ,patient safety and quality of care. The failure to ensure that specific QAPI program activities were met created the potential for persistent poor healthcare practices and placed patients at risk for harm.(Cross Reference A-0283)

13. Quality Program was implemented, data was correctly gathered and reported, and events that could affect the safety of the hospital were reviewed and discussed within the Quality Committee of the Governing Board. The failure created the risk of persistent poor practices and an unsafe environment. (Cross Reference A-0309)

14. Had adequate allocation of resources for implementation of the quality assurance program. The failure had the risk of persistent poor practices and substandard healthcare.(Cross Reference A-0315).


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 ensure licensed staff performed and documented patient pain assessments according to policy and procedure for four out of 34 sampled patients (N400, N201,N106, N505).

These facility failures had the potential for inadequate management and treatment of pain.

Findings:

1. During a review of the facility policy and procedures titled, "Pain assessment and Management- Adult," dated 1/19, indicated in part ... "Pain control is a basic patient right ...patients will be assessed for the presence and history of pain on admission to the unit, at regular intervals (at least every shift), or as patient condition warrants, before a procedure, treatment, therapy session, and/or pain producing event ...pain intensity and pain relief/comfort as reported by the patient will be reassessed and documented: after each procedure, treatment, therapy session, pain producing event, or more often as needed, whenever the patient complains of pain... within 60 minutes following a non-medication therapeutic treatment, following a PO (by mouth) or IM (intra-muscular) medication, and continuous epidural."

During a concurrent interview and record review on 4/27/21, at 10:40 a.m., with licensed nurse (LN 2) and labor and delivery manager (NM 6), patient N 400's clinical record was reviewed. The labor record flowsheet, dated 4/26/21, indicated patient N 400 was having uterine cramping/contractions and pain rating of 8, on a 0-10 pain rating scale. LN 2 verbalized patient N 400 was asking for an epidural (anesthesia used mainly for surgery of the lower belly and legs, often used in childbrth, can also be used to control pain after major surgery to the belly or chest) for pain management. LN 2 verbalized patient N 400 received the epidural at 10:17 a.m. Upon further review of patient N 400's labor record flowsheet, LN 2 and NM 6 acknowledged there was no documentation and no reassessment of pain after patient N 400 received an epidural. LN 2 verbalized if it is not documented it was not done. NM 6 further verbalized patient N 400's pain assessment should have been documented.



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2. During an interview with Nurse Manager (NM6), on 4/28/21, starting at 9:30 a.m., while concurrently reviewing the electronic medical record of sampled Patient 201, medication record revealed that Patient 201, on 4/27/21 at 2:09 p.m., received 0.2 milligrams of Hydromorphone (a narcotic) intravenous(via the vein) for complaints of pain. Further record review of medication records did not reveal reassessment of pain relief per hospital policy. NM6 acknowledged that reevaluation of pain and assessment should have occurred 30 minutes after administration of PRN (when ever necessary) pain medications.

Review of hospital policy and procedure titled, "Patient Rights and Responsibilities," dated 10/01/11, pg. 3/5, under header title of "Patient's Rights/Responsibilities, Your Rights As A Patient:...9. Appropriate assessment and management of your pain, information about pain, pain relief measures and to participate in pain management decisions...."





Surveyor: Citrowske, Elvira





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3.The hospital's policy and procedure entitled "Pain Assessment and Management- Adult", revised 1/19, in the PROCEDURE part indicated "A (1) Patients will be assessed for the presence and history of pain; c. before a procedure, treatment, therapy session, and/or pain producing event. B (1) Pain reassessment may include, but not limited to: a. evaluation and documentation of response(s) to pain intervention(s) ... 2 (d) Within 30 minutes i. Following an IVP (IV Push) medication."

During a review of the clinical record for Patient 106 and concurrent interview with the nurse (NM 4) who was navigating the record in the cardiovascular unit (CVU) on 4/28/21 at 11:38 a.m., the record revealed Patient 106 was administered Morphine (moderate- strong medication) IVP intravenous push on 4/28/21 at 3:17 a.m. However, there was no pain assessment before and after morphine medication administration. NM 4 navigated the record for a while in attempts to locate the pain assessments. But no pain assessments were located in the record. NM 4 stated "There is no documentation of any assessments before and after the pain medication administration."



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4.a pain intensity of 6 out of 10 and was medicated with oral pain medication. The PCF further indicates that on 9:04 a.m., the patient was reassessed for pain and only showed "pain reduced," but did not include a numerical scale rating as previously done.

During an interview on 4/28/21, at 9:30 a.m., with Nurse Manager (NM3), NM3 agreed that whenever pain assessment is done, it should appropriately be followed by reassessment accordingly.

During a review of the facility policy and procedure (P&P) titled, "Pain Assessment and Management - Adult," dated 01/2019, the P&P indicated "All healthcare providers shall be able to: 2. Demonstrate the correct use of a pain scale based on the patient's age, ability to understand, and medical condition ...under A. Pain Assessment, 3. Use the same pain scale consistently, unless patient condition changes ...under B. Pain Reassessment, 2. Pain intensity and pain relief/comfort as reported by the patient will be reassessed and documented: c. Within 60 minutes, b. Following a PO (by mouth) or IM (intra-muscular) medication."

During a review of nursing standards of care in Elsevier Mosby Potter-Perry "Fundamentals of Nursing" 6th Edition, page 1240 in the Assessment section indicated, " ...deciding on appropriate interventions, and evaluating the client's response (outcomes) to the interventions are contingent on the fundamental activity of a factual, timely, accurate pain assessment." The same reference on page 1241 further indicated, " ...the nurse primarily assesses the location, severity, and quality of the pain."

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

1. Ensure the anesthesiologist secured an Informed Consent and properly documented in the medical record prior to the procedure for two of 34 sampled patients (N504 and N505).

2. Ensure the surgical consent form was appropriately completed for one of 34 sampled patients (N402)

These failures have the potential to place patients at risk of not providing them the right to make informed decisions about their surgical procedures or treatments, and not knowing when the consents were properly executed.

Findings:

1. During a review of patient N504's "Pre-Anesthesia Evaluation," (PAE), dated 4/26/21, the PAE did not indicate any discussion made with the patient about the Anesthetic plan, alternatives, risks, side effects, and benefits. Instead, the PAE indicated, "Consenting person understands and agrees to proceed."

During a review of patient N505's PAE, dated 4/27/21, the PAE did not indicate any discussion made with the patient about the Anesthetic plan, alternatives, risks, side effects, and benefits. Instead, the PAE indicated, "Consenting person understands and agrees to proceed."

During an interview on 4/28/21, at 9:00 a.m., with Nurse Manager (NM3), NM3 agreed that the PAEs were inconsistent, and lacked the wording necessary in securing informed consents.

During an interview on 4/29/21, at 10:30 a.m., with Director of Acute Care Services (DACS), DACS agreed with the inconsistently worded PAEs, and admits she does not know the exact regulations, but stated would have to defer to the facility policy.

During a review of the facility's policy and procedure (P&P) titled, "Consents," dated 7/2018, the P&P indicated "1. An Informed Consent ...is required whenever the treatment or procedure is associated with risks not generally understood and usually of a significant nature. The patient must be instructed on: the nature of the proposed care ...including the anesthesia used, and the indications ...potential benefits, short and long term material risks, or side effects, including potential problems ...reasonable treatment alternatives ...the physician performing the procedure, anesthesia ...2. The physician is responsible for documenting in the patient's medical center medical record that he/she has obtained an Informed Consent ..."

During a review of the facility's P&P titled, "Anesthesia Assessment Requirements," dated 10/20, the P&P indicated "The pre-anesthesia evaluation of the patient should include ...development of the plan for the patient's anesthesia care ...and any special post-operative considerations as well as discussion with the patient (or patient's representative) of the risks and benefits of the delivery of anesthesia."



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2. During a concurrent interview and record review on 4/27/21, at 2:38 p.m., with licensed nurse (LN1), patient
N 402's informed consent was reviewed. The consent titled, "Consent to Surgery/Special Procedure/Anesthesia" indicated in part ... "4. Your physicians and surgeons have recommended the following operation or procedure: incision and drainage of abscess... 9. Your signature to this form indicates that you have read and understand the information provided in this form: Date and Time [was left blank], and the Witness Signature [was left blank]. LN 1 acknowledged the consent was incomplete and further verbalized the date and time should be filled out and the witness should have signed the consent.

During a review of the facility policy and procedures titled, "Consents", dated 7/18, indicated in part ... " Informed consent must be obtained for all procedures performed in the operating room ...invasive diagnostic or therapeutic procedures ...the person is expected only to confirm that the person signing the form appeared reasonably competent and appeared to understand what he or she was signing ... the witness/hospital representative should legibly print his or her name, sign the document, and note the date and time."

Based on record review and interview, the hospital failed to ensure staff implemented their Restraint policy and procedure for two of 34 sampled patients (Patient 101 and 201).

Findings:

1.The hospital's policy and procedure entitled "Restraints/Seclusion for NON-VIOLENT/Non-Self Destructive Behavior", revised 12/20, in the PROCEDURE part indicated "4(D) Each calendar day, the patient will be reassessed by the RN to continue the restraint episode. If patient meets the ongoing criterial, update the restraint order in EHR using the order mode "per signed order." 6 (A) The RN assesses on initiation and reassesses the patient's status and response to restraints at intervals not greater than two (2) hours."

During a review of the clinical record for Patient 101 and concurrent interview with the charge nurse (CN) who was navigating the record in the critical care unit on 4/27/21 at 11:32 a.m., the record revealed Patient 101 was placed on non-behavioral bilateral wrist restraint (wrist ties to prevent arm movement) on 3/24/21 at 6:00 a.m., restraints remain ongoing until to date. On 3/24/21 no restraint reassessment was performed from 10:00 a.m., to 6:00 p.m. On 4/6/21 no restraint reassessment was performed in regards to the evidence as to the justification for the need of restraints from 8:00 a.m., to 6:00 p.m. On 4/7/21 no restraint reassessment was performed from 6:00 a.m., to 8:00 p.m. On 4/9/21 no restraint reassessment was performed from 4:00 p.m., to 6:00 p.m. On 4/10/21 no restraint reassessment was performed from 10:00 a.m., to 6:00 p.m. On 4/16/21 no restraint reassessment was performed in regards to the evidence as to the justification for the need of restraints from 8:00 a.m., to 7:00 p.m. On 4/17/21 no restraint reassessment was performed in regards to the evidence as to the justification for the need of restraints from 8:00 a.m., to 6:00 p.m. On 4/18/21 no restraint reassessment was performed in regards to the evidence as to the justification for the need of restraints from 8:00 a.m., to 6:00 p.m. On 4/20/21 no restraint reassessment was performed from 10:00 a.m., to 6:00 p.m. The CN was acknowledged and confirmed Patient 101's restraints were not reassessed every two hours as per their policy.

During the same clinical record review for Patient 101 and concurrent interview with the critical care unit nurse director (ND) on 4/27/21 at 12:25 p.m., the record revealed Patient 101 had no physician's renewal restraint orders for 3/27/21, 3/31/21, 4/1/21, 4/6/21, 4/13/21, 4/14/21, and 4/15/21. The ND acknowledged the record review observation and agreed physician's orders for restraints were missing on those dates.


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2. During an interview with Director of Acute Care Services (DACS), on 4/28/21, at 9:30 a.m., while concurrently reviewing sampled Patient 201 medical record, the record revealed Patient 201 was placed in restraints on 4/25/21, at 6:05 p.m., for non-violent behavior. Review of the individual reassessment by RN did not reveal a skin and circulation assessment. DACS, acknowledging the skin reassessment was not completed per hospital policy, stated, "Because the patient had skin pressure issues, the nurse should have documented in the formal skin evaluation, but that didn't happen."

The hospital policy and procedure titled, "Restraint for Non-Violent/Non-Self Destructive Behavior," dated 04/2021, page 6, indicated in part, " A. The RN assesses on initiation and reassesses the patients status and response to restraints at intervals not greater than two (2) hours. The RN; ... 4. Assesses skin integrity under the restraint..."

The CONDITION OF PARTICIPATION is not met when :


1. The hospital's governing body failed to assume responsibility and accountability for ensuring that an ongoing program for effective quality improvement was defined, implemented, and maintained. (Cross Reference A0309, A0283 and A0315).


2. The QAPI program failed to set priorities for it's performance improvement activities that focused on high risk/high volume activities impacting year 2020, when the hospital experienced significant Covid outbreaks for both staff and patients with surveillance data not monitored consistently. Review of the hospital's calendar year 2020 QAPI program, did not reflect the development or implementation of performance improvement project(s) that addressed the known high risk activities, in order for the hospital to implement preventative actions. (Cross-Reference A-0283)


3. The hospital failed to ensure a effective QAPI program was in place, when they failed to measure, analyze and track hospital operations to provide infection control activities, in order to ensure the provision of patient care in a safe environment (Cross Reference A-0309).

4.The hospital failed to ensure adequate resources were allocated for implementation of the quality assurance program, creating the risk of persistent poor practices and substandard healthcare (Cross Reference A-0315).


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

Based on interview and record review, the hospital failed to prioritize its performance improvement activities that: Focus on high-risk, high-volume, or problem prone areas; consider the incidence, prevalence, and severity of problems in those areas and affect health outcome ,patient safety and quality of care. The failure to ensure that specific QAPI program activities were met created the potential for persistent poor healthcare practices and placed patients at risk for harm.

Findings:

Review of hospital's 2020 Quality Assurance plan titled, " (name of the hospital) Plan for the Provision of Care and Organization Performance Improvement 2020.", page 17 of 54 indicated in part... " B. Performance measures based on high volume , high risk, high costs, problem prone functions, opportunities for breakthrough improvement..." pg 18/54 revealed in part... " At the discretion of the Performance Improvement Committee and Governing Board, changes may be made in the organization wide quality and/or program structure at a time other than the formal evaluation."

During an interview with the Director of Acute Care Services (DACA), on 4/26/21, starting at 10:35 a.m., DARCA explaining the outbreaks of 2020/2021 Covid infections for both patients and staff, stated, "During the surges approximately fifty percent or about 100 of 200 patients admitted were positive for Covid infection." When asked about staffing experience for positive Covid, DACA stated, "We had to use both Travelers (a temporary nursing staffing agency) and requests to the State for emergency staffing to care for incoming positive patients." When asked if Covid infections was possibly the most high risk /high volume activity occurrence in 2020 ? DACA stated, "Yes, I think so."

During an interview with QA Manager (QAM) on 4/27/21, at 10:50 a.m., while reviewing the hospital's process improvement projects (PIP) for 2020, QAM described process for selection of individual PIP, based on 2019 data experience and corporate recommendations. QAM acknowledged the impact of Covid on hospital systems as high risk and high volume and that 2020 PIP did not include Covid infection process improvement projects. When asked if 2020 projects were altered or discussed to review opportunities to include Covid related process improvement projects QAM stated, "No, I don't believe we changed from the original 2020 PIP plan (developed and approved in 2019)."

Based on observation, interview and record review, the Governing Body failed to be responsible for the implementation of the quality program because it failed to ensure that data was correctly gathered and reported, and because events that could affect the safety of the hospital were not reviewed and discussed within the Quality Committee of the Governing Board, creating the risk of persistent poor practices and an unsafe environment.

Findings:

Review of hospital's 2020 Quality Assurance plan titled, " (name of the hospital) Plan for the Provision of Care and Organization Performance Improvement 2020.", page 15 of 53, indicated in part.... "Chapter Three. Performance Improvement A. Authority and Accountability. 1. Governing Board.... The Board authorizes Administration and Medical Staff to monitor and evaluate the services provided, to pursue opportunities for process improvement.

1. During a interview with Infection Control Manager (IP), on 4/27/21, starting at 8:10 a.m.,while reviewing the QA committee processes, IP manager stated, " The infection control committee meets on a quarterly basis." When asked to see the minutes for the 2020 infection control committee, IP manager stated, " We only met twice in 2020, because we were too busy."

Asked to review the metrics for "social distancing break room logs and aerosol generating procedure logs" described by IP as monitoring processes for prevention of hospital acquired infections, IP was only able supply the templates. When asked about the metrics and data for 2020, IP Stated, "We didn't keep this information, we did these observations sporadic when I was up on the unit, only on the day shift because there are only two of us. I just shared information with the charge nurse."

During a interview with Infection Control Manager (IP), on 4/27/21, starting at 8:10 a.m.,while concurrently reviewing QA records of Infection Control, metrics for observations of proper PPE(personal protection equipment) compliance, for the third quarter QA Committee recorded, 12 observations in 08/20, 48 observations in 09/20, and 12 observation in 10/20 . When asked how many observation were identified for monitoring, IP stated, "forty." Asked why the lack of observations for 2 out of 3 months in the last quarter, IP stated, " There are only two of us in the department and we really didn't have time."


2. During a concurrent interview and record review with Antibiotic Stewardship Pharmacist 1 (AP1), on 4/26/2021 at 11:30 am, revealed that all of the Pharmacists in the hospital's Pharmacy, had currently been using the hospital's 2019 AEARA document. Interview with the Chairperson of Antimicrobial Stewardship Program (CAS) on 4/26/201 at 12:20 pm, revealed that the hospital had a 2020 AEARA version which been created and approved by the hospital's Governing Body for current implementation on 1/4/2021 (almost four months ago), yet this version of the AEARA, could not be found on the hospital's computer system (known as "Epic"). The hospital's 2019 AEARA version, had been placed in "Epic", after its approval, allowing access to this document by all of the hospital's staff (Nurses, Pharmacists, Medical staff, etc.).

Interview and document review with the Director of Pharmacy (DOP) on 4/27/2021 at 12:00 pm revealed that the hospital's Pharmacy had conducted a Medication Utilization Evaluation (MUE) in 5/2020 and the overall evaluation of the report had been completed in 10/2020. The MUE report revealed that in comparison to the hospital's other five sister hospital's (in Southern California), this hospital had the highest use of Meropenem (a broad spectrum antibiotic), for sepsis and pneumonia diagnoses, which the Antimicrobial Stewardship determined, could have been treated, just as effectively with a less expensive, equally effective, and a narrower spectrum antibiotic (Cefepime). Through this study, the hospital's Antibiotic Stewardship Committee decided to start dramatically reduce its use of Meropenem and replace this antibiotic with Cefepime for certain disease diagnoses (as long as the patient did not have an allergy to penicillin like drugs). This change resulted in the revision of the hospital's 2019 AEARA to the 2020 version of the AEARA.

During a concurrent interview and record review with staff Pharmacist 1 (SP1) on 4/27/2021 at 3:10 pm, SP1, was asked he was aware of any updates to the 2019 AEARA. SP1 replied, that he was not aware of any newer versions of the AEARA 2019 document. SP1, was also asked during this interview, if he had ever seen the hospital's Medication Use Evaluation (MUE) report on Meropenem. SP1, indicated that he had never seen this evaluation before and he also indicated that no one from the hospital had ever spoken with or shared the results of this study with him. SP1, was completely unaware of the hospital's attempt to reduce the use of Meropenem and its replacement with Cefepime (a narrower spectrum antibiotic), based on the Antibiotic Stewardship's most current (2020) of its AEARA.

The Governing Body Committee (Quality Board Committee), [which approved the 2020 version of the AEARA on 1/4/2021], never appeared to question the ease of use or the clarity of the new 2020 version of the hospital's AEARA Guidelines. It almost appeared that this Committee moved this version of the 2020 AEARA guideline through without any concerns.

The hospital's governing body failed to ensure that the 2020 AEARA, which the committee had approved, had been implemented and monitored after 1/4/2021.


3. According to the Association of periOperative Registered Nurses (AORN) guidelines for perioperative practice titled: "Environmental Cleaning" dated 2012-2021, indicated in part ..." Having an interdisciplinary team select disinfectants for use in the perioperative setting based on the following factors: Environmental Protection Agency (EPA) registration and hospital grade rating ...targeted microorganisms...contact times...chemical manufacturers' instructions for use (MFU's) ...compatibility with surfaces, cleaning materials, and equipment."

During a concurrent observation, and interview, on 4/26/21, at 12:40 p.m., with environmental services staff (EVS 1), the EVS cart, on the labor and delivery unit, was observed. EVS 1 verbalized the cleaning bucket contained oxyvir solution (disinfectant to kill microorganisms-virucide-bactericide, tuberculocide, and fungicide) and the mop bucket contained stride solution (a neutral cleaner). EVS 1 verbalized the oxyvir was used on the hard surfaces, countertops, and beds. The stride solution was used on the floors. EVS 1 further verbalized the solutions are premixed and stored in the EVS closet. The jug of oxyvir solution was observed in the EVS closet and the manufacturers label indicated the solution was a cleaner and disinfectant. The stride solution was observed on a wall dispensing unit, in the EVS closet, and the manufacturers label indicated the solution was a neutral cleaner not a disinfectant.

During an interview on 4/26/21, at 12:45 p.m., with the director of environmental services staff (DEVS), DEVS acknowledged the stride cleaner was not a disinfectant and should not be used to clean the floors. DEVS verbalized oxyvir should be used on all surfaces, countertops, and floors throughout the whole hospital.

During a concurrent observation and interview on 4/27/21, at 9:18 a.m., with environmental services staff (EVS 2), during a room turnover (cleaning the operating room between patients), in labor and delivery operating room (OR 1), was observed. EVS 2 verbalized OR 1 floor was cleaned with stride.

During an interview on 4/27/21, at 10:00 a.m., with DEVS, DEVS acknowledged stride should not be used to clean the operating room floors.

4. During a review of the facility's policy and procedures titled "Surgical & Special Procedures Area Cleaning" dated 1/17, indicated in part ... "Surgery and special procedure rooms are the most critical areas of the hospital ...extreme care must be taken to ensure that established scheduled cleaning is carried out rigorously and in accordance with established procedures ...between case cleaning: move and wash OR table, lights and furniture with germicidal solution ...spot wash walls and any equipment as needed with germicidal solution ...wet mop floor of the OR suite with germicidal solution."

During a concurrent observation and interview on 4/27/21, at 8:50 a.m., with Environmental Services Staff (EVS3), by the Emergency Room (ER) EVS cleaning closet, it was observed that various cleaning products were inside. When asked to distinguish which products are used, EVS1 stated that "Glance" (a glass and multi-surface cleaner) is for glass surfaces, "Oxivir" for all touched surfaces, and "Stride" for cleaning all ER floors.

During an concurrent observation and interview on 4/27/21, at 3:10 p.m., with EVS4 and Nurse Manager (NM3), at the Medical/Surgical fourth floor wing, EVS2 showed the EVS cleaning closet and discussed what products were used in that particular unit. EVS2 stated that "Glance" is for glass surfaces, "Oxivir" for all surfaces, while "Stride" is no longer used hospital-wide.

During a group interview on 4/27/21, at 4:50 p.m., with the Infection Preventionist (IP), the IP confirmed that Oxivir is a disinfectant, while Stride is a cleaner, used on the hospital floors. The IP agreed that the cleaning/disinfecting products are inconsistently used all over the hospital. The IP further states that cleaning and disinfecting should be enhanced and not decreased.

During a review of the facility's policy and procedure (P&P) titled, "RME & Emergency Department Cleaning Procedure," dated 01/16/2017, the P&P indicated, "Purpose: To provide a standard routine for cleaning; to ensure correct and effective cleaning techniques while maintaining infection control in designated area."

5.According to AORN guidelines titled, "Flexible Endoscopes-Processing Area", dated 2012-2021, the guidelines indicated in part, ..." Except for precleaning processes performed at the point of use, perform endoscope processing in a room where only processing activities are performed and that is physically separated from locations where patient care activities are performed ...limiting endoscope processing activities to designated processing rooms may help prevent contamination of procedure rooms and patient care areas ...the endoscopy processing room should include a door that provides access to and from the decontamination area or decontamination room and a separate door that provides access to and from the clean area or clean workroom ...doors to the decontamination area and clean area help contain contaminants within the processing room and help prevent cross contamination."

During a concurrent observation, and interview, on 4/28/21, at 10:45 a.m., in the gastrointestinal laboratory (GI Lab- (where endoscopic procedures take place to help doctors diagnose and treat conditions of the digestive tract),with the GI Lab nurse manager (NM 2) and endoscope technician (ET 1), it was observed there was an AER machine. The AER machine was approximately eight feet from the patient procedure bay. There was no door or barrier between the AER machine and patient care bay. When asked if the AER machine had always been in the GI Lab,
NM 2 stated, "Yes it has always been here". When asked had there been a door or barrier between the patient procedure bay and the AER machine, NM 2 stated, "No". ET 1 verbalized the endoscope is transported to the decontamination room to get manually cleaned and then is brought back to the GI Lab for high level disinfection in the AER machine. When asked if the AER machine is processing scopes at the same time as patient procedures, ET 1 stated, "Yes".

During and interview on 4/28/21, at 1:28 p.m., with the POD and the surgical services manager (NM 1), Both POD and NM 1 acknowledged they use AORN guidelines for reprocessing endoscopes.

During a review of the facility policy and procedures titled, "Endoscope - GI Reprocessing", dated 4/21, indicated in part ... " Automated endoscope reprocessor (AER): the manufacturer's recommendation for both the scope and the reprocessor should be consulted to ensure that they are compatible for high level disinfection." The policy did not indicate where the AER machine should be stored.


6. The 2019, Guidelines for Peri-Operative Practice, in part 1X.b, indicated "Flexible endoscopes should be stored in accordance with the endoscope and storage cabinet manufacturers' IFU. Following the manufacturers' IFU helps ensure safe and effective storage of endoscopes. In part 1X.b.1, indicated "Flexible endoscopes should be stored in a drying cabinet.[High Evidence]. The collective evidence shows that optimal storage of flexible endoscopes facilitates drying, decreases the potential for contamination, and provides protection from environmental contaminants ... A wide variety of storage cabinets include a dying system that circulates HEPA-filtered air through the cabinet while filtered air under pressure is forced through the endoscope channels. The internal and external surfaces of the endoscope are continuously dried, suppressing bacteria growth."

The hospital policy and procedure entitled "Endoscope- GI Reprocessing", last revised 11/16, in the Endoscope Maintenance part indicated "1. Endoscopes should be maintained according to manufacturers' recommendations ..."
The [Manufacturer Name] endoscopes manufacturer's information for use (IFUs), undated, in part 8.2 Storing and Disinfecting Endoscopes indicated "Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices. Be sure that the endoscope storage cabinet is properly maintained, clean and well ventilated."

During a tour of the gastroenterology (GI) lab and concurrent interview with the peri-operative director (POD) on 4/28/21 at 4:30 p.m., thirteen (13) Olympus endoscopes (scope-a long, thin tube with a tiny camera attached at the end used to see inside the intestines) were observed stored in a two compartment storage cabinet/closet. The cabinet was inspected to ensure that there was some type of open area or ventilation area. However, the cabinet did not have any openings or any area where air could enter into the cabinet. The POD confirmed the hospital had adopted Society of Gastroenterology Nurses and Associates (SGNA) and Association of PeriOperative Registered Nurses (AORN) professional guidelines for the GI lab services. A review of the [Manufacturer Name] endoscopes manufacturer's information for use (IFUs) was conducted with the POD. The manufacture's IFUs indicated to store the scopes in a "well ventilated area." A review of the SGNA guidelines was conducted with the POD. The SGNA guidelines indicated to follow the scopes manufacture's IFUs. A review of the AORN guidelines was conducted with the POD. The AORN guidelines indicated "flexible endoscopes should be stored in a drying cabinet." The POD acknowledged the observation and agreed currently the endoscopes are not being stored properly and as per manufacture's IFUs, SGNA and AORN guidelines. POD stated "I agree this cabinet does not have an open area for ventilation and does not have a HEPA filter (inside the cabinet)."

During a review of the AORN guidelines with the infection preventionist (IP) on 4/28/21 at 4:59 p.m., the IP acknowledged and agreed that storing the endoscopes in this cabinet has a high risk of growing bacteria therefore there's a high risk of patients acquiring infections. This is a patient safety concern.


7. According to the centers for disease control (CDC) in the guideline titled "Following Infection Prevention and Control Recommendations in Healthcare Settings During the COVID-19 Pandemic", revised 6/9/20 indicated "Maintain physical distance as much as possible. Use video conferencing and increase workstation spacing. Reduce the number of individuals allowed in common areas such as breakrooms and on elevators. Source control helps prevent transmission from infected individuals who may or may not have symptoms of COVID-19. Cloth face coverings are not considered personal protective equipment (PPE); they are source control. HCP should wear appropriate PPE ..."

During an interview with the infection preventionist (IP) on 4/26/21 at 10:47 a.m., the IP reported that on 11/23/20 there was a COVID-19 outbreak in the rehabilitation services (P.T.) area. Two physical therapist P.T. and one P.T. aide tested positive for COVID-19 virus. This occurred after a Pizza and a staff farewell gathering that took place in the P.T. department on 11/23/20. The IP was asked if she performed line tracing or tracking of the patients that had been exposed to these three COVID-19 positive staff and line tracing of staff that gathered together in the same area on 11/23/20. IP explained she did not performed line tracing or tracking of any patients or staff that potentially were exposed to COVID-19 virus. According to the IP, the Los Angeles county department of public health indicated there was no need to perform line trancing for hospital patients that have had contact with these three P.T. staff as long as the patients and staff were wearing the appropriate personal protective equipment (PPE). However, the IP was not able to provide evidence of such communication with the L.A. county public health department. Furthermore, the IP was not able to provide evidence the P.T. staff and patients were wearing the appropriate PPE.

During an observation of the P.T. department and concurrent interview with administrative director of physical therapy (ADPT) on 4/26/21 at 11:30 a.m., the ADPT confirmed staff took breaks, ate and gathered inside the P.T department. This was the only area where the staff can gather or take a break. The department area was small and cluttered with P. T. supplies. Tables with computers (use for documenting) were observed all around the department. Small refrigerator, water bottles, ultrasound therapy machine...were observed inside this small department.

During an interview with physical therapist (PT 2) on 4/26/21 at 12:49 p.m., PT 2 explained on 11/23/20 the P.T. department had a pizza and a staff farewell gathering in the P.T department. Up to ten staff gathered in the same place and time. According to PT 2, a PT aide have had a "bad flu" earlier to the gathering on 11/23/20. PT 2 indicated the gathering in the P.T department was the source of COVID-19 infection outbreak. Furthermore, PT 2 reported inside the P.T department there was no room for social distancing of 6 feet. There was also no signage anywhere in the P.T. department as to how many staff could be inside the department at the same time based on the area square footage.

During an interview with PT aide (PTA) on 4/27/21 at 2:51 p.m., PTA explained that on 11/23/20 the rehabilitation staff had a pizza, a staff farewell and a staff meeting gathering, all at the same time in the P.T. department. Most of the staff attended the staff meeting at the same time. Staff were not told how many staff could be inside the P.T department at the same time (based on the department room size). PTA reported not seeing and having any signage in regards to six feet social distancing inside the P.T. department. Furthermore PTA reported the staff meeting that took place on 11/23/20 was the source of the COVID-19 infection outbreak.

During an interview with physical therapist (PT 4) on 4/29/21 at 9:39 a.m., PT 4 explained on 11/23/20 the P.T. department had a pizza, a staff farewell and a staff meeting gathering in the P.T department. Most of the staff attended the staff meeting all together. PT 4 had not seen any signage on six feet social distancing and number of staff allowed inside the department, at the same time. According to PT 4, the staff meeting was the source of COVID-19 infection outbreak.

During an interview with PT 1 on 4/26/21 at 11:58 a.m., PT 1 reported not having or seeing any signage inside the P.T department in regards to social distancing and as to how many staff were allowed inside the department at the same time.

During an interview with the ADPT on 4/26/21 at 11:27 a.m., the ADPT confirmed the rehabilitation services department gathering on 11/23/20 and that this event was coordinated by him. Furthermore, ADPT acknowledged that during the gathering staff removed their mouth mask to eat the pizza. The P.T. department area is too small to house the rehabilitation services staff at the same time. There was no social distancing between staff due to the size of the department. ADPT reported not knowing how many staff could be allowed inside the P.T department, at the same time based on the size of the area or square footage.

A review of the rehabilitation services department staff schedule for 11/23/20 was conducted. The staff schedule indicated two speech therapist, two occupational therapist and eight physical therapist worked on 11/23/20. A total of 12 staff were working on this date.

During an interview with the IP on 4/27/21 at 8:58 a.m., IP acknowledged and confirmed the hospital had not addressed social distancing and signage as to the number of staff allowed inside a breakroom area/room based on square feet until after the 11/23/20 COVID-19 outbreak.

Based on interview and record review, the hospital did not ensure that adequate resources were allocated for implementation of the quality assurance program, creating the risk of persistent poor practices and substandard healthcare.

Findings:

Review of hospital's 2020 Quality Assurance plan titled, " (name of the hospital) Plan for the Provision of Care and Organization Performance Improvement 2020.", page 15 of 53, indicated in part.... "Chapter Three. Performance Improvement A. Authority and Accountability. 1. Governing Board.... The Board authorizes Administration and Medical Staff to monitor and evaluate the services provided, to pursue opportunities for process improvement. The board has made the commitment to provide the support necessary for the program so that Administration can provide the specific resources indicated."

During a interview with Infection Control Manager (IP), on 4/27/21, starting at 8:10 a.m.,while reviewing the QA committee processes, IP manager stated, " The infection control committee meets on a quarterly basis." When asked to see the minutes for the 2020 infection control committee , IP manager stated, " We only met twice in 2020, because we were too busy."

Asked to review the metrics for "social distancing break room logs and aerosol generating procedure logs" described by IP as monitoring processes for prevention of hospital aquired infections, IP was only able supply the templates. When asked about the metrics and data for 2020, IP Stated, "We didn't keep this information, we did these observations sporadic when I was up on the unit, only on the day shift because there are only two of us. I just shared information with the charge nurse."

During a interview with Infection Control Manager (IP), on 4/27/21, starting at 8:10 a.m.,while concurrently reviewing QA records of Infection Control, metrics for observations of proper PPE(personal protection equipment) compliance, for the third quarter QA Committee recorded, 12 observations in 08/20, 48 observations in 09/20, and 12 observation in 10/20 . When asked how many observation were identified for monitoring, IP stated, "forty." Asked why the lack of observations for 2 out of 3 months in the last quarter, IP stated, " There are only two of us in the department and we really didn't have time."

The CONDITION OF PARTICIPATION is not met as evidenced by:

1. Filter machines (HEPA) used in COVID -19 (highly contagious virus causing respiratory infection and distress reason for nation-wide Public Health Emergency-PHE) designated patient rooms were not checked if functioning properly to prevent and control transmission of infectious materails and staff protective equipments (PPE) were not stored properly. ( Cross Reference A0749).

2. a. Hospital using a common cleaning solution and not the authorized disinfectant to sanitize and disinfect floors, hard surfaces, high touch areas, counters, in hospital's operating, labor and delivery, and emergency rooms according to hospital policy and procedure and Enviromental Protection Agency (EPA).
b. Cleaning the operating rooms (ORs) in between patient use according to Association of Operating Room Nurses(AORN).
c. AORN guidelines were not followed when the automated endoscope reprocessor (AER) was found in a patient care area.
d. AORN guidelines and manufaturer's instructions for use (MFU's) were not followed when the AER was found in a non-negative pressue room.
e. Hospital equipment was not stored or cleaned according to policy and procedure and centers of Disease Control (CDC) standards of practice.
f. AORN guidelines and MFU's were not followed in the storage of endoscopes (elongated thin instrument with attached camera to view the intestines).
g. Three hospital employees with COVID -19 symptoms were found not following the PHE guidelines while inside the hospital premises. (index case) ( Cross Reference A0750).

3. No system had been put in place for tracking of infection surveillance, and implemented success or sustainability of hospital's antibiotic use activities. (Cross Reference A0770).

4. Infection Control Manager failed to consistently record documentation of all surveillance, prevention and control activities -no inclusion of gathering documentation for monitoring of surveillance and prevention control activities. (Cross Reference A0773).

5. Infection Preventionist failed to ensure Rehabilitation Staff (Physical Therapist and Physical Therapist Aides) were educated and demonstrated competence in the donning and doffing of PPE in compliance with the PHE guidance to prevent transmission of COVID -19 infection in the the Rehabilitation Department. ( Cross Reference A0775).

6. Failure of the Antibiotic Stewardship Program leadership to effectively communicate and collaborate with Medical Staff ( Hospitalist, Nursing and Pharmacy) on anitbiotic use and the hospital's version of the "Adult Empiric Antibiotic Recommendations and Antibiogram -(AEARA)." (Cross Reference A0780).

7. Lack of competency-based training and education of facility personnel with the guidelines, policies, and procedures of the antibiotic stewardship program (Cross Reference A0781).


On 4/27/21, at 5:38 p.m., the survey team called an Immediate Jeopardy (IJ) after identifying multiple inconsistent sanitation issues in various areas, and revealed a pattern of unsafe infection control practices in the facility. The facility failed to safeguard the health and wellbeing of patients and staff with the potential to spread and transmit infections and follow infection control standards of practice. (Refer to A0750, Item 1)

On 4/28/21, at 1:35 p.m. the survey team calls the second IJ when the Automated Endoscope Reprocessor (AER) machine was located within the GI Lab's patient care area. Upon further investigation, the endoscope reprocessing area was found to be in a non-negative pressure room. Again, a failure to protect the health and wellbeing of patients and staff, with the potential to spread deadly microorganisms within the reprocessing area, and not adhering to nationally recognized infection control best practices. (Refer to A0750, Items 3&4)

The cumulative effects of these systemic problems resulted in the facility's inability to ensure effective system-wide programs in providing quality health care in a safe and sanitary patient environment.

Based on observation, interview and record review the hospital staff failed to:
1. Ensure the HEPA filter machines in the COVID-19 virus (a highly contagious respiratory disease caused by SARS-CoV-2 that can trigger an acute respiratory tract infection and syndrome) designated rooms were properly functioning for preventing and controlling the transmission of infections.
2. Staff personal protective equipment (PPE) was stored inappropriately.

These failures placed patients and staff at risk of acquiring infections.

Findings:

1. During a tour of the overflow Critical care unit rooms (115, 116, 117, and 118) and concurrent interview with the unit nurse director (ND) on 4/28/21 at 10:09 a.m., the ND explained these four rooms have been assigned to be ready for used for the Covid positive patients. These four rooms do not have negative pressure. However each room has a HEPA filter machine to help circulate the air inside the room when there is a positive Covid patient inside. The HEPA filter machine is an air purifier with a HEPA filter that removes 99.97% of dust, pollen, mold, bacteria and airborne particles.The nursing staff turns on the HEPA filter machine. The machine goes through its cycle. The LED light and the filter light are supposed to be green indicating the HEPA filter and light in machine are functioning correctly. If the LED light or the filter light turns red this indicates the filter or the LED light needs to be replaced. The HEPA filter machine in room 117 was turn on. The filter machine went through its cycle. However the filter light was observed to remain red indicating the filter needed to be replaced. It was communicated to ND there was a concern because we do not know how long the filter red light has been red. ND was asked who monitors the HEPA machines to ensure they are functioning properly. ND indicated no nursing staff in the critical care unit or facilities monitors the HEPA filters to ensure that they are working correctly. ND acknowledged the observation and agreed that this is a patient safety issue if a Covid positive patient is in one of the rooms and the HEPA filter machine it's not functioning properly.

During an interview the facilities director (FD) on 4/28/21 at 11:02 a.m., the FD confirmed the HEPA filter machine red light indicates the filter must be replaced. FD stated "I will take this HEPA machine away and replace the filter."

The hospital's policy and procedure entitled "Infection Prevention: Portable HEPA Filter", revised 2/20, indicated "It is the policy of [Hospital Name] to develop processes and procedures to prevent potential exposure from any patient who is confirmed infectious for Aerosol Transmissible disease. In the part Patient Safety- Nursing indicated "2. Follow the Service indicator lights on the control panel for Air Quality, Air Filter and UV Lamp Service."

The portable HEPA Filter machine manufacturer's information for use (IFUs) provided by FD on 4/28/21 in the Maintenance part indicated "Indicator lights on the Service Panel tell you if either the air filter or the germicidal ultraviolet lamp will soon need to be cleaned or replaced. Air Filter Indicator Light:* Red LED light is On- The filter has been in service for more than six months. It is time to vacuum off the top pre-filter to maintain maximum air flow."



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2. During a concurrent observation, and interview, on 4/26/21, at 12:10 p.m., with physical therapist (PT1), the physical therapy department was inspected. Within the physical therapy department used N95 respirators were observed stored in the following locations, in a plastic container, a staff cubby, hanging from a bulletin board and hanging from a wall fixture. Inside the physical therapy departments bathroom, personal protective equipment (PPE) was found, including, gowns and face shields. Patient socks, a rice cooker, and various kitchen utensils were also stored in the bathroom. PT 1 acknowledged storing two used N95 respirators alongside two used surgical masks in a paper bag. PT 1 further acknowledged the used N95 respirators found throughout the physical therapy department were not stored correctly. PT 1 acknowledged the bathroom of the physical therapy department was also used for storage of PPE supplies, patient socks, and kitchen utensils and equipment.

During an interview on 4/27/21, at 3:11 p.m., with infection preventionist (IP 1), IP 1 was shown images of the used N95 masks stored in the physical therapy department along with images of the bathroom used as the physical therapy departments storage room and kitchen. IP 1 verbalized the hospital stopped the practice of reusing N95 respirators earlier in the year and the staff shouldn't be reusing N95 respirators. IP 1 further acknowledged the used N95 respirators kept in the physical therapy department were stored incorrectly. IP 1 further acknowledged that hospital supplies and kitchen equipment and utensils should not have been stored in the bathroom.

During a review of "Updated Covid-19 Personal Protective Equipment (PPE) Use Instructions for Caregivers -March 2021" dated 3/19/21, indicated in part "Providence has returned to a position of confidence in disposable N95 respirator and facemask supply and has determined that reuse and extended use strategies are no longer required to maintain PPE supply ...these strategies should be discontinued for disposable N95 respirators and facemasks being used for standard or transmission- based precautions."

Based on observation, interview, and record review, the facility failed to ensure a safe and sanitary environment when:

1. Using a cleaner not a disinfectant to clean:
(a).The floors in labor and delivery
(b).The hard surfaces, counter tops, and floors in the operating rooms (OR's)
(c).The floors in the emergency room

2. Cleaning the OR's between patients (room turn over) was not done according to The Association of periOperative Registered Nurses (AORN) guidelines.

3. AORN guidelines were not followed when the automated endoscope reprocessor (AER) machine was found to be in a patient care area.

4. AORN guidelines and manufacturer's instructions for use (MFU's) were not followed when the AER machine was found to be in a non-negative pressure room.

5. Hospital equipment was not stored or cleaned according to policy and procedures and centers for disease control (CDC) standards of practice.

6. AORN guidelines and MFU's were not followed in the storage of endoscopes (a long, thin tube with a tiny camera attached at the end used to see inside the intestines)

7. Three employees contracted the COVID-19 virus (a highly contagious respiratory disease caused by SARS-CoV-2 that can trigger an acute respiratory tract infection and syndrome)

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, potential to result in procedural and surgical site infections, and resulted in three staff members contracting the COVID-19 virus.

Findings:

1.(a). According to the Association of periOperative Registered Nurses (AORN) guidelines for perioperative practice titled: "Environmental Cleaning" dated 2012-2021, indicated in part ..." Having an interdisciplinary team select disinfectants for use in the perioperative setting based on the following factors: Environmental Protection Agency (EPA) registration and hospital grade rating ...targeted microorganisms...contact times...chemical manufacturers' instructions for use (MFU's) ...compatibility with surfaces, cleaning materials, and equipment."

During a concurrent observation, and interview, on 4/26/21, at 12:40 p.m., with environmental services staff (EVS 1), the EVS cart, on the labor and delivery unit, was observed. EVS 1 verbalized the cleaning bucket contained oxyvir solution (disinfectant to kill microorganisms-virucide-bactericide, tuberculocide, and fungicide) and the mop bucket contained stride solution (a neutral cleaner). EVS 1 verbalized the oxyvir was used on the hard surfaces, countertops, and beds. The stride solution was used on the floors. EVS 1 further verbalized the solutions are premixed and stored in the EVS closet. The jug of oxyvir solution was observed in the EVS closet and the manufacturers label indicated the solution was a cleaner and disinfectant. The stride solution was observed on a wall dispensing unit, in the EVS closet, and the manufacturers label indicated the solution was a neutral cleaner not a disinfectant.

During an interview on 4/26/21, at 12:45 p.m., with the director of environmental services staff (DEVS), DEVS acknowledged the stride cleaner was not a disinfectant and should not be used to clean the floors. DEVS verbalized oxyvir should be used on all surfaces, countertops, and floors throughout the whole hospital.

During a concurrent observation and interview on 4/27/21, at 9:18 a.m., with environmental services staff (EVS 2), during a room turnover (cleaning the operating room between patients), in labor and delivery operating room (OR 1), was observed. EVS 2 verbalized OR 1 floor was cleaned with stride.

During an interview on 4/27/21, at 10:00 a.m., with DEVS, DEVS acknowledged stride should not be used to clean the operating room floors.

During a review of the facility's policy and procedures titled "Surgical & Special Procedures Area Cleaning" dated 1/17, indicated in part ... "Surgery and special procedure rooms are the most critical areas of the hospital ...extreme care must be taken to ensure that established scheduled cleaning is carried out rigorously and in accordance with established procedures ...between case cleaning: move and wash OR table, lights and furniture with germicidal solution ...spot wash walls and any equipment as needed with germicidal solution ...wet mop floor of the OR suite with germicidal solution."

1 (b). During an interview, on 4/27/21, at 9:53 a.m., with surgical tech (ST 1) and nurse manager NM 1, ST 1 was asked what product was used on hard surfaces during operating room turnovers. ST 1 verbalized the staff used "Stride" ( a cleaning agent which is not an EPA registered disinfectant). ST 1 further verbalized that "Stride" was used for overhead lights, counter tops and blood splashes. NM 1 confirmed ST 1's statement regarding "Stride" being used for hard surfaces during operating room turnovers.

1 (c). During a concurrent observation and interview on 4/27/21, at 8:50 a.m., with Environmental Services Staff (EVS3), by the Emergency Room (ER) EVS cleaning closet, it was observed that various cleaning products were inside. When asked to distinguish which products are used, EVS1 stated that "Glance" (a glass and multi-surface cleaner) is for glass surfaces, "Oxivir" for all touched surfaces, and "Stride" for cleaning all ER floors.

During an concurrent observation and interview on 4/27/21, at 3:10 p.m., with EVS4 and Nurse Manager (NM3), at the Medical/Surgical fourth floor wing, EVS2 showed the EVS cleaning closet and discussed what products were used in that particular unit. EVS2 stated that "Glance" is for glass surfaces, "Oxivir" for all surfaces, while "Stride" is no longer used hospital-wide.

During a group interview on 4/27/21, at 4:50 p.m., with the Infection Preventionist (IP), the IP confirmed that Oxivir is a disinfectant, while Stride is a cleaner, used on the hospital floors. The IP agreed that the cleaning/disinfecting products are inconsistently used all over the hospital. The IP further states that cleaning and disinfecting should be enhanced and not decreased.

During a review of the facility's policy and procedure (P&P) titled, "RME & Emergency Department Cleaning Procedure," dated 01/16/2017, the P&P indicated, "Purpose: To provide a standard routine for cleaning; to ensure correct and effective cleaning techniques while maintaining infection control in designated area."


2. According to AORN guidelines for perioperative practice titled: "Environmental Cleaning" dated 2012-2021, indicated in part... "All personnel should take precautionary measures to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ..perform cleaning activities in a methodical pattern that limits transmission of microorganisms...the method for cleaning may limit transmission of microorganisms and reduce the risk of cross contamination of environmental surfaces...cleaning should progress from clean to dirty areas...cleaning should progress from top to bottom areas...clockwise or counter-clockwise cleaning may be performed when used in conjunction with clean-to-dirty and top-to-bottom methods...always consider floors in the perioperative practice setting to be contaminated...when mopping, progress from the cleanest to dirtiest areas of the floor...the center of the room, where most of the patient care occurs, is most likely to have higher levels of contamination."

During an observation on 4/27/21, at 9:20 a.m., in OR 1, in labor and delivery, EVS 2 was cleaning the operating room between patients. EVS 2 proceeded to clean the lights, then cleaned the bed, then cleaned outer periphery counter tops and equipment. The cleaning method (flow pattern) went from clean to dirty and then back to clean. EVS 2 proceeded to mop the floor from periphery of the room, then moved toward the middle of room, then around the bed, then outward toward the periphery of the room, then exited the room. Mopping flow pattern went from clean to dirty then back to clean.

During an interview on 4/27/21, at 9:35 a.m., with the perioperative director (POD), POD observed the cleaning sequence of OR 1, in labor and delivery, and verbalized it was not correct. POD acknowledged AORN guidelines indicating the cleaning flow pattern should go from clean to dirty.

During a concurrent observation and interview on 4/28/21, at 9:43 a.m., in operating room four with nurse manager (NM 1) a room turnover was observed. Environmental Services Technician (EVS 5) and environmental services technician (EVS 6) proceeded to clean the overhead lights, then the bed, then back up to the ceiling to clean blood splatter. EVS 5 and EVS 6 then cleaned the periphery of the room where operating room equipment was located. The cleaning method flow pattern went from clean to dirty back to clean. EVS 5 and EVS 6 mopped from the center of the room to periphery while other operating room staff members in the room were setting up for the next case not allowing the floor to dry first. NM 1 acknowledged EVS 5 and EVS 6 were not following proper cleaning sequence.

3. According to AORN guidelines titled, "Flexible Endoscopes-Processing Area", dated 2012-2021, the guidelines indicated in part, ..." Except for precleaning processes performed at the point of use, perform endoscope processing in a room where only processing activities are performed and that is physically separated from locations where patient care activities are performed ...limiting endoscope processing activities to designated processing rooms may help prevent contamination of procedure rooms and patient care areas ...the endoscopy processing room should include a door that provides access to and from the decontamination area or decontamination room and a separate door that provides access to and from the clean area or clean workroom ...doors to the decontamination area and clean area help contain contaminants within the processing room and help prevent cross contamination."

During a concurrent observation, and interview, on 4/28/21, at 10:45 a.m., in the gastrointestinal laboratory (GI Lab- (where endoscopic procedures take place to help doctors diagnose and treat conditions of the digestive tract),with the GI Lab nurse manager (NM 2) and endoscope technician (ET 1), it was observed there was an AER machine. The AER machine was approximately eight feet from the patient procedure bay. There was no door or barrier between the AER machine and patient care bay. When asked if the AER machine had always been in the GI Lab,
NM 2 stated, "Yes it has always been here". When asked had there been a door or barrier between the patient procedure bay and the AER machine, NM 2 stated, "No". ET 1 verbalized the endoscope is transported to the decontamination room to get manually cleaned and then is brought back to the GI Lab for high level disinfection in the AER machine. When asked if the AER machine is processing scopes at the same time as patient procedures, ET 1 stated, "Yes".

During and interview on 4/28/21, at 1:28 p.m., with the POD and the surgical services manager (NM 1), Both POD and NM 1 acknowledged they use AORN guidelines for reprocessing endoscopes.

During a review of the facility policy and procedures titled, "Endoscope - GI Reprocessing", dated 4/21, indicated in part ... " Automated endoscope reprocessor (AER): the manufacturer's recommendation for both the scope and the reprocessor should be consulted to ensure that they are compatible for high level disinfection." The policy did not indicate where the AER machine should be stored.

4. During a concurrent observation, and interview, on 4/28/21, at 11:15 a.m., in the GI Lab, with NM 2 and ET 1, it was observed there was an AER machine located in the room. When asked if the room was a negative pressure room, ET 1 verbalized this is not a negative pressure room (negative pressure-air pressure inside the room is lower than air pressure outside of the room. When door is opened, potentially contaminated air or other dangerous particles from inside the room will not flow outside into the non-contaminated areas).

The "DSD Edge-Endoscope Reprocessing System", MFU's, dated 2018, indicated in part ... "Ventilation: It is a health and safety requirement to have a minimum of ten air exchanges per hour in the room ...during cycle operation, chemical vapor may be produced ...the air exchange will minimize staff exposure to chemical vapors."

During and interview on 4/28/21, at 3:35 p.m., with the facilities director (FD), FD disagreed with ET 1's statement and verbalized the GI Lab exceeds the air exchange requirement at 22 air exchanges per hour and is a negative pressure environment.

During a review of the facility, "Engineering Negative Air Pressure Room Checks" log, dated 4/23/21, indicated all the rooms being monitored for negative air flow. The GI Lab was not documented in the log.

During a concurrent observation and interview on 4/28/21, at 4:08 p.m., with FD, in the GI Lab, a tissue test for negative pressure (tissue test-hold a piece of tissue in front of the door, approximately one inch above the floor, outside of the room. If air pressure is appropriatly negative, the tissue will be pulled in towards the room. This is an acceptable air flow) was performed. The tissue was expected to be drawn into the negative pressure room, which did not occur. The tissue was blown outward into the positive pressure area. The tissue was placed at the other door of the GI Lab and had the same results. FD acknowledged the tissue was not pulled into the room. The concerns about the air flow and negative pressure of the GI LAB were verbalized to the FD. When asked if the Heating Ventilation and Air Conditioning (HVAC) system was working, FD verbalized he did not know what the problem was. FD verbalized that he calculated the negative pressure in the room based on the square footage. FD verbalized he did not have a vaneometer (a tool used to measure air velocity [speed and flow of air] to assess ventilation) to check negative pressure of the GI Lab. FD acknowledged he would need to have the HVAC inspected to see if the GI Lab has negative pressure air flow.

According to AORN guidelines titled, "Flexible Endoscopes-Processing Area", dated 2012-2021, the guidelines indicated in part ... "Heating, Ventilation, and air conditioning (HVAC) systems for the endoscopy suite should be designed in compliance with state and local building codes ...HVAC systems control the air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas ...the HVAC system is intended to reduce the amount of environmental contamination (eg, microbial-laden skin squames, dust and lint) in the endoscopy suite ...HVAC design parameters for endoscopy suites ...two room design- decontamination room: minimum air exchanges is 10, setting for airflow patterns (pressure) is negative ...clean workroom: minimum air exchanges is 10, setting for airflow patterns (pressure) is negative ...endoscopy procedure room: minimum air exchanges is 6, setting for airflow patterns (pressure) is no recommendation."







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

The hospital's policy and procedure entitled "Cleaning of Movable Medical Equipment", revised 6/18, indicated "A. Immediately after use on a patient, non-dedicated equipment will be cleaned by the person using the equipment (End User) ... B. Once cleaned the equipment will be placed in the clean equipment room on the appropriate shelf, available for use."

During an observation and concurrent interview with the emergency department (ED) nurse director (ND) on 4/26/21 at 11:06 a.m., seven wheelchairs were observed in a heavy traffic hallway outside of the ED. Unclear whether the wheelchairs were clean or dirty. There was nothing on wheelchairs or on the area where the wheelchairs were stored indicating this was a clean area. The ED ND explained the process is to have the ED staff clean the wheelchairs and place them in the hallway. However there is no way to distinguish between the clean and dirty wheelchairs. The ED ND stated "I agree there's no way to tell which wheelchairs are dirty and which are clean. There is room for improvement."

During an observation and concurrent interview with physical therapist (PT 1) on 4/26/21 at 11:47 a.m., seven walkers were observed stored in the corner of the physical therapy (PT) department. One walker was wrapped with plastic. Two canes were stored in the same area. PT 1 indicated all of this walkers and canes were clean and ready to be used with patients. PT 1 was ask why one of the walkers is wrapped with plastic and the others are not. PT 1 explained the walker that is wrapped with plastic indicates that this walker is clean. PT 1 was asked does that mean the walkers that are not wrapped with plastic are dirty. If so, clean and dirty walkers are being stored together. PT 1 stated "I don't know I just know some equipment when they're clean they are wrapped with plastic." PT 1 acknowledged the observation and agreed dirty and clean walkers are stored together. This is cross-contamination.

During a tour of the physical therapy (PT) department and concurrent interview with physical therapist (PT 1) on 4/26/21 at 12:08 p.m., a scooter was observed with dark powder dust- like substance on top of the scooter. According to PT 1, the scooter is clean, ready to be use on patients. PT 1 was asked to witness the substance. PT 1 acknowledged and confirmed the scooter is not clean due to the substance on it. On the same corner, PT 1 indicated clean wheelchairs are stored here. A wheelchair was observed with a sticky, glue like substance on the back of the wheelchair. On the same corner, one wheelchair was observed with sticky tape wrap around the wheelchair handles. PT 1 acknowledged and confirmed the substance on wheelchairs and indicated the wheelchairs were not clean.

During the same PT department tour and concurrent interview with PT 1 on 4/26/21 at 12:10 p.m., a wheelchair was observed with multiple cracks or open areas on the area where the patient sits on. PT 1 acknowledged and confirmed the observation and agreed the wheelchair is not considered clean.

During the same PT department tour and concurrent interview with PT 1 on 4/26/21 at 12:26 p.m., an ultrasound machine was observed stored in the narrow little hallway leading towards the bathroom. PT 1 was ask if this ultrasound machine (used to give therapy) was clean or dirty. PT 1 indicated this ultrasound machine was clean and ready to be use on patients. PT 1 was ask what was the indication or how can I tell if this machine is clean or dirty. P T 1 stated "there is no nothing on the machine to indicate if this machine has been clean or not." PT 1 acknowledged the observation and agreed that this ultrasound machine is unclear whether it's clean or dirty. More likely the machine is dirty since it's stored in an area that is narrow, close to the bathroom, staff probably have touched the machine while on their way to or from the bathroom. This is a method for contamination.

During a tour of the cardiovascular unit (CVU) and concurrent interview with certified nursing assistant (CNA 1) on 4/28/21 at 9:40 a.m., a portable vital sign machine (use to take blood pressure, pulse, temperature measurements)was observed with dark dry substance on machine. Two vital signs machines were observed stored in a heavy traffic hallway. CNA 1 explained the vital sign machines are clean with Sani-wipes between patients uses by everyone who uses the vital sign machine. Once the vitals sign machines are clean they are stored in the (heavy traffic) hallway without any indication if the vitals sign machines have been cleaned or not.

During the vital sign machine observation and concurrent interview with unit nurse manager (NM4) on 4/28/21 at 9:40 a.m., it was shared with NM 4 this is a concern that the vital sign machines are stored in a heavy traffic hallway and one machine has a dark substance on the machine. The vitals sign machines are at risk of being touched, handled, cough on by visitors or by staff and then brought inside the patient's room to take their vital signs. NM 4 acknowledged the observation and agreed that storing the clean vital signs machines in the hallway is a risk for cross contamination and a patient safety concern.

During an observation and concurrent interview with the CVU nurse manager (NM 4) on 4/28/21 at 9:59 a.m., in the same heavy traffic hallway a portable interpreter language machine was observed stored in the hallway. The interpreter machine also had no indication of whether the machine was clean or dirty. The NM 4 explained the machine is clean between patients with a Sani- wipe then stored in the hallway. It was communicated to NM 4 that once again the machine could have been touched, handled, cough on by visitors and then the machine brought into the patient's room for use. NM 4 acknowledged the observation and agreed the interpreter machine has no indication as to whether being clean or dirty and is a method of cross-contamination. MN 4 stated "I understand there is no method or way to distinguish which portable equipment is clean or dirty. I agree there is room for improvement."

During an interview with the infection preventionist (IP) on 4/28/21 at 5:20 p.m., the pictures of the below observations were shared with the IP for infection control practices standpoint feedback.
-ED wheelchairs stored outside the heavy traffic hallway, unknown if whellchairs were clean or dirty.
-CVU heavy traffic hallway storage of vital signs machines and the interpreter language machine. Unknown if machines are clean or dirty. The one vital machine with dark substance on machine.
-The P.T. department walkers stored in the corner. One walker wrapped with plastic indicating clean. However, the rest of the walkers unwrapped. But according to P.T staff those walkers are also clean. Storage of clean and dirty equipment together at risk for cross-contamination.
-P.T. department scooter with power dusk-like substance. According to PT 1 this scooter was clean ready to be used with patients.
-The P.T. department wheelchair had cracks on the area where patient sits on.
-P.T. department wheelchair with sticky- glue substance on back of chair.
-P.T. department wheelchair with sticky tape wrapped on handles.
-P.T department ultrasound machine stored in narrow hallway leading to bathroom without indication whether machine was clean or dirty. PT 1 indicated machine was clean ready to use on patients. This is a method of contamination.

The IP acknowledged the observations based on the pictures shown. IP indicated there is a huge problem with movable equipment. There is no consistency as to how to distinguish which equipment is clean or dirty. In some units the equipment is wrapped with plastic to indicate the equipment is clean. But this is not the practice throughout the hospital. This is a source of cross-contamination and high risk for infections.


6. The 2019, Guidelines for Peri-Operative Practice, in part 1X.b, indicated "Flexible endoscopes should be stored in accordance with the endoscope and storage cabinet manufacturers' IFU. Following the manufacturers' IFU helps ensure safe and effective storage of endoscopes. In part 1X.b.1, indicated "Flexible endoscopes should be stored in a drying cabinet.[High Evidence]. The collective evidence shows that optimal storage of flexible endoscopes facilitates drying, decreases the potential for contamination, and provides protection from environmental contaminants ... A wide variety of storage cabinets include a dying system that circulates HEPA-filtered air through the cabinet while filtered air under pressure is forced through the endoscope channels. The internal and external surfaces of the endoscope are continuously dried, suppressing bacteria growth."

The hospital policy and procedure entitled "Endoscope- GI Reprocessing", last revised 11/16, in the Endoscope Maintenance part indicated "1. Endoscopes should be maintained according to manufacturers' recommendations ..."
The [Manufacturer Name] endoscopes manufacturer's information for use (IFUs), undated, in part 8.2 Storing and Disinfecting Endoscopes indicated "Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices. Be sure that the endoscope storage cabinet is properly maintained, clean and well ventilated."

During a tour of the gastroenterology (GI) lab and concurrent interview with the peri-operative director (POD) on 4/28/21 at 4:30 p.m., thirteen (13) Olympus endoscopes (scope-a long, thin tube with a tiny camera attached at the end used to see inside the intestines) were observed stored in a two compartment storage cabinet/closet. The cabinet was inspected to ensure that there was some type of open area or ventilation area. However, the cabinet did not have any openings or any area where air could enter into the cabinet. The POD confirmed the hospital had adopted Society of Gastroenterology Nurses and Associates (SGNA) and Association of PeriOperative Registered Nurses (AORN) professional guidelines for the GI lab services. A review of the [Manufacturer Name] endoscopes manufacturer's information for use (IFUs) was conducted with the POD. The manufacture's IFUs indicated to store the scopes in a "well ventilated area." A review of the SGNA guidelines was conducted with the POD. The SGNA guidelines indicated to follow the scopes manufacture's IFUs. A review of the AORN guidelines was conducted with the POD. The AORN guidelines indicated "flexible endoscopes should be stored in a drying cabinet." The POD acknowledged the observation and agreed currently the endoscopes are not being stored properly and as per manufacture's IFUs, SGNA and AORN guidelines. POD stated "I agree this cabinet does not have an open area for ventilation and does not have a HEPA filter (inside the cabinet)."

During a review of the AORN guidelines with the infection preventionist (IP) on 4/28/21 at 4:59 p.m., the IP acknowledged and agreed that storing the endoscopes in this cabinet has a high risk of growing bacteria therefore there's a high risk of patients acquiring infections. This is a patient safety concern.


7. According to the centers for disease control (CDC) in the guideline titled "Following Infection Prevention and Control Recommendations in Healthcare Settings During the COVID-19 Pandemic", revised 6/9/20 indicated "Maintain physical distance as much as possible. Use video conferencing and increase workstation spacing. Reduce the number of individuals allowed in common areas such as breakrooms and on elevators. Source control helps prevent transmission from infected individuals who may or may not have symptoms of COVID-19. Cloth face coverings are not considered personal protective equipment (PPE); they are source control. HCP should wear appropriate PPE ..."

During an interview with the infection preventionist (IP) on 4/26/21 at 10:47 a.m., the IP reported that on 11/23/20 there was a COVID-19 outbreak in the rehabilitation services (P.T.) area. Two physical therapist P.T. and one P.T. aide tested positive for COVID-19 virus. This occurred after a Pizza and a staff farewell gathering that took place in the P.T. department on 11/23/20. The IP was asked if she performed line tracing or tracking of the patients that had been exposed to these three COVID-19 positive staff and line tracing of staff that gathered together in the same area on 11/23/20. IP explained she did not performed line tracing or tracking of any patients or staff that potentially were exposed to COVID-19 virus. According to the IP, the Los Angeles county department of public health indicated there was no need to perform line trancing for hospital patients that have had contact with these three P.T. staff as long as the patients and staff were wearing the appropriate personal protective equipment (PPE). However, the IP was not able to provide evidence of such communication with the L.A. county public health department. Furthermore, the IP was not able to provide evidence the P.T. staff and patients were wearing the appropriate PPE.

During an observation of the P.T. department and concurrent interview with administrative director of physical therapy (ADPT) on 4/26/21 at 11:30 a.m., the ADPT confirmed staff took breaks, ate and gathered inside the P.T department. This was the only area where the staff can gather or take a break. The department area was small and cluttered with P. T. supplies. Tables with computers (use for documenting) were observed all around the department. Small refrigerator, water bottles, ultrasound therapy machine...were observed inside this small department.

During an interview with physical therapist (PT 2) on 4/26/21 at 12:49 p.m., PT 2 explained on 11/23/20 the P.T. department had a pizza and a staff farewell gathering in the P.T department. Up to ten staff gathered in the same place and time. According to PT 2, a PT aide have had a "bad flu" earlier to the gathering on 11/23/20. PT 2 indicated the gathering in the P.T department was the source of COVID-19 infection outbreak. Furthermore, PT 2 reported inside the P.T department there was no room for social distancing of 6 feet. There was also no signage anywhere in the P.T. department as to how many staff could be inside the department at the same time based on the area square footage.

During an interview with PT aide (PTA) on 4/27/21 at 2:51 p.m., PTA explained that on 11/23/20 the rehabilitation staff had a pizza, a staff farewell and a staff meeting gathering, all at the same time in the P.T. department. Most of the staff attended the staff meeting at the same time. Staff were not told how many staff could be inside the P.T department at the same time (based on the department room size). PTA reported not seeing and having any signage in regards to six feet social distancing inside the P.T. department. Furthermore PTA reported the staff meeting that took place on 11/23/20 was the source of the COVID-19 infection outbreak.

During an interview with physical therapist (PT 4) on 4/29/21 at 9:39 a.m., PT 4 explained on 11/23/20 the P.T. department had a pizza, a staff farewell and a staff meeting gathering in the P.T department. Most of the staff attended the staff meeting all together. PT 4 had not seen any signage on six feet social distancing and number of staff allowed inside the department, at the same time. According to PT 4, the staff meeting was the source of COVID-19 infection outbreak.

During an interview with PT 1 on 4/26/21 at 11:58 a.m., PT 1 reported not having or seeing any signage inside the P.T department in regards to social distancing and as to how many staff were allowed inside the department at the same time.

During an interview with the ADPT on 4/26/21 at 11:27 a.m., the ADPT confirmed the rehabilitation services department gathering on 11/23/20 and that this event was coordinated by him. Furthermore, ADPT acknowledged that during the gathering staff removed their mouth mask to eat the pizza. The P.T. department area is too small to house the rehabilitation services staff at the same time. There was no social distancing between staff due to the size of the department. ADPT reported not knowing how many staff could be allowed inside the P.T department, at the same time based on the size of the area or square footage.

A review of the rehabilitation services department staff schedule for 11/23/20 was conducted. The staff schedule indicated two speech therapist, two occupational therapist and eight physical therapist worked on 11/23/20. A total of 12 staff were working on this date.

During an interview with the IP on 4/27/21 at 8:58 a.m., IP acknowledged and confirmed the hospital had not addressed social distancing and signage as to the number of staff allowed inside a breakroom area/room based on square feet until after the 11/23/20 COVID-19 outbreak.

Based on interview and record review the hospital's governing body failed to ensure that a system had been put into place for the tracking of infection surveillance and that the hospital had implemented success and sustainability of the hospital's antibiotic use activities.
This failure resulted in Pharmacy, Nursing, and Medical staff not being aware of the hospital's most current, "Adult Empiric Antibiotic Recommendations and Antibiogram"( AEARA), which would have allowed the hospital to provide optimal antibiotic coverage and use for their patients.

Findings:

During a concurrent interview and record review with Antibiotic Stewardship Pharmacist 1 (AP1), on 4/26/2021 at 11:30 am, revealed that all of the Pharmacists in the hospital's Pharmacy, had currently been using the hospital's 2019 AEARA document. Interview with the Chairperson of Antimicrobial Stewardship Program (CAS) on 4/26/201 at 12:20 pm, revealed that the hospital had a 2020 AEARA version which been created and approved by the hospital's Governing Body for current implementation on 1/4/2021 (almost four months ago), yet this version of the AEARA, could not be found on the hospital's computer system (known as "Epic"). The hospital's 2019 AEARA version, had been placed in "Epic", after its approval, allowing access to this document by all of the hospital's staff (Nurses, Pharmacists, Medical staff, etc.).

Interview and document review with the Director of Pharmacy (DOP) on 4/27/2021 at 12:00 pm revealed that the hospital's Pharmacy had conducted a Medication Utilization Evaluation (MUE) in 5/2020 and the overall evaluation of the report had been completed in 10/2020. The MUE report revealed that in comparison to the hospital's other five sister hospital's (in Southern California), this hospital had the highest use of Meropenem (a broad spectrum antibiotic), for sepsis and pneumonia diagnoses, which the Antimicrobial Stewardship determined, could have been treated, just as effectively with a less expensive, equally effective, and a narrower spectrum antibiotic (Cefepime). Through this study, the hospital's Antibiotic Stewardship Committee decided to start dramatically reduce its use of Meropenem and replace this antibiotic with Cefepime for certain disease diagnoses (as long as the patient did not have an allergy to penicillin like drugs). This change resulted in the revision of the hospital's 2019 AEARA to the 2020 version of the AEARA.

During a concurrent interview and record review with staff Pharmacist 1 (SP1) on 4/27/2021 at 3:10 pm, SP1, was asked he was aware of any updates to the 2019 AEARA. SP1 replied, that he was not aware of any newer versions of the AEARA 2019 document. SP1, was also asked during this interview, if he had ever seen the hospital's Medication Use Evaluation (MUE) report on Meropenem. SP1, indicated that he had never seen this evaluation before and he also indicated that no one from the hospital had ever spoken with or shared the results of this study with him. SP1, was completely unaware of the hospital's attempt to reduce the use of Meropenem and its replacement with Cefepime (a narrower spectrum antibiotic), based on the Antibiotic Stewardship's most current (2020) of its AEARA.

The Governing Body Committee (Quality Board Committee), [which approved the 2020 version of the AEARA on 1/4/2021], never appeared to question the ease of use or the clarity of the new 2020 version of the hospital's AEARA Guidelines. It almost appeared that this Committee moved this version of the 2020 AEARA guideline through without any concerns.

The hospital's governing body failed to ensure that the 2020 AEARA, which the committee had approved, had been implemented and monitored after 1/4/2021.




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2. 1. During a interview with Infection Control Manager (IP), on 4/27/21, starting at 8:10 a.m.,while reviewing the QA committee processes, IP manager stated, " The infection control committee meets on a quarterly basis." When asked to see the minutes for the 2020 infection control committee, IP manager stated, " We only met twice in 2020, because we were too busy."

Asked to review the metrics for "social distancing break room logs and aerosol generating procedure logs" described by IP as monitoring processes for prevention of hospital acquired infections, IP was only able supply the templates. When asked about the metrics and data for 2020, IP Stated, "We didn't keep this information, we did these observations sporadic when I was up on the unit, only on the day shift because there are only two of us. I just shared information with the charge nurse."

During a interview with Infection Control Manager (IP), on 4/27/21, starting at 8:10 a.m.,while concurrently reviewing QA records of Infection Control, metrics for observations of proper PPE(personal protection equipment) compliance, for the third quarter QA Committee recorded, 12 observations in 08/20, 48 observations in 09/20, and 12 observation in 10/20 . When asked how many observation were identified for monitoring, IP stated, "forty." Asked why the lack of observations for 2 out of 3 months in the last quarter, IP stated, " There are only two of us in the department and we really didn't have time."

Based on observation, interview and record review the Infection Control Manager (IP) failed to consistently record all documentation of all surveillance, prevention and control activities. IP did not include or gather documentation for monitoring of surveillance and prevention control activities. This failure created the potential risk of persistent poor practices and an unsafe environment.

Findings:

The hospital policy and procedure titled, " Infection Prevention: Infection Prevention Program Plan and Risk Assessment," last revised "03/2021," on page 1 of 13 the plan document revealed in part .... "The purpose of the infection Prevention program plan is to identify infections and reduce the risks of disease transmission through the introduction of preventive measures..." Further review of the plan, on pg. 3 of 13 indicated in part... " The IP manager has been given the authority of the IPP ( Infection Prevention Plan) and is responsible for:...3. Coordinating infection prevention activities and projects within the hospital. 4. Facilitate ongoing monitoring of the program activities and interventions effectiveness."

1. During a interview with Infection Control Manager (IP), on 4/27/21, starting at 8:10 a.m.,while reviewing the QA committee processes, IP manager stated, " The infection control committee meets on a quarterly basis." When asked to see the minutes for the 2020 infection control committee, IP manager stated, " We only met twice in 2020, because we were too busy."

Asked to review the metrics for "social distancing break room logs and aerosol generating procedure logs" described by IP as monitoring processes for prevention of hospital acquired infections, IP was only able supply the templates. When asked about the metrics and data for 2020, IP Stated, "We didn't keep this information, we did these observations sporadic when I was up on the unit, only on the day shift because there are only two of us. I just shared information with the charge nurse."

During a interview with Infection Control Manager (IP), on 4/27/21, starting at 8:10 a.m.,while concurrently reviewing QA records of Infection Control, metrics for observations of proper PPE(personal protection equipment) compliance, for the third quarter QA Committee recorded, 12 observations in 08/20, 48 observations in 09/20, and 12 observation in 10/20 . When asked how many observation were identified for monitoring, IP stated, "forty." Asked why the lack of observations for 2 out of 3 months in the last quarter, IP stated, " There are only two of us in the department and we really didn't have time."

2. According to the Association of periOperative Registered Nurses (AORN) guidelines for perioperative practice titled: "Environmental Cleaning" dated 2012-2021, indicated in part ..." Having an interdisciplinary team select disinfectants for use in the perioperative setting based on the following factors: Environmental Protection Agency (EPA) registration and hospital grade rating ...targeted microorganisms...contact times...chemical manufacturers' instructions for use (MFU's) ...compatibility with surfaces, cleaning materials, and equipment."

During a concurrent observation, and interview, on 4/26/21, at 12:40 p.m., with environmental services staff (EVS 1), the EVS cart, on the labor and delivery unit, was observed. EVS 1 verbalized the cleaning bucket contained oxyvir solution (disinfectant to kill microorganisms-virucide-bactericide, tuberculocide, and fungicide) and the mop bucket contained stride solution (a neutral cleaner). EVS 1 verbalized the oxyvir was used on the hard surfaces, countertops, and beds. The stride solution was used on the floors. EVS 1 further verbalized the solutions are premixed and stored in the EVS closet. The jug of oxyvir solution was observed in the EVS closet and the manufacturers label indicated the solution was a cleaner and disinfectant. The stride solution was observed on a wall dispensing unit, in the EVS closet, and the manufacturers label indicated the solution was a neutral cleaner not a disinfectant.

During an interview on 4/26/21, at 12:45 p.m., with the director of environmental services staff (DEVS), DEVS acknowledged the stride cleaner was not a disinfectant and should not be used to clean the floors. DEVS verbalized oxyvir should be used on all surfaces, countertops, and floors throughout the whole hospital.

During a concurrent observation and interview on 4/27/21, at 9:18 a.m., with environmental services staff (EVS 2), during a room turnover (cleaning the operating room between patients), in labor and delivery operating room (OR 1), was observed. EVS 2 verbalized OR 1 floor was cleaned with stride.

During an interview on 4/27/21, at 10:00 a.m., with DEVS, DEVS acknowledged stride should not be used to clean the operating room floors.

During a review of the facility's policy and procedures titled "Surgical & Special Procedures Area Cleaning" dated 1/17, indicated in part ... "Surgery and special procedure rooms are the most critical areas of the hospital ...extreme care must be taken to ensure that established scheduled cleaning is carried out rigorously and in accordance with established procedures ...between case cleaning: move and wash OR table, lights and furniture with germicidal solution ...spot wash walls and any equipment as needed with germicidal solution ...wet mop floor of the OR suite with germicidal solution."

3. During a concurrent observation and interview on 4/27/21, at 8:50 a.m., with Environmental Services Staff (EVS3), by the Emergency Room (ER) EVS cleaning closet, it was observed that various cleaning products were inside. When asked to distinguish which products are used, EVS1 stated that "Glance" (a glass and multi-surface cleaner) is for glass surfaces, "Oxivir" for all touched surfaces, and "Stride" for cleaning all ER floors.

During an concurrent observation and interview on 4/27/21, at 3:10 p.m., with EVS4 and Nurse Manager (NM3), at the Medical/Surgical fourth floor wing, EVS2 showed the EVS cleaning closet and discussed what products were used in that particular unit. EVS2 stated that "Glance" is for glass surfaces, "Oxivir" for all surfaces, while "Stride" is no longer used hospital-wide.

During a group interview on 4/27/21, at 4:50 p.m., with the Infection Preventionist (IP), the IP confirmed that Oxivir is a disinfectant, while Stride is a cleaner, used on the hospital floors. The IP agreed that the cleaning/disinfecting products are inconsistently used all over the hospital. The IP further states that cleaning and disinfecting should be enhanced and not decreased. IP further acknowledged that hospital, stating, "Use to use a black light spot checks for surveillance for cleaning and then results were reported to the Infection Control Committee but this practice was stopped during Covid pandemic."

Based on interview and record review, the infection preventionist (IP) failed to ensure the rehabilitation staff (physical therapist (PT) and PT aides) were educated and competent in the donning and doffing of personal protective equipment (PPE) during the COVID-19 virus (a highly contagious respiratory disease caused by SARS-CoV-2 that can trigger an acute respiratory tract infection and syndrome) pandemic to prevent a COVID-19 virus outbreak in the rehabilitation (PT) department.

This failure resulted in three staff testing positive for COVID-19 virus.

The hospital's Infection Prevention Program Plan and Risk Assessment, revised 11/19, in the Education and Training of Healthcare Workers part indicated "C. Education programs are evaluated periodically for effectiveness; Infection Prevention maintains records for department specific presentations. D. The goal of the educational programs is to meet the department/group needs and to provide leaning opportunities for staff, tailoring to the wide range of educational backgrounds and work responsibilities."

The hospital's policy and procedure entitled "Donning and Doffing Personal Protective Equipment (PPE), revised 5/18, indicated "To reduce the risks of exposureto pathogens and prevent workplace illnesses for all staff, physician's and volunteers. Don-to put on PPE. Doff- to remove PPE."

During an interview with the infection preventionist (IP) on 4/26/21 at 10:47 a.m., the IP reported that on 11/23/20 there was a COVID-19 outbreak in the rehabilitation services (P.T.) area. Two physical therapist P.T. and one P.T. aide tested positive for COVID-19 virus. Furthermore, the IP was not able to provide evidence the P.T. staff was wearing their PPE properly.

During an interview with physical therapist (PT 2) on 4/26/21 at 12:49 p.m., PT 2 explained several P.T. staff tested positive for COVID-19 virus in November, 2020. PT 2 reported providing direct patient care to patients with COVID-19 virus positive diagnosis. When asked where did s/he thought s/he was exposed or acquired the COVID-virus infection, s/he responded "I got COVID here when taking care of COVID patients." PT 2 was asked when s/he was last determined competent with donning and doffing of PPE. PT 2 stated "It was a long time."

During an interview with PT aide (PTA) on 4/27/21 at 2:51 p.m., PTA reported being sick and testing positive for the COVID-19 virus in November 2020. PTA also reported providing direct patient care to patients with COVID-19 virus positive diagnosis. Furthermore, indicated s/he was exposed to COVID-19 virus here in the hospital. PT 2 was asked when s/he was last determined competent with donning and doffing of PPE. PTA stated "It was a long time. When I was hired. I don't remember."

During an interview with physical therapist (PT 4) on 4/29/21 at 9:39 a.m., PT 4 explained back in November 2020 three P.T staff tested positive for the COVID-19 virus, including PT 4. . PT 4 also reported providing direct patient care to patients with COVID-19 diagnosis and being exposed to COVID-19 virus here in the hospital. PT 4 was asked when s/he was last determined competent with donning and doffing of PPE. PT 4 stated "A while back. Not recently. A long time ago."

During a review of the education and competencies provided to hospital staff and concurrent interview with the education director (ED) on 4/27/21 at 10:02 a.m., the ED explained the nursing staff had performed a Donning and Doffing of PPE competency last year (2020). The same competency was requested for the rehabilitation services staff.

During a review of the education provided to the rehabilitation services staff and concurrent interview with the education director on 4/29/21 at 8:30 a.m., the ED was asked again for the P.T. department Donning and Doffing PPE competency. The ED confirmed the rehabilitation services staff did not performed the PPE competency. The ED had no explanation as to the rationale for the P.T. staff not receiving the competency for donning and doffing of PPE.

During a review of the education provided to the rehabilitation services staff and concurrent interview with the infection preventionist (IP) on 4/29/21 at 10:05 a.m., the IP was asked the rationale for the P.T. staff not being provided with the Donning and Doffing of PPE competency and validating their competency as they did with the nursing staff. The rehabilitation staff also provided direct patient care to COVID-19 positive diagnosis patients. It was shared that it was the responsibility of the hospital's leadership to ensure the staff is competent with skills on donning and doffing of PPE appropriately. Especially when those staff are providing direct patient care to COVID-19 positive patients and in the middle of a COVID-19 virus pandemic. The IP agreed that every staff providing direct patient care (including PTs) should have been validated for appropriate donning and doffing of PPE and determine if they were competent or not.

Based on interview, record review and policy and procedure review, the hospital failed to ensure that the leaders of the Antibiotic Stewardship program provided effective communication and collaboration with the Medical staff (including the Hospitalist), Nursing, and Pharmacy leadership on antibiotic use and the hospital's 2020 version of the "Adult Empiric Antibiotic Recommendations and Antibiogram" (AEARA).
This failure resulted in the hospital's inability to utilize their most current governing body approved "Adult Empiric Antibiotic Recommendations and Antibiogram" to optimize patient antibiotic therapy and care.

Findings:

Interview and document review with the Director of Pharmacy (DOP), on 4/29/2021 at 8:30 am revealed that the hospital's Nursing staff, Hospitalist (Medical Staff), and the Director of Pharmacy, were all unable to explain/understand and follow the governing body approved 2020 version of the "Adult Empiric Antibiotic Recommendations and Antibiogram" (AEARA) document. During a concurrent document review and interview with the Chair of the Antibiotic Stewardship Committee (CAS), on 4/27/2021 at 12:20 pm, the Chair indicated he was unable to explain this newly approved 2020 AEARA, as the version which the governing body had approved was not the document that he had wanted to send to the hospital's governing body. Unfortunately the Pharmacy and Therapeutics Committee (which approved the 2020 version of the AEARA on 11/18/2020), the Medical Executive Committee (which approved 2020 version of the AEARA on 12/2020, and the Governing Body Committee (Quality Board Committee), [which approved the 2020 version of the AEARA on 1/4/2021]. None of these Committee's appeared to question the ease of use or the clarity of the AEARA Guidelines. These Committees appeared to move the 2020 version of the AEARA guideline through without any comments or questions.

There was a lack of communication between the leadership of the Antibiotic Stewardship program and the rest of the hospital's staff, as it related to antibiotic therapy use.

Based on interview and record review the hospital failed to ensure that the leaders of the Antibiotic Stewardship program provided any competency-based training and education to hospital personnel and staff, (medical staff, including hospitalist), Nursing staff, and Pharmacy staff, related to the hospital's antibiotic stewardship guidelines, policies, and procedures.
The Antibiotic Stewardship program's failure to provide training to the hospital's staff, had the potential to hinder the hospital's ability to reduce patient days of stay in this hospital.

Findings:

Interview and policy and procedure review with the Director of Pharmacy (DOP), on 4/29/2021 at 9:00 am revealed that the hospital's Nursing staff, Hospitalist (Medical Staff), and the Pharmacy staff had not been provided with any antimicrobial stewardship education within the last 12 months, as outlined in the hospital's policy and procedure below. No evidence of any formal education regarding antimicrobial stewardship updates, for Nursing, the hospitalist (Medical staff), Pharmacy staff, or patients could be provided by the hospital's antimicrobial stewardship team.
Review of the hospital's policy and procedure entitled: "Pharmacy: Antimicrobial Stewardship", dated 2/2017, stated:" D. The antimicrobial team provides educational recommendations for: 1. LIP (Licensed Independent Practitioners at the initial appointment and re-appointment as well as ongoing by CME (Continuing Medical Education) and P&T (Pharmacy and Therapeutics) newsletter. 2. Hospital staff (e.g. Nurses, Pharmacists) by P&T newsletter and as needed. 3. Patients as needed."

During a telephone interview with the Antimicrobial Stewardship team Pharmacist (ASTP) on 4/29/2021 at 9:00 am, she confirmed that the Antimicrobial Stewardship team had not done any teaching as outlined in the hospital's policy and procedure within the last 12 months.