HospitalInspections.org

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Based on interview and document review, the hospital's Governing Body failed to provide oversight of the hospital's quality program in order to ensure the program reflected the complexity of the hospital's organization and also failed to include all departments and services.

Failure of the Governing Body to ensure the quality program reflected the complexity of the hospital's organization and services, can result in a disorganized monitoring of programs and services, putting patients at risk of medical errors.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Quality, Safety & Performance Improvement Plan," approved 04/10/19, showed a description of the plan and the ongoing systematic organizational-wide process to continuously improve quality and safety. The plan also aids as a guide to plan, design, measure, assess and improve organizational performance; identify, minimize, and prevent organizational risks; and ensure delivery of safe patient care.

a. Document review of a hospital's document titled, "VMM Clinics," no date, showed a list of the outpatient clinics that operate under the hospital's acute care license. The document shows twenty-nine patient care clinics located at other building sites, that operate under the hospital's license.

2. On 10/13/20 and 10/14/20 between 8:30 AM and 2:00 PM, Investigator #10 and Investigator #11, toured 4 of the 29 outpatient clinics and reviewed each clinic's quality measures and benchmarks. The review showed the following:

a. A tour of the wound center showed that the clinic manages patient's non-healing wounds and skin issues. The clinic also uses traditional practice and medicine for wound healing with technology, such as hyperbaric oxygen therapy. The center's multi-disciplinary team provides treatment for wounds such as; diabetic ulcers, burn wounds, pressure ulcers, wounds associated with radiation treatment, surgical wounds and infections, trauma, bone infections, gangrene, and wounds associated with skin grafts.

During an interview on 10/13/20 at 2:00 PM, with the center's Sr. Clinic Manager (Staff #1003), revealed that the cllinic collects several metrics including data on wound healing time. But when asked how often their metrics are reported to the hospital's quality program, the Manager stated that their metrics are not reported to the hospital's quality program.

Investigator #10 found no evidence that wound center collected, measured, or analyzed it's patient use of their hyperbaric oxygen therapy.

b. A tour of the Cornerstone Clinic showed that the clinic manages the health needs of the adult patient.
An interview on 10/14/20 at 11:00 AM, with the clinic's Sr. Director (Staff #1004) and Clinic Manager (Staff #1005) revealed that the clinic provides medical treatment to the elderly and care is managed by internal medicine providers. The clinic manager stated that two quality metrics they collect are hand hygiene and fall risk assessments. Both Staff #1004 and #1005 could not provide evidence that their data is reported to the hospital's quality program.

3. On 10/15/20 at 10:20 AM, the hospital's Sr. Director Safety & Compliance Officer (Staff #1006), confirmed the above observations.

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Based on observation, interview, and document review, the hospital failed to develop and implement an effective infection prevention and control program.

Failure to develop and implement an effective infection prevention and control program puts patients, staff and visitors at risk of illness from communicable diseases.

Findings included:

1. The hospital failed to ensure that staff wore masks or had masks available for use to which they were fit tested.

Cross Reference: Tag A-0749

2. The hospital failed to ensure that staff properly stored masks subject to extended use or reuse.

Cross Reference: Tag A-0749

3. The hospital failed to ensure that powered air purifying respirator (PAPR) filter changes were conducted and documented.

Cross Reference: Tag A-0749

4. The hospital failed to ensure that only NIOSH approved respirators were put into circulation for staff use.

Cross Reference: Tag A-0749

5. The hospital failed to conduct and document activities listed in the water management program.

Cross Reference: Tag A-0749

6. The hospital failed to ensure that cath lab staff properly disinfected equipment that dropped to the floor prior to the next case.

Cross Reference: Tag A-0749

7. The hospital failed to ensure that staff did not use large surface spray methods that produce mists when cleaning hyperbaric chambers after patient care.

Cross Reference: Tag A-0749

8. The hospital and failed to ensure that tubing used for patient care was not resting on the floor during use.

Cross Reference: Tag A-0749

9. The hospital failed to ensure that staff followed nationally recognized standards when screening patient or visitors at the entrance of the hospital.

Cross Reference: Tag A-0750

Due to the scope and severity of deficiencies cited under §42 CFR 482.42, the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs was NOT MET.

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Based on observation, interview, and record review, the hospital failed to ensure that staff wore masks or had masks available for use to which they were fit tested (Item #1), failed to ensure that staff properly stored masks subject to extended use or reuse (Item #2), failed to ensure that powered air purifying respirator (PAPR) filter changes were conducted and documented (Item #3), failed to ensure that only NIOSH approved respirators were put into circulation for staff use (Item #4), failed to conduct and document activities listed in the water management program (Item #5), failed to ensure that cath lab staff properly disinfected equipment that dropped to the floor prior to the next case (Item #6), failed to ensure that staff did not use large surface spray methods that produce mists when cleaning hyperbaric chambers after patient care (Item #7), and failed to ensure that tubing used for patient care was not resting on the floor during use (Item #8).

Failure to comply with policies and procedures to prevent transmission of infections puts patients, staff, and visitors at risk from communicable illnesses.

Findings included:

Item #1 - Respirator Fit Testing and Use

1. Record review of the document titled, "Personal Protective Equipment (PPE) Priority Use," version 05, dated 04/06/20, showed that staff will use fit tested N95 masks when working in COVID patient rooms.

2. On 10/07/20 from 9:25 AM to 10:45 AM, Investigators #2 and #12 toured the emergency department of the hospital. During the tour, the investigators observed a registered nurse (Staff #208) wearing a white respirator as a mask. Investigator #2 interviewed the nurse about the mask being worn. The nurse stated that she was unsure what mask she was fit tested to and wore the mask that fit best.

3. Record review of the fit testing records for the registered nurse (Staff #208) showed that she was fit tested for a Hope 220 mask and a BYD DE2322 mask on 10/07/20, the day of the observation of mask use. No time was listed on the form.

4. On 10/07/20 from 9:25 AM to 10:45 AM, Investigators #2 and #12 toured the emergency department of the hospital. The investigators observed a registered nurse (Staff #209) enter an emergency department room 19 with a patient under Airborne Droplet precautions wearing an N95 respirator. Following patient care, Investigator #2 interviewed the nurse about the respirator she was wearing. The nurse stated she was unaware of what model for which she was fit tested. Investigator #2 asked to see the mask and observed the model to be a 3M 8210 model.

5. Record review of the fit testing records for the registered nurse (Staff #209) showed that she was fit tested for a BYD DE2322 mask on 07/23/20.

6. On 10/07/20 at 2:30 PM, Investigators #2 and #12 toured the inpatient psychiatric unit of the hospital. During the tour, the investigators interviewed the psychiatric department manager (Staff #210) about staff response to symptomatic or COVID-positive patients. Staff #210 stated that staff have access to a "COVID kit" that contains PPE, including N95 respirators, in the event that patient care necessitated their use.

7. On 10/08/20 at 2:55 PM, Investigator #2 inspected the "COVID kit" on the psychiatric unit. The observation showed that the kit contained 3M 1860, 3M 8210, and BYD DE2322 respirators.

8. Record review of the fit testing records for registered nurse on the psychiatric unit (Staff #211) showed that he was fit tested for a 3M 1870+ respirator on 03/18/20, which was not available for use on the psychiatric unit.

9. Record review of the fit testing records for certified nursing assistant on the psychiatric unit (Staff #212) showed that she was fit tested for a 3M 1870+ respirator on 03/18/20, which was not available for use on the psychiatric unit.

10. On 10/07/20 at 1:00 PM, Investigator #2 observed that the masks available for use on the 5N unit of the hospital were BYD DE2322 models.

11. Record review of a document listing model numbers for N95 respirators to which fifth floor staff were fitted, provided by the unit manager (Staff #213) to Investigator #10, showed that a registered nurse (Staff #214) was fitted to a 3M 1860R on 04/13 (no year provided).

12. Record review of the fit testing records for the registered nurse (Staff #214) showed that she was fit tested for a 3M 1870+ respirator on 03/04/20, which was not available for use on the 5th floor and did not match the master list that the unit manager provided.

Item #2 - N95 Storage

1. Record review of an untitled document with hospital respirator reuse guidance, dated 04/14/20, showed that staff are to store N95 masks subject to reuse in a clean paper bag or other breathable container between uses.

2. On 10/07/20 at 10:45 AM, Investigator #2 observed an N95 stored in the anteroom between patient rooms 240 and 241 of the intensive care unit. The mask was stored on top of a cart and was not in a paper bag or container.

3. During the observation, the clinical care nurse manager (Staff #207) confirmed the observation of the uncontained respirator.

4. On 10/07/20 at 11:00 AM, Investigator #2 observed an N95 respirator not stored in a paper bag or other container on a cart outside a patient room on the 2W unit.

5. During the observation, the investigator interviewed the nurse manager for the unit (Staff #215) about N95 storage. The manager stated that masks should be stored in paper bags and confirmed the observation of the mask not being stored properly.

Item #3 - PAPR Filter Maintenance

1. Record review of the document titled, "FAQs," from MaxAir (the manufacturer of PAPR units), showed that should be changed when a yellow light illuminates on the unit or at an interval of every six to twelve months.

2. On 10/07/20 at 10:45 AM, Investigator #2 observed two PAPR units stored in the anteroom between rooms 240 and 241. One PAPR had a date of 03/30/20 on the filter in the hood, but the other PAPR had no date recorded.

3. During the observation, the critical care nurse manager (Staff #207) stated that the clinical engineering department manages the maintenance of the PAPR units.

4. On 10/08/20 at 3:06 PM, Investigator #2 observed a PAPR on unit 3W with no date for the filter change documented.

5. On 10/08/20 at 1:21 PM, Investigator #2 interviewed the Employee Health Nurse Manager (Staff #215) and the Clinical Engineering Manager (Staff #216) regarding PAPR filter maintenance. The interview showed that unit management is responsible for filter maintenance rather than employee health or clinical engineering. No filter change records for the undated PAPRs were provided.

Item #4 - Non-Approved Respirators

1. Record review of the hospital policy titled, "Respiratory Protection Plan," no policy number, reviewed 07/28/20, showed that the manager of employee health will administer the program and the administrator will select NIOSH approved respirators.

2. On 10/07/20 from 9:25 AM to 10:45 AM, Investigators #2 and #12 toured the emergency department of the hospital. During the tour, the investigators observed a registered nurse (Staff #208) wearing a white respirator as a mask. Investigator #2 interviewed the nurse about the mask being worn. The nurse stated that she was unsure what mask she was fit tested to and wore the mask that fit best.

3. Record review of the fit testing records for the registered nurse (Staff #208) showed that she was fit tested for a Hope 220 mask and a BYD DE2322 mask on 10/07/20, the day of the observation of mask use. No time was listed on the form.

4. Review of the Hope 220 mask and associated packaging and materials showed that the mask was not labelled with NIOSH approval and the packaging contained no approval number.

5. Review of the CDC NIOSH approved respirator list, updated 09/02/20, showed that the Hope 220 respirator was not on the list of approved respirators.

6. On 10/08/20 at 4:30 PM, Investigators #2, #10, #11, and #12 conducted an infection control interview with the Interim Chief Nursing Officer (Staff #217), the Chief of Hospital Medicine (Staff #218), the Medical Director for Infection Prevention (Staff #219), the Director of Quality (Staff #220), the Director of Infection Prevention (Staff #221), and the Senior Director of Regulatory Compliance (Staff #222). During the interview, Investigator #2 asked the committee about their involvement with respiratory selection and approval and management of the respiratory protection program. They stated that respirator selection is handled between employee health and supply chain and not the infection control committee. The committee was unaware that staff were fitted and wearing non-NIOSH approved respirators.

Item #5 - Water Management Program

1. Record review of the hospital policy titled, "Water Management Program to Prevent Waterborne Pathogens," no policy number, effective date 08/15/18, showed that the hospital will conduct culture testing of the water biannually.

Record review of the document titled, "Yakima Valley Memorial Hospital Hazard Analysis," developed by Phigenics (a contracted water management service), no date, showed that decorative water features would be cleaned and treated with biocides periodically.

2. Record review of the water management meeting minutes, dated 02/11/20, showed that a vendor change was scheduled to take place and that the water testing was yet to be scheduled.

3. On 10/15/20 at 9:25 AM, Investigator #2 interviewed the Facilities Director (Staff #201) about the water management program at the hospital. Staff #201 stated that the initial testing form the vendor was conducted on 03/05/19 and that the hospital has an annual testing expectation. The director stated that the contractor was being changed and testing would resume in the future. The investigator also asked Staff #201 about cleaning and maintenance of a water feature at the North Star Lodge (an offsite location of the hospital). Staff #201 stated that the water features were routinely cleaned and maintained with antialgal treatments, but that this process was not generated as part of staff standard work. No documentation of its completion could be provided.

Item #6 - Cath Lab Cleaning

1. Record review of the hospital policy titled, "Surgery Room Turnover Workflow," no policy number, approved 10/04/18, showed that staff are to wipe down all attachments to the operating room bed. The policy did not state what to do if items were dropped on the floor during the turnover cleaning.

2. On 10/13/20 at 1:45 PM, Investigator #2 and Investigator #12 observed a between case cleaning of a cath lab procedure room by the Imaging Supervisor (Staff #202) and two Cath Lab Technicians (Staff #203, and #204). During the procedure, a piece of equipment attached to the foot of the procedural table dropped to the ground. The staff members retrieved the item from the ground and returned it to the table without disinfecting the piece of equipment.

3. Following the observation, Investigator #2 mentioned the lack of cleaning of the equipment that touched the ground to the Cath Lab Nurse Manager (Staff #205), who confirmed the observation.

Item # 7 - Hyperbaric Chamber Cleaning

Reference: Guidelines for environmental infection control in health-care facilities. Recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). 2004. Pg 134. "E. Recommendations - Environmental Services. I. Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas. G. Avoid large-surface cleaning methods that produce mists or aerosols or disperse dust in patient-care areas."

1. Record review of the hospital policy titled, "Hyperbaric Infection Control," no policy number, reviewed 10/05/15, showed that staff are to spray the gurney with hyperbaric approved antiseptic. At the end of the day, the chamber will be wiped down with approved antiseptic.

2. On 10/13/20 at 2:10 PM, Investigator #2 interviewed a hyperbaric RN (Staff #206) about the cleaning process for the hyperbaric chambers following patient care. Staff #206 stated that the staff use a spray bottle of hyperbaric disinfectant (Ecolab Asepti-HB) and spray directly onto the surfaces being cleaned.

Item #8 - Cross Contamination of Patient Care Equipment

1. On 10/07/20 at 10:45, Investigator #2 inspected the intensive care unit of the hospital. During the inspection, the investigator observed infusion pumps outside of a COVID positive patient room with lines run through the door to the patient inside the room. One of the lines of tubing running from the pump to the patient was resting on the floor of the room.

2. During the observation, the Critical Care Nurse Manager (Staff #207) confirmed that the tube was on the floor and a staff member was instructed to correct the tube placement.

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Based on observation, interview, and review of hospital documents, the hospital failed to ensure staff followed nationally recognized Centers for Disease Control and Prevention (CDC) recommendations when screening visitors or patients presenting at the entrance of the hospital (Item #1) and failed to follow hospital policy when screening staff (Item #2).

Failure to follow CDC infection prevention and control recommendations places patients and staff at risk of exposure to the SARS-CoV2 virus.

Reference: Centers for Disease Control and Prevention (CDC), "Interim Infection Prevention and Control Recommendations for Healthcare Personnel during the Coronavirus Disease 2019 (COVID-19) Pandemic," updated 11/04/20, recommends using additional infection prevention/control practices during the COVID-19 pandemic-

Implement Universal Use of Personal Protective Equipment

HCP working in facilities located in areas with moderate to substantial community transmission are more likely to encounter asymptomatic or pre-symptomatic patients with SARS-CoV-2 infection. If SARS-CoV-2 infection is not suspected in a patient presenting for care (based on symptom and exposure history), HCP should follow Standard Precautions (and Transmission-Based Precautions if required based on the suspected diagnosis).

They should also: Wear eye protection in addition to their facemask to ensure the eyes, nose, and mouth are all protected from exposure to respiratory secretions during patient care encounters.

Findings included:

1. Record review of a hospital's document titled, "Main Entrance Screening/Security Screening," no date, showed that staff assigned at the screening station will greet visitors/patients, ask if they have a fever, chills, vomiting/diarrhea, un-explained cough, un-explained muscle aches, sore throat, loss their sense of taste or smell, or new onset headache. Then the screener explains that their temperature will be taken and scans them for a fever. The individual is then given a colored band with the temperature written on the band. If the individual measures a temperature greater than 37.5c (99.6F), then they will be denied entry into the hospital.

b. Record review of a hospital's document titled, "Clinical Screening at ED (emergency department) entrance," no date, showed that screeners will screen individuals entering the ED as noted above. But the ED patient will be allowed only one visitor. If the patient is suspected to have COVID-19, they are not allowed visitors. The document further shows that all patients/visitors must always have a face mask on.

2. On 10/07/20 at 08:30 AM, Investigator #10 entered the main hospital entry, approached a screening station in the Foyer and was met by a screener. The investigator observed that the screener was wearing a face mask and gloves but without eye protection. The screener was observed standing at a podium that was not protected by a plexiglass or shield. The investigator's temperature was scanned, then provided a colored band; however, the screener did not ask the investigator if they had symptoms consistent with COVID-19. Then the investigator was directed to proceed to the security station and there the security guard was observed wearing only a face mask and gloves. The guard was not wearing eye protection and was also observed sitting at an unprotected desk.

3. During an interview on 10/08/20 at 10:40 AM, the Environmental Services (EVS) Director (Staff #1001), stated that he hires the screening staff and that his screeners are non-clinical employees. The EVS Director stated that he has not been informed of the latest "CDC Interim Infection Prevention and Control Recommendations," and that he is not sure if his staff has been trained on these prevention recommendations.

4. During another interview on 10/08/20 at 3:00 PM, the Regulatory Compliance Director (Staff #1002) confirmed the screeners were not following CDC infection prevention and control practices.

Item #2 - Staff Screening

1. Record review of a hospital's document titled, "Daily COVID-19 Screening," updated 08/10/20, showed that all VMM employees are asked to attest at the beginning of their shift that:

- they are aware of VMMS expectations and that they do not have symptoms listed here:
- fever or chills
- new cough that is not explained by another medical condition
- new muscle aches not explained by another medical condition or specific activity
- throat pain not explained by another medical condition
- new shortness of breath not explained by another medical condition
- vomiting or diarrhea (expect diarrhea caused by another condition (IBS, Crohn's, etc.)
- new loss of taste or smell

The document also shows that if an employee presents with any of these symptoms, they are to notify their manager and call employee health.

2. On 10/07/20 between 9:30 AM - 1:30 PM, Investigator #10 and Investigator #11 interviewed direct care staff from three different care units. Four staff members were interviewed and revealed the following:

- All four staff members stated that at the beginning of their shift and during their morning huddle on the unit, the charge nurse would ask how they are feeling. Each staff member stated that they did not have their temperature taken or asked specific screening questions. They added that a verbal attestation was acceptable, that there was no need to sign a document.

3. During an interview on 10/08/20 at 8:45 AM, the Interim Operating Room (OR) Manager (Staff #1007), stated that the OR staff is screened by verbal attestation at their 6:45 AM huddle. When asked about the remaining staff that report at variable times (5:00 AM, 7:00 PM) the manager stated that she is not sure how staff that stagger their shift are screened for COVID-19.

4. On 10/07/20 at 2:30 PM, Investigator #2 toured the inpatient psychiatric unit of the hospital. During the tour, the investigator observed the employee symptom attestation form that employees sign when reporting to each shift. The observation showed that there was no form that listed the symptoms to which staff were attesting and no thermometer was present to perform active temperature monitoring.

5. During the observation on10/07/20 at 2:30 PM, Investigator #2 interviewed the Psychiatric Unit Manager (Staff #210) about staff screening. Staff #210 stated that the employees sign a sheet when they report to their shift. Staff #210 stated that staff sign the attestation and that their training materials direct them on symptoms.

6. During an interview on 10/08/20 at 9:15 AM, the Employee Health Nurse (Staff #1008), stated that their office manages employees who report symptoms, or have tested positive. Staff #1008 stated that the Employee Health clinic will manage and monitor the employee who reports symptoms or tests positive. However, she stated that the clinic does not direct or are involved in the screening process of employees prior to patient care.
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