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Based on observations, interviews, review of the CAH's list of off-campus locations and review of SA licensing documents related to building plans submission it was determined that the CAH failed to ensure that the physical environment, both on-campus and off-campus, was safe and constructed in accordance with State licensing building plans requirements:
* Space in the existing cafeteria had been designated and was in use as an ED overflow space without building plans review and the approval of the SA.
* The existing Med/Surg/ED nurses' station was under construction for alterations at the time of the survey without building plans review and the approval of the SA.
* The CAH operated eight off-campus locations at which it provided laboratory phlebotomy and specimen collection services without building plans review and approval and licensure by the SA.

The findings identified during the survey reflect the CAH's limited capacity to provide safe and adequate care and services and represent a Condition-level deficiency of CFR 485.608, Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations.

Findings include:

1. Refer to the deficiency cited at Tag C-816, CFR 485.608(c) - Standard: Licensure of CAH.

2. Refer to the deficiency cited at Tag C-826, CFR 485.610(e)(2)(3) - Standard: Off-campus and Co-Location Requirements for CAHs.

3. Refer to the deficiency cited at Tag C-910, CFR 485.623 - Condition of Participation: Physical Plant and Environment.

4. Refer to the deficiency cited at Tag C-960, CFR 485.627 - Condition of Participation: Organizational Structure

Based on observations, interviews, review of the CAH's list of off-campus locations and review of SA licensing documents and records it was determined that the CAH failed to ensure it was in compliance with applicable State laws and rules related to hospital licensing and changes in the building and physical environment.

Hospital licensing OAR 333-500-0045 requires that a hospital submit building plans and specifications to the SA, the State of Oregon hospital licensing authority, for review and approval prior to building construction, alterations or additions. Impacted areas may not operate until building plans review and licensing processes have been completed and approval for the project(s) is received from the SA FPS Unit. The CAH failed to comply as follows:
* The CAH converted a portion of the hospital cafeteria/dining space into an overflow ED space without FPS Unit plans review and approval.
* The CAH commenced building alterations of the Med/Surg/ED nurse's station without FPS Unit plans review and approval.

Hospital licensing OAR 333-500-0025 requires that off-campus satellite locations where the hospital provides services must have received SA FPS Unit approval and be licensed as part of the hospital prior to commencing services. The CAH failed to comply as follows:
* The CAH operated phlebotomy services at eight off-campus clinics that had not been licensed as part of the CAH, including the required FPS Unit plans review and approval

Findings include:

1.a. An undated document titled "West Valley Hospital Phlebotomy Sites" was reviewed. It reflected that phlebotomy services were provided at the following clinics:

* Boulder Creek, 2485 12th St. SE, Salem, OR 97302
* Compass Medical, 607 SE Jefferson, Dallas, OR 97338
* Edgewater Clinic, 1049 Edgewater St. NW, Salem OR 97304
* Uglow Clinic, 1000 SE Uglow Ave., Dallas, OR 97338
* Independence Clinic, 1430 Monmouth St., Independence, OR 97351
* River Road North, 5100 River Road N., Keizer, OR 97303
* River Road Clinic, 2925 River Rd. South, Salem, OR 97301
* Skyline, 5050 Skyline Village Loop, Salem, OR 97306

There were no suite or room numbers included in the addresses to designate the SHWVH phlebotomy service space within each clinic.

1.b. During interview with SHWVH leadership staff on 06/16/2022 beginning at 1030 the CAO provided the following information:
* SHWVH operated the phlebotomy services within each clinic and those services were in dedicated spaces or rooms in each clinic.
* The phlebotomy staff were SHWVH employees assigned to those locations and they provided services during clinic hours.
* Phlebotomy supplies, and the equipment used to properly manage and store specimens for transport to the hospital's lab (i.e., centrifuges, refrigerators), were provided and maintained by SHWVH.
* Services provided at those locations were billed as SHWVH hospital services.

1.c. Information provided by the SA Licensing and FPS Unit revealed the following:
* There were no records to reflect that SHWVH had submitted plans for FPS Unit review and licensing approval for the eight locations listed under Findings 1.a. above.
* The River Road Clinic at 2925 River Road S. had received FPS Unit plans and licensing approved in 2010 for another hospital, Salem Health hospital in Salem, OR.
* The Edgewater Clinic at 1049 Edgewater St. had received FPS Unit plans and licensing approval in 2012 for another hospital, Salem Health hospital in Salem, OR.
* There was no record of a request to change the licensing status of the two clinics in this finding from Salem Health hospital to SHWVH.

1.d. In an email dated 07/25/2022 SHWVH staff provided the following information regarding the dates that SHWVH had begun to provide services at each of the off-campus locations:

* Boulder Creek, 2485 12th St. SE, Salem, OR 97302 - "January 2020 - Present"
* Compass Medical, 607 SE Jefferson, Dallas, OR 97338 - "February 2014 - Present"
* Edgewater Clinic, 1049 Edgewater St. NW, Salem OR 97304 - "January 2020 - Present"
* Uglow Clinic, 1000 SE Uglow Ave., Dallas, OR 97338 - "January 2020 - Present"
* Independence Clinic, 1430 Monmouth St., Independence, OR 97351 - "August 2021 - Present"
* River Road North, 5100 River Road N., Keizer, OR 97303 - "January 2020-Present"
* River Road Clinic, 2925 River Rd. South, Salem, OR 97301 - "January 2020 - Present"
* Skyline, 5050 Skyline Village Loop, Salem, OR 97306 - "January 2020 - Present"


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2.a. Observations in the CAH's cafeteria dining room adjacent to the kitchen on 06/14/2022 at 1315 revealed:
* Upon dining room entry, a counter and large window where food was ordered from separated the kitchen from the dining room. Three individuals were in line at the window and counter area.
* A curtain was observed spanning across the opposite end of the dining room near the window and counter. There was an opening between the bottom edge of the curtain and floor; and a sheer mesh material opening between the top edge of the curtain and the ceiling. Items that looked like furniture or equipment were visible beneath the curtain. One side of the curtain had an opening large enough to easily walk in and out of the curtained area.
* A door within the curtained area with a sign on it read "ED Lobby" with an arrow indicating the door led to the ED lobby.
* Dining tables and chairs were observed in the remaining dining room space that was not curtained off including just outside the curtained area and near the opening of the curtained area. Three individuals were observed sitting at the tables near the curtain opening.
* While surveyors were standing in line at the dining room window and counter area, discussions regarding patient care were heard coming from inside the curtained area including a discussion about an IV insertion. This situation created a lack of patient privacy and confidentiality during provision of patient care within the curtained area. An individual who identified him/herself as a PAS was present at the time of these observations, and stated the curtained area was "overflow ED" and a "results pending area."

2.b. During tour of the ED on 06/14/2022 at approximately 1700 with the ED ANM and Med/Surg ANM and other hospital staff, observation of the ED overflow area in the dining room revealed a gurney, a patient recliner, portable privacy curtain, vital signs machine, sharps disposal container, boxes of exam gloves, computer on wheels, IV pole, and other patient equipment and supplies. A bedside table was observed across from the gurney and recliner. The bedside table had a Phillips "doorbell" button on top of it with a sticker below it labeled "Nurse Call Button." A patient sitting in a wheelchair and a visitor were observed in the area. No handwashing sink was observed. During an interview with the ED ANM on 06/14/2022 at the time of these observations, he/she confirmed the area was used for ED services. The ED ANM stated patients with ESI level 4 and 5 were provided care in the ED overflow area; and patients waiting for lab, imaging or other "results" also waited there.

2.c. Review of an undated document describing ED services provided in the ED overflow area in the dining room reflected "Description and outline of Café usage for patient care overflow and results pending. Under the temporary licensure for Covid-19 response and patient surge the Café at West Valley Hospital has been partitioned to accommodate patient needs in relation to increased patient volumes being seen at West Valley Emergency Department ... For context, the emergency room began seeing a steady increase in monthly patient volumes starting in May of 2021 ... By August 2021 the Emergency Department has seen increasing volumes for the preceding five months. Initially the Café was used for results pending / type 4 and 5 ESI patients and during hours of closure of the kitchen. November 8th the curtain was installed as the data was indicating the need to maintain a surge plan state. To date the patient volumes remain much higher than in months and years past ... to accommodate the Emergency Department has utilized the Café space to ensure patient safety and reduced lobby wait times."

2.d. Review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH obtained SA review and approval prior to commencement of ED services in the cafeteria dining room.

Hospital licensing records further reflected that the hospital had obtained temporary building plans approval and licensure earlier in the COVID-19 pandemic for other changes it made. However, there was no documentation to reflect that had occurred for the ED services in the cafeteria dining room.

3.a. Observations near the Med/Surg/ED "Nurse Server" area on 06/15/2022 at approximately 1040 with the ED ANM revealed floor to ceiling plastic barriers near the ice machine, refrigerator, and other areas. The ED ANM stated a Med/Surg/ED nurse station remodel was occurring within the barriered area. Observations within the barriered area revealed new-appearing nurse station counters, several ceiling tiles removed with numerous wires dangling from within the ceiling openings, a construction ladder, blue sticky floor mats, and a large garbage collection container.

3.b. Review of an undated document describing the Med/Surg/ED nurse station remodel revealed that an "ED Nurses station refresh" project commenced on 05/12/2022, and the project scope entailed "Demo old casework, patch flooring, relocate boiler and HVAC alarms, Pain (sic) and install new casework."

3.c. Review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had submitted plans to the SA for review and approval of the ED nurse station remodel.

3.d. During interview with the QA on 06/16/2022 at 1045, he/she confirmed the hospital did not go through the SA FPS review and approval process for the ED nurse station remodel.

4. In response to a request for CAH P&Ps that ensured CAH construction, renovations, and changed use of space complied with SA FPS requirements, a P&P titled "Construction and Renovation," effective "December 2021" was provided. Review of the P&P revealed it was primarily related to ICRA activities and did not include information related to compliance with SA FPS requirements. No other P&Ps were provided. This was confirmed during an interview with the QA on 06/16/2022 at approximately 1045. He/she stated they'd given us what they had.

Based on interview, review of the CAH's list of off-campus locations, review of SA licensing documents and records and review of CMS certification records it was determined that the CAH failed to ensure that the eight off-campus satellite locations it operated were located more than a 35 mile drive from another hospital or CAH.

Findings include:

1.a. An undated document titled "West Valley Hospital Phlebotomy Sites" was reviewed. It reflected that phlebotomy services were provided at the following clinics:

* Boulder Creek, 2485 12th St. SE, Salem, OR 97302
* Compass Medical, 607 SE Jefferson, Dallas, OR 97338
* Edgewater Clinic, 1049 Edgewater St. NW, Salem OR 97304
* Uglow Clinic, 1000 SE Uglow Ave., Dallas, OR 97338
* Independence Clinic, 1430 Monmouth St., Independence, OR 97351
* River Road North, 5100 River Road N., Keizer, OR 97303
* River Road Clinic, 2925 River Rd. South, Salem, OR 97301
* Skyline, 5050 Skyline Village Loop, Salem, OR 97306

There were no suite or room numbers included in the addresses to designate the SHWVH phlebotomy service space within each clinic.

1.b. The nearest hospital to the CAH was another AC hospital located 15 miles from the CAH in Salem, OR. The CAH's eight off-campus locations are all located within 5 to 17 miles distance from the AC hospital in Salem:

1.c. During interview with SHWVH leadership staff on 06/16/2022 beginning at 1030 the CAO provided the following information:
* SHWVH operated the phlebotomy services within each clinic and those services were in dedicated spaces or rooms in each clinic.
* The phlebotomy staff were SHWVH employees assigned to those locations and they provided services during clinic hours.
* Phlebotomy supplies, and the equipment used to properly manage and store specimens for transport to the hospital's lab (i.e., centrifuges, refrigerators), were provided and maintained by SHWVH.
* Services provided at those locations were billed as SHWVH hospital services.

1.d. Information provided by the SA Licensing and FPS Unit revealed the following:
* There were no records to reflect that SHWVH had submitted plans for FPS Unit review and licensing approval for the eight locations listed under Findings 1.a. above.
* The River Road Clinic at 2925 River Road S. had received FPS Unit plans and licensing approved in 2010 for another hospital, Salem Health hospital in Salem, OR.
* The Edgewater Clinic at 1049 Edgewater St. had received FPS Unit plans and licensing approval in 2012 for another hospital, Salem Health hospital in Salem, OR.
* There was no record of a request to change the licensing status of the two clinics in this finding from Salem Health hospital to SHWVH.

1.e. Information provided by CMS revealed that there were no records to reflect CMS had approved the eight off-campus locations.

1.f. In an email dated 07/25/2022 SHWVH staff provided the following information regarding the dates that SHWVH had begun to provide services at each of the off-campus locations:

* Boulder Creek, 2485 12th St. SE, Salem, OR 97302 - "January 2020 - Present"
* Compass Medical, 607 SE Jefferson, Dallas, OR 97338 - "February 2014 - Present"
* Edgewater Clinic, 1049 Edgewater St. NW, Salem OR 97304 - "January 2020 - Present"
* Uglow Clinic, 1000 SE Uglow Ave., Dallas, OR 97338 - "January 2020 - Present"
* Independence Clinic, 1430 Monmouth St., Independence, OR 97351 - "August 2021 - Present"
* River Road North, 5100 River Road N., Keizer, OR 97303 - "January 2020-Present"
* River Road Clinic, 2925 River Rd. South, Salem, OR 97301 - "January 2020 - Present"
* Skyline, 5050 Skyline Village Loop, Salem, OR 97306 - "January 2020 - Present"

Based on observations, interviews, review of fire drill and fire extinguisher documentation, review of the CAH's list of off-campus locations and review of SA licensing documents related to building plans submission it was determined that the CAH failed to ensure that staff were trained and competent to respond to fire events, that equipment for response to fires was in proper working order, and that the physical environment, both on-campus and off-campus, was safe and constructed in accordance with State licensing building plans requirements:
* The hospital failed to comply with the Life Safety From Fire requirements as indicated on the attached Life Safety from Fire CMS 2567 SOD Report at Tag K-712. This finding represented an IJ situation. Refer also to Tag C-0000 at the beginning of this SOD report for the details of the IJ identification and removal.
* Space in the existing cafeteria had been designated and was in use as an ED overflow space without building plans review and the approval of the SA.
* The existing Med/Surg/ED nurses' stafion was under construction for alterations at the time of the survey without building plans review and the approval of the SA.
* The CAH operated eight off-campus locations at which it provided laboratory phlebotomy and specimen collection services without building plans review and approval and licensure by the SA.

Although the IJ situation was verified to be removed during the survey, the findings identified during the survey reflect the CAH's limited capacity to provide safe and adequate care and services and represent a Condition-level deficiency of CFR 485.623, Condition of Participation: Physical Plant and Environment.

Findings include:

1. Refer to the deficiency cited at Tag C-912, CFR 485.623(a) - Standard: Construction.

2. Refer to the deficiency cited at Tag C-930, CFR 485.623(c) - Standard: Life Safety From Fire.

3. Refer to the deficiency cited at Tag C-810, CFR 485.608 - Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations.

4. Refer to the deficienty cited at Tag C-816, CFR 485.608(c) - Standard: Licensure of CAH.

Based on observations, interviews, review of the CAH's list of off-campus locations and review of SA licensing documents related to building plan submission it was determined that the CAH failed to construct, arrange and maintain the physical environment, both on-campus and off-campus, to ensure the safety of patients, and adequate space for the provision of services:
* Space in the existing cafeteria had been designated and was in use as an ED overflow space without building plans review and the approval of the SA.
* The existing Med/Surg/ED nurses' station area was under construction for alterations at the time of the survey without building plans review and the approval of the SA.
* The CAH operated eight off-campus locations at which it provided laboratory phlebotomy and specimen collection services without building plans review and approval and licensure by the SA.
* Multiple areas in the physical environment had not been maintained in good order and were in need of repair.

Findings include:

1. Refer to the deficiency cited at Tag C-810, CFR 485.608 - Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations.

2. Refer to the deficiency cited at Tag C-816, CFR 485.608(c) - Standard: Licensure of CAH.


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3. During a tour of the Salem Health West Valley Medical Clinic - Monmouth on 06/15/2022 beginning at 0915 with the Clinic Manager and staff the following observation were made:
* A patient room in the rehab area had water damage under the sink. This created the potential for mold and insects/pests. The findings were confirmed with the Clinic Manager at that time.

4. Observations of the ED on 06/15/2022 beginning at 1100 with the ED ANM, Med/Surg ANM, and other hospital staff revealed:
* In the Med/Surg/ED nurses' station patient nourishment and clean supply area, under the handwashing sink gray colored liquid splatter marks were observed on the bottom of the sink cupboard. This created the potential for mold and other unsanitary conditions. Peeled, chipped paint was observed on the top and side edges of a yellow wound care cart.
* In the soiled utility room, a deep scratch approximately 3 feet in length was observed along the wall across from the sink counter. A portion of the scratch was gouged and sheet rock appearing wall material was exposed. Several patched, gouged and unpainted areas were observed surrounding an electrical outlet cover near the paper towel dispenser and sink. A deep scrape approximately 6 inches in length was observed on the interior of the wood or wood-like entry door below the door handle. These surfaces were in disrepair and uncleanable.

5. Observations of the CAH's main lobby entry on 06/15/2022 and 06/16/2022 revealed a large stainless steal plate attached to the wall in an alcove. The plate had two square holes in it, each with four surrounding screw holes. Insulation-like material and pipes were observed inside the holes. This created the potential for entry of insects, rodents and other pests. During the survey, the FM stated a drinking fountain had been removed from that wall area.


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Based on observations, interviews and review of fire drill and fire extinguisher documentation, it was determined that the CAH failed to ensure that staff were trained and competent to respond to fire events and that equipment for response to fires was in proper working order. The hospital failed to comply with the Life Safety From Fire requirements as indicated on the attached Life Safety from Fire CMS 2567 SOD reports for Building-01, the main hospital, and Building-02, a satellite location, and on the CMS 2567 SOD report for Emergency Preparedness.

Findings described at Tag K-712 on the Building-01 SOD report were determined to represent an IJ situation. Refer also to Tag C-0000 at the beginning of this SOD report for the details of the IJ identification and removal.

Findings include:

1. Refer to the findings on the Life Safety from Fire CMS 2567 SOD reports for:
* Building-01, the main hospital.
* Building-02, a satellite location.
* Emergency Preparedness.

Based on observations, interviews, review of fire drill and fire extinguisher documentation, review of the CAH's list of off-campus locations and review of SA licensing documents related to building plans submission it was determined that the governing body or designated responsible individual failed to ensure that staff were trained and competent to respond to fire events, that equipment for response to fires was in proper working order and that the physical environment, both on-campus and off-campus, was safe and constructed in accordance with State licensing building plans requirements.
* The hospital failed to comply with the Life Safety From Fire requirements as indicated on the attached Life Safety from Fire CMS 2567 SOD Report at Tag K-712. This finding represented an IJ situation. Refer also to Tag C-0000 at the beginning of this SOD report for the details of the IJ identification and removal.
* Space in the existing cafeteria had been designated and was in use as an ED overflow space without building plans review and the approval of the SA.
* The existing Med/Surg/ED nurses' stafion was under construction for alterations at the time of the survey without building plans review and the approval of the SA.
* The CAH operated eight off-campus locations at which it provided laboratory phlebotomy and specimen collection services without building plans review and approval and licensure by the SA.

Although the IJ situation was verified to be removed during the survey, the findings identified during the survey reflect the CAH's limited capacity to provide safe and adequate care and services and represent a Condition-level deficiency of CFR 485.627, Condition of Participation: Organizational Structure.

Findings include:

1. Refer to the deficiency cited at Tag C-962, CFR 485.627(a), Standard: Governing Body or Responsible Individual.

2. Refer to the deficiency cited at Tag C-910, CFR 485.623, Condition of Participation: Physical Plant and Environment.

3. Refer to the deficiency cited at Tag C-810, CFR 485.608, Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations.

Based on observations, interviews, review of fire drill and fire extinguisher documentation, review of the CAH's list of off-campus locations and review of SA licensing documents related to building plans submission it was determined that the governing body or designated responsible individual failed to ensure that staff were trained and competent to respond to fire events, that equipment for response to fires was in proper working order and that the physical environment, both on-campus and off-campus, was safe and constructed in accordance with State licensing building plans requirements:
* The hospital failed to comply with the Life Safety From Fire requirements as indicated on the attached Life Safety from Fire CMS 2567 SOD Report at Tag K-712.
* Space in the existing cafeteria had been designated and was in use as an ED overflow space without building plans review and the approval of the SA.
* The existing Med/Surg/ED nurses' stafion was under construction for alterations at the time of the survey without building plans review and the approval of the SA.
* The CAH operated eight off-campus locations at which it provided laboratory phlebotomy and specimen collection services without building plans review and approval and licensure by the SA.

Findings include:

1. Refer to the deficiency cited at Tag C-910, CFR 485.623 - Condition of Participation: Physical Plant and Environment.

2. Refer to the deficiency cited at Tag C-810, CFR 485.608 - Condition of Participation: Compliance with Federal, State, and Local Laws and Regulations.

Based on observations, interviews, review of grievance documentation for 3 of 4 patients reviewed for grievances (Patients 8, 9 and 10) review of P&Ps and review of SA licensing records it was determined that the hospital failed to fully develop and implement P&Ps that recognized and protected each patient's rights as follows:
* Timely and complete investigation and written responses to complaints and grievances were not provided.
* Privacy and confidentiality of patient information was not provided as patient care discussions in the unapproved ED overflow area located in the cafeteria could be heard from the cafeteria dining area.

Findings include:

1.a. The P&P titled "Resolution of Patient Complaints / Grievances" dated as approved "11/2021" included the following direction:
* "If a patient or health representative expresses a concern, steps should be taken promptly to resolve the issue, if possible, by the staff present. If the concern requires additional investigation, the Patient Advocate Office, or like entity, is responsible for managing the process."
* "The employee first hearing a patient's complaint or receiving a patient grievance has the responsibility to enter the information into the RL Reporting System. The case will automatically be routed to the Patient advocate, or like entity, for follow up. The Patient Advocate, or like entity, will assign the grievances to one or more managers and/or specialty section chief who have oversight of the area ... for investigation and response back to the patient or authorized representative."
* "All allegations of abuse or neglect, that occurred while patient is in Salem Health's care, require a formal grievance process initiated by the staff member who witnessed or was first made aware of the allegation."
* "The assigned manager upon completion of an investigation shall send a written response to the patient or authorized representative raising the initial grievance within seven (7) business days ... of receipt of a grievance. For those grievances requiring longer than seven (7) business days to resolve, the responsible manager shall inform the complainant of such requirements immediately, either in writing or by telephone, and shall establish an acceptable schedule for ongoing update prior to final resolution."
* "Managers will conduct, coordinate and collect investigations of the grievance ... The investigation must include a personal interview with clinical staff involved in patient's care and thorough review of the patient medical records as appropriate."
* "Communication with the patient or health representative during the investigation or as part of the grievance process, may take the form of a meeting or telephone conference, although a final letter is always required."
* "The written response must provide adequate information to respond to the issue brought forward by the patient, while identifying, investigating, and resolving any deeper, systemic problems indicated by the grievance. The letter must contain the following: ... apology ... name of hospital contact person ... steps taken on behalf of the patient to investigate the complaint ... results of the investigation and grievance process ... date the investigation was completed ..."
* "All verbal or written complaints or allegations of abuse and neglect that occurred while patient is under Salem Health's care ... are always to be considered a grievance."
* "Any concerns raised by the patient, or their legal representative ... which cannot be resolved at the time of complaint by staff present ... requires investigation and/or requires further actions for resolution is considered a grievance."

1.b. A document titled "Standard Work: Complaints intake and investigation (other than billing)" dated 01/15/2018 also included the following:
* "For hospital care complaints Provide (sic) with outcome within 7 business days (call as appropriate - apology and outcome letter must be sent within 7 business days)."
* "If unable to complete investigation in appropriate amount of business days, contact patient letting then know investigation is ongoing. In addition, send letter stating extension needed for investigation to be completed. Letter should indicate 30 business days for investigation to be completed (completion date 30 business days from letter date)."

2.a. Review of incident documentation for Patient 8 dated as entered on 01/23/2020 by the CAH's QM reflected the report was about an ED encounter that occurred on 01/07/2020. That report included the following:
* Patient 8 "Concerned that during recent visit 'a couple weeks ago' a [gender] nurse was in the room and when no one else was in the room was very mean to [him/her] ... States that [he/she] asked to not have this nurse and the staff gave [him/her] this nurse. States that this nurse was aggressive to [him/her] and made [him/her] feel anxious, [he/she] was not able to stay a long time for the visit because of it."
* "Also upset that is having new trouble with back pain and cant (sic) get seen as there are no PCPS in the area that can see [him/her]. Talked with [patient] about care management and was agreeable to having care management involvement ... Spoke with care management after this and planned to write letter ... care management feels that can get patient in sooner ... Letter written and left at ED desk sealed in envelop (sic) with address to patient ... case management card was included."
* The only reference to the stated concern about treatment by staff was dated 01/23/2020 and reflected "[EDANM] was notified of patient concern regarding [gender] staff taking care of nurse (sic) and what patient felt. Will be aware for the future and keep an eye on the situation as patient is a frequent visitor ... Closing as complaint. Will continue to monitor for future events."

There was no documentation to reflect that the patient's concerns about treatment by a staff person had been investigated and a written grievance response provided to the patient in the same manner that a written letter related to care management concerns had been provided.

2.b. An incident document for Patient 8 dated as entered on 05/21/2020 by the PA reflected the report was about an ED encounter that occurred on 05/21/2020. That report included the following:
* "This afternoon [Patient 8] was seen in the [SHWVH] ED this afternoon. (sic) ... I learned this when [he/she] called me from [his/her] vehicle after being seen in the ED and asked (sic) to leave after behavior with a nurse that inspired staff to call Dallas PD to address [his/her] disruptive behavior."
* "I was called earlier to the ED to inform me (sic) that [Patient 8] was in the ED and that [he/she] had requested that I 'better get down there' to see [him/her] and help [him/her] because 'that doctor is on again and [the doctor] doesn't like me.' via (sic) [his/her] phone call to admin. I went to the ED but did not make my presence known to the patient at that time. I discussed with the physician [his/her] perceptions and request for me to come to [him/her]."
* "Patient is demanding and assertive ... Requesting that security review footage from patient visit in room 11 of [SHWVH] ED as well as outside footage ... Security notified and requested them to save and send video for case review."
* The first follow-up documentation was dated 06/02/2020 by the PA and reflected "Patient left several voice messages about [his/her] concern for [his/her] experience ... Tabling this concern at this time. We have worked to help this patient by helping to coordinate [his/her] care ... connecting with [his/her] primary physician ... search for a bladder infection cure. We will continue to be of assistance when and if [he/she] is needing that."

Although the incident timeline was unclear and confusing, it reflected that the PA went to the ED on 05/21/2020 in response to a specific request from the patient. However, the PA intentionally did not make his/her presence know to the patient and did not speak with the patient while he/she was in the ED as requested. The PA documented that he/she spoke to the physician but there was no documentation about the outcome of that conversation. There was no documentation to reflect that the patient's concerns about his/her experience had been thoroughly investigated, including the video review that was requested, and that a written grievance response was provided to the patient.

2.c. During review of grievance documentation with the PA and the CNO on 06/16/2022 at 1100 it was revealed that there were no grievance response letters written to address Patient 8's concerns described in incident documentation. The PA stated that Patient 8 demanded many things and the advocate had had numerous calls and in-person encounters with the patient. The advocate stated that there were no written letters provided to the patient because the incident documentation for Patient 8 hadn't been "filed as grievances but as information."

3.a. Review of grievance documentation for Patient 9 reflected a written grievance was submitted to SHWVH by letter and email on 01/28/2022. The concerns in the grievance included that the spouse of the patient was not allowed to accompany the patient into the ED to advocate and was "locked" out of the ED, and that a certain blood test and and MRI or CT scans were not conducted. The grievance documentation reflected the following:
* An email was sent to the complainant on 01/28/2022 that indicated a "formal complaint process" had been initiated. However, there was no information in the email that provided the complainant with a date or timeline for completion of the investigation within the next 30 days.
* There were no investigation tasks or outcome documented in the grievance notes.
* A copy of a letter to Patient 9 dated 03/07/2022 reflected "A review of care was completed and your thoughts and concerns were shared with the manager of the ED and the Medical Director who in turn worked with the staff to observe moments they can improve communication during these circumstances."

The written response was not provided to the patient within 7 business days and it lacked the "... steps taken on behalf of the patient to investigate the complaint ... results of the investigation and grievance process ... date the investigation was completed ..." specific to the concerns expressed in the grievance.

3.b. The lack of a timely written response to Patient 9 was confirmed during interview with the PA and the CNO at the time of the grievance review on 06/16/2022 beginning at 1100.

4.a. Review of grievance documentation for Patient 10 reflected he/she submitted a verbal grievance over the phone on 02/07/2022 related to rough physical treatment and verbal abuse during an imaging procedure. The investigation was assigned to a staff person. The grievance documentation reflected the following:
* The only investigation task documented was a discussion dated 02/17/2022 about Patient 10's encounter with the imaging tech involved.
* The only other documentation of follow-up was a "sign-off" note dated 02/17/2022 that reflected the staff person "spoke with" Patient 10 and during the discussion the patient continued to verbalize that the tech had yelled at him/her. The patient stated that in the future he/she "wanted to have a different tech. I told him we would do our best, but can't always accommodate due to our size."

There was no documentation that a complete investigation of the alleged physical and verbal abuse had been conducted and that a written response provided to Patient 10 that included "... steps taken on behalf of the patient to investigate the complaint ... results of the investigation and grievance process ... date the investigation was completed ..." specific to the concerns expressed in the grievance.

4.b. The lack of a written response to Patient 10 was confirmed during interview with the PA and the CNO at the time of the grievance review on 06/16/2022 beginning at 1100.


29708


5. Refer to the findings cited at Tag C-816 that reflect the CAH failed to develop and implement P&Ps that ensured patient privacy and confidentiality was maintained during provision of ED services in the unapproved ED overflow area located in the cafeteria.

Based on observation, interview and review of the CAH's list of services furnished under contract, arrangement or agreement it was determined that the list of all services furnished under contract, arrangement or agreement was not complete.
* The list did not include all such services.
* The list did not include descriptions of the nature and scope of the services provided, to include at a minimum: The service(s) being offered; The individual(s) or entity providing the service(s); Whether the services are offered on- or off-site; Whether there is any limit on the volume or frequency of the services provided; and When the service(s) are available.

Findings included:

1. An undated document titled "West Valley Hospital Clinical Contract Service Evaluation 2022" was reviewed. The document contained a list of 20 "Agency" or company/organization names. The list did not reflect all services provided under contract, arrangement or agreement. For example:

* During a tour on 06/14/2022 at ~ 1205 observations in the soiled linen hold room revealed a large covered bin with a sign attached to it that read "Dallas Laundry." During interview with EVS staff and the CAO it was stated that certain specialty items were processed by a local business by the name of "Dallas Laundry." In addition, observations and interview during the tour revealed medical/biohazard waste management services were provided by a company by the name of "Stericycle." The list of services furnished under contract, arrangement or agreement did not include those services.
* During interview on 06/16/2022 beginning at ~ 0945 it was confirmed by leadership staff, including the CAO, that the following services were in part provided by contract, arrangement or agreement: Lithotripsy services and Nuclear Medicine services. In addition, it was revealed that the SHWVH Dietician was an employee of another hospital, Salem Health hospital. The list of services furnished under contract, arrangement or agreement did not include those services.
* Review of the SHWVH "Plan for Provision of Patient Care Services" dated "January 2021" reflected that after hours pharmacy services were provided by another hospital, Salem Health hospital, through a "Shared Services Agreement." The list of services furnished under contract, arrangement or agreement did not include those services.
* During tour of a SHWVH off-campus satellite location in Monmouth, OR on 06/14/2022 it was revealed that medical gas, commercial cleaning, transcription, and patient linen and "textile" services were furnished under contract, arrangement or agreement. However, none of those services were included on the list.
* Similarly, throughout the course of the survey the following services furnished under contract, arrangement or agreement that were not identified on the list included: In the Imaging Department services were identified as furnished by Phillips, GE, and Siemens. In the Pharmacy Department services were identified as furnished Cardinal Health.

2. The list of services did not contain a description of the nature and scope of services provided under those contracts, arrangements or agreements.

3. During interview with the CAO on 06/16/2022 at 1245 he/she confirmed that the list did not include all services provided at SHWVH under contract, arrangement or agreement nor did it contain the required descriptions of the nature and scope of services provided.

44104

Based on observations, interview, review of infection control P&Ps, and other documentation, it was determined that the CAH failed to ensure it clearly identified and designated an infection preventionist who was responsible for and ensured development and implementation of infection prevention P&Ps and control program.
* P&Ps and other documents regarding an infection preventionist for the CAH were unclear and inconsistent.

Findings included:

1. The "West Valley Hospital" organizational chart dated "June 10, 2022" was reviewed and reflected:
* An "Infection Prevention" department was not included in the hospital's organizational chart.
* An "Infection Prevention" manager was not included in the hospital's organizational chart.

1. a. A document titled "SHWV Phone List by Department" provided by the hospital and dated "March 25, 2021" was reviewed.
* There was no Infection Prevention department listed.

1. b. A policy titled "Salem Health Infection Prevention Program Administrative House Wide Policy and Procedures ... Effective Date: August 2021 [SHWVH]" was reviewed. It reflected:
* Under the section "Policy Content" was written, "Although each facility's infection prevention program functions independently on a daily basis, the Salem Hospital Infection Prevention Department functions in a consultant capacity to [SHWVH], with the [SHWVH] Infection Prevention nurse functioning as a designee to the Salem Health Infection Prevention Department."
* Under the section "Authority for Program" was written, "Hospital Administration and the Medical Staff ... gives authority to ... the [SHIPM] and the [SHWVHIPN]."
* "The Infection Prevention Manager is responsible for the program ... The Infection Prevention Manager also serves as a liaison between the Medical Staff and the Hospital for infection prevention issues. At [SHWVH], the IP nurse performs this function and reports to the Director of Clinical Operations." Although the policy specified that the SHWVH "IP nurse" was a "designee" of the SHIPM, no "IP nurse" was listed on the organizational chart nor on the "[SHWVH] Phone List."

1. c. During a tour of Surgical Services on 06/14/2022, with the SSD and the Surgical Services ANM beginning at 1300, when asked about IP responsibilities, and specifically about the tracking and reporting of surgical site infections, both identified the QA as the person responsible for IP at SHWVH.

1. d. During a tour of the Infusion and Wound Clinic on 06/15/2022, with IWC NM and the IWC ANM, beginning at 1538, when asked about what HAIs were monitored, both identified the QA as the person responsible for IP at SHWVH. The SSD stated that "what to monitor comes from [QA name]."

1. e. An email sent by the QA dated "06/23/2022," was reviewed and reflected:
* "The designated Infection Preventionist/Infection Control professional for West Valley is [SHIPM] who is the infection prevention manager for the system as a whole." The email further indicated that the QA served as a "liaison to the larger system ... able to answer onsite questions and clarifications of ... overarching policies and procedures ..." but that the QA was not the " ... designated infection preventionist."

1. f. In a follow up email dated "06/23/2022," the QA indicated that Finding 1.e. had been in place prior to 2016. It was unclear if the QA was the SHIPM designee, as the email reflected he/she was a "liaison to the larger system." It was additionally unclear if the QA was the IP nurse for the CAH.

29708

Based on observations, interview, review of infection control P&Ps, and other documentation, it was determined that the hospital failed to ensure that infection prevention policies and procedures had been fully developed and implemented. Procedures and processes to prevent cross-contamination, HAIs, and to ensure infection prevention had not been fully developed and enforced in the following areas:
* Instrument/device pre-cleaning processes in ED were unclear, inconsistent, and not fully developed and implemented.
* Ultrasound probe disinfection processes were not conducted in a manner to prevent cross-contamination nor in accordance with P&Ps to ensure proper disinfection.
* Environmental temperatures were not monitored to ensure integrity of high-level disinfectant testing strips.
* All environmental surfaces were not clean and/or cleanable.
* Expired or otherwise unusable lab supplies, disinfectant wipes and other supplies were available for use and their integrity could not be assured.
* Refrigerated food in Med/Surg/ED was available for patient use and was not labeled with legible expiration and other information in accordance with CAH policies and procedures.
* The unapproved ED overflow area in the cafeteria dining room was not evaluated for potential infection control risk.
* A water-borne pathogens program had not been developed and implemented.
* A CAH infection preventionist was not clearly and consistently identified; and responsible and ensured development and implementation of infection control P&Ps, and CAH surveillance activities.

Findings included:

1. Regarding instrument pre-cleaning processes:

1. a. Observations in the ED soiled utility room on 06/15/2022 at 1220 with the ED ANM, Med/Surg ANM and other hospital staff revealed:
* Two signs observed posted on the wall above the handwashing sink describing processes for pre-cleaning reusable surgical instruments and devices.
- The first sign titled "Standard Work: Cleaning Instrumentation immediately after use with Wetting Agent" dated 10/07/2019 reflected "Wear PPE including gloves and eye protection ... Make sure all instruments are open at the lock box or disassembled before placing them into a red bin or Rigid Container ... Spray Wetting Agent on stainless instrumentation at least three (3) feet away from patient, spray away from the direction of the patient ... Spray directly onto instrumentation immediately after procedure and prior to the instruments drying, coating the instruments ... Continue to spray each time additional instruments are added to contaminated instrument trays or red bins ... Frequency of Use: Immediately after use of instruments, done at the point of care. If instruments are offsite, use Pre-Klenz to maintain wetness for up to 72 hours." It was unclear what was meant by "offsite" including whether that was applicable to the contaminated instruments in the red bin.
- The second sign titled "Standard Work: Transporting Biohazard Instruments," dated 12/12/2019 reflected " ... collect clean red biohazard container from: Cupboard in room 3 ... Place bin and instrument(s) in patient's room for provider used and remove clean sticker ... any instruments brought to patient room, even when not opened/used, are considered dirty and require pre-cleaning ... When provider completes use of instruments ... Place instruments into red biohazard bin and place cover on red biohazard container. Lock bin with clips ... Transport to soiled utility room ... Perform hand hygiene ... Don gloves and face shield ... Open cover on red biohazard container ... Spray ALL instruments with generous amount of moistening spray or enzymatic [a picture of a container of Pre-Klenz Point of Use Processing Gel was next to this] ... Place cover on red biohazard container ... Remove gloves and face shield ... Perform hand hygiene." These instructions did not specify how long the Pre-Klenz was effective after the instruments were sprayed.
*A red tote was observed on the counter near the sink. The tote had a lid on it clipped in the closed position. The lid had a permanent label that read "Contains Contaminated Reusable Sharps" and "ED" written with a Sharpie pen, and a green and white paper label that read "Clean." Observation of the inside of the bin revealed it was empty. Red bandage scissors were observed on the counter next to the bin. It was unclear if the bin marked as "Clean" was actually clean or dirty. It was unclear if the scissors were clean or dirty, and why they were on the counter in the soiled utility room.
*Another red tote was observed on the counter on the other side of the sink. The tote had a lid on it clipped in the closed position. The lid had an orange "Dirty Biohazard" label on it and "[SHWVH] ED" written with a Sharpie pen. Observation of the inside of the bin revealed 2 speculums in the closed position, and one speculum in the open position. The instructions posted above stipulated that all instruments were to be open or disassembled before placing into a red bin.
* There was no information on the bins or elsewhere in the room that reflected how long the contaminated instruments/devices (speculums) had been in the bin, and when they were sprayed with enzymatic.
* No protective face shields or other eye protection were observed in the room and readily available for staff use in accordance with the posted instructions.
These observations were confirmed with staff present at the time of the observation.

The posted instructions were unclear and inconsistent. For example:
* It was unclear if one or both posted instructions were applicable.
* The first sign stated "If instruments are offsite, use Pre-Klenz to maintain wetness for up to 72 hours." It was unclear if "offsite" was applicable to the instruments observed in the red bin.
* The first sign referred to spraying instruments "at least three (3) feet away from patient ... immediately after procedure" and the second sign referred to spraying instruments after transport to the soiled utility room. It was unclear whether instruments should be sprayed in patient area immediately after procedure, after transport to soiled utility, or both.

1. b. During an interview with the ED ANM and SS ANM on 06/15/22 at 1145, the following information was provided:
* Contaminated instruments should be placed in a red bin at the time of use, brought to soiled utility room, sprayed with Pre-Klenz foam, and "Clean" sticker removed from bin.
* Sterile Processing staff come to the soiled utility room on Tuesdays and Fridays and pick up red bins of contaminated instruments and take them to the sterile processing department for processing.
* The red bin with the "Clean" label on it should not be in the soiled utility room.
* The scissors observed on the counter were reusable, it was not clear if they were clean or dirty, and "there is no standard work for scissors."

2. During a tour of the Imaging Department with the Interim Imaging Manager and Lead Imaging Tech on 06/14/2022 at 1030, a Trophon ultrasound transducer disinfection machine was observed in a hallway nook sitting on a rolling cart next to a rolling vital signs machine. The nook had a rolling cart with a plastic drawer full of towels and disinfectant wipes on top of the drawer. There was a diagram of a transducer being washed under running water above the vital signs machine. The nook did not have a sink or door as required in processing areas.

* The P&P titled "High Level Disinfection of Ultrasound Probes Using the Trophon System Administrative Department Level Policy" dated approved "01/2020" was reviewed, it reflected:
* "Wash and dry probe to be sanitized. All foreign material must be removed and probe must be completely dry."

* During interview with the ultrasound tech on 06/14/2022 at 10:45, he/she stated the used transducer is wrapped in a towel and placed in a biohazard container. The container is taken out of Ultrasound Room 2 to the nook processing area where it is wiped with disinfectant cleaner wipes and dried with a lint free towel. The transducer is than placed in the disinfectant machine to run through the disinfectant cycle. When the cycle is complete, the transducer is removed and hung back up in Ultrasound Room 2. The biohazard container is wiped off with disinfectant wipes and a "clean" sticker is placed on it and returned to Ultrasound Room 2.

3. Regarding high-level disinfectant test strips:

3. a. Observations during tour of Surgical Services on 06/14/2022 beginning at 0945 with the SS ANM and Outpatient NM revealed:
*In the scope processing room, a container of Revital-Ox Solution test strips and a container of Acecide-C test strips were observed on an upper shelf above the scope cleaning sink. A blue bin with a lid on it was observed on the sink counter. An AER used to reprocess contaminated endoscopes was observed.

3. b. Review of IFUs dated 11/01/2015 for Revital-Ox Solution test strips reflected "The Revital-Ox [Test Strip] is a single use, high level disinfectant concentration monitor designed to determine whether the concentration of hydrogen peroxide, the active ingredient in Revital-Ox ... High Level Disinfectant-Chemosterilant is above the minimum recommended concentration (MRC) of 1.5%." The "Storage Conditions" reflected "Store ... Solution Test Strips in the original bottle with the cap tightly closed at 6-30 [degrees] C (43-86) [degrees] F and 30-80% relative humidity."

3. c. Review of IFUs dated [03/2019] for Acecide-C test strips reflected "To utilize the Test Strips correctly and safely, please read and follow the instructions for use for Acecide-C [Test Strips] ... Use test strips to monitor peracetic acid (PAA) concentration of Acecide-C prior to each reprocessing cycle and replace the Acecide-C when the test strip fails the evaluation." The "Storage" section reflected "Store sealed canister at or below 25 [degrees] C (77) [degrees] F."

3. d. During an interview with the SS ANM on 06/14/2022 at 1210 and 06/16/2022 at 1100, he/she provided the following information:
* The blue bin with the lid was used for high level disinfection of heat sensitive devices such as airway blades and esophagus procedure dilaters. Revital-Ox Solution test strips were used to test Revitalox, a high-level disinfectant used to disinfect those devices.
* Acecide-C test strips were used to test Acecide-C, a high-level disinfectant used in the AER.
* Temperatures were not monitored in the room where Revital-Ox Solution test strips and Acecide-C test strips were observed and stored.

Due to the lack of environmental room temperature monitoring, and consideration of the small size of the room where the strips were observed, the room door in the closed position, and times when electrical equipment was running, there was no assurance the test strips were maintained within the storage temperatures ranges in accordance with the IFUs.

4. Regarding uncleanable and unclean surfaces:

Refer to the findings cited at Tag C-912 related to unclean and uncleanable surfaces, water damage, and areas of potential insect/pest entry in the physical environment.

5. Regarding expired lab, disinfectant, and other supplies:

5. a. During tour of the ED on 06/14/2022 beginning at 1650 with the ED ANM, Med/Surg ANM, and other hospital staff, a 16-oz. container of 3M Cavilon Moisturing Hand Lotion with expiration 03/2019 was observed.

5. b. During tour of the Salem Health West Valley Medical Clinic - Monmouth on 06/15/2022 beginning at 0915 with the Clinic Manager and staff the following observation was made:
* There was one container of expired disinfectant wipes in a rehab patient exam room. The findings were confirmed with the Clinic Manager at that time.

5. c. During tour of the outpatient IWC on 06/15/2022 at 1600 with the IWC ANM, 2 purple top blood collection tubes and 1 red top blood collection tube were observed in a blood transfusion reaction kit. The purple top tubes were observed to be expired 03/21/2022; and the red top tube tube was observed to be expired 03/22/2022. This was confirmed with the IWC ANM at the time of the observation.

6. Regarding expired nutrition products and refrigerated food:

6. a. During tour of the ED on 06/14/2022 beginning at 1650 with the ED ANM, Med/Surg ANM, and other hospital staff, a container of Thick-It food thickener was observed to be dated "open" 12/15/2019, and "Best If Used By Mar 2022."

6. b. During tour of the ED on 06/15/2022 beginning at 1100 with the ED ANM, Med/Surg ANM, and other hospital staff, observations of the Med/Surg/ED patient refrigerator revealed 3 plastic Ziploc bags containing slices of bread, cheese, and meat. The bags had illegible markings written on them with a Sharpie pen and no legible expiration date or other label or information including the name of the food and its original use-by or expiration date. This was confirmed with staff present at the time of the observation.

6. c. Review of the P&P titled "Food Handling," dated last revised "12/2020" reflected "Any open perishable food items are labeled and dated with expiration date per department standard."

6. d. Review of the P&P titled "Standard Work: Storage Life of Foods (Date Marking Products/Expiration Dates Nutrition Services," dated "Feb 8, 2019" reflected " ... Follow FDA Guidelines on date marking of foods to ensure safety. All potentially hazardous foods will be marked with a 7 day or less pull date to ensure safety and quality ... If food is taken out of its original package, it must be put in a clean, sanitized food storage container and covered tightly. Or (sic) placed in a new Ziploc bag, sealed. The new container must be labeled with the name of the food being stored and its original use-by or expiration date.

7. Regarding cafeteria dining room ED overflow:

7. a. Refer to the findings cited at Tag C-816 that reflects provision of patient care in an unapproved ED overflow area in the cafeteria dining room in close proximity to staff and visitors.

7. b. Review of the following CAH infection prevention P&Ps, and other documents revealed no documentation that reflected the unapproved ED overflow area was evaluated for infection control risk:
* A document titled "Salem Health West Valley Plan for Provision of Patient Care Services" dated "January 2021."
* A P&P titled "Construction and Renovation," dated last reviewed and approved "10/2021."
* A document titled "Salem Health Infection Prevention Program," approved "06/2021."
* The CAH's infection prevention risk assessment titled "West Valley Hospital Infection Prevention Risk Assessment FY2022" dated "Approved/Reviewed BY IP manager on 7/9/2021."
* A document titled "FY 2022 Infection Prevention Plan."
* "Infection Prevention Committee" meeting minutes dated 07/01/2021 through 06/02/2022. Meeting minutes dated 01/20/2022 at 1210 reflected [QA] shared that [SHWVH] surged into nontraditional areas ... ED patients were moved to Med Surg. The ED was overflowing with patients." However, there was no information regarding patient care provided in the CAH cafeteria, including consideration of infection control.

The lack of an infection control risk evaluation was confirmed in an email from the QA dated 06/28/2022 at 1523. In response to the question "Do you have documentation of an IC risk evaluation for the ED overflow area in the dining room?," the email from the QA reflected "I do not have documentation of such an assessment."

8. Regarding the water management program:

Review of the CAH's IP program and water management documentation reflected it was unclear, incomplete and lacked evidence of an organized waterborne pathogens program. Examples included:

8. a. Review of a document titled "Salem Health Infection Prevention Program" approved "06/2021" included no reference to a water management program, P&Ps, risk assessment, or testing protocols.

8. b. Review of the CAH's infection prevention risk assessment titled "West Valley Hospital Infection Prevention Risk Assessment FY2022" dated "Approved/Reviewed BY IP manager on 7/9/2021" included one water related focus area under the category "Environmental & Construction Risks" titled "Water Issues - Intrusions." The risk level score for the focus area was recorded 7 out of a possible 12 points. There was no further information on the risk assessment that reflected what the water issues category included. It was unclear if risk of water issues and intrusions included waterborne pathogens.

8. c. A 61-page document titled "Salem Health Hospitals & Clinics Water Management Program For Building Water Systems Site Management Plan" dated "Date Updated January 7, 2022" was reviewed. The address on the title page and the contents within the plan reflected it was applicable to Salem Health Hospital and did not include the CAH. Examples included but were not limited to:
* The title page reflected Salem Health Hospital 890 Oak St. SE Salem, OR 97301. There was no reference to the CAH or CAH's address.
* The plan included 6 pages of "Process Flow" diagrams with headings including but not limited to "Salem Hospital Building A Domestic Water System ... Salem Hospital Building B Domestic Water System ... Salem Hospital Building Domestic Water System ... Salem Hospital Building D Domestic Water System ... " There were no CAH water system diagrams in the plan.
* "Water Monitoring Locations" in the plan included "Building A ... Building B South ... Building B North ... Building C ... Building D ... Building E ... Building M ... " There were no CAH water monitoring locations in the plan.

8. d. A document titled "Salem Hospital Legionella Testing Protocols" dated "Next Review: January 2023" was provided and reviewed. The document was applicable to "Salem Health main campus." There was no reference to the CAH in the document.

During an interview with the QA on 06/16/2022 at approximately 1300, he/she confirmed the "Salem Hospital Legionella Testing Protocols" document did not include the CAH. The QA stated, "There is nothing about [Salem Health] West Valley in here."

8. e. "Infection Prevention Committee" meeting minutes dated 07/01/2021 through 06/02/2022 were reviewed. The minutes included no CAH water management program information, including water testing or other CAH water management activities. This was confirmed during an interview with the QA and FM on 06/16/2022 at approximately 1310. The FM stated, "Any Legionella testing is only about Salem [Hospital]."

8. f. In response to a request for the CAH's water management program P&Ps, the QA and FM provided the following 2 documents:
*A one-page undated document titled "Standard Work: Water Management Plan." The "Purpose" reflected "Ensure safe water management at [SHWVH] ... Inputs: Filters, water bottles." The "Brief summary of task" reflected "Filters placed on all equipment using water ... Removed all public eater fountains and replaced with bottled water ... Filters on all equipment that uses water for cleaning and changed at recommended cadence ... EVS runs water in patient rooms while cleaning to prevent dead ends in water system ... Frequency of Use: Daily."
*A one-page document titled "Standard-Work: EVS Water Management" dated "January 2021." The "Purpose" reflected "Increasing movement of water in pipes to prevent bacteria." The "Brief summary of task" reflected "Sanitize hands and put on gloves ... go to sink or shower ... turn on water ... Let water flow ... Finish cleaning area ... Turn off water flow ... Remove gloves and sanitize hands ... Frequency of Use: Daily."

During an interview with the QA and FM on 06/16/2022 at 1250, it was stated "These are the only policies for [Salem Health] West Valley."

No further information was provided including:
* No CAH risk assessment to identify where Legionella and other opportunistic waterborne pathogens could grow and spread in the facility water system.
* No evidence of a fully developed and implemented water management program; P&Ps including testing protocols, acceptable ranges for control measures, documentation of testing results, and corrective actions when control limits are not maintained; and staff training requirements.

9. Regarding the Infection Preventionist:

Refer to the deficiency cited under Tag C-1204 that reflects the CAH's failure to clearly identify and designate an infection preventionist.

10. Regarding surveillance; and infection prevention and control P&Ps:

10. a. A document titled "Salem Health West Valley Plan for Provision of Patient Care Services" dated "January 2021" was reviewed. It reflected:
* Under "Surveillance, Prevention, Control of Infection" was written, "The hospital provides continual monitoring of infections through the Infection Control Nurse or designee, in collaboration with Salem Health Infection Prevention Department who tracks nosocomial infections and ... notifies the department if a trend is noted." Although the title clearly stated "Salem Health West Valley ... " the IP nurse or "designee" for SHWVH was not clear. Refer to the findings cited under Tag C-1204 related to the lack of a clearly identified and defined; and responsible CAH infection preventionist.

10. b. The P&P titled "Salem Health Infection Prevention Program Administrative House Wide Policy and Procedure," dated effective "August 2021 [SHWVH]" was reviewed. It reflected:
* Under "Applicable Campus" it reflected "Salem Hospital and West Valley Hospital."
* Under "Risk Assessment & Goal Development" was written, "A risk assessment is completed annually and adjusted as needed, dependent upon what is occurring at Salem Health, in the community, nationally, internationally, and at the state and local level in regards to infection risks. Based on the priorities established with the risk assessment, goals and tactics are specified, implemented, and evaluated. The Infection Prevention Committee or [SHWVH] Medical Advisory Committee reviews the Risk Assessment, approves the plan and evaluates achievement of the goals and tactics annually."
* Under "Surveillance Activities" was written "Surveillance is a systematic, comprehensive process that provides for the collection and analysis of data regarding the distribution and determinants of important hospital-acquired infections occurring in Salem Health ... The Salem Hospital Infection Prevention Department will monitor for the threat of infectious diseases and emerging organisms affecting our hospitals ... Data generated from IP surveillance is analyzed and reported to the relevant departments, committees, and individuals ... The Infection Prevention Manager will update the Salem Hospital leadership ... when infectious disease outbreaks occur ..."
* Under "Performance Improvement (PI)" was written, "The Infection Prevention Manager, or their designee, has overall responsibility for the Infection Prevention Performance Improvement Plan and follow-up, and is responsible for coordinating data collection and evaluating information for the department ... The Infection Prevention Program reports results at Salem Hospital to the Infection Prevention Committee, clinical services, the Quality Operations Council and the Board."

The policy did not clearly describe the surveillance processes that were specific for "[SHWVH]" as indicated by the title of the P&P, where "SH" was clearly separated from "[SHWVH]." For example:
* The risk assessment referred to "what is occurring at Salem Health." Additionally, it was unclear if the "[SHWVH] Medical Advisory Committee" was interchangeable with the "Infection Prevention Committee" as the policy stated, "The Infection Prevention Committee or [SHWVH] Medical Advisory Committee reviews the Risk Assessment, approves the plan and evaluates achievement of the goals and tactics annually." SHWVH was also not listed in the description of "Surveillance Activities," as there was no mention of the "Infection Prevention Manager" updating the SHWVH leadership when "infectious disease outbreaks occur ..." or why only 'results at Salem Hospital" were reported to the "Infection Prevention Committee."

10. c. A document titled "West Valley Hospital Infection Prevention Risk Assessment FY2022" approved by the "IP manager on 7/9/2021," was reviewed. The risk assessment reflected several areas where surveillance was not fully implemented in the SHWVH IP Program. For example:
* Under "Availability of Resources ... Surveillance ... Organization Preparedness to address Risk at This Time," was rated as "2," "Fair."
* Under "Availability of Resources ... Validation of Surveillance Systems ... Organization Preparedness to address Risk at This Time," was rated as "2," "Fair."
* Under "Availability of Resources ... Public Health Reporting ... Organization Preparedness to address Risk at This Time," was rated as "2," "Fair."
* Under "Availability of Resources ... Staffing/Rounding resources ... Organization Preparedness to address Risk at This Time," was rated as "3," "Poor."

Additionally, it was unclear if the risk assessment was approved by the "IP Manager" as noted on the document, or by the "Infection Prevention Committee," or the "[SHWVH] Medical Advisory Committee" as described in the P&P. It was unclear if staff and leadership from SHWVH were involved in the input and approval of the risk assessment.

10. d. A document titled "FY 2022 [SHWVH] Infection Prevention Plan" dated as "Version 1.1 9.29.21," was reviewed. It reflected:
* Under "This Year's Action Plan ... Goals," 7 "Infection Prevention Focus" items from the risk assessment were identified as "goals" and which included but were not limited to "Create a process for SSI monitoring."

10. e. During an interview with the SHIPM and the QA on 06/16/2022, at 1241, when asked about the progress of the "SSI monitoring" that was reflected on the "FY 2022 [SHWVH] Infection Prevention Plan," the QA stated that the goal had not been met due to a delay in IT support in building a report for surveillance. Additionally, when asked about the QA's ability to conduct surveillance of SSIs for surgery patients, the QA stated that "Salem hospital does the monitoring" and that the QA did not have direct access to "views" in the EHR system in order to monitor SSIs at SHWVH. When asked about IP "rounding" as part of a nationally recognized method for IP surveillance, the QA responded that rounding often occurred "on the way to the cafeteria" but could not provide documentation of the dates, times and findings of the impromptu rounding.

10. f. The CAH's infection prevention meeting minutes for the past year were requested. Meeting minutes titled "Infection Prevention Committee" without a facility name dated 07/01/2021 through 06/02/2022 were provided and reviewed. Minutes included SHWVH and other Salem Health system attendees. Information in the minutes was unclear regarding what hospital/CAH it pertained to. For example:
* On 07/15/2021 at 1210, under "Blood Culture Contamination Rate" discussion notes reflected "[Name] shared that housewide we are under the 3% benchmark. ED blood culture draws are slightly higher in incidence than phlebotomy blood culture draws, but each group is still below the 3% benchmark ... what are the factors we are using to determine contamination rates?" Under "Regulatory Compliance" the discussion notes reflected "[Name] shared information about TJC Infection Control Standards ... [Name] shared that [he/she] and [name] have goals ... to collaborative rounding to address these regulatory needs." There was no documentation in the minutes that reflected which hospital or CAH these discussions of blood culture contamination rates and rounding goals pertained to.
* On 09/23/2021 at 1210, discussion notes reflected " ... SH is still seeing increased (sic) in CAUTI and CLABSI, but we are keeping a close eye on it ... " There was no documentation in the minutes that reflected what hospital/CAH this discussion of increased infections pertained to.
* On 10/07/2021 at 1210, under "MDRO review for FY22," discussion notes reflected "[Name] reviews positive cultures/monthly/patients ... We have seen higher numbers of ESBL due to the pandemic ... VRE infections correspond to the high number of MRSA infections ... " There was no documentation in the minutes that reflected what hospital/CAH this discussion of numbers of infections and other information pertained to.
* On 05/19/2022 at 1210, under "MDRO case review for FY22," discussion notes reflected "[Name] went over the clarity report and with MDROs we saw a peak in January with seven cases ... CRE/CRO remaining pretty steady with 1-2 cases per month ... will continue to monitor." There was no documentation in the minutes that reflected what hospital/CAH this discussion of numbers of MDRO and other information pertained to.
Although the meeting minutes included infection prevention, monitoring and surveillance information, it was unclear what activities pertained to the CAH versus other facilities.
























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44104

Based on observations, interviews, review of infection control P&Ps, and other documentation, it was determined the CAH failed ensure an infection prevention and control professional was clearly and consistently identified, determined, and responsible to ensure development and implementation of facility-wide infection control P&Ps and surveillance that adhered to nationally recognized guidelines.

Findings included:

1. Refer to the deficiencies cited at Tags C-1204 and C-1208 related to lack of a clearly designated infection prevention professional responsible to ensure development and implementation of facility-wide infection surveillance, prevention, and infection control P&Ps.


44104

Based on review of exemption documenting for 1 of 1 contracted staff (Staff 69) and review of CSV P&Ps it was determined that the hospital failed to fully develop and implement CSV P&Ps that complied with the requirements in relation to non-employees and that ensured documentation of CSV status for all staff, as defined, was clear and complete:
* The CSV P&P was not complete in relation to verification of vaccination status and exemption for contracted staff and for additional precautions and contingency plans for non-employee categories of staff.
* Additional precautions and contingency plans for an exempt contracted staff member were not consistent with the hospital's P&P.

In addition to the references to "Staff" identified in the CFR 485.640(f) language contained in this deficiency, the CMS definitions for terms used in CFR 485.640(f) reflects:
"Staff" refers to individuals who provide any care, treatment, or other services for the CAH and/or its patients, including employees; licensed practitioners; adult students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the CAH and/or its patients, under contract or by other arrangement. This also includes individuals under contract or by arrangement with the CAH, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, licensed practitioners, or adult students, trainees or volunteers. Staff would not include anyone who provides only telemedicine services or support services outside of the CAH and who does not have any direct contact with patients and other staff specified in paragraph (f)(1)."

Findings include:

1. The P&P titled "Covid-19 Vaccination Requirement - Administrative House wide Policy and Procedure" with approval date of "03/2022" included the following direction for "Non-employed contractors, vendors or individuals who provide service to [SHWVH] greater than one time per week within the healthcare setting:"
* "The purpose of this policy is to outline how [SHWVH] complies COVID-19 Vaccination Requirement ..., and the actions which must be taken by ... employees, licensed practitioners, students, trainees, volunteers and individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or by other arrangement who are not fully vaccinated against COVID-19."
* "Proof of vaccination by non-employed contractors or other individuals providing services under other arrangements are the responsibility of their employer. Non-employed healthcare providers and healthcare staff must provide their employer, contractor or responsible party with either: (a) proof of vaccination showing they are fully vaccinated; or (b) documentation of medical or religious exception."
* "[SHWVH], in accordance with [SHWVH] policy, may at any time request an audit of compliance with this rule and mandate a response within 24 business hours to any [SHWVH] urgent request to provide proof of vaccination or approved religious/medical exemption/exception."
* "The process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19 includes the following ... Contingency plans for staff who are not fully vaccinated for COVID-19:
1. Screening: All Staff who are not fully vaccinated must enter [SHWVH] at a designated entry point and submit to in-person screening ...
2. Weekly Testing: All employees and medical staff members ... as well as patient-facing contractors who perform direct patient care ... shall be tested weekly ...
3. Training: All employees, medical staff members, and patient-facing contractors ... must perform additional Computer Based Trainings ... Non-patient-facing contractors will review [SHWVH] vaccination policy ...
4. Reassigning staff: ... Employees, medical staff members and contractors ... shall not perform direct patient care in the following areas ...
5. Physical distancing is encouraged as able
6. Universal Source control: N95 masking."

The P&P was not clear or complete. For example:
* There are no provisions in the CFR that allow different standards of verification and documentation for contracted staff versus non-contracted staff for fully vaccinated, medical and religious exemption, and additional precautions and contingency plans for exempt staff.
* There were no provisions in the P&P that ensured that employers of non-employed healthcare providers, healthcare staff, contractors or other individuals providing services under other arrangements maintained evidence and documentation of vaccination status that was equivalent to, at a minimum, that which the hospital required for non-contracted staff, prior to hire or start date. That included proof of fully vaccinated as required for non-contracted staff, and proof of appropriately processed exemptions with additional precautions and contingency plans equivalent to non-contracted staff.
* The P&P addressed additional precautions and contingency plans for exempt staff categories of employees, medical staff, and patient-facing contractors only, with the exception that non-patient-facing contractors would read the P&P. There were no provisions for exempt volunteers, students and trainees, or for non-patient-facing contractors who come into contact with other staff.

2. CSV documentation of an exemption approved by the contract employer for contracted Staff 69 was dated 03/28/2022. It reflected that "[Company] project team is working with the client to clarify exemption requirements, but currently exempt employees must wear a KN95 mask at a minimum, when in occupied spaces of the hospital. This requirement may change to weekly testing, facilitated by the Salem Health ... Final accommodation agreed upon: Wearing KN95 mask while in occupied spaces on hospital campus."

The documentation was not clear as follows:
* The SHWVH P&P specifically required that a "N95" mask be worn as an additional precaution. However, the exemption documentation reflected that the exempt staff was instructed to wear a "KN95" mask.
* The exemption documentation reflected that contractor would be or may be "in occupied spaces of the hospital." In that case it was not clear if the contractor was considered "patient-facing" or "non-patient facing."
* It was not clear if the referenced clarification of exemption requirements had been made, including for the "weekly testing" also referenced.
* There was no additional documentation to reflect that the other additional precautions and contingency plans specified in the P&P had been planned or implemented for contracted Staff 69.