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Based on observations, interview, review of CAH scope of service documentation, 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 an ICU room into a storage space and an OP Infusion department without FPS Unit plans review and approval.

Findings include:

1.a. A document titled "Provision of Patient Care, SCHS Plan for the," dated 07/01/2021 was reviewed. The "SCHS Scope of Service" section on page five reflected that St. Charles Madras provided "Infusion Services."

1.b. A P&P describing OP Infusion services titled "Madras Outpatient Infusion Ordering, Scheduling & Documentation - Policy," dated 05/04/2022 was reviewed and reflected:
* "It is the policy of St. Charles Health System (SCHS) to provide guidelines for the treatment of patients receiving outpatient infusion services ... at St. Charles Madras. Services may include IV infusions, injections, blood transfusion, hydration, port-a-cath care, etc."

1.c. During interview on 07/13/2022 beginning at 1500 the RAS provided the following information regarding OP Infusion services:
* The space where OP Infusion services are currently provided has undergone multiple changes of use over the years. Those include:
- The space was initially a double occupancy ICU room.
- "At some point," the ICU room was changed to "storage space" and was used for storage for "at least eight years."
- During the Covid-19 pandemic the room was approved for inpatient use under an "1135 waiver."
- Eighteen months ago, the CAH initiated OP infusion services in the space, and the space continues to be used for OP infusion services at this time.
- The CAH has not notified the SA FPS Unit of these changes.

1.d. Review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH obtained SA review and approval prior to changing the use of the previously approved ICU room as described in finding 1.c.

1.e. Observations in the CAH's OP Infusion services area on 07/13/2022 at 1500 with the PNM and ISM revealed:
* A rectangular shaped room with wall lights, wall mounted oxygen flow meters, suction, and privacy curtains separating areas where hospital beds would be located in a double occupancy ICU room. No beds were observed. Two recliners and 2 overbed tables were observed on one side of the room. In a corner of the room, approximately 8 IV pumps/poles on wheels and other patient equipment on wheels were observed crowded together with cords disorganized and tangled. It was not clear if these were clean or dirty. At the other end of the room, items and equipment were cluttered, croweded, and disorganized. For example, 6 IV pumps were observed on a rolling cart with electrical cords disorganized and draped on the floor. An IV pump on a pole with an electrical cord draped on the floor was observed next to the rolling cart. A CAPR supply cart was also observed next to the rolling cart. The front of the CAPR supply cart had doors that were blocked by the IV supply cart. It was not clear if these patient and staff supplies were clean or dirty.
* Across the room from the patient recliners, patient items and equipment were crowded together including another recliner, a chair, a hamper on wheels with cloth-looking liner and no lid, a green and beige supply cart, a wound care supply cart, a transfer board, IV supplies, an ultrasound machine on wheels, a vital signs machine on wheels, and a large white supply cart. It was not clear if the patient equipment and furniture was clean or dirty.
* Three handwashing sinks were observed in the room. Two handwashing sinks were observed on the right side of the room. Observation of one of the handwashing sinks revealed it was at a work counter with a wood-look cupboard below it. The sink and surrounding work counter had dried white splash and ring marks on them. The sink had a hot water dispenser/aerator faucet that had "190 [degree] Steaming Hot Water" printed on it. The dispenser/aerator was not functioning appropriately as it dispensed cold water when activated. In the cupboard under the sink, dry, gray matter was observed on the bottom of the cupboard under the hot water dispenser/aerator tank. Across from the handwashing sink, a small room with a hopper and handwashing sink was observed. The hopper had a piece of flat plexi-glass with a handle on it covering the bowl. The plexi-glass had an unknown whitish-colored, dry substance on it. It was not clear the intended purpose of the plexi-glass. The plexi-glass was also a convenient place to set clean items or supplies.

1.f. During an interview with the PNM and ISM on 07/13/2022 at 1500 the following information was provided regarding OP Infusion services:
* OP Infusion services included outpatient iron, antibiotic, and blood transfusions 4-5 times per week.
* The green and beige supply cart contained M/S unit wound care supplies. The transfer board was for M/S unit patients. The IV supplies and ultrasound machine on wheels were IV Team supplies.
* The PMN did not know if an IP had conducted a risk assessment of the space where OP Infusion services were provided.

Based on observations, interviews and record review, it was determined that the CAH failed to comply with the Life Safety From Fire requirements as indicated on the attached Life Safety from Fire CMS 2567 SOD report for Building-01, the main hospital; and on the CMS 2567 SOD report for Emergency Preparedness.

Findings include:

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

Based on observation, interview, and review of P&Ps it was determined that the CAH failed to implement P&Ps that ensured safe and appropriate management and labeling of drugs; and ensured expired or otherwise unusable drugs were not available for patient use.
* Drugs and biologicals were available for patient use and were not appropriately verified and labeled in accordance with CAH P&Ps, and the expiration was not clear.

Findings include:

1.a. The P&P titled "Use of Patient's Own Medications," dated effective 03/13/2020 was reviewed and reflected:
* "POM's (sic) must be clearly labeled and stored within the original prescription or OTC container."
* "Pharmacist verifies patient will have their own medication available for use."
* "The pharmacist is responsible for inspecting the following prior to authorizing use of a POM ... properly packaged in clearly labeled prescription containers or clearly labeled manufacturer's packaging ... identifiable imprint codes on the drug match the correct dose and strength of the prescribed POM ... patient properly stored the medication and medication is not expired ..."
* "The nurse is responsible for ... ensuring the medication has been inspected and verified by a pharmacist before it is administered to the patient ... barcode scanning and documenting all administrations of POM's (sic) within the EHR."
* "Storage of patient's own medications being administered ... POM to be administered will be stored in the patient care areas with other patient specific medications ... POM's (sic) not used will be collected and secured by Patient Access Services ..."
* "Instruction on process to follow when verifying POMs ... Provider enters a non-formulary order in the EMAR with the POM's (sic) dose, route, and frequency ... Caregiver hand delivers POM to the pharmacy or a decentralized pharmacist for verification ... Clinical Pharmacist to review each POM for appropriate use, storage, and expiration dating ... replace any previously entered admin instruction comments with 'Patient's Own Med - verified by Pharmacy on (date of verification) for inpatient use' ... confirm the POM label has a barcode for bedside scanning ... Pharmacist to sign the label and set aside for delivery ... Licensed pharmacy personnel hand delivers non-controlled POM to the patient's designated medication delivery area."

1.b. During tour of M/S Unit on 07/12/2022 at 1135 with ISM, observations in a patient room revealed a locked wall mounted cabinet with a Lantus insulin injection 3 ml pen inside. There was no pharmacy label, barcode or other evidence that reflected the pharmacist had inspected and verified the drug for appropriate use, strength, dose, proper storage, expiration, labeling and barcode in accordance with the CAH's P&P. In addition, the insulin pen had unclear expiration information on it. For example, a sticker on it reflected "Exp 2024-04-30" and another sticker, loosely affixed reflected "EXPIRES 6/29." The part of the sticker after "6/29" was missing and looked like it had been torn off. An open container of Trueplus glucose tablets was observed in the cabinet with no pharmacy label, barcode or other evidence that reflected the pharmacist had inspected and verified it was appropriate for patient use.

1.c. During an interview with the ISM on 07/12/2022 at 1140, the ISM stated the drugs "should be verified with pharmacy" and they stated that had not been done. The ISM stated the drugs should not be in the cabinet and "should be sent home."

2.a. During tour of the SSD on 07/13/2022 beginning at 1015 with PANM, observations in OR1 at 1300 revealed:
* A shelf labeled "Peppermint/Nausea Relief Supply" with a metal container labeled "Cotton Balls" and an open container of Young Living Peppermint 100% Pure, Therapeutic-Grade Oil 15 mL. The container of peppermint oil had "For Nausea" handwritten in black Sharpie over the manufacturer label; and "OR 1" handwritten with black Sharpie marker on the lid. There was no pharmacy label, opened date or expiration date. There was no information on the container that reflected where it came from or who it was intended for, including whether it was intended for one patient or multiple patients.
* Individually wrapped Ricola cough drops with no administation instructions, no pharmacy label, and no expiration date.

2.b. During an interview on 07/13/2022 at 1300 with PANM, they confirmed the peppermint oil observed was used for treatment of patients experiencing nausea in the OR.

Based on interview, review of medical record documentation for 1 of 2 patients reviewed for blood transfusions (Patient 1), and review of P&Ps it was determined that the hospital failed to ensure that blood transfusion information was verified prior to transfusion, and that transfusions were administered timely, in accordance with standards required in P&Ps.

Findings include:

1. The P&P titled "Blood Component Administration and Transfusion Reactions," with "Effective Date" 04/08/2019, was reviewed. It included the following requirement:
* "Hang blood/component within 30 min. of leaving blood bank."
* "Two RNs will verify the physician's order ... At the patient's bedside the same two nurses will verify the blood/component information with the patient's arm bands (hospital and blood bank), with the bag tag, blood unit, and order in the EHR ... Document the patient and unit verification on the flowsheets including the transfusionist and witness."
* "The transfusion start time is ... when the blood product reaches the patient's vein. Document the time when the blood product reaches the patient's vein ..."

2. Medical record documentation for Patient 1 reflected that on 04/09/2022 a unit of platelets was started and "time blood product reached vein" was recorded as 1315. The transfusion documentation reflected that the two RN verification of required information was completed at 1328, after the transfusion had begun.

Medical record and blood bank documentation for Patient 1 reflected that on 04/09/2022 a unit of red blood cells was issued by the lab to nursing personnel at 1248. Transfusion documentation reflected that the two RN verification of required information was completed at 1356, the transfusion was started and "time blood product reached vein" was recorded as 1400. That was 72 minutes after the unit was removed from the blood bank.

3. During interviews at the time of the review of medical records with nursing, quality, and laboratory staff on 07/13/2022 beginning at 1015, they confirmed the transfusion findings for Patient 1.

Based on documentation in 3 of 3 medical records reviewed for anesthesia services (15, 16 and 17) and review of medical staff rules and regulations, it was determined that the hospital failed to implement its medical staff rules and regulations to ensure that a post-anesthesia evaluation was completed and documented by a qualified practitioner before discharge to evaluate for proper anesthesia recovery.

Findings included:

1. The "St Charles Health System - Bend Medical Staff Rules and Regulations," dated approved 12/16/2021 provided in response to a request for P&Ps that addressed pre/post anesthesia evaluation was reviewed. Under "Article III - Medical Records," section 3.12 "Post-Anesthesia Notes" it reflected "A post-anesthesia evaluation shall be placed in the record within forty-eight (48) hours after the completion of a procedure involving anesthesia or deep sedation. The note shall be entered by an anesthesia provider or by the physician who administered the deep sedation. This note should contain the following information: a. Respiratory function, including respiratory rate, airway patency, and oxygen saturation; b. Cardiovascular function, including pulse rate and blood pressure; c. Mental status; d. Temperature; e. Pain; f. Nausea and vomiting; and g. Postoperative hydration."

2. Review of the record of Patient 15 reflected that the patient underwent an open umbilical hernia repair with mesh procedure on 07/11/2022. "Case Tracking Events" documentation reflected the "Case Start" time was 0824 and the "Case Finish" time was 0943. The CRNA "Anesthesia Postprocedure (sic) Evaluation" dated 07/11/2022 at 1217 reflected the anesthesia type was "general" anesthesia; and anesthesia started at 0802 and stopped at 0955. The patient was discharged from the CAH on 07/11/2022. There was no documentation of post-anesthesia evaluation of nausea, vomiting and postoperative hydration prior to discharge.

3. Review of the record of Patient 16 reflected that the patient underwent an excision of pilonidal sinus procedure on 07/11/2022. "Case Tracking Events" documentation reflected the "Case Start" time was 1436 and the "Case Finish" time was 1505. The CRNA "Anesthesia Postprocedure (sic) Evaluation" dated 07/11/2022 at 1529 reflected the anesthesia type was "general" anesthesia; and anesthesia started at 1419 and stopped at 1516. The patient was discharged from the CAH on 07/11/2022. There was no documentation of post-anesthesia evaluation of nausea and vomiting prior to discharge.

4. Review of the record of Patient 17 reflected that the patient underwent an open left inguinal hernia repair with mesh procedure on 07/11/2022. "Case Tracking Events" documentation reflected the "Case Start" time was 1036 and the "Case Finish" time was 1203. The CRNA "Anesthesia Postprocedure (sic) Evaluation" dated 07/11/2022 at 1235 reflected the anesthesia type was "general" anesthesia; and anesthesia started at 1019 and stopped at 1211. The patient was discharged from the CAH on 07/11/2022. There was no documentation of post-anesthesia evaluation of nausea, vomiting and postoperative hydration prior to discharge.

Based on 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 include:

1. The "CAH Hospitals SCM Organizational Chart SCP Organizational Chart" dated "5/16/2022" 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 "St. Charles Health System Infection Prevention and Control" dated "01/29/2021," was reviewed and reflected:
* Under "Authority and Responsibility" was written "The Hospital Infectious Disease Medical Director ... and the Infection Prevention Director have clinical authority over the program. The responsibility for monitoring and evaluating the Infection Prevention Program is vested in a multidisciplinary Infection Control Committee. Committee membership include: (sic) Medical Staff (Chairperson), Administration, Nursing, and Infection Prevention."
* Under "Role of Service" was written "The program is an active, ongoing, system-wide program ... The Infection Prevention Department functions in the system to set standards designed to minimize risk of transmission of infection ... Using the premise of one standard of care, the department sets the infection prevention standards for the health system ... Infection prevention objectives are based on the annual Infection Control Risk Analysis Grid ..."

The hospital's P&P did not clearly identify an Infection Preventionist for the Madras facility, and instead stated that the Infection Prevention "department sets the infection prevention standard for the health system."

1.b. An electronic document titled "St. Charles Health System - Redmond Infection Prevention Risk Analysis/Assessment 2021" was provided by the hospital in response to a request for the "annual Infection Control Risk Analysis" for the Madras facility. It was reviewed and reflected:
* The title of the electronic copy of the risk assessment on the hospital's computerized file directory was identified as "Madras."
* When the 14-page file was opened by the IPD during interview with the IP department on 07/14/2022, beginning at 1030, the title reflected, "St. Charles Health System - Redmond Infection Prevention Risk Analysis/Assessment 2021."
* The footer at the bottom of each page reflected, "2021 IP Risk Assessment for Bend."
* The title page of the embedded "Infection Control Risk Analysis Grid" reflected "Prineville."
* The information "contributing to the risk analysis" as described in the provided risk assessment included facility information for "St. Charles Medical Center-Bend ... St. Charles Redmond ... St. Charles Madras ... St. Charles Prineville."

It was unclear whether an annual "Infection Control Risk Analysis" as described in the hospital's P&P had been conducted for the Madras facility and if so, whether the risk assessment was facility specific or whether it encompassed the entire St. Charles Health System, including the Bend, Redmond, and Prineville facilities.

1.c. A document titled "St. Charles Healthcare System Charter: Infection Prevention Committee" provided by the hospital and dated "April, 2021" was reviewed.
* Under "Team Members" was written, "Include interdisciplinary and inter-professional representatives from key stakeholder areas who have been granted decision-making authority."
* Under "Roles & Responsibilities" was written, " ... Every other month, the IPC meets to review SCHS healthcare associated infection metrics & trends ..."
* Under "Boundaries" was written, "SCHS."

The IP charter addressed system-wide responsibilities and did not clearly reflect how Madras-specific "infection metrics & trends" were addressed or incorporated into the IPC. It was unclear whether IP representatives for Madras were part of the "Team Members" or included as "key" stakeholders on the IPC.

1.d. IPC minutes dated, July 21, 2021; February 17, 2022; Mar 16, 2022; and May 18, 2022," were provided by the hospital. They were reviewed and reflected:
* On 07/21/2021, IPs listed on the IPC Minutes roster were: "Interim Director Infection Prevention ... SCHS Infection Preventionists Redmond," and 2 "SCHS Infection Preventionists," with no designated facility after their names.
* On 02/17/2022, IPs listed on the IPC Minutes roster were: 2 individuals identified as "Infection Prevention," with no designated facility after their names; an "Interim Director Infection Prevention" and "Infection Prevention Redmond."
* On 03/16/2022, IPs listed on the IPC Minutes roster were: 2 individuals identified as "Infection Prevention," with no designated facility after their names; an "Interim Director Infection Prevention" and "Infection Prevention Redmond."
* On 05/18/2022, IPs listed on the IPC Minutes roster were: 2 individuals identified as "Infection Prevention," with no designated facility after their names; an "Interim Director Infection Prevention" and "Infection Prevention Redmond."

It was unclear whether IP representatives for Madras were included as "key" stakeholders on the IPC.

1.e. During an interview with IP staff on 07/14/2022, beginning at 1030, they confirmed Findings 1.a., 1.b., 1.c., and 1.d. The IPD stated that there was "no designated IP for Madras." The IPD further stated that the Redmond IP "floats" to the Madras campus, but that there were no "set hours" and no "set schedule." They explained that the IP presence at Madras depended on "what is happening ... but typically every other week ... IP rounding [included] verifying patient isolation, signage is posted, making sure PPE is being followed, hand hygiene and a check-in with nursing." When asked whether those rounds were documented, the IPR stated, "Not typically ... only if a nursing note is needed or a note for communication" and that the IPR uses a "mental checklist" and if there are "findings, I connect with managers and provide documentation of findings by sending an email."

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Based on observations, interview, documentation in 3 of 12 employee and contract staff TB screening records (Staff 2, 3 and 14), 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 P&Ps were not clear, complete, and carried out in a manner that prevented cross-contamination.
* Single-use device processing P&Ps were not developed and processes were unclear.
* Ultrasound probe disinfection processes were incomplete and unclear.
* P&Ps for transporting and storing endoscopes shared between facilities were not developed and processes were unclear.
* Hydrocollator temperature and cleaning P&Ps were not developed and implemented.
* Disinfectant testing processes were not carried out in accordance with posted instructions and disinfectant testing records were not clearly documented.
* Cleaning products and patient supplies were expired; and unlabeled or unclearly labeled.
* PPE was not readily accessible and not used by staff when handling disinfectant solutions in EVS.
* Hazardous waste containers were over-filled.
* Hand hygiene supplies and handwashing sinks were not readily accessible, and arranged in a manner that prevented cross-contamination.
* Clean and dirty supplies were not maintained separately.
* A clean and sanitary environment was not maintained.
* TB screening for employees and contracted staff was not complete or timely in accordance with hospital P&Ps and CDC recommendations.
* A CAH specific antibiotic stewardship program had not been clearly 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/device pre-cleaning.

1.a. Observations in WOC on 07/12/2022 at 1245 with the OWC, PNM, and other hospital staff revealed the department consisted of one room with one treatment recliner; and a supply closet.
* An office-style two-drawer metal filing cabinet was observed with a piece of paper on top with "Dirty Instruments" handwritten on it. The filing cabinet was observed directly next to an ABI machine and printer on wheels with two binders on top of it to the right of the filing cabinet. A computer station was observed attached to the wall directly above the filing cabinet, and a rolling stool was observed to the left and next to the cabinet. The patient recliner was observed on the other side of the stool. The inside of the bottom drawer of the filing cabinet was observed splattered with a colorless, gel-looking substance. A red container with a lid that was labeled "Biohazard" was observed inside the drawer. Upon opening the red container, two pair of scissors with a similar colorless, gel-looking substance on them were observed inside the red container.

1.b. During an interview on 07/12/2022 with staff present at the time of these observations, they stated the scissors were contaminated, and the gel-looking substance on the scissors and splattered inside the filing cabinet was Pre-Klens that staff had sprayed on the instruments.

1.c. The following two documents were provided in response to a request for the CAH's P&Ps for management of contaminated reusable instruments in WOC: An undated document titled "Work Process for Instrument Processing & Transport, Madras" and a P&P titled "Instrument Transport and Processing Outside of Central Processing," dated 01/14/2020.

1.d. Review of undated "Work Process for Instrument Processing & Transport, Madras" document reflected:
* "Please refer to 'SCMG Instrument Processing and Transport' Document # 8914 v. 1'"
* "Procedure for Instrument Processing and Transport for Madras St Charles Wound & Ostomy Clinic ... After use, gross debris is to be wiped off at the point of care with water. Cleaning to remove organic material must always precede disinfection or sterilization because residual debris reduces the effectiveness of the disinfection and sterilization process ... Once debris is removed, the item is to be placed into a designated labeled container with BioHazard stickers attached. This bin must be in a lockable cabinet and have a lid."
* "The item is to be sprayed with an enzymatic cleaner (Pre-Klens spray gel), coating completely."
* "Clinical staff will fill out the 'Instrument Processing and Transport' delivery sheet, noting how many bins and instruments were delivered to Central Processing."
* "The Madras Wound & Ostomy staff will place the designated bins in the Madras Soiled/Biohazard Utility Room."
* "Transport of dirty instruments will occur every 48-72 hours on Mondays, Wednesdays, and Fridays. Pre-Klens enzymatic cleanser can be in place for up to 72 hours of continuous exposure, and is an approved product of St. Charles."
* The transport bin will be decontaminated by Madras Central Processing ..."
* The bottom of the work process document, under "Contact Information," was the name and phone number for an IP and a CST.

The work process document was not clear. For example, it reflected:
* "Please refer to 'SCMG Instrument Processing and Transport' Document # 8914 v. 1..'" However, no document titled "SCMG Instrument Processing and Transport' Document # 8914 v. 1" was provided with the work process document.
* "Once debris is removed, the item is to be placed into a designated labeled container with BioHazard stickers attached. This bin must be in a lockable cabinet and have a lid." It was not clear if the "designated labeled container" and the "bin" were the same or different receptacles. It was not clear where the "lockable cabinet" was located, and whether it was required to be locked.
* "The item is to be sprayed with an enzymatic cleaner (Pre-Klens spray gel), coating completely." It was not clear where and when this activity should occur.
* "The Madras Wound & Ostomy staff will place the designated bins in the Madras Soiled/Biohazard Utility Room." It was not clear when this should occur.
* "Transport of dirty instruments will occur every 48-72 hours on Mondays, Wednesdays, and Fridays ..." It was not clear what the dirty instruments were transported in, who transported them, and where they were transported to.
* The process did not address the observed and stated practice of placing a tote containing contaminated instruments into a filing cabinet directly next to clean patient care equipment and a nurse charting station; and spraying with enzymatic with sufficient force to splatter the inside surfaces of the filing cabinet. It was not clear if these activities had been evaluated for infection control risks.
* It was not clear whether the filing cabinet was leak proof, and had been evaluated and determined appropriate for storing contaminated instruments, and conducting contaminated instrument cleaning processes, and had been assessed for infection control risks. It was additionally not clear if someone was responsible for cleaning the splatter observed inside the filing cabinet.

1.e. Review of a P&P titled "Instrument Transport and Processing Outside of Central Processing," dated 01/14/2020 reflected:
* "It is the policy of St. Charles Healthcare System that ... Instruments used at POC will be properly processed at POC and transported safely to Central Processing for proper cleaning, sterilization and packaging. In Prineville the instruments are placed in soiled hold for CP staff to pick up. In Madras and Redmond instruments are picked up from departments by CP staff."
* "The following steps are taken to move contaminated items for (sic) POC to Central Processing ... Gross debris will be wiped off the item at POC, prior to placing them in a storage container ... The contaminated instrument should be placed in a storage tote and sprayed with an enzymatic cleaner. Enzymatic spray used is (sic) Bend in (sic) Getinge Renuzyme. Prineville uses Pre-Klens spray gel. This will keep the instruments moist and prevent bioburden build up until they are transported."
* "The storage tote will have a closeable lid and a biohazard sticker or marking on the outside ... Instruments will remain in the tote until CP processes them. CP will be responsible for cleaning of the tote ... For the Madras and Prineville campuses, the instruments are processed by CP each morning M-F. There is no staff available Saturday and Sunday to process instruments."

The P&P was not clear. For example:
* It was not clear where in the departments instruments were kept before picked up by CP staff.
* It was not clear if the "storage container" and "storage tote" were the same receptacle.
* Whereas, the P&P specified enzymatic cleaners used at "Bend" and "Prineville," it was not clear what enzymatic cleaner should be used at St. Charles Madras.
* It was not clear where instruments in the container or tote should be sprayed with respect to the observed and stated practice of placing a tote containing contaminated instruments into a filing cabinet directly next to clean patient care equipment and a nurse charting station; and spraying with enzymatic with sufficient force to splatter the inside surfaces of the filing cabinet.

1.f. During an interview with an IP on 07/14/2022 beginning at 1210, the IP stated WOC was not evaluated by IP staff for infection control risk. The IP stated they were not involved in the setup of WOC. The IP stated they were not aware of the contaminated instruments in the filing cabinet.

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2. Regarding single use devices:

2.a. During an observation of the CPD on 07/13/2022, with the PNM, the ANM, the ORT and others at approximately 1330, a 5-gal bucket was observed on the floor next to an uncovered hopper in the decontamination room. The lid of the bucket was labeled with the following handwritten notation, "Return to [name of staff member] ED." A label affixed to the outside of the bucket read, "Centurion Instrument Recycling Program Please Place Only Disinfected Centurion Instruments in the Bucket Provided When bucket is full, contact your sales representative at: Centurion Medical Products." A second affixed label contained the name of the hospital, the name of the same ED staff person and a customer number. The bucket contained approximately 12 single-use instruments including stainless steel tweezers, hemostatic forceps, and scissors. The instruments were in various open and closed positions, including hemostatic forceps which appeared to be in a closed and locked position, therefore it was not clear if they had been "disinfected" per the labeled instructions. When asked about the bucket, the ORT stated that the instruments were being collected for a RN in the ED. They further explained that the instruments were "hand washed" and "went through the instrument washer" and were not sterilized. When asked if there was a contract or if the company reprocessing the instruments was certified for reprocessing single-use instruments, the ORT and others present stated that they did not know.

2.b. A contract titled "Centurion Medical Products Instrument Recycling Agreement" dated and signed by the EDNM, and a RAS of Centurion Medical Products on "7/28/20," was provided by the hospital. It was reviewed and reflected:
* Attached to the contract was a "Hospital Disinfection Protocol Survey" that was signed and dated on "7/28/20," by an "OR Manager." The current ANM was listed as the "Primary Contact" and included the ANM email and phone number.

2.c.. During an interview with the IP department on 07/14/2022, with the IPD, and the IPR beginning at 1030, they were asked about a P&P for the single-use instruments being collected for reprocessing in the CPD. The IPR stated that they were not aware that instruments were being collected and that there was no policy.

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3. Regarding ultrasound probes.

3.a. The disinfection process for ultrasound probes was unclear and there was lack of provisions for staff handwashing in the Imaging Department Ultrasound Room. Observations in that room on 07/12/2022 at 1230 revealed the handwashing sink was not available for staff use as an undated sign taped on the paper towel dispenser above the handwashing sink in the room read "Sink Not For Washing Hands Thank You." There was no other information on the paper sign. There was no explanation for the posted instructions. However, on the countertop to the right of the sink a "nanosonics trophon" device was observed. Review of the P&P titled "Trophon Ultrasound Probe High Level Disinfection" reflected that "The sole purpose of the trophon EPR is to high level disinfect validated ultrasound probes." The P&P instructions included "The probe must be pre-cleaned and dried BEFORE the High-Level Disinfection process can commence in the trophon EPR." However, there was no direction or steps to reflect how and where the probe was to be "pre-cleaned." Further, there was no handwashing sink available for staff who were performing disinfection procedures in a patient treatment room.

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4. Regarding transporting and storing endoscopes:

4.a. The policy titled "Loan Rental of Instruments and Equipment to non-SCHS Facilities" dated "08/04/2016," was reviewed and reflected:

* "SCHS Central Processing loans or rents equipment and instruments and sells supplies to other, non-SCHS facilities when requested pending availability ... Requesting facility call the Central Processing Manager, Supervisor, or Special Request Coordinator to place the request ...The requesting facility is responsible for pick up and return of instruments and equipment ... All equipment/instruments must be returned immediately following the procedure. Prior to the departure of the instruments/equipment, a Contract Charge Continuation form, and a loaner return check-in form notating any missing inventory must be completed along with the Loaner System document (SCHS facility form)for (sic) daily report and tracking purposes ... The CP Manager, Supervisor, or Special Request Coordinator will log on Loaner Log - Loan Rental of Instruments and Equipment to other Facilities the date, the requesting facility, individual requesting the item(s), description of equipment/instrument, date/time sent, and date/time returned ... The CP will charge the requesting facility a $50.00 processing fee per peel pack item and $125.00 per instrument tray loaned. This 'per tray' fee applies even when cases use multiple trays (i.e. (sic) 3 trays in one case = $375) ... These fees apply to instruments that SCHS owns and to instruments that are consigned at SCHS when SCHS must perform the check in and sterilization work."

4.b. The document titled, "Scope tracking log" dated "revised 11/30/2021," was reviewed and reflected:

* The log contained 6 columns titled, "date, scope description, scope S/N, out to, reason, date returned."
* On "2-23-22" an "EGD," an endoscope, was on "loan" to "Prineville" and returned on "2-24-22."
* On "2-23-22," a "colonoscope" was on "loan" to "Prineville" and returned on "2-24-22."
* On "5-16-22" an "EGD" was on "loan" to "Prineville" and returned on "5-18-22."
* On "7-12-22" an "EGD" was on "loan" to "Prineville" and returned on "7-13-22."
* On "7-12-22" an "EGD" was on "loan" to "Prinevill" (sic) and returned on "7-13-22."

4.c. During an observation of the CPD on 07/13/2022, at approximately 1245, an empty, foam-lined silver case was observed stored on the floor directly under a sink in the anesthesia work room. The sink was located near a high traffic area where dust and other particles could be aerosolized when walking through the door of the anesthesia work room. When asked what the case was used for, the PNM stated that the case was used for "storing and transporting [loaned] scopes between facilities." When asked whether the normal storage location of the case was on the floor and under the sink, the PNM responded "No." When asked how the transport case was cleaned and disinfected between uses, the PNM stated that a disinfectant wipe was used to wipe down both the inside foam lining and the outside of the case.

Neither the policy nor the log described how scopes were transported between facilities, or whether the transport case was used to transport dirty, clean, or HLD processed scopes. The policy provided did not specifically address EGDs or colonoscopes. The P&P described "trays," and "cases" with "multiple trays" however, it did not address the foam-lined case. It was unclear how the hospital ensured pre-cleaning of scopes at other facilities prior to transport as the policy stated, "All equipment/instruments must be returned immediately following the procedure," and did not include pre-cleaning or transporting instructions. There was no documentation to ensure that loaned instruments were appropriately cleaned, packaged, and transported following basic infection prevention principles. It was unclear whether the case was used for short-term or long-term storage, contrary to general EGD storage recommendations. It was unclear whether the disinfectant wipes used to clean and disinfect the inner lining of the case had been validated as an effective method as the foam was comprised of porous material rather than a smooth, easily cleanable surface.

4.d. During an interview with the IPD and the IPR on 07/14/2022, at approximately 1210, they confirmed that there was no policy regarding the transporting of endoscopes. Additionally, they said that the endoscopes were disinfected via HLD and that they were transported back and forth between facilities using the manufacturer's case. When asked whether the case should be stored under a sink, the IPR responded the case could be stored in an office, but would prefer that it not be stored under a sink.

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5. Regarding hyrdocollator temperature and cleaning:

5.a. In the Rehabilitation Department Gym Room on 07/12/2022 at ~ 1425 a Hydrocollator unit for heating hot packs was observed to be full of water. Review of the "Hydrocollator ... Temperature & Cleaning Log" for the month of "July 2022" revealed that the water temperature of the device was to be maintained between "(145 - 165)" degrees. Documentation on the form reflected that water temperatures were taken on six dates in July 2022 as of the date of the survey. The temperatures recorded on 07/01/2022, 07/05/2022, 07/06/2022, 07/07/2022, 07/11/2022, and 07/12/2022 were documented as 167.2, 167.9, 167.7, 167.9, 167.7, and 167.5 respectively. Although all the dates were recorded as outside of the acceptable range there was no evidence of follow-up or actions taken. This was confirmed during interview with the Rehabilitation Manager and other staff present during the observation. A hospital P&P for use and maintenance of the heating unit was not provided in response to surveyor request.

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6. Regarding disinfectant testing processes.

6.a. In a soiled utility room on 07/12/2022 at 1215, an open container of Virex disinfectant was observed inside a wall mounted auto dispensing unit. There was no opened date, expiration date, or other information on the container that indicated when the disinfectant was opened or expired. During an interview with an EVS staff on 07/12/2022 at the time of the observation, they pointed out a document titled "Virex test log" posted on the wall next to the auto dispensing unit. The EVS staff stated when the container of Virex disinfectant was opened, staff were supposed to "test" the disinfectant using a "Diversey" test strip, and record the results on the log. Observation of the log reflected test strip results were recorded on 10/08/2021, 11/16/2021, 12/14/2021, and 04/07/2022; and the results were "Pass." However, there were no open dates or other information on the Virex container or the log that reflected whether any of the passing test results correlated with the container of Virex disinfectant that was observed in the auto dispensing unit.

6.b. In an EVS closet in the administration hallway on 07/12/2022 at 1220 with an EVS staff, PNM, and other hospital staff the following observations were made:
- An open 2.5 Liter container of Alpha-HP disinfectant/cleaner was observed expired on "05/2019." - An unopen 2.5 Liter container of Alpha-HP disinfectant/cleaner was observed expired on 01/14/2022.
- An open 2.5 Liter container of Perdiem General Purpose Cleaner with Hydrogen Peroxide was observed with no opened date or expiration date.
- An open container of Virex disinfectant was observed inside a wall mounted auto dispensing unit. The container had a manufacturer stamp "06212018NW01" on it. It was not clear what the stamped numbers/letters meant. There was no opened date, expiration date, or other information on the container that indicated when the disinfectant was opened or expired. During an interview with an EVS staff on 07/12/2022 at the time of the observation, they pointed out a hospital generated document titled "Virex test log" posted on the wall next to the auto dispensing unit. The log was the same as the log observed in the soiled utility room on 07/12/2022 at 1215 above. The EVS staff stated when a new container of Virex disinfectant was opened, staff were supposed to "test" the disinfectant using a "Diversey" test strip, and record the results on the log.
Observation of the log reflected 18 dates ranging from 09/29/2021 through 06/07/2022. Each date had a corresponding "Pass" result. However, there were no open dates or other information on the Virex container or the log that reflected whether any of the passing test results correlated with the container of Virex disinfectant that was observed in the auto dispensing unit.
The posted log included the following Virex disinfectant concentration testing instructions: "Testing Process: 1. Insert new bottle of Virex 256 in solution center 2. Fill disposable cup ¼ full. Tear off 1 ½ inch of test paper and dip into cup. 3. Compare test strip to chart immediately and note PPM reading on log. 4. Note ppm and Pass/fail on log. If test fails, run chemical for 10 seconds and retest. If it continues to fail DO NOT USE and immediately report to manager ..." Observation of the EVS staff while they conducted a test, revealed they did not follow the instructions on the log while conducting the test. For example, they obtained a piece of "Diversey" test paper (strip), and with ungloved hands dispensed Virex disinfectant directly from the auto dispensing unit onto the test strip. Disinfectant splashed on the floor and was observed not evenly distributed on the test paper. The EVS staff held the test paper with disinfectant on it next to a color-coded chart on the "Diversey" test paper container. The EVS staff stated the test paper should turn dark green to show a passing result. Observation of the test paper reflected it was mottled with areas of yellow, and varying shades of green. Therefore, it could not be determined whether the disinfectant in the auto dispensing unit was the appropriate concentration. The EVS staff did not use any PPE, including gown, gloves, or protective eye wear during these observations.
The only protective eye wear observed in the EVS closet was on a top shelf above the floor drain sink. However, observation revealed the EVS staff was not able to reach the eye wear without stepping on the elevated sink edge that was unstable, in disrepair, and held together with duct tape. Protective eye wear was not readily accessible for staff handling, refilling, and testing disinfectants in the EVS closet. No disposable cups were observed in the EVS closet to pour Virex disinfectant into for the disinfectant testing process as indicated on the posted log instructions. Further, a sign posted in the EVS closet reflected "Virex Refill Process ... 1. Put on gloves and safety glasses for splash protection ..." These observations were confirmed on 07/12/2022 during interview with the PNM, EVS staff, and other staff present during the observations.

6.c. Manufacturer's IFUs provided for the auto dispensing unit titled "QuattroSelect Owner's Guide," under "Safety Instructions," reflected "Wear protective clothing and eyewear when dispensing chemical or other materials. Always observe safety and handling instructions on product labels ... Always direct discharge stream away from you and other persons ... Always dispense cleaners and chemicals in accordance with instructions ..."

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7. Regarding expired and unlabeled products and supplies:

7.a. On 07/12/2022 at 1030, a spray bottle with a manufacturer label indicating it contained PERdiem General Purpose Cleaner with Hydrogen Peroxide was observed on an EVS cart with an EVS staff present. There was no opened date or expiration date on the bottle. During an interview with the EVS staff at the time of the observation regarding the bottle of cleaning solution, they stated, "We dump them out and change them every morning or evening." However, there was no information on the bottle that reflected when or if that had been done.

7.b. Review of a P&P titled, "Environmental Services-Infection Prevention and Control," dated effective 09/16/2020 reflected "Germicide Selection: Always use correct dilutions and contact times of only Infection Prevention Committee-approved germicide solutions according to manufacturer's recommendations. All containers will be properly labeled as to product contents and concentration ... If a germicidal agent is poured/dispensed into a secondary container (i.e., spray bottle), the secondary container must be clearly labeled as to the product contents and expiration date."

7.c. Observations revealed expired or unclearly labeled products:
* In a cabinet in the Imaging Department CT Room, on 07/12/2022 at 1205, four gray-top, aqua-top, and purple-top blood collection tubes were observed that had expiration dates of 01/30/2022, 01/31/2022, and 03/31/2022 respectively.
* In the Phlebotomy Room in the Laboratory, on 07/12/2022 at 1030, six red-top blood collection tubes were observed that had expiration dates of 04/30/2022.
* On a counter-top in the Laboratory, on 07/12/2022 at 1050, a bottled of "Strep A" reagent was observed with an expiration date of 04/2022.
* On a counter-top in the Laboratory, on 07/12/2022 at 1050, two urine specimen type containers that contained liquid were observed. Each container had a label that had spaces for "Name, Room, Doctor, Date, Medical Record No." Handwritten on that label on one container was "0.5% Bleach 4/27/22," and either "4/17/22" or 4/13/22" had been written but was scribbled over. It was unclear what those dates indicated. Handwritten on the label on the second container was only "70% Denatured Ethanol cephaid (sic) cleaning."
* On 07/13/2022 at 0930 a bottle of "germ-X" hand sanitizer observed in the M/S storage unit bathroom had an expiration date of 05/2022.

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8. Regarding PPE.

8.a. Refer to Finding 6.b and 6.c. that reflected PPE was not readily accessible and was not used in accordance with manufacturer IFUs.

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9. Regarding hazardous waste:

9.a. In a M/S patient room on 07/12/2022 at 1140, observations with ISM present revealed an over-filled wall mounted sharps disposal container.

9.b. In M/S soiled utility room on 07/12/2022 at 1210, observations revealed a large wire basket over-filled with contaminated sharps disposal containers.

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10. Regarding hand hygiene supplies and handwashing sinks.

10.a. In an EVS closet in the administration hallway on 07/12/2022 at 1235, a wall mounted Purell hand sanitizer dispenser was observed empty and there were no other hand hygiene supplies observed available for use in the EVS closet. This was confirmed with an EVS staff at the time of the observation.

10.b. In the Rehabilitation Department on 07/12/2022 beginning at 1430 the following observations were made:
* A low, mini-handwashing sink was observed in a corner of the Gym Room next to a wall on the right side of it. The sink was not readily accessible for handwashing as it was completely surrounded by a soiled linen container and a wastebasket. A piece of equipment and a cabinet were also in close vicinity and contributed to the lack of easy access by ambulatory individuals or persons using wheelchairs.
* The sink in the janitor's closet in the department hallway was not accessible as the sink and the surrounding countertop were filled and covered with a number of items.

10.c. Observations in WOC on 07/12/2022 at 1245 with the OWC, PNM, and other hospital staff revealed one handwashing sink. A metal cabinet was observed directly to the left of the sink. A wall mounted paper towel dispenser was observed above the metal cabinet. The cabinet had various items crowded on top of it including a box of 4x4 dressings directly next to the left side of the sink; a container of Clorox Bleach Germicidal Wipes; a mesh container with scissors, pens, and disposable measuring devices inside it; a metal file rack; and an electronic computer device with a charging cord attached to it that was draped onto the cabinet and plugged into an electrical outlet near the sink. A second charging cord was observed draped over the top of the cabinet and in between the cabinet and the sink. The surveyor washed their hands at the sink and when reaching for paper towels from the paper towel dispenser, water dripped onto the box of 4x4s and other items on top of the metal cabinet because they were in the path between the sink and the paper towel dispenser. This situation created the possibility of contamination of items on the cabinet.

10.d. During an interview with an IP on 07/14/2022 beginning at 1210, IP stated they were not aware of handwashing sink and paper towel dispenser next to patient wound care and other supplies and items in WOC.

10.e. Refer to Finding 3.a. that reflects lack of provisions for staff handwashing in the Imaging Department Ultrasound Room.

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11. Regarding separation of clean and dirty supplies.

11.a. Observations revealed that a variety of patient care supplies were stored in bathroom and shower rooms, and in other areas, and did not ensure separation of clean and dirty:
* In the SLP treatment room in the Rehabilitation Department on 07/12/2022 at 1450 a three-shelf wall cabinet was observed to contain a number of items that included, for example: a cup of lollipop suckers, a bottle of "Virex II 256" spray disinfectant, a number of children's toys, a container of disinfectant wipes, a "pulse oximeter" device on a lanyard, etc.
* A room on the M/S unit in which patient care supplies were stored, including equipment and linens, was observed on 07/12/2022 at 1500. On a shelf in the room was a bin in which was observed a partially used bottle of shampoo, a partially used bottle of hair conditioner, a stack of small medication pass cups, and a spray can of "RID Home Lice, Bedbug & Dust Mite Spray." The room also included a bathroom with a toilet, handwashing sink and shower. In the bathroom, a large multi-shelf rack was placed in the shower stall. The shelves were covered with a variety of supplies and items that included: clocks, CD players, game books, games, pencils, crayons, etc. A sign attached to the cart reflected "[Swing-Bed] activity items" and contained a list of items. Located next to the cart was a smaller cart on wheels that contained a number of personal care supplies that included, for example: hand sanitizer, bottles of nail polish, emery boards, hair care supplies, curling irons, reading eyeglasses, crocheted/knitted items, etc. During interview at the time of the observations staff indicated the storage room had previously been a patient room.
* A room in the administration hallway was identified by a wall sign next to the room as a "Restroom" and by a sign on the door as a "Shower." Observations on 07/14/2022 at 1530 revealed the room contained a large quantity of supplies placed on the shower stall floors and on tables placed in the shower stalls and throughout the room. A number of plastic bins and cardboard boxes were placed on the floor an

Based on interview, review of medical record documentation for 2 of 2 swing-bed patients reviewed for patient's rights (Patients 3 and 4), and review of P&Ps it was determined that the hospital failed to inform swing-bed patients of their additional rights in accordance with hospital P&Ps.

Findings include:

1. The P&P titled "[Swing-Bed] Patient Rights and Responsibilities," with "Effective date" 03/08/2017, was reviewed. It included the following requirement:
* "It is the responsibility of the St. Charles Health System [Swing-Bed] Program to ensure that all patients are informed both orally and in writing in a language they understand their rights and responsibilities."
* "Upon [Swing-Bed] admission, the admitting Nurse or their designee will discuss the SCHS [Swing-Bed] Patient Rights and Responsibilities with the patient and/or their family, caregiver or representative. The Patient Rights and Responsibilities will be signed by the patient, family, caregiver or representative as well as the hospital representative that discussed it ... One copy of the executed Patient Rights and Responsibilities will be sent to Health Information Management to be scanned into the electronic medical record ..."

2. Medical record documentation for Patient 3 reflected that they were admitted to the swing-bed program on 05/23/2022. There was no documentation in the record to reflect that the patient had been informed of their swing-bed program patient rights and responsibilities.

During interviews at the time of the review of medical records with staff that included nursing, quality, and swing-bed staff on 07/13/2022 at 1050 and again at 1230, they confirmed that they were unable to find the swing-bed patient rights form required by the P&P to reflect that Patient 3 had been informed in writing about those rights.

3. Medical record documentation for Patient 4 reflected that they were admitted to the swing-bed program on 05/30/2022. The documentation in the record reflected that it wasn't clear that the patient had been informed of their swing-bed patient rights at the time of admission to the swing-bed program. The "[Swing-Bed] Rights and Responsibilities" form was signed by the patient, however, the space for the "Date/Time" of the patient's signature was blank.

A second form titled "[Swing-Bed] Patient Notice of Services" contained disclosure information about what services payment was covered by Medicare for and what services were not covered. The form was signed by the patient, however, the space for the "Date/Time" of the patient's signature was blank. The form was also signed by a SCM staff person whose signature was dated as "6-22-22," 23 days after the patient was admitted.

During interviews at the time of the review of medical records with staff that included nursing, quality, and swing-bed staff on 07/13/2022 at approximately 1100, they confirmed the lack of a date to reflect when Patient 4 signed the patient rights forms.

Based on interview, review of medical record documentation for 2 of 2 swing-bed patients reviewed for patient's rights (Patients 3 and 4), and review of P&Ps it was determined that the hospital failed to inform swing-bed patients of their additional rights in accordance with hospital P&Ps, including their transfer and discharge rights.

Findings include:

1. Refer to the findings identified under Tag C1608, CFR 485.645(d)(1), Standard: SNF Services.

Based on interview, review of medical record documentation for 2 of 2 swing-bed patients reviewed for patient's rights (Patients 3 and 4), and review of P&Ps it was determined that the hospital failed to inform swing-bed patients of their additional rights in accordance with hospital P&Ps, including their right to be from abuse, neglect and exploitation.

Findings include:

1. Refer to the findings identified under Tag C1608, CFR 485.645(d)(1), Standard: SNF Services.