Asante Rogue Regional Medical Center

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 29708 Based on interview, documentation reviewed in the medical records of 3 of 3 CVICU patients who experienced pressure ulcers and other skin conditions (Patients 1, 2 and 3), review of incident documentation for 8 of 8 ED and CVICU patients who received uncrossmatched blood transfusions (Patients 5, 6, 7, 8, 9, 10, 11, and 12), review of policies and procedures, and review of other documentation, it was determined that the hospital failed to ensure the RN supervised and evaluated patients in accordance with policies and procedures as follows: * Regarding Patients 1, 2 and 3, RN staff failed to notify the physician and wound care team when the patients developed new or deteriorating skin conditions. * Regarding Patients 2 and 3, RN staff failed to ensure the patient’s wound care was carried out in accordance with physician and wound care team orders and Patient 2’s coccyx pressure ulcer subsequently deteriorated. * Regarding Patient 3, RN staff failed to ensure clear, complete and timely assessments and documentation of pressure ulcers. * Regarding Patient 1, RN staff failed to complete an incident report and investigation when the patient sustained a new skin tear. * Regarding ED Patients 5, 6, 7, 8, 9, 10 and 11; and CVICU Patient 12, RN staff failed to: - Ensure physicians took responsibility for the increased risk of transfusing uncrossmatched blood by obtaining a physician signature on the Transfusion Record for each unit of uncrossmatched blood transfused. - Identify physician signature gaps on Transfusion Records; and complete timely incident reports, investigations and corrective actions. Findings include: 1.a. The policy and procedure titled “Pressure Injury Prevention/ Interventions, Guidelines, & Documentation; Braden Scale (ASANTE),” dated effective 07/10/2024 was reviewed and reflected: * “Nurses ... Responsible for comprehensive skin assessment, focused skin assessment ... pressure injury staging, pressure injury prevention interventions ... Responsible for all basic wound care interventions and treatments. Facilitates consultation with wound care team ... for stage 2 or greater pressure injury, unstageable pressure injury, or deep tissue injury ... Documentation in the EMR.” * “The nurse will add a wound LDA into the patient EHR upon discovery of a pressure injury ... Assessments will be documented every shift and PRN ... Interventions will be documented as ordered or PRN ... The bedside nurse will communicate to the provider and wound care team ... when the following are present ... Stage 2 or greater pressure injury, unstageable injury, or deep tissue injury ...” 1.b. The policy and procedure titled “Responsible Event Reporting and Analysis in a Culture of Safety (ASANTE),” dated effective 07/25/2024 reflected: * “Procedure ... Responsible Event Report (RER) is completed for any event that is not consistent with routine patient care or routine operations of the facility. An RER should be completed when an abnormal/unusual event has, or threatens to have, an adverse effect on a patient or visitor, and justifies evaluation or corrective action. The event report is completed by the employee who ... Participated in the event ... Witnessed the event ... First discovered the event; or ... First received a report of the event.” * “The following events will be documented ... Skin Integrity/Pressure Ulcer Event: For skin tears, bruising, pressure ulcers (including those present on admission) and any other skin events or injuries ... The event should be completed during the shift in which it occurred ...” * “The Unit/Department Manager or Supervisor of the most appropriate department will ... Investigate and document follow-up of all event reports within a two-week time frame from when the event report was entered ... Assist with any needed system changes to help prevent a similar incident from occurring ... Evaluate the nature of the error(s) and develop action plans to appropriately address the error(s) ... * “The following is a list of circumstances requiring an RER ... Policy, rules, or standards not followed that affect a patient ... Pressure ulcer present on admission ... Pressure ulcers acquired after admission ... Other skin integrity issues ... Error (omission or commission) ...” 2.a. The medical record of Patient 1 was reviewed on 05/07/2026 with CINS 5, DCVICU, MCVICU and other hospital staff. The record reflected the patient was admitted to CVICU on 05/31/2025 at 0147 with diagnoses that included critical aortic valve stenosis. * An RN note dated 05/31/2025 at 0200 reflected the patient’s skin was “WDL” (within defined limits). * On 06/10/2025 at 1846 RN “Flowsheets” documentation reflected the patient had a skin tear that was not present when the patient was admitted. The documentation reflected “Wound 06/10/25 Skin Tear Pretibial Right; Lower; Medial linear skin tear prior to my shift ... Wound Properties Date First Assessed: 06/10/25 Time First Assessed: 1700 ... Present on Original Admission: No ... Wound Location Orientation: Right; Lower; Medial ...” There was no documentation that reflected an RN notified a physician, other LIP or the wound care team regarding the new skin tear. * WOCN notes dated 06/18/2025 at 1130 and 06/20/2025 at 1245 reflected the patient had necrotic fingers and toes that were not present on admission. The documentation reflected: “Wound 06/17/25 Soft Tissue Necrosis Finger D2, index Anterior; Right Nail bed, tip ... Date First Assessed/Time First Assessed: 06/17/25 2000 ...” “Wound 06/17/25 Soft Tissue Necrosis Finger D2, index Anterior; Left ... Date First Assessed/Time First Assessed: 06/17/25 2000 ...” “Wound 06/17/25 Soft Tissue Necrosis Toe D2, second Anterior; Right All four toes ... Date First Assessed/Time First Assessed: 06/17/25 2000 ...” “Wound 06/17/25 Soft Tissue Necrosis Toe D2, second Anterior; Left ... Date First Assessed/Time First Assessed: 06/17/25 2000 ...” There was no documentation that reflected RN staff notified a physician or other LIP regarding the patient’s necrotic fingers and toes. * RN “Flowsheets” documentation reflected the patient developed a pressure injury to their neck that was not present on admission. The documentation reflected “06/24/25 Pressure Injury Neck Anterior peri trach stoma ... Date First Assessed: 06/24/25 ... Time First Assessed: 1743 ... Present on Original Admission: No ...” * Review of the “Care Plan” reflected “Problem: Compromised Skin Integrity ... Dates: Start: 06/25/25 ... Disciplines: Interdisciplinary ... Goal: Skin integrity is maintained or improved ... Dates: Start: 06/25/25 ... Disciplines: Interdisciplinary ... Intervention: Perform a comprehensive risk assessment and Braden risk assessment per policy ... Dates: Start: 06/25/25 ... Intervention: Follow Pressure Injury Care Bundle per policy ... Dates: Start: 06/25/25 ... Intervention: Follow Provider/Wound Care treatment and intervention orders for wound and skin ... Dates: Start: 06/25/25 ... Intervention: Consult with Wound Care for a stage 2 or greater pressure injury, an unstageable pressure injury, a deep tissue injury, or if unsure of appropriate treatment ... Dates: Start: 06/25/25 ... Outcomes.” The care plan was generic and lacked patient-specific, individualized problems, goals and interventions related to the patient’s multiple changing and deteriorating skin conditions. * The patient expired on 07/16/2025. 2.b. During interview with CINS 5, DCVICU and MCVICU on 05/07/2026 at the time of Patient 1’s medical record review the following information was provided: * CINS 5 stated “WDL” documented by the RN on 05/31/2025 at 0147 meant the patient had no skin issues on admission. * MCVICU confirmed there was no documentation that RN staff notified a physician or other LIP about the patient’s new skin tear. * MCVICU confirmed there was no documentation that RN staff notified a physician or other LIP about the patient’s necrotic fingers and toes. * CINS 5 confirmed the lack of a patient-specific, individualized nursing care plan. 3.a. The medical record of Patient 2 was reviewed on 05/07/2026 with CINS 5, DCVICU, MCVICU and other hospital staff. The record reflected the patient was admitted to CVICU on 05/13/2024 at 0220 with multiple diagnoses that included acute mitral valve insufficiency. * RN “Flowsheets” documentation dated 05/13/2024 at 0400 reflected the patient’s skin assessment was “WDL.” * On 05/20/2024 at 1150 RN “Flowsheets” documentation described the patient’s coccyx as “Intact” and “blanchable.” * On 05/21/2024 at 1842 RN “Flowsheets” documentation described the patient’s coccyx as “Intact” * On 05/22/2024, 05/23/2024, 05/24/2024, 05/25/2024 and 05/26/2024 RN “Flowsheets” documentation described the patient’s coccyx as “intact” and “redness.” * On 05/30/2024 at 1900 RN “Flowsheets” documentation described the patient’s coccyx as “abrasion” and “bruising.” * On 05/31/2024 at 0350 RN “Flowsheets” documentation described the patient’s coccyx as “bruising.” * On 05/31/2024 at 1828 RN “Flowsheets” documentation described the patient’s coccyx as “Abrasion,” “Redness” and “Ecchymotic.” * On 06/01/2024 RN “Flowsheets” documentation reflected the patient had a coccyx pressure injury. The documentation reflected “... Wound 06/01/24 Pressure Injury Coccyx ... Wound Properties Date First Assessed: 06/01/24 ... Present on Original Admission: No ...” There was no documentation that reflected the physician was notified of the pressure injury. * On 06/04/2024 at 1122, wound care team documentation with photos reflected the patient had a coccyx deep tissue pressure injury. There was no documentation that reflected an RN notified a physician or other LIP of the new deep tissue pressure injury. * A wound care team order dated 06/04/2024 at 1224 with coccyx wound care instructions included cleansing coccyx with normal saline or wound cleanser, wiping with gauze, applying xeroform to open areas, covering with foam dressing, changing daily, and contacting physician or wound care team if wound declines. * On 06/11/2024, wound care team documentation reflected the coccyx pressure injury was healing. * On 06/15/2024 at 0800, RN notes reflected coccyx wound care was conducted. * On 06/16/2024, there was no documentation that reflected coccyx wound care was conducted in accordance with the wound care team orders dated 06/04/2024 at 1224. * On 06/19/2024 wound care team documentation and a corresponding photo reflected the coccyx pressure injury was deteriorating. The documentation reflected “Date First Assessed/Time First Assessed: 06/01/24 2000 ... Present on Original Admission: No ... Primary Wound Type: Pressure Injury Location: Coccyx ... Wound Assessment ... Eschar; Fibrinous; Pink; Slough; Friable ... State of Healing ... Deteriorating ... Wound Length ... 13 cm ... Wound Width ... 7 cm ... Wound Depth ... 0.2 cm ...” * WOCN addendum documentation with photos dated 06/19/2024 at 1358 reflected the patient had multiple skin conditions that were not present on admission. The documentation reflected: - “Trach ulcer is non-healing with fibrinous/necrotic base but may be cauterized tissue. Anal wound is not healing with fibrinous tissue and larger measurements. Sacrum/coccyx ulcer is deteriorating and would benefit from surgical consult to debride necrotic tissue. Will need diligent offloading to encourage wound healing ...” - “Wound 06/04/24 Moisture Anus Date First Assessed/Time First Assessed: 06/04/24 1102 Present on Original Admission: No ...” - “Wound 06/12/24 Pressure Injury Neck Anterior ... Date First Assessed/Time First Assessed: 06/12/24 0530 Present on Original Admission: No ...” * On 06/20/2024, RN documentation reflected the coccyx pressure injury was deteriorating. There was no documentation that reflected the RN notified the physician, other LIP or wound care team that the patient’s coccyx pressure injury was deteriorating in accordance with wound care team orders. * On 06/24/2024 and 06/25/2024, RN documentation reflected the patient’s coccyx pressure injury continued to deteriorate. There was no documentation that reflected the RN notified the physician, other LIP or wound care team that the patient’s coccyx pressure injury was deteriorating in accordance with wound care team orders. * On 07/01/2024 at 1400, RN documentation reflected NPWT (negative pressure wound therapy) was initiated to the patient’s coccyx. The documentation reflected “Negative Pressure Wound Therapy NPWT ... Placement Date: 07/01/24 ... Placement Time: 1400 ... Location: Coccyx ...” * Review of the “Care Plan” with “Start” date 06/02/2024 was nearly the same as Patient 1’s in finding 2.a. above. The Care Plan reflected “Problem: Compromised Skin Integrity ... Dates: Start: 06/02/24 ... Disciplines: Interdisciplinary ... Goal: Skin integrity is maintained or improved ... Intervention: Perform a comprehensive risk assessment and Braden risk assessment per policy ... Dates: Start: 06/02/24 ... Intervention: Follow Pressure Injury Care Bundle per policy ... Dates: Start: 06/02/24 ... Intervention: Follow Provider/Wound Care treatment and intervention orders for wound and skin ... Dates: Start: 06/02/24 ... Intervention: Consult with Wound Care for a stage 2 or greater pressure injury, an unstageable pressure injury, a deep tissue injury, or if unsure of appropriate treatment. Dates: Start: 06/02/24.” The care plan was generic and lacked patient-specific, individualized problems, goals and interventions related to the patient’s multiple changing and deteriorating skin conditions. * The patient expired on 07/02/2024. 3.b. During interview with CINS 5, DCVICU and other hospital staff on 05/07/2026 at the time of Patient 2’s medical record review the following information was provided: - The hospital staff were provided an opportunity and were unable to find documentation reflecting that an RN notified a physician or other LIP of the onset, nor worsening of the patient’s coccyx pressure injury. - The hospital staff were provided an opportunity and were unable to find documentation reflecting that an RN notified the wound care team of the worsening coccyx pressure injury. 4.a. The medical record of Patient 3 was reviewed on 05/06/2026 and 05/07/2026 with CINS 5, DCVICU, MCVICU and other hospital staff. The record reflected the patient presented to the ED by ambulance on 05/09/2025 at 2013 for chronic wounds on lower legs. * On 05/09/2025 at 2025 RN documentation reflected “Integumentary ... Skin Condition/Temp Flaky ... Right Upper Extremity Ecchymotic;Tear ... Right Lower Extremity Redness; Ecchymotic; Weeping ... Left Lower Extremity Ecchymotic; Redness;Weeping.” * On 05/09/2025 at 2026 a Provider note reflected “... concerns with worsening redness primarily to the right lower extremity when compared to the left ... has been weeping which is new ... has noted some small blisters which are also new ... Extremities ... bullae which are serous on the right lower extremity compared to the left ... right wound is consistent with superficial pressure ulcer ... There is a similar appearing pressure ulcer on the left ... Skin: No rashes or bruising noted ... Lower extremity wounds are more consistent with chronic stasis ulcers than frank cellulitis however [patient is] a poorly controlled diabetic ...” * On 05/10/2025 at 0030, an RN note reflected “... High Risk Skin Areas: Buttocks; Perineum ... Skin Color: Appropriate for ethnicity; Ruddy Skin Condition/Temp: Warm; Dry Skin Turgor: Epidermis thin with loss of subcutaneous tissue ... Right Lower Extremity: Redness; Scaling; Weeping; Other (Comment) (blisters) ... Left Lower Extremity: Scaling; Redness; Weeping; Abrasion ... Perineum: Redness ... Buttocks: Redness.” * On 05/10/2025 at 1100, an RN note reflected “RLE Edema: Moderate pitting, indentation subsides rapidly ... LLE Edema: Mild pitting, slight indentation ... Integumentary ... High Risk Skin Areas: Buttocks; Perineum ... Right Upper Extremity: Scaling; Redness; Abrasion ... Left Upper Extremity: Scaling; Redness; Abrasion ... Right Lower Extremity: Redness; Scaling; Weeping ... Left Lower Extremity: Scaling; Redness; Weeping; Abrasion ... Perineum: Redness ... Buttocks: Redness.” * On 5/11/25 at 0205 the patient was admitted to CVICU. * On 05/11/2025 at 0222 RN documentation reflected “High Risk Skin Areas ... Buttocks; Perineum; Heel (Right); Heel (Left); Coccyx ... Right Upper Extremity ... Redness; Scaling;Weeping ... Left Upper Extremity ... Scaling; Redness; Abrasion ... Right Lower Extremity ... Redness; Scaling; Weeping ... Left Lower Extremity ... Scaling; Redness; Weeping; Abrasion ... Perineum ... Redness ... Buttocks ... Redness.” There was no RN assessment of the right and left heels. There was no documentation of the specific location(s)/site(s) of the right and left lower extremities skin conditions. * On 05/12/2025 at 1337, wound care team documentation with photos of the patient’s bilateral heels and other lower extremity skin conditions included “Assessed heels and noted suspicious purple discoloration that [patient] reports painful with palpation. Skin is intact. Cleansed and applied silicone bordered foam dressing to protect ... Wound 05/12/25 Pressure Injury Heel Left; Posterior; Plantar DTIPI ... Date First Assessed/Time First Assessed: 05/12/25 1100 Present on Original Admission: Yes Primary Wound Type: Pressure Injury Location: Heel Wound Location Orientation: Left; Posterior; Plantar ...” - The documentation reflected the left heel pressure ulcer was “Present on Original Admission” However, there was no RN or wound care team assessment of the left heel pressure ulcer prior to this note as previous notes reflected only “LLE,” “Left Lower Extremity” or other unclear and vague location/site descriptions. Refer to the hospital’s pressure ulcer log in finding 4.c. below in this tag that indicates the patient was admitted with a pressure ulcer that was not assessed until 05/12/2025, three days after the patient was admitted. * Regarding “right wound ... pressure ulcer” documented by a Provider on 05/09/2025 at 2026, there was no RN or wound care team assessment, clarification, or other reference in this or subsequent RN or wound care team notes. * On 05/15/2025 at 1402 RN notes reflected the left heel pressure ulcer was “Deteriorating.” There was no documentation that reflected an RN notified a physician or other LIP that the patient’s left heel pressure ulcer was deteriorating. * A physician order dated 05/16/2025 at 1405 reflected “Left posterior heel ... Nursing to cleanse wound and periwound with normal saline and gauze. Gently dry the skin around the wound ... Apply no sting skin barrier film wipe to periwound, let dry ... Apply a double layer of xeroform over intact blister or open wound ... Cover with a silicone foam border dressing ... Nursing to change 3x per week and prn saturation/soiling. Contact physician or wound care team if wound declines, fails to progress, and any other concerns ... Frequency: Routine Q Su, Tues, Thurs ...” * On 05/17/2025 at 1452, 1640 and 2034 RN notes reflected the left heel pressure ulcer was “Deteriorating.” There was no documentation that reflected an RN notified a physician or other LIP that the patient’s left heel pressure ulcer was deteriorating. * On 05/17/2025 at 1640 RN documentation reflected both “Coccyx ... intact” and “Pressure Injury Coccyx ... Present on Original Admission: No ... Drainage Amount ... Scant ... Drainage Description ... Serous ... Treatments ... Cleansed ... Dressing ... Foam with border.” The RN documentation included an “Avatar” document with the posterior view of a full body person figure. The coccyx area on the figure had a band-aid shape indicating a skin condition present at that site. The coccyx skin documentation was unclear as it reflected on the same date and time both “intact” and “pressure ulcer.” There was no documentation that reflected an RN notified a physician or other LIP regarding the coccyx pressure ulcer. There was no documentation that reflected an RN notified the wound care team regarding the coccyx pressure ulcer, nor that the wound care team assessed the coccyx pressure ulcer. * A physician order dated 05/22/2025 at 1412 reflected “Left posterior heel ... Nursing to cleanse wound and periwound with normal saline and gauze. Gently dry the skin around the wound ... Apply no sting skin barrier film wipe to periwound, let dry ... Apply a double layer of xeroform if wound opens ... Cover with a silicone foam border dressing ... Nursing to change 3x [times] per week and prn saturation/soiling. Contact physician or wound care team if wound declines, fails to progress, and any other concerns ... Frequency: Routine Q [every] Su, Tues, Thurs 05/25/25 1300 ...” * An RN note reflected the left heel dressing was changed Thursday, 05/22/2025. The next time the left heel dressing was changed was Tuesday, 05/27/2025, 5 days later. There was no documentation that reflected the dressing was changed Sunday, 05/25/2025 in accordance with physician orders. * An RN note reflected the left heel dressing was changed Thursday, 05/29/2025. The next time the left heel dressing was changed was Tuesday, 06/03/2025, 5 days later. There was no documentation that reflected the dressing was changed Sunday, 06/01/2025 in accordance with physician orders. * The “Care Plan” with “Start” date 05/12/2025 and “Resolved:” date 05/24/2025 was nearly the same as Patient 1’s Care Plan in finding 2.a. and Patient 2’s Care Plan in finding 3.a. above in this tag. The Care Plan reflected “Problem: Compromised Skin Integrity ... Disciplines: Interdisciplinary ... Goal: Skin integrity is maintained or improved ... Intervention: Perform a comprehensive risk assessment and Braden risk assessment per policy (Completed) ... Dates: Start: 05/12/25 End: 05/24/25 ... Intervention: Follow Pressure Injury Care Bundle per policy (Completed) ... Dates: Start: 05/12/25 End: 05/24/25 ... Intervention: Follow Provider/Wound Care treatment and intervention orders for wound and skin (Completed).” The care plan was generic and lacked patient-specific, individualized problems, goals and interventions related to the patient’s multiple changing and deteriorating skin conditions. * The patient discharged to a skilled nursing facility on 06/04/2025. 4.b. During interview with CINS 5, DCVICU and other hospital staff on 05/07/2026 at the time of Patient 3’s medical record review the following information was provided: * CINS 5 confirmed there was no documentation that reflected an RN assessment of the patient’s left heel pressure ulcer prior to 05/12/2025. The DCVICU stated “They don’t get down to that detail.” * The staff confirmed there was no documentation that an RN notified the physician that the patient’s left heel pressure ulcer was deteriorating on 05/15/2025, 05/16/2025 and 05/17/2025. CINS 5 stated “That is correct.” * CINS 5 confirmed there was no documentation that reflected an RN notified a physician, other LIP or the wound care team regarding the coccyx pressure ulcer. * MCVICU confirmed there was no documentation that reflected the wound care team assessed the patient’s coccyx pressure ulcer. DCVICU stated “I’m not finding anything in the notes. I don’t recall seeing a wound care consult for this.” * CINS 5 confirmed the lack of documentation of left heel dressing changes in accordance with physician orders. 4.c. Regarding Patient 3, review of the hospital’s pressure ulcer log titled “CVICU Skin Breakdown Incidents- 1.1.24 - 5.6.26” reflected: * “Comments ... 5/12/2025 2:26 PM ... Left heel with non-blanching purple discoloration ... Event Date ... 05/12/2025 ... Location ... CVICU ... Event Type ... Skin Integrity, Pressure Ulcer Not Present on Admission ... Outcome ... Pressure Injury, Deep Tissue Injury ...” * “Comments ... 05/12/2025 2:30 PM Heels resting on bed. Assessment noted purple non-blanching discoloration with pain on palpation ... Event Date ... 05/12/2025 ... Location ... CVICU ... Event Type ... Skin Integrity, Pressure Ulcer Not Present on Admission ... Outcome ... Pressure Injury, Deep Tissue Injury ...” 5. RN staff failed to ensure physicians took responsibility for the increased risk of transfusing uncrossmatched blood by obtaining physician signatures on the Transfusion Records as required by hospital policy and procedure. Refer to findings 5.a. through 12 below in this tag. 5.a. The “Blood Band and Transfusion Services - Operational Plan - ARRMC” dated effective 08/02/2023 states that “In emergency situations, uncrossmatched blood can be released ... The use of uncrossmatched blood carries a higher risk to the patient, and the physician ordering the blood under these circumstances must take the responsibility for this increased risk by signing the paper Transfusion Record that accompanies the uncrossmatched blood unit ... It is the responsibility of Nursing staff to ensure the physician has signed the Transfusion Record accompanying the unit ...” 6.a. Incident report documentation for ED Patient 10 was reviewed and reflected: * On 11/26/2024 the patient was transfused a unit of uncrossmatched blood. “Unit [number] was transfused uncrossmatched to patient. Per FDA regulations each unit transfused must be reviewed and signed for by a physician. Asante policy states the transfusing RN is responsible for obtaining physician signature on paper transfusion record and sending to Medical Records to be placed in the patient chart. A retrospective review determined documentation was missing for this unit. Blood Bank retrospectively obtained a physician signature and placed documentation in patient chart to ensure regulatory compliance ...” * The date the incident report was received was 11/05/2025, more than 11 months after the blood transfusion occurred. * “Why did this event occur and how could it have been [prevented] ... RN and physician did not complete uncrossmatched transfusion chart signature requirements per FDA and Asante policy.” * An entry dated 11/07/2025 reflected “Response(s) to above ... A message has been sent to the team members, education is currently taking place, and this has been added to both provider and nursing staff meetings. For the specific lab related events that are reported over and over and over again, utilizing cut and paste, I feel like there could be a better way to report these. Taking the time to fill out the Midas and questions are not applicable and do not add value with each and every event is not the best use of time. We could be utilizing these hours to address a solution to the problem. When there are multiple events to address from the same documentation issue it would be of benefit from our perspective, to communicate to [sic] that of [sic] to the department directly and allow them some time to fix before reporting in mass bundles. The time it takes to respond to each of these events without allowing time for a solution and implementation seems counterproductive when compared to the man-hours it takes to address incomplete [sic] each of these events individually. I would like to highly encouraged [sic] utilizing a different process going forward.” * “Was this event preventable?: “[Yes].” * “Was there a deviation from generally accepted performance: [Yes].” * “Contributing Factor(s): Policy/Procedure/Protocol Not Followed.” * “Possible Trend?: [Yes] ... Trend Type ... provider signature not obtained on transfusion paperwork.” There was no documentation that reflected RN staff obtained the required physician signature on the Transfusion Record, identified the physician signature gap; and completed a timely incident report, investigation and corrective action. 6.b. Incident documentation involving Patient 10 reflected another (second) unit of uncrossmatched blood was transfused on 11/26/2024. The date the incident report was received was 11/05/2025. There was no documentation that reflected RN staff obtained the required physician signature on the Transfusion Record, identified the physician signature gap; and completed a timely incident report, investigation and corrective action. 7.a. Incident report documentation for ED Patient 8 was reviewed and reflected: * On 03/25/2025 the patient was transfused a unit of uncrossmatched blood. “Unit [number] was transfused uncrossmatched to patient. Per FDA regulations each unit transfused must be reviewed and signed for by a physician. Asante policy states the transfusing RN is responsible for obtaining physician signature on paper transfusion record and sending to Medical Records to be placed in the patient chart. A retrospective review determined documentation was missing for this unit. Blood Bank retrospectively obtained a physician signature and placed documentation in patient chart to ensure regulatory compliance ...” * The date the incident report was received was 09/29/2025, 6 months after the blood transfusion occurred. * “Why did this event occur and how could it have been [prevented] ... RN and physician did not complete uncrossmatched transfusion chart signature requirements per FDA and Asante policy.” * “Outcomes: Unknown.” * An entry dated 10/01/2025 reflected “Response(s) to above ... Emergent situation, appreciate Blood Banks [sic] support to help gather the signature after this emergent life threat to the pt was [sic] stabilized. We have 20ish of these just submitted, will educate staff and place in department huddle for awareness. Is this a recent change? Unusual we would all of a sudden have this amount reported all at once. It may be more efficient and a better use of time to report these as a cluster instead of requiring an individual response for the great amount of reports that were batched and entered at the same time.” * “Was this event preventable?: “[Yes].” * “Was there a deviation from generally accepted performance: [Yes].” * “Contributing Factor(s): Policy/Procedure/Protocol Not Followed.” * “Possible Trend?: [Yes] ... Trend Type ... provider signature not obtained on transfusion paperwork.” There was no documentation that reflected RN staff obtained the required physician signature on the Transfusion Record, identified the physician signature gap; and completed a timely incident report, investigation and corrective action. 8.a. Incident documentation for ED Patient 5 was reviewed and reflected: * On 05/25/2025 the patient was transfused a unit of uncrossmatched blood. The documentation reflected “Unit [number] was transfused uncrossmatched to patient. Per FDA regulations each unit transfused must be reviewed and signed for by a physician. Asante policy states the transfusing RN is responsible for obtaining physician signature on paper transfusion record and sending to Medical Records to be placed in the patient chart. A retrospective review determined documentation was missing for this unit. Blood Bank retrospectively obtained a physician signature and placed documentation in patient chart to ensure regulatory compliance ...” The documentation included: * Incident report received date 9/29/2025, 4 months after the blood transfusion occurred. * “Why did this event occur and how could it have been [prevented]” RN and physician did not complete uncrossmatched transfusion chart signature requirements per FDA and Asante policy.” * “Outcomes: Unknown.” * An entry dated 11/11/2025, “Response(s) to above ... A message has been sent to the team members, education is currently taking place, and this has been added to both provider and nursing staff meetings. For the specific lab related events that are reported over and over and over again, utilizing cut and paste, I feel like there could be a better way to report these. Taking the time to fill out the Midas and questions are not applicable and do not add value with each and every event is not the best use of time. We could be utilizing these hours to address a solution to the problem. When there are multiple events to address from the same documentation issue it would be of benefit from our perspective, to communicate to [sic] that of [sic] to the department directly and allow them some time to fix before reporting in mass bundles. The time it takes to respond to each of these events without allowing time for a solution and implementation seems counterproductive when compared to the man-hours it takes to address incomplete [sic] each of these events individually. I would like to highly encouraged [sic] utilizing a different process going forward.” * “Was this event preventable?: [Yes]” * “Was there a deviation from generally accepted performance: [Yes].” * “Contributing Factor(s): Policy/Procedure/Protocol Not Followed.” * “Possible Trend?: [Yes] ... Trend Type ... provider signature not obtained on transfusion paperwork.” There was no documentation that reflected RN staff obtained the required physician signature on the Transfusion Record, identified the physician signature gap; and completed a timely incident report, investigation and corrective action. 8.b. Incident documentation for ED Patient 5 was reviewed and reflected: * On 05/25/2025 the patient was transfused another (second) unit of uncrossmatched blood. * “Unit [number] was transfused uncrossmatched to patient. Per FDA regulations each unit transfused must be reviewed and signed for by a physician. Asante policy states the transfusing RN is responsible for obtaining physician signature on paper transfusion record and sending to Medical Records to be placed in the patient chart. A retrospective review determined documentation was missing for this unit. Blood Bank retrospectively obtained a physician signature and placed documentation in patient chart to ensure regulatory compliance ...” * The incident report received date was 9/29/2025, 4 months after the blood transfusion occurred. * “Why did this event occur and how could it have been [prevented] ... RN and physician did not complete uncrossmatched transfusion chart signature requirements per FDA and Asante policy.” * “Outcomes: Unknown.” * “Emergent situation, appreciate Blood Banks [sic] support to help gather the signature after this emergent life threat to the pt was [sic] stabilized. We have 20ish of these just submitted, will educate staff and place in department huddle for awareness. Is this a recent change? Unusual we would all of a sudden have this amount reported all at once. It may be more efficient and a better use of time to report these as a cluster instead of requiring an individual response for the great amount of reports that were batched and entered at the same time.” * “Was this event preventable?: [Yes].” * “Was there a deviation from generally accepted performance: [Yes].” * “Contributing Factor(s): Policy/Procedure/Protocol Not Followed.” * “Possible Trend?: [Yes] ... Trend Type ... provider signature not obtained on transfusion paperwork.” There was no documentation that reflected RN staff obtained the required physician signature on the Transfusion Record, identified the physician signature gap; and completed a timely incident report, investigation and corrective action. 9.a. Incident documentation for ED Patient 9 was reviewed and reflected: * On 06/14/2025 the patient was transfused a unit of uncrossmatched blood. * The incident report received date was 11/05/2025, 5 months after the blood transfusion occurred. * “Unit [number] was transfused uncrossmatched to patient. Per FDA regulations each unit transfused must be reviewed and signed for by a physician. Asante policy states the transfusing RN is responsible for obtaining physician signature on paper transfusion record and sending to Medical Records to be placed in the patient chart. A retrospective review determined documentation was missing for this unit. Blood Bank retrospectively obtained a physician signature and placed documentation in patient chart to ensure regulatory compliance ...” * “Outcomes: No Adverse Outcome.” * Sections “Why did this event occur ... Was this event preventable ... Was there a deviation from generally accepted performance ... Contributing Factor(s) ... Possible Trend? ... Trend Type ... Response to above ...” were the same as finding 8.a. above in this tag regarding ED Patient 5. 9.b. Incident documentation for ED Patient 9 was reviewed and reflected: * On 06/14/2025 the patient was transfused another (second) unit of uncrossmatched blood. * The incident report received date was 11/05/2025, 5 months after the blood transfusion occurred. * “Unit [number] was transfused uncrossmatched to patient. Per FDA regulations each unit transfused must be reviewed and signed for by a physician. Asante policy states the transfusing RN is responsible for obtaining the physician signature on paper transfusion record ... documentation was missing from this unit ...” * “Outcomes: No Adverse Outcome.” * Sections “Why did this event occur ... Was this event preventable ... Was there a deviation from generally accepted performance ... Contributing Factor(s) ... Possible Trend? ... Trend Type ... Response to above ...” were the same as finding 8.a. above in this tag regarding ED Patient 5. 9.c. Incident documentation for ED Patient 9 was reviewed and reflected: * On 06/14/2025 the patient was transfused another (third) unit of uncrossmatched blood. * The incident report received date was 11/05/2025. * “Unit [number] was transfused uncrossmatched to patient. Per FDA regulations each unit transfused must be reviewed and signed for by a physician. Asante policy states the transfusing RN is responsible for obtaining physician signature on paper transfusion record ... documentation was missing from this unit ...” * “Outcomes: No Adverse Outcome.” * Sections “Why did this event occur ... Was this event preventable ... Was there a deviation from generally accepted performance ... Contributing Factor(s) ... Possible Trend? ... Trend Type ... Response to above ...” were the same as finding 8.a. above in this tag regarding ED Patient 5. 9.d. Regarding ED Patient 9, there was no documentation that reflected RN staff obtained required signatures on the Transfusion Records, identified the physician signature gaps; and completed timely incident reports, investigations and corrective actions. 10.a. Incident documentation for ED Patient 7 was reviewed and reflected: * On 06/22/2025 the patient was transfused a unit of uncrossmatched blood. * The incident report received date was 11/05/2025, more than 4 months after the blood transfusion occurred. * “Unit [number] was transfused uncrossmatched to patient. Per FDA regulations each unit transfused must be reviewed and signed for by a physician. Asante policy states the transfusing RN is responsible for obtaining physician signature on paper transfusion record ... documentation was missing from this unit ...” * “Outcomes: No Adverse Outcome.” * “Why did this event occur ...”, “Was this event preventable ...”, “Was there a deviation from generally accepted performance ...”, “Contributing Factor(s) ...”, “Possible Trend? ...”, “Trend Type ...” and “Response to above ...” were the same as finding 8.a. above in this tag regarding ED Patient 5. 10.b. Regarding ED Patient 7, there was no documentation that reflected RN staff obtained required signatures on the Transfusion Records, identified the physician signature gaps; and completed timely incident reports, investigations and corrective actions. 11.a. Incident documentation for ED Patient 6 was reviewed and reflected: * On 07/25/2025 the patient was transfused a unit of uncrossmatched blood. * The incident report received date was 11/05/2025, more than 3 months after the blood transfusion occurred. * “Unit [number] was transfused uncrossmatched to patient. Per FDA regulations each unit transfused must be reviewed and signed for by a physician. Asante policy states the transfusing RN is responsible for obtaining physician signature on paper transfusion record ... documentation was missing from this unit ...” * “Outcomes: No Adverse Outcome.” * An entry dated 11/07/2025, “This message was provided to the provider and [sic] fault for education as well as the medical director for the emergency department who is adding it to the staff meeting agenda for the providers.” * Sections “Why did this event occur ... Was this event preventable ... Was there a deviation from generally accepted performance ... Contributing Factor(s) ... Possible Trend? ... Trend Type ...” were the same as finding 8.a. above in this tag regarding ED Patient 5. 11.b. Regarding ED Patient 6, there was no documentation that reflected RN staff obtained the required signatures on the Transfusion Records, identified the physician signature gaps; and completed timely incident reports, investigations and corrective actions. 12. Similar findings were identified regarding Patients 11 and 12. Review of uncrossmatched blood transfusion documentation reflected RN staff failed to ensure physicians took responsibility for the increased risk of transfusing uncrossmatched blood by ensuring a physician signed a Transfusion Record for each unit as required by hospital policy: * Regarding ED Patient 11: The patient received a unit of uncrossmatched blood on 08/02/2025. Incident documentation was initiated 11/05/2025, 3 months later. There was no documentation that reflected RN staff obtained the required signatures on the Transfusion Records, identified the physician signature gaps; and completed timely incident reports, investigations and corrective actions. * Regarding CVICU Patient 12. The patient received 2 units of uncrossmatched blood on 09/02/2025. Incident documentation was initiated 11/05/2025, 3 months later. There was no documentation that reflected RN staff obtained required signatures on the Transfusion Records, identified the physician signature gaps; and completed timely incident reports, investigations and corrective actions.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 29708 Based on interviews, review of medical record documentation for 3 of 3 CVICU patients who acquired skin conditions during their hospital encounter (Patients 1, 2 and 3), review of policies and procedures, and review of other documentation, it was determined the hospital failed to ensure the RN developed and kept current a nursing care plan that included goals, nursing care, and interventions to be provided based on an assessment of the patients’ individualized and patient specific needs. Findings include: 1. The nursing policy and procedure titled “Pressure Injury Prevention/ Interventions, Guidelines, & Documentation; Braden Scale (ASANTE),” dated effective 07/10/2024 was reviewed and reflected: * “Nurses ... Responsible for comprehensive skin assessment, focused skin assessment ... pressure injury prevention interventions, and care planning around prevention or healing ... Documentation in the EMR.” * “The bedside nurse is to ensure the following is communicated during handoff and documented within 4 hours of admission, once a shift, and upon transfer to another unit, change in level of care, or change in patient condition ... Pressure Injury Prevention Care Plan as needed ...” 2. Regarding Patients 1, 2, and 3, refer to the findings cited under Tag A395, CFR 482.23(b)(3), CoP Nursing Services - Standard: RN supervision and evaluation of nursing care that reflects a lack of patient specific individualized nursing care plans. 2.a. Patient 1, admitted 05/31/2025 and expired 07/16/2026, had numerous skin conditions that were not present on admission. Those include necrotic toes, tibia skin tear, and anterior neck pressure ulcer. The nursing care plan lacked patient specific, individualized problems, goals and interventions based on an RN assessment of the patient’s skin conditions. 2.b. Patient 2, admitted 05/13/2024 and expired 07/02/2024, had numerous skin conditions that were not present on admission including trach area pressure ulcer, anal wound, and coccyx deep tissue pressure ulcer. The nursing care plan lacked patient specific, individualized problems, goals and interventions based on an RN assessment of the patient’s skin conditions. 2.c. Patient 3, admitted 05/09/2025 and discharged 06/06/2025, had numerous skin conditions including but not limited to coccyx pressure ulcer, buttocks redness, perineal redness, lower extremity blisters and stasis ulcers, and left heel pressure ulcer. Some of those skin conditions were not present on admission. The nursing care plan lacked patient specific, individualized problems, goals and interventions based on an RN assessment of the patient’s skin conditions.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1-32 and 34-46), review of pharmacy audit documentation, review of education/training records for 8 of 8 ICU nursing staff (Employees 1-8), review of hospital P&Ps, and review of other documentation, it was determined that the governing body failed to ensure the provision of safe and appropriate care to patients in the hospital in a manner that complied with all Conditions of Participation. The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the hospital to provide safe and adequate care. Findings include: 1. Refer to the findings cited at Condition Tag A-115 under CFR 482.13 - CoP: Patient’s Rights. Those findings reflect the hospital’s failure to ensure each patient’s rights were protected and promoted, including the right to receive care in a safe setting; failure to ensure proactive, diligent and timely responses to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients; failure to fully develop and implement effective systems and P&Ps that ensured fentanyl and other CS were accurately accounted for and documented (A-144); and failure to ensure incidents involving improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to ensure safe care and prevent recurrence for affected patients and others (Tags A144 and A-145). 2. Refer to the findings cited at Condition Tag A-263 under CFR 482.21 - CoP: QAPI. Those findings reflect the hospital’s governing body failed to develop and implement an effective, ongoing, hospital-wide QAPI Program including failure to ensure potential drug diversion and other related medication events were investigated and integrated into the hospital’s QAPI Program in a manner that was effective and identified and addressed new problems and opportunities for continuous improvement (Tag A-491); failure to ensure the QAPI and IPC Programs communicated and collaborated on emerging IPC issues (Tag A-774); and failure to ensure the IPC Program considered issues that were localized to ARRMC, a single separately certified hospital, and that those individualized issues were identified and addressed in collaboration with the hospital’s QAPI Program as concerns unique to that hospital (Tag A-788). 3. Refer to the findings cited at Condition Tag A-385 under CFR 482.23 - CoP: Nursing Services. Those findings reflect the hospital’s failure to ensure that the nursing services were organized and managed to ensure the provision of safe and appropriate care to each patient in the hospital including failure to ensure an RN supervised and evaluated the nursing care of each patient. This included failure to proactively, diligently and timely report and respond to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients; and leaving critically ill, unstable ventilated patients unattended (Tag A-395); failure to ensure incidents involving improper narcotic handling, an ICU nurse’s behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to ensure safe care and prevent recurrence for affected patients and others (Tag A-145); failure to ensure the DNS provided adequate supervision and evaluation of the hospital’s nursing staff including ensuring nursing staff adhered to P&Ps in response to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients; failure to ensure performance evaluations and new hire reference checks were completed in accordance with the hospital’s P&Ps and required processes; failure to investigate and prevent recurrence of incidents involving improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents; and failure to prevent unaccounted for and undocumented CS (Tag A-398). 4. Refer to the findings cited at Condition Tag A-489 under CFR 482.25 - CoP: Pharmaceutical Services. Those findings reflect the hospital’s failure to ensure the hospital and medical staff developed and implemented effective P&Ps that minimized drug diversion and drug errors involving fentanyl and other CS creating the risk for patient harm. This included failure to ensure proactive, diligent and timely efforts to detect and address activities suspicious for drug diversion involving IV fentanyl and other CS that created the risk for patient infections and other patient safety events (Tags A-144 and A-491); failure to develop and implement effective P&Ps regarding wasting and accounting for IV fentanyl and other CS; and failure to ensure nursing staff were trained and had demonstrated competency for accurate accounting for and wasting of IV fentanyl and other CS (Tag A-491); failure to ensure incidents suspicious for drug diversion and other medication related incidents were investigated, analyzed, and integrated into the QAPI Program in a manner that was effective and identified opportunities for continuous improvement (Tag A-491); failure to ensure instances of unaccounted for and undocumented IV fentanyl were investigated, accounted for, reconciled, and discrepancies resolved (A-494); and failure to develop and implement P&Ps that ensured timely and accurate accounting for and documentation of IV fentanyl and other CS including situations that involved infusion rate changes, boluses, and waste procedures (Tag A-494). 5. Refer to the findings cited at Condition Tag A-747 under CFR 482.42 - CoP: IPC and Antibiotic Stewardship Programs. Those findings reflect the hospital’s failure to fully develop and implement an effective hospital-wide IPC Program and systems for surveillance, prevention, and control of HAIs and other infectious diseases including failure to identify an infection preventionist/infection control professional responsible for the IPC Program; and to ensure the governing body appointed an infection preventionist/infection control professional (Tag A-748); failure to ensure a clean and sanitary environment; to implement recommendations made by the state public health authority; to ensure infections and outbreaks were detected, investigated and controlled; to ensure that the IPC Program reflected the scope and complexity of the hospital’s services, was hospital-wide and unique to the hospital’s environment, and evaluated the IPC Program on an ongoing basis and responded to changes (Tag A-751); failure to ensure the IPC Program and P&Ps were consistent with nationally recognized guidelines including collaboration with the pharmacy department on safe injection practices, including IV drug diversion; considered IPC responsibilities including detection, investigation, monitoring and reporting requirements during an outbreak; and mitigated the risk of infection for patients exposed to IC breaches (Tag A-772); failure to ensure the IPC Program communicated and collaborated with QAPI on IPC issues. (Tag A-774); failure to ensure the IPC Program audited staff adherence to IPC P&Ps; and considered IPC responsibilities in adhering to nationally recognized guidelines including responses to breaches in safe injection practices and drug diversion, and ensuring mitigation strategies for outbreaks were followed (Tag A-776); failure to ensure its unified IPC Program established and implemented P&Ps that addressed the needs and concerns of each separately certified hospital, and failed to consider the unique practices and locations of each hospital (Tag A-787); and failure to ensure its unified IPC Program considered issues that were localized to a single separately certified hospital, and that those individualized issues were identified and addressed in collaboration with QAPI as concerns unique to that particular hospital (Tag A-788).”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28 and 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1-32 and 34-46), review of education/training records for 8 of 8 ICU nursing staff (Employees 1-8), review of pharmacy audit documentation, review of hospital P&Ps, and review of other documentation, it was determined the hospital failed to ensure each patient’s rights were protected and promoted, including the right to receive care in a safe setting, and the right to freedom from all forms of abuse and neglect. Those failures contributed to patient harm and created the likelihood of harm to other patients. The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the hospital to provide safe and adequate care. Findings include: 1. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety that reflects the hospital’s failure to fully develop and implement clearly written P&Ps and staff training to ensure each patient’s right to receive care in a safe setting. Failures included: * Failure to ensure proactive, diligent and timely responses to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients. Behaviors and activities were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. * Failure to fully develop and implement effective systems and P&Ps that ensured fentanyl and other CS were accurately accounted for and documented in a timely manner creating the risk for drug diversion and patient harm including: - Waste processes involving infusion tubing and bags were not developed and implemented. - Processes involving infusion rate changes and boluses were not developed and implemented. - Training/education materials were not developed to ensure nursing staff were educated on and had demonstrated competency for accurate accounting and wasting of IV fentanyl and other CS; and nursing staff had not been trained to accurately account for CS. - Instances of suspected drug diversion were not reported to the RRDT, through the hospital’s incident reporting system, and to hospital leadership in accordance with P&Ps. * Failure to ensure improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to prevent recurrence for affected patients and others. 2. Refer to the findings cited at Tag A-145 under CFR 482.13(c)(3) - Standard: Privacy and Safety that reflects the hospital failed to ensure incidents involving improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to ensure safe care and prevent recurrence for affected patients and others.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1-32 and 34-46), review of education/training records for 8 of 8 ICU nursing staff (Employees 1-8), review of QAPI documentation, review of hospital P&Ps, review of pharmacy audit documentation, and review of other documentation, it was determined the hospital’s governing body failed to develop and implement an effective, ongoing, hospital-wide QAPI Program that reflected the complexity of the hospital’s organization and services, that focused on improved health outcomes, prevention and reduction of medical errors, and safe patient care. Failures included: * Failures to ensure potential drug diversion and other medication related events that reflected potential abuse and neglect were investigated and integrated into the hospital’s QAPI Program in a manner that was effective and identified and addressed new problems and opportunities for continuous improvement. * Failures to ensure the QAPI and IPC Programs communicated and collaborated on emerging IPC issues. * Failures to ensure the IPC Program considered issues that were localized to ARRMC, a single separately certified hospital, and that those individualized issues were identified and addressed in collaboration with the hospital’s QAPI Program as concerns unique to that hospital. The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the hospital to provide safe and adequate care. Findings include: 1. Refer to the findings cited under Tag A-491 at CFR 482.25(a) - Standard: Pharmacy Management and Administration that reflects the hospital’s failure to ensure proactive, diligent, and timely efforts to detect and address activities suspicious for drug diversion; and ensure incidents suspicious for drug diversion, and other medication related events that reflected potential abuse and neglect were investigated in a timely manner, analyzed, and integrated into the QAPI Program in a manner that was effective and identified and addressed opportunities for continuous improvement and refinement of P&Ps. 2. Refer to the findings cited under Tag A-774 at CFR 482.42(c)(2)(iii) - Standard: Leadership Responsibilities that reflects the hospital failed to ensure the IPC Program communicated and collaborated with the QAPI Program on emerging IPC issues. 3. Refer to the findings cited under Tag A-788 at CFR 482.42(d)(3) - Standard: Unified and Integrated Infection Prevention and Control for Multi-hospital Systems that reflects the hospital failed to ensure its unified IPC Program considered issues that were localized to a single separately certified hospital, and that those individualized issues were identified and addressed in collaboration with the QAPI Program as concerns unique to that particular hospital.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of patient lists for 45 of 45 ICU patients (Patients 1-32 and 34-46), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of education/training records for 8 of 8 ICU nursing staff (Employees 1- 8), review of hospital P&Ps, and review of other documentation, it was determined that the hospital failed to ensure that the nursing services were organized and managed to ensure the provision of safe and appropriate care of each patient in the hospital. Failures included: * Failure to ensure an RN supervised and evaluated the nursing care of each patient including failure to proactively, diligently and timely respond to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns; and failure to ensure critically ill, unstable ventilated patients were not left unattended. * Failure to ensure incidents involving improper narcotic handling, an ICU nurse’s behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to ensure safe care and prevent recurrence for affected patients and others. * Failure to ensure the DNS provided adequate supervision and evaluation of the hospital’s nursing staff that was within the responsibility of the nursing service to ensure the provision of safe and appropriate care. Failures included ensuring nursing staff adhered to P&Ps in response to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns; failure to ensure performance evaluations and new hire reference checks were completed; failure to prevent recurrence of incidents involving improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents; and failure to prevent unaccounted for and undocumented CS. The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the hospital to provide safe and adequate care. Findings include: 1. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety that reflects the hospital’s failure to fully develop and implement clearly written P&Ps and staff training to ensure each patient’s right to receive care in a safe setting. Failures included: * Failure to ensure proactive, diligent and timely responses to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients. Behaviors and activities were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. * Failure to fully develop and implement effective systems and P&Ps that ensured fentanyl and other CS were accurately accounted for and documented in a timely manner creating the risk for drug diversion and patient harm: - Waste processes involving infusion tubing and bags were not developed and implemented. - Processes involving infusion rate changes and boluses were not developed and implemented. - Training/education materials were not developed to ensure nursing staff were educated on and had demonstrated competency for accurate accounting and wasting of IV fentanyl and other CS; and nursing staff had not been trained to accurately account for CS. - Instances of suspected drug diversion were not reported to the RRDT, through the hospital’s incident reporting system, and to hospital leadership in accordance with P&Ps. * Failure to ensure improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to prevent recurrence for affected patients and others. 2. Refer to the findings cited at Tag A-145 under CFR 482.13(c)(3) - Standard: Privacy and Safety that reflects the hospital failed to ensure incidents involving improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to ensure safe care and prevent recurrence for affected patients and others. 3. Refer to the findings cited at Tag A-395 under CFR 482.23(b)(3) - Standard: Staffing and Delivery of Care that reflects the hospital failed to ensure RNs supervised and evaluated the nursing care of each patient, and care and services were provided in a manner that ensured the ongoing health and safety of the hospital’s ICU patients and other patients including failure to prevent nursing staff from leaving critically ill, unstable ventilated ICU patients and other patients unattended creating the risk for patient harm; and failure to ensure nursing staff proactively,diligently and timely reported and responded to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns involving multiple patients in accordance with P&Ps. 4. Refer to the findings cited at Tag A-398 under CFR 482.23(b)(6) - Standard: Staffing and Delivery of Care that reflects the hospital failed to ensure the DNS provided adequate supervision and evaluation of the hospital’s nursing staff within the responsibility of the nursing service including failure to ensure staff adhered to the hospital’s Fit for Duty, RRDT, incident reporting and other P&Ps in response to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients; failure to ensure new hire reference checks were conducted in accordance with the hospital’s required processes; failure to ensure performance evaluations were conducted annually in accordance with hospital P&Ps; failure to recognize and address performance and behavior concerns during performance evaluations in accordance with hospital P&Ps; failure to investigate and prevent recurrence of incidents involving improper narcotic handling, behaviors and activities suspicious for drug diversion and impairment, and other medication related incidents in ICU and other units, including those involving traveler RNs in accordance with hospital P&Ps; and failure to prevent unaccounted for and undocumented IV fentanyl and other CS.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1- 32 and 34 - 46), review of pharmacy audit documentation for 34 of 34 patients (Patients 1-32, 37 and 63), review of education/training records for 8 of 8 ICU nursing staff (Employees 1-8), review of education/training materials, review of pharmacy audit documentation, review of P&Ps, and review of other documentation, it was determined the hospital failed to ensure the pharmaceutical service developed and implemented effective P&Ps that minimized drug diversion and drug errors involving fentanyl and other CS creating the risk for patient harm including infections. Failures included: * Failure to ensure proactive, diligent and timely efforts to detect and address activities suspicious for drug diversion involving IV fentanyl and other CS that created the risk for patient infections and other patient safety events. * Failure to develop and implement effective P&Ps regarding wasting and accounting for IV fentanyl and other CS; and failure to ensure nursing staff were trained and had demonstrated competency for accurate accounting for and wasting of IV fentanyl and other CS. * Failure to ensure incidents suspicious for drug diversion and other medication related incidents that reflected potential abuse and neglect were investigated, analyzed, and integrated into the QAPI Program in a manner that was effective and identified opportunities for continuous improvement. * Failure to ensure instances of unaccounted for and undocumented IV fentanyl were investigated, accounted for, reconciled and discrepancies resolved. * Failure to develop and implement P&Ps that ensured timely and accurate accounting for and documentation of IV fentanyl and other CS including situations that involved infusion rate changes, boluses, and waste procedures. The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the hospital to provide safe and adequate care. Findings include: 1. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety that reflects the hospital’s failure to fully develop and implement clearly written P&Ps and staff training to ensure each patient’s right to receive care in a safe setting. Failures included: * Failure to ensure proactive, diligent and timely responses to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients. Behaviors and activities were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. * Failure to fully develop and implement effective systems and P&Ps that ensured fentanyl and other CS were accurately accounted for and documented in a timely manner creating the risk for drug diversion and patient harm: - Waste processes involving infusion tubing and bags were not developed and implemented. - Processes involving infusion rate changes and boluses were not developed and implemented. - Training/education materials were not developed to ensure nursing staff were educated on and had demonstrated competency for accurate accounting and wasting of IV fentanyl and other CS; and nursing staff had not been trained to accurately account for CS. - Instances of suspected drug diversion were not reported to the RRDT, through the hospital’s incident reporting system, and to hospital leadership in accordance with P&Ps. * Failure to ensure improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to prevent recurrence for affected patients and others. 2. Refer to the findings cited at Tag A-491 under CFR 482.25(a) - Standard: Pharmacy Management and Administration. Those findings reflect the hospital’s failure to ensure pharmaceutical P&Ps were fully developed, implemented, effective and in accordance with professional principles including failure to ensure proactive, diligent, and timely efforts to detect and address activities suspicious for drug diversion involving IV fentanyl and other CS that created the risk for patient infections and other adverse events; failure to develop and implement clearly written P&Ps regarding wasting and accounting for IV fentanyl and other CS that created the risk of diversion and patient harm; failure to ensure staff were trained and had demonstrated competency for accounting and wasting IV fentanyl and other CS in accordance with hospital P&Ps; and failure to ensure incidents suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect were investigated and analyzed in a timely manner, trends detected, and integrated into the hospital’s QAPI program in a manner that was effective and identified new problems and opportunities for continuous improvement, and refinement of P&Ps. 3. Refer to the findings cited at Tag A-494 under CFR 48225(a)(3) - Standard: Pharmacy Management and Administration. Those findings reflect the hospital’s failure to develop and implement effective P&Ps that minimized drug diversion and ensured current and accurate records of IV fentanyl and other CS were maintained; failure to ensure IV fentanyl and other CS were accounted for, reconciled and discrepancies resolved including but not limited to situations involving infusion rate changes, boluses, and waste that created the risk for diversion and patient harm; and failure to proactively and diligently identify, investigate and respond to behaviors and activities suspicious for drug diversion.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of patient lists and other documentation for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1-32 and 34-46), review of IPC Program documentation, review of hospital P&Ps, and review of other documentation, it was determined the hospital failed to fully develop and implement an effective hospital-wide IPC Program and systems for surveillance, prevention, and control of HAIs and other infectious diseases. Failures included: * Failure to identify an infection preventionist/infection control professional responsible for the IPC Program; and to ensure the governing body appointed an infection preventionist/infection control professional. * Failure to ensure a clean and sanitary environment; to implement recommendations made by the state public health authority; to ensure infections and outbreaks were detected, investigated and controlled; to ensure that the IPC Program reflected the scope and complexity of the hospital’s services, was hospital-wide and unique to the hospital’s environment, and evaluated the IPC Program on an ongoing basis and responded to changes. * Failure to ensure the IPC Program and P&Ps were consistent with nationally recognized guidelines including collaboration with the pharmacy department on safe injection practices, including IV drug diversion; considered IPC responsibilities including detection, investigation, monitoring and reporting requirements during an outbreak; and mitigated the risk of infection for patients exposed to IC breaches. * Failure to ensure the IPC Program communicated and collaborated with QAPI on IPC issues. * Failure to ensure the IPC Program audited staff adherence to IPC P&Ps; and considered IPC responsibilities in adhering to nationally recognized guidelines including responses to breaches in safe injection practices and drug diversion, and ensuring mitigation strategies for outbreaks were followed. * Failure to ensure its unified IPC Program established and implemented P&Ps that addressed the needs and concerns of each separately certified hospital, and failed to consider the unique practices and locations of each hospital. * Failure to ensure its unified IPC Program considered issues that were localized to a single separately certified hospital, and that those individualized issues were identified and addressed in collaboration with QAPI as concerns unique to that particular hospital. The cumulative effect of these systemic failures resulted in this Condition-level deficiency that represents a limited capacity on the part of the hospital to provide safe and adequate care. Findings include: 1. Refer to the findings cited under Tag A-748 at CFR 482.42(a)(1) - Standard: Infection Prevention and Control Program, Organization and Policies that reflects the hospital failed to identify an infection preventionist(s)/infection control professional(s) and the governing body failed to appoint an infection preventionist(s)/infection control professional(s) responsible for the IPC Program. 2. Refer to the findings cited at Tag A-750 under CFR 482.42(a)(3) - Standard: Infection Prevention and Control Program, Organization and Policies that reflects the hospital failed to ensure a clean and sanitary environment, that recommendations made by the state public health authority were implemented, and that infections and outbreaks were detected, investigated and controlled. 3. Refer to the findings cited at Tag A-751 under CFR 482.42(a)(4) - Standard: Infection Prevention and Control Program, Organization and Policies that reflects the hospital failed to ensure that the IPC Program reflected the scope and complexity of the hospital’s services, was hospital-wide and unique to the hospital’s environment, evaluated the IPC Program on an ongoing basis and responded to changes. 4. Refer to the findings cited at Tag A-772 under CFR 482.42 - (c)(2)(i) - Standard: Leadership Responsibilities that reflects the hospital failed to ensure the IPC Program and P&Ps were consistent with nationally recognized guidelines and collaborated with the pharmacy department on safe injection practices, including IV drug diversion. The hospital failed to consider IPC responsibilities including detection, investigation, monitoring and reporting requirements during an outbreak. The hospital failed to ensure P&Ps were consistent with nationally recognized guidelines to mitigate the risk of infection for patients exposed to an IC breach. 5. Refer to the findings cited at Tag A-774 under CFR 482.42(c)(2)(iii) - Standard: Leadership Responsibilities that reflects the hospital failed to ensure the IPC Program communicated and collaborated with QAPI on IPC issues. 6. Refer to the findings cited at Tag A-776 under CFR 482.42(c)(2)(v) - Standard: Leadership Responsibilities that reflects the hospital failed to ensure the IPC Program audited staff adherence to IPC P&Ps and failed to consider IPC responsibilities in adhering to nationally recognized guidelines including responses to breaches in safe injection practices and drug diversion, and ensuring mitigation strategies for outbreaks were followed. 7. Refer to the findings cited at Tag A-787 under CFR 482.42(d)(2) - Standard: Unified and Integrated Infection Prevention and Control for Multi-hospital Systems that reflects the hospital failed to ensure its unified IPC Program established and implemented P&Ps that addressed the needs and concerns of each separately certified hospital, and failed to consider the unique practices and locations of each hospital. 8. Refer to the findings cited at Tag A-788 under CFR 482.42(d)(3) - Standard: Unified and Integrated Infection Prevention and Control for Multi-hospital Systems that reflects the hospital failed to ensure its unified IPC Program considered issues that were localized to a single separately certified hospital, and that those individualized issues were identified and addressed in collaboration with QAPI as concerns unique to that particular hospital. 44104”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1-32 and 34-46), review of personnel records, review of education/training records for 8 of 8 ICU nursing staff (Employees 1-8), review of education/training materials, review of pharmacy audit documentation, review of hospital P&Ps, and review of other documentation, it was determined the hospital failed to fully develop and implement clearly written P&Ps and staff training to ensure each patient’s right to receive care in a safe setting. Failures included: * Failure to ensure proactive, diligent and timely responses to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients. This created the risk for patient harm and actual harm. Behaviors and activities were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. * Failure to fully develop and implement effective systems and P&Ps that ensured fentanyl and other CS were accurately accounted for and documented in a timely manner creating the risk for drug diversion and patient harm: - Waste processes involving infusion tubing and bags were not developed and implemented. - Processes involving infusion rate changes and boluses were not developed and implemented. - Training/education materials were not developed to ensure nursing staff were educated on and had demonstrated competency for accurate accounting and wasting of IV fentanyl and other CS; and nursing staff had not been trained to accurately account for CS. - Instances of suspected drug diversion were not reported to the RRDT, through the hospital’s incident reporting system, and to hospital leadership in accordance with P&Ps. * Failure to ensure improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to prevent recurrence for affected patients and others. Findings include: 1. The P&P titled, “Patient Rights (ASANTE),” dated effective 07/29/2020 included “... Patients have the following Rights ... Provision of care in a safe setting; our hospital staff will follow current standards of practice for patient environmental safety, infection control, and security. Our hospital will protect vulnerable patients ...” Regarding failure to ensure proactive and timely responses to reports of an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while on duty: 2.a. During review of the hospital’s internal investigation documentation and interviews with CLO, IPD, MDCC, AGC, DRM, PM, DPS, MICU and other hospital leadership, it was revealed that “over a period from October 2022 through July 2023” an ICU nurse, RN4 diverted fentanyl that had been prescribed for patient care. The hospital’s investigation reflected that “... Asante believes that this nurse extracted quantities of fentanyl from intravenous administration bags, and refilled the bags with tap water to obscure [their] extraction of the drug product. Asante believes that the nurse’s actions led to infections in patients’ bloodstreams.” * In “May 2022” the hospital started identifying BSIs with “stenos [Stenotrophomonas maltophilia]” in the ICU. * On “Approximately” 09/30/2022 the hospital identified an outbreak or cluster of BSIs in the ICU. Organisms associated with the outbreak included Stenotrophomonas maltophilia, Chryseobacterium indologenes, Ochrobactrium anthropi, Delftia acidovorans, Enterobacter cloacae, Achromaobacter xylosoxidans, Acinetobacter and Burkholderia species, and those organisms could grow in liquids such as tap water. * In 2022 and 2023 the hospital’s IP team engaged with state and federal agencies that included onsite audits, environmental case review, and environmental feedback. * July 2023 RN4’s employment terminated when they refused to participate in a Fit for Duty evaluation and drug screen. * In September and October 2023, the hospital engaged an expert in outbreaks of infectious disease from UCLA, who undertook an investigation that revealed the “root cause” of the BSIs may be related to drug diversion. Following that review, the hospital conducted further investigation that included staff time card audits and determined that each patient who experienced an infection had been prescribed IV administration of fentanyl and that one nurse, RN4 was associated with the care of all involved patients. The hospital’s investigation further reflected that “... evidence supports a finding that the ICU nurse diverted an unknown amount of fentanyl from intravenous bags prescribed for the patients at issue, and refilled the bags with tap water, leading to infections in patients’ bloodstreams.” * The hospital made no association between RN4’s drug diversion and ICU patients’ infections until November 2023 after the timecard audits were conducted. A hospital staff stated “We had no clue it was tied to the RN.” * The hospital’s initial internal investigation included a list of 32 ICU patients admitted to the hospital between 06/16/2022 and 07/11/2023 (Patients 1-32) that the hospital believed were affected by the ICU nurse’s drug diversion. Twelve of the 32 patients on the list were identified as “deceased.” 2.b. The hospital provided documentation regarding ICU Patients 1-32 that included admission date, discharge date, organism(s), method of organism detection, date of preliminary and final positive lab results, and disposition for each patient. Final positive lab results were dated between 06/20/2022 and 07/25/2023, and were obtained by blood culture with exception of four which were obtained by ET aspirate. 2.c. On 03/01/2024, hospital staff reported that as a result of the hospital’s ongoing internal investigation, they believed 13 additional ICU patients were similarly affected by RN4’s drug diversion activities. The hospital provided a list of those 13 patients who were admitted to the hospital between 07/17/2022 and 07/18/2023 (Patients 34-46). Seven of the 13 patients on the list were identified as “deceased.” Hospital leadership stated there may be additional affected patients not yet identified at the time of this survey because the hospital was still undergoing internal investigation. 2.d. The hospital provided documentation regarding ICU Patients 34-46 that included admission date, discharge date, organism(s), lab test performed, date of preliminary and final positive lab results, and disposition for each patient. Final positive lab results were dated between 07/29/2022 and 07/27/2023. All were obtained by blood culture. 3. Review of documentation beginning May 2022 identified that an ICU nurse, RN4 demonstrated a cumulative pattern of behaviors and activities suspicious of drug diversion, impairment, and other patient safety concerns. The documentation reflected those behaviors and activities continued through 07/26/2023 when RN4’s employment terminated, and included numerous observations, reports, audits, complaints and other information received from multiple hospital departments, co-workers, patients and families during which the hospital failed to take timely and effective actions to detect and prevent potential drug diversion and impairment, and ensure patients were appropriately monitored, supervised, protected and afforded the right to safe care. During that same period of time beginning May 2022 through July 2023, at least 45 ICU patients experienced infections, including BSIs. Examples follow in Findings 3.a. through 13 below in this tag. 3.a. An untitled document “Authored by [SICU]” dated 12/12/2022 included multiple excerpts dated between 05/17/2022 and 12/08/2022 describing behaviors and activities suspicious for drug diversion, impairment and patient safety concerns involving RN4. 3.b. An excerpt dated 05/17/2022 from the document in Finding 3.a. reflected “... As a bedside RN, I had an interaction with [RN4] which led me to question if [they were] diverting meds. I ... was in the process of discontinuing a Dilaudid PCA when [RN4] came into my room and offered to waste the medication with me. I went to the Omnicell with [RN4] and pulled my patient up while [RN4] handled disconnecting my tubing from the syringe and disposing of the medication into the [CS] bin. There was a bag of saline attached to the tubing as well which [RN4] poured into the [CS] bin while simultaneously ‘emptying’ the Dilaudid syringe into the bin. I was busy pulling the patient profile up into the [Omnicell] ... to perform the waste ... I glanced over to [RN4] as I was doing this and did not see that [RN4] was depressing the [flange] of the syringe. I could hear liquid entering the bin from the saline bag being emptied, but something felt off. [RN4] finished ‘wasting’ the medication ... [RN4] seemed to be protecting the right side of [their] jacket, holding [their] hand against [their] jacket (as if to prevent something from falling out) and was turned away from me slightly as [they] put [their] information into the [Omnicell]. [RN4] then left the med room and went directly into the clean utility room. Immediately after [RN4] left, I investigated the blue sharps bin to verify the PCA syringe was there as expected and found it was missing ... [I] approached the [CN] for assistance. I told [them] what I saw and asked what I should do next. [CN] went to our manager ... who came into the unit ... About 30 minutes had elapsed ... during which time I witnessed [RN4] go in and out of the clean utility room multiple times ... I approached [RN4] ... let [them] know I did not see syringe go into the sharps container ... [RN4] laughed and told [me] it was in the bin ... denied moving the medication ... We went into the med room and there was an empty Dilaudid PCA syringe ... This was not present when I first examined the bin ... I spent the remainder of my shift watching [RN4] closely for impairment ... I reported all of these observations and concerns to leadership.” Although a bedside RN, a CN, a manager, and a “leadership” individual observed or were made aware of these activities suspicious for drug diversion, there was no documentation that reflected the RRDT was notified, pharmacy department notified, PM notified, nor an RER completed in accordance with hospital P&Ps. There was no information that reflected who in “leadership” these observations and concerns were reported to, nor when they were reported. There was no documentation that reflected diversion had been ruled out. 3.c. A “Coaching” document dated 09/01/2022 reflected “Department/Entity: ICU/RRMC ... Manager/Supervisor Name: [MICU] ... The conversation described below was informal in nature and is not considered corrective action ... [RN4] has failed to follow Asante’s established [P&Ps] around the handling and documentation of narcotics ... 5/3/2022-at 1738 removed IV Ativan 2 mg. This medication was not administered, wasted, or returned. Per [RN4], this was pulled for another RN ... 7/30/2022 at 0751 removed 1 oxycodone 5mg tablet. This medication was not administered, wasted, or returned ... 8/24/2022-at 0752 removed fentanyl 1250 mcg Premix. This ‘new bag’ was not documented, returned or wasted. There was no documentation of a rate change at 0800 ... [RN4] understands that an additional narcotic discrepancy prior to 5/3/2023 may result in disciplinary action.” The document had spaces for manager and employee signatures, dates and employee comments all of which were blank. Although the documentation identified RN4 failed to follow hospital P&Ps related to handling and documenting CS, including IV fentanyl, there was no documentation of further investigation into what happened to those CS including potential impact on patient safety and care. There was no documentation that reflected the RRDT was notified, pharmacy department notified, nor an RER completed. There was no documentation that reflected diversion had been ruled out. 3.d. An excerpt dated 11/16/2022 from the document in Finding 3.a. reflected “[RN4] attended ICP class. [RN4] was unable to stay awake/keep [their] eyes open. [RN4] was expected to return to the nursing unit immediately after the class however, [they were] unable to be located for at least 30 minutes.” There was no documentation that reflected further investigation or follow-up to these concerns. 3.e. An excerpt dated 11/17/2022 from the document in Finding 3.a. reflected “Approached by [staff] asking if [RN4] was ok. [Staff name] was concerned because [RN4] seemed super [run] down lately and very off.” There was no documentation that reflected further investigation or follow-up to these concerns. 3.f. An excerpt dated “June - November 2022” from the document in Finding 3.a. reflected “I transitioned into my new role as ICU supervisor in June and began to monitor [RN4] more closely ... started to notice a possible trend ... it seemed like [whenever] I would round on [RN4]’s patients, [their] IV lines were often brand new ... There were a few instances where I observed [RN4] having fresh tubing on [their] narcotic tubing multiple days in a row ... I asked [RN4] once why [they] had to change [their] tubing again ... [RN4] told me it had been disconnected and left hanging on the pump ... This was a Fentanyl gtt which is not something which would ordinarily be disconnected and left there ... [RN4] had shown several behaviors over the past few months which continue to lead to suspicion ... takes frequent bathroom breaks ... often in the bathroom for extended periods of time ... goes in and out of the clean utility room frequently throughout [their] shifts. I have noticed a change in [their] demeanor. [RN4] has become more irritable and prone to outburst. I have been getting more frequent complaints from patients/families that [RN4] has spoken rudely to them or been very ‘short’ in [their] interactions with them. When approached [RN4] is very defensive ... often placing blame back on the patient and/or family... [name] reported [RN4] to be sleepy and ‘off’ on a couple occasions ... also reported finding a used, shielded needle on the bathroom floor ... immediately upon [RN4]’s exit from the bathroom.” There was no further information nor investigation of these activities, including but not limited to dates, times and potential impact on patient safety and care. There was no documentation that reflected the ICU supervisor considered or had taken actions to ensure RN4 had physical and cognitive capacity to safely perform their job duties, including but not limited to referral to EH for a Fit for Duty evaluation in accordance with the hospital’s P&P in Finding 14 below in this tag. There was no documentation that reflected the RRDT was notified, pharmacy department notified, PM notified, an RER completed, nor that nursing leadership were notified, any of which should have prompted further investigation and follow-up actions. 3.g. An excerpt dated 12/08/2022 from the document in Finding 3.a. reflected that a “break” nurse reported RN4 was taking long bathroom breaks and syringes and a bloody alcohol swab were found in a bathroom after RN4 left the bathroom. The documentation reflected, “I was alerted by break RN ... that [RN4] was taking an extended bathroom break after returning from [their] scheduled break ... I decided to track [RN4]’s movements as closely as possible to determine if [they were] spending an excessive amount of time away from [their] patient assignment ... 08-1815 [they] were on [their] scheduled break ... went into the back staff bathroom. [They were] there from 0820-0832 ... From 1030-1100 [they were] on scheduled lunch break. At 1105, I was again alerted [they were] back in the bathroom ... came out of the bathroom at 1119 ... I entered the bathroom and investigated the trash can where I saw a tissue and alcohol swab with bright red blood on it sitting on top of paper towels. At 1135, I observed [RN4] come out of the clean utility room and then walk into the front visitor bathroom ... I observed the corner of what I recognized to be the package of a saline flush ... and saw that there were two empty saline flushes in the trash can. There was also a small amount of blood on a separate paper towel in the trash ...” There was no documentation that reflected the author’s supervisor was notified, RRDT notified, pharmacy department notified, PM notified, nor an RER completed, any of which should have prompted further investigation and follow-up actions. There was no documentation that reflected further investigation of these activities including potential impact on patient safety and care, nor follow-up actions. 3.h. A “Chart Review” document involving RN4 reflected that an “audit” had been conducted on 12/13/2022. The document reflected “Submitted by [MICU] ... Date [RN4] cared for patient: 12/8/2022 ... Patient Name: [Patient 10] ... Saline flush found in bathroom near entrance to ICU after [RN4] exited the bathroom. Dilaudid administered at 1216 for wound care ... No other narcotics given by [RN4]. This seems to align with the med admin of other nurses ... Pain assessment completed with administration. No obvious changes in [RN4]’s pain assessment when compared to shift before and shift after.” Although concerning behaviors were reported and “tracked” in an excerpt dated 12/08/2022 in Finding 3.g., there was no documentation that reflected further investigation or follow-up until this MAR audit dated five days later on 12/13/2022. There was no investigation or follow-up into possible reasons saline flushes were found in a bathroom after RN4 exited. There was no documentation that reflected MICU’s supervisor was notified or an RER was completed which should have prompted a thorough investigation in accordance with the hospital’s P&Ps. There was no documentation that reflected diversion had been ruled out. 3.i. An email sent to MICU dated 12/13/2022 at 1151 reflected “... I wouldn’t be bringing these topics to your attention unless it is a well-established pattern ... in ICU Rounds 3-4x/week, I’ve noticed [RN4] is very noncompliant with wearing [their] mask ... just today while we were rounding on the patient in room [number], I saw [RN4] enter and exit room [number] with [their] mask below [their] chin 4x in a 5 minute span ... [RN4] definitely sticks out as an outlier in this regard ... in my observation [RN4] turns therapy away at a significantly higher rate compared to many other nurses in ICU ... from my experience, [RN4] has not been willing to have a collaborative discussion if I (or another discipline) makes gentle suggestions to improve or optimize patient care ... I’m not sure if [RN4] is experiencing burnout or is struggling in some other way ...” There was no documentation that reflected further investigation of these concerns including potential impact on patient safety and care, nor follow-up actions particularly in light of numerous prior reports of concerning activities and behaviors suspicious for drug diversion and impairment. 3.j. An email sent to SICU dated 12/13/2022 at 2010 reflected “... multiple [RTs] are having similar concerns and ‘it’s getting to the point where someone had to say something’ ... [RN4] is very rude, unwilling to collaborate, short-tempered ... we have all noticed a change in [their] behavior in the past few months ... seems angry all the time ...’” There was no documentation that reflected further investigation of these concerns including potential impact on patient safety and care, nor follow-up actions. 3.k. A five-page document titled “[RN4] Observations” was reviewed. SICU’s name, credentials and “Signed 12/30/2022 1650” were typed on the bottom of page five. The document included excerpts dated between 12/13/2022 and 12/28/2022 describing observations and reports of behaviors and activities suspicious for drug diversion and impairment involving RN4. 3.l. An excerpt dated 12/13/2022 from the document in Finding 3.k. reflected “Closely observed [RN4]’s movements throughout the shift ... Based on recommendations from rapid response team, I interviewed the patient in [room number] regarding [their] pain management ... it is well managed with Tylenol. No other analgesic agents ordered. 0828-0849 - scheduled break 0943 - seen leaving unit, did not ask for anyone to watch [their] patient while gone 0956 - remains off unit, patient in ICU [room number] called for assistance ... Upset because ‘the nurse said [they’d] be back in 5 minutes and it’s been 20’ ... 1000 - [RN4] returned to the unit, apologizing ... 1020 - sitting at desk, noted to be pretty sleepy, heavy eyes ... 1032 - video of [RN4] falling asleep while drinking from [their] water bottle ... 1135-1154 - scheduled lunch break. Came back ... entered the clean utility room for a few moments, exited ... and went into the back bathroom ... came out of bathroom at 1200 and returned to [their] desk ... 1210 - sitting at desk, very sleepy ... asked [another RN] to cosign restarting [their] heparin drip ... said [they] should have restarted it 45 minutes ago, but [they] forgot ... 1214 - Video of [RN4] falling asleep while sitting at desk ... 1216 - back in clean utility room for ~ 2 minutes ... 1220 - entered room [number] where [they] were expecting an admission ... [RN4] was seen rummaging in the corner by the sink with [their] back towards the camera. [RN4] reached into the right leg pocket of [their] scrubs, but it was unclear if [they were] retrieving or placing any items within ... 1530 - approached by [break nurse] ... [break nurse] saw [RN4] ... enter into the ... locker room. [They] were in there for about 20 minutes ... noticed that [RN4’s] patient had arrived in ICU [room number] while [RN4] was gone. Other RNs were working to get the patient settled in. [RN4] returned to the unit shortly after ... took over admitting care of the patient ... [break nurse] overheard people commenting that nobody knew where [RN4] was and that [RN4] had not responded to Doc Halo notifying [them] of [their] patient’s arrival.” There was no documentation that reflected further investigation of RN4’s concerning behaviors and activities including but not limited to falling asleep, forgetting to administer heparin medication, leaving the unit and assigned patients without ensuring their patient was monitored in their absence, lack of response to their coworkers’ efforts to locate them, and potential impact on patient safety and care. There was no documentation that reflected SICU or other staff had considered actions to ensure RN4 had physical and cognitive capacity to safely perform their job duties, including but not limited to referral to EH for a Fit for Duty evaluation in accordance with hospital P&Ps. Although the documentation suggested RRDT had made “recommendations” regarding RN4, there was no documentation that reflected when RRDT was initially informed, who informed them, what prompted notification, nor any other information regarding possible RRDT involvement. There was no documentation that reflected SICU’s supervisor was notified. There was no documentation that reflected an RER had been completed including further investigation and follow-up actions. 3.m. An excerpt dated 12/21/2022 from the document in Finding 3.k. reflected “Spent around 3 hours in the unit today observing [RN4]’s movements ... Again, [RN4] appeared tired and groggy ... [RN4] was assigned to patient in room [number] who was intubated and on a Fentanyl drip. Due to concerns of possible diversion, I went and marked [their] [IV] tubing with a Sharpie [sic] ... so it would be clear to me if the tubing was changed during the shift ... Around 1400, [CCU Supervisor] was in the ICU and noticed [RN4] falling asleep at [their] desk ... [RN4] was sitting at [their] computer with [their] hand on [the] mouse, eyes closed, wavering a little in [their] ability to keep [their] head upright. I said [their] name and [they] woke easily ... did not seem altered once awake ... said [they were] very tired ...” There was no documentation of further investigation including potential impact on patient safety and care with respect to RN4’s pattern of difficulty staying awake and falling asleep while on duty. There was no documentation that reflected SICU or other staff had considered actions to ensure RN4 had physical and cognitive capacity to safely perform their job duties, including but not limited to referral to EH for a Fit for Duty evaluation in accordance with hospital P&Ps. There was no documentation that reflected an RER was completed or that SICU’s supervisor was notified. Although the documentation reflected there were “concerns of possible diversion”, there was no documentation that reflected RRDT was informed in accordance with hospital P&Ps. 3.n. A document titled “Chart Review 2” reflected an “audit” had been conducted on 12/21/2022. The document, which included MAR and flowsheet screenshots, reflected “Date [RN4] cared for patient: 12/21/2022 ... Patient Name: [Patient 13] ... Patient has orders for Fentanyl drip to maintain RASS -3, -4 with ‘no coughing’. Administration by [RN4] includes 3 50mcg bolus from bag doses plus an increase in rate from 75 mcg per hour to 100 mcg per hour ... Based on RASS documentation, there is no clear indication for the administration of additional fentanyl ... There is documentation of presence of pain at 1400, but no documentation of interventions performed and or effect of interventions ... Administration of fentanyl does not match ordered indications ... 0957 administration includes comment that it was given for wound care. WOCN note indicates [they] saw patient at 1351 and that the patient experienced no pain ... There is no wound or wound care documentation during the shift by [ RN4].” There was no further investigation of these audit findings including possible reasons why “Administration of fentanyl does not match ordered indications.” There was no documentation that reflected an RER had been completed. It was additionally not clear what prompted the audit. 3.o. “[Record of Communication]” documentation involving RN4 dated 12/22/2022 at 1400 reflected “I met with [RN4] to discuss behavioral concerns ... shared with [RN4] that [they] had been informed that [RN4] had been disengaged, non-collaborative, short tempered, and irritable ... this seemed out of character for [RN4] ... I asked [RN4] if [they were] doing OK. [RN4] responded by letting me know that [they] knew exactly which week had created the issues ...” This communication suggested concerns were limited to a specific week and did not include further investigation into reports and observations going back more than six months that included but were not limited to RN4 falling asleep while on duty, leaving the unit without notifying coworkers, concerning medication audit findings, and other activities suspicious for drug diversion, impairment and patient safety concerns. 3.p. An undated document regarding Patient 13 reflected “I have done the math ... overall, it looks like [RN4] is the only person that is giving the patient a Bolus consistently. But the math does not add up with the hanging of bags the rate and the bolus ... hopefully this is a good picture of some suspicious incidents from 12/21-23/2022.” There was no further information regarding these “suspicious incidents.” There was no documentation that reflected an RER had been completed including further investigation and follow-up actions. There was no documentation that reflected diversion had been ruled out. 3.q. An excerpt dated 12/28/2022 from the document in Finding 3.k. above reflected “At 0742, [PM] alerted me to suspicious behavior with [RN4]’s management of fentanyl infusions ... [They] shared a spreadsheet which outlined administration of boluses and adjustments to Fentanyl infusions and appeared to highlight some missing volumes ... Informatics emailed again at 1219 alerting me to active suspicious behavior with the math and charting [RN4]’s infusion ... 1416 - Observed [RN4] walking back on unit. [They] had a syringe in [their] right pants pocket which was sticking out a bit. I recognized this as a syringe 10mLs ... Very few medications are prepared in this size syringe. I reviewed [RN4]’s patient’s MAR and did not see any administrations of medications which are prepared in this size syringe around this time. Of note, [RN4] was walking very slowly down the hallway towards [their] patient’s room ... not stumbling ... but the speed which [they were] walking was abnormal for [them] ... at 1421 I observed [RN4] standing at [their] workstation/computer in [their] patient’s room with [their] back to the door. I watched [RN4] for a few minutes stand idly at [their] computer, not interacting with anything and slightly swaying forwards & backwards ... [they] stood there for a few minutes before slowly reaching towards the table and fumbling to insert a blood sugar strip into the glucometer. [RN4] then picked up a vial of medication to draw up which was done very slowly and clumsily. While all of this was happening, [their] intubated patient was fairly awake, grimacing, moving [their] head around and gripping the side rails. [RN4] seemed unaware of [their] patient and did not respond to [their] activity in any way. I took a video of this behavior (back turned, slow movement, swaying) and went directly to [name] with concerns of impairment. [They] advised me to contact informatics to see what information they had gathered from today and to notify HR. 1456 - I called Informatics and spoke with tech who was working on tracking Fentanyl usage/documentation. [They] said based on [their] math, there was 100mL of missing Fentanyl from this shift based on when new bags were scanned/hung in [RN4]’s room ... This information further led me to feel that immediate action was needed ... 1630 ... brought [RN4] to my office to discuss concerns of signs of impairment while at work ... I let [RN4] know that because of concerns over [their] level of consciousness, we would need to proceed with fit for duty examination and rule out substance use as a factor ...” There was no documentation that reflected an RER had been completed. There was no further documentation of investigation into these concerns including with respect to RN4’s assigned patient(s), potential presence and extent of harm related to RN4’s lack of awareness and response to their intubated patient’s symptoms of distress, “grimacing, moving [their] head around and gripping the side rails”. There was no documentation that reflected abuse and neglect had been ruled out. 4.a. An “Asante RN Annual Performance Evaluation 2022” for [RN4] with “Performance Review Period” 01/01/2022 through 12/31/2022 was reviewed and included: - “[RN4] is a top-notch critical care RN. [They share] time, energy, and knowledge with others as [they collaborate] with the multidisciplinary team to optimize patient outcomes ... [They stay] up to date with changes to [P&Ps] ... [They’re] attentive to details, adhering to care bundles, documenting accurately, and checking their email routinely ... combines sound theoretical knowledge with strong clinical skills to provide excellent patient care ...” - “[RN4] certainly has a passion for excellence, as evidenced by [their] commitment to critical care through most of the most challenging times in healthcare. [They strive] to provide excellent, detail oriented care and it shows in [their] patients [sic] outcomes. [They are] honest and kind, acting with integrity ... strives to do whatever is needed for the team in the moment ... [Their] hard work and commitment to [their] team are some of the reasons whey we are so lucky to have [them in] ICU!” - The documentation reflected RN4 was rated “Level 5: Exceeds Expectations” for all sections on the evaluation. Those included “Communication”, “Patient-Centered Care”, “Clinical Safety”, “Attention to Detail”, “Evidence-Based Practice”, “Collaboration”, “Excellence”, “Respect”, “Honesty”, “Service” and “Teamwork”. The performance evaluation was dated and acknowledged by RN4 on 12/23/2022 at 1018, eight days before the end of the performance evaluation period. None of the activities and behaviors suspicious for drug diversion, impairment and other patient safety and care concerns identified in Findings 3-3.q. were addressed in RN4’s annual performance evaluation. 4.b. During an interview on 02/02/2024 at ~ 0925 with MICU, RN4’s 2022 annual performance evaluation was reviewed. MICU provided the following information: * MICU stated they knew about RN4’s behaviors suspicious of drug diversion between 05/17/2022 and 12/08/2022. MICU stated “[SICU] was communicating with me regularly about this.” MICU stated “We had seen an increase in sleepiness, irritability, and [RN4] missing from [their] work station. MICU stated “Symptoms started Fall of 2022.” MICU stated they did not know if those behaviors and symptoms were investigated. * MICU stated they met with RRDT two or three times in December 2022 and RRDT was “giving me guidance to monitor [RN4].” However, MICU stated they had no documentation of those meetings. * MICU acknowledged they completed RN4’s 2022 annual performance evaluation in Finding 4.a. MICU confirmed the performance evaluation did not address any of RN4’s activities and behaviors suspicious for drug diversion, impairment and other patient safety concerns. MICU stated that a Fit for Duty and drug screen were done in December 2022. MICU stated the drug screen came back negative and “our understanding was [RN4’s] behaviors were a medical issue.” MICU stated “HR was telling us to watch [RN4] and take notes.” MICU was asked by the surveyor if they had developed a plan to address RN4’s concerning behaviors in order to ensure patients received safe care when RN4 was assigned to and caring for patients. MICU stated that no plan had been put into place. 5. Beginning May 2022 through December 2022, as reflected in Findings 3.a.-3.q., documentation reflected hospital staff and others observed and reported multiple activities and behaviors suspicious for drug diversion, impairment and other patient safety concerns involving RN4. The documentation of those activities and behaviors failed to reflect that hospital staff reported, investigated, and addressed those concerns in accordance with hospital P&Ps. Patient lists and other documentation provided by the hospital revealed that within approximately that same period of time, beginning May 2022 through January 2023, multiple patients admitted to ICU had positive lab results consistent with infections, including BSIs as follows: * Patient 1 admitted 06/16/2022 and discharged 06/30/2022: Final blood culture results 06/20/2022 identified Stenotrophomonas maltophilia. * Patient 2 admitted 09/08/2022 and final ET aspirate results 09/23/2022 identified Stenotrophomonas maltophilia. The patient expired 01/01/2023. * Patient 3 admitted 09/10/2022 and final ET aspirate results 09/16/2022 identified Stenotrophomonas maltophilia. The patient expired 09/30/2022. * Patient 4 admitted 09/10/2022 and discharged 10/14/2022. Final blood culture results 9/29/2022, 10/03/2022 and 9/29/2022 identified Stenotrophomonas maltophilia, Acinetobacter calcoaceticus and Ochrobactrum anthropi, respectively. * Patient 5 admitted 09/11/2022 and final ET aspirate results 09/26/2022 identified Stenotrophomonas maltophilia. The patient expired 10/02/2022. * Patient 6 admitted 09/22/2022 and discharged 10/03/2022. Final blood culture results 10/02/2022 identified Chryseobacterium indologenes. * Patient 7 admitted 09/27/2022 and discharged 11/14/2022. Final blood culture results 10/13/2022 identified Ochrobactrum anthropi. * Patient 8 admitted 10/03/2022 and discharged 10/04/2022. Final blood culture results 10/08/2022 identified Chryseobacterium indologenes. * Patient 9 admitted 10/15/2022 and final blood culture results 11/08/2022 identified Stenotrophomonas maltophilia. The patient expired 11/11/2022. * Patient 10 admitted 11/06/2022 and discharged 12/22/2022. Final blood culture results 11/14/2022 identified Acinetobacter species and Delftia acidovorans; and 12/02/2022 identified Burkholderia species. * Patient 11 admitted 11/12/2022 and discharged 01/09/2023. Final blood culture results 11/22/2022 identified Delftia acidovirans and Stenotrophomonas maltophilia. * Patient 12 admitted 11/29/2022 and final ET aspirate results 12/07/2022 and 12/08/2022 identified Stenotrophomonas maltophilia and Achromobacter xylosoxidans, respectively. The patient expired 12/07/2022, prior to the 12/08/2022 final results. * Patient 14 admitted 12/06/2022 and final blood culture results results 12/19/2022 identified “gram-negative rods”. The patient expired 12/18/2022. * Patient 34 admitted 07/17/2022 and discharged 08/09/2022. Final blood culture results 07/29/2022 identified Stenotrophomonas maltophilia. * Patient 35 admitted 07/29/2022 and final blood culture results 08/08/2022 identified Enterobacter. The patient expired 10/01/2022. * Patient 36 admitted 09/19/2022 and final blood culture results 09/23/2022 identified Enterobacter cloacae. The patient expired 09/22/2022. * Patient 37 admitted 10/21/2022 and final positive blood culture results 10/25/2022 identified Enterobacter. The patient expired 11/01/2022. * Patient 38 admitted 11/15/2022 and final blood culture results 11/27/2022 identified Enterobacter. The patient expired 11/30/2022. * Patient 13 admitted 12/04/2022 and discharged 02/02/2023. Final blood culture results 01/08/2023 identified Achromobacter species and Ochrobactrum anthropi. 5.a. Refer to the findings cited at Tag A-494 under CFR 482.25(a)(3) - Standard: Pharmacy Management and Administration. Those findings include pharmacy audits that reflect unclear, undocumented and unaccounted for volumes of fentanyl infusions involving Patients 2-14 and 37 as described under Findings 1-1.n., 3.a. and 3.b. 5.b. Review of Patient 1’s medical record confirmed the patient admitted to the hospital 06/16/2022, final positive blood culture results identified Stenotrophomonas maltophilia, and the patient discharged 06/30/2022 as reflected in Finding 5. 5.c. Similarly, medical records reviewed for Patients 2, 5, 6, 7, 9, and 12 confirmed admission dates, discharge/expiration dates, and blood culture or ET aspirate results regarding those same patients as reflected in Finding 5. 6. Review of EH records reflected RN4 was off duty from 12/28/2022 and “cleared to regular work” on 01/24/2023. After RN4 returned to work, hospital staff continued to report activities suspicious for drug diversion and impairment involving RN4 described in Findings 7.a.-7.p. and 8.a. in this tag. 7.a. An email from an ICU CN dated 02/01/2023 at 1604 reflected “... I observed [RN4] (via camera) enter another nurse’s room and was pulling fluid off with a syringe from behind the pump while looking out of the room suspiciously. Once [RN4] stopped holding the IV tubing [they] walked behind the back of the room and when [they] came around the boom [sic] the syringe was no longer in [their] hand. I asked the pt’s nurse how long the fentanyl gtt had been off they [sic] said since about 0930 in the morning and this occurred at 1505 ...” There was no documentation that reflected further investigation or follow-up to these concerns. 7.b. An email from an ICU CN dated 02/01/2023 at 1626 reflected “My fear of the system failing us is strong ... I agree with some of these coworkers that [RN4] may be better suited working not in critical care.” There was no documentation that reflected further investigation or follow-up to this concern. 7.c. “Record of Conversation” documentation dated 02/08/2023 at 1040, a week after the concerns in Finding 7.a. reflected “I met with [RN4] regarding the following concern: I observed [RN4] (via camera) enter another nurse’s room and was pulling fluid off with a syringe from behind the pump while looking out of the room suspiciously. Once [they] stopped holding the IV tubing [they] walked behind the back of the room and when [they] came around the boom [sic] the syringe was no longer in [their] hand. I asked the pt’s nurse how long the fentanyl gtt had been off they [sic] said since about 0930 in the morning and this occurred at 1505 ...” The documentation included an interview with [RN4] that reflected “[RN4] shared [they didn’t] remember specifically being in this patient’s room or helping fix the pump but that it was certainly possible as [their] normal practice is to help.” There was no information that reflected who documented the “Record of Conversation” and interview. There was no conclusion or determination whether these activities were considered suspicious for drug diversion, and if so, whether RRDT was or should have been notified. There was no documentation that reflected an RER had been completed including an investigation and follow-up actions. 7.d. An email from PM dated 02/09/2023 at 1235 reflected “... There is a big gap in documentation of what happened after the notification of Fit for Duty. On 1/10/2023, the communication was that [RN4] did not violate the Fit for Duty policy as it pertains to impairment; however, we needed to evaluate whether [RN4 is] safe to perform [their] job and will need to be evaluated by EH before returning to work. I was not on-site on the day [RN4] was sent for Fit for Duty, but Informatics brought up the concern that a large portion of a fentanyl infusion was missing. Did this get discussed? In the meantime, I will tell Informatics to continue to monitor.” There was no documentation that reflected further investigation of the missing “large portion of a fentanyl infusion” including outcome and whether the fentanyl was ever accounted for. 7.e. A three-page document titled “[RN4] Observations” dated 07/24/2023 was reviewed. SICU’s name and title was printed at the end of the document. The document included excerpts dated between 06/27/2023 and 07/11/2023 that described continued observations and reports of behaviors and activities suspicious for drug diversion and impairment involving RN4. Those are described in Findings 7.f., 7.h., and 7.j.-7.l. in this tag. 7.f. An excerpt dated 06/27/2023 from the document in Finding 7.e. reflected “... RT reported concerns about [RN4]’s medication handling when taking their intubated patient to CT ... [RN4] drew up a syringe of propofol and brought it to CT ... and ended up giving the patient a bolus of Propofol as they were in CT. The RT felt this was an odd practice and brought the concern up to the charge RN ... RT also reported [RN4] was away from [their] desk most of the day and each time RT went to locate [them, they were] found to be in the bathroom. The RT had asked the RNs near to [RN4]’s assignment if they were watching for [RN4] which they denied. This was an unstable patient on the ventilator ...” Refer to the findings cited at Tag A-145 under CFR 482.13(c)(3) - Standard: Privacy and Safety. Finding 9.a. under that tag reflects an incident involving Patient 58 dated 06/27/2023 in which staff reported concerns related to RN4 repeatedly leaving a critical patient unattended, improper handling of propofol and other patient safety concerns during a CT procedure in which the patient’s outcome was noted as hypoxia, and the hospital’s failure to conduct a timely and thorough investigation and follow-up actions to prevent reoccurrence. 7.g. Handwritten notes titled “[RN4’s initials] Investigation: Cont” included “[Patient 28] ... [06/27/2023] 0751 [New Bag] @ 100 mcg (20mL) - [RN4’s initials] ... 1527 [New Bag] @ 100 mcg (20mL) - [RN4’s initials] ... 1853 [New Bag] @ 100 mcg (20mL) - [RN4’s initials] ... Total infused: 325mL ... Total issued: 750mL ... wasted 125mL @ 0240 ... 300 mL - outstanding”. The notes suggested 300 mL medication was “outstanding” or missing. There was no documentation that reflected further investigation to determine the reason for the missing medication. Review of the hospital’s incident log dated 01/01/2023-01/29/2024 reflected there was no documentation that reflected an RER had been completed regarding Patient 28’s “outstanding” medication. There was no documentation that reflected further investigation had been conducted or that diversion was ruled out. 7.h. An excerpt dated 07/01/2023 from the document in Finding 7.e. reflected “... [RN4] was caring for the patient in ICU [room number] who was on CRRT. [Physician] tried to call to speak with [RN4] on the phone ... After the 4th attempt to reach [RN4], [physician] called back and asked to speak to the house supervisor ... When asked where [RN4] was, the US said [RN4] came out of the bathroom. The US mentioned that [RN4] uses the bathroom numerous times throughout [their] shift without asking anyone to keep an eye on [their] patients. While giving report to night shift, [RN4] told the [night shift] RN that [RN4] had been struggling with air bubble alarms on [their] IV pumps the entire day. Because of this they had pulled a fresh bag of Fentanyl & primed new tubing to swap the patient over to ...” There was no documentation that reflected further investigation or follow-up to these concerns including whether the patient or patients experienced harm when RN4 was in the bathroom “without asking anyone to keep an eye on [their] patients”. 7.i. A copy of handwritten notes involving Patient 59 titled “Notes - [RN4’s initials] Investigation” included “7/1 [2023] ... witnessed odd behavior. [RN4’s initials] left extra bag of [fentanyl infusion] for [other initials] to use ... Total issued: 500mL ... 160-230mL missing ...” Although the documentation reflected “odd behavior” was witnessed and 160-230mL fentanyl was missing, review of the hospital’s incident log reflected there was no documentation that reflected an RER had been completed regarding missing fentanyl for Patient 59. There was no documentation that reflected diversion had been ruled out. 7.j. An excerpt dated 07/02/2023 from the document in Finding 7.e. reflected “... CNA entered [patient] room ... found [RN4] standing with [their] back to the door, tucked into the alcove between the half-wall and closet to the room. This struck [them] as odd as that is not a normal space for nurses to work from ... [RN4] was tucking an unknown object down the front of [their] scrub pants ... Once [RN4] heard [them] come into the room, [they] acted ‘panicked’ and began rushing to finish whatever [they] were doing ... [CNA] spoke with [their] charge RN to let [them] know what [they] saw ... The CNA noted that [RN4]’s behavior throughout the rest of the day (as well as the past few months) has been off ... [RN4] is constantly gone away from [their] patients and frequently uses the bathroom. On Sunday morning ... night shift was waiting to give [RN4] report, and nobody knew where [RN4 was] ... there were several times throughout the day when [RN4] couldn’t be found (despite having a patient on CRRT) and the nurses around [them] denied being asked to watch for [them] ... the CNA ‘couldn’t ignore [their] gut’ and feels something more is going on ... Another incident happened ... reported by an RN. Around 1800 [RN4] was helping this RN reposition [their] patient ... [RN4] ... asked the RN if [they] would like [them] to grab a new bag of Fentanyl ... [RN4] was told not to worry about it ... When the RN was giving report ... [they] noticed that [RN4] was in [their] patient’s room, hanging a new bag of Fentanyl ... The RN had cleared [their] pumps around 1800 and after this situation double checked the infused volume and found the pump read 40mL infused. The drip was running at 10mL/hr and [RN4] had charted 25mcg (5mL) bolus. There should have been 15mL infused in that period, not 40mL.” Similarly, there was no documentation of further investigation or follow-up, no RER, and no documentation that diversion had been ruled out. 7.k. An excerpt dated 07/05/2023 from the document in Finding 7.e. reflected “ [RN4] was gone from [their] patient assignment multiple times throughout the shift. One of [their] patients was intubated and the other was on pressors. Around 1800, Xray showed up to [RN4]’s ventilated patient room and were unable to locate [RN4] ... [RN4] was not in any patient rooms or either the staff or visitor bathrooms within ICU. After about 20 minutes, [RN4] walked back onto the unit. [RN4] did not give an explanation as to where [they were] and was annoyed the Xray hadn’t been done.” Similarly, there was no documentation of further investigation or follow-up to these concerns. 7.l. An excerpt dated 07/11/2023 from the document in Finding 7.e. reflected “... [RN4] was expecting an admission ... When they tried to call report, the MT answered the phone and sent [RN4] a doc halo letting [them] know they were on the phone. After some time, AACH called again and said nobody had picked up the phone and asked if they could give report. This time, the charge RN messaged [RN4] again via Doc Halo and sent the US around the unit to see if [they] could locate [RN4]. [They] walked through the unit ... and [were] unable to locate [RN4]. While looking ... [they] poked [their] head into ICU [room number] (assigned to [RN4]) and saw the patient had pulled out [their] IV ... texted [RN4] on [their] personal cell ... [RN4] did not respond ... Staff working in the adjacent rooms and the break RN denied being asked to watch [RN4]’s patient while [they were] away ...” Similarly, there was no documentation of further investigation or follow-up to these concerns. 7.m. An email sent to PM dated 07/19/2023 at 1516 reflected “... We have two patients we were looking into ... [Patient 59] ... [07/01/2023 and 07/02/2023] [Patient 28] ... [06/27/2023] ... [RN4] was the primary RN on the dates listed ... I started to dig in and noticed missing volumes of Fentanyl just from my quick review and would like to see what the pharmacy reports show ... I’m compiling my notes of recent odd behavior which has [sic] been reported to me which adds to our suspicion of this nurse ...” 7.n. “[Record of Communication]: [RN4] Fit For Duty (FFD) inquiry” dated 07/25/2023 reflected “... today I was notified that HR received a call concerning [RN4] being drowsy during multidisciplinary rounds and that the caller was concerned [RN4 was] impaired. I was asked to investigate ... I asked [CN] if [they] had any reason to believe that any staff were impaired today. [They] said no. [They] knew who the inquisition was referring to and stated that with [RN4’s] [other] issues [they] never [know] ‘which [RN4] is going to show up’. [CN] usually just gives [RN4] one patient and then just plans on watching out for [RN4] during the day ... I witnessed no behaviors that were concerning for impairment ... I called [HR] upon completion of this investigation and shared with [them] the findings ... a [Fit for Duty] was not completed ... Respectfully [MICU].” There was no RER completed and no documentation of further investigation into the CN’s statement that they never knew “which [RN4] is going to show up” nor that the the CN managed this by assigning [RN4] only one patient and “watching out” for them. 7.o. Email documentation with “Subject: [Record of Communication RN4] 7.25.2023” dated 08/14/2023 at 1535 from SICU reflected “I met with [RN4] today to talk about continued reports of [their] leaving [their] patient assignments without asking for anyone to cover for [them]. [RN4] recalled from our conversation earlier in the month that [they were] not supposed to leave [their] patients unattended ... I told [RN4] ... [they] must ask someone to keep an eye on [their] patients if [they] are leaving them unattended for any amount of time ... My concern is that, despite our conversation, not even three weeks ago, [RN4] has continued to leave [their] patient assignment without asking for anyone to watch out. I reminded [RN4] that with our pumps beeping, air in line, [they] could have the most stable patient in the world, but if that pump stops ... it only takes a few seconds for [their] patient to suffer harm. Even if [RN4] thinks [they are] only going to be gone for a few minutes using the bathroom, that could be life or death for someone if their IV pump stops ...” 7.p. An untitled document dated 07/26/2023 reflected “I asked [RN4] to come to my office ... because of [their] missing from [their] work station and [their] drowsiness, we were required to perform another fit for duty ... [RN4] refused to proceed with the fit for duty ... [A peer RN] today was reaching out to share concerns re [sic] [RN4]’s behavior ... The peer [RN] reported fluttering eyes, swaying, zoning in and out, nodding off/spacing out while standing, and slow decision making.” 8.a. An “Employment” document dated 07/28/2023 reflected that “On 7/25/2023, it was reported that [RN4] was observed to be ‘dozing off’ while on the clock and expected to be engaging in patient care in the Intensive Care Unit ... Additionally, over the past month there have been multiple concerns reported that [RN4] disappears during [their] shift for long periods of time leaving critically ill patients unattended, failing to respond when contact attempts are made, and has had multiple instances of unaccounted for abnormally high volumes of Fentanyl on 06/27/2023, 07/01/2023, 07/02/2023, 07/25/2023, and 07/26/2023. Additionally, it was reported that [RN4] was taking it upon [themselves] to administer Fentanyl for [their] co-worker’s patients without consent which resulted in unaccounted amounts of Fentanyl missing ... Asante Leadership exercised its ‘reasonable grounds’ right to test due to suspected cognitive impairment, a pattern of unexplained absences from [their] normal work area, and multiple instances of unexplained and unaccounted for volumes of a [CS] ...” The document reflected RN4’s employment terminated 07/26/2023. 8.b. During interview on 02/02/2024 at ~ 0925 with MICU, the employment documentation involving RN4 in Finding 8.a. was reviewed. Regarding instances of unaccounted fentanyl on 06/27/2023, 07/01/2023, 07/02/2023, 07/25/2023, and 07/26/2023, MICU stated “I don’t know if those were investigated.” MICU stated that accounting for IV fentanyl was problematic because the infusion pumps that were used to administer IV fentanyl were alarming more frequently than usual requiring nurses to change the IV tubing more often. MICU stated the hospital had no process for accounting for fentanyl waste in IV tubing, including when tubing was changed. MICU additionally stated that nurses did not consistently document fentanyl boluses in the MAR and this also created problems accounting for fentanyl. 9. Documentation February 2023-July 2023, as reflected in Findings 7.a.-7.p. and 8.b. reflected hospital staff observed multiple activities and behaviors suspicious for drug diversion, impairment and other patient safety and care concerns involving RN4. The documentation of those activities and behaviors failed to reflect that hospital staff reported, investigated and addressed those concerns in a timely manner and in accordance with hospital P&Ps. Similar to Finding 5, Patient lists and other documentation provided by the hospital revealed that within that same period of time, beginning February 2023 through July 2023, multiple patients admitted to ICU had positive lab results consistent with BSIs as follows: * Patient 1 admitted 05/05/2023 and discharged 05/18/2023. Final blood culture results 05/16/2023 identified Delftia acidovorans. * Patient 15 admitted 01/24/2023 and discharged 02/24/2023. Final blood culture results 02/06/2023 identified Acinetobacter baumannii and Stenotrophomonas maltophilia. * Patient 16 admitted 02/12/2023 and discharged 03/17/2023. Final blood culture results 02/26/2023 identified Stenotrophomonas maltophilia. * Patient 17 admitted 03/15/2023 and discharged 03/23/2023. Final blood culture results 03/21/2023 identified Chryseobacterium indologenes, Delftia acidovorans, and Stenotrophomonas maltophilia; and 04/04/2023 Delftia acidovirans. * Patient 18 admitted 03/26/2023 and discharged 04/14/2023. Final blood culture results 04/06/2023 identified Ochrobactrum anthropi. * Patient 19 admitted 04/12/2023 and discharged 04/22/2023. Final blood culture results 04/18/2023 identified Chryseobacterium indologenes and Stenotrophomonas maltophilia. * Patient 20 admitted 04/12/2023 and discharged 05/04/2023. Final blood culture results 04/17/2023 identified Stenotrophomonas maltophilia. * Patient 21, admitted 04/19/2023 and discharged 04/22/2023. Final blood culture results 04/21/2023 identified Chryseobacterium indologenes and Delftia acidovorans. * Patient 22 admitted 05/20/2023 and discharged 07/14/2023. Final blood culture results 05/26/2023 and 05/27/2023 identified Ochrobactrum anthropi and Enterobacter cloacae, respectively. * Patient 23 admitted 05/21/2023 and final blood culture results 05/24/2023 identified Chryseobacterium indologenes. The patient expired 05/22/2023. * Patient 24 admitted 05/21/2023 and discharged 05/27/2023. Final blood culture results 05/24/2023 identified Chryseobacterium indologenes. * Patient 25 admitted 06/01/2023 and final blood culture results 06/17/2023 identified Ochrobactrum anthropi. The patient expired 06/18/2023. * Patient 26 admitted 06/03/2023 and discharged 06/22/2023. Final blood culture results 06/08/2023 and 06/12/2023 identified Delftia acidovirans and Ochrobactrum anthropi, respectively. * Patient 27 admitted 06/08/2023 and final blood culture results 06/17/2023 identified Chryseobacterium indologenes and Stenotrophomonas maltophilia. The patient expired 06/09/2023. * Patient 28 admitted 06/13/2023 and final blood culture results 07/06/2023 identified Stenotrophomonas maltophilia. The patient expired 07/16/2023. * Patient 29 admitted 06/27/2023 and discharged 07/19/2023. Final blood culture results 07/07/2023 identified Chryseobacterium indologenes and Stenotrophomonas maltophilia. * Patient 30 admitted 06/29/2023 and discharged 07/07/2023. Final blood culture results 07/06/2023 and 07/12/2023 identified Stenotrophomonas maltophilia and Acinetobacter calcoacetius, respectively. * Patient 31 admitted 07/02/2023 and final blood culture results 07/07/2023 identified Chryseobacterium indologenes. The patient expired 07/05/2023. * Patient 32 admitted 07/11/2023 and final blood culture results 07/25/2023 identified Stenotrophomonas maltophilia. The patient expired 07/26/2023. * Patient 39 admitted 03/20/2023 and discharged 04/28/2023. Final blood culture results 04/21/2023 identified Enterobacter. * Patient 40 admitted 03/28/2023 and final blood culture results 04/02/2023 identified Enterobacter and Stenotrophomonas. The patient expired 04/06/2023. * Patient 41 admitted 03/29/2023 and final blood culture results 04/23/2023 identified Acinetobacter and Enterobacter. The patient expired 04/27/2023. * Patient 42 admitted 04/04/2023 and discharged 04/19/2023. Final blood culture results 04/10/2023 identified Enterobacter. * Patient 43 admitted 05/22/2023 and discharged 06/05/2023. Final blood culture results 05/28/2023 identified Acinetobacter and Enterobacter. * Patient 44 admitted 05/28/2023 and discharged 06/13/2023. Final blood culture results 06/08/2023 identified Enterobacter. * Patient 45 admitted 06/21/2023 and discharged 07/02/2023. Final blood culture results 06/25/2023 identified Enterobacter. * Patient 46 admitted 07/18/2023 and final blood culture results 07/27/2023 identified Enterobacter. The patient expired 08/19/2023. 9.a. Refer to the findings cited at Tag A-494 under CFR 482.25(a)(3) - Standard: Pharmacy Management and Administration. Those findings include pharmacy audits that reflect unclear, undocumented and unaccounted for volumes of fentanyl infusions involving Patients 1 and 15-32 as described under Findings 2-2.p. 10. Review of Patient 16’s medical record confirmed the patient admitted to the hospital 02/12/2023, final positive blood culture results identified Stenotrophomonas maltophilia, and the patient discharged 03/17/2023 as reflected in Finding 9 in this tag. Similarly, medical records reviewed for Patients 22, 23, 28, 31, and 32 confirmed admission dates, discharge/expiration dates, and blood culture results regarding those same patients as reflected in Finding 9 in this tag. 11. During interview 02/01/2024 at ~1140, CLO provided the following information regarding RN4: * RN4 began working in the hospital’s ICU March 2017. * Regarding suspicious behaviors 05/17/2022, 11/16/2022, 12/8/2022 in Findings 3.b., 3.d., and 3.g., respectively CLO confirmed the RRDT was not called, an RRDT investigation was not conducted, an RER was not completed, and nursing leadership was not notified. CLO stated the RRDT should have been called but was not. * Regarding excerpts “June - November 2022” in Findings 3.f., CLO confirmed the RRDT was not called, no RRDT investigation was conducted, and no RER was completed. * On 12/08/2022 trends suspicious for drug diversion related to administration of oxycodone and fentanyl were identified. “December 2022,” the RRDT was called. No RRDT Diversion Incident Checklist, Appendix A in Finding 17 was completed as required by hospital P&Ps. CLO stated this was a process gap. * On 12/28/2022, RN4 was referred for a Fit for Duty evaluation and drug test. The drug test did not include testing RN4 for fentanyl and RN4 passed the drug test. CLO stated RN4 should have been tested for fentanyl but was not. CLO stated RRDT should have been called and a Fit for Duty evaluation conducted sooner but “culturally” there was a gap. CLO stated “All of [RN4’s] behaviors were being attributed to [their] health issues.” * CLO stated that RRDT should be called every time drug diversion was suspected. CLO acknowledged that was not done until after hospital staff had observed multiple instances of suspected drug diversion. * In “July 2023”, RN4 was swaying and falling asleep while on duty, and was referred for a Fit for Duty evaluation a second time. RN4 refused to submit to the Fit for Duty evaluation and their employment terminated. 12. During interview 02/01/2024 at ~ 1620, PM and DPS provided the following information: * PM stated they had over-all responsibility for the hospital’s pharmacy department. PM stated they first became aware of potential drug diversion involving RN4 on 05/17/2022 when they received an email that RN4 was acting suspicious when performing PCA “waste” tasks. PM stated they conducted an audit of RN4’s medication activities and “reported to” MICU. PM stated “two things stood out.” The first was that RN4 was not scanning during medication administration processes “which means you wonder if [the medication] was actually given ... this is suspect behavior for diversion”. The second was that RN4 was administering increased dosages of narcotics without documenting a reason “which is also suspect behavior.” PM stated, “After this, the communication dropped” and the next time they heard anything about RN4 was 12/08/2022, eight months later when they received a communication from MICU stating they believed the “situation [involving RN4] was ongoing”. PM stated they had additional communications with MICU on 12/20/2022 and 12/21/2022. MICU was suspicious about IV tubing changes and planned to “focus on fentanyl” and “track tubing changes”. PM stated the next time they were made aware of potential narcotic discrepancies involving RN4 was July 2023, seven months later. Regarding RN4, DPS stated a “deep dive audit” was done 07/24/2023 and the RRDT was called. DPS stated there was no documentation of the RRDT’s activities and decision-making. * Regarding instances of unaccounted fentanyl involving RN4 on 06/27/2023, 07/01/2023, 07/02/2023, 07/25/2023 and 07/26/2023 in Findings 8.a. and 8.b. PM stated nobody told them about the missing fentanyl. * Regarding infusion rate changes, “Fentanyl infusions have discrepancy issues all the time due to frequent rate changes.” * Regarding fentanyl waste in infusion tubing, PM and DPS stated it was supposed to be accounted for and documented during Omnicell waste processes and nurses were not doing that. 13. During interview 02/29/2024 at 1030 with MDCC and IPD, MDCC stated in May 2022, they started identifying BSIs involving “stenos [Stenotrophomonas maltophilia]” and in October 2022, there was a “dramatic change ... we saw organisms that we had never encountered in our careers.” IPD stated on 04/19/2023 they contacted OHA HAI IP because they had seen an increase in BSIs. MDCC stated that on 04/27/2023 the hospital had a meeting with OHA HAI IP and during the meeting the possibility of staff drug diversion involving opiates and tap water was discussed. Refer to Finding 2.a. in this tag which reflects that the hospital made no association between RN4’s drug diversion and BSIs until November 2023, seven months after the meeting with OHA HAI IP in which potential staff drug diversion and increased BSIs were discussed. 14. The P&P titled, “Fit for Duty (ASANTE)” dated effective 10/21/2019 reflected “... Asante employees are expected to report to work fit for duty (work). The term ‘Fit-For-Duty’ means able to perform all the essential job functions in a safe, appropriate, and effective manner; free from the adverse effects of physical, mental, emotional and personal problems.” The P&P included: * “Physical and Cognitive Incapacity ... There is a broad array of medical conditions which may lead to an employee’s inability to perform essential job functions. These include acute/chronic injuries, acute/chronic medical illnesses, and physical or cognitive conditions ... If an employee is unable to perform the essential job functions then management action will be necessary. The manager will conduct a fair investigation and if there is any reason to believe physical or cognitive incapacity is present, the employee will be sent to Employee Health for a Fit For-Duty assessment to ensure the employee is able to safely perform the essential functions of the position ... After returning to work, should the employee demonstrate an inability to perform all essential job functions, re-assessment will be necessary ...” * “Cognitive Impairment ... is defined ... as an acute change in thinking/thought process adversely affecting the employee’s ability to perform the essential functions of the job. There is a broad array of conditions that may lead to cognitive impairment, including but not limited to prescription medication use, illicit [drug] or alcohol use, and/or a combination ... The manager will evaluate the employee and, if impaired, safely remove the employee from the work environment ... The employee will be required to submit to a drug screen and breath alcohol test. Failure to ... fully cooperate with such alcohol or drug testing ... will be considered grounds for immediate termination. Such failure will also be considered a positive test ... The employee will be suspended from work pending drug screen results. A confirmed positive [test] will result in termination of employment ... If the test is negative the employee will work with Employee Health regarding the requirements needed to return to work ...” * “Right to Test ... When reasonable grounds exist to believe an Asante employee ... may be impaired or in violation of company [P&Ps], Asante may exercise its ‘reasonable grounds’ right to test. Among situations where Asante may exercise its ‘reasonable grounds’ right to test are the following ... Observable symptoms of an employee’s conduct that may indicate the possibility of being impaired ... Unexplained significant changes in individual job performance ... Unexplained significant changes in behavior (e.g. abusive behavior, repeated disregard of safety rules or procedures, insubordination, etc.) ... Suspected diversion ... Unexplained absences from normal work areas ... In such cases of suspected diversion, a separate expanded panel will be used during the Fit for Duty process. Should the drug of interest not be included in this panel, it may be requested as an add-on to the drug screen panel.” * “Responsibilities ... Managers are responsible for monitoring the attendance, performance and behavior of all their direct staff ... In order to protect the safety of personnel, patients and property, the manager or designee must take action when an employee’s performance/behavior appears to be unsafe, ineffective, and/or inappropriate ... Employee Health department is designated to manage the Fit-For-Duty process ...” 15. The P&P titled, “Controlled Substance Management Policy (ASANTE),” dated effective 06/13/2022 included: * “It is Asante policy to prevent diversion and strengthen accountability of [CS]. Procedures which enhance proper use of CS and enable rapid identification of and response to misuse of CS control shall be implemented ...” * “A multilayered, interdisciplinary, system-level Controlled Substance Diversion Prevention Program (CSDPP) shall be maintained in place. This program shall govern CS practices across Asante in consultation with executive leadership ... The CSDPP shall be governed by a CSDPP Committee led by the Chief Pharmacy Officer ... Committee membership should include a broad selection of members ... The CSDPP Committee shall ... Be proactive in its efforts to actively address diversion detection and prevention, support incident investigations ... monitor reports and detect trends, enhance quality improvement, and coordinate [CS] activities ... Ensure [P&Ps] cover all aspects of CS use and integrate segregation of duties where there are overlapping processes for diversion risk enhancing opportunities for detection.” * “Pharmacy Compliance ... The PIC at each entity is responsible for coordinating response to CS incidents at that entity. Any CS incident identified at an entity must be communicated to the PIC for that entity.” * “Each entity shall have procedures in place ... guiding secure CS use by authorized HCW including dispensing, returning, counting, and wasting in the ADUs ... Authorized HCWs shall be trained and demonstrate competence in the use of all [CS] storage mechanisms ...” * “Administration ... All CS will be documented accurately in the EMR, generally using the [MAR] ... All identified documentation discrepancies will be resolved ...” * “Return, Waste and Removal ... Each entity shall have procedures in place, as approved by the PIC, to manage return, waste and removal of CS ... All CS wastage shall be performed as soon as possible following access of the medication, administration or refusal ...” * “Discrepancies ... Each discrepancy must be reconciled, resolved and documented as soon as possible. Resolution must be accompanied by a clear explanation of the events and why it can be certain that no diversion occurred ... If there is a discrepancy in an ADU or in the manual system that cannot be resolved, the manager for the affected unit will be notified and the event will be documented in the surveillance system ... The PIC, in collaboration with the clinical manager of the location where the discrepancy occurs, is responsible for validating no diversion took place ... whether resolved or unresolved ... In the event that diversion is suspected, the clinical manager and/or PIC ... shall notify the Chief Pharmacy Officer to engage the Diversion Rapid Response Team for investigation ... Any concern or suspicion of CS diversion will be immediately reported to the PIC or the Chief Pharmacy Officer ...” 16. The P&P titled “Resolution of Controlled Substance Handling Discrepancies [ASANTE,” dated “Approval: 10/21/2022,” was reviewed and reflected “Asante Pharmacy Informatics will trend employees responsible for the [CS] discrepancies. Employees with multiple incidents or suspicious trends will be communicated to the Pharmacy Manager, Direct Supervisor, Department Manager, and/or Director responsible for the clinical area. A fair and appropriate investigation will be conducted, and corrective action may be warranted ... If diversion is suspected, it will be investigated ...” 17. The P&P titled, “Diversion Investigation and Reporting (ASANTE),” dated effective 01/04/2022 reflected that “The prevention of drug diversion is essential to the safety of Asante patients ...” The P&P included: * “Asante workforce members are required to report known or suspected incidents of drug diversion ... All suspected incidents of drug diversion will be thoroughly investigated ... Suspicion of drug diversion may arise from a variety of circumstances, including, but not limited to ... A witnessed incident of probable drug diversion ... Behaviors that may indicate an impaired individual ... Routine Pharmacy Activity Audits ... The Rapid Response Diversion Team will manage the investigation of all reports of suspected drug diversion ... Asante Leadership will receive prompt notification of incidents of probable drug diversion ... Any Asante workforce member who suspects drug diversion shall notify their supervisor. The Asante supervisor may notify any person listed in the Rapid Response Diversion Team ... An ad hoc team (“Rapid Response Diversion Team”) will immediately convene and will include the following membership ... Dir Pharmacy Services & Chief Pharmacy Officer (DEA Registrant) ... Human Resources Employee Relations Representative ... Legal Officer and General Counsel ... Department Manager, Director, Vice President or Medical Staff leader of the employee or workforce member ... Pharmacy Manager of the Entity ... Medication Safety Coordinator, as needed ... The Rapid Response Diversion Team will open an investigation, review the concern and any related documentation, and determine whether additional information is needed ... if the Rapid Response Diversion Team determines that there is sufficient evidence to support a suspected diversion, the employee will immediately be sent for a ‘Fit for Duty/Right to Test’ evaluation ... The Fit for Duty/Right to Test shall not be unnecessarily delayed ... Following the Fit for Duty/Right to Test drug test, the Asante workforce member will be suspended without pay until test results are returned ...” * “The Rapid Response Team shall complete the Diversion Incident Checklist in Appendix A for any diversion incident.” Appendix A, titled, “Diversion Incident Checklist” was reviewed and included sections for recording RRDT members, concerns and source of concerns, investigation documentation, total doses diverted, drug test results, Compliance Officer review, completion of HR and manager paperwork, and reports submitted to hospital leadership, DEA, Oregon Board of Pharmacy, professional licensing agencies, law enforcement, and others. The checklist included spaces for recording the date each section was completed. 18. The P&P titled “Controlled Substance Management Policy (ASANTE)” dated effective 06/13/2022 reflected that an RER was the hospital’s event reporting system used to report and track “medication misadventures, [P&P] variances, CS discrepancies, as well as adverse events” and included that an “RER shall be completed to permit clinical manager and PIC follow up.” Regarding the hospital’s failure to fully develop and implement effective systems and P&Ps that ensured fentanyl and other CS were accurately accounted for and documented in a timely manner creating the risk for drug diversion and patient harm: 19.a. Refer to the findings cited at Tag A-491 under CFR 482.25(a) - Standard: Pharmacy Management and Administration. Those findings reflect the hospital’s failure to develop and implement effective and clearly written P&Ps that ensured IV fentanyl and other CS were accurately accounted for including during waste processes, infusion rate changes, and IV boluses as described under Findings 2 and 2.a. in that tag. 19.b. Refer to findings 8.b. and 12 in this tag that reflect: * Finding 8.b. reflects MICU revealed that the hospital had no process to account for fentanyl waste in IV tubing; and nurses did not consistently document fentanyl boluses in the MAR and this created problems accounting for fentanyl. * Regarding fentanyl infusion rate changes, Finding 12 reflects pharmacy leadership revealed that fentanyl infusions had discrepancy issues all the time. * Regarding fentanyl waste in infusion tubing, Finding 12 reflects pharmacy leadership stated it was supposed to be accounted for and documented during Omnicell waste processes and nurses were not doing that. 19.c. Refer to the findings cited at Tag A-494 under CFR 482.25(a)(3) - Pharmacy Management and Administration, Finding 5.a. that reflected the hospital lacked P&Ps developed and implemented regarding: * How volumes of fentanyl in infusion tubing and infusion bags should be measured and accounted for during waste procedures. * How fentanyl should be accounted for during infusion rate changes. Regarding the hospital’s failure to ensure nurse training/education included procedures for accounting for and wasting IV fentanyl and other CS: Regarding the hospital’s failure to ensure nurse training/education materials were developed to ensure nursing staff were educated on and had demonstrated competency for accurate accounting and wasting IV fentanyl and other CS: 20. Refer to the findings cited at Tag A-491 under CFR 482.25(a) - Standard: Pharmacy Management and Administration. Those findings reflect the hospital’s failure to ensure nursing staff were trained and had demonstrated competency for situations involving wasting and accounting for IV fentanyl and other CS in accordance with hospital P&Ps as described under Findings 3-3.i. under that tag. Regarding the hospital’s failure to ensure hospital staff reported behaviors and activities suspicious for drug diversion to RRDT, through the hospital’s incident reporting system, and to hospital leadership in accordance with hospital P&Ps: 21.a. Refer to Findings 2-18 in this tag. Those findings reflect multiple instances of behaviors and activities suspicious for drug diversion and the hospital’s failure to ensure those were reported to RRDT, through the hospital’s incident reporting system, and to hospital leadership in accordance with hospital P&Ps. 21.b. Refer to Findings 11 and 15 in this tag. Those findings reflect that hospital staff were required to notify the RRDT every time drug diversion was suspected in accordance with hospital P&Ps. 21.c. Refer to Finding 17 in this tag. That finding reflects hospital P&P required “Asante Leadership will receive prompt notification of incidents of probable drug diversion” and that hospital staff were required to notify their supervisor of suspected drug diversion. 21.d. Email documentation from AGC dated 02/15/2024 at 1616 and 03/08/2024 at 1226 confirmed the hospital’s failure to ensure hospital leadership were notified of suspected drug diversion involving RN4. The response to a request for documentation reflecting that MICU who was aware of RN4’s suspected drug diversion in 2022 and 2023 informed their supervisor of those concerns was “[MICU] emailed [their] supervisor [DNS] ... regarding suspected drug diversion involving [RN4] in 2022 and 2023, on the following dates ... On 01.10.23, at 3:33pm ... On 02.01.23, at 4:54pm ... On 02.09.23, at 2:10pm ... I’ve completed the search, and determined that there are no additional emails ...” Although behaviors and activities were documented for over a year beginning at least May 2022, there was no documentation that reflected nursing leadership was notified until 01/10/2023, which was eight months after initial concerns were identified. The documentation reflected concerns regarding drug diversion continued until July 2023 when RN4’s employment terminated. However, there was no documentation that reflected nursing leadership was notified after 02/01/2023 and 02/09/2023. Regarding the hospital’s failure to ensure improper narcotic handling and other medication related incidents included timely, clear and complete investigations: 22. Refer to the findings cited at Tag A-145 under CFR 482.13(c)(3) - Standard: Privacy and Safety. Those findings reflect the hospital’s failure to ensure improper narcotic handling, behaviors and activities suspicious for drug diversion, and other medication related incidents that reflected potential abuse and neglect included timely, clear and complete investigations and follow-up actions.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 29708 Based on interview, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, and 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients (Patients 1-32 and 34-46), review of hospital P&Ps, and review of other documentation, it was determined that the hospital failed to ensure each patient’s right to be free from all forms of abuse and neglect. Prevention of, identification of, investigations of, and response to incidents that reflected potential abuse and neglect that resulted in actual and potential patient harm, were not clear, complete, and accurate to ensure those incidents and events did not recur for the hospital’s ICU patients and other patients. Failures included: * Failure to prevent patient harm and potential harm as result of failures to ensure proactive, diligent, and timely investigations and responses to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment, and other patient safety concerns while assigned to and caring for patients. * Failure to ensure improper narcotic handling and other medication related incidents included timely, clear and complete investigations to identify causes and to plan and implement corrective actions to prevent recurrence for affected patients and others. Findings include: 1.a. The P&P titled, “Patient Rights (ASANTE),” dated effective 07/29/2020 reflected “... Patients have the following Rights ... Freedom from all forms of abuse or harassment; abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. Our hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs ...” 1.b. The P&P titled, “Responsible Event Reporting and Analysis in a Culture of Safety (ASANTE),” dated effective 04/01/2022 reflected “A Responsible Event Report (RER) is completed for any event that is not consistent with routine patient care or routine operations of the facility. An RER should be completed when an abnormal/unusual event has, or threatens to have, an adverse effect on a patient or visitor ... The event report is completed by the employee who: Participated in the event ... Witnessed the event ... First discovered the event; or ... First received a report of the event ... The event should be completed during the shift in which it occurred ... Unit/Department Manager or Supervisor of the most appropriate department will ... Investigate and document follow-up of all event reports within a two-week time frame ... Assist with any needed system changes to help prevent a similar incident from occurring ...” 1.c. The Pharmaceutical P&P titled, “Medication Error Reporting (ASANTE)” dated effective 03/23/2021 reflected “The pharmacies will use MIDAS+ Event Reporting to record all events or potential events ... Medication errors ... should be reported in the RER program ... The types of events that are to be reported include ... events where safety to staff or patients is compromised ... Events which ... are outside regulation or policy ...” 1.d. The P&P titled “Controlled Substance Management Policy (ASANTE)” dated “effective 06/13/2022 reflected “In the event that diversion is suspected, the clinical manager and/or PIC of the location where the event occurred shall notify the Chief Pharmacy Officer to engage the Diversion Rapid Response Team to [sic] for investigation ...” 2.a. Incident and investigation documentation involving Patient 48 categorized “Medication, Improper Narcotic Handling” with “Event Date” 06/25/2022, and “Event location” ICU reflected: * An entry dated 06/26/2022 at 1933 reflected “During shift change the day charge nurse and I discovered that the nurse [name] who had [Patient 48] in [first room] and [another patient in second room] had pulled 1mg dilaudid IV on one of these patients and gave 0.5mg to the patient in [first room] and 0.5mg to the patient in [second room] ... “ * An entry dated 06/27/2022 at 1155 reflected “... appears dilaudid was split between 2 patients. Any risk of cross contamination between the 2 patients?” An entry dated 06/28/2022 at 0929 reflected “... forwarding to ICU leadership as using 1 syringe to give doses to 2 different patients would not be an acceptable practice.” An entry dated 07/11/2022 at 1431 reflected “[No] cross contamination risk noted. [Addressed] this with RN involved ... No further investigation needed. [Closing].” Undated “Additional Manager/Supervisor Comments:” reflected: “Was this event preventable: Yes ...” An email dated 06/27/2022 at 1507 reflected “... On 6/25 I was the primary RN for [both patient rooms in] the ICU. Timeline as follows. 1735 - both patients required 0.5mg of Dilaudid ... 1737 - removed a 1mg syringe of Dilaudid (0.5mg syringes unavailable) from the omnicell under patient in [first room] ... 1740 - administered 0.5mg of Dilaudid to patient in [first room] ... 1743 - administered remaining 0.5mg from 1mg syringe to patient in [second room] ... 1834 - patient in [second room] expired ... I understand that taking medications from one patient room to another is unacceptable. Given the circumstance, with [patient in second room] actively dying on comfort care, I administered meds in this fashion in a time saving effort ...” * The documentation reflected “No Adverse Outcome”. The documentation lacked a clear and timely investigation. For example, it was not clear how “no cross contamination risk” was determined. There was no investigation that reflected whether the incident was evaluated against hospital P&Ps related to IPC and safe injection practices breaches. The only follow-up action was “[Addressed] this with RN involved. [They are] aware of expectations.” There was no documentation that reflected the specific aspects of the incident that were addressed with the RN, nor how and when that occurred. There was no documentation of further investigation or follow-up actions. There was no assurance similar incidents involving other patients would be prevented. 2.b. During interview on 02/29/2024 at ~ 1030, IPD stated needles and single-use medications were not to be used for “multi-use”. IPD stated they did not know if IP had been informed of the incident in Finding 2.a. and stated, “Risk would have expertise on how these events are managed.” 3.a. Incident and investigation documentation involving an ICU nurse, RN4 and Patient 49 was reviewed. The incident was categorized “Medication, Given But Not Charted” with “Event Date” 07/30/2022 at 0751, “Date Received” 09/06/2022, and no patient name. The documentation reflected: * “... Looks like maybe the med was pulled under the wrong pt’s name or I accidentally left myself logged in the omnicell & another nurse pulled meds under my name. Pharmacy has the corrected information ... Upon further investigation, it looks like there was a mix up with the pt and the nurse and pharmacy has corrected this. I’m writing this as I’m not sure if I still need to since it wasn’t for the pt I was caring for, not [sic] do I believe the pt is who received the med ...” An entry dated 09/07/2022 at 0851 reflected “Not much info to go on - no patient name, medication name, etc ...” An entry dated 09/15/2022 at 0819 reflected “Reviewed with informatics. This was related to an oxycodone 5 mg discrepancy. It was administered on the wrong patient. Appears both patients had orders for oxycodone but was pulled from omnicell on a different patient than it was charted on. This has been corrected.” The documentation lacked a thorough and timely investigation. For example, the event date was 07/30/2022. However, the documentation suggested the incident was not reported until 09/06/2022, five weeks later. There was no investigation that reflected whether staff were interviewed in effort to determine further details about how the incident occurred, including potential contributing factors. There was no investigation that reflected whether the incident was evaluated against hospital P&Ps such as those related to administration and documentation of CS and patient monitoring. The documentation reflected oxycodone was administered to the wrong patient. However, it was not clear who received the medication as there were no patient names or other identifying information. There was no documentation that reflected diversion had been ruled out. There was no documentation of further investigation or follow-up actions. There was no assurance similar incidents involving this patient or other patients would be prevented. 3.b. In an email dated 02/28/2024 at 1601, AGC confirmed there was no further investigation or follow-up actions, and no patient name associated with the incident in Finding 3.a. in this tag. 4. Incident and investigation documentation involving Patient 51 categorized “Medication, Improper Narcotic Handling” with “Event Date” 10/30/2022 and “Event location” Neuro/Ortho reflected: * An entry dated 05/04/2023 at 0813 reflected “RN pulled hydromorphone but did not issue, waste or return. This was a Traveler RN that is no long [sic] with Asante. An entry dated 05/05/2023 at 1154 reflected “Including pharmacy referral for med rec of unaccounted for med.” An entry dated 05/08/2023 at 1228 reflected “Sent information to pharmacy informatics.” The documentation lacked an investigation and follow-up actions. There was no documentation of interviews, observations, or other information in effort to determine potential causes and contributing factors. There was no investigation that reflected: * Whether the hospital had provided the traveler RN training/education, as applicable regarding the hospital’s P&Ps such as those related to narcotic medication administration and waste procedures. * Whether the traveler RN had been involved in other improper narcotic handling incidents and whether drug diversion had been ruled out. * Whether the incident was evaluated against hospital P&Ps, as applicable, such as those related to narcotic medication administration, narcotic medication waste procedures, and incident investigations including how those should be managed for incidents involving traveler RNs when their contract ended before narcotic discrepancies could be resolved. There was no investigation that reflected abuse and neglect had been ruled out. There was no documentation of further investigation or follow-up actions. There was no assurance similar incidents involving this patient and other patients would be prevented. 5. Incident and investigation documentation involving Patient 53 categorized “Medication, Improper Narcotic Handling” with “Event Date” 12/26/2022, “Received Date” 04/13/2023 and “Event location” Neuro/Ortho reflected: * An entry dated 04/13/2023 at 0836 reflected “Issued without [administration], return, or waste - Medication discrepancy.” * An entry dated 04/14/2023 at 0916 reflected “Unsure which staff member and if they still work here?” An entry dated 04/14/2023 at 1308 reflected “This was a traveler RN [name] and [they are] no longer [with] Asante.” The final entry dated 04/18/2023 at 1533 reflected “Will inform pharmacy informatics.” The documentation lacked a thorough and timely investigation. For example, the documentation reflected the incident occurred 12/26/2022. However, there was no documentation of further investigation until more than three months later on 04/13/2023. There was no documentation of name, dose, or route of narcotic medication issued. There was no investigation that reflected whether diversion had been ruled out. There was no investigation that reflected abuse and neglect had been ruled out. There was no documentation of follow-up actions. There was no assurance similar incidents involving this patient and other patients would be prevented. 6. Incident and investigation documentation involving Patient 54 categorized “Medication, Improper Narcotic Handling” with “Event Date” 12/26/2022, “Received Date” 04/13/2023 and “Event location” Neuro/Ortho reflected: * An entry dated 04/13/2023 at 0835, more than three months after the event date, reflected “RN issued 2mg, wasted 1mg, 1mg outstanding. Medication discrepancy.” An entry dated 04/14/2023 at 0915 reflected “Unsure which staff member and if they still work here?” * An entry dated 04/14/2023 at 1307 reflected “This was a traveler RN [name] and [they do] not work here anymore.” The next and final entry dated 04/18/2023 at 1532 reflected “Will inform pharmacy informatics.” * The documentation reflected “No Adverse Outcome.” The documentation lacked a thorough and timely investigation. For example, there was no investigation that reflected how no adverse outcome was determined. There was no investigation that reflected diversion had been ruled out. There was no investigation that reflected abuse and neglect had been ruled out. There was no documentation of further investigation or follow-up actions. There was no assurance similar incidents involving this patient and other patients would be prevented. 7. Incident and investigation documentation involving Patient 55 categorized “Medication, Improper Narcotic Handling” with “Event Date” 12/29/2022, “Received Date” 04/25/2023 and “Event location” Neuro/Ortho reflected: * An entry dated 04/25/2023 at 1539, four months after the event date, reflected “RN issued did not [administer] waste or return. RN was a traveler RN.” The next and final entry dated 04/26/2023 at 1316 reflected “Manager/[Supervisor] entered event so management is aware of the issue. Risk to close.” The space for documenting “Outcome(s)” was blank. The documentation lacked a thorough and timely investigation. For example, there was no investigation that reflected whether the patient experienced harm. There was no investigation that reflected the type of “Narcotic”, dose or other information in effort to determine a potential pattern of similar incidents. There was no investigation that reflected diversion had been ruled out. There was no documentation of further investigation or follow-up actions. There was no assurance similar incidents involving this patient and other patients would be prevented. 8. Incident and investigation documentation involving Patient 57 categorized “Medication, Improper Wastage” with “Event Date” 05/19/2023, “Event location” ICU, and no patient name reflected: * An entry dated 05/19/2023 at 1855 reflected “fentanyl citrate 50mcg/1ml 1ml vial was drawn up into syringe. [Both] the vial (empty) and syringe (with fentanyl inside) were placed into return bin and was returned as 1 vial instead of wasted. [There] was no indication that the liquid in the syringe was in fact fentanyl.” An entry dated 05/22/2023 at 1535 reflected “... unsure if there’s any way to figure out a patient name or staff member name? Sounds like this was a return bin but not an omnicell return bin?” The next entry dated 06/12/2023 1534 reflected “will send out a general reminder on wasting procedure. If we can find out who the user was I will follow up individually.” The final entry dated 07/04/2023 at 1408, more than a month later reflected “Correct, this was placed in a non secured return bin based on my understanding. Would be difficult to attempt to determine specific individual in this case.” Although the documentation reflected there was no indication that the liquid in the syringe was in fact fentanyl, there was no documentation of attempts to further investigate this. There was no documentation that reflected diversion had been ruled out. There was no documentation of follow-up actions aside from “will send out a general reminder on wasting procedure.” 9.a. Incident and investigation documentation involving RN4 and Patient 58 with “Event Date” 06/27/2023, “Date Received” 07/04/2023, “Event location” ICU, and no patient name was reviewed and reflected: * An entry dated 07/04/2023 at 1642 reflected “Multiple times this shift I found ICU [room number] patient unattended. RN was in bathroom multiple [times] without another nurse watching [their] patient. This happened at least 5 times during this shift. RN did not follow [P&P] and improper handling of medication causing an unsafe and stressful transport of a critical covid patient ... Transport arrived to take patient to CT. [RN] states [they were] not taking any pumps with [them] and we needed to hurry to get that patient back to ICU. RN pulled syringe and needle from drawer and drew up a med ... [RN] continued to pressure us to hurry because [they] did not want to take pumps with [them] ... Patient laid on [CT] table ... did not tolerate being laid flat ... Patient was coughing and desaturated while nurse was frustrated, making comments to just complete the scan. [RN] pulled a syringe of propofol out from somewhere and gave [patient] a bolus. After this I felt very unsafe and questioned why [they] did not bring the pump to control sedation. Pt was strapped in for [CT] scan and [SpO2] monitor became disconnected and RN told us ‘It’s fine, lets just hurry and do the scan, [patient] has been 92% all day’. I told [RN] No I was not sending [patient] through [CT] [without] the SpO2 monitor. [RN] continued to be annoyed and walked out of the room while the CT tech and I unstrapped [patient] and hooked [SpO2] back up. [RN] saw us struggling because it was stuck under [patient’s] arm and ripped it out aggressively from under [patient] ... we were again rushed by nurse to get patient back to ICU as fast as we could ... [RN] began hooking patient back up to pumps ... I contacted ICU [charge nurse] because it was a stressful transport that felt very unsafe. [Charge nurse] validated my concerns ... I am concerned this may not be the first time this nurse has transported without pumps and propofol in [their] pocket.” An entry dated 07/05/2023 at 1336 reflected “Note: ... ‘hypoxia’ was entered as an outcome ... this event was not connected to a patient name, which would have been most appropriate ...” The documentation lacked a thorough investigation. For example, there was no further documentation of interviews, observations, or other information in effort to determine potential causes and contributing factors. There was no documentation of further investigation regarding: * Whether RN4 had been involved in similar incidents involving the same or other patients. * The patient’s outcome of “hypoxia” including how long the patient experienced hypoxia and whether the patient experienced additional harm including related to documentation that reflected RN4 “ripped [SpO2 monitor] out aggressively from under [patient]”. * Efforts to identity the patient. * Whether the incident was evaluated against hospital P&Ps, as applicable, such as those related to patient transport between departments, propofol administration during CT scan, RN monitoring and supervision during CT while under sedation, and RN coverage while on break or otherwise unavailable to assigned patients. There was no investigation that reflected abuse and neglect had been ruled out. There was no documentation of further investigation or follow-up actions. There was no assurance similar incidents involving the patient and other patients would be prevented. 9.b. An email dated 04/03/2024 at 1547 from AGC regarding Finding 9.a. reflected “The patient [Patient 58] associated with incident [number], which happened on 06/27/23, is not known.” 10. Incident and investigation documentation involving Patient 60 categorized “Medication, Improper Narcotic Handling” with “Event Date” 12/22/2023, “Event location” ICU, and no patient name was reviewed and reflected: * An entry dated 12/22/2023 at 2216 reflected “Lock box with bag of Fentanyl and tubing attached in dirty utility. Estimated amount of fentanyl in bag and tubing was 30 mL. I cannot be sure what patient this medication belonged to ...” * An entry dated 12/26/2023 at 1154 reflected “For manager review, also including referral to pharmacy, might be looking for missing documentation of waste on a particular patient, are the bags of fentanyl in the lock boxes not labeled with the patient names?...” * An entry dated 12/26/2023 1353 reflected “If the fentanyl infusion was standard concentration which we obtain from an outsourcing pharmacy, it would have been loaded in the Omnicell and could be pulled from their profile. The bag would not however be labeled with the patient information as it wouldn’t have been dispensed from the pharmacy.” * The next and final entry dated 12/26/2023 at 1605 reflected “Will make pharmacy informatics aware for any reconciliation.” The documentation lacked a thorough investigation. For example, there was no further documentation of interviews, observations or other information in effort to determine potential causes, contributing factors, and follow-up actions to prevent reoccurrence. The documentation reflected there was a possible patient associated with the fentanyl medication. However, there was no further investigation regarding how long the fentanyl had been in the dirty utility room, who found it and when, nor interviews with staff in effort to understand why the fentanyl was left in a dirty utility room. There was no investigation that reflected whether the incident was evaluated against hospital P&Ps, as applicable, such as those related to waste processes involving CS. There was no investigation that reflected whether diversion had been ruled out. There was no documentation of further investigation or follow-up actions. There was no assurance similar incidents involving other patients would be prevented. 11. Incident and investigation documentation involving Patient 61 categorized “Med, IV Smart Pump” with “Event Date” 01/18/2024 and “Event location” ICU was reviewed and reflected: * An entry dated 01/18/2024 at 1134 reflected “RN was standing at bedside and able to immediately respond to an air in line alarm on the levophed infusion. Despite being able to immediately respond and fix alarm, patient BP dropped from 110/75 to 65/40. Had [RN] not been right there to fix this, the patient could have arrested.” An entry dated 01/19/2024 at 0808 reflected “For manager review, was this air in line alarm d/t the micro air bubbles that have been an ongoing issue? Or was this a large air bubble? Was the BP drop d/t having to trouble shoot, change tubing, etc? Unable to tell from the flowsheets how long the BP was decreased, is that able to be determined? Including referrals to pharmacy, biomed ... ongoing concern with air bubble alarms on smart pumps.” * An entry dated 01/19/2024 at 1349 reflected “... referred to system level medication safety/pharmacy.” * An entry dated 01/23/2024 at 0741 reflected “Will validate with purchasing if new tubing from b [sic] braun has arrived or not and if it has, is it distributed and the older tubing removed from critical care ... will add it to a log to see if this trend continues after new tubing is being used.” * The next and final entry dated 01/23/2024 at 1026 reflected “Yes, this was r/t micro bubbles. During purging, no visible air bubbles were present. All involved pumps were sequestered and sent to biomed with the proper documentation. This significantly impacted the patient and contributed to [their] deterioration.” The documentation lacked a thorough investigation. For example, the documentation reflected there had been an “ongoing” concern with air bubble alarms and IV smart pumps and all involved pumps had been sequestered. However, there was no documentation that reflected how long those concerns had been occurring, when the pumps were sequestered, and what was being done to ensure patient safety during the time the pumps remained in use. It was additionally not clear if there was a problem with the pumps, tubing or both. There was no documentation of follow-up regarding: * How long the patient’s blood pressure had been decreased. * Further information about how the patient had been “significantly impacted” by the incident. * How the incident contributed to the patient’s decline. There was no investigation that reflected whether the incident was evaluated against hospital P&Ps, as applicable, such as those related to ensuring patient care equipment was safe and appropriately maintained when in use. There was no investigation that reflected abuse and neglect had been ruled out. There was no documentation of further investigation or follow-up actions. 12. Refer to the findings cited at Tag A144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Those findings reflect incidents regarding: * Patient 10, behaviors suspicious for staff diversion involving RN4 on 12/08/2022 described under Finding 3.h. in that tag. * Patient 13, behaviors suspicious for staff diversion involving RN4 on 12/21/2022 described under Findings 3.n. and 3.p. in that tag. * Patient 28, 300 mL “outstanding” medication and “missing volume of Fentanyl” involving RN4 on 06/27/2023 or 06/28/2023 described under Findings 7.g. and 7.m. in that tag. * Patient 59, missing fentanyl involving RN4 on 07/01/2023 and 07/02/2023 described under Findings 7.i. and 7.m. in that tag. There was no documentation that reflected an RER had been completed, nor a timely and thorough investigation and follow-up actions to those incidents involving Patients 10, 13, 28, and 59. 13. Similar findings were identified related to the hospital’s failure to conduct clear and timely investigations and follow-up actions regarding improper narcotic handling and other medication related incidents involving: * Patient 47, incident categorized “Medication, Improper Narcotic Handling” with “Event Date” 01/29/2022. * Patient 50, incident categorized “Medication, Improper Narcotic Handling” with “Event Date” 10/26/2022. * Patient 52, incident categorized “Medication, Improper Narcotic Handling” with “Event Date” 12/25/2022. * Patient 56, incident categorized “Medication, Dosage/Rate Incorrect” with “Event Date” 05/19/2023. * Patient 59, incident categorized “Medication, Order Related” with “Event Date” 07/08/2023. 14. An email dated 02/08/2024 at 1537 from AGC confirmed there was no documentation of further investigation or follow-up actions regarding the incidents involving Patients 50-57, 60 and 61. 15.a. Refer to Findings 2-13 cited at Tag A144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Those findings reflect that hospital staff and others observed numerous incidents of behaviors and activities suspicious for drug diversion, impairment, and other patient safety concerns involving RN4 and ICU patients. Behaviors and activities were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. Prevention, identification, investigations, and response to those incidents that reflected potential abuse, neglect and patient harm, were not conducted or were not timely, clear and thorough to ensure they did not recur. 15.b. During an interview on 02/01/2024 at 1140 CLO stated the hospital had conducted a search of its incident reporting system and found only two RERs involving RN4. The CLO provided those RERs and they are described in Findings 3.a. and 9.a. in this tag regarding Patients 49 and 58, respectively. CLO confirmed there were no other RERs regarding RN4’s behaviors and activities suspicious for drug diversion, impairment, and other patient safety concerns involving multiple patients as described in Findings 2.a.-13 cited under Tag A144.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1-32 and 34-46), review of education/training records for 8 of 8 ICU nursing staff (Employees 1-8), review of education/training materials, review of hospital P&Ps, and review of other documentation, it was determined that the hospital failed to ensure an RN supervised and evaluated the nursing care of each patient, and nursing care and services were provided in a manner that ensured the ongoing health and safety of the hospital’s ICU patients and other patients. Failures included: * Failure to prevent nursing staff from leaving critically ill, unstable ventilated ICU patients and other patients unattended creating the risk for patient harm. * Failure to ensure nursing staff proactively, diligently and timely reported and responded to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns involving multiple patients in accordance with P&Ps creating the risk for patient harm, including BSIs. Findings include: 1. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Those findings reflect: * Failures of the nursing department and nursing staff from preventing critically ill, unstable ventilated ICU patients and other patients from being left unattended. Examples include but are not limited to those described in Findings 7.f., 7.h., 7.j., 7.l. and 8.a. * Failures of the nursing department and nursing staff to adhere to the hospital’s Fit for Duty, RRDT, incident reporting, and other P&Ps to ensure proactive and timely responses to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients as described in Findings 2-13.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1-32 and 34-46), review of education/training records for 8 of 8 ICU nursing staff (Employees 1-8), review of education/training materials, review of hospital P&Ps, and review of other documentation, it was determined that the hospital failed to ensure the DNS provided adequate supervision and evaluation of the hospital’s nursing staff within the responsibility of the nursing service. Failures included: * Failure to ensure nursing staff adhered to the hospital’s Fit for Duty, RRDT, incident reporting and other P&Ps in response to an ICU nurse’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients creating the risk for diversion and patient harm, including BSIs. * Failure to ensure new hire reference checks were conducted in accordance with the hospital’s required processes. * Failure to ensure performance evaluations were conducted annually in accordance with hospital P&Ps. * Failure to recognize and address performance and behavior concerns during performance evaluations in accordance with hospital P&Ps. * Failure to investigate and prevent recurrence of incidents involving improper narcotic handling, behaviors and activities suspicious for drug diversion and impairment, and other medication related incidents in ICU and other units, including those involving traveler RNs in accordance with hospital P&Ps. * Failure to prevent unaccounted for and undocumented IV fentanyl and other CS. Findings include: 1. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Findings 2-16.a. reflect the hospital’s failure to ensure nursing staff adhered to the hospital’s P&Ps in response to ICU nurse, RN4’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns while assigned to and caring for patients creating the risk for diversion and patient harm, including BSIs. 2. During interview with CLO on 02/01/2024 at ~1140, CLO stated RN4 was hired in 2016. 2.a. Review of personnel record documentation revealed no documentation that reflected the hospital had completed pre-employment professional and personal reference checks for RN4 in accordance with hospital P&Ps in effect at that time. Refer to Finding 2.b. in this tag that reflects the hospital required pre-employment professional and personal reference checks when RN4 was hired in 2016. 2.b. Regarding pre-employment professional and personal reference checks, email documentation from AGC dated 02/08/2024 at 1539 reflected “In 2016, Asante required reference checks for all external new hire candidates including RNs ... Asante searched its own files, and cannot locate any references or reference reports for the nurse in question [RN4] ...” 3.a. Review of personnel record documentation revealed RN4’s employment terminated 07/26/2023. There was no documentation of an annual performance evaluation for RN4 for 2021. 3.b. Email documentation from AGC dated 03/05/2024 at 1435 reflected “There was no performance evaluation for [RN4] in 2021 ...” 3.c. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Findings 4.a. and 4.b. reflect the hospital’s failure to recognize and address RN4’s behaviors and activities suspicious for drug diversion, impairment and other patient safety concerns in their annual performance evaluation; and failed to develop a plan to address those concerns to ensure patients received safe care. 3.d. The P&P titled “Performance and Competency Management (ASANTE),” dated effective 02/02/2021 reflected “The steps to performance management include planning, coaching, mentoring, review, and development and reward to recognize contributions, skills, performance, and competency to prepare employees for continued growth with Asante and to assure staff is competent to provide care to our patients and fulfill the requirements of their job ... Coaching/Mentoring ... On an ongoing basis, supervisors ... and others provide input to employees toward achieving the performance standards for their positions ... Problems and challenges are identified as early as practical and employees are provided direction by supervision and management including resources needed to meet performance standards ... Past performance or behavior concerns not successfully managed through coaching may progress to corrective action ... Manager/Employee Review: Annually (or more frequently if desired) ... During this process, performance and behavioral standards are reviewed ... Annually and no later than 12/31, managers/supervisors complete a summary of each employee’s performance discussions. The evaluation contains ... Identification of specific performance or behavioral standards that are not being met ...” 4. Refer to the findings cited at Tag A-145 under CFR 482.13 (c)(3) - Standard: Privacy and Safety. Those findings reflect the hospital’s failure to investigate and prevent recurrence of improper narcotic handling and other medication related incidents that reflected potential abuse and neglect. Those involved nursing staff in ICU including RN4, nursing staff in other units, and Patients 10, 13, 28, and 47-61 as described in Findings 2.a., 2.b., 3.a., 3.b., 4-8, 9.a., 9.b. and 10-13 in that tag. 5. Refer to the findings cited at Tag A-494 under CFR 482.25(a)(3) - Standard: Pharmacy Management and Administration. Those findings reflect the hospital’s failure to ensure unaccounted for and undocumented IV fentanyl and other CS were prevented including but not limited to those involving infusion rate changes, boluses, and waste procedures described in Findings 1.a.-5.a. in that tag.”

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1- 32 and 34 - 46), review of education/training records for 8 of 8 ICU nursing staff (Employees 1-8), review of education/training materials, review of pharmacy audit documentation, review of diversion committee documentation, review of quality and patient safety committee documentation, review of hospital P&Ps, and review of other documentation, it was determined the hospital failed to ensure pharmaceutical P&Ps were fully developed, implemented, effective and in accordance with professional principles as follows: * Failure to ensure proactive, diligent, and timely efforts to detect and address activities suspicious for drug diversion involving IV fentanyl and other CS that created the risk for patient infections and other adverse events. * Failure to develop and implement clearly written P&Ps regarding wasting and accounting for IV fentanyl and other CS that created the risk of diversion and patient harm. * Failure to ensure staff were trained and had demonstrated competency for accounting and wasting IV fentanyl and other CS in accordance with hospital P&Ps. * Failure to ensure incidents suspicious for drug diversion, and other medication related events that reflected potential abuse and neglect were investigated in a timely manner, analyzed, trends detected, and integrated into the hospital’s QAPI program in a manner that was effective and identified new problems and opportunities for continuous improvement, and refinement of P&Ps. Findings include: The hospital failed to ensure proactive, diligent, and timely efforts to detect and address activities suspicious for drug diversion involving IV fentanyl and other CS that created the risk for patient infections and other adverse events: 1. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Those findings reflect the failure to ensure proactive, diligent, and timely efforts to detect and address activities suspicious for drug diversion involving IV fentanyl and other CS that created the risk for patient infections and other adverse events as described in Findings 2.a.-13. Documentation of those activities involved ICU nurse, RN4 and behaviors and activities were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. The hospital failed to develop and implement clearly written, comprehensive, and effective P&Ps regarding wasting and accounting for IV fentanyl and other CS that created the risk of diversion and patient harm. Refer to Findings 2-2.c. in this tag. 2. Pharmaceutical and other P&Ps were reviewed and failed to include procedures that ensured volumes of IV fentanyl and other CS were accurately accounted for including waste from infusion bags and tubing; and situations involving infusion rate changes and IV boluses. Examples of P&Ps reviewed included but were not limited to: * The P&P titled, “Controlled Substance Management Policy (ASANTE),” dated effective 06/13/2022 reflected “The CSDPP Committee shall ... Ensure [P&Ps] cover all aspects of CS use ... The PIC is responsible for ensuring policy-compliant procedures are in place and followed pertaining to procurement, storage, prescribing, preparation and dispensing, administration, transfer, waste ... of CS at their respective sites ...” The P&P did not include information about how volumes of fentanyl and other CS should be managed to ensure accurate accounting including waste from infusion bags and tubing; and situations involving infusion rate changes and IV boluses. 2.a. Similarly, the following P&Ps failed to describe how volumes of fentanyl and other CS should be managed to ensure accurate accounting including waste from infusion bags and tubing; and situations involving infusion rate changes and boluses: * “Lock Box for Controlled Substances Infusions (ASANTE)” dated effective 12/05/2019. * “Controlled Substance Chain of Custody Procedure (ARRMC)” dated effective 08/06/2020. * “Medication Automated Dispensing Units (ADU) (ASANTE)” dated effective 07/15/2021. * “Resolution of Controlled Substance Handling Discrepancies (ASANTE)” dated effective 11/09/2021. * “Resolution of Controlled Substance Handling Discrepancies (ASANTE)” dated effective 03/31/2022. * “Pharmaceutical Waste Management (ASANTE)” dated effective 03/28/2023. * “Controlled Substance Chain of Custody Procedure (ARRMC)” dated effective 05/01/2023. * “Resolution of Controlled Substance Handling Discrepancies (ASANTE)” dated effective 07/10/2023. 2.b. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Those finding reflects the pharmaceutical department failed to develop and implement P&Ps that ensured IV fentanyl was accurately accounted for including situations involving boluses, infusion tubing, infusion bags, and waste processes as described in Findings 8.b. and 12. 2.c. Refer to the findings cited at Tag A-494 under CFR 482.25(a)(3) - Standard: Pharmacy Management and Administration. Those findings reflects the pharmaceutical department failed to develop and implement P&Ps that ensured IV fentanyl was accurately accounted for including situations involving infusion rate changes, infusion tubing, infusion bags, and waste processes as described in Finding 5.a. The hospital failed to ensure staff were trained and had demonstrated competency for accounting and wasting IV fentanyl and other CS in accordance with P&Ps. Refer to Findings 3.a.-3.i. in this tag. 3.a. The P&P titled, “Controlled Substance Management Policy (ASANTE),” dated effective 06/13/2022 reflected: * “... When diverted from proper use, controlled substances can lead to patient safety issues ... [and] regulatory noncompliance ... HCWs shall be trained and demonstrate competence in established policies, procedures, and regulatory requirements ... Each entity shall have procedures in place, as approved by the PIC, guiding secure CS use by authorized HCW including dispensing, returning, counting, and wasting in the ADUs ... Authorized HCWs shall be trained and demonstrate competence in the use of all controlled substance storage mechanisms ...” 3.b. A training/education slide presentation titled, “Asante Pharmaceutical Waste Management and Compliance Program” dated 09/15/2022 reflected “Safe Disposal of all Pharmaceutical Waste ... lowers drug diversion of controlled substances ... Pharmaceutical waste is any leftover, unused or expired medication that is not creditable and is to be discarded. This includes LEFTOVER or UNADMINISTERED medication in ... Partially full or full vials, ampoules, syringes ... Medicated IV bags ... Partially used patches ... Tablets, pills, capsules ... ointments and creams ... Liquids, drops, syrups”. There was no information regarding how volumes of fentanyl and other CS in infusion tubing and bags were to be accurately accounted for and documented during waste processes, nor for frequent infusion rate changes and boluses. 3.c. A training document titled, “Elements 2023 Drug Diversion” reflected: * “What is drug diversion? Any act or deviation that removes a prescription drug from its intended path from the manufacturer to the patient. By nature, diversion is a secretive activity. Just because you are not aware of drug diversion does not mean it is not happening around you ...” * “Impact on the organization ... Patient safety/quality of care concerns ...” * “Medication best practice workflows ... Pull medication for one patient at a time and administer immediately ... Complete controlled substance documentation within 30 minutes ... Take responsibility for any medication you remove from the Omnicell ... Correct any Omnicell discrepancies before the end of shift ... Ensure appropriate disposal of controlled substances ...” * “Recognizing RED FLAG behaviors ... Tardiness, unexpected absences ... Inconsistent compliance with best-practice workflows ... Pattern of narcotics near end of shift ... Isolation from peers ... Rounding at odd hours ... Decreased quality of care, lack of concentration... Interpersonal relationships with colleagues, staff and patients suffer ... Frequent trips to bathroom or to personal belongings”. * “Examples of diversion interventions ... Drug vials found in wrong containers ... Tampered waste containers ... Empty medication wrappers in bathroom ...” There was no information regarding how quantities of fentanyl and other CS in infusion tubing and bags were to be accurately accounted for and documented during waste processes, nor after frequent infusion rate changes and after administration of boluses. 3.d. Regarding Employee 1, RN with ICU start date 08/13/2013, training/education records failed to address how fentanyl and other CS in infusion tubing and bags were to be accurately accounted for and documented during waste processes, nor after frequent infusion rate changes. For example, Employee 1’s training/education records reflected they had completed “Elements 2023: Drug Diversion Training” on 12/14/2023. However, review of that training/education material reflected it did not address how volumes of fentanyl and other CS in infusion tubing and bags were to be accurately accounted for and documented during waste processes, nor for infusion rate changes and boluses. 3.e. Regarding Employee 2, RN with ICU start date 03/01/2020, training/education records failed to address how fentanyl and other CS in infusion tubing and bags were to be accurately accounted for and documented during waste processes, nor after frequent infusion rate changes. For example, Employee 2’s training/education records reflected they had completed “Clinical Elements 2023 - Asante Pharmaceutical Waste Management and Compliance Program” on 05/09/2023, and “Elements 2023: Drug Diversion Training” on 10/01/2023. However, neither of those training/education materials addressed how quantities of fentanyl and other CS in infusion tubing and bags were to be accurately accounted for and documented during waste processes, nor for infusion rate changes and boluses. 3.f. Regarding Employee 3, RN with ICU start date 04/18/2016, training/education records failed to address how fentanyl and other CS in infusion tubing and bags were to be accurately accounted for and documented during waste processes, nor after frequent infusion rate changes. Employee 3’s training/education records reflected they had completed “Clinical Elements 2023 - Asante Pharmaceutical Waste Management and Compliance Program” on 05/23/2023, and “Elements 2023: Drug Diversion Training” on 12/28/2023. However, neither of those training/education materials addressed how fentanyl and other CS in infusion tubing and bags were to be accurately accounted for and documented during waste processes, nor for infusion rate changes and boluses. 3.i. Review of training/education records for the following nursing staff revealed similar findings regarding the hospital’s failure to address how fentanyl and other CS were to be accurately accounted for and documented: * Employee 4, RN with ICU start date 01/11/2016. * Employee 5, RN with ICU start date 10/30/2017. * Employee 6, RN with ICU start date 03/01/2021. * Employee 7, RN with ICU start date 08/09/2021. * Employee 8, RN with ICU start date 10/17/2022. The hospital failed to ensure behaviors and activities suspicious for drug diversion, and other medication related events that reflected potential abuse and neglect were investigated and analyzed timely, trends detected, and integrated into the hospital’s QAPI program in a manner that identified new problems and opportunities for continuous improvement, and refinement of P&Ps: 4.a. The Pharmacy P&P titled, “Controlled Substance Management Policy (ASANTE)” dated effective 06/13/2022 reflected “... A multilayered, interdisciplinary, system-level Controlled Substance Diversion Prevention Program (CSDPP) shall be maintained in place. This program shall govern CS practices across Asante in consultation with executive leadership ... The CSDPP Committee shall ... Report at least annually to Asante Quality Management Review ... Be proactive in its efforts to actively address diversion detection and prevention, support incident investigations as necessary, monitor reports and detect trends, enhance quality improvement, and coordinate controlled substance activities ...” It was not clear how potential or actual drug diversion concerns at individual, separately certified hospitals, units, and departments within the system would be monitored, trends detected, opportunities for continuous improvement identified, and integrated into ARRMC’s QAPI Program. 4.b. The P&P titled, “Medication Handling and Administration (ASANTE)” dated effective 11/03/2023 reflected “QUALITY IMPROVEMENT ... Medication-related safety concerns should be reported via the Responsible Event Reporting (RER) system. Medication events related to medication administration timing will be reviewed and trended ... Medication events data is shared at Asante Pharmacy and Therapeutics (P&T) and Quality Council committee meetings and the Medication Safety Council ... Controlled substance reports are reviewed by clinical leadership.” Although the P&P reflected that “medication events data” was shared at pharmacy, quality, and safety committees and CS reports were reviewed by clinical leadership, it was not clear if this included potential and actual drug diversion concerns. It was not clear how potential or actual drug diversion concerns at individual, separately certified hospitals, units, and departments within the system would be monitored, trends detected, opportunities for continuous improvement identified, and integrated into ARRMC’s QAPI Program. 4.c. The P&P titled, “Medication Automated Dispensing Units (ADU) (ASANTE)” dated effective 07/15/2021 reflected “Quality Assurance ... The overall plan for the monitoring and surveillance of medications stocked or removed from ADUs include ... Routine diversion surveillance is conducted using a third-party vendor and reported to Pharmacy Informatics and PICs for follow-up with nursing leaders.” It was not clear how potential or actual drug diversion concerns at individual, separately certified hospitals, units, and departments within the system would be monitored, trends detected, opportunities for continuous improvement identified, and integrated into ARRMC’s QAPI Program. 4.d. The P&P titled, “Responsible Event Reporting and Analysis in a Culture of Safety (ASANTE),” dated effective 06/23/2021 included “This policy is designed to ... Guide employees in accurately reporting the details of patient or visitor safety events ... Assist in identifying human and system problems ... A Responsible Event Report (RER) is completed for any event that is not consistent with routine patient care ...” It was not clear how potential or actual drug diversion concerns at individual, separately certified hospitals, units and departments within the system would be monitored, trends detected, opportunities for continuous improvement identified, and integrated into ARRMC’s QAPI Program. 5. Refer to the findings cited at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety. Those findings reflect the hospital failed to ensure staff reported, investigated, and responded in a timely manner to numerous behaviors and activities suspicious for drug diversion and impairment involving an ICU nurse, RN4. Behaviors and activities were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated as described in Findings 2-13. Within that period of time, the hospital identified a pattern of BSIs in the ICU. These failures to report and respond impacted opportunities to identify gaps in processes, new problems, continuous improvement activities, refinement of P&Ps, and integration into ARRMC’s QAPI Program. 6. Refer to the findings cited at Tag A-145 under CFR 482.13(c)(3) - Standard: Privacy and Safety. Those findings reflect the hospital failed to report and conduct thorough and timely investigations of incidents of “improper narcotic handling”, behaviors and activities suspicious of drug diversion, and other medication related incidents that reflected potential abuse and neglect. These failures impacted opportunities to identify gaps in processes, new problems, continuous improvement activities, integration into ARRMC’s QAPI Program, and refinement of P&Ps. 7.a. Diversion Prevention Oversight Committee meeting minutes dated 05/16/2022 reflected “Purpose: Promote appropriate use and security of controlled substances across Asante ... Diversion Investigation Report ... 1 Rapid Response investigation in Qtr 1 - no diversion confirmed, employee in the corrective action process ... 1 Rapid Response investigation in Qtr 2 - no findings ... No questions on either”. It was not clear which units, departments, or separately certified hospital this information pertained to. It was not clear how actual or potential diversion would be incorporated into ARRMC’s QAPI Program. 7.b. Diversion Prevention Oversight Committee meeting minutes dated 08/15/2022 reflected “Purpose: Promote appropriate use and security of controlled substances across Asante ...” * “Diversion Investigation Report ... No Rapid Response investigations in Qtr 3 ... Identified some nurses have uncertainty which meds are narcotics ... Don’t know if it’s a training issue with graduates ... Solutions: ... Communicate and Med Safety Rounding ... Increase communication at all meetings.” It was not clear which units, departments, or separately certified hospital this information pertained to. There was no information about RN4’s behaviors and activities suspicious for drug diversion and impairment in ARRMC’s ICU that were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. It was not clear how actual or potential diversion would be incorporated into ARRMC’s QAPI Program. 7.c. Diversion Prevention Oversight Committee meeting minutes dated 02/20/2023 reflected: * “Diversion Investigation Report ... Alerts Generated ... Approximately 600 alerts monthly due to documentation issues ... Incidents Reviewed ... 15-25 alerts/month require deeper investigation ... Rapid Response Investigations ... 2 Rapid Response - 1 proceeded to corrective action and 1 still under investigation ... Process Improvement Initiatives ... CS Waste Reduction ... Fentanyl, midazolam, oxycodone, hydromorphone/ Pending reports ... Large amount of waste, prime for diversion opportunities ... Reports are inconsistently available [name] working with vendor to get to nursing leader ...: * “Fentanyl Drip Documentation ... Recent Rapid Response identified an opportunity on documentation of the bolus process and reconciling the end of the bag. [Name] is working with [name] on this ...” It was not clear which units, departments, or separately certified hospital this information pertained to. There was no information about RN4’s behaviors and activities suspicious for drug diversion and impairment in ARRMC’s ICU that were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. It was not clear how actual or potential diversion would be incorporated into ARRMC’s QAPI Program. 7.d. Diversion Prevention Oversight Committee meeting minutes dated 05/15/2023 reflected: * “Diversion Investigation Report ... Alerts Generated >600 alerts per month ... Incidents Investigated: 2 Unusual access of controlled substances & 23 Excessive Waste ... Rapid Response Investigations - none in Qtr 2 ... Documentation Accountability ... Fentanyl Drip Documentation ... reviewing data with ... (informatics) assistance.” * “Process Improvement Initiatives ... CS Waste Reduction ... Fentanyl, oxycodone, hydromorphone ... FairWarning previewed new reporting with MAR reconciliation ... Next week pharmacy team will drill into data and analyze report accuracy ... Closed-Loop Accountability ... New features will be closed loop accountability (CLA) for anesthesia workstations ...” It was not clear which units, departments, or separately certified hospital this information pertained to. It was not clear how actual or potential diversion would be incorporated into the hospital’s QAPI Program. The minutes referred to “anesthesia workstations”. However, it was not clear where those were located. There was no information about RN4’s behaviors and activities suspicious for drug diversion and impairment in ARRMC’s ICU that were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. It was not clear how actual or potential diversion would be incorporated into ARRMC’s QAPI Program. 8.a. “Asante Patient Safety Council” meeting minutes dated 02/13/2023 were reviewed and included information related to three separately Medicare certified hospitals, AACH, ARRMC and ATRMC. The minutes included 24 attendees with no titles or other information regarding what department, unit, hospital or other organization each represented. The minutes included “Asante RER System Trends & Dashboards ... Continued focus on barcode scanning and the 5 rights of administration: incorrect dosage, incorrect date/time, incorrect route, incorrect medication,” but did not reflect which separately certified hospital those pertained to. Similarly, regarding “Quarterly Smart Pump Compliance Data,” the minutes reflected “BBraun drug alarms are concentrated in 2 areas: Downstream Occlusion and VTBI Near End. Focusing on occlusion and air in line alarms in critical care ... investigating the use of an anti-siphon valve to reduce these alarms. BBraun Qtr 1 on-library use was 92.5 % ... ICU Medical compliance rate is 52.8% ...” Similarly, it was not clear which separately certified hospital this information pertained to and there was no information about RN4’s behaviors and activities suspicious for drug diversion and impairment in ARRMC’s ICU that were documented for over a year beginning at least May 2022 through July 2023. It was not clear how actual or potential diversion would be incorporated into ARRMC’s QAPI Program. It was not clear how opportunities to flag new problems necessary for continued improvement and refinement of pharmaceutical and other P&Ps specific to ARRMC might be considered and achieved. 8.b. Similarly, review of the following “Asante Patient Safety Council” meeting minutes lacked information about RN4’s behaviors and activities suspicious for drug diversion and impairment in ARRMC’s ICU that were documented for over a year beginning at least May 2022 through July 2023. It was not clear how actual or potential diversion would be incorporated into ARRMC’s QAPI Program. It was not clear how opportunities to flag new problems necessary for continued improvement and refinement of pharmaceutical and other P&Ps specific to ARRMC might be considered and achieved: * “Asante Patient Safety Council” meeting minutes dated 04/10/2023. * “Asante Patient Safety Council” meeting minutes dated 05/08/2023. * “Asante Patient Safety Council” meeting minutes dated 07/10/2023. 9. During interview on 02/26/2024 at ~ 1430 with DPS and PM, DPS stated they attended quarterly Patient Safety Council Committee meetings and provided a report that included CS transactions that “had to be looked at,” those that turned into investigations, and confirmed diversion cases. DPS stated data provided at Patient Safety Committee meetings was a system-level report and was not separated according to each separately certified hospital. The DPS stated the same system-level report was provided at Quality Committee meetings and Quality Management Review meetings. DPS was asked by the surveyor how quality committee meeting members would know which separately certified hospital or hospitals within the system had potential or actual drug diversion problems. DPS stated “I didn’t give data by hospital. We were not separating out the data. We manage our [drug diversion] surveillance as a system.” DPS additionally stated that quality committees did not consider drug diversion from “an infection prevention standpoint”. 10. Behaviors and activities suspicious for drug diversion and impairment involving ARRMC ICU RN4 were documented for over a year beginning at least May 2022 through July 2023 when the nurse’s employment terminated. However, Quality Committee meeting minutes dated 10/29/2022, 11/20/2022, 12/20/2022, 01/19/2023, 03/23/2023 and 05/18/2023 were reviewed and included no information regarding reports of potential or actual drug diversion as it related to patient safety, adverse events and/or medication errors in ARRMC’s ICU between May 2022 and July 2023. 11. During interview on 02/01/2024 at ~ 1140, CLO stated the hospital made no association between drug diversion and BSIs until November 2023, and this delay was partly because one group was looking at drug diversion and another group was looking at BSIs. The groups were “siloed”, “not cohesive” and “did not connect the dots”. 12. During interview with DPS and PM on 02/01/2024 at ~ 1620 regarding potential or actual diversion events, DPS stated “I have never had to report to QAPI.””

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 29708 Based on observations, interviews, review of medical record documentation for 13 of 15 ICU patients (Patients 1, 2, 5, 6, 7, 9, 12, 16, 22, 23, 28, 31 and 32), review of incident documentation regarding improper narcotic handling, activities and behaviors suspicious for drug diversion, and other medication related incidents involving 18 of 18 patients who received hospital services (Patients 10, 13, 28, 47-61), review of incident investigation documentation, review of patient lists for 45 of 45 ICU patients who experienced infections, including BSIs (Patients 1- 32 and 34 - 46), review of education/training records for 8 of 8 ICU nursing staff (Employees 1-8), review of education/training materials, review of pharmacy audit documentation, review of hospital P&Ps, and review of other documentation, it was determined the hospital failed to develop and implement effective P&Ps that minimized drug diversion and ensured current and accurate records of IV fentanyl and other CS were maintained. Failures included: * Failure to ensure instances of unaccounted for and undocumented IV fentanyl and other CS were accounted for, reconciled and discrepancies resolved in a timely manner including but not limited to situations involving infusion rate changes, boluses, and waste that created the risk for diversion and patient harm. * Failure to proactively and diligently identify, investigate and respond to behaviors and activities suspicious for drug diversion that reflected potential abuse and neglect. Findings include: The hospital failed to ensure instances of unaccounted for and undocumented IV fentanyl and other CS were accounted for, reconciled and discrepancies resolved: 1.a. A pharmacy informatics audit with file name “2022 [Fentanyl] [RN4] audits” was reviewed. The audit had columns titled “User:”, “Patient”, “Medication:”, “TX type:”, “Date:”, “Time Start:, “Time Stop:”, “Total Time (hours):”, “Dose (mcg)”, “Rate Volume (mL/hr)”, “[Quantity] administered/Documented (mL):”, “Undocumented/Remaining amount:”, and “Notes”. Documentation in the file included multiple instances of undocumented/unaccounted for and over documented amounts of IV fentanyl. Examples from the file follow in Findings 1.b.-1.n. below in this tag. 1.b. Regarding Patient 4, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 09/10/2022-09/29/2022 was reviewed. Examples from the audit included but were not limited to: * On 09/10/2022 a new bag of IV fentanyl in 0.9% NaCl 1250 mcg/250 mL (5 mcg/mL) solution 250 mL bag was started at 2202 and stopped at 0858. The “Undocumented/Remaining amount” column reflected 65.25 mL and the “Notes” reflected “Undocumented amount”. Between the time the infusion was started and stopped, there had been two infusion rate changes. * On 09/11/2022 a new bag of IV fentanyl solution 250 mL (similar to above) was started at 0858 and stopped at 1601. The “Undocumented/Remaining amount” column reflected 58.25 mL and the “Notes” reflected “Undocumented amount”. Between the time the infusion started and stopped, there had been three infusion rate changes. * On 09/13/2022 a new bag of IV fentanyl solution 250 mL was started at 0000 and stopped at 0316. The “Undocumented/Remaining amount” was -22.66 mL. The “Notes” reflected “Would have run out prior to new bag”. * On 09/13/2022 a new bag of IV fentanyl solution 250 mL was started at 0316 and stopped at 1048. The “Undocumented/Remaining amount” was -51.33 mL. The “Notes” reflected “Would have run out prior to new bag”. * On 09/15/2022 a new bag of IV fentanyl solution 250 mL was started at 0402 and stopped at 1135. The “Undocumented/Remaining amount” was -52.00 mL. The “Notes” reflected “Would have run out prior to new bag”. * On 09/16/2022 a new bag of IV fentanyl solution 250 mL was started at 1134 and stopped at 1828. The “Undocumented/Remaining amount” was 78.33 mL. Between the time the infusion started and stopped, there had been one infusion rate change. A new bag was dispensed at 1826 and started at 1828. * On 09/17/2022 a new bag of IV fentanyl solution 250 mL was started at 0535 and stopped at 1709. The “Undocumented/Remaining amount” was -39.17 mL. The “Notes” reflected “Would have run out prior to new bag”. * On 09/21/2022 a new bag of IV fentanyl solution 250 mL was started at 1809 and stopped at 2344. The “Undocumented/Remaining amount” was 64.75 mL. Between the time the infusion started and stopped, there had been one infusion rate change. * On 09/21/2022 a new bag of IV fentanyl solution 250 mL was started at 2344 and stopped at 0356. The “Undocumented/Remaining amount” was 82.01 mL. A new bag was dispensed at 0355 and started at 0356. * On 09/24/2022 a new bag of IV fentanyl solution 250 mL was dispensed at 1429, started at 1433 and stopped at 1845. The “Undocumented/Remaining amount” was 85.25 mL. Between the time the bag was dispensed and the infusion stopped, there had been two infusion rate changes. * On 09/25/2022 a new bag of IV fentanyl solution 250 mL was started at 0000 and stopped at 0202. The “Undocumented/Remaining amount” was -41.32 mL. The “Notes” reflected “Would have run out prior to new bag”. * On 09/26/2022 a new bag of IV fentanyl solution 250 mL was started at 0240 and stopped at 0815. The “Undocumented/Remaining amount” was -41.92 mL. The “Notes” reflected “Would have run out prior to new bag”. * On 09/28/2022 a new bag of IV fentanyl solution 250 mL was dispensed at 1322 and started at 1334. On 09/29/2024 at 0619, the infusion was stopped. The “Undocumented/Remaining amount” was 80.50 mL. A new bag was dispensed at 0611 and started at 0619. The audit included approximately 45 instances of undocumented/remaining amounts fentanyl. A summary at the end of the audit reflected 2286.34 mL undocumented” and 946.75 mL “Over documented” fentanyl. The audit also reflected there had been 35 users, 65 bags dispensed, 14 infusion rate changes (increases), and 14 infusion rate changes (decreases). There was no documentation of further investigation that explained the undocumented and over documented amounts of fentanyl. There was no documentation that reflected diversion had been ruled out. Refer to Finding 7.b. in this tag that reflects hospital P&P requires that “Each discrepancy must be reconciled, resolved and documented as soon as possible. Resolution must be accompanied by a clear explanation of the events and why it can be certain that no diversion occurred ...” 1.c. Regarding Patient 2, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 09/08/2022-09/15/2022 included similar information and unaccounted fentanyl as Finding 1.b. For example, it included four instances of undocumented/remaining amounts fentanyl ranging from 12.04 mL to 144.67 mL. A summary at the end of the audit reflected 318.73 mL fentanyl was “undocumented” and 43.9 mL “Over documented.” The audit reflected there had been seven bags dispensed, ten rate changes (increases), eight rate changes (decreases), and 13 “users”. There was no documentation that explained or attempted to explain the undocumented and “over documented” amounts of fentanyl. 1.d. Regarding Patient 3, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 09/12/2022-09/24/2022 included similar information and unaccounted fentanyl. For example, it included 14 instances of undocumented/remaining amounts fentanyl ranging from 9.33 mL to 84.24 mL. A summary at the end of the audit reflected a total of 640.31 mL fentanyl was “undocumented”, 14 bags dispensed, 6 rate changes (increases), eight rate changes (decreases) and 19 users. The audit included that on 09/21/2022 a new bag of 250 mL IV fentanyl solution was dispensed (from the ADU) at 2011 and started on 09/22/2022 at 0413, 8 hours later. The “Notes” reflected “Didn’t start bag until the next morning.” There was no documentation that explained the reason 640.31 mL fentanyl was undocumented, nor why there was a delay between when the bag was dispensed and when it was started. There was no documentation that reflected diversion had been ruled out. Review of audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. included similar information and unaccounted fentanyl for the following patients: 1.e. Regarding Patient 5, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 09/15/2022-10/02/2022: The summary reflected 306.19 mL fentanyl was “undocumented” and 133.22 mL “Over documented”. 1.f. Regarding Patient 6, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 09/22/2022-10/01/2022: The summary reflected 623.02 mL was “undocumented” and 118.87 mL “Over documented”. 1.g. Regarding Patient 7, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 09/27/2022-10/07/2022: The summary reflected 809.37 mL fentanyl was “undocumented” and 296.45 mL was “Over documented”. 1.h. Regarding Patient 8, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 10/03/2022-10/04/2022: The summary reflected 180.01 mL was “undocumented” and 43.9 mL”Over documented”. 1.i. Regarding Patient 9, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 10/16/2022-11/05/2022: The summary reflected 882.86 mL was “undocumented” and 379.33 mL “Over documented”. 1.j. Regarding Patient 10, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 11/08/2022-12/06/2022: The summary reflected 1567.09 mL fentanyl was “undocumented” and 84.99 mL “Over documented”. The audit reflected 14 bags dispensed, 7 rate changes (increases), and 9 rate changes (decreases) and included the following notes: - On 11/13/2022 a new bag of IV fentanyl solution 250 mL was started at 0433 and stopped at 0613. The “Undocumented/Remaining amount” was -79.99 mL. The “Notes” reflected “Bag would have run out before next one was hung”. - On 11/23/2022 a new bag of 250 mL IV fentanyl solution was dispensed at 1558 and started at 1659, an hour later. The “Notes” reflected “RN [administered] to patient 1 hour after dispensing and there was still 76 mL left in the bag”. - On 11/26/2022 a new bag of 250 mL IV fentanyl solution was dispensed at 0017 and started at 0100. The “Notes” reflected “RN [administered] to patient almost 45 mins after dispense and there should be over 100 mL left in the bag.” - On 12/02/2022 a new bag of 250 mL IV fentanyl solution was dispensed at 1932 and started at 2027. The “Notes” reflected “RN [administered] bag to patient 1 hour after dispense with over 150 mL left in bag”. - On 12/04/2022 a new bag of 250 mL IV fentanyl solution was dispensed at 0053 and started at 0158. The “Notes” reflected “RN [administered] to patient 1+ hour after bag was dispensed and previous bag should still have over 100 mL remaining.” There was no further information that accounted for or explained the discrepancies, nor the reason the new bags of fentanyl were administered more than 30 minutes after dispensed. Refer to Finding 1.l. in this tag that reflects “Policy is 30 minutes.” 1.k. Regarding Patient 11, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 11/15/2022-11/18022 included similar unaccounted fentanyl and unexplained information. 1.l. Regarding Patient 12, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 12/03/2022-12/07/2022: The summary reflected 233.51 mL was “undocumented”, 40.66 mL “Over documented”, 5 bags dispensed, 3 rate changes (increases), 3 rate changes (decreases), and 5 users. The audit also included that on 12/03/2022 a new bag of 250 mL IV fentanyl solution was dispensed at 1328 and started at 1508. The “Notes” reflected “Started 1.67 hours after dispensing the bag. Policy is 30 minutes.” There was no documentation that explained why the infusion start was delayed. 1.m. Regarding Patient 13, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 12/14/2022-12/28/2022: The summary reflected 1355.97 mL” undocumented”, 310.72 mL “Over documented”, 36 bags dispensed, 12 rate changes (increases), 12 rate changes (decreases), and 22 users. The audit also included that on 12/23/2022 a new bag of 250 mL IV fentanyl solution was dispensed at 0718 and started at 0810. The “Notes” reflected “RN [administered] to patient 1 hour after dispense. There was still 56mL remaining in the bag.” 1.n. Regarding Patient 14, audit documentation from file name “2022 [Fentanyl] [RN4] audits” in Finding 1.a. dated 12/11/2022-12/18/2022: The summary reflected 450.61 mL “undocumented”, 20.04 mL “Over documented”, 14 bags dispensed, 16 rate changes (increases), 4 rate changes (decreases), and 10 users. 1.o. Regarding Findings 1.a.-1.n. above in this tag, there was no documentation that reflected diversion had been ruled out, nor further explanation for the undocumented and over documented amounts of fentanyl. 2. The pharmacy informatics audit with file name “2023 [Fentanyl] [RN4] audits” dated “Created” 12/29/2023 at 0825 reflected in Findings 2.a.-2.p. below included similar unexplained information regarding unaccounted for, undocumented and over documented fentanyl. 2.a. Regarding Patient 1, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 05/06/2023-05/14/2023: The summary at the end of the audit reflected a total of 575.49 mL fentanyl was “undocumented” and 110.90 mL “Over documented”. 2.b. Regarding Patient 15, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 01/24/2023-02/09/2023: The summary at the end of the audit reflected a total of 1183.02 mL fentanyl was “undocumented” and 25.74 mL “Over documented”. 2.c. Regarding Patient 16, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 02/12/2023-02/26/2023: The summary reflected a total of 545.54 mL fentanyl was “undocumented” and 52.08 mL “Over documented”. 2.d. Regarding Patient 17, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 03/15/2023-06/15/2023: A total of 402.18 mL fentanyl was “undocumented” and 55 mL “Over documented”. 2.e. Regarding Patient 18, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 03/26/2023-03/27/2023: A total of 119.75 mL fentanyl was “undocumented” and 63 mL “Over documented”. 2.f. Regarding Patient 19, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 04/12/2023-04/19/2023: A total of 138.56 mL fentanyl was “undocumented” and 24.13 mL “Over documented”. 2.g. Regarding Patient 20, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 04/12/2023-04/15/2023: A total of 205.47 mL fentanyl was “undocumented” and 24.13 mL “Over documented”. 2.h. Regarding Patient 21, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 04/19/2023-04/22/2023: A total of 204.84 mL fentanyl was “undocumented” and 2.33 mL “Over documented”. 2.i. Regarding Patient 22, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 05/20/2023-05/21/2023: A total of 196.26 mL fentanyl was “undocumented” and 49.42 mL “Over documented”. 2.j. Regarding Patient 23, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 05/21/2023-05/22/2023 included similar instances of unexplained, unaccounted for, and undocumented fentanyl as reflected in Findings 2.a.-2.i. above. 2.k. Regarding Patient 24, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 05/21/2023-05/22/2023 included similar instances of unexplained, unaccounted for, and undocumented fentanyl as reflected in Findings 2.a.-2.i. above. 2.l. Regarding Patient 25, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 06/04/2023-06/11/2023 included similar instances of unexplained, unaccounted for, and undocumented fentanyl. The summary at the end reflected a total of 122 mL fentanyl mL was “undocumented”. The audit included that on 06/08/2022 a new bag of 250 mL IV fentanyl solution was started at 1958, stopped at 2018 and wasted on 06/11/2023 at 1004. The “Notes” reflected “Undocumented amount. Wasted nearly 3 days later ...” There was no information that explained why there was a 3 day delay before the fentanyl was wasted. 2.m. Regarding Patient 26, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 06/03/2023-06/05/2023 included similar instances of unexplained, unaccounted for, and undocumented fentanyl as reflected in Findings 2.a.-2.i. above. 2.n. Regarding Patient 27, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 06/08/2023-06/09/2023 reflected that on 06/08/2023 a new bag of 250 mL IV fentanyl solution was dispensed at 1440, started at 1522, and stopped at 1720. The “[Quantity] administered/Documented (mL)” reflected 19.67 mL. The “Notes” dated 06/09/2023 reflected “Wasted entire bag, but it had been administered to patient so there shouldn’t have been a full bag to waste.” There was no further information that explained the reason for this discrepancy. 2.o. Regarding Patient 28, audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 dated 06/23/2023-07/15/2023 reflected 1232.38 mL fentanyl was “undocumented” and 444.99 mL “Over documented”. 2.p. Review of audit documentation from file name “2023 [Fentanyl] [RN4] audits” in Finding 2 included similar instances of unexplained, unaccounted for, and undocumented fentanyl for the following patients and dates: * Patient 29, 06/27/2023-07/06/2023; * Patient 30, 06/30/2023-07/07/2023; * Patient 31, 07/02/2023-07/05/2023; and * Patient 32, 07/14/2023-07/17/2023. 2.q. Regarding Findings 2-2.p. above in this tag, there was no documentation that reflected diversion had been ruled out, nor further explanation for the undocumented and over documented amounts of fentanyl. 3. Pharmacy audit with file name “[RN4] Audit October-November 2022” dated “Created” 02/22/2022 at 1144 and “Last Modified” 02/13/2024 at 1707 was reviewed and included but was not limited to: 3.a. Regarding Patient 10, audit documentation from file name “[RN4] Audit October-November 2022” in Finding 3 included the following information regarding fentanyl infusions and boluses administered 11/09/2022: “Scanned [at] 0802 [at]10ml/hr until 0946, then increased to 20ml/hr, bolused 50mcg @1148, [at]1355 w/action time of 1255, [physician name] documented continued by anesthesia [at] 20ml/hr [at] 1515 new bag was hung. 10ml X 2hrs=20ml (0802-0946), 20ml X 3hrs=60ml (0946-1240), Bolus of 50mcg =10ml @1148, 20ml X 3hrs =60ml (1240-1515) equals 150mls total leaving 100mls outstanding from 0750 bag.” There was no further information about 100 mLs fentanyl “outstanding”. There was no documentation that reflected diversion had been ruled out. Refer to Finding 8.b. at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety that reflects nurses were not documenting fentanyl boluses in the MAR and this created problems accounting for IV fentanyl and opportunities for diversion. 3.b. Regarding Patient 37, audit documentation from file name “[RN4] Audit October-November 2022” in Finding 3 reflected that on 10/23/2022 at 0840 a 250 mL bag of IV fentanyl solution was dispensed. The “Notes” reflected “Previous bag was hung on 10/22/2022 @1751 with a rate of 20ml/hr from 1751-2332 (5.5 X20ml =110ml) 14ml/hr from 2332-0200 (2.5 X14=35ml), then 10ml/hr 0200-0841 (7X10=70ml). Leaving 35ml outstanding could be [tubing]?” There was no further information about the questionable “outstanding” amount that “could be [tubing]”. 3.c. Regarding Findings 3-3.b. above in this tag, there was no documentation that reflected diversion had been ruled out, nor further explanation for the “outstanding” amounts of fentanyl. 4. Review of pharmacy informatics audit with file name “RGID ... 3. 5-23.2023 [Fentanyl] audit” dated “Created” 04/05/2023 at 1436, regarding Patient 63 with dates 03/05/2023-03/23/2023 included similar examples of unaccounted fentanyl: * On 03/07/2023 a new bag of IV fentanyl in 0.9% NaCl 1250 mcg/250 mL (5 mcg/mL) solution was started at 1251 and stopped at 1315. The “Undocumented/Remaining amount” column reflected 246 mL. A new bag was dispensed on 03/09/2023 at 0706 and started at 0707. * On 03/09/2023 a new bag of IV fentanyl solution 250 mL (similar to above) was started at 2334 and stopped on 03/10/2023 at 0709. The “Undocumented/Remaining amount” column reflected 98.3 mL. A new bag was dispensed on 03/10/2023 at 0708 and started at 0709. * On 03/11/2023 a new bag of IV fentanyl solution 250 mL was started at 0202 and stopped on 03/11/2023 at 1234. The “Undocumented/Remaining amount” column reflected 109.8 mL. Between the time the bag was dispensed and the infusion stopped, there had been 3 infusion rate changes, 1 rate increase, and 2 rate decreases. * On 03/11/2023 a new bag of IV fentanyl solution 250 mL was started at 1234 and stopped on 03/12/2023 at 0552. The “Undocumented/Remaining amount” column reflected 89.55 mL. Between the time the bag was dispensed and the infusion stopped, there had been 3 infusion rate changes, 1 rate increase, and 2 rate decreases. A new bag was dispensed on 03/12/2023 at 0523 and started at 0552. * On 03/17/2023 a new bag of IV fentanyl solution 250 mL was started at 0652 and stopped on 03/17/2023 at 2017. The “Undocumented/Remaining amount” column reflected 46.75 mL. Between the time the bag was dispensed and the infusion stopped, there had been 3 infusion rate changes. A new bag was dispensed on 03/17/2023 at 2016 and started at 2017. The audit documentation included 24 instances of undocumented/remaining amounts fentanyl ranging from 5.7 mL to 246 mL. A summary at the end reflected “1441.837 mL (5.77 bags)” fentanyl was “undocumented” and 157.1 mL was “Over documented.” The audit reflected there had been 31 bags dispensed, 31 rate changes (increases), and 33 rate changes (decreases). There was no further information or explanation for the undocumented and over documented fentanyl. There was no documentation that reflected diversion had been ruled out. 5.a. During interview and review of pharmacy informatics audits with DPS, PM and PI on 02/26/2024 at ~ 1430 the following information was provided: * PI stated the positive volumes of fentanyl were unaccounted for fentanyl that was never documented, wasted, or returned to the pharmacy. * DPS stated the negative volumes of fentanyl were amounts of fentanyl that had been documented as infused but were more than the original volume in the bags. * PI stated any amounts of undocumented fentanyl in “triple digits” on audits would be “a real concern” and should be investigated. * DPS, PM and PI were asked by the surveyor if any of the undocumented/unaccounted amounts of fentanyl on the pharmacy audits were further investigated and accounted for. PI stated “I believe we attempted on some of them but not all of them.” * PI stated the hospital had no P&P that specified how much “undocumented/remaining” fentanyl required an investigation. DPM stated “We don’t’ have anything in policy that says what we do at what volume.” Regarding fentanyl infusion waste processes: * Fentanyl waste in infusion tubing, including during tubing changes was supposed to be accounted for and documented during Omnicell waste procedures. Fentanyl discrepancies and accounting issues from waste in infusion tubing were “in part” due to nurses not documenting during Omnicell waste procedures or on I&O flowsheets, and this created opportunities for diversion. They were not aware of a hospital P&P that described how volumes of waste in infusion tubing should be measured and accounted for. * DPS stated staff were not consistently measuring and accounting for waste left in infusion bags. DPS “Whatever was left in the bag was a guesstimate.” DPS stated this created opportunities for diversion. DPS stated they were not aware of a hospital P&P that described how volumes of waste in infusion bags should be measured and accounted for. * Regarding waste from infusion tubing and bags, DPS stated “There was no expectation as to how staff should measure the waste.” * Regarding infusion rate changes, DPS stated staff were not consistently documenting infusion rate changes in the MAR. DPS stated “of course” this created opportunities for diversion. DPS stated they were not aware of a P&P that described how fentanyl should be accounted for during infusion rate changes. 6.a. During a tour of ICU on 01/31/2024 beginning at 1450, MICU was asked how the Omnicell tracked discrepancies of controlled substances. MICU demonstrated how to generate a “Discrepancy Resolution” report from the Omnicell. The report reflected the following information: “Item: LORazepam 2MG/1ML 1ML INJ”; “Item Alias: ATIVAN”; “Found by: [Name]”; “Found at: Mon 01/29/24 13:16:57”; “Witness: [This was blank]”; “Previous User: [Employee Name]”; “Qty Expected: 2 EA”; “Qty Found: 1 EA”; “Adj Down: 1 EA”; “Qty Remaining: 1 EA”; and “Resolution Reason: [This was blank]”. Instructions at the bottom of the onscreen report reflected “Please enter the reason for the discrepancy or select a reason from the list.” An icon with a red light was highlighted which was labeled, “Resolve Discrep”. 6.b. MICU stated that the discrepancy report had not been received which is usually printed every 12 hours. MICU stated that they suspected the employee was either a NOC shift employee or that the employee was off as part of their regular schedule. MICU stated that discrepancies were normally resolved at the end of each shift before an RN leaves shift. MICU stated they expected to see the discrepancy on the next report on 02/01/2024. 6.c. During tour of ICU on 02/02/2024 beginning at 1200, MICU generated a “Discrepancy Resolution” report from the same Omnicell as they had done during the 01/31/2024 observation. The report reflected: “Item: LORazepam 2MG/1ML 1ML INJ”; “Item Alias: ATIVAN”; “Found by: [Name]”; “Found at: Mon 01/29/24 13:16:57”; “Witness: [This was blank]”; “Previous User: [Employee Name]”; “Qty Expected: 2 EA”; “Qty Found: 1 EA”; “Adj Down: 1 EA”; “Qty Remaining: 1 EA”; and “Resolution Reason: [This was blank]”. Instructions at the bottom of the onscreen report reflected “Please enter the reason for the discrepancy or select a reason from the list.” An icon with a red light was highlighted which was labeled, “Resolve Discrep”. 6.d. MICU confirmed that the discrepancy report had not been resolved and that it was the same discrepancy report as observed on 01/31/2024 in Finding 6.a. in this tag. MICU stated they had not received an email about this discrepancy nor had they received the report which should have been printed every 12 hours. Further, MICU stated this “Ativan” should have been on “the 2/1/24” report and it was not. 6.e. During interview with DPS, PM and PI on 02/01/2024 at ~ 1620 the following information was provided: * An Omnicell report gets generated daily on all units that includes medication discrepancies for all nurses on the unit. Nurses are to review the report and fix the discrepancy before they leave the hospital. * If there is a medication discrepancy, Pharmacy Informatics sends an email to the NM and the nurse who should respond to the email within 24 hours. In many cases the NM works with the nurse to “figure out” the discrepancy. 7.a. The P&P titled “Controlled Substance Documentation Discrepancy Surveillance (ASANTE)” dated effective 10/04/2022 reflected: * “Pharmacy Informatics runs daily reports for ‘Unresolved Discrepancies’ from the Omnicell ... Omnicell sends a daily CSM discrepancy report to each site’s main printer and designated manager and supervisor’s email for investigation and resolution ...” * “FairWarning software identifies and flags possible investigations for Omnicell discrepancies, delayed waste and return of controlled substances ... If investigation determines follow up is needed, informatics will send provided FairWarning memorandum to designated unit managers and/or supervisors ... Upon receipt of follow-up of events, informatics or the pharmacy manager will document the resolution in FairWarning and assign risk level, corrective and HR actions. Informatics or pharmacy managers will then close the investigation ...” The P&P reflected “informatics will send provided FairWarning memorandum to designated unit managers ...” It was not clear how promptly unit managers were sent discrepancies information, when follow up was expected, and how patient safety was ensured during the investigation. 7.b. The P&P titled “Controlled Substance Management Policy (ASANTE)” dated “effective 06/13/2022 included that “All identified documentation discrepancies will be resolved ... Each entity shall have procedures in place, as approved by the PIC, to manage return, waste and removal of CS at their site ... All CS wastage shall be performed as soon as possible following access of the medication, administration or refusal ... Each entity shall have procedures ... to manage discrepancies ... Each discrepancy must be reconciled, resolved and documented as soon as possible. Resolution must be accompanied by a clear explanation of the events and why it can be certain that no diversion occurred ... The PIC, in collaboration with the clinical manager of the location where the discrepancy occurs, is responsible for validating no diversion took place as a result of any discrepancy whether resolved or unresolved ... In the event that diversion is suspected, the clinical manager and/or PIC of the location where the event occurred shall notify the Chief Pharmacy Officer to engage the [RRDT] for investigation and validation of diversion ...” The P&P was not clear regarding how urgently RRDT notification and investigation should occur following discrepancies and suspected diversion, nor what should be done to ensure patients were safe during the course of an investigation. Refer to Findings 2-13 at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety that reflects RN4’s behaviors and activities suspicious for drug diversion and the hospital’s failure to investigate and validate that no diversion took place. Refer to Findings 1.a.-5.a. in this tag that reflect multiple instances of CS discrepancies and the hospital’s failure to investigate, resolve the discrepancies, and validate that no diversion took place. 7.c. Refer to Findings 2-2.c. at Tag A-491 under CFR 482.25(a) - Standard: Pharmacy Management and Administration that reflect the hospital failed to fully develop and implement P&Ps that ensured volumes of IV fentanyl and other CS were accurately accounted for including situations involving waste from infusion bags and tubing, rate changes, and boluses that created the risk for diversion and patient harm. 7.d. Refer to Finding 8.b. at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety that reflects the hospital failed to fully develop and implement P&Ps that ensured fentanyl in IV tubing was accounted for during waste processes. This created opportunities for discrepancies, diversion, and patient harm. 7.e. Refer to Finding 5.a. in this tag that reflects the hospital failed to fully develop and implement P&Ps that ensured volumes of IV fentanyl were documented and accurately accounted for including waste from infusion bags and tubing, and situations involving rate changes. This created opportunities for discrepancies, diversion, and patient harm. 8.a. The P&P titled “Medication Handling and Administration (ASANTE)” dated effective 11/03/2023 reflected “... Controlled Substances should be administered and documented within 30 minutes of removal from the ADU, whenever possible.” 8.b. Refer to Findings 1.j. and 1.l. in this tag that reflect instances of CS were administered more than 30 minutes after dispensed creating the risk for diversion. The hospital failed to proactively and diligently identify, investigate and respond to behaviors and activities suspicious for drug diversion: 8.a. Refer to Findings 2-13 at Tag A-144 under CFR 482.13(c)(2) - Standard: Privacy and Safety that reflect the hospital’s failure to proactively and diligently identify, investigate and respond to an ICU nurse’s behaviors and activities suspicious for drug diversion involving fentanyl and multiple ICU patients. 44104”

“INFECTION CONTROL PROFESSIONAL CFR(s): 482.42(a) Infection prevention and control program organization and policies. The hospital must demonstrate that: (1) An individual (or individuals), who is qualified through education, training, experience, or certification in infection prevention and control, is appointed by the governing body as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership; This Standard is not met as evidenced by: 44104 Based on interview, review of infection control P&Ps, IPC meeting minutes, HAI TT meeting minutes, and other documentation, it was determined that the hospital failed to ensure it clearly identified and designated an infection preventionist(s) who was responsible for and ensured development and implementation of an IPC Program specific to ARRMC. * P&Ps and other documents regarding an infection preventionist for the hospital were inconsistent and did not clearly identify an infection preventionist(s)/infection control professional(s) responsible for the ARRMC IPC Program. * The hospital failed to ensure the governing body appointed an infection preventionist(s)/infection control professional(s) responsible for the ARRMC IPC Program. * The hospital failed to ensure that the appointment of an ARRMC infection preventionist(s)/infection control professional(s) was based on the recommendations of medical staff leadership and nursing leadership. Findings include: 1. Review of the policy titled “Infection Prevention - Operational Plan (ASANTE)”, dated 02/24/2022 was reviewed and reflected: * “Operational Summary ... Asante Infection Prevention ... provides support and leadership to improve patient outcomes through reducing hospital acquired infections and preventing transmission of communicable diseases within Asante hospitals ...” * “Operational Detail ... Area Description: Location - an Infection Prevention office is maintained at each hospital location.” * “Scope of Services ... All hospital-licensed departments and services ... The Infection Prevention program encompasses a hospital-wide multi-disciplinary approach ...” * “Authority Statement ... The Infection Prevention Manager (or designee) serves as the infection control officer for Asante.” * “Administration and Organization of Area ... Nursing Direction: Vice Presidents of Nursing and Nursing Operations Leaders”. * “Medical Direction ... The Asante Infection Prevention Medical Director”. * “Leadership Direction ... Chief Medical Officer and Vice President of Quality and Patient Safety and/or Director of Infection Prevention”. * “Staffing Structure and Plan ... Staff ratios ... Staffing is based on facility size and services; the team includes Director-level leadership, Manager and/or Supervisor, Infection Preventionists, and Infection Prevention Analyst(s) or Staff assistant(s). An annual review of the staffing needs ... is performed by the Director based on the needs of the hospitals and ... the Asante IP Department.” The policy failed to clearly state that an IPD, or that IPs were designated for the ARRMC hospital. For example, the policy stated: - “Asante Infection Prevention ... provides support and leadership to ... Asante hospitals ...” and did not indicate a hospital-specific IP Program. - IP offices were “maintained” at each hospital, but the policy did not clearly state that IPs had been designated and were responsible for a specific hospital. - “All hospital-licensed departments and services ... “ were included in the scope of services, and inferred that the IP Program was system-wide and not hospital-specific. Regarding the IP manager, the policy stated the IP Manager “serves as the infection control officer for Asante” and did not clearly state that an IP manager had been designated for ARRMC. Additionally, the policy stated that nursing direction for the IP Department was provided by “Vice Presidents of Nursing”, however, the IP department was not listed on the either of the organizational charts titled “ARRMC AACH VPO” or “Patient Care Services” as described in Findings 2 and 2.a., Asante organizational charts. The policy stated that staffing was based on facility size and the needs of the “hospitals” and the “Asante IP Department”, however, it did not state that IPs were designated for each hospital nor did it state whether IPs were assigned duties specific to ARRMC. 2.a. Organizational charts provided by the hospital on 01/29/2024 were reviewed and reflected: * The organizational chart titled “Medical Affairs”, dated “January 2024” reflected a “Hospital organizational chart that depicts all departments and services reporting to hospital leadership.” The organizational chart did not include an IP Department, IP Medical Director, IP Manager/Director, or IPs for ARRMC. * The organizational chart titled “Patient Care Services”, dated “January 2024” reflected a “Hospital organizational chart that depicts all departments and services reporting to hospital leadership.” The organizational chart did not include an IP Department, IP Medical Director, IP Manager/Director, or IPs for ARRMC. * The organizational chart titled “ARRMC AACH VPO”, dated “January 2024” did not include an IP Department, IP Medical Director, IP Manager/Director, or IPs for ARRMC. * The organizational chart titled “ARRMC AACH CEO”, dated “January 2024” did not include an IP Department, IP Medical Director, IP Manager/Director, or IPs for ARRMC. 2.b. Organizational charts provided by the hospital on 02/02/2024, and on 02/28/2024, respectively, were reviewed and reflected: * The organizational chart titled “Asante Performance Improvement (PI) and Infection Prevention (IP)” dated “2/2/2024” did not include an IP Department, IP Medical Director, IP Manager/Director, or IPs unique to ARRMC. The chart reflected “Asante = Corporate (RRMC, TRMC & AACH)”. Each IP listed had “IP” under their names, but no designated hospital or location was listed. * The organizational chart titled “Asante Quality Organizational Structure” dated “2/2/2024” did not include an IP Department, IP Medical Director, IP Manager/Director, or IPs unique to ARRMC. The chart reflected “Asante = RRMC, TRMC & AACH”. Under “Quality Departments” was listed “PI/IP Director”. It was unclear whether the “PI/IP Director” was designated for ARRMC or the entire Asante healthcare system. 3. Review of 2022 and 2023 Infection Prevention Committee meetings failed to demonstrate that an IP or other IP professionals were designated and responsible for the IPC Program at ARRMC. For example, the Infection Prevention Committee meeting minutes did not reflect the hospital, department, or titles of the attendees who participated in the meetings. It was unclear whether the ARRMC had any designated IPs, or an IPD representing ARRMC in attendance for 12 of 12 meetings dated 02/04/2022, 04/04/2022, 06/06/2022, 08/02/2022, 10/03/2022, 12/05/2022, 02/02/2023, 04/06/2023, 06/01/2023, 08/03/2023, 10/05/2023, and 12/07/2023. 4. Review of 2022 and 2023 HAI TT Committee meetings failed to demonstrate a designated IP or other IP professionals who were responsible for the ARRMC IPC Program. For example, HAI TT Committee meeting minutes failed to reflect the hospital, department, or titles of the attendees who participated in the meetings. It was unclear whether the hospital had any designated IPs, or an IPD representing ARRMC in attendance for 37 of 37 meetings dated 01/05/2022, 01/19/2022, 02/02/2022, 02/16/2022, 03/16/2022, 04/06/2022, 05/04/2022, 05/18/2022, 06/20/2022, 07/06/2022, 07/20/2022, 08/03/2022, 08/15/2022, 10/05/2022, 10/17/2022, 11/03/2022, 11/21/2022, 12/07/2022, 01/04/2023, 02/01/2023, 02/20/2023, 03/01/2023, 03/20/2023, 04/05/2023, 05/03/2023, 05/15/2023, 06/07/2023, 06/19/2023, 07/05/2023, 07/17/2023, 08/02/2023, 08/21/2023, 09/06/2023, 09/18/2023, 10/04/2023, 10/16/2023, 11/01/2023. 5. Review of an undated job description titled “Infection Preventionist Asante” printed on “February 28, 2024” was reviewed and reflected: * “Job Summary ... Infection Preventionist performs the infection prevention and control functions of surveillance, data collection, analysis of data, dissemination of results, education, policy development, and consultation.” * “Participates in RRMC’s Infection Control Program...” * “Participates in the Infection Prevention and Control Committee meeting.” * “Identifies and investigates the occurrence of outbreaks and clusters if infectious diseases (including emerging pathogens) or infection control related complication or event as requested by the manager.” * “Makes regular rounds in patient care areas, observing for adherence to Standard Precautions, isolation, hand hygiene, and other infection prevention and control measures. Provides immediate feedback to staff when appropriate.” Other than “Participates in RRMC’s Infection Control Program” there were no other principal duties, responsibilities, or hospital location which indicated that an IP would be designated for each individual hospital, including ARRMC. The job description lacked a requirement that the IP position was to be appointed by the governing body, and that the appointment was based on the recommendations of medical staff leadership and nursing leadership. 6. Review of an undated job description titled “Dir Quality - Perf Improvement & Infection Prevention” printed on “February 28, 2024” was reviewed and reflected: * Under “Job Summary” was written, in its entirety, “The Director of Quality - Performance Improvement and Infection Prevention is responsible for designing, implementing and maintaining the clinical quality measurement and analytics system for Asante Health System and designated ancillary services. Directs quality analytics for measurement and delivery of actionable reports quantifying areas in need of improvement. Develops and guides near and long-term strategies for improved clinical quality metric performance. Responsible for developing long [sic] and short-range goals for the department, in collaboration with the Asante Executive Leadership Team. Provides education and assistance to all leaders and stakeholders related to clinical quality performance. Responsible for departmental operations and the supervision, development and training of performance improvement staff.” The job description did not reflect any infection prevention-specific duties. The job description lacked any reference that the IPD would be hospital-specific. The job description lacked a requirement that the IPD position was to be appointed by the governing body, and that the appointment was based on the recommendations of medical staff leadership and nursing leadership. The job description lacked requirements that the IPD be qualified through education, training, experience, or certification in infection prevention and control. 7. During interview on 02/01/2024 at 1355, the IPD confirmed Findings 1-5. The IPD was asked whether there were dedicated IPs responsible for the ARRMC Infection Prevention Program, or whether ARRMC had a dedicated IPD. The IPD stated, “We are not structured that way.” 8. During an interview on 02/29/2024 at 1030 with the IPD, the MDCC and the AGC, the AGC confirmed Finding 6. The IPD job description was reviewed with the participants. They confirmed that specialized training in infection prevention was not a listed requirement for the IPD position. The IPD stated, “I don’t recall seeing any.” The AGC stated, “None of us are seeing any mention of specialized training in infection prevention.” 9. Emails from the AGC confirmed Finding 5. The AGC confirmed that the none of the IP professionals, including the IPD, had been appointed to their positions by the governing body based on the recommendations of medical staff leadership and nursing leadership as required by CMS. * In an email dated 03/08/2024 at 0913, the AGC stated, “For 2022 and 2023: We checked our governing body minutes and could not locate an official appointment of our former Director of Infection Prevention & Performance Improvement, [IPD], by the governing body.” * In an email dated 03/08/2024 at 1214, in response to the question, “In 2022 and 2023, did ARRMC have any infection preventionist(s)/infection control professional(s) that had been appointed by the governing body?” The AGC responded, “The answer ... is no.” * In an email dated 03/13/2024 at 1658, the AGC stated, “No, the 3 IPs listed below were not recommended to their positions by Nursing or Med Staff leadership.””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of P&Ps and other documentation, it was determined the hospital failed to ensure its IPC Program included clearly written, and fully developed and implemented P&Ps in the following areas: * The IPC processes and systems to maintain a clean and sanitary environment were not fully developed, implemented, or followed. * The hospital failed to fully implement recommendations made by the state public health authority to mitigate the risk of infection to patients from IPC issues identified by public health authorities, (OHA). * The processes and systems to detect, investigate and control infections and outbreaks, including common-source outbreaks, were not fully developed, implemented, or followed. Interpretive guidelines include: * The hospital should know how to recognize and contain infectious disease outbreaks. An outbreak is the occurrence of more cases than expected in a given area or among a specific group of people over a particular period of time.” * “In the event of an outbreak of an infectious disease, hospitals should have policies and procedures in place to address the appropriate steps to diagnose and manage cases, implement appropriate precautions, and prevent further transmission of the disease as well as documentation of follow-up activity in response and comply with state and local public health authority requirements for identification, reporting, and containing communicable diseases and outbreaks.” Findings include: Regarding clearly written, and fully developed and implemented P&Ps to maintain a clean and sanitary environment: 1. The P&P titled, “Facility Environmental Cleaning and Disinfection (ASANTE)” dated effective 08/02/2023 reflected: * “Purpose: To ensure consistency in cleaning and disinfection strategies across the Asante hospitals and to define appropriate cleaning actions for any given area at each hospital ... “ * “Environmental Services ... will clean all 24/7 departments on a daily basis.” * “No tap water is to come in contact with cleaning or patient care supplies or equipment.” * “No supplies or equipment will be placed or stored within three feet of a water source (e.g., patient room sinks, or dirty or clean utility room sinks or hoppers).” * “Surface Treatment ... Remove any gross or visible soiling before disinfecting ... wipe all surfaces using hospital-approved disinfectant per IFU ... Surface including but not limited to ... ice/water dispensers and ice/water trays ... See Appendix A: EVS Daily Checklist.” * “Appendix A: EVS Daily Checklist ... Common or Core Area Cleaning ... Nursing Stations, Nourishment ... Clean exterior ice makers and refrigerators ... “ * “Required: Subject Matter Expert ... EVS Supervisors ... Asante Infection Prevention”. * “Reviewed by ... Mgr Hospitality ARRMC ... Supv Environmental Services AACH ... Supv Hospitality Services ATRMC”. 2. The P&P titled, “Environmental Cleaning and Disinfection (ASANTE)” dated effective 11/14/2023 reflected: * “Surfaces must be intact and cleanable ... Report cracks, breakdown wear or damage to supervisor or Facilities ... Take any damaged items out of service, where applicable.” * “Store non-critical patient care equipment in a matter that maintains cleanliness and prevents cross-contamination ... Clean equipment will be managed so that staff can readily distinguish clean equipment ready for patient use from equipment that has not been cleaned ... Clean equipment is stored separate from used equipment, either in a clean utility room or in a designated area ... If a clean equipment room is not available, clean equipment may be identified by a ‘bag or tag’ method or other indicator ...” * “Cleaning the Environment and Equipment ... Surfaces must be intact and cleanable ... Remove any tape, sticky residue or other substances impairing the ability to clean the surface.” * “Report stained or misplaced ceiling tiles, fixtures, or walls so they can be replaced or repaired. Report to clinical leaders on the unit.” * “Upholstered furniture and other cloth or soft furnishings that cannot be cleaned and disinfected should not be used in patient care areas ... Replace worn, stained, torn or cracked or otherwise degraded furnishings ... Report worn, stained or torn items to the area supervisor.” * “Water Dispensers and Ice Machines/Bins ... Clean exterior surfaces routinely with hospital-approved disinfectant as least daily ... Focused attention should be placed on catch tray to avoid microbial growth ... Flush and clean water dispensers and ice machines quarterly ... Thoroughly disinfect dispensers and machines ... Descale dispensers as needed to remove deposits impeding disinfection ...” * “Emerging Pathogens and Outbreak Events ... Cleaners and disinfectants are reviewed on a periodic basis to ensure coverage of the emerging pathogen(s) ... There may be a requirement for additional/enhanced cleaning of the environment during an outbreak situation to contain spread ... Clean and disinfect all affected areas at the end of the outbreak.” * “Required: Subject Matter Expert ... Asante Infection Prevention Director”. * “Reviewed by ... Chief Nursing Officer ASANTE ... VP Nursing ASANTE ... Director of Nursing Professional Development ASANTE ... Director[s] of Support Services ATRMC ... ARRMC ... Director of Ancillary & Support Services AACH ... Manager[s] Facilities AARMC ... ATRMC ... Director Ambulatory Quality”. * “Revision date: 11/14/2023 ... Revision Description: New Policy”. 3.a. An undated slide presentation titled, “Roadmap for WBD [and] Created 10/06/2022” was presented at the IPC meeting and the ICU staff meeting on 02/02/2023, and 02/16/2023, respectively, in response to the increase in BSIs. Refer to Finding 3.c. below, AGC email. The presentation was reviewed and reflected: * “Avoid placement of patient care items or personal items on counters next to sinks.” * “Install and utilize hopper and toilet covers.” * “General information; outbreak/cluster ... Although investigations are generally divided into steps, it is important to remember that outbreaks/clusters generally do not unfold in a linear or orderly manner.” * “Identify, Report and Communicate ... If you are a staff member and you want to report a concern of a possible outbreak, connect with your leader ... Medical Staff will report to their VPMA ... Leadership will report concerns to Asante Infection Prevention via email ... AIP will reach out to managers to initiate relevant [IPC] measures ... AIP will report to the appropriate agencies if an outbreak determination is made ... Taking prompt action as soon as an outbreak is suspected may keep the outbreak from expanding.” * “Relevant [IPC] measures for Waterborne Organisms; All Staff - All Services ... Do not place items, prepare medications, or prepare procedures, etc., within 3 feet of a water source (i.e., splash zone)”. * “AIP ... Connects with stakeholders regarding policies & procedures/current practices ... Conducts site/unit visits ... Conducts staff interviews”. * “Ensure staff do not place ANY patient care supplies, including meds, on or near a sink that does not have a barrier to avoid droplet splash”. * “Dispensers: use single use cup or container only for dispensing ice”. * “Ensure staff disinfect ALL equipment between patient use (e.g., stethoscope, glucometers, portable BP machine ... Confirm nursing and CNA staff are disinfecting patient environment or equipment: Between patient use or when visibly soiled)”. * “Environmental Services ... Confirm ice and water dispensers’ surfaces (including the drip tray) are cleaned and disinfected daily”. * “Additional steps to be taken during an unusual increase in the incidence (cluster or outbreak) of cases or other recognized concern ... Reinforcement of initial response action, adding some observation and monitoring by operational leaders”. * “Consider Additional Measures and/or sources ... When initial/prior mitigating steps have not stopped positive case reports ... Establish a Mitigation Team ... Asante Infection Prevention conducts additional site investigation and/or staff interviews ... Additional mitigation may be required, for example ... Reassess- consider additional hypothesis as to possible source/other sources”. * “Environmental Sampling and Collection ... Routine environmental-surface sampling is neither cost-effective or warranted and should be conducted with multidisciplinary approval ... During an outbreak can be used to determine, potential environmental reservoirs, surface survival, or source of contamination ... Refer to Guidelines for Environmental Infection Control in Health-Care Facilities, Outbreak Investigations: APIC Text & Healthcare Outbreaks Associated With a Water Reservoir ... “. * Under “References” were direct links to “Oregon Health Authority Mandatory Reporting requirements” and “Oregon Health Authority Guidelines for Investigating HAI Outbreaks”. 3.b. An email dated 04/19/2024 from the AGC stated, “I’m unable to 100% confirm that a mitigation team was set up ...” as described in the presentation created on “10/06/2022”, Finding 3.a. 3.c. An email dated 04/22/2024 from the AGC reflected: * “WBD Roadmap presentation was given at the Infection Prevention Committee on 02/02/23 and the ICU staff meeting on 02/16/23.” * “... the presentation was specifically developed as a response to the increase in bloodstream infections.” The hospital failed to follow its own recommendations and failed to identify the increase in BSIs associated with the ICU as an outbreak or cluster, or establish a mitigation team once other hospital departments began referring to the BSI increases as an “outbreak”. Refer to Finding 3, slide show presentation created October 2022 and which stated, “outbreak/cluster ... it is important to remember that outbreaks/clusters generally do not unfold in a linear or orderly manner ...” and “Additional steps to be taken during an unusual increase in the incidence (cluster or outbreak) of cases or other recognized concern ... When initial/prior mitigating steps have not stopped positive case reports ... Establish a Mitigation Team ...” Refer to Finding 3.b., failure to establish a mitigation team. Refer to Finding 12.c., MICU email dated 01/31/2023 which described an “outbreak of waterborne pathogen infections in ICU”. Refer also to Findings 13.a. and 13.b., data that reflected significant increases in ICU-associated BSIs as early as the 4th quarter of 2022 and Finding 18, IPD statement, “We did not classify it as a cluster ... we did not use the word ‘outbreak’.” Lastly, refer to Tag A-144, Finding 2.a., the hospital statement that they “became aware of a pattern of BSIs” September 30 2022. 4. A document titled, “Preventing Waterborne Infection Fast Facts” dated 02/07/2023 included: * “Recognize ice is water ... Only use ice from water dispensers that filter water for drinks. Use a single-use cup or sleeve to dispense ice; do not refill patient cups from dispensers.” * “Manage sink splash zones and toilet plumes ... Do not place any patient care supplies or equipment next to sinks ... Splash zone is within 3 feet of the sink.” 5. A document titled, “Clean Environment Fast Facts” dated 09/07/2023 included: * “Keeping the Asante Health System environment clean is an important step to prevent infections. Germs can reside anywhere and by maintaining a clean environment, we reduce the chances of spreading infections to others.” * “Where to start? Establish department or task-specific policies and procedures to guide staff on how and when to clean the environment in their area and delineate responsibilities for who is performing the cleaning ...” * “Use Hospital-approved Disinfectants ... Follow manufacturer’s instructions for use (IFU) to wipe surfaces with a hospital-approved disinfectant.” * “All surfaces must be intact ... Report chipped, peeling, torn or otherwise compromised surfaces to your supervisor to be repaired or replaced ... Surfaces should be of a non-porous material that can be easily cleaned and disinfected ... Avoid items with mesh, fine grooves or other textures ... Limit fabric items to those routinely changed or cleaned by EVS (e.g., linens, curtains) ...” * “Separate Clean and Dirty ... Disinfect items after each patient use with hospital-approved disinfectant. Visually inspect before placing into clean supply or designated area for next patient use. Includes small items like zebra phones and stethoscopes ... Clean storage must be well ventilated and protect supplies from contamination, moisture, dust, temperature/humidity extremes and sunlight. Shelves should be 2 inches from an exterior wall, bottom shelves should have a solid, cleanable surface 8 inches from the floor and top shelves should be 18 inches from the ceiling ... No cardboard or other non-cleanable surfaces are permitted in clean storage areas. Contact Material management for assistance with cleanable storage bins options ... Linens must be continuously covered in designated storage shelves/bin or transport carts.” * “Protect surfaces and supplies from splashes and water contamination. This may require reorganizing the space and/or installing splash guards.” * “Don PPE just outside of isolation room; Doff PPE just inside the door on exit of isolation room or just outside the door into a covered trash can.” 6. A slide presentation titled, “Preventing Waterborne Infections” dated “2023” presented during an ICU staff meeting on or around 02/20/2023 reflected: * “Ice Dispensers ... Use single-use cup or sleeve to dispense ice ... Do not refill patient cup from dispensers ...” * “Avoid the Splash Zone ... Do not place any patient care supplies or equipment next to sink ... Splash Zone is within 3 feet of the sink” * “Assess integrity of hopper splash guards” * “EVS ... Ensure ice and water dispensers’ surfaces (including the drip tray) are cleaned & disinfected daily” * “Facilities ... Splash guards for sinks, toilets or hoppers, as needed” Regarding recommendations to mitigate the IPC issues identified by state public health authorities, the following emails and other communications from OHA to the IP department, including the IPD, reflected: 7.a. A document titled, “Asante Rogue Regional Infection Control Consult (CRE)” dated 05/25/2022 was reviewed and reflected: * “Key Recommendations: Ensure ... a process ... for lab to notify Infection Prevention when there is a suspected case of CRE so that a manual flag can be placed ... Perform regular maintenance of ice machines ... Ensure ... sinks outside of patient rooms have splash guards ... Plan ... storage ... in patient bathrooms / other locations ... are not exposed to spray ... Ensure ... regular cleaning / maintenance of sink drains / p-traps ... Cover hopper(s) or at minimum install splash guards (or hopper lids) and provide staff training about use of PPE when using the hopper and the closing the lid prior to flushing ... Provide education for staff on hire and annually regarding CRE, hand hygiene, PPE donning / doffing, catheter associated urinary tract infections (CAUTI), central line associated blood stream infections (CLABSI), environmental cleaning, device reprocessing ... Consider developing a policy or protocol specific to CRE.” * “Ice Machines ... Ensure that only clean (un-used) receptacles are used to collect ice, i.e., no use of personal water bottles, used cups, etc. ... Schedule regular daily cleaning (as a high touch surface) and include the bottom grate and water receptacle under the grate.” * “Sinks ... Install splash guards around sinks outside of patient rooms to protect equipment and supplies from spray contamination ... Evaluate sinks at nurse’s stations, dirty utility, supply rooms, etc. ... Evaluate and move paper towel dispensers and glove boxes that are within the splash zone ... Validate that water flow from all faucets (not just patient rooms) is directed away from the drain to decrease contamination of supplies, surfaces, equipment, caregiver’s hands, etc. ... Ensure there are regular cleaning/maintenance of sink drains/p-traps ... Plan to provide storage areas for patient toiletries, so they are not stored on the sink counter where splash occurs.” * “Hoppers ... Install covers or splash guards on hoppers ... Educate staff to wear appropriate PPE when using hopper and remove all items that are in the splash zone.” * “Equipment Cleaning ... Ensure that staff who are cleaning equipment have been trained on how to clean each piece of equipment per manufacturers [sic] recommendations using the approved disinfectant.” * “Education and Training of Staff ... Educate and train staff on-hire and annually for the following ... how to prevent Catheter Associated Urinary Tract Infections ... Aseptic catheter insertion ... Care of catheter ... Auditing of practices to prevent CAUTI ... how to prevent Central Line Associated Bloodstream Infections ... Steps of catheter Insertion - ensuring bundles are followed ... Care and maintenance of central lines ... Auditing of practices to prevent CLABSI ... Educate/train staff on hand hygiene ... Educate/train staff on PPE donning/doffing ... Educate/train staff on device reprocessing ... Educate/train staff on environmental cleaning ... Cleaning and disinfection of equipment based on manufacturers [sic] recommendations ... Ensure there is a “tagging” system (or other process) for cleaned equipment ... Disinfectant storage, dilution and contact time ... Educate/train staff on CRE ... Provide on-hire and annual education and training for staff (caregivers, EVS, physicians, etc.,) about the significance of controlling CRE and Asante’s protocols when a patient with CRE is receiving care ... Review written information that is available for patients/visitors ... Develop protocols to ensure that education is received by the patient/visitor as soon as possible after diagnosis.” * “Policy/Protocol Development ... development of policy or protocol ... related to CRE ... use of enhanced environmental cleaning measures, (i.e., UV light, hydrogen peroxide vapor) ... CHG bathing of CRE patients and possibly unit wide CHG bathing ... Determine if it is reasonable to perform CRE screening in patients who are high risk ... Increase cleaning of high touch surfaces in CRE patient room and affected units ... If staffing allows dedicate nursing staff to CRE patients”. * Links to the following were embedded in the document: “Oregon CRE Toolkit ... AHRQ CRE Toolkit ... CDC CRE Toolkit ... CDC Generic ICAR form”. The CDC Generic ICAR tool link included a list of modules to assist IPs in assessing the facility’s infection prevention practices, including Injection Safety/Drug Diversion. 7.b. An OHA consult report dated “12.6.22” reflected: * “Infection Prevention Recommendations For: Asante Rogue Regional Medical ... Consult Type: Center On-site ... Consult Reason CP-CRE response”. * “Below are the recommendations to reduce the risk of MDRO’s [sic] from our visit and ... the recommendations from our ... visit in May ...” * “Hyperlinks ... and resources are provided in the document ... recommend these links be saved for ... future reference.” * “Summary - Key Action Items ... Control for environmental contamination from sink and drain splash ... Toilet seat covers on toilets in patient rooms ... without a dedicated restroom ... Install splash guards on all sinks ... in areas with storage or other activities within 3 feet of the sink ... Consider removing the staff hand hygiene sink next to the computer in the ICU/CCU/IMCU rooms ... Consider regular cleaning of drains and P-traps ... Hand Hygiene, particularly related to artificial fingernails and hand hygiene compliance ... Use single patient use packets of gels, ointments, and creams ... Transmission based precautions ... Duration of precautions and notifications ... Position of garbage bins for doffed PPE ... Use during patient care and hopper use ... Environmental cleaning ... Standardize Disinfectant Agents ... Provide all staff education for use, audit proper use by non-EVS staff ... Evaluate the OR cleaning practices for compliance with best practice standards, identify gaps in practice, and develop action plans to address those gaps.” * “Specific Recommendations ... install splash guards on all sinks that have storage or work space within 3 feet of the sink ... Remove paper towel dispensers from the splash zone ... Consider removing hoppers that are unused or no longer needed, particularly if hopper covers cannot be installed ... Provide education for staff on the need for proper PPE when using a hopper ... Provide staff ... education on the use of the products, particularly the wet time and necessary PPE ...” 7.c. An email from the OHA HAI IP dated “April 28, 2023” reflected: * “... will be meeting with ... CDC ... asking the following questions ... Link between environmental pathogens and possible substance abuse exposure ... Advice for defining HA-outbreak (vs. present on admission) in the context of polymicrobial, environmental pathogen BSIs” * “Recommend: Reviewing your CHG bathing and bedside bathing practices. Reviewing medication administration practices to identify any commonly administered medications prior to initial culture positive. Not mentioned on call, but recommend taking a look at IV bag storage to ensure bags are intact, unopened, within date of expiration, etc. Reviewing peripheral IV start and maintenance practices, including presence of field starts. Assess whether any commonalities in access site for blood culture collection (peripheral stick vs. pull from existing line, etc).” 7.d. An email from the OHA HAI IP dated “5/4/2023” reflected: * “Our conversation ... with CDC HAI colleagues revealed a few additional items to consider regarding this potential cluster ... If not already complete, assess for any commonalities in hospital areas that patient may have ... received contrast or other injections ... In addition to broadly reviewing medication administration practices, also review injection safety practices ... particularly among those with patient contact early in their hospital stays.” 7.e. An OHA consult report dated “05.19.23” reflected: * “Infection Prevention Recommendations For: Asante Rogue Regional Medical Center ... Consult Type: Center On-site ... Consult Reason 6 month follow up CP-CRE case”. * “Continue ... splash guard installation, improved ‘splash zone’ practices ...” * “Additional Recommendations ... Injection Safety ... Strongly recommend comparing current practices for IV contrast media in radiology with CDC’s recommendations on injection safety and the product’s instructions for use (IFU’s).” * “Continue to replace worn and damaged furniture ... Recommend removing all tape and adhesive residue from surfaces, including work surfaces and equipment.” * The “CDC’s recommendations” contained an embedded hyper link which opened to a web page that prominently displayed a link to drug diversion. The CDC web page had a last reviewed date of “May 2, 2012”. 8. During tour of ICU on 01/31/2023 at 1450 and on 02/02/2024 beginning at 1200 with MICU, the following observations were made: * An unopened NS syringe and a dusty bucket previously used to collect outdated items were on the floor under the clean supply shelves in the clean utility room. A box of 30 surgical scrub brush sponges with nail cleaner for provider use was located next to the sink and inside of the splash zone. Three to four scrub brush wrappings were seen laying directly in front of the box. The lower wall on the left side of the sink had visible gouges exposing the sheet rock underneath and created an uncleanable surface. Next to the sink and protected by the splash guard was the bath wipe warmer, however, directly in front of the warmer were two packaged items, a “Closed Wound Suction Evacuator” kit and another unidentified item. Underneath the counter and on the floor were two plastic bins containing patient care supplies that were sitting upon a rigid plastic grid pad, similar to those used in car ports, patios and animal stalls. The rigid pads elevated the bins approximately 2 inches off the ground. One bin had no lid and contained CHG cloth wipes, the other bin with a lid had an open package of “ComfortGlide” bed pads sitting on top. A single, dry alcohol prep pad was laying on top of one of the plastic grids and “dust bunnies” could be seen directly under both plastic floor grids. Some of the cupboards and drawers were labeled with blue masking tape and other labels which interfered with the cleanable surfaces. * The soiled utility room was crowded and unorganized. Several items such as the pharmaceutical tubing waste bin, a white bucket filled with cords, a leg brace, a blood pressure cuff and other items were piled up to approximately 6 inches under the hand sanitizer wall dispenser and inhibited easy access to it. The “ARRMC EVS Checklist for Cleaning the Soiled Utility Room” lacked initials of completion for several “Daily Cleaning” dates. These dates included, “1/21, 1/22, 1/23, 1/28, and 1/29”. The “EVS Leadership Review ... Weekly” reflected no initials in any of the boxes. * A water and ice dispenser machine had visible white scale residue along the back edge, the side edges and throughout the grate of the drip tray. The MICU was asked who was responsible to clean it and whether there was a cleaning schedule for the ice/water dispensing machine. The MICU responded that they believed that servicing was conducted monthly by Facilities but was unsure whether daily cleaning was conducted. A cup was seen on the grate and the MICU was asked whether ice/water was dispensed directly into personal cups or containers. The MICU responded, “I am sure that happens.” * A second sink near the ice/water dispensing machine had a splash guard in place, however, inside the splash zone and not protected by the splash guard, were several items. These items included: - An open paper towel holder with paper towels exposed to the splash zone and approximately 8 inches above the sink. The inside metal wall of the dispenser was hanging down and had visible water droplet drip lines. - A bottle brush sitting in a container of water. - Two spatulas, normally used for cooking. - A Sharpie pen. - Various eating utensils. - A food container with lid. - A bottle of dish detergent 3/4 full. - An empty bottle of dish detergent laying on its side behind the faucet’s cold water handle, and under the paper towel dispenser. - A container lid. - A ceramic cup. - A package of coffee machine cleaner. * A patient occupied room had several items, including personal care items, sitting on the counter next to the sink in the splash zone. Items included: - A toothbrush sitting in a paper cup. - A bottle of mouthwash. - A manual blood pressure cuff and accompanying storage bag. - A handheld Doppler instrument. - A phone cord plugged into an electrical outlet and draped down onto the right side of the sink as it led to the patient’s side table which had been placed within 3 inches of the sink and in the splash zone. - Items on the patient’s side table included unopened medication packages, swabs, and a bottle of topical fungal powder. * Three other sinks on the ICU were observed with items located within the splash guards and within the splash zone. These items included: - Paper towel holders located either directly above the sinks, or slightly off-center to the right/left of the sinks. - Hibiclens cleansers. - Boxes of surgical scrub brushes. - A large, medical grade pill crusher. - A bin of vacutainer luer-lok access devices used for blood draws. - A tray of phlebotomy collection vials. The MICU stated at the time of the observation, “They [the phlebotomy vials] could have been left there after a busy day and thinking that they would just be back the next day.” * A black and white office style chair at a computer workstation outside a patient room. The upholstery along the top edge of the seat back was torn and cracked exposing whitish-colored material underneath. “ICU” was handwritten in black Sharpie on the back of the chair. * Reusable patient care equipment including a walker, behavioral health restraints, automatic blood pressure machines on wheels, and IV poles were observed in the ICU. There was no information on or near the equipment reflecting whether they were clean or dirty/contaminated. * The housekeeping closet contained a hopper without a hopper cover. The wall behind the hopper had approximately 10-12 gouges exposing the drywall underneath which interfered with the cleanable surface. A paper note was posted above the hopper which was curling from moisture and was a non-cleanable surface. * Several cabinets and drawers throughout the ICU had labels, tape, or non-laminated paper notes/signs taped on the outside of the cabinets and drawers interfering with the cleanable surfaces. * The MICU verified the observations at the time of the tours. Additionally, the MICU and the SICU were asked about patient education on CP-CRE. Per the SICU, “That’s only available in EPIC patient charting” and no printed material was available for patients. The MICU added, “I don’t know if we’ve been well-versed on providing this education.” When the MICU was asked how the hospital assured that patient care equipment had been cleaned after POC use, and prior to use on another patient, the MICU stated, “It’s in our policy and we trust that they are wiping down equipment after use. We don’t audit to verify equipment has been cleaned.” The SICU was asked about staff education on equipment cleaning, they stated that outside of initial training they were “unsure if inservices had been provided” to ICU staff. When asked about manufacturer’s IFUs, specifically, disinfectant storage, dilution and contact time, the SICU stated they were unsure, and that initial training may have included that information. The MICU was asked about education on hand hygiene for ICU staff. The MICU replied that they did not know if inservices or emails had been provided, but that the ICU staff had requested that training. The MICU was asked about other education that had been recommended by OHA such as, donning and doffing of PPE, and CLABSI. The MICU replied that the education was provided on hire and annually but was unsure about any other recent inservices and that the ICU staff had been requesting that education. The hospital failed to fully implement P&Ps as described in Findings 1-6, Asante facility cleaning policies, daily cleaning checklist, and IP presentations on cleaning protocols. The hospital failed to address issues identified by the state public health authority for approximately 1 year and eight months after the first recommendations were made by the state public health authority, refer to Findings 7.a. - 7.e., OHA consult reports and emails to the IP department with IPC recommendations, including recommendations to review injection safety practices, the administration of medications, and possible substance abuse exposure. It was unclear whether the hospital had provided adequate supplemental education as recommended by OHA. This was evidenced by the unit observations, and both the MICU and SICU’s responses as to whether additional education on OHA recommended topics, other than initial or annual education, had been conducted. Additionally, although splash guards had been installed per OHA recommendations, patient care items and equipment, such as patient toothbrushes and phlebotomy tubes, were being stored inside the splash guards, and within the splash zone. The IP department lacked documentation that regular auditing of staff adherence to hospital infection prevention policies was occurring as required by policy and as described in the IP job description duties. Refer to Findings 9.a. and 9.b., IPD environmental rounds documentation, and Finding 10, IPD interview acknowledging gaps in IP protocols, and Tag A-748, Finding 5, IP job responsibilities that included regular rounds in patient care areas “observing for adherence to ... [IPC] measures.” 9.a. IP program environmental rounds for the ICU were reviewed and reflected: * Documentation of weekly IP rounding provided by the hospital reflected dates that began 06/08/2023 through 02/05/2024. * Three IP audits for the ICU were documented in 2023: June 8, 2023, September 10, 2023, and December 8, 2023. * Three IP audits for the ICU were documented in 2024: January 26, 2024, February 1, 2024, and February 5, 2024. The hospital failed to conduct weekly IP rounds as described by the IPD in Finding 10, IPD interview. 9.b. An email on 03/14/2024 from the AGC confirmed Finding 9.a. The AGC stated, “Attached ... are the logs for rounding in the ICU that we have ... The dates captured here are 05/2023 to present. We searched for logs going back to 05/2022 but haven’t been able to find any.” 10. During an interview on 02/01/2024 at 1355, the IPD provided the following information: * Regarding ice/water dispensing machine, the IPD stated they believed EVS did daily cleaning and facilities did quarterly PM. The IPD acknowledged EVS policy “Facility Environmental Cleaning and Disinfection” did not “specifically say ‘ice machine’ should be cleaned daily as recommended by the state public health authority in Finding 7.a., “Schedule regular daily cleaning.” The IPD stated, “It’s been an ongoing challenge. I wish I could say it was improved.” * Regarding phlebotomy tubes next to sink, IPD stated that would not be acceptable. * Regarding patient personal items next to sink, IPD stated those should not have been there. IPD stated, “Nothing gets placed there.” * IPD stated IP rounds were conducted weekly on the ICU and “pictures are sent to leadership if issues are found.” IPD stated IP rounds were last done 01/26/2024. However, they stated no pictures were taken “because the unit is moving in a week and no issues were big enough to address.” Regarding failure to detect, investigate and manage infections and outbreaks, including common-source outbreaks: 11.a. The P&P titled, “Management of Communicable Disease Exposures (ASANTE)” dated effective 07/27/2021 reflected: * “Infection Prevention Responsibilities ... Promptly investigates any reported communicable disease exposure, confirming the diagnosis and developing the exposure criteria ... For exposure criteria, refer to the Oregon Disease Investigative Guidelines online for current information ... “ This was followed by a link to the state public health authority website. * “Notifies the appropriate public health department if it is a reportable communicable disease ... “ This was followed by the phone numbers of the two local county health authorities within whose jurisdiction the Asante Health System was located. * “Notifies the appropriate public health department if EMTs, paramedics, or other first-responders were potentially exposed, requesting that they notify those individuals.” * “Alerts Employee Health (and if appropriate, the House Supervisor and Medical Director for Infection Prevention) to the potential exposure.” * “Identifies any potential patient contacts and notifies their attending provider (for inpatients) and/or their primary care provider (for outpatients) of the potential exposure.” * “Identifies departments/areas that had potential contact with the infectious patient ... Notifies managers of those departments in writing of the potential exposure and the exposure criteria, requesting they identify any healthcare personnel ... who meet the exposure criteria.” * “In conjunction with Employee Health, reports the exposure investigation to the Infection Prevention Committee, including the number of exposed patients ... “ * “Department Manager Responsibilities ... Using the exposure criteria provided in the notification from Infection Prevention or the Oregon Disease Investigative Guidelines, identifies any employee who met the criteria for exposure, completes the Communicable Disease Exposure Contact List ... Asks exposed employee(s) to contact Employee Health for instructions.” * “Employee Health Responsibilities ... Receives and compiles employee list from Department Manager(s) ... Contacts the employee(s) on the Communicable Disease Exposure Contact List(s) ... Verifies exposure criteria is met and if so, directs them to Employee Health (or ED in EH absence) for treatment, if indicated ... During the staff interview(s), investigates any further contacts not clearly documented on the patient record.” * “Determines immunization status, treats, and implements work restrictions as applicable (see Policy ... “Work Restrictions for Healthcare Workers Exposed to or Infected with Infectious Diseases”) ... Notifies the employee’s Department Manager if work restrictions are required or if Employee Health has not been able to contact the employee ... Notifies Infection Prevention, who can escalate to the appropriate committee as needed (i.e. [sic] Infection Prevention Committee) including the number of exposed employees, work restrictions, and clinical outcomes.” * “House Supervisor Responsibilities ... In the absence of Infection Prevention or Employee Health, the House Supervisor assumes or delegates their responsibilities ... In the absence of Employee Health, the House Supervisor arranges for employee evaluation in the Emergency Department.” * “Required: Subject Matter Expert ... Infection Prevention Supervisor”. * “Reviewed By ... Clinic APP ... Medical Director Work Health ... Asante Infection Control Committee ... Employee Health Provider APP ... Director Nursing, AACH ... ARRMC ... ATRMC”. This was the only policy the hospital provided in response to a request of policies regarding the detection, investigation, and control of outbreaks. The policy lacked clear definitions of what diseases, conditions, and exposure incidents, such as an outbreak or suspected outbreak, were required to be reported to local and state public health authorities. Although a link to the state public health authority’s website was provided, the policy didn’t clearly state that exposure criteria related to an outbreak investigation would also be available at that site. The words “cluster” or “outbreak” were never reflected in the policy. The hospital failed to follow and fully implement the Communicable Disease Exposure policy as the policy stated that IP was required to notify the Infection Prevention Committee of a communicable disease investigation, including the “number of exposed patients”. However, review of IPC meeting minutes did not reflect any notification of an outbreak or number of patients affected by an outbreak, refer to Finding 15, IPC meetings. The policy minimally addressed investigation of potential exposures to patients from healthcare workers, or other patients. The policy stated, “Identifies any potential patient contacts and notifies their attending provider (for inpatients) and/or their primary care provider (for outpatients) of the potential exposure.” The policy’s primary focus was on exposure from a patient to an employee, as evidenced by the statements regarding employees “who meet the exposure criteria” and “identifies any employee who met the criteria for exposure” as well as Employee Health, Infection Prevention and House Supervisor follow-up for employee evaluation. The policy failed to provide the appropriate steps, or IP responsibilities for patients who may have suffered an exposure incident from a common source, including exposures to BBPs, through breaches in safe injection practices, exposures via non-intact skin, or mucous membranes. The hospital provided no other policies that contained guidance on the identification, management, and implementation of appropriate precautions to prevent further transmission when a suspected, presumptive, or confirmed HAI outbreak, or a common-source outbreak, was identified. There were no other policies provided with guidance on follow-up testing or verification of the BBP status for a HCW or patients when a suspected common-source outbreak related to breaches in safe injection practices was identified. Refer to Finding 18, IPD statement that the hospital did not have a policy that defined an outbreak. Refer to Tag A-772, Finding 11, the hospital’s BBP Exposure Plan that was provided as part of a request for information on the BBP status of RN4 and patient follow-up after a common-source outbreak was identified due to RN4’s suspected drug diversion involving a breach in safe injection practices. 11.b. An attachment to the Management of Communicable Disease Exposures policy titled, “Communicable Disease Exposure Contact List” reflected: * Instructions at the top of the form were: “Complete and return to Employee Health no later than: _________ ... Name of person completing form ... Department/Unit ... Disease ... N. meningitidis ... Varicella ... Pertussis ... Tuberculosis ... Other ...” Followed by: Exposure Criteria ... No Exposures”. * The instructions were followed by a table and included four columns for Manager or designee documentation and two columns for Employee Health documentation, followed by a section for entering information. * Under the Manager responsibilities were: “Name ... Phone ... Meets exposure criteria? ... Date of Exposure”. * Under the Employee Health responsibilities were: “Treatment/Prophylaxis ... Comments”. It was unclear whether this form would be used to track exposed patients as well as exposed employees as the policy in Finding 11.a. stated that the patient’s attending provider would be notified of potential exposure. Therefore, it was unclear how the hospital identified. tracked, and monitored multiple patients exposed to a suspected, potential, or confirmed outbreak, or whether Infection Prevention or Employee Health would be responsible for outbreak follow-up when patients required further interventions and/or evaluations after a communicable disease exposure. 12.a. Emails sent by the MICU, the SICU and others reflected that BSIs with specific waterborne organisms were occurring as early as October, 2022. For example, an email dated “10/10/2022” sent by the MICU to the CCU, ICU, IMCU and critical care traveler staff reflected: * “Did you see the AsanteNews STAT article (Best practice alert: Preventing spread of Stenotrophomonas) on best practices to break the chain of transmission for waterborne organisms, like Stenotrophomonas? The same article was distributed to Medical Staff ... Critical care patients are particularly vulnerable to these pathogens. The common sources or fomites for nosocomial transmission are listed in tabular form in the article ... Please also note the key interventions to prevent transmission to our patients - with emphasis on reenforcing [sic] the basics: Ensure strict adherence to hand hygiene practices ... Ensure clean and dirty procedures are performed in completely separated areas ... Adhere to isolation requirements, particularly in the ICU, IMCU and CCU settings ... Ensure strict adherence to manufacturer’s instructions for use for all equipment that comes into contact with a patient or patient’s environment.” 12.b. An email dated “10/28/2022” sent by the MICU to the ICU and IMCU staff reflected: * “Critical care patients are particularly susceptible to waterborne pathogens such as stenotrophomonas [sic]. Please be mindful of the following key interventions to prevent transmission: Ensure strict adherence to hand hygiene practices ... Ensure clean and dirty procedures are performed in completely separated areas, as able ... Adhere to isolation requirements ... Ensure strict adherence to manufacturer’s instructions for use for all equipment that comes into contact with a patient or patient’s environment ... Use sterile water for patient use (i.e.: flushing OG tubes) ... Avoid allowing water to pool in standing areas (i.e.: dependent tubing).” 12.c. An email dated “01/31/2023” sent to the ICU staff by the MCICU reflected: * “In light of an outbreak of waterborne pathogen infections in ICU, the February ICU staff meeting has an increased sense of urgency and I need all hands on deck. Attendance at this staff meeting is required.” 12.d. An email dated “02/11/2023” sent to the ICU staff by the MICU reflected: * “I’ve been engaged in lots of great discussions about waterborne infections. Please keep asking these great questions and please bring them up at the staff meeting!! We will have many great minds available to help us talk through some of these things! We are still working through several process improvements. Your roll [sic] right now is to be mindful and limit tap water for use in your patients when you can. The ice machine and filtered water is safe to use if your patients are drinking water.” 12.e. An email dated “02/20/2023” sent to the ICU staff by the SICU reflected: * “To summarize what was missed: [the IPD] began [their] presentation on waterborne disease prevention which is being done as a result of recent CLABSI’s [sic] in ICU positive for waterborne organisms.” Attached to the email was the slide show presentation titled, “WBD Education” described in Finding 6. 12.f. An email dated “02/23/2023” sent to twenty-one staff members by the SICU reflected: * “Subject: **RESPONSE NEEDED** February Staff Meeting ... Urgent: High ... Follow up ... I was unable to capture you in attendance for the February staff meeting and waterborne disease presentation. I sent out a separate email with the recording and PowerPoint slides. Please respond to this email by February 28th with tidbits gleaned from the meeting and any follow up questions you may have. This is a mandatory meeting for all critical care employees who perform patient care.” Communication to the ICU staff by unit leadership reflected the progression of a “suspected” outbreak to a “presumptive” outbreak that culminated with the MICU stating an outbreak was occurring in the email dated “01/31/2023”. Also, refer to Tag A-144, Finding 2.a., where the hospital stated that they “became aware of a pattern of BSIs” September 30, 2022. Despite the increased communication surrounding a potential ICU-associated outbreak, the IP program failed to identify the outbreak or to consider drug diversion/injection safety breaches as a possible common-source of the ICU-associated BSIs until November 2023, approximately one year after the first pattern of ICU-associated BSIs had appeared. Refer to Finding 18, date that IP first learned that drug diversion/injection safety breaches by one staff member was a possible common-source of the outbreak and IPD statement, “We did not classify it as a cluster ... we did not use the word ‘outbreak’.” 13.a. Documents provided by the hospital reflected ARRMC, ICU-associated BSI data and included patients affected by the outbreak, organisms identified, the method of detection and the dates of final lab results. BSIs with final result dates reported prior to the end of the calendar year, from June 20, 2022 through December 19, 2022, reflected a total of 16 BSIs associated with the ICU that had been reported as of the date of this survey. This data was reviewed and reflected: * June 2022, 1 ICU-associated BSI was identified: Stenotrophomonas spp., Patient 1. * July 2022, 1 ICU-associated BSI was identified: Stenotrophomonas spp., Patient 34. * August 2022, 1 ICU-associated BSI was identified: Enterobacter spp., Patient 35. * September 2022, 2 ICU-associated BSIs were identified: Patient 4 with Onchrobactrum spp. and Stenotrophomonas spp.; Patient 36 with Enterobacter spp. Samples from ET aspirate also identified 3 Stenotrophomonas spp. in Patients 2, 3 and 5. * October 2022, 5 ICU-associated BSIs were identified: Patient 4 with Acinetobacter spp.; Patient 6 with Chryseobacterium spp.; Patient 7 with Onchrobactrum spp.; Patient 8 with Chryseobacterium spp.; and Patient 37 with Enterobacter spp. * November 2022, 4 ICU-associated BSIs were identified: Patient 9 with Stenotrophomonas spp.; Patient 10 with Acinetobacter spp. and Delftia spp.; Patient 11 with Delftia spp. and Stenotrophomonas spp.; and Patient 38 with Enterobacter spp. * December 2022, 2 ICU-associated BSIs were identified: Patient 10 with Burkholderia spp.; and Patient 14 with “Only gram-negative rods are identified”. Sample(s) from ET aspirate also identified Achromobacter spp. and Stenotrophomonas spp. in Patient 12. Data reflected a total of 16 ICU-associated CLABSI/BSIs reported from June 20, 2022 - December 22, 2022. The hospital failed to develop an effective IPC Program that was able to recognize and “Determine trends of infections, including sources and risk factors, and institute appropriate control measures ... Detect presence of clusters of infection, infections due to unusual organisms or outbreaks of diseases” per the hospital’s 2022 and 2023 AIP Operational Plans, refer to Tag A-751, Findings 1 -3, Asante IP Operational Plans. A breach in safe injection practices, aka drug diversion, was not considered or identified. This practice may have led to increased BSIs in the 14-bed specialty unit, the ICU, first identified in September 2022, refer to Finding 18, interview with the IPD, MDCC and the AGC. Although the hospital reached out to the state infection prevention consultants, the 2022 recommendations by OHA were not fully considered or implemented, including a review of injection safety practice breaches, such as drug diversion, refer to Findings 7.a. and 7.b., OHA recommendations dated 5/2022 and 12/2022; refer to Finding 8, ICU observations, and Finding 18, IPD interview, drug diversion/injection safety breaches were not considered a risk factor until November 2023. IP concern continued to escalate when clinicians observed a respiratory organism, Stenotrophomonas, presented in blood cultures more frequently by September 2022, refer to Finding 18, IP interview and MDCC statement about the changes in Stenotrophomonas presentation. The data reflected a third indicator of IP concern by October 2022, which was the emergence of polymicrobial BSI results, refer to Finding 18, IP interview and MDCC statement regarding the “dramatic” changes observed in organisms of concern. Despite IP and clinician concerns, the increase of BSIs in one isolated unit, and noted changes in pathogen patterns, the IP department “at no point ... [identified] the BSIs as a cluster or outbreak.” Refer to Finding 18, IP interview. The hospital allowed a common-source outbreak to continue for approximately one year, even though 2022-year end data reflected a CLABSI increase of 250% from 4 CLABSIs reported in CY2021, hospital-wide at ARRMC, to 14 CLABSI/BSI events in one ARRMC unit within a 6-month period, June - November 2022. Refer to Finding 14 below, the 02/04/2022 IPC meeting minutes which reflected the CLABSI data for ARRMC, 2021. Of note, during the 12/05/2022 IPC meeting, the IP department presented its annual risk assessment and IP plan for 2023, approximately one week after the 14th ICU-associated BSI had been reported. The risk assessment had not been updated since 09/23/2021 to include the increases in ICU-associated BSIs or risks associated with an outbreak, and was based on system-wide data, refer to Tag A-751, Findings 5, 6 and 7, AIP Risk Assessments. Additionally, a suspected, potential, or actual outbreak of BSIs in the ICU was not reported to the IPC’s multi-disciplinary members, nor to members participating in the HAI TT meetings. These meetings were established to analyze “patterns or trends, investigating issues, or concerns” of infectious origins. Refer to Findings 14 and 15, IPC and HAI TT meeting minutes from 06/06/2022 through 12/05/2022 which reflected a significant lack of ICU specific BSI discussions, no outbreak discussions, and no consideration of drug diversion/injection safety breaches as a possible common source; refer to Tag A-751, Finding 4, IPC Charter, purpose of an IPC Committee. A charter for the HAI TT meetings was not provided. 13.b. BSIs with final result dates reported for the first 7 months of CY2023, from January 8, 2023 through July 27, 2023, reflected a total of 28 BSIs associated with the ICU that had been reported as of the date of this survey. This data was reviewed and reflected: * January 2023, 1 ICU-associated BSI: Patient 13 with Achromobacter spp. and Onchrobactrum spp. * February 2023, 2 ICU-associated BSIs: Patient 15 with Acinetobacter spp. and Stenotrophomonas spp.; and Patient 16 with Stenotrophomonas spp. * March 2023, 1 ICU-associated BSI in Patient 17 with Chryseobacterium spp., Delftia spp. and Stenotrophomonas spp. * April 2023, a total of 8 ICU-associated BSIs: Patient 18 with Onchrobactrum spp.; Patient 19 with Chryseobacterium spp. and Stenotrophomonas spp.; Patient 20 with Stenotrophomonas spp.; Patient 21 with Chryseobacterium spp. and Delftia spp.; Patient 39 with Enterobacter spp.; Patient 40 with Enterobacter spp. and Stenotrophomonas spp.; Patient 41 with Acinetobacter spp. and Enterobacter spp.; and Patient 42 with Enterobacter spp. * May 2023, a total of 5 ICU-associated BSIs were identified: Patient 1 with Delftia spp.; Patient 22 with Enterobacter spp. and Onchrobactrum spp.; Patient 23 with Chryseobacterium spp.; Patient 24 with Chryseobacterium spp.; and Patient 43 with Enterobacter spp. and Acinetobacter spp. * June 2023, a total of 5 ICU-associated BSIs were identified: Patient 25 with Onchrobactrum spp.; Patient 26 with Delftia spp. and Onchrobactrum spp.; Patient 27 with Chryseobacterium spp. and Stenotrophomonas spp.; Patient 44 with Enterobacter spp.; and Patient 45 with Enterobacter spp. * July 2023, a total of 6 ICU-associated BSIs were identified; Patient 28 with Stenotrophomonas spp.; Patient 29 with Chryseobacterium spp. and Stenotrophomonas spp.; Patient 30 with Acinetobacter spp. and Stenotrophomonas spp.; Patient 31 with Chryseobacterium spp.; Patient 32 with Stenotrophomonas spp.; and Patient 46 with Enterobacter spp. Data reflected a total of 28 lab reported ICU-associated BSIs during a seven month period in 2023, an increase of 75% from the 16 BSIs reported in CY2022. The hospital failed to implement an effective IPC Program that was able to “Determine trends of infections, including sources and risk factors, and institute appropriate control measures ... Detect presence of clusters of infection, infections due to unusual organisms or outbreaks of diseases” per the hospital’s AIP Operational Plans, refer to Tag A-751, Findings 1 - 3, the AIP Operational Plans. IP meeting minutes failed to reflect that a suspected, potential, or actual ICU-associated BSI outbreak had been identified and reported out to the committee members. Refer to Finding 14, IPC meeting minutes, and Finding 15, HAI TT meeting minutes which reflected lack of ICU specific BSI outbreak discussions, breaches in injection safety practices, including consideration of drug diversion as a possible common source. The IP department did not consider drug diversion/injection safety breaches as a risk factor until November 2023, when a UCLA expert report pointed to drug diversion as a possible common source of the outbreak. Refer to Finding 18, IP interview. Even after the potential risk was identified, the IP department failed to update the annual risk assessment to include drug diversion, injection safety or outbreak management. Refer to Tag 0751, Finding, 12 AGC email confirming dates of the risk assessments. The IP program failed to base its annual risk assessment on patient care services, patient care environment, staff, patients and/or risks that were unique to the ARRMC hospital and instead used system-wide data to determine prioritized infection prevention risks, refer to Tag A-751, Findings 5, 6, and 7, 2022, 2023, and 2024 AIP Risk Assessments. The IP department failed to develop an annual plan based on a hospital-specific risk assessment, refer to Tag A-751, Finding 14, AGC acknowledgement that AIP Risk Assessments and Annual Plans were based on system-wide data, and on three separately certified hospitals which were not identical in environment, staffing needs, population served, or services provided. 14. A document titled, “Healthcare-Acquired Infection (HAI) Workup Fast Facts” dated 07/27/2023 was reviewed and reflected: * “What is the HAI workup process? A HAI is defined as a case or event whereby a patient develops an infection that was not present prior to or at the time of admission. Each of these HAI events are formally reviewed to identify successes, opportunities, and action plans to mitigate future infections.” * “Who determines if the patient cases meet criteria as a HAI? Performance Improvement abstracts the patient cases following ... CDC ... NHSN ... definitions.” * “NHSN HAI metrics include ... CAUTI ... CLABSI ... CDIFF ... MRSA ... SSI ... HYST ... COLO ... HPRO ... KPRO” * “How am I notified that an event has occurred in my area? New HAI events are distributed by the Weekly Clinical Outlook each Monday morning to clinical and executive leadership ... includes patient information, HAI type, unit where the positive specimen was collected ... brief summary of how the case met NHSN HAI criteria ... serves as the trigger for the Investigational Meeting invite ... with the slide template to be sent to the unit leader ... sent out the same week as the event with the slide template ... sent to the unit leader ... The Investigational meeting itself typically occurs 1-2 weeks in the future to give time for leaders to review the case.” * “What do I need to do if an event occurs in my area? Review the case for successes, opportunities, and action planning ... Identify leaders or other areas to be invited to the investigational meeting ... Have conversations with staff involved ... to identify opportunities or barriers to care, including issues with physical environment ... Act on any immediate findings (e.g., in the moment education, log tickets with facilities for repairs).” * “What is my role at the Investigational meeting? Unit leader discusses findings from their review of case, operational practices/processes & discussions with staff ... Additional area leaders similarly contribute their findings, where applicable ... Discuss gaps, questions, or areas of opportunities to improve care ... to prevent the spread of disease ... Unit leader captures successes, opportunities and action plans on HAI slide template & returns by deadline ... 2 days prior to HAI Tiger Team ... meeting...”. * “What is the role of Infection Prevention resources? Shares any contributors noted during the event review ... Discuss fundamentals of preventing infections ... Asks questions about ... policies and procedures ... Shares any trends identified across the system ... Discusses possible linkages during episodes or outbreak with same organism, where applicable.” * “What is my role at the HAI Tiger Team? Unit Leader presents slides and findings ... Members contribute ideas and suggestions, observed trends & any identify [sic] barriers ... Leaders take accountability for action items & next steps.” * “What is my role after I present at the HAI Tiger Team? Cascade opportunities & successes with frontline staff ... Share successes & learnings from education/competency assessment, adjusted practices, created policies/produces [sic] with staff and at HAI TT ... Bring forward barriers to accomplishing action plans at HAI TT.” The process was unclear whether the HAI TT process and meeting were intended to meet the hospital’s obligation to identify, investigate, monitor, and control identified IPC risks. For example, the “What is the HAI workup process?” stated that “Each of these HAI events are formally reviewed to identify successes, opportunities, and action plans to mitigate future infections” and then a review process was described and definitions for NHSN-specific HAIs were provided. The definitions, however, failed to include other reportable infections or HAI events as stated in the hospital’s “Management of Communicable Disease Exposures” policy which included a link to the “Oregon Disease Investigative Guidelines” and reportable conditions, such as outbreaks, and emerging infections. Refer to Finding 11, the hospital’s communicable disease management policy and the link to other, non-NHSN reportable infections. Further, when the IPD was asked how the hospital identified, tracked, and followed up with HAIs, the IPD described the HAI TT process as one of the first steps used in identifying infectious issues, refer to Finding 17, IPD interview describing how HAIs were identified, tracked and reviewed. The process was unclear as to whether unit leaders or IP staff were responsible for investigating HAIs on the units. The process did not describe any infection prevention, disease investigation or outbreak investigation competencies required by those tasked to lead the “HAI workup process”, i.e., the unit leaders and “Performance Improvement” staff. For example, the process stated that “Performance Improvement abstracts the patient cases following NHSN definitions”, and did not include additional HAI concerns, such as an outbreak, drug diversion/injection safety breaches, and patient exposure to BBPs. Although the “Performance Improvement” Director was also the IPD, the PI/IPD position was not required to have any specialized training or experience in infection prevention, refer to Tag A-748, Finding 6, the IPD job description which lacked requirements for specialized training, knowledge, or experience in IPC. Roles described in the process required the unit leaders to “Review the case ... Identify leaders ... to be invited to the investigational meeting [HAI TT meeting] ... to have conversations with staff ... discusses findings ... discuss gaps, questions ...”, explain how to improve care to prevent the spread of disease, and to develop action plans and slide presentations of the cases. It was unclear whether the unit leaders were qualified through education, training, experience, or certification in IPC, to conduct a thorough and complete review from an infection prevention perspective and apply disease investigative principles. For example, the process did not mention any specialized training provided to unit leaders, or whether those unit leaders had backgrounds in epidemiology, recognition of disease trends, or formal education in the identification of communicable diseases and outbreaks. The process failed to ensure that once trends, clusters, or outbreaks were identified that IP would take accountability for action items and next steps. Further, the process stated “What is my role at the HAI Tiger Team? Unit Leader presents slides and findings ... Members contribute ideas and suggestions, observed trends & any identify [sic] barriers ... Leaders take accountability for action items & next steps” and “What is the role of Infection Prevention ... Discuss fundamentals of preventing infections ... Asks questions about ... policies and procedures ... Shares any trends identified across the system ... Discusses possible linkages during episodes or outbreak with same organism, where applicable.” The process did not discuss who would continue the investigative process, or that identified cases would continue to be monitored, and shared with the HAI Team, or leadership. It was unclear whether a trend of breaches in infection prevention principles, such as drug diversion/injection safety practices, by one person, met the criteria of “where applicable” when sharing “possible linkages during episodes or outbreak”, refer to Finding 16, HAI TT meetings where an ICU-associated BSI outbreak was not discussed in 29 out of 29 HAI TT meetings. It was unclear whether a delay of “1-2 weeks” to discuss the cases at the “Investigational meeting” met the IP responsibility of “Promptly investigates any reported communicable disease exposure ...” as stated in Finding 11, hospital policy “Management of Communicable Disease Exposures (ASANTE)”. 15. The IPC meetings, an interdisciplinary committee “comprised of RRMC/TRMC/AACH vice presidents of medical affairs (VPMA), patient care and operations leaders and staff, and IP ...” and whose goals were to “maintain and improve clinical/operational performance and safety by monitoring key attributes of an effective infection prevention program ... assessing for patterns or trends, investigating issues or concerns and developing and implementing initiatives and enhancements for a safe, clean environment for care and management of patients with infections [sic] diseases ...” were reviewed. Refer to Tag A-751, Finding 4, IPC Charter. Dates reviewed included: 02/04/2022, 04/04/2022, 06/06/2022, 08/02/2022, 10/03/2022, 12/05/2022, 02/02/2023, 04/06/2023, 06/01/2023, 08/03/2023, 10/05/2023, and 12/07/2023. They reflected: * The 02/04/2022 IPC meeting minutes reflected that in 2021, “ARRMC had four events, which was a decrease from the seven reported in 2020.” Departments or units where the CLABSIs occurred was not documented. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. * The 04/04/2022 IPC meeting minutes reflected that CLABSIs events were decreased across the “system” in 2021 and no CLABSI or BSI data was noted. Also, regarding CLABSI data and other HAI data, the calendar year was referenced as the data range used. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. * The 06/03/2022 IPC meeting minutes reflected “April and May there were no infection [sic] identified” for CLABSIs at ARRMC. However, “blood culture contamination” rates were noted to have a “50%” spike at ARRMC. No specific department or unit was noted, such as ICU. Additionally, the meeting minutes reflected, “HAI surveillance has moved to the PI team ... HAI Investigation Revamp - The team has shifted away from the data collection to focus more on what went well and what are the opportunities.” No CLABSI or BSI data was noted. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. There were no notes indicating that an ICU-associated BSI outbreak was occurring. There were no notes regarding drug diversion/injection safety breaches as a potential infection prevention risk. * The 08/02/2022 IPC meeting minutes reflected one CLABSI event in June at ARRMC. No specific department or unit was noted, such as an ICU-associated BSI identified in July 2022. Refer to Finding 13.a, ICU-associated CLABSI and/or BSI events identified by month. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. There were no notes indicating that an ICU-associated BSI outbreak was occurring. There were no notes that drug diversion was a potential infection prevention risk associated with safe injection practices. * The 10/03/2022 IPC meeting minutes reflected one CLABSI event in August at ARRMC. No specific department or unit was noted. ICU-associated BSI events from June, July, or September were not noted. Refer to Finding 13.a., reported dates for ICU-associated CLABSI and/or BSI events identified by month. Top initiatives noted for “CY2023” included “Annual IP Risk Assessment and Plan”. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. There were no notes indicating that an ICU-associated BSI outbreak was occurring. There were no notes that drug diversion/injection safety practice breaches were a potential infection prevention risk. * The 12/05/2022 IPC meeting minutes reflected one CLABSI event in September and one in October 2022 at ARRMC. No specific department or unit was noted, such as ICU. Refer to Finding 13.a., ICU-associated CLABSI and/or BSI events. Specifically, in a two month period there were five BSIs identified in October 2022, and four BSIs identified in November 2022, a 125% increase from the four “ARRMC” CLABSIs reported for the year 2021, and a 28.6% increase from seven reported in 2020. As of the December 2022 IPC meeting, a total of 14 ICU-associated BSIs had been identified since June 2022, an increase of 250% in a six month period from the previous year’s total of 4 events. No cluster or outbreak of CLABSI/BSI events in the ICU were noted. Refer to Tag A-144, Finding 2.a., when the hospital first identified the ICU outbreak, September 2022. The “IP Annual Risk Assessment and & Plan” was presented and listed “top priorities for CY 2023” but did not include outbreak response, safe injection practices or drug diversion in that list. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. There were no notes indicating that an ICU-associated BSI outbreak was occurring. There were no notes regarding drug diversion/injection safety practice breaches as a potential infection prevention risk. * The 02/02/2023 IPC meeting minutes reflected two CLABSI events in November 2022, five in December 2022 and one in January 2023 at ARRMC. No specific department or unit was noted, such as ICU. The minutes noted, “These cases are being investigated.” Additionally, a bullet point regarding “Mitigating CP-CRE” referenced OHA, “OHA audited twice in response to two cases in 2022” and OHA recommendations were listed. No cluster or outbreak of CLABSI/BSI events in the ICU were noted. Refer to Findings 13.a. and 13.b., ICU-associated CLABSI and/or BSI events. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. There were no notes indicating that an ICU-associated BSI outbreak was occurring. There were no notes regarding drug diversion/injection safety practice breaches as a potential infection prevention risk. * The 04/06/2023 IPC meeting minutes reflected two CLABSI events in February at ARRMC. No specific department or unit was noted, such as ICU. No CLABSI/BSI events were noted for April 2023. Refer to Findings 13.a. and 13.b., ICU-associated CLABSI and/or BSI events. Additionally, a bullet point regarding “Changes in MRSA and VRE Isolation” referenced OHA, “Aligned to OHA and CDC recommendation for isolation and infection flagging.” HAI data for the calendar year were reviewed. No cluster or outbreak of CLABSI/BSI events in the ICU were noted. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. * The 06/01/2023 IPC meeting minutes reflected one CLABSI event in March, one in April, and “zero events in May” at ARRMC. No specific department or unit was noted, such as ICU. Refer to Finding 13.b., ICU-associated CLABSI and/or BSI events, specifically eight ICU-associated BSIs in April at ARRMC and five ICU-associated BSIs in May at ARRMC. Water Management data and IUSS data reported out by Fiscal Year. No cluster or outbreak of CLABSI/BSI events in the ICU were noted. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. OHA recommendations noted from April 28, 2023, regarding injection safety practices or drug diversion were not noted in the meeting minutes. There were no notes indicating that an ICU-associated BSI outbreak was occurring. There were no notes regarding drug diversion/injection safety practice breaches as a potential infection prevention risk. * The 08/03/2023 IPC meeting minutes reflected four CLABSI events in June, and “zero in July” at ARRMC. Noted was “These events have been investigated and presented at HAI TT meeting.” The organism “Stenotrophomonas” was mentioned for the first time in meeting minutes. OHA findings were listed, however, there were no notes reflecting OHA recommendations from April 2023, regarding injection safety or “opiate ... diversion with tap water.” Water Management data was reported out by Fiscal Year. No specific department or unit was noted, such as ICU. No cluster or outbreak of CLABSI/BSI events in the ICU were noted. Refer to Finding 13.b., ICU-associated CLABSI and/or BSI events. Specifically, five ICU-associated BSIs in June 2023, and six ICU-associated BSIs in July 2023, for a total of 11 ICU-associated BSIs since the 06/01/2023 IPC meeting. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. There were no notes indicating that an ICU-associated BSI outbreak was occurring. There were no notes indicating breaches in injection safety practices or drug diversion had been considered as a common-source for the outbreak. A “Standard Precautions Policy” was noted as “under review - Due Aug 11” and bullet points about the review included a list of new “reviewers ... expanded details on best practices and standards ... incorporated guidance ... on FAQs, SBARS, findings, CDC updates ... New sections for Environmental Guidelines ...” There were no notes that the IPC members provided additional input or approved the changes to the policy. Refer to Tag A-751, Findings 1, 2, and 3, AIP Operational Plans and the process for developing and revising policies. * The 10/05/2023 IPC meeting minutes reflected one CLABSI event in August, and “zero” events in September at ARRMC. No specific department or unit was noted, such as ICU. Also noted, “This event has been investigated and presented at the HAI TT meeting.” No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. There were no notes indicating that an ICU-associated BSI outbreak was occurring. There were no notes indicating breaches in injection safety practices or drug diversion had been considered as a common-source for the outbreak. A new policy titled “Environmental Cleaning and Disinfection” was noted as “under review - Due Oct 27” and bullet points about the review included a list of new “Wipe with hospital-approved disinfection per manufacturer’s instructions for use, including contact time ...” There were no notes that the IPC members provided additional input or approved the policy content. Refer to Tag A-751, Findings 1,2, and 3, AIP Operational Plans and the process for developing and revising policies. * The 12/07/2023 IPC meeting minutes reflected a report of CLABSIs: one in September 2023, one in October 2023, and one in November 2023 at ARRMC. The IP “Annual Risk Assessment” was presented and included “top priorities for CY 2024”. No specific department or unit was noted, such as ICU. No cluster or outbreak of CLABSI/BSI events in the ICU were noted. No attendee titles, departments or hospital affiliations were noted. It was unclear whether pharmacy or others involved in drug diversion investigations were in attendance. There were no notes that reflected OHA recommendations from April 28, 2023, regarding injection safety practices or drug diversion. There were no notes indicating that an ICU-associated BSI outbreak was occurring. There were no notes reflecting drug diversion/injection safety practice breaches were considered as the common-source of the BSI outbreak as indicated by the outside UCLA expert’s opinion. Refer to Tag A-144, Finding 2.a., investigation by an expert in outbreaks of infectious disease from UCLA. The hospital failed to regularly apprise the IPC Committee of the increase in ICU-associated BSIs. The hospital failed to fully inform the IPC Committee, an essential component in the assessment and identification of infection patterns and trends, and in investigating infectious issues, of all potential sources of the ICU-associated BSIs. The hospital failed to fully share the state public health authority’s recommendations with the IPC Committee, including recommendations to review safe injection practice breaches, medication administration and possible substance abuse exposure. Refer to Tag A-751, Finding 4, IPC Charter which stated the purpose and goals of the IPC. 16. The following HAI TT meetings were reviewed: 06/20/2022, 07/06/2022, 07/20/2022, 08/03/2022, 08/15/2022, 10/05/2022, 10/17/2022, 11/03/2022, 11/21/2022, 12/07/2022, 01/04/2023, 02/01/2023, 02/20/2023, 03/01/2023, 03/20/2023, 04/05/2023, 05/03/2023, 05/15/2023, 06/07/2023, 06/19/2023, 07/05/2023, 07/17/2023, 08/02/2023, 08/21/2023, 09/06/2023, 09/18/2023, 10/04/2023, 10/16/2023, 11/01/2023. There was no charter for the HAI TT committee. The meeting minutes reflected: * Similar to the IPC meeting minutes, the HAI TT minutes reflected minimal CLABSI/BSI information, such as: * 06/20/2022 HAI TT - “Zero” CLABSI events for June, system-wide. No specific department or unit was noted, such as ICU. * 07/06/2022 HAI TT - one CLABSI event for ARRMC. No specific department or unit was noted, such as ICU. * 07/20/2022 HAI TT - one CLABSI event for ARRMC. No specific department or unit was noted, such as ICU. * 08/03/2022 HAI TT - six CLABSI events for ARRMC. HAI data reported out for fiscal year. No specific department or unit was noted, such as ICU. * 08/15/2022 HAI TT - one CLABSI case for ARRMC was reviewed and it was not an ICU-associated BSI. Noted were seven CLABSI events for ARRMC. No other departments or units were noted, specifically, no ICU-associated BSI events were identified. * 10/05/2022 HAI TT - one CLABSI event for ARRMC in August, with the following noted, “Currently under investigation.” HAI data reported out for fiscal year. No specific department or unit was noted, such as ICU. * 10/17/2022 HAI TT - “There were zero [CLABSI] events in September. There are some charts still being investigated.” No specific hospital, department or unit was noted, such as ARRMC, ICU. * 11/03/2022 HAI TT - one CLABSI case for ARRMC was reviewed and it was not associated with the ICU BSI outbreak. No other CLABSI data was noted, although “... reviewed the HAI data with the team” was noted. * 11/21/2022 HAI TT - one ICU CLABSI case with a 09/2022 lab result date was reviewed. The organism was not associated with the ICU BSI outbreak. There was one CLABSI reported for ARRMC, and no specific department or unit was noted. * 12/07/2022 HAI TT - No ARRMC cases or data were noted as discussed. * 01/04/2023 HAI TT - one CLABSI case for ARRMC was reviewed and it was not associated with the ICU BSI outbreak was reviewed. One CLABSI case associated with the ICU BSI outbreak was reviewed. The case was presented by the SICU and not by IP staff. It was unclear whether the case had been investigated by IP or solely by unit leadership. Refer to Finding 14, HAI case review process. A single OHA recommendation related to CHG baths for CRE patients was noted. No other CLABSI data was reflected, although “[VPQ] reviewed the NHSN data with the team” was noted. * 02/01/2023 HAI TT - one CLABSI case for ARRMC was reviewed and it was not associated with the ICU BSI outbreak. No other CLABSI data was reflected, although “... reviewed the NHSN data with the team” was noted. * 02/20/2023 HAI TT - three CLABSI cases associated with the ICU BSI outbreak were reviewed. Lab result dates for these cases were: “12/5”, “12/15”, and “10/4”. The cases were presented by the MICU and not by IP staff. It was unclear whether the case had been investigated by IP or solely by unit leadership. For example, MICU notes included, “Action Plan: Investigate if procedural departments access CL, investigate art line workflows, educate staff on WBD prevention, WBD environment work, summarize case and share with staff.” It was unclear whether breaches in injection safety practices, drug diversion, or other infection control breaches had been investigated. Refer to Finding 14, HAI case review process. A single OHA recommendation related to artificial nails was noted. No other CLABSI data was reflected in the minutes. * 03/01/2023 HAI TT - two ICU CLABSI cases were reviewed, but only one ICU CLABSI case involved the organism associated with the ICU BSI outbreak. Lab result date for this case was: “12/19”. The cases were presented by the SICU and not by IP staff. It was unclear whether the case had been investigated by IP or solely by unit leadership. Refer to Finding 14, HAI case review process. No other ICU CLABSI data was reflected, although “[VPQ] reviewed the HAI data with the team” was noted. * 03/20/2023 HAI TT - one ICU CLABSI case associated with the outbreak was reviewed and the lab result date for this case was: “11/27”. The case was presented by the SCCU and not by IP staff. It was unclear whether the case investigation was led by IP or solely by unit leadership. For example, SCCU notes reflected, “Action Plan: Collaboration amongst the above groups [‘Infectious Disease, Intensivists, and CC leadership’] to develop plan on waterborne illness, staff meeting to introduce [IPD] and the waterborne illness information, increase hand hygiene compliance, and assess CVC site selection process with the Intensivist team.” No other CLABSI data was reflected in the minutes, no IP led follow-up process was noted. * 04/05/2023 HAI TT - one CLABSI case for ARRMC was reviewed and it was not associated with the ICU BSI outbreak. No other CLABSI data was reflected, although “[VPQ] reviewed the HAI data with the team” was noted. * 05/03/2023 HAI TT - one CLABSI case for ARRMC was reviewed and it was not associated with the ICU BSI outbreak. No other CLABSI data was reflected, although “[VPQ] reviewed the HAI data with the team” was noted. * 05/15/2023 HAI TT - No CLABSI cases were reviewed. No other CLABSI data was reflected. * 06/07/2023 HAI TT - one CLABSI case for ARRMC was reviewed and it was not associated with the ICU BSI outbreak. No other CLABSI data was reflected, although “[VPQ] reviewed the HAI data with the team” was noted. * 06/19/2023 HAI TT - No CLABSI cases were reviewed. No other CLABSI data was reflected. * 07/05/2023 HAI TT - No CLABSI cases were reviewed. No other CLABSI data was reflected, although “[VPQ] reviewed the HAI data with the team” was noted. * 07/17/2023 HAI TT - two CLABSI cases associated with the ICU BSI outbreak were reviewed. Lab result dates for these cases were: “5/23” and “5/25”. The cases were presented by the MICU and the SICU and not by IP staff. It was unclear whether the case investigations were led by IP or solely by unit leadership. Refer to Finding 14, HAI case review process. For example, “Action Plan” noted by the unit leader, MICU, for the 05/23/2023 case indicated “Share case with staff and at the intensivists meeting, education r/t fem line placement, increased compliance r/t artificial nails, and share up to data [sic] HAI data with staff”. And for the 05/25/2023 case the SICU, unit leader, noted “Share case with staff and at the intensivists meeting, enforce hand hygiene policy re: artificial nails, a [sic] continued WBD prevention education to staff, working on controlling water flow to help prevent less splash, and share up-to-date HAI data with staff.” Also noted was “HAI Process Overview ... [IPD] reviewed the HAI investigation process with the team (slides included in meeting packet).” No other CLABSI data was reflected, no IP follow-up process was noted. * 08/02/2023 HAI TT - No CLABSI cases were reviewed. No other CLABSI data was reflected, although “HAI data is included in the meeting packet for review” was noted. * 08/21/2023 HAI TT - one CLABSI case for ARRMC was reviewed and it was not associated with the ICU BSI outbreak. No other CLABSI data was reflected, although “Data Review [VPQ] ... NHSN data is included in the meeting packet for review” was noted. * 09/06/2023 HAI TT - two CLABSI cases for ARRMC were reviewed and they were not associated with the ICU BSI outbreak. No other CLABSI data was reflected, although “[VPQ] reviewed the HAI data with the team” was noted. * 09/18/2023 HAI TT - one CLABSI case for ARRMC was reviewed and it was not associated with the ICU BSI outbreak. No other CLABSI data was reflected, although “Data Review [VPQ] ... NHSN data is included in the meeting packet for review” was noted. * Additionally: - 29 out of 29 HAI TT meeting minutes did not reflect attendee titles, departments, or hospital affiliations. - 29 out of 29 HAI TT meeting minutes did not identify the ICU-associated BSIs as a cluster, or outbreak. - 29 out of 29 HAI TT meeting minutes did not note whether injection safety practice breaches/drug diversion as a possible common-source for the BSI outbreak in ARRMC ICU was considered. The hospital failed to fully involve the HAI TT, an essential component of the hospital’s IP surveillance system for identifying a suspected outbreak, in the progressive and continual increase of ICU-associated BSIs. Refer to Finding 17, the IPD interview that reflected the HAI TT was a working meeting for IP case review. The hospital failed to fully inform the HAI TT of all potential sources of the ICU-associated BSIs and the state public health authority’s recommendations that included recommendations to review safe injection practice breaches, medication administration and possible substance abuse exposure. 17. During an interview on 02/01/2024 at 1355, the IPD provided the following information: * When asked how HAIs were identified, tracked, and followed up, the IPD stated, “HAI fast facts are released weekly to managers and above for initial review and an opportunity is provided to meet with IP and talk about the case. Successes, opportunities for improvement and action plans are presented at the HAI Tiger Team meetings as well as trends, workflow and barriers.” * Regarding the IP surveillance system and identifying a suspected outbreak the IPD stated, “Daily report of organisms is reviewed. Events over time are tracked for trends. These are available for huddles. Data rolls up to Rogue Quality committee and then the board weekly. Quality runs HAI Tiger Team and IPs attend the Tiger Team Meeting; a working meeting.” The IPD stated that the HAI TT meetings are held twice monthly. Additionally, “A daily spreadsheet is generated. A micro report with a 7-day look back. We keep a running list and do our best with the same day look back.” * The IPD was asked how reportable communicable diseases were identified and the IPD responded via the “NHSN” criteria. They also added that there was a module in EPIC for cases qualifying for an event and that “confirmed cases” go to a line list. “Aggregated data is on NHSN dashboards”, report forms and trending data is provided to unit leaders and then is cascaded to front line staff.” Unit leaders then have an opportunity to perform an initial review and meet with IP to talk about the case. * Regarding OHA IP email dated 04/28/2023 with reference to “substance abuse exposure”, the IPD stated, “Substance abuse is our demographic. We thought given the demographics of the patients that it was a risk factor for environmental exposure to opportunistic infections.” However, they further stated, “We did not consider diversion with tap water at all. We just didn’t have diversion in our strategic thinking.” The IPD further stated that they did not recall any of the OHA conversations that indicated drug diversion was a possibility. * IPD stated there was no IP present during diversion meetings and they did not know if there was IP representation on the P&T committee. 18. During an interview on 02/29/2024 at 1030 with the IPD, the MDCC, and the AGC the following information was provided: * The IPD confirmed that there was no Medical Director for IP during the time of the ICU-associated BSI outbreak. The IPD stated, “[IPMD name] was the Medical Director until May 2022, and there hasn’t been a replacement since.” * When asked when a concern with the ICU-associated BSIs was first identified, the MDCC stated, “We started identifying these BSIs, stenos in May 2022.” Three similar BSIs had been identified at that time via a daily manual data mining process from an exported EPIC report comprised of a “7-day lookback.” The IPD was asked what the previous baseline had been, and whether the IP department had considered the baseline for these infections, the IPD stated “I believe we did.” * Regarding IP identification of a common-source BSI outbreak given a “7-day lookback” period, the IPD was asked how the outbreak was first identified. The IPD stated they “were alerted” to an issue “identified in September of 2022.” The IPD stated, “I can give you confirmation that at the end of September we were aware we had” a concern. There was a “pattern of central line infections and the pattern shifted. It was different.” A common respiratory organism in ET aspirate, “Stenotrophomonas ... had changed and was now being seen in blood cultures, but “at no point did we identify the BSIs as a cluster or outbreak.” * Regarding the process that IP used when an unusual “spike” in cases, or when an unusual organism was detected, the IPD stated, “If reportable, we’ll report to OHA” or for some cases, they would be sent up through leadership and they would have a “conversation”. * The IPD was asked how the hospital defined an outbreak or a cluster. The IPD stated that there was no definition for either. The IPD further acknowledged that there was no hospital policy that contained an outbreak definition. * The hospital policy, “Management of Communicable Disease Exposures (ASANTE)” was shared with the IPD. The policy contained a link to the state public health authority’s website which included informational posters on reportable conditions, including an HAI poster that provided information on mandatory outbreak reporting, and suspected common-source outbreaks. An additional link to guidelines for outbreak reporting was located at the bottom of the poster and provided the definition of an outbreak. The IPD stated they were not familiar with the poster of Oregon HAI reporting laws. * When asked when the hospital first reported the increase in ICU BSIs to local health authorities, the IPD stated they reported on 04/19/2023. “We did not classify it as a cluster, we reached out to OHA. We sought assistance when we saw an increase in BSIs. We contacted OHA about the increase in BSIs, but we did not use the word ‘outbreak.’ We saw patterns that looked different, needed some help, so we reached out ...” * In response to the question, “When did the IP department first learn that the infections may be related to drug diversion?” The IPD responded, “Not until the UCLA report came out” in November of 2023. *The MDCC stated that the “trigger was the polymicrobial bacterium with the specific organisms: Stenotrophomonas, Chryseobacterium, and Onchrobactrum were the standouts ... [and] were first clued in ... by October of 2022, due to qualitative and quantitative changes in BSIs that providers were comparing notes very early on [because of ] ... dramatic changes. There were informal discussions and more formal considerations by April, 2023.” The MDCC further stated that there was “Such a dramatic change that it was just not a lapse in technique.” * The participants were asked whether they recalled any OHA discussions on injection safety or drug division. The MDCC stated that based on their notes, “opiate diversion with tap water was discussed” in the April 27, 2023 meeting with OHA. However, both the IPD and the MDCC stated, “It was not a light bulb moment” and that “diversion was not a central line of thought.” * The participants were asked whether they followed up on diversion as recommended by OHA. Both replied “No.” * The participants were asked whether any investigation into diversion occurred after the April 27, 2023 conversation with OHA. Both replied, “No.” * The participants were asked whether any communication with the diversion team occurred after the April 27, 2023 conversation with OHA. The MDCC replied, “Not to my knowledge.” The IPD acknowledged that follow-up with the diversion team had not occurred. * The IPD was asked whether the IP investigation evaluated the data for risks associated with diversion. The IPD stated, “We did not take it a step further nor were we involved in the diversion process. Nothing stuck out as diversion.” * The IPD was asked whether the IP department participated in injection safety training. The IPD replied, “No. We are not. NPD would be the one to determine how that was developed.” * When asked whether the IP department would follow patients exposed to a BBP, the IPD replied, “Risk would have more expertise on how those risks are managed.” 19. A follow-up request was sent to the hospital for clarification regarding the dates when an ICU-associated BSI cluster or outbreak was first identified and reported to the state public heath authority per OARs. In an email dated 02/28/2024 at 1644, the AGC provided the following information: * When asked “Please clarify ... exact date of when the outbreak, or cluster of BSIs, in the ICU was first identified by IP.” The AGC response was “Approximately September 30, 2022.” *When asked “Provide the date and time when the outbreak was reported to federal, state or local authorities per hospital policy.” The AGC response was “Our first report was to OHA on 04/19/23 at 1530.” * When asked “Please include how it was reported and to whom.” The AGC response was “A meeting with regional OHA IP, [name] ... on 04/27/23.” The hospital could not provide a consistent and specific date of when the IPC Program identified the ICU-associated BSI outbreak, further evidence that the IPC Program failed to fully develop, implement, or follow systems and processes to detect, investigate and control infections and outbreaks, including common-source outbreaks. For example, several different outbreak identification dates provided during interviews were: September 2022, October 2022, April 2023, and October 2023. Refer to Finding A-144, Finding 2.a., (September 2022), and Finding 18, IPD interview that identified a cluster of BSIs as early as “September 2022” and Finding 19, the AGC response that the first report to the state public health authority was on “04/19/2023” and “04/27/2023”. Additionally, the hospital failed to report the outbreak to either the local public health authority or the state public health authority in a timely manner. The outbreak was reported approximately 7 months after the first cluster of BSIs were identified on “Approximately September 30, 2022”.”

“INFECTION CONTROL SCOPE COMPLEXITY CFR(s): The infection prevention and control program reflects the scope and complexity of the hospital services provided. This Standard is not met as evidenced by: 44104 Based on interviews, observations, review of P&Ps and other documents, it was determined the hospital failed to develop and implement an IPC Program that reflected the scope and complexity of the hospital services provided in the following areas: * Failure to develop and implement a comprehensive IPC Program for ARRMC that was hospital-wide, unique to ARRMC’s environment, and program-specific. * Failure to fully assess and evaluate the IPC Program on an ongoing basis to ensure it responded to changes in the hospital environment. Findings include: 1. The policy titled, “Infection Prevention - Operational Plan (ASANTE)” with “Approval Date: 02/24/2022” approved by the “VPQ” was reviewed and reflected: * “Asante Infection Prevention (IP) provides support and leadership to improve patient outcomes through reducing hospital acquired infections and preventing transmission of communicable diseases within Asante hospitals ... Infection risks to patients, personnel and public will be minimized through an active Infection Prevention Program that conducts surveillance, analyzes, and reports data and implements infection prevention best practices.” * “Location - an Infection Prevention office is maintained at each hospital location.” * “Number of licensed beds ... Asante Ashland Community Hospital: 49-bed community hospital ... Asante Three Rivers Medical Center: 125-bed medical center serving Josephine County and surrounding areas ... Asante Rogue Regional Medical Center: 378-bed regional referral and trauma center with a neonatal intensive care unit” * “Scope of Services ... All hospital-licensed departments and services ... also applies to the Special Purpose Renal Dialysis Facility ... The program reports to Management Review and the Medical Executive Committees, , [sic] and Emergency Preparedness ... The Infection Prevention program encompasses a hospital-wide multi-disciplinary approach to ... patient care ... as it pertains to reducing the transmission of diseases amongst patients, visitors, staff, and the community. Plans of action developed by the Infection Prevention program focus on prevention of infections, monitoring of infections, and control of infections when they occur.” * “Policies: Infection Prevention policies are based on recognized guidelines and applicable laws and regulations. Asante Infection Prevention develops and implements policies governing control of infections and communicable diseases, in collaboration with appropriate Subject Matter Experts ... Policies are reviewed, revised, and approved in accordance with Asante’s document control standards. New policies, and those with major revisions, are routed through the Infection Prevention Committee. The Infection Prevention Program will review and recommend changes in procedures and programs including, but not limited to ... Cleaning, disinfection, and sterilization ... Standard precautions, including hand hygiene ... Isolation protocols ... Employee Health communicable disease responsibilities ... Environment of care including sanitation ... “ * “Committee Structure: The Infection Prevention Committee is a multidisciplinary group that oversees the Asante Infection Prevention Program. Core and Guest membership includes representation from Medical Staff, Administration, Pharmacy, Facilities, Environmental Services, Perioperative Services, Employee Health, and Microbiology/Laboratory ... The Asante Infection Prevention Medical Director serves as the meeting Chair. The Infection Prevention Committee is responsible for routine identification and analysis of the incidence and cause of infectious diseases occurring with the hospital and is for developing and implementing plans for the surveillance, prevention and control of infection hazards. This includes policy development, surveillance and reporting, isolation guidelines and practices, reporting of communicable diseases to local and state health departments and education of healthcare staff.” * “Risk Assessment and Prioritization of Goals: The Infection Prevention Program identifies risks for acquiring and transmitting infections based on factors including but not limited to ... The community, its environment and the characteristics of the population served ... care, treatment, and services provided ... analysis of surveillance activities and other infection control data ... The Infection Prevention team in conjunction with the Asante Infection Prevention Medical Director and IP Committee, develops a risk assessment that identifies and prioritizes risks at least annually. The Infection Prevention team develops a written plan that addresses the prioritized risks and sets goals to minimize, reduce, or eliminate the risk of infection.” * “Authority Statement ... the [IPC] Program is responsible for ... Developing, implementing, and reviewing policies governing control of infections and communicable diseases of patients and personnel ... Developing a system for identifying, reporting, investigating, controlling, and preventing infections and communicable diseases ... Determine trends of infections, including sources and risk factors, and institute appropriate control measures ... Detect presence of clusters of infection, infections due to unusual organisms or outbreaks of diseases ... Utilize epidemiologic principles that enable extrapolation of data for comparison with national statistics ... Ensuring that appropriate isolation policies are implemented. Infection Prevention Leadership have [sic] authority to take appropriate control measures ... to prevent transmission of infection. These measures may include ... Accessing and reviewing patient medical records as needed in the course of performing expected infection prevention duties ... Initiating supplemental isolation precautions ... Ordering cultures or other tests as indicated ... Suspending activities or patient admissions to areas of the hospital until the risk is resolved ... Reporting communicable diseases in accordance with the federal, state and local regulations ... Coordinating with federal, state, and local emergency preparedness and health authorities ... Orienting and educating healthcare personnel on infection prevention ... The information presented will include, disease prevention, blood-borne pathogens, hand washing, transmission-based precautions, equipment cleaning and department specific issues regarding cleanliness ... Collecting and analyzing data relating to infections in the hospital ... The Infection Prevention Manager (or designee) serves as the infection control officer for Asante.” * “Administration and Organization of Area ... Nursing Direction: Vice Presidents of Nursing and Nursing Operations Leaders ... Medical Direction ... Asante Infection Prevention Medical Director ... provides oversight to the IP Program, and collaborates with the IP Manager and Infection Preventionists ... and serves as a resource for the department staff and Employee Health Practitioners for infection prevention related challenges. If the individual is unavailable, consultation with the Chief Medical Officer and the Vice President of Quality and Patient Safety along with an appropriate and available Infectious Disease Physician, Jackson County Health Department, or Josephine County Health Department will be sought.” * “Leadership Direction: Chief Medical Officer and Vice President of Quality and Patient Safety and/or Director of Infection Prevention ...” * “As required by ... CMS ... the Chief Executive Officer, Vice President of Quality and Patient Safety, Medical Staff, and the Vice Presidents of Nursing (1) ensure that hospital-wide performance improvement program and training programs address problems identified by the Infection Prevention Officer or officers; and (2) are responsible for the implementation of successful corrective action plans in affected problem areas.” * “Practice Guidelines ... Annual review of the Infection Prevention Program is led by the IP Director and presented to the IP Committee as well as to the Quality oversight of the organization. National guidelines and standards are followed in the structure and function of the Infection Prevention Program such as the CDC ... APIC ... SHEA ... and related professional organizations.” * “Staffing Structure and Plan ... Staffing is based on facility size and services; the team includes Director-level leadership, Manager and/or Supervisor, Infection Preventionists, and Infection Prevention Analyst(s) or Staff Assistant(s). An annual review of the staffing needs and resources available is performed by the Director based on the needs of the hospitals and the requirements and demands of the Asante IP Department. This review is shared with the Infection Prevention Committees during the annual review process, and as needed.” * “Utilization of Services ... Asante Infection Prevention at AACH: [external phone number], internal extension ... ATRMC: [external phone number], internal extension ... ARRMC: [external phone number], internal extension ... After hours and weekend coverage are available ... An Infection Preventionist will be available 24/7 for consultation.” * “Performance Improvement ... Quality Control Measures: The program is integrated into the Asante Quality and Performance Improvement programs. Performance Improvement Quality Measures tracked regularly include but are not limited to ... CAUTI ... CLABSI ... SSI ... C. difficile infection ... MRSA ... Hand Hygiene compliance”. The Operational Plan failed to clearly state that each separately certified hospital was required to have an IPC Program that was program-specific and hospital-specific. For example, the Operational Plan stated that the IP program provided leadership and support to “Asante hospitals”. The “Location” reflected that an IP office was “maintained” at each hospital, however, it did not clearly state that an IP was designated for each separately certified hospital. The description of the number of beds included all three hospitals, AACH, ATRMC and ARRMC. Although the “Utilization of Services” provided IP office phone numbers for each hospital, other areas cited in the Operational Plan did not provide an assurance that designated IP(s) had been assigned to those hospitals, specifically to ARRMC, or whether those IPs were part of a unified, system-wide IP Program. The Operational Plan failed to ensure an assessment and reevaluation of the IPC Program would occur on an ongoing basis in response to changes in the hospital environment, such as emerging infections or an outbreak. 2. The policy titled, “Infection Prevention - Operational Plan (ASANTE)” with “Approval Date: 01/26/2023” and approved by the “VPQ” was reviewed and reflected minor changes to the overall policy, such as: * “Committee Structure ... The Asante Infection Prevention Medical Director serves as the meeting co-Chair.” * “Risk Assessment and Prioritization of Goals ... The Infection Prevention team develops a risk assessment that identifies and prioritizes risks at least annually. The Infection Prevention team develops a written plan that addresses the prioritized risks and sets goals to minimize, reduce, or eliminate the risk of infection. The plans are presented, refined and resourced in conjunction with the IPC.” * “Practice Guidelines ... Annual review of the Infection Prevention Program is led by the IP Director and presented to the IP Committee as well as to the Quality oversight of the organization, where appropriate.” * “Staffing Structure and Plan ... Staffing is based on facility size and services; the team includes Director-level leadership, Manager and/or Supervisor, Infection Preventionists, and Infection Prevention Analyst(s) or Staff Assistant(s). An annual review of the staffing needs and resources available is performed by the Director based on the needs of the hospitals and the requirements and demands of the Asante IP Department. This review is shared with the Infection Prevention Committee during the annual review process, and as needed.” * “Utilization of Services ... Asante Infection Prevention at [one external phone number], internal extension [number] or [Asante IP email address]”. The Operational Plan failed to clearly state that each separately certified hospital was required to have an IPC Program that was program-specific, hospital-specific. The “Operational Summary” stated that the IP program provided leadership and support to “Asante hospitals”. The “Location” stated that an IP office was “maintained” at each hospital, however it was unclear whether an IP was designated for each office or hospital. Additionally, the “Number of licensed beds” included all three hospitals, AACH, ATRMC and ARRMC. It was unclear how thoroughly the IP Program had been evaluated and updated. For example, the “Scope of Services” stated that the IP Program covered “All hospital-licensed departments and services ... also applies to the Special Purpose Renal Dialysis Facility”. However, the Special Purpose Renal Dialysis Facility was not listed on any of the organizational charts, and state licensing records accessed on 05/08/2024, noted a voluntary termination of services was recorded on 11/30/2022, approximately two months before the last update. This was confirmed with the AGC via email on 05/10/2024. The “Utilization of Services” which listed IP contact information, had been updated from the previous version (Finding 1) and in lieu of three separate contact numbers for the IP offices at each hospital, one office phone number for the Infection Prevention Program was provided. The Operational Plan did not provide an assurance that a designated IP(s) had been assigned to those hospitals, and specifically to ARRMC, or whether those IPs were part of a unified, system-wide IP Program. The Operational Plan failed to ensure an assessment and reevaluation of the IPC Program would occur on an ongoing basis in response to changes in the hospital environment, such as a change in services, emerging infections or an outbreak. 3. The policy titled, “Infection Prevention - Operational Plan (ASANTE)” with “Approval Date: 12/12/2023” and approved by the “CCO” was reviewed and reflected minor changes to the overall policy, such as: * “Scope of Services ... The program reports to Management Review and the Medical Executive Committees, and is represented on various hospital committees including, but not limited to: Patient Safety, and Emergency Preparedness.” The Operational Plan failed to clearly state that each separately certified hospital was required to have an IPC Program that was program-specific and hospital-specific. The “Operational Summary” stated that the IP program provided leadership and support to “Asante hospitals”. The “Location” stated that an IP office was “maintained” at each hospital, however it was unclear whether an IP was designated for each hospital. Additionally, the “Number of licensed beds” included all three hospitals, AACH, ATRMC and ARRMC. It was unclear how thoroughly the IP Program had been evaluated and updated. For example, the “Scope of Services” stated that the IP Program covered “All hospital-licensed departments and services ... also applies to the Special Purpose Renal Dialysis Facility”. However, the Special Purpose Renal Dialysis Facility was not listed on any of the organizational charts, and state licensing records accessed on 05/08/2024, noted a voluntary termination of services was recorded on 11/30/2022, approximately 12 months before the last update. This was confirmed with the AGC via email on 05/10/2024. The “Utilization of Services” continued to reflect one contact number for the Infection Prevention Program, refer to Finding 2. The Operational Plan did not provide an assurance that designated IP(s) had been assigned to those hospitals, and specifically to ARRMC, or whether those IPs were part of a unified, system-wide IP Program. The Operational Plan failed to ensure an assessment and reevaluation of the IPC Program would occur on an ongoing basis in response to changes in the hospital environment, such as a change in services, emerging infections, or an outbreak. 4. A document titled, “ASANTE Infection Prevention Committee Charter” signed and dated on 11/21/2022 by the VPQ and the CMO was reviewed and reflected: * “Purpose ... The ... IPC... serves as the ... oversight group for the [IPC] Plan ... provides a forum and structure to efficiently and effectively address infrastructure and clinical operational topics as it relates to infection prevention.” * “IPC is a system-wide committee, including Asante hospitals, ambulatory and clinical care centers. Topics are focused on infections and communicable diseases: prevention, management, trends/patterns and reporting. The agenda is set by the chairs and Infection Prevention ... department, and content is developed by operational areas across the system...” * “Goals ... To maintain and improve clinical/operational performance and safety by monitoring key attributes of an effective infection prevention program: assessing for patterns or trends, investigating issues or concerns and developing and implementing initiatives and enhancements for a safe, clean environment for care and management of patients with infections [sic] diseases.” * “Membership ... IPC is co-chaired by an appointed medical and current quality leader. IPC is comprised of RRMC/TRMC/AACH vice presidents of medical affairs ... patient care and operational leaders and staff, and IP.” * “Responsibilities ... “ - “IPC Co-Chairs ... Lead IPC meetings including review and approval of the agenda topics and meeting minutes ... Report IPC activities to Management Review and/or Medical Executive Committee ... where appropriate.” - “Hospital Leaders ... Provide guidance ... Attend and participate in meetings ... Participate in the identification and selection of improvement activities ... in the analysis of data and the development and implementation of action plans.” - “IPC members ... Attend and participate in IPC meetings ... Provide and present data and information ... Participate in the analysis of data and ... discussion of next steps ... Develop and implement action plans ... within their span of control.” - “IP ... Attend and participate in IPC meetings ... Provide programmatic support, including generating draft agenda ... Provide and present data and ... Participate in analysis of data and the discussion of next steps ... Develop and implement action plans ... within their span of control.” * “Reporting Structure ... Reports summary of key components of the infection prevention program to Management Review ... on an annual basis via the Co-chairs, Infection Prevention leadership and/or RRMC/TRMC/AACH VPMAs.” * “Charter Approval ... The IPC Chairs will review the committee charter annually.” The IPC charter reflected that the AIP program was a system-wide program and was not unique to ARRMC. For example, the charter stated that the IPC is a “system-wide committee” and that the IPC was “comprised of RRMC/TRMC/AACH vice presidents of medical affairs ... patient care and operational leaders and staff, and IP.” The IPC membership also included non-hospital facilities, such as “ambulatory and clinical care centers”, which further supported the determination that the AIP program was not hospital-specific. It was unclear whether the IPC reported significant events or outbreaks to Leadership when they occurred, or more often than annually when there was a change in the hospital environment. For example, the IPC co-chair “Responsibilities” reflected that IP activities would be reported to Management Review and/or Medical Executive Committee “where appropriate”. It was unclear what was meant by “where a appropriate”. Further, the “Reporting Structure” reflected that key components of the IPC were reported annually to “Management Review”. However, it was unclear whether the “key components” and “IPC activities” would be reported more frequently than annually when significant events or changes in the hospital environment occurred. Additionally, it was unclear whether the ASANTE IPC charter had been reviewed annually as stated under “Charter Approval” as the hospital failed to provide additional IPC charters that had been signed before or after 11/21/2022. Refer to Finding 13, AGC email confirming lack of additional IPC charters. 5. An undated document titled, “2022 AIP Risk Assessment” was reviewed and reflected: * The document, an excel spreadsheet, contained two pages: The first page titled, “Sheet 1” contained a table of “Identified risks” with seven scoring categories: - “Probability of Occurrence” It noted scoring options of: “0 = none (never), 1 = Low (rarely), 2 = Medium (likely), 3= High (expect it)”. - “Potential Impact on Patients” It noted scoring options of: “0 = None, 1 = Minimal harm, 2 = Moderate harm, 3 = Permanent harm or prolonged LOS, 4 = Life threatening”. - “Potential Impact on Staff” It noted scoring options of: “0 = None, 1 = Minimal harm, 2 = Moderate harm, 3 = Life threatening”. - “Current Preparedness” It noted scoring options of: “0 = Excellent, 1 = Good, 2 = Fair, 3 = Poor”. - “Risk Level” It noted scoring options of: “0-13”. - “National Initiative/Regulatory & Financial Incentive (Organizational Impact)” It noted scoring options of: “0 = Not a Nat’l initiative and no financial incentive, 1 = Incentive sometime in the future, 2 = Both Nat’l initiative and financial initiative next year, 3 = Both Nat’l initiative and financial incentive this year”. - “Risk + Organizational Impact” was the last column designed to enter the total assessed risk score. *The second page titled, “Options” contained a scoring key with examples. * Under “Identified risks”, 45 risks listed were scored in the seven categories. * The scored risks included but were not limited to: - Under the heading “Geographic/Community Risk” was “Emerging infection” and was scored as follows: “Probability of Occurrence: 3; Potential Impact on Patients: 3; Potential Impact on Staff: 2; Current Preparedness: 1; Risk Level: 9; National Initiative: [No score noted]; Risk+: 9”. - Under the heading “Multidrug-Resistant Organism” were two risks. First, “ESBL or other MDR gram negative” was scored as follows: “Probability of Occurrence: 2; Potential Impact on Patients: 3; Potential Impact on Staff: 1; Current Preparedness: 1; Risk Level: 7; National Initiative: [No score noted]; “Risk+: 7”. Second, “CRE” was scored as follows: “Probability of Occurrence: 1; Potential Impact on Patients: 3; Potential Impact on Staff: 1; Current Preparedness: 1; Risk Level: 6; National Initiative: [No score noted]; Risk+: 6”. - Under the heading “Device-Associated Infections” was “CLABSI” and scored as follows: “Probability of Occurrence: 2; Potential Impact on Patients: 3; Potential Impact on Staff: 0; Current Preparedness: 1; Risk Level: 6; National Initiative: 3; Risk+: 9”. - Under the heading “Other Significant Organisms (healthcare -associated)” was “Unexpected exposure to communicable disease” and scored as follows: “Probability of Occurrence: 3; Potential Impact on Patients: 3; Potential Impact on Staff: 2; Current Preparedness: 2; Risk Level: 10; National Initiative: [No score noted]; Risk+: 10”. - Under the heading “Processes/Employees” was “Lack of timely notification of employee with communicable illness/disease” and scored as follows: “Probability of Occurrence: 1; Potential Impact on Patients: 2; Potential Impact on Staff: 2; Current Preparedness: 1; Risk Level: 6; National Initiative: [No score noted]; Risk+: 6”. - Under the heading “Environment” was “Ineffective cleaning / disinfection of environment” and scored as follows: “Probability of Occurrence: 2; Potential Impact on Patients: 3; Potential Impact on Staff: 2; Current Preparedness: 2; Risk Level: 9; National Initiative: [No score noted]; Risk+: 9”. - Under the heading “Resources/Supplies/Equipment” were two risks. First, “Improper low-level disinfection of equipment between patient uses” and scored as follows: “Probability of Occurrence: 3; Potential Impact on Patients: 2; Potential Impact on Staff: 0; Current Preparedness: 2; Risk Level: 7; National Initiative: [No score noted]; Risk+: 7”. Second, “Lack of adequate resources to accomplish the task required for the infection prevention program” and scored as follows: “Probability of Occurrence: 3; Potential Impact on Patients: 2; Potential Impact on Staff: 2; Current Preparedness: 2; Risk Level: 9; National Initiative: [No score noted]; Risk+: 9”. The hospital failed to clearly identify whether the risk assessment was hospital-specific or system-wide, or whether the environment, patient population, programs or units, and patient care services unique to ARRMC had been considered. There was no hospital, department or unit associated with the identified risks. Refer to Finding 14, AGC email dated 03/19/2024, acknowledgement that IP risks, goals and plans were based on system-wide data, and confirmation of differences in hospital services. The risk assessment failed to clearly capture the time frame in which the assessment was conducted and data collected, resulting in an incomplete risk assessment. For example, the risk assessment was undated, completed three months prior to the end of 2021, and there was no documentation that data from 09/28/2021 through 12/31/2021 had been included in the assessment, or that the risk assessment had been updated after that date. Refer to Finding 11, IP interview, which noted the 2022 AIP Risk Assessment had been completed in September 2021. Additionally, the IPD was uncertain whether the data on which the risk assessment was based was collected as FY data or CY data, refer to Finding 11 IP interview, IPD statement regarding data collection time frame. Also refer to Finding 12, email from the AGC, the dates of the annual risk assessments, and Tag A-0750, Findings 14 and 15, the IP meetings where HAI data was presented as both FY data and CY data. The hospital failed to update the risk assessment in response to changes in the hospital environment on an ongoing basis, refer to Finding 11, IPD interview and acknowledgement that risk assessments had not been updated although the hospital had identified a concern with the ARRMC ICU-associated BSIs by September 2022. Refer also to Tag A-0750, Finding 7.a., May 2022 OHA recommendations, which reflected recommendations for emerging infections, CRE, CLABSI, equipment and environmental cleaning and disinfection. Refer also to Tag A-0750, Finding 13.a. which reflects a steady increase of ARRMC ICU-associated BSIs during CY 2022. For example, in response to the increase in ICU-associated BSIs, the changing pattern of the identified organisms, and OHA recommendations, a risk level reassessment in the following areas would have been appropriate after 09/28/2021, the date of the 2022 AIP risk assessment: - “Emerging infection” - “ESBL or other MDR gram negative” - “CRE” - “CLABSI” - “Unexpected exposure to communicable disease” - “Ineffective cleaning/disinfection of environment” - “Improper low-level disinfection of equipment between patient uses” 6. An undated document titled, “2023 AIP Risk Assessment” was reviewed and reflected: * The document, an excel spreadsheet, contained two pages: The first page titled, “2022 IP Plan” contained a table of “Identified risks” with five scoring categories: - “Probability of Occurrence” with scoring options of: 0 = none (never), 1 = Low (rarely), 2 = Medium (likely), 3= High (expect it) - “Potential Impact on Patients” with scoring options of: 0 = None, 1 = Minimal harm, 2 = Moderate harm, 3 = Permanent harm or prolonged LOS, 4 = Life threatening - “Potential Impact on Staff” with scoring options of: 0 = None, 1 = Minimal harm, 2 = Moderate harm, 3 = Life threatening - “Current Preparedness” with scoring options of: 0 = Excellent, 1 = Good, 2 = Fair, 3 = Poor - “Risk Level (0-13) - “Comments ... Considerations as ranked topic” *The second page titled, “Definitions” contained a scoring key with examples. * Under “Identified risks”, 48 risks, scored in the five categories, were listed. Four previously listed risks were removed and those were: - “Community acquired MRSA” - “Community acquired C. difficile” - “Lap chole SSI” - “C-section” * Seven additional risks had been added from the previous year and those were: - “Community acquired Legionella” - “Community acquired COVID-19” - “Insufficient policies and procedures for best practice guidelines & standards” and a noted under comments “meal sharing, animals in the hosptilations [sic], linen handling, nurse servers, clean supply storage, hydration station, fans, plants, medical gels, CHG warmer, personal devices, water (& mold) remediation, etc.” This was scored as follows: “Probability of Occurrence: 3; Potential Impact on Patients: 3; Potential Impact on Staff: 1; Current Preparedness: 3; Risk Level: 10”. - “Improper storage of clean and sterile supplies” This was scored as follows: “Probability of Occurrence: 3; Potential Impact on Patients: 3; Potential Impact on Staff: 1; Current Preparedness: 2; Risk Level: 9”. - “Insufficient Antibiotic Stewardship program per DNV requirements” - “Lack of comprehensive organism report for surveillance & mandated reporting” This was scored as follows: “Probability of Occurrence: 3; Potential Impact on Patients: 3; Potential Impact on Staff: 1; Current Preparedness: 3; Risk Level: 10”. - “Lack of robust Infection Disease Emergency Response (IDER) Plan” This was not scored but noted as a “placeholder for CY2023 RA”. * The scored risks updated from the previous 2022 AIP risk assessment included but were not limited to: - “Emerging infection” The probability of occurrence was previously scored “High (expect it) to “Medium (likely)” and current preparedness changed from “Good” to “Fair”. The overall risk score remained the same. - “ESBL or other MDR gram negative” The risk scores for this category were unchanged from the previous year, although a note in the comments reflected, “uptick may require more focus”. - “CRE” The risk scores for this category were unchanged from the previous year. - “CLABSI” The overall risk score decreased from a “6” for 2022 to a “5” for 2023. Of note, the current preparedness score changed from “Good” to “Excellent” despite the ICU-associated BSI outbreak. - “Unexpected exposure to communicable disease” The overall risk score remained the same, however, updated risk scores were noted. For example, probability of occurrence changed from a “High (expect it) for 2022, to a “2 Medium (likely)” for 2023. Of note, the current preparedness score changed from “Fair” to “Poor”. - “Ineffective cleaning / disinfection of environment” The overall risk score remained the same, however, updated risk scores were noted. For example, potential impact on staff changed from “Moderate harm” for 2022, to a “Minimal harm” for 2023. Of note, the current preparedness score changed from “Fair” to “Poor”. Additionally, a note in the comments section stated, “DNV cited”. - “Improper low-level disinfection of equipment between patient uses” The overall risk score increased from a “7” for 2022 to a “8” for 2023. Of note, the current preparedness score changed from “Fair” to “Poor” The hospital failed to clearly identify whether the risk assessment was hospital-specific or system-wide, or whether the environment, patient population, programs or units, and patient care services unique to ARRMC had been considered. There was no hospital, department or unit associated with the identified risks. Refer to Finding 14, AGC email on 03/19/2024, acknowledgement that IP risks, goals and plans were based on system-wide data, and that confirmed differences in hospital services. The risk assessment failed to clearly capture the time frame in which the assessment was conducted, and data collected. For example, the risk assessment was undated, and was completed 26 days prior to the end of 2022, therefore it encompassed an incomplete analysis of the data as there was no documentation that data from 12/05/2022 through 12/31/2022 was included in the risk assessment. There was no documentation that more significant changes in the hospital environment in 2023 were considered. Refer to Finding 11, IP interview, which noted the 2023 AIP Risk Assessment had been completed in December of 2022 and presented to the IPC on 12/05/2022. Additionally, the IPD was uncertain whether the data on which the risk assessment was based on FY data or CY data, refer to Finding 11 IP interview; IPD statement regarding data collection time frame. Also refer to Finding 12, email from the AGC, the dates of the annual risk assessments, and Tag A-0750, Findings 14 and 15, the IP meetings where HAI data was presented as both FY data and CY data. The hospital failed to update the risk assessment in response to changes in the hospital environment on an ongoing basis, refer to Finding 11, IPD acknowledgement that risk assessments had not been updated although the hospital had identified a “dramatic” increase in ICU-associated BSIs during the 4th quarter of 2022. Refer to Tag A-0750, Findings 13.a., and 13.b., data on ICU-associated CLABSI/BSIs reflecting substantial increases in lab identified cases reported 26 days prior to year-end 2022. For example, in response to the increase in ICU-associated BSIs, the changing pattern of the identified organisms in 2022 and 2023, and OHA recommendations, a change in risk level would have been appropriate in the following areas: - “ESBL or other MDR gram negative” - “CRE” - “CLABSI” The overall risk score for CLABSI decreased despite measurable increases: a 300% increase in ICU-associated BSIs from four to 16 by the end of CY2022, and a 75% increase in the first seven months of CY2023, from 16 to 28 ICU-associated BSIs. There were no notations or indications that the IP program had considered drug diversion/injection safety practice breaches, patient exposure to BBPs, or lack of an outbreak management P&P as infection prevention risks despite OHA recommendations, and a UCLA expert’s opinion presented to the hospital in November 2023, in which drug diversion was suggested as the likely cause of the ICU-associated BSI outbreak. The hospital failed to document a reassessment or reevaluation of the IP program in response to changes in the hospital environment, such as emerging infections, drug diversion, and/or an outbreak. 7. An undated document titled, “2024 AIP Risk Assessment” was reviewed and reflected: * The document, an excel spreadsheet, contained two pages: The first page titled, “2023 IP Plan” contained a table of “Identified risks” with five scoring categories: - “Probability of Occurrence” with scoring options of: 0 = none (never), 1 = Low (rarely), 2 = Medium (likely), 3= High (expect it) - “Potential Impact on Patients” with scoring options of: 0 = None, 1 = Minimal harm, 2 = Moderate harm, 3 = Permanent harm or prolonged LOS, 4 = Life threatening - “Potential Impact on Staff” with scoring options of: 0 = None, 1 = Minimal harm, 2 = Moderate harm, 3 = Life threatening - “Current Preparedness” with scoring options of: 0 = Excellent, 1 = Good, 2 = Fair, 3 = Poor - “Risk Level (0-13) - “Comments ... Considerations as ranked topic” * The second page titled, “Definitions” contained a scoring key with examples. * Under “Identified risks”, 52 risks, scored in the five categories, were listed. None of the previously 48 risks from 2023 were removed. * Four additional risks had been added from the previous year and those were: - “CP-CRO” Scored as: probability of occurrence - “3” High (expect it); potential impact on patients - “4” Life threatening; potential impact on staff - “1” minimal harm; current preparedness - “1” good; and overall risk level was scored as “9”. - “C. auris” Scored as: probability of occurrence - “2” Medium (likely); potential impact on patients - “4” Life threatening; potential impact on staff - “1” minimal harm; current preparedness - “1” good; and overall risk level was scored as “8”. - “CJD/Prion” Scored as: probability of occurrence - “2” Medium (likely); potential impact on patients - “4” Life threatening; potential impact on staff - “0” none; current preparedness - “2” fair; and overall risk level was scored as “8”. - “Preplannning for Contructions [sic] process” Scored as: probability of occurrence - “1” low (rarely); potential impact on patients - “3” Permanent harm or prolonged LOS; potential impact on staff - “1” minimal harm; current preparedness - “1” good; and overall risk level was scored as “6”. * Other notable scored risks included but were not limited to: - “Emerging infection” The probability of occurrence was previously scored as “Medium (likely)”, changed to “High (expect it)” and current preparedness remained the same at “Fair”. The overall risk score increased from nine to 10. Noted in the comments was “Communicable Disease P&P”. - “ESBL or other MDR gram negative” The risk scores for this category were unchanged from the previous two years, although a note in the comments reflected, “uptick may require more focus”. - “CRE” The risk score for probability of occurrence changed from “Low (rarely)” to “High (expect it)”. The overall risk score increased from six to eight. - “CLABSI” The overall risk score decreased from a “6” for 2022 to a “5” for 2023, and remained unchanged for 2024. The current preparedness score remained as “Excellent” despite the ICU-associated BSI outbreak. In the comments was noted, “Bad last year. Looking good”. - “Unexpected exposure to communicable disease” The overall risk score decreased from 10 to nine. The current preparedness score changed from “Poor” to “Fair”. - “Ineffective cleaning/disinfection of environment” The overall risk score decreased from “9” in 2023 to “8” in 2024. Updated risk scores included: the current preparedness score changed from “Poor” to “Fair”. Additionally, a note in the comments section stated, “Numerous citings; P&P live”. - “Insufficient policies and procedures for best practice guidelines & standards”. The overall risk score decreased from “10” in 2023 to “8” for 2024. The only notable score change was in the area of current preparedness which decreased from three “Poor” to one “Good”. Comments noted: “Redid Standard precautions and environmental guidelines; new Environ P&P; equip almost done”. - “Improper storage of clean and sterile supplies” The overall risk score decreased from “9” in 2023 to “8” for 2024. Probability of occurrence was the only noted change from “3” High (expect it) to “2” Medium (likely). - “Improper low-level disinfection of equipment between patient uses” The overall risk score increased from a “7” for 2022 to a “8” for 2023 and there was no change in the 2024 risk scoring. - “Lack of comprehensive organism report for surveillance & mandated reporting” The overall risk score decreased from “10” in 2023 to “8” for 2024. Changes included: probability of occurrence decreased from “3” High (expect it) to “2” Medium (likely) and potential impact on patients decreased from “3” Permanent harm or prolonged LOS to “2” moderate harm. The 2024 AIP Risk Assessment failed to reflect that data had been analyzed and risks identified which were hospital-wide and program-specific. For example, there was no indication or notation whether risks were based on the hospital’s unique environment, patient population served, ARRMC-specific units, or patient care services offered, also refer to Finding 14, AGC email that confirmed risk assessments were not program or hospital-specific. There were no notations or indications that the IP program had considered injection safety practice breaches, exposure to BBPs, drug diversion, or lack of an outbreak management P&P as infection prevention risks despite OHA recommendations, and an November 2023 UCLA expert’s report in which drug diversion was suggested as the likely cause of the ICU-associated BSI outbreak. The risk assessment failed to clearly capture the time frame in which the assessment was conducted, and data collected. For example, the risk assessment was undated, and was completed 24 days prior to the end of 2023, therefore it encompassed an incomplete analysis of the data from 2023 as there was no documentation provided that data from 12/07/2023 through 12/31/2023 was included. Refer to Finding 12, AGC email that provided the date of the 2024 AIP Risk Assessment as 12/07/2023. * Refer to Tag A-750, Findings 7.a. - 7.e., OHA guidance and recommendations that began 05/25/2022 and which reflected recommendations for: - CDC injection safety/drug diversion as well as links to CDC modules for conducting assessments of the facility’s infection prevention practices, including injection safety/drug diversion. * Refer to Finding 11, interview with the IPD, the MDCC and the AGC, acknowledging failure to update AIP Risk assessments to include the infection risk to patients from injection safety practice breaches and drug diversion. 8. An undated document with digital file title of “2022 Asante IC Plan.pdf” was provided by the hospital. It was reviewed and reflected: * The document was titled, “Asante Health System 2021 Infection Prevention and Control Plan”. * The document was formatted as a table with four columns titled: “[IPC] Goal ... Risk Score ... Includes organizational impact ... Objectives Internal targets Public Reporting Thresholds ... Activities”. * The table reflected 20 identified goals, all scored as “9” or higher. * At the end of the table was noted, “*Risk score range is 0-17. Refer to the 2021 [IPC] Risk Assessment for details. Items reflected here scored > 9.” * Also noted at the end of the plan was a list of committees for IP participation and reporting. Pharmacy-related or Diversion-related committees were not included. The committees listed were: - Asante Infection Prevention Committee - Asante Management Review per calendar - Asante Medical Outcomes Review Committee ad hoc - Asante Patient Safety Council - Asante HAI/SSI Tiger Team - Asante Clinical Value Analysis Team - Asante Water Management Plan Committee - ARRMC Cardiac Surgery/Cardiovascular CCT - ARRMC Pediatric Patient Safety ad hoc - ARRMC NICU CCT ad hoc - ARRMC Cancer Operations Committee ad hoc - ARRMC Women & Newborns CCT ad hoc - ARRMC Safety Committee - Digital Transformation and Utilization Group - Epic Key User Group - Hand Hygiene Committee - Asante PPE Committee - Nurse Advisory Council ad hoc It was unclear what time frame was reflected in the “2022 Asante IC Plan” as the file provided by the hospital identified it as the “2022” plan, yet the document was titled, “2021 [IPC] Plan”, and it also noted that readers should “Refer to the 2021 [IPC] Risk Assessment for details” instead of the “2022 AIP Risk Assessment”. The risk scores of the 20 listed items aligned with the same items listed on the 2022 Risk Assessment and the risk scores were identical, however, similar to the risk assessment, there was no indication or notation that data analyzed, and goals identified were hospital-wide and program-specific to ARRMC. For example, there was no indication or notation whether goals listed, or the plan, were based on the hospital’s unique environment, patient population served, ARRMC-specific units, or patient care services offered. The plan failed to ensure that a reassessment and reevaluation of the Infection Prevention Program would occur on an ongoing basis in response to changes in the hospital environment, or in response to an updated risk assessment. Additionally, inconsistent with the “2022 AIP Risk Assessment”, whose risk level range was noted as “0-13”, the “2022 Asante IC Plan” stated that the “Risk score range is 0-17.” The hospital failed to document a reassessment or reevaluation of the IP program’s plan in response to changes in the hospital environment, such as emerging infections and/or an outbreak, refer to Finding 11, IP interview that reflected AIP Annual Plans were based on the AIP Risk Assessments. Those risk assessments had not been updated in response to changes in the hospital environment, refer to Findings 5, 6, and 7 above, the hospital’s lack of updated AIP risk reassessments. The plan failed to address outbreak management, a significant event which began in 2022, continued into 2023, and whose effects were ongoing. The ARRMC IP plan was based on a risk assessment that did not reflect hospital-specific data, was incomplete, and lacked clear documentation that data from the 4th quarter of 2022 was considered. Refer to Finding 5 above, the 2022 AIP Risk Assessment. 9.a. An undated document titled, “Asante Infection Prevention - 2023 Annual Plan Review” was reviewed and reflected: * The document was formatted as a table with two columns and three priority areas. * The three areas were: “Clean Environment ... Clean Equipment ... Communicable Disease Management” * Each area contained the following subheadings: “Risk Assessment Topics ... Objective ... Key Plans & Status ... Other Accomplishments”. * Under “Clean Environment ... Risk Assessment Topics” was listed: “Ineffective Cleaning/Disinfection of Environment, Poor Adherence to Standard Precautions, Insufficient Policies for Best Practice Guidelines and Standards, Improper Storage of Clean Supplies, Lack of adequate Resources to Accomplish the Task Required for the Infection Prevention Program, Internal Flood or Water Damage”. * Under “Priority 2. Clean Equipment ... Risk Assessment Topics” was listed: “Improper Low-level Disinfection of Equipment between Patient Uses, Lack of adequate resources to accomplish the task required for the infection prevention program”. * Under “Priority 3. Communicable Disease Management ... Risk Assessment Topics” was listed: “Emerging Infection, Low Vaccination Rates, Unexpected exposure to communicable disease, Poor hand hygiene, Lack of Timely Notification of Employee with Communicable Illness/Disease, Poor Compliance with Annual Flu Vaccination, Lack of Comprehensive Organism Report for Surveillance & Mandated Reporting, Lack of Adequate Resources to Accomplish the Task Required for the Infection Prevention Program, Surge of infectious patients, Insufficient Infection Control-related Supplies for Long Term Emergencies, Pandemics”. It was unclear when the undated plan was reviewed or created. It was unclear whether the “2023 Annual Plan Review” included a review of practices that were program specific and hospital-wide for ARRMC. There was no indication or notation whether the review or the priorities were based on the hospital’s unique environment, patient population served, ARRMC-specific units, or patient care services offered. The 2023 Annual Plan Review failed to ensure that a reassessment and reevaluation of the IPC Program would occur on an ongoing basis in response to changes in the hospital environment. The hospital failed to document a reassessment or reevaluation of the IP plan in response to changes in the hospital environment, such as drug diversion/injection safety practice breaches, emerging infections and/or an outbreak, refer to Finding 11, IP interview that reflected AIP Annual Plans were based on the AIP Risk Assessments, and that those risk assessments had not been updated since the creation dates. The plan failed to address drug diversion/injection safety practice breaches, patient BBP exposure, or outbreak management, significant events which occurred in 2022 and 2023, and whose effects were ongoing. The ARRMC IP plan was based on a risk assessment that did not reflect hospital-specific data, was incomplete, and lacked clear documentation that data from the 4th quarter of 2022 was considered. Refer to Finding 6 above, the 2023 AIP Risk Assessment. 9.b. An undated document titled, “2023 AIP Action Plan” was provided by the hospital. It was reviewed and reflected: * The document was formatted as an excel spreadsheet and contained three pages titled, “Clean Environ [sic] ... Clean Equip [sic] ... Communicable Diseases” which aligned with the priorities listed in the “Asante Infection Prevention - 2023 Annual Plan Review”. * Under the “File Info” a creation date was recorded as “08/31/2022” by the IPD. * Under “Clean Environ ... Priority 1: Environmental Cleaning” was noted: - “Objective ... Revamp EVS processes for self monitoring and performance ... Revamp Facilities processes for self monitoring and performance ... Revamp OR processes for self monitoring and performance” followed by the listed “Activities”, which, respectively were: - “Learn what EVS tracks and report out performance at IPC by hospital ... Learn what Facilities tracks and report out performance at IPC by hospital ... Learn what OR tracks and report out performance at IPC by hospital” * Under “Clean Equip ... Priority 2: Cleaning, Disinfection and Sterilization of Equipment” was noted - “Objective ... Revamp EVS processes for self monitoring and performance ... Revamp Facilities processes for self monitoring and performance ... Revamp OR processes for self monitoring and performance” followed by the listed “Activities”, which, respectively were: - “Learn what EVS tracks and report out performance at IPC by hospital ... Learn what Facilities tracks and report out performance at IPC by hospital ... Learn what OR tracks and report out performance at IPC by hospital” * Under “Communicable Diseases ... Priority 3: Communicable Disease Management: was noted: - “Objective ... Revise and update Communicable Disease management” followed by the listed “Activities”, which were: “broaden roles and responsibility ... categories of organisms based on risk, consider appendix for outbreak: when to identify outbreak (threshold) and mini IC group formation, action steps (close unit, mitigation, contact tracing, prioritizing testing). Eg [sic] respiratory or gi distress. When to scale to Emergency management or IC and engage public health department or OHA. Specifying by unit location (general floor, ED vs BHU/IRC etc) It was unclear when the undated action plan was reviewed or implemented, or how priority items were determined specifically for ARRMC. For example, the ARRMC IP “2023 Action Plan” was provided as part of the “Asante 2023” IP plan review which was based on a risk assessment that did not reflect hospital-specific data, and was incomplete, refer to Finding 6 above, the 2023 AIP Risk Assessment. The “OR” and “EVS” related activities were the only activities noted that were program-specific, and reported at IPC meetings. The action plan did not specify whether programs or departments were ARRMC-specific or system-wide. Although the hospital addressed “outbreaks” under communicable diseases, it failed to address drug diversion/injection safety practice breaches, patient exposure to BBPs due to drug diversion, or significant events which occurred in 2022 and 2023, and whose effects were ongoing. 10.a. An undated document titled, “Asante Infection Prevention and Control Program - 2024” was provided by the hospital. It was reviewed and reflected: * “Purpose ... The purpose of IPCP is to provide structure, authority, and expertise to plan, develop, implement, manage, and evaluate infection prevention ... activities.” * “Responsibility ... The Infection Prevention Committee ... has the responsibility to oversee the IPCP ... Asante Infection Prevention ... has the responsibility of the day-to-day IP activities, with leadership direction as outlined in the IP Operational Plan ... AIP ... has the authority to recommend to Operational Leaders ... the implementation of appropriate prevention measures ... when there is risk to the health of patients ... Operational Leaders have the responsibility of ensuring appropriate infection prevention measures are in place ... clear policies and procedures are developed to set expectations and established P&P are followed.” * “Scope ... The IPCP shall apply organization-wide to all organization locations and departments ... “ * “Objectives ... overall objective encompass [sic] five general functions: risk assessment, prevention, surveillance, education and control.” * “Annual Risk Assessment ... Risks ... are based on ... geographic location, the environments of the communities in which clinics are located, the programs and services provided, and the characteristics of the populations served ... Risks are assessed and prioritized annually ... Risk assessments are ongoing, and priorities are revised based on the identification of patient care needs, resources, data trends and analysis, outbreaks, and evidence-based initiatives.” * “Annual Goals ... are developed based on the risks identified. Based on the risk assessment ... Priority 1. Clean Environment ... Priority 2. Cleaning, Disinfection and Sterilization of Equipment ... Priority 3. Communicable Diseases Management ... Integrate into emerging Fit for Duty policies and procedures, where appropriate.” * “Prevention ... Developing, implementing, evaluating, and reviewing ... policies ... based on risk ... Developing, implementing, and evaluating an annual IPCP ... Identifying high risk areas and situations where transmission of disease and/or infection is likely ...” * “Surveillance ... Preparing staff and providers to identify and quickly report to AIP and/or EH any clusters of patients or any staff with symptoms of certain high-risk illnesses ... or other conditions which may be identified as high risk ... Investigating outbreaks and developing strategies to prevent further occurrences ... performing a risk assessment of the needs of the organization on at least a yearly basis ...” * “Control ... Recognizing outbreak situations ... Reporting infection surveillance ... internally ...” * “Program strategies ... Conduct an Infection Control Risk Assessment to identify and review potential risk factors for infection related to the care ... the environment of care ... Receive public health alerts on ... trends from CC, the state health department ... Develop the organization’s IPCP ... using strategies that are specific to the prioritized risks and include ... ongoing risk assessment, and analysis”. * “Surveillance and Reporting ... Surveillance definitions and criteria for all specific types of infections as determined by CDC/NHSN, or other relevant evidence-based guidelines, will be used in determining the presence of infection ... Diagnosis of the specific infections, diseases and conditions listed by OPH will be promptly reported as required ...” * “Targeted Surveillance ... Bloodborne Pathogens ... Employee exposures to bloodborne pathogens are monitored through an incident/event reporting process by the Risk Manager, Employee Safety Program Manager, and Employee Health ...” * “Environmental Monitoring ... AIP ... perform routine rounding to assess the hospital environment for adherence to basic [IPC] practices including ... Overall cleanliness of the environment ... Intact cleanable surfaces ... Adherence to clean supply standards ... Barriers for water contamination (e.g., splash guards) ... “ * “Communicable Diseases ... Each hospital will respond to a sudden influx of potentially infectious patients by following emergency preparedness protocols ... “ It was unclear when the undated plan was reviewed, updated or finalized. The hospital failed to develop an “[IPC] Program” plan for 2024 that described a review of practices that were program-specific and hospital-wide for ARRMC. The plan clearly stated that “The IPCP shall apply organization-wide to all organization locations and departments ...” and provided no additional indication or notation that the review or the priorities were based on the hospital’s unique environment, patient population served, ARRMC-specific units, or patient care services offered. The ARRMC IP plan was based on a risk assessment that did not reflect hospital-specific data and was incomplete, refer to Finding 7 above, the 2024 AIP Risk Assessment completed 12/07/2023. The plan failed to clearly address significant events which occurred in 2022 and 2023, and whose effects were ongoing, such as drug diversion/injection safety practice breaches, patient BBP exposure, or outbreak management. 10.b. An undated document titled, “Appendix A 2024 IPCP Work Plan” was reviewed and reflected: * There were 12 areas listed, and each with the following subheadings: “Objective ... Goal ... Method ... Evaluation”. * Examples of objectives, goals, methods, and evaluation of those areas were: * “1. Clean Environment: Surface Cleaning/Disinfection/Housekeeping ... - Objective ... Asante has new policies ... for environmental cleaning and disinfection of surfaces and general housekeeping - Goal ... Surfaces are cleaned and disinfected according to established policies ... using effective products according to the IFUs, reducing the risk of HAI from a dirty environment - Method ... Monitor compliance with established cleaning and disinfection protocols during environmental rounding ... Select cleaning and disinfection products that are EPA registered and hospital-approved ... Report non-intact or cleanable surfaces for repair - Evaluation ... Routine AIP and leader monitoring of clinical areas to ensure compliance 2. Clean Environment: Clean Storage - Objective ... Asante has clear, science-based protocols regarding clean storage and handling of supplies to the clinics, and these protocols are consistently followed in all locations - Goal ... Supplies are handled appropriately and stored in cleanable bins ... in a clean environment away from dirt, dust, moisture, mice, insects, or vermin, preventing the risk of HAI from contaminated supplies - Method ... Monitor compliance with established clean storage standards ... Create checklist for operational leaders including but not limited to: overall cleanliness of environment, intact/cleanable surfaces, appropriate hand hygiene and PPE stations, meeting clean supply standards ... splash guards, and meeting appropriate cleaning and disinfection standards - Evaluation ... Routine AIP and leader monitoring of clinical areas to ensure compliance 8. Communicable Disease Mgmt: Notification and response - Objective ... Asante has policies and procedures for communication and responsiveness to cases of concern, clusters or outbreaks - Goal ... Improve recognition and response to suspected or confirmed infection events - Method ... Clarify roles and responsibilities to recognize suspected or identified infections ... Further document roles in response, including exposure notification - Evaluation ... Published updated Communicable Disease Management policy” 11. Communicable Disease Mgmt: Emerging/High consequence preparedness - Objective ... Asante has policies and procedures in preparation and response to emerging pathogens ... and high consequence organisms ... - Goal ... Develop a communicable disease management program that equips staff to deliver care while managing and preventing the spread of emerging/high consequence pathogens - Method ... Remain versed and follow infection guidelines from WHO, CDC, and OHA ... Maintain a safe, effective, comprehensive vaccination campaign, where applicable ... Mitigate spread through PPE, testing, isolation, treatment, IP principles ... Educate staff, patients, and visitors on response and preventative measures - Evaluation ... Incorporate key guidelines into Communicable Disease Management policy and establish and maintain an infectious disease emergency response (IDER) plan” * Objectives, goals, methods and evaluation were written similarly for the following areas: “3. Clean Environment: Response to water intrusion ... 4. Clean Environment: Waterborne illness in facility water system ... 5. Clean Equipment: Equipment cleaning and disinfection - patient floors ... 6. Clean Equipment: Cleaning and disinfection - targeted areas ... 7. Clean Equipment: Clean vs dirty tagging system ... 9. Communicable Disease Mgmt: MDRO strategy ... 10. Communicable Disease Mgmt: Seasonal respiratory illness ... 12. Communicable Disease Mgmt: Annual Fit testing” The document failed to establish clearly identified goals which were measurable, time-related or achievable. For example, “Clean Environment: Surface Cleaning ...” stated a goal that did not provide a measurable increase or outcome, such as by what percentage the HAI risk might be reduced, or a timeframe in which that goal was to be achieved. The “Method” stated that the goal would be accomplished by “Monitor ... during environmental rounding”, however, rounding documentation provided by the hospital reflected that rounding was not consistent and actions, such as “Report non-intact ... surfaces for repair” were not followed up on, refer to Tag A-750, Finding 8, ICU observations, and Tag A-750, Findings 9.a, 9.b., and 10, hospital IP rounds documentation for the ICU. Evaluation methods did not specify how the evaluations were conducted, by whom, how often progress was evaluated or whether the evaluation results would be reported out and shared with leadership, quality, or stakeholders. For example, of the four “evaluations” in the areas listed above, two listed “Routine AIP and leader monitoring of clinical areas to ensure compliance”, the third listed, “Published updated Communicable Disease Management policy” and the fourth listed, “Incorporate key guidelines into Communicable Disease Management policy and establish and maintain an infectious disease emergency response (IDER) plan”. Additionally, there was no assurance that goals would be reevaluated, updated or re-prioritized once an evaluation had been completed. 11. During an interview on 02/29/2024 at 1030 with the IPD, the MDCC, and the AGC the following information was provided: * In response to the question, “When did the IP department first learn that the infections may be related to drug diversion?” The IPD responded, “Not until the UCLA report came out” in November of 2023. * In response to the question, “When was a concern with the ICU-associated BSIs first identified?” The MDCC stated, “We started identifying these BSIs, stenos in May 2022.” * The MDCC stated that the “trigger was the polymicrobial bacterium with the specific organisms: Stenotrophomonas, Chryseobacterium, and Onchrobactrum were the standouts ... [and they] “were first clued in ... by October of 2022, due to qualitative and quantitative changes in BSIs that providers were comparing notes very early on because of ... dramatic changes. There were informal discussions and more formal considerations by April, 2023.” The MDCC further stated that there was “Such a dramatic change that it was just not a lapse in technique.” * The IPD was asked to verify the dates of the AIP Risk Assessments. The IPD stated, “Perhaps we should include a date at the top because it’s hard to determine.” The IPD also stated that they started preparing the 2023 annual risk assessment in August 2022 and completed it in December 2022 and it was presented to the IPC on 12/05/2022. * Due to the IPD response that the AIP annual risk assessment had been started in August, the IPD was asked whether the risk assessments were based on fiscal year data or calendar year data. The IPD stated that they did not know. Refer to Finding 12, AGC email with dates of the 2022, 2023 and 2024 AIP Risk Assessments. The IPD confirmed that the AIP Annual Plans are based on the AIP Risk Assessments. * The IPD asked whether the risk assessments were updated in response to the increase in BSIs related to the Stenotrophomonas organism. The IPD stated, “No. We did not make any changes to the 2022 risk assessment to capture this.” * The IPD was asked whether the CLABSI/BSI events and/or the organisms of concern were included on the AIP risk assessment and the IPD stated, “Not on this risk assessment.” * The IPD was asked whether the AIP had been updated in response to those events, and the IPD stated, “I don’t think so.” * The IPD was asked whether drug diversion was an infection prevention risk for patients, and they stated “Yes.” * The IPD acknowledged that drug diversion was not included on either the 2022 AIP Risk Assessment or the 2023 AIP Risk assessment. When asked where it might be addressed on the risk assessments, the IPD stated, “I see the CLABSI line.” Additionally, the IPD stated, “The risk assessment [2022] predates the stenos.” * In response to the question, “What is your policy about updating your risk assessment following identification of an outbreak?” The IPD stated, “I’m not sure that there is a formal process. Prioritization of resources is not based on the risk assessment.” * In response to the question, “Are there circumstances where you might conduct an infection prevention risk assessment more than annually?” The IPD stated, “Not that I am aware of.” 12. An email dated 02/28/2024 from the AGC reflected: * Regarding a request for the completion dates of the AIP Risk Assessments for 2022, 2023, 2024, the AGC responded, “We believe the dates are: For the 2022 report, 09/28/21; 2023 was 12/05/22; 2024 was 12/07/23.” 13. An email string dated 03/11/2024 and 03/14/2024 from the AGC reflected the following regarding IPC and HAI TT meeting charters: * 03/11/2024, “There is not a charter for the HAI TT.” * 03/14/2024, “...we have not located any IPC charters before the one in effect from 11/21/22 forward.” 14. An email dated 03/19/2024 from the AGC reflected: * Regarding the question whether the “2022 Asante Annual IC Plan” reflected planning for the Asante system (all three hospitals), the AGC responded, “Yes”, and specifically the AGC was asked whether the IP goals, objectives and planned activities for each hospital were combined into one unified plan, the AGC responded, “Correct.” * Regarding whether the 2022 AIP plan was developed based on a risk assessment that combined risks identified across the system, the AGC responded, “Yes.” * Regarding all three Asante Infection Prevention Risk Assessments, the AGC was asked whether the 2022 - 2024 AIP Risk Assessments reflected identified and combined risks for the Asante health system (all three hospitals) the AGC responded, “Yes.” * Regarding the 2023 AIP Annual Plan Review, the AGC was asked whether it reflected a review of the Asante Health system IP Plan, which included all three hospitals, the AGC responded, “Yes.” * Regarding whether the 2023 & 2024 AIP Action Plans reflected planning for the Asante system based on the previous years’ data and identified risks for the Asante system (all three hospitals), the AGC responded, “Yes.” * Regarding whether the IP P&Ps provided reflected P&Ps for the Asante health system, including the IP Operational Plan dated “04/28/2022”, the AGC responded, “Yes.” * In response to the question, “Are all three hospitals identical in services? For example: Do they each have a NICU? A Behavioral Health Unit? A Coronary Care Unit? An ICU?” The AGC responded, “No, each hospital is not identical in services.””

“IC PROFESSIONAL RESPONSIBILITIES POLICIES CFR(s): Standard: Leadership responsibilities (2) The infection preventionist(s)/infection control professional(s) is responsible for: (i) The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of P&Ps and other documentation, it was determined the hospital failed to ensure its IPC Program fully developed and implemented P&Ps that were consistent with nationally recognized guidelines in the following areas: * The hospital failed to ensure a hospital-wide IPC Program that included collaboration with the pharmacy department on safe injection practices, including BBP exposure follow-up when breaches in safe injection practices occurred involving pharmaceutical IV drug diversion. * The hospital failed to consider IPC responsibilities, including detection, investigation, monitoring and reporting requirements when a common-source outbreak occurred, i.e. multiple patient exposures from a safe injection practice breach involving pharmaceutical IV drug diversion. * The hospital failed to develop and implement P&Ps that were consistent with nationally recognized guidelines to mitigate the risk of infection for patients exposed to a common-source infection control breach, i.e., an outbreak management protocol had not been developed or implemented. Findings include: 1. A policy titled, “Safe Medication Administration Practices (APP)” with an “Effective Date: 05/11/2022” was reviewed and reflected: * “Multi dose vial (MDV) may be utilized when single dose vials (SDV) are unavailable.” * “If using an MDV follow the below steps ... After initial spike, place label on MDV with date ... Place foil seal over the rubber cap in between uses ... Clean the vial cap with alcohol prior to each use ... Check initial spike date and manufacturer expiration date prior to each use ... Discard MDV after 28 days from initial spike.” * “Required: Subject Matter Expert ... Director of Ambulatory Quality and Nursing”. * “Reviewed by ... Clinical Quality Program Manager ... Director of Pharmacy Services and Chief Pharmacy Office”. The hospital failed to ensure hospital-wide P&Ps that contained an IP component, such as safe injection practices, were developed to align with nationally recognized IP guidelines. For example, neither the “Subject Matter Expert” nor the “Reviewed by” included IP professionals to ensure that procedures provided aligned with IP P&Ps that contained similar information. The P&P failed to document IP review of the safe injection practice procedures that ensured they adhered to nationally recognized infection prevention standards and guidelines. Refer to Tag A-751, Findings 1, 2, and 3, the AIP Operational Plans which stated that IP P&Ps were developed “in collaboration with appropriate subject matter experts ... The Infection Prevention Program will review and recommend changes in procedures and programs including, but not limited to ... Cleaning, disinfection, and sterilization ... Standard precautions, including hand hygiene... “ 2. A policy titled, “Safe Medication Administration Practices (APP)” with an “Effective Date: 05/16/2023” was reviewed and reflected: * “Multi dose vial (MDV) may be utilized when single dose vials (SDV) are unavailable.” * “If using an MDV follow the below steps ... After initial spike, place label on MDV with date ... Place foil seal over the rubber cap in between uses ... Clean the vial cap with alcohol prior to each use ... Check initial spike date and manufacturer expiration date prior to each use ... Discard MDV after 28 days from initial spike.” * “Required: Subject Matter Expert ... Director of Ambulatory Quality and Nursing”. * “Reviewed by ... Clinical Quality Program Manager ... Director of Pharmacy Services and Chief Pharmacy Office”. The hospital failed to ensure hospital-wide P&Ps that contained an IP component, such as safe injection practices, were developed to align with nationally recognized IP guidelines. For example, neither the “Subject Matter Expert” nor the “Reviewed by” included IP professionals to ensure that procedures provided aligned with IP P&Ps that contained similar information. The P&P failed to document IP review of the safe injection practice procedures that ensured they adhered to nationally recognized infection prevention standards and guidelines. Refer to Tag A-751, Findings 1, 2, and 3, the AIP Operational Plans which stated that IP P&Ps were developed “in collaboration with appropriate subject matter experts ... The Infection Prevention Program will review and recommend changes in procedures and programs including, but not limited to ... Cleaning, disinfection, and sterilization ... Standard precautions, including hand hygiene...” 3. A policy titled, “Medication Handling and Administration (ASANTE)” with an “Effective Date: 11/03/2023” was reviewed and reflected: * “This policy outlines the process for safely administering ... medications. Medications will be administered to patients by qualified healthcare professionals ... following accepted guidelines of safe medication administration ... “ * “Scope ... This policy includes overarching information regarding general medication ... administration, and practice related to medication delivery for patients of all ages ... Table of Contents ... Infection Prevention ...” * “Infection Prevention ... applies to all direct care patient care areas ...” * “Safe injection practices: employe [sic] standard precautions and use aseptic technique to avoid contamination of sterile injection equipment ... Disinfect the rubber septum on all medication vials by wiping with 70% isopropyl alcohol and allow to air dry prior to each entry, even after removing the cap of a new, unused vial ... Disinfect the neck of an ampule with 70% isopropyl alcohol and allow to air dry prior to breaking the ampule ... Disinfect catheter hubs, connectors, and injection ports with 70% isopropyl alcohol and allow to air dry prior to each entry; this may occur via products such as disinfecting port protectors.” * “Use a single needle and single syringe for a single patient (this includes manufacturer pre-filled syringes and cartridge devices such as insulin pens) ... Do not administer medications from a single syringe to multiple patients, even if the needle or cannula is changed ... Do not reuse needles or cannulas for another patient or to access a medication or solution that might be used for another patient ... Do not leave a needle or spike in a vial for multiple medication draws.” * “All Intravenous bags, tubing, and connectors are intended for single patient use only ... A syringe or needle/cannula is considered contaminated once it has been used to enter or connect to a patient’s IV bag or administration set ... Do not use bags or bottles of IV solutions as common source of supply for multiple patients (e.g., using a 250ml bag of NS for batching saline flushes).” * “Single dose vials (SDVs) ... of medicine are used preferentially for all parenteral administration whenever possible ... Medications prepared using SDVs will be administered to a single patient and not to multiple patients ... Promptly discard vials labeled ‘single patient use’, ‘single dose vial’ or ‘preservative free’ after use on a single patient ... Parenteral medications prepared outside the pharmacy’s controlled sterile-compounding environment are considered ‘immediate use’ and administration must commence within one (1) hour of the start of the compounding procedure. Beyond one (1) hour, the preparation must be discarded if administration has not commenced.” * “Multidose vials (MDVs) are used for only one patient, unless authorized and communicated by pharmacy ... If MDVs must be used (i.e., SDV is unavailable), both the needle or cannula and syringe used to access the vial must be sterile ... MDVs are stored in a centralized medication area and must be carefully and thoroughly disinfected upon return ... Label the patient-specific MDV ...” * “Multidose Topical Medications ... Label and restrict to single patient only ... Topical medications taken to immediate patient care area must be disinfected prior to returning to the medication storage area.” * “All Single-dose and Multidose medication containers ... are discarded when ... medication has reached ... BUD or manufacturer’s expiration date, whichever is earlier ... medication container is discovered unlabeled ... Contamination is suspected ...” * “Required: Subject Matter Expert ... Asante Medication Safety Coordinator ... Clinical Practice Advisor” * “Reviewed by: Asante Medication Administration and Safety Committee ... Senior Vice President of Nursing ... Vice President of Nursing & Patient Care Services ... Asante Pharmacy & Therapeutics Committee” The hospital failed to ensure hospital-wide P&Ps containing an IP component, such as safe injection practices, were developed to align with nationally recognized IP guidelines. For example, neither the “Subject Matter Expert” nor the “Reviewed by” included IP professionals to ensure safe injection practices procedures provided aligned with IP P&Ps that contained similar information. Refer to Findings 5 and 6, IP P&Ps which addressed safe injection practices. The policy failed to document IP review of the safe injection practice procedures that ensured they adhered to nationally recognized infection prevention standards and guidelines. The committees listed did not include IP professionals as members. Refer to Tag A-751, Findings 1, 2, and 3, the AIP Operational Plans which stated that IP P&Ps were developed “in collaboration with appropriate subject matter experts ... The Infection Prevention Program will review and recommend changes in procedures and programs including, but not limited to ... Cleaning, disinfection, and sterilization ... Standard precautions, including hand hygiene ...” Refer to Tag A-751, Finding 8, the list of committees in which the IP professionals participated, which did not include “Asante Medication Administration and Safety Committee” or the “Asante Pharmacy & Therapeutics Committee”. 4. A 7-page policy titled, “Standard Precautions (ASANTE) ... Document Number: 00-IC-IC-0109” with an “Effective Date: 01/23/2023” was reviewed and reflected: * “Safe Injection and Administration Practices ... These include adherence to basic principles of aseptic technique during the preparation and administration of parenteral medications, including ... Use of sterile, single-use, disposable needle and syringe for each injection given ... Prevention of contamination of injection equipment and medication, including use of single dose [sic] vials rather than multiple-dose vials whenever possible ... Use of IV bags, tubing and connectors for one patient only ... Labeling and restriction of topical medications to single patient use.” * “Refer to 400-MEDS-003: Medication Handling and Administration (Asante) for additional details.” * “Required: Subject Matter Expert ... Asante Infection Prevention Director”. * “Reviewed by ... VP Nursing (Asante)”. The hospital failed to ensure hospital-wide IP P&Ps were developed in collaboration with appropriate subject matter experts per hospital policy. For example, neither the “Subject Matter Expert” nor the “Reviewed by” included pharmacy professionals to ensure that the safe injection practices provided aligned with pharmacy P&Ps that contained similar information. Although the policy contained a reference to the “Medication Handling and Administration” policy, the policy failed to document pharmacy review of the safe injection practice procedures that ensured P&Ps captured key components as determined by stakeholders and subject matter experts. Refer to Tag A-751, Findings 1, 2, and 3, the AIP Operational Plans whereby the hospital stated that development of IP P&Ps were developed “in collaboration with appropriate subject matter experts.” 5. A 15-page policy titled, “Standard Precautions and Environmental Guidelines (ASANTE) ... Document Number: 00-IC-IC-0109” with an “Effective Date: 09/01/2023” was reviewed and reflected: * “Injection Safety... Practice injection safety to prevent transmission of viruses and microorganisms during procedures by adhering to Standard Precautions and basic principles of aseptic technique ... Perform hand hygiene before accessing and preparing medications ... Use aseptic technique in all aspects of parenteral medication preparation, administration, medication vial use, injection, and point-of-care testing ... Do not administer medications from a syringe to multiple patients, even if the needle or cannula of the syringe is changed ... Do not enter a vial, IV bag or ampule with a used syringe or needle ... Use fluid infusion and administration sets (i.e., intravenous bags, tubing and connectors) for one patient only and dispose appropriately after use ... Consider a syringe or needle/cannula contaminated once it has been used to enter or connect to a patient’s intravenous infusion bag or administration set ... Use single-dose vials for parenteral medications whenever possible ... Never use single-use vials or ampules for multiple patients or combine leftover contents for later use ... Multidose vials are avoided ... If ... must be used, both the needle or the cannula and syringe used to access the multidose vial must be sterile ... Do not use bags or bottles of intravenous solution as a common source of supply for more than one patient ... Spiked IV solutions and medications drawn from a single-dose vials [sic] or compounded outside the pharmacy must be administered or initiated within on hour of preparation. For additional details, see the following ... 400-MEDS-003: Medication Handling and Administration (Asante)”. * “Required: Subject Matter Expert ... Asante Infection Prevention Director”. * “Reviewed by ... Chief Nursing Officer (ASANTE) ...VP Nursing (ASANTE) ... Director Nursing Professional Development (ASANTE) ... Director Surgery TRMC ... RRMC & AACH ... Director Support Services TRMC ... RRMC ... Director Ancillary & Support Services AACH ... Manager Facilities RRMC ... TRMC ... Manager Emergency Management System ... Director Work Health ... Director Ambulatory Quality ... Employee Safety Program Manager”. The hospital failed to ensure hospital-wide IP P&Ps were developed in collaboration with appropriate subject matter experts per hospital policy. For example, neither the “Subject Matter Expert” nor the “Reviewed by” included pharmacy professionals to ensure that the safe injection practices for administering medication aligned with pharmacy P&Ps that contained similar information. Although the policy contained a reference to the “Medication Handling and Administration” policy, the policy failed to document pharmacy review of the safe injection practices that ensured they captured key components as determined by stakeholders. Additionally, it was unclear whether the IPC members provided input or approved changes to this policy. Refer also to Tag A-751, Findings 1, 2, and 3, the AIP Operational Plans whereby the hospital stated that new IP P&Ps “and those with major revisions, are routed through the Infection Prevention Committee” and that “The Infection Prevention Committee is responsible for ... surveillance, prevention and control of infection hazards. This includes policy development...” It was unclear whether the IP program had sufficiently solicited input from the IPC members for the “major” policy revisions, or whether IPC input was incorporated into this policy. Refer also to Tag A-750, Finding 15, IPC meeting minutes dated 08/03/2023 which lacked documentation of IPC members’ input on the revised policy. Additionally, the hospital failed to fully implement its IP program policy, “”Standard Precautions and Environmental Guidelines”. Refer to Tag A-750, Finding 8, ICU tour with observations of failure to adhere to IP environmental cleaning protocols. 6. A document titled “Prevention of Central Line Associated Blood Stream Infection (CLABSI)” dated “07/27/2022” was reviewed and reflected: * “Line Maintenance ... Access/manipulate line using aseptic technique ...Use disinfecting cap to cover all ports at all times ... Scrub the hub with alcohol for at least 15 seconds, allowing it to dry completely, prior to and between port access (in between medication administration). Use a new antiseptic pad for each port or hub.” * The footer included the department responsible for the document, “400-NPD-0038 (07/27/2022) Page 1 of 1”. The hospital failed to ensure education on hospital-wide IP P&Ps were developed to align with nationally recognized guidelines when the education covered practices that were addressed in other departmental P&Ps, such as safe injection practices for medication administration and “Standard Precautions ...”. The “Fast Facts” document included additional information on how long to “scrub the hub” as well as to “Use a new antiseptic pad for each port or hub”, information which was not included in the pharmacy program’s hospital-wide P&Ps on “Safe Medication Administration Practices” and “Medication Handling and Administration (ASANTE)”. The “Scrub the hub for at least 15 seconds” and use of a new antiseptic pad were also not included in the IP program’s hospital-wide policy, “Standard Precautions ...”. Although the “Fast Facts” document provided additional detail about disinfection processes when accessing a site for injectable medications, there was no documentation that the “15 seconds” was consistent with nationally recognized guidelines for either the IP or Pharmacy programs. Refer to Findings 1-5, Pharmacy and IP hospital-wide P&Ps that referenced disinfection of catheter ports and hubs as part of safe injection practices for medication administration. 7. The policy titled “Environmental Cleaning and Disinfection (ASANTE)” dated “Effective 11/14/2023” was reviewed. Refer to Tag A-750, Finding 2, excerpts from this policy including: * “Required: Subject Matter Expert ... Asante Infection Prevention Director”. * “Reviewed by ... Chief Nursing Officer ASANTE ... VP Nursing ASANTE ... Director of Nursing Professional Development ASANTE ... Director[s] of Support Services ATRMC ... ARRMC ... Director of Ancillary & Support Services AACH ... Manager[s] Facilities AARMC ... ATRMC ... Director Ambulatory Quality”. * “Revision date: 11/14/2023 ... Revision Description: New Policy”. The hospital failed to document whether IPC members participated in the development of this new policy. It was unclear whether the IP program had sufficiently solicited input from the IPC members for the “new” policy, or whether IPC members’ input was incorporated in this policy. Refer to Finding 15, IPC meeting minutes dated 10/05/2023 which failed to document that IPC members provided additional input or approval of the new policy’s content. Refer also to Tag A-751, Findings 1, 2, and 3, the AIP Operational Plans whereby the hospital stated that new IP P&Ps “are routed through the Infection Prevention Committee” and that “The Infection Prevention Committee is responsible for ... surveillance, prevention and control of infection hazards. This includes policy development ...” 8. The policy titled, “Fit for Duty (ASANTE)” dated effective 10/21/2019 reflected: * “Key Words ... substance abuse ...” * “Asante has a strong commitment to provide and maintain a safe and healthy working environment for employees, patients and the community.” * “Physical and Cognitive Incapacity” * “Cognitive Impairment” * “A confirmed positive test** will result in termination of employment.” * “Right to Test ... Among situations where Asante may exercise its “reasonable grounds” right to test are ... Suspected diversion ... Employee admissions regarding ... drug use ...” * “Illicit drug: Any drug that is not legal under federal and or/state law [sic] ... ** Positive test: Drug level above a standard cutoff with no medical explanation or no authorized use, and/or not legal under state and/or federal law.” * “Employee Health ... will provide medical consultation regarding policy/protocol, as needed.” * “Required: Subject Matter Expert ... Work Health Operations Manager” * “Reviewed By ... Director Employee and Labor Relations ... Legal Officer/General Counsel ... Supervisor Human Resources ... Manager Human Resources ... Employee Health” The policy failed to reflect collaboration with the IP program in the development and implementation of the “Fit for Duty” policy, specifically whether a breach of safe injection practices would be an infection risk to patients, an IP concern. The policy failed to specify whether drug diversion that involved a breach of safe injection practices warranted additional IP follow-up, such as a review of potential BBP exposure evaluation and monitoring, and if so, who would be responsible for the post-exposure evaluation, testing, treatment or monitoring of the exposed patient. Refer to Finding 11, the hospital’s BBP Exposure Control Plan based on nationally recognized guidelines for workplace BBP exposures which provided definitions of BBPs and OPIMs, potential exposure routes, and required post-exposure evaluation guidance for employees. None of the hospital’s P&Ps, “Fit for Duty”, “Management of Communicable Disease Exposure”, or their “Bloodborne Pathogens Exposure Control Plan” provided IP protocols when a patient was potentially exposed to an infectious employee, or a potentially infectious employee when a breach in safe injection practices occurred, such as employee drug diversion of injectable medications. Refer to Tag A-750, Finding 11, the “Management of Communicable Diseases” which focused on employees exposed to an infectious patient. Although the “Management of Communicable Diseases” policy stated, “Identifies any potential patient contacts and notifies their attending provider ... and/or their primary care provider ... of the potential exposure ...”. The policy did not address outbreaks, nor did it address required IP follow-up for investigation, tracking or monitoring outbreaks involving multiple patient exposures. The P&Ps did not address IP responsibilities regarding the state mandated reporting of common-source outbreaks. 9. The policy titled, “Fit for Duty (ASANTE)” dated effective 12/01/2023 reflected: * “Key Words ... substance abuse ...” * “Asante has a strong commitment to provide and maintain a safe and healthy working environment for employees, patients and the community.” * “Cognitive impairment (emphasis on illicit drug ... medication use)”. * “Physical and Cognitive Incapacity” * “Cognitive Impairment” * “A confirmed positive test** will result in termination of employment.” * “Right to Test ... Among situations where Asante may exercise its “reasonable grounds” right to test are ... Suspected diversion ... Employee admissions regarding ... drug use ... In all cases of suspected diversion, a separate expanded panel shall be used during the Fit for Duty process ... When diversion is suspected, Employee Health shall conduct a physical examination for evidence of track marks on arms, fingers, and toes.” * “Illicit drug: Any drug that is not legal under federal and or/state law [sic] ... ** Positive test: Drug level above a standard cutoff with no medical explanation or no authorized use, and/or not legal under state and/or federal law.” * “Employee Health ... will provide medical consultation regarding policy/protocol, as needed.” * “Required: Subject Matter Expert ... Alternative Access Operations Support - APP” * Reviewed By ... Acting Director Employee & Labor Relations and Absence Management ... Supervisor and Associate General Counsel (Interim) ... Supervisor Practice Operations Employee Health ... Chief Legal Officer”. * “Revisions/Summary of Changes ... Included ... physical exam requirements when diversion is suspected.” The policy failed to reflect collaboration with the IP program in the development and implementation of the “Fit for Duty” policy, specifically whether a breach of safe injection practices would be an infection risk to patients, an IP concern. The policy failed to specify whether drug diversion that involved a breach of safe injection practices warranted additional IP follow-up, such as a review of potential BBP exposure evaluation and monitoring, and if so, who would be responsible for the post-exposure evaluation, testing, treatment or monitoring of the exposed patient. Refer to Finding 11, the hospital’s BBP Exposure Control Plan based on nationally recognized guidelines for workplace BBP exposures which provided definitions of BBPs and OPIMs, potential exposure routes, and required post-exposure evaluation guidance for employees. None of the hospital’s P&Ps, “Fit for Duty”, “Management of Communicable Disease Exposure”, or their “Bloodborne Pathogens Exposure Control Plan” provided IP protocols when a patient was potentially exposed to an infectious employee, or a potentially infectious employee when a breach in safe injection practices occurred, such as employee drug diversion of injectable medications. Refer to Tag A-750, Finding 11, the “Management of Communicable Diseases” with a focus on employees exposed to an infectious patient. Although the “Management of Communicable Diseases” P&P stated, “Identifies any potential patient contacts and notifies their attending provider ... and/or their primary care provider ... of the potential exposure ... “ the policy did not address outbreaks, nor did it address required IP follow-up for investigation, tracking or monitoring outbreaks involving multiple patient exposures. The hospital failed to address potential IP concerns in its “Fit for Duty” policy even after a potential breach in safe injection practices (drug diversion) may have exposed greater than 30 patients to BBPs or OPIMs as acknowledged by the hospital in Finding 12, the AGC email which stated that patients who were under RN4’s care, a nurse identified as repeatedly suspicious for diverting IV Fentanyl, were advised to undergo testing for BBPs. 10. The policy titled, “Diversion Investigation and Reporting (ASANTE),” dated effective 01/04/2022 reflected: * “Purpose ... To provide a systematic, coordinated and continuous approach to the prevention, recognition and reporting of drug diversion to ensure safe medication practices ... to prevent patient harm.” * “All suspected incidents of drug diversion will be thoroughly investigated.” * “If an Asante workforce member is determined to have committed drug diversion, the Asante workforce member shall be subject to corrective action.” * “Required: Subject Matter Expert ... Dir Pharmacy Services & Chief Pharmacy Officer” * “Reviewed By ... Legal Officer & General Counsel ... Director of Employee & Labor Relations ... Controlled Substance Diversion Prevention Program Committee”. The policy failed to collaborate with the IP program in the development and implementation of the “Fit for Duty” process. The policy failed to specify whether drug diversion that involved a breach of safe injection practices warranted additional IP follow-up, such as implementing a communicable disease investigation. For instance, even after a serious breach in safe injection practices (drug diversion) had been identified in July 2023 which potentially exposed more than 30 patients to BBPs and OPIMs, IP was unaware that a simultaneous BSI outbreak occurring in the ICU may have been related to the drug diversion event. Refer to Tag A-750, Findings 13 - 13.b., BSIs identified from June 2022 - July 2023 in patients cared for by RN4, a nurse identified as repeatedly suspicious for diverting injectable medication from ICU patients. Also refer to Tag A-750, Finding 18, IP interview where the IPD stated, “ ... we saw an increase in BSIs ... We saw patterns that looked different ...” and when asked, “When did the IP department first learn that the infections may be related to drug diversion?” The IPD responded, “Not until the UCLA report came out” in November of 2023. The hospital-wide policy failed to identify the need to communicate critical information regarding patient infection risks and possible exposures to BBPs or OPIMs when a breach in safe injection practices (drug diversion) occurred. Refer to Finding 11, the hospital’s BBP Exposure Control Plan based on nationally recognized guidelines for BBP exposures and included the definitions of BBPs and OPIMs, potential exposure routes, and required post-exposure evaluation guidance. Even after the hospital identified a possible connection between the RN4’s drug diversion and the increase in ICU-associated BSIs, the policy failed to consider IP roles and responsibilities in conducting and gathering surveillance data, including a requirement to conduct communicable disease investigations to identify, monitor and track patients exposed to HAIs, or who were part of an outbreak. Refer to Tag A-750, Finding 11, the hospital-wide “Management of Communicable Disease Exposures” policy that required IP to “Promptly investigates any reported communicable disease exposure, confirming the diagnosis and developing the exposure criteria” and “Identifies any potential patient contacts and notifies their attending provider (for inpatients) and/or their primary care provider (for outpatients) of the potential exposure ... In conjunction with Employee Health, reports the exposure investigation to the Infection Prevention Committee, including the number of exposed patients ...” 10.a. A document attached to the “Diversion Investigation and Reporting” policy titled, “Appendix A ... Diversion Incident Checklist” reflected: * The document noted 5 areas of follow-up. These were: “Concern reported ... Investigation Documentation ... Termination ... Internal Reporting ... External Reporting”. * Under the investigation documentation was listed: “Date of origin ... Total doses diverted ... Key documents to support case ... Drug Test Result”. * Under internal reporting was listed: “CEO, CNO/CMO, and other leaders, as appropriate ... Controlled Substance Diversion Prevention Program Committee”. The hospital failed to develop and implement a hospital-wide policy that addressed nationally recognized standards and post-exposure protocol for patients exposed to BBPs or OPIMs as a result of injectable medication drug diversion. Refer to Finding 10, the hospital’s “Diversion Investigation and Reporting” policy which lacked IP consideration. As a result, the “Diversion Incident Checklist” lacked IP notification, and post-exposure evaluation and follow-up for patients, extent of the potential patient exposures, or whether an outbreak was identified and reported to public health authorities. Refer to Tag A-750, Finding 11, the hospital-wide “Management of Communicable Disease Exposures” policy that requires IP “Notifies the appropriate public health department if it is a reportable communicable disease ... Identifies any potential patient contacts and notifies their attending provider (for inpatients) and/or their primary care provider (for outpatients) of the potential exposure ... In conjunction with Employee Health, reports the exposure investigation to the Infection Prevention Committee, including the number of exposed patients ...” 11. The policy titled, “Bloodborne Pathogens Exposure Control Plan (ASANTE) dated effective 06/27/2023 reflected: * The purpose of this policy is to eliminate or minimize employee occupational exposure to blood or other potentially infectious material (OPIM), identify employees occupationally exposed to blood or OPIM in the performance of their regular job duties, provide information and training to employees exposed to blood and OPIM, and comply with OSHA Bloodborne Pathogen standard ...” * “Bloodborne Pathogens ... are pathogenic microorganisms that are present in human blood; these and other potentially infectious materials (OPIM) can cause disease. Examples include hepatitis B ... hepatitis C ... and ... HIV”. * “Hepatitis B ... The Hepatitis B vaccine series is offered, at not cost, to all employees ... Previously vaccinated new hires must provide a vaccination record that includes the vaccination dates and a lab titer or a lab titer showing proof of immunity. Employees must sign a declination statement if the vaccination record is not available and revaccination is declined or not appropriate.” * “Exposure Incident and Post-Exposure Evaluation and Follow-up ... An exposure incident to bloodborne pathogens is defined as an eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee’s duties.” * “... any exposed employees should be medically evaluated as soon as possible after the exposure incident to assure that post-exposure prophylaxis, if recommended, can be initiated promptly.” * “The medical evaluation is to include the route(s) of exposure and the exposure incident circumstances: identification and documentation/testing of the source individual, where feasible; exposed employee blood collection and testing of blood for HBV, HCV, and HIV antigen and serological status; post-exposure prophylaxis, where indicated; counseling; and evaluation of reported illness.” * “Medical records for HCW with occupational exposure to bloodborne pathogens include the HCW’s ... hepatitis B status, including dates of hepatitis B vaccination ... Medical records are kept for the duration of employment plus 30 years ... Medical records are confidential. Employees must sign a written consent for disclosure.” * “Bloodborne pathogen exposure records: all [sic] medical records for an exposure are kept by Employee Health, including hepatitis B, hepatitis C, and HIV testing for the healthcare worker, and, if available, the source patient.” As expected, the policy addressed BBP/OPIM exposures to employees while performing their duties. While not applicable to potentially exposed patients, the policy demonstrated that the hospital was aware of nationally recognized standards and protocols for post-exposure management in the event of a BBP exposure incident; steps that were not reflected in other IP or Pharmacy P&Ps provided as a result of the potential breaches in safe injection practices, i.e., drug diversion. The hospital failed to develop and implement an IP or Pharmacy policy that addressed post-exposure management protocol for patients when suspected diversion of injectable medications occurred. Refer to Finding 9, the “Fit for Duty” policy, and Finding 11, the “Management of Communicable Disease Exposure” which lacked post-exposure processes. Neither of these P&Ps, nor the “Bloodborne Pathogens Exposure Control Plan” provided IP protocol when a patient was potentially exposed to an infectious employee, or a potentially infectious employee, from a breach in safe injection practices. Although the “Management of Communicable Diseases” policy stated, “Identifies any potential patient contacts and notifies their attending provider ... and/or their primary care provider ... of the potential exposure ... “ the policy did not address outbreaks, nor did it address required IP follow-up for investigation, tracking or monitoring outbreaks involving multiple patient exposures. The hospital failed to address potential IP concerns in its “Fit for Duty” policy even after a potential breach in safe injection practices (drug diversion) may have exposed greater than 30 patients to BBPs or OPIMs as acknowledged by the hospital in Finding 12, the AGC email stating that patients who were under RN4’s care were advised to undergo testing for BBPs. 12. During an interview with the IPD on 02/29/2024, beginning at 1030, the IPD was asked whether the hospital had an outbreak management P&P. The IPD stated that they only had the policies that were provided, and nothing specific to an outbreak protocol or P&P. The hospital did provide a P&P that outlined the appropriate steps to diagnose and manage cases, implement appropriate precautions, and prevent further transmission of an outbreak. The hospital did not provide a P&P that described outbreak response activities such as documentation of follow-up activity and responses that complied with state and local public health authority requirements for identification, reporting, and containment of communicable diseases and outbreaks. Refer to Finding 11, the hospital’s communicable disease management policy and the link to other, non-NHSN reportable infections. Additionally, the hospital failed to fully develop and implement their “Management of Communicable Disease Exposure” policy as the IP program was not informed of a breach of safe injection practices which potentially exposed patients to BBPs and OPIMs during a suspected drug diversion event(s). Refer to Tag A-750, Finding 18, IP interview, IPD statement that they were unaware of a possible connection with the ICU-associated BSI outbreak and drug diversion until November 2023, therefore, they were unaware of a potential BBP/OPIM exposure event(s). The IP program could not provide documentation that the IP program “Promptly investigates any reported communicable disease exposure, confirming the diagnosis and developing the exposure criteria” or “Identifies any potential patient contacts and notifies their attending provider (for inpatients) and/or their primary care provider (for outpatients) of the potential exposure ... In conjunction with Employee Health, reports the exposure investigation to the Infection Prevention Committee, including the number of exposed patients ...”. The hospital’s Infection Prevention Program failed to fully develop and implement hospital-wide infection surveillance, prevention, and control P&Ps that adhered to nationally recognized guidelines. Refer also to Tag A-750, Findings 18 and 19, IP interview which reflected that the hospital first identified a concern with BSIs in May 2022, did not identify an outbreak until September 2022, four months later, and did not report the outbreak to public health authorities until April 2023, approximately seven months after the outbreak was identified. Refer also to Tag A-750, Finding 15, IPC meeting minutes which demonstrated IP failure to fully implement the “Management of Communicable Disease Exposure” policy by failing to report the outbreak and patients to the IPC. 13. An email from the AGC dated 03/22/2024 at 1517 acknowledged that patients cared for by RN4, a nurse identified as repeatedly suspicious for diverting injectable medication from ICU patients, were potentially exposed to BBPs. The AGC was asked, “... did they [the hospital] or Employee Health verify [RN4’s] BBP status? ... Were the patients whose fentanyl may have been diverted by [RN4] tested, as determined by the hospitals’ [sic] investigation, or advised to be tested for any BBPs as part of the investigation?” The AGC stated, “When Asante learned that the BSIs may have been the result of [RN4’s] drug diversion conduct ... As the investigation continued, Asante took steps to check [RN4’s] BBP status ... When Asante disclosed the BSIs to the affected patients, it recommended that they get tested for BBP.” The hospital’s drug diversion investigation and management P&Ps failed to address nationally recognized standards for BBP post-exposure management, including prompt post-exposure treatment when a breach in safe injection practices such as drug diversion occurred. Refer to Finding 11, the hospital’s BBP exposure control plan for employees that provided nationally recognized standards for post-exposure management and that an exposed person “... should be medically evaluated as soon as possible after the exposure incident to assure that post-exposure prophylaxis, if recommended, can be initiated promptly.””

“IC PROFESSIONAL COMMUNICATION QAPI CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (iii) Communication and collaboration with the hospital’s QAPI program on infection prevention and control issues. This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of P&Ps and other documentation, it was determined the hospital failed to ensure its IPC Program fully communicated and collaborated with its QAPI program on emerging IPC issues. Specifically: * Meeting minutes failed to reflect all attendee hospital affiliations, departments, or unit affiliations. It was unclear whether IP professionals were in attendance. * Data reported on BSIs and CLABSIs was incomplete, was not unit-specific, did not reflect up-to-date BSI numbers, and data reported failed to reflect the substantial and steady increases in ICU-associated BSIs. Presentation of HAI data did not clearly communicate a concern for emerging pathogens in a patient-specific, unit-specific population. * The meeting minutes did not adequately reflect that communication of a potential, unit-specific outbreak occurred, or whether the IP program was conducting or conducted an outbreak investigation. * The meeting minutes were unclear as to whether the IP program solicited input from the other attendees and collaborated with members of the hospital’s QAPI program on the emerging IPC issue in the ARRMC ICU. Findings include: 1. The hospital’s ARRMC Quality Council meetings dated 09/22/2022, 10/20/2022, 11/22/2022, 12/20/2022, 01/19/2023, 03/23/2023, 04/20/2023, 05/18/2023, 06/22/2023, 08/24/2023, 09/21/2023, and 10/19/2023 were reviewed and reflected: * 09/22/2022 - The IPC report for the QC meeting noted, “... HAIs ... CLABSI - 1 in June”. There were no notes about a concern for the changing pattern of emerging pathogens or a potential BSI outbreak. The 3 BSIs identified in the second and third quarters of 2022 were not reported. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 10/20/2022 - The “Asante Flu Update Campaign” presentation for the QC meeting included a graph titled “ARRMC Patient Outcomes and Nurse Staffing” that depicted 1 CLABSI in the ARRMC ICU. - An “HAI Update” noted “CLABSI FY21 3 ... FY22 8 CLABSI”. Also noted “... we’ve had these clusters of infections and how those are aligning with what we’re seeing with national trends ... we’re doing the right things. And we’re starting to see those improvements ... This graph is looking at our central line infections (CLABSI). We had that cluster of infections starting in from September into March that aligns with what they saw nationally and NHSN submitted a report in 2020. They saw up to 47% increases in central line infections. They continue to see an increase in infections across the nation that did align with COVID surges. We have seen a couple of infections here at the end of June and August. We’re continuing to investigate those.” There were no notes about a concern for the changing pattern of emerging pathogens, or whether a potential ICU-associated BSI outbreak was being investigated. The 9 ICU-associated BSIs identified in the second, third and fourth quarters of 2022 were not reported. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 11/22/2022 - The IPC report for the QC meeting noted, “Hand Hygiene - ATRMC is doing very well. AACH and ARRMC still have a way to go ... HAIs ... CLABSI - 1 August”. There were no notes about a concern for the changing pattern of emerging pathogens, or whether a potential ICU-associated BSI outbreak was being investigated. The 12 ICU-associated BSIs identified in the second, third and fourth quarters of 2022 were not reported. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 12/20/2022 - There was no IPC report for the QC meeting noted. - An “ICU Annual Report 2023” noted, “CLABSI - 2022 ... February ... 1 ... ICU ... September ... 1 ... ICU ... 2022CYTD 4 RRMC Total ... CLABSI trend ... 2018 ... 1 ... 2019 ... 2 ... 2020 ... 8 ... 2021 ... 4 .... 2022 ... 4” * 01/19/2023 - The IPC report for the QC meeting noted, “HAIs ... CLABSI - ARRMC had one event in September and one event in October. The cases have been investigated and looking at trends. Focusing on opportunities where alternative lines can be used.” There were no notes about a concern for the changing pattern of emerging pathogens, or whether a potential ICU-associated BSI outbreak was being investigated. A total of 16 ICU-associated BSIs that had been identified in the second, third and fourth quarters of 2022 were not reported. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 03/23/2023 - The IPC report for the QC meeting noted, “CLABSI - ARRMC had 2 events in November, 5 in December and 2 in January. Many of these had to do with environmental organisms such as bacteria found in water reservoirs. It was identified that the sinks led to these CLABSI events so the IPC team is working diligently to reduce bacteria. Splash guards were created, sinks are being sterilized monthly, sterile water is being used, etc.” There were no notes that reflected whether a potential ICU-associated BSI outbreak was being investigated. The 4 ICU-associated BSIs identified in the first quarter of 2023 and prior to the 03/23/2023 QC meeting were not reported. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 04/20/2023 - Under “Balanced Score Card Summary” was, “We reported out that we are seeing an increase in central line infections. We do think that we probably will be yellow for that next quarter, but there is a robust number of actions going on related to the central line infections and how to mitigate that. The good news in this is that we have gone three weeks into our 4th week with no central line infections. That is how critical this is to us as we are counting it week by week, so a lot of great work here”. The 6 ICU-associated BSIs (from 03/21/2023 - 04/18/2023) identified within the 4 weeks prior to QC meeting, were not reported. - A presentation titled “ARRMC Quality Board” reflected a table with HAI data, “CLABSI - FY21 3 FY22 7 FY23 16”. Included were slides on “Waterborne Central Line Infections” which reflected education, P&Ps, and work processes. There were no notes about a concern for a potential BSI outbreak in the ARRMC ICU. The 9 ICU-associated BSIs identified since 01/18/2023 through 04/18/2023 were not reported. The 24 ICU-associated BSIs from 07/01/2022 through 04/18/2023, were not reported. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 05/18/2023 - The IPC report for the QC meeting noted, “CLABSI - ARRMC is not doing well with a 0.698 SIR. There were 16 events with 12 being related to environmental pathogens. There is a lot of work being done by Infection Prevention to identify the reason(s).” There were no notes about whether a potential ICU-associated BSI outbreak was being investigated. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 06/22/2023 - There was no IPC report for the QC meeting noted. * 08/24/2023 - There was no IPC report for the QC meeting noted. - The “Nursing Staffing” slide presentation contained a graph depicting ~ 13 CLABSIs in the ARRMC ICU through the first, second and third quarters “FY23”. Notes from the finalized minutes stated, “There has been a significant increase in healthcare acquired infections at ARRMC, which does not appear to correlate with short staffing. There may be a link to between the increased infection rate due to new and inexperienced staff and use of travelers, as they are not as familiar with Asante’s key initiatives such as bundle compliance and hand hygiene. In reviewing the data provided, most of the healthcare acquired infections were in the critical care units.” - The HAI data noted, “This has been a challenging time with central line blood infections. Diligent work continues. Outside counsel may be brought in to help decrease the rate.” Neither a hospital nor unit with the “challenging” central line infections were noted. - A presentation titled “Patient Outcome” included HAI data “... Mitigate infections related to waterborne disease transmission through the following efforts (1.) Education to critical care units, (2.) Policy and Procedural updates related to the risk of tap water, (3.) Environmental factors mitigation through cleaning and workflow processes”. - A “Patient Safety” report noted the following regarding CLABSI rates, “The stoplight status is yellow with an actual performance rate of 0.42 on a target of 0.31. There have been challenges relating to water born [sic] CLABSIs. The medical staff and nursing teams have done an incredible job collaborating to identify root cause. Overall, there has been an increase in infections and there is increased focus to ensure we are following processes 100% of the time. This relates to line compliance and bundle compliance and assisting leaders in helping emphasize the importance of these items to our staff. Hand hygiene is another opportunity, and we are seeing improvements in this area.” Specific units, such as the ICU which had increased BSIs, were not noted. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 09/21/2023 - The IPC report for the QC meeting noted, “CLABSI - ARRMC had four events in June. There were zero events in July. The events have been investigated by the Tiger Team. Continued work on HH, CHG bathing, peripheral IVs, and environmental contaminants. A lot of great engagement and efforts.” - Recommendations form OHA were noted, “OHA Bloodstream Infection Findings ... Tweak policies/procedures ... Improve HH compliance; disallow artificial nails ... Stressed clean environment ... Stressed clean equipment and supplies” - A report of the VPMA noted, “Infectious Disease - There is a lot of great work being done by the Infection Protection Committee. There have been zero HAIs in the last few months.” - A “Patient Safety” report noted the following regarding CLABSI rates, “The stoplight status is yellow with an actual performance rate of 0.42 on a target of 0.31. There have been challenges relating to water born [sic] CLABSIs. The medical staff and nursing teams have done an incredible job collaborating to identify root cause. Overall, there has been an increase in infections and there is increased focus to ensure we are following processes 100% of the time. This relates to line compliance and bundle compliance and assisting leaders in helping emphasize the importance of these items to our staff. Hand hygiene is another opportunity, and we are seeing improvements in this area.” - HAI presentation data noted, “CLABSI FY21 3 FY 22 7 FY23 23 “ARRMC HAI Focus Team - Weekly leadership huddle - Focus on identifying root causes - Removing barriers - Rapid implementation and Improvement” - Additional notes from the finalized QC meeting notes included, “CLABSI - The number of infections in FY23 was twenty-three, twelve of which were in the ICU. For the Central Line bundle elements there is still work to be done., [sic] The bundle elements are pieces that are put into place to ensure we are providing adequate care to prevent infections. These include indication, dressing CDI, dressing dated, biopatch, tubing dated, tubing end, disinfection caps, CHG, and central line composite. There has been much work done on staff education and there are opportunities in tubing dates, and disinfection of caps. The number of lines audited has been increased.” This meeting was the first meeting in which the ICU-associated BSIs were noted, approximately 1 year since the hospital “... started identifying these BSIs, stenos” as a possible cluster in September 2022. Refer to Tag A-750, Finding 18, IPD and MDCC interview. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 10/19/2023 - HAI data was not presented this meeting. - A report of the VPMA noted, “Hospital Acquired Infections (HAIs) - There is a lot of work being done by Infection Protection [sic] regarding HAIs ... Central lines - Bundle compliance, escalation policy ... Hand washing - Stressing the importance and direct correlation with HAIs., [sic] hand washing importance.” Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. The ARRMC QC meeting minutes contained incomplete and inconsistent IP and HAI data. For example, 12 of 12 QC meeting minutes lacked reporting of the emerging infection pattern for Stenotrophomonas spp. and other organisms of concern that were presenting in the ARRMC ICU environment. Although CLABSI data was reported in 10 of 12 QC meetings, surveillance data did not consistently reflect the number of BSIs that were lab identified, refer to Tag A-750, Findings 13.a. and 13.b., lab results for 2022 and 2023. The committee’s review of the previous month’s QC meeting minutes did not reflect any updated or corrected HAI surveillance numbers once final numbers were adjusted. For example, meeting minutes from 04/20/2023 stated “we have gone three weeks into our 4th week with no central line infections.” However, this communication failed to include that 6 new ARRMC ICU-associated BSIs had been reported prior to the date of the QC meeting. IPC reports to the QC committee failed to communicate the emerging outbreak in the ARRMC ICU, and HAI infection information provided failed to disclose the unit in which an increase in CLABSIs/BSIs occurred. Refer to Tag A-750, Findings 13.a. and 13.b., lab results for 2022 and 2023. Refer to Tag A-750, Finding 18, the IP interview and IPD statements regarding the date a pattern of emerging infections was identified as well as MDCC statement regarding other identified organisms of concern. Additionally, the IPD stated they “were alerted” to an issue “identified in September of 2022” and that there was a “pattern of central line infections and the pattern shifted. It was different.” A common respiratory organism in ET aspirate, “Stenotrophomonas ... had changed and was now being seen in blood cultures ...”. The first meeting in which the ARRMC ICU was associated with an increasing number of CLABSIs/BSIs was 09/21/2023, approximately 1 year and 4 months after the emerging infection pattern was observed and an increase in BSIs was identified. There were no notes about a common-source outbreak due to drug diversion/safe injection practice breaches, even after a UCLA expert’s report suggested that safe injection practice breaches were the likely common-source for the ICU-associated BSIs. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. 2. The Patient Safety Council meeting minutes for 02/13/2023, 03/13/2023, 04/10/2023, 05/08/2023, 07/10/2023, and 10/09/2023 were reviewed and reflected: * 02/13/2023 - “HAI Data” noted, “CLABSI - There were 5 events at ARRMC for the month of December and one event in January, and an additional 1 in November. FY 2023 total is 12 (AACH 0, ARRMC 12, ATRMC 0). Currently a high-level focus on care of the environment and hand hygiene performance. There is a robust action plan being worked on regarding the use of tap water. Infection Prevention has been conducting mandatory waterborne disease education.” Also noted under “... Central Line Bundle Compliance: Continued focus on right lines and the right patients ... ARRMC ... Overall composite for Central Line was 90% with fall outs in indication and CHG. Focusing on CHG and indication. Overall doing well even with the current staffing issues.” There were no notes about a concern for the changing pattern of emerging pathogens, a potential BSI outbreak, or the unit(s) in which the CLABSIs had been identified, although units for increased pressure ulcer injuries were reported, “ARRMC ... there were 174 tracked pressure injuries ... Units with the highest pressure injury counts are 4T Gen Surg (33) and ICU (33).” Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 03/13/2023 - “HAI Data” noted, “CLABSI - There were 2 events at ARRMC for the month of February and one additional event in January. FY 2023 total is 15 (AACH 0, ARRMC 15, ATRMC 0). Continued high-level focus on care of the environment and hand hygiene performance. There was a central line update that was in the Asante News last week. Many of these infections are related to waterborne bacteria disease. The Infection Prevention Team conducted educational meetings within the critical care units. Continuing to work through action items including low chlorine levels in ice machines. The ARRMC ICU ice machine was found to have low chlorine levels, the filter was taking too much chlorine out. So far in the month of March no new infections have been identified.” Also noted under “... Central Line Bundle Compliance: Continued focus on right lines and the right patients” was “ARRMC ... Overall composite for Central Line was 88% with fall outs in indication, CHG, and tubing dated. Hand hygiene continues to be a focus and good dialogue when the care improvement nurse audits are sent out.” There were no notes about a concern for the changing pattern of emerging pathogens, a potential BSI outbreak, or the unit(s) in which the CLABSIs had been identified, although units for increased pressure ulcer injuries were reported. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 04/10/2023 - “HAI Data” noted, “CLABSI - There were zero events in March. FY 2023 total is 15 (AACH 0, ARRMC 15, ATRMC 0).” Noted under “... Central Line Bundle Compliance” was “ARRMC ... Overall composite for Central Line was 86% with fall outs in indication, CHG, and tubing dated, tubing end, and disinfecting caps. Data will be discussed at the team meetings along with good dialogue when the care improvement nurse audits are sent out.” There were no notes about a concern for the changing pattern of emerging pathogens, a potential BSI outbreak, or the unit(s) in which the CLABSIs had been identified, although units for increased pressure ulcer injuries were reported. Neither the 1 ICU-associated BSI identified in March, nor the 2 BSIs identified in April prior to the date of this meeting were reported. A “Pharmacy & Medication Safety” report noted “Q1 open investigation still under increased surveillance with no indication of diversion ... “ was noted. The unit where the investigation was ongoing was not noted. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 05/08/2023 - “HAI Data” noted, “CLABSI - There was one event at ARRMC in March and zero events in April. FY 2023 total is 16 (AACH 0, ARRMC 16, ATRMC 0).” A “Waterborne Bacteria Presentation” was noted. The presentation listed two of the organisms of concern that had been identified in September 2022, “Stenotrophomonas” and “Chryseobacterium”. The presentation listed possible causes such as “Breaches in skin (open wounds, central lines)” however, safe injection practices/drug diversion were not listed. Under “... Central Line Bundle Compliance” was “ARRMC ... Overall composite for Central Line was 89% with fall outs in dressing dated, CHG, tubing dated, tubing end, and disinfecting caps. Data will be discussed at the team meetings.” There were no notes about a concern for the changing pattern of emerging pathogens, a potential BSI outbreak, or the unit(s) in which the CLABSIs had been identified, although units for increased pressure ulcer injuries were reported. The 8 ICU-associated BSIs identified in April were not reported. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 07/10/2023 - “HAI Data” noted, “CLABSI - There were two events at ARRMC in June. FY 2023 total is 19 (AACH 0, ARRMC 19, ATRMC 0). These events are currently under investigation and will be presented at the HAI TT meeting.” Noted under “... Central Line Bundle Compliance” was “ARRMC ... Overall composite for Central Line was 89% with fall outs in dressing dated, CHG, tubing dated, tubing end, and disinfecting caps.” There were no notes about a concern for the changing pattern of emerging pathogens, a potential BSI outbreak, or the unit(s) in which the CLABSIs had been identified, although units for increased pressure ulcer injuries were reported. The 8 ICU-associated BSIs identified in April, 5 BSIs identified in May, and the 5 BSIs identified in June were not reported. A “Pharmacy & Medication Safety” report noted “No diversion investigations in Q3 ... “, although the hospital had suspected ICU RN4 was diverting IV Fentanyl beginning May 2022 through July 26, 2023, when RN4 was terminated due to diversion. Refer to Tag A-144, Finding 1. The unit, the ICU, in which the suspected diversion occurred was not noted. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. * 10/09/2023 - “HAI Data” noted, “CLABSI - There was one event at ARRMC in August. FY 2023 total is 23 (AACH 0, ARRMC 23, ATRMC 0)”. Also noted under “... Central Line Bundle Compliance” was “ARRMC ... Overall composite for Central Line was 95% with fall outs in tubing dated, tubing end, CHG, and disinfecting caps.” There were no notes about a concern for the changing pattern of emerging pathogens, a potential BSI outbreak, or the unit(s) in which the CLABSIs had been identified, although units for increased pressure ulcer injuries were reported. The 6 ICU-associated BSIs identified in July were not reported. A “Pharmacy & Medication Safety” report noted “In FY23Q4 the Rapid Response Team had one full investigation on a repeat individual; no confirmed diversion or external reporting, employee was terminated.” The unit where the suspected diversion occurred, the ICU, was not noted. Not all attendee hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. The PSC meeting minutes contained incomplete and inconsistent IP and HAI data. For example, 5 of 6 PSC meeting minutes lacked reporting of the emerging infection pattern for Stenotrophomonas spp. and other organisms of concern; 6 of 6 PSC minutes failed to identify the ARRMC ICU environment as the focus for additional waterborne disease education due to an increase in BSIs. Although CLABSI data was reported in 6 of 6 PSC meetings, surveillance data did not accurately reflect the number of infections that were occurring. For example, meeting minutes from 05/08/2023 reflected “zero events in April” when the actual number of reported BSIs for that month was 8. Refer to Tag A-750, Finding 13.b., lab results for 2023. The IP program failed to report a concern for the changing pattern of emerging pathogens, or that a cluster of BSIs in the ICU had been identified. Refer to Tag A-750, Findings 13.a. and 13.b., lab results for 2022 and 2023. Refer to Tag A-750, Finding 18, the IP interview and IPD statements regarding the date a pattern of emerging infections was identified as well as MDCC statement regarding other identified organisms of concern. There were no notes about a common-source outbreak due to drug diversion/safe injection practice breaches, even after pharmacy reported out that an employee had been terminated for suspected drug diversion; the unit in which the suspected drug diversion occurred was not noted in 6 of 6 meeting minutes. No attendee titles, hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance. 3. The Management Review meeting minutes for 07/14/2022, 05/11/2023, 07/13/2023, 09/14/2023, and 11/09/2023 were reviewed and reflected: * 07/14/2022 - Under “Consent Calendar” the PSC minutes review reflected, “The May and June Patient Safety Council minutes were included in the packet for review. The committee continues to focus on hospital acquired conditions, hospital acquired infections, and medication safety. Full details can be found in the minutes.” There were no notes about a concern for the changing pattern of emerging pathogens, or whether a potential BSI outbreak in the ARRMC ICU was or had been investigated. * No minutes were provided for any month between August 2022 - December 2022. * No minutes were provided for any month between January 2023 - April 2023. * 05/11/2023 - Under “Consent Calendar” the PSC minutes review reflected, “The March and April Patient Safety Council minutes were included in the packet for review. Attention was given to the central line infections and actions. Information and work will continue to be reported through the Patient Safety Council and any barrier or issues will be escalated to Management Review Council as appropriate.” The hospital or unit(s) in which the “central line infections” had been identified were not noted. There were no notes about a concern for the changing pattern of emerging pathogens, or whether a potential BSI outbreak in the ARRMC ICU was or had been investigated. * 07/13/2023 - Under “Consent Calendar” the PSC minutes review reflected, “The May and June Patient Safety Council minutes were included in the packet for review. Robust conversations are occurring around water born [sic] bacteria at ARRMC ICU, including action plans and focus work; all of which is included in the Patient Safety Council minutes. Additional work and focus continue around hand hygiene. Improvements are being seen around the system.” This was the first month that ICU-associated infections had been reported although a concern for the changing pattern of emerging pathogens had been identified as early as May of 2022. It was unclear how the waterborne bacteria at “ARRMC ICU” was reported out in the Management Review meeting as the PSC May minutes did not reflect that information and there were no June meeting minutes. * 09/14/2023 - Under “Consent Calendar” the PSC minutes review reflected, “The July and August Patient Safety Council minutes were included in the packet for review. The council continues to focus on HAI. Rapid action teams were established at ARRMC to focus on opportunities. Hand hygiene continues to be a focus. ATRMC accomplished >90% hand hygiene compliance for over a year and celebrations for staff will occur in the next couple of weeks. As a system, Asante has accomplished >90% hand hygiene compliance for the last four consecutive months.” There were no notes about a concern for the changing pattern of emerging pathogens, or whether a potential BSI outbreak in the ARRMC ICU was or had been investigated. * 11/09/2023 - Under “Consent Calendar” the PSC minutes review reflected, “The September and October Patient Safety Council minutes were included in the packet for review. Continuing to work on HAI, the rapid action team is responsible for improving rates and driving corrective action. Overall, seeing a decreased trend in infection rate. For the month of October, all hospitals had a hand hygiene rate above 90%. As a health system the hand hygiene rate has been above 90% for 6-months.” There were no notes about a concern for the changing pattern of emerging pathogens, or whether a potential BSI outbreak in the ARRMC ICU was being or had been investigated. There were no notes about the concern that safe injection practice breaches, aka drug diversion, was suspected as the common-source for the ICU-associated BSI outbreak. The Management Review meeting minutes contained incomplete and inconsistent IP and HAI data. For example, communication of IP program prevention and control issues consisted of reviewing PSC meeting minutes which failed to report the emerging infection pattern for Stenotrophomonas spp. and other organisms of concern, and which also failed to identify the ARRMC ICU environment as the focus for increased waterborne disease education due to an increase in BSIs. Refer to Finding 2, PSC meeting minutes. There were no notes about a common-source outbreak due to drug diversion/safe injection practice breaches, even after a UCLA expert’s report suggested that safe injection practice breaches were the likely common-source for the ICU-associated BSIs. No attendee titles, hospital affiliations, departments or unit affiliations were listed on the meeting minutes. It was unclear whether IP professionals were in attendance.”

“IC PROFESSIONAL ADHERENCE TO POLICIES CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (v) The prevention and control of HAIs, including auditing of adherence to infection prevention and control policies and procedures by hospital personnel. This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of P&Ps and other documentation, it was determined the hospital failed to ensure its IPC Program regularly and consistently audited staff adherence to IPC P&Ps. The hospital failed to consider IPC responsibilities in adhering to nationally recognized guidelines as well as the IP program’s required responses to breaches in safe injection practices/drug diversion, including ensuring adherence to mitigation strategies for a common-source outbreak were followed. Findings include: 1. Refer to Tag A-750, maintaining a clean and sanitary environment to avoid sources and transmission of infection, and to address any infection control issues identified by the state public health authority, Finding 8, tour of the ICU and breaches of infection prevention practices observed, including failure to fully implement infection prevention and control recommendations by the state public health authority. 2. Refer to A Tag-750, Findings 9.a. and 9.b., dates of IP auditing rounds of the ICU, and confirmation email from the AGC who stated that the hospital lacked documentation of IP ICU auditing rounds from “5/22” through 06/07/2023. 3. Refer to Tag A-750, Finding 10, IP interview dated 02/01/2024, and IPD statement that ICU audit rounds were conducted “weekly” and IPD statement acknowledging breaches of infection prevention practices observed during the ICU tour. 4. Refer to Tag A-772, Findings 8, 9 and 10, hospital-wide P&Ps developed without addressing IP responsibilities and adherence to IP principles. The hospital and its IP program failed to develop, implement, and adhere to hospital-wide infectious disease surveillance, prevention, and control P&Ps that were consistent with nationally recognized guidelines for breaches in safe injection practices and outbreak investigation. Pharmacy failed to collaborate with the IP program in the development and implementation of hospital-wide P&Ps that addressed drug diversion, and in doing so, the IP program was unable to adhere to required surveillance, investigation, reporting, monitoring, and follow up of a common-source outbreak, including the auditing of safe injection practices.”

“SYSTEM IC-ABX STEWARDSHIP POLICIES CFR(s): The unified and integrated infection prevention and control and antibiotic stewardship programs establish and implement policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration; This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of P&Ps and other documentation, it was determined the hospital failed to ensure its unified IPC Program established and implemented P&Ps that addressed the needs and concerns of each separately certified hospital and failed to consider the unique practices and locations of each hospital. Findings include: 1. Refer to Tag A-751, Findings 1-3, the hospital’s IP Operational Plans which reflected the hospital was operating under a unified IP system that did not consider the differences in each separately certified hospital’s environment, staff, population served, or services offered. 2. Refer to Tag A-751, Findings 5-7, the hospital’s annual Risk Assessments which reflected the hospital determined the risk levels of the hospital based on the combined data from three separately certified hospitals, ARRMC, ATRMC and AACH. 3. Refer to Tag A-751, Findings 8-10.b., the hospital’s IP “Work” plans, IP “Action” plans and annual IP plan reviews based on risk assessments which were determined by combined data from three separately certified hospitals, ARRMC, ATRMC, and AACH. 4. Refer to Tag A-751, Finding 14, AGC email confirming that the hospital’s annual Risk Assessments were determined by combined data from three separately certified hospitals, and that the hospital’s annual IP Plans were based on those risk assessments. The AGC confirmed that the hospital’s annual IP Plan was a system-wide plan for three hospitals within the Asante health system, ARRMC, ATRMC, and AACH. 5. Refer to Tag A-774, Findings 1, 2, and 3; Quality Council, Patient Safety Council, and Management Review meeting minutes where the hospital failed to consistently report identified IP infectious issues that were specific to each individually certified hospital, or unit, and instead reported infectious issues as system-wide events.”

“SYSTEM IC-ABX STEWARDSHIP MECHANISMS CFR(s): The unified and integrated infection prevention and control and antibiotic stewardship programs have mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed; and This Standard is not met as evidenced by: 44104 Based on observations, interviews, reviews of P&Ps and other documentation the hospital failed to develop and implement a unified IPC Program that fully considered issues that were localized to a single separately certified hospital, and that those individualized issues were identified and addressed in collaboration with QAPI as concerns unique to that particular hospital. Findings include: 1. Refer to Tag A-751, Findings 1-3, the hospital’s IP Operational Plans which reflected the hospital was operating under a unified IP system that did not consider the individualized IPC issues at each separately certified hospital. 2. Refer to Tag A-751, Findings 5-7, the hospital’s annual Risk Assessments which reflected the hospital determined the risk levels of a separately certified hospital, ARRMC, based on the combined data from three separately certified hospitals, ARRMC, ATRMC and AACH. Risks were combined, and the unique environments, population served, or the services provided by each separately certified hospital were not considered in the Risk Assessment. 3. Refer to Tag A-751, Findings 8-10.b., the hospital’s IP “Work” plans, “Action” plans and annual IP plan reviews that were based on Risk Assessments which were determined by combined data from three separately certified hospitals, ARRMC, ATRMC, and AACH. 4. Refer to Tag A-751, Finding 14, AGC email confirming that the hospital’s annual Risk Assessments were determined by combined data from three separately certified hospitals, and that the hospital’s annual IP Plans were based on those Risk Assessments. The AGC confirmed that the hospital’s annual IP Plan was a system-wide plan for three hospitals within the Asante health system, ARRMC, ATRMC, and AACH, and did not consider the unique environments, population served or the services provided by each hospital. 5. Refer to Tag A-774, Findings 1, 2, and 3; Quality Council, Patient Safety Council, and Management Review meeting minutes where the hospital failed to consistently report IP identified infectious issues that were specific to each individually certified hospital and unit. The hospital reported increases in BSIs/CLABSIs as a system-wide QAPI concern and failed to consistently consider and address the specific hospital and specialized unit in which the increased infections were occurring.”