Shasta Regional Medical Center

“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: 49418 The facility failed to meet the regulatory requirements for the Condition of Participation Code of Federal Regulations 482.23, Nursing Services, as evidenced by the following: 1. Based on interview, and record review, the facility failed to ensure nursing staff followed policies and procedures (P&Ps) for assessments and reassessments as well as care planning for five of five sampled patients (Patients 1-5), who developed healthcare-acquired pressure injuries (HAPIs) during hospitalization at the facility (Refer to A-0398). A. Patient 1 was brought in by ambulance a transfer from another hospital on 2/1/26, for altered level of consciousness (ALOC) following a non-ST-elevation myocardial infarction (NSTEMI or heart attack). Records indicated Patient 1 was sedated and intubated (a ventilation tube was inserted down the throat to help the patient breathe) on arrival and had “acute mental status changes.” During concurrent interview, with Wound Nurse (WN) A, and Clinical Supervisor of Wound Care (CSWC), and review of Patient 1’s medical record on 4/9/26 at 10 am, WN A noted Patient 1’s Braden scores were documented between 15 and 17 (mild risk for pressure ulcer) from admission 2/2/26 until 2/20/26. WN A stated, that she would expect Patient 1’s admission Braden score to be “between 6 and 8” (severe risk) due to sedation, limited mobility and activity (bedfast due to restraints), limited nutrition due to intubation, and potential friction/shear from frequent repositioning by nursing staff. WN A stated, “Nurses are not using Braden scores appropriately,” and they were in the process of educating nurses (Refer to A-0398, Finding 1). B. Review of document titled “Admission/Registration” indicated that Patient 2 was in his late 60s, admitted on 11/28/25 for “intractable (unrelenting) abdominal pain,” nausea and vomiting, and decreased output from his ostomy. During concurrent interview with WN A and CSWC and review of Patient 2’s medical record on 4/9/26 at 10:50 am, WN A stated that Patient 2’s Braden scores were 14 on 11/28/25 and 11/29/25, 13 on 12/3/25, and 12 on 12/5/25, “the first low Braden,” (scores of 12 or below alert the wound care team for consultation). WN A stated Patient 2 “should have been a low Braden before 12/5/25,” and stated the 12/1/25 two-person skin exam indicating no areas of skin breakdown was “likely not performed accurately” (Refer to A-0398, Finding 2). C. Review of a document titled “History & Physical,” dated 2/24/26 at 6:19 pm, indicated that Patient 3 was in her late 90s, admitted for possible small bowel obstruction with complaints of “unbearable” pain associated with episodes of vomiting. A two-person skin assessment on 2/25/26 indicated no skin findings. Review of document titled “Root Cause Analysis (RCA)/Intensive Case Analysis Tool,” completed by the facility on 3/19/26, indicated that Patient 3 was admitted on 2/24/26 and developed a Stage 2 injury to the sacrum (large bone at base of spine) and “unstageable injury” to coccyx on 3/6/26. -RCA Findings Identified: Patient 3 had lived independently at home, now very weak and “pretty much immobile due to bowel surgery,” malnourished with “poor nutritional intake,” and had incontinence. “Refusing care at times.” Patient had hernia repair surgery on 3/2/26, and “difficult and slow recovery.” -Action/Correction Plan: Continue with staff education via skills fair, orientation, floor binders. Meet with individual staff as needed to educate. Despite documentation of two facility-acquired pressure injuries on 3/6/26, review of document titled “Two (2) Person Skin Assessment” by RN P and RN Q, dated 3/8/26 at 7 pm, indicated “Findings: None.” During a concurrent interview with WN A and CSWC and review of Patient 3’s medical records on 4/9/26 at 10:50 am, WN A and CSWC acknowledged that RN P and RN Q “did not do a thorough two-person skin exam on 3/8/26” and agreed Patient 3 should have been assessed with a low Braden on admission (Refer to A-0398, Finding 3). D. Review of document titled “History & Physical,” dated 9/11/25 at 6:40 pm, indicated Patient 4 was in his late 80s, admitted for a large episode of bright red blood from the rectum and progressive generalized weakness. Patient 4 had a history of coronary artery disease (CAD), previous heart surgery, high blood pressure, severe peripheral artery disease (narrowed arteries in arms and legs due to fatty plaque), and narrowing of the spinal canal (causes pinched spinal cord and/or nerves) with back pain. Review of document titled “Two (2) Person Skin Assessment” by RN S and RN T, dated 9/11/25 at 11:01 pm, indicated Patient 4 had a wound on the left great toe, wound pictures in chart; bruising on the lower abdomen due to heparin (blood thinner) shots outpatient; and scabs on both legs. Review of document titled “Two (2) RN/LVN Skin Assessment” by RN N and RN V, dated 9/16/25 at 5:52 pm, indicated that Patient 4 had a skin tear on the left forearm, surgical sites on right shoulder and right abdomen were well approximated (wound edges were aligned), wound to left great toe, blister on foot, bilateral heel pressure wounds, bruising on the left arm, scabs on both legs, fasciotomy on left lateral leg, PICO dressing (small disposable pump connected to an absorbent dressing that removes excess fluid from a wound) on bilateral groin, redness on coccyx, and swollen, edematous, bruised penis. Wound photos of Patient 4’s left forearm skin tear, surgical sites, and left arm bruising were not provided by the facility. Review of wound photographs and documentation on the corresponding forms indicated Patient 4 was admitted with an “acute, unknown origin” wound to the left great toe, developed new right and left heel DTIs (9/15/25), and new “blisters” to left lower extremity (9/17/25). Review of photograph taken by WN A on 9/17/25 at 11:30 am indicated that the left heel wound was reclassified as “Pressure Ulcer Stage III (3),” “evolved from DTI on 9/15/25,” measuring 1.5 cm long, 2 cm wide, with 0.2 cm depth. The left heel wound appeared to have opened, with a large bloody area observed across the bottom and back of the heel. During concurrent interview and review of Patient 4’s medical records on 4/9/26 at 10:30 am with WN A and CSWC, WN A acknowledged Braden scores were assessed at 18 (minimal to no risk of pressure injury) on 9/11/25 and 9/12/25, and the first low Braden was not documented until 9/15/25. WN A noted new heel wounds were charted on 9/14/25, and Wound Care saw Patient 4 the following day for the first time. WN A and CSWC agreed that Patient 4’s Braden score should not have been 18 on admission as he was unable to walk, which should have given him a low mobility score, and he came in with pre-existing wounds. WN A stated, “There’s definitely a breakdown in communication” (Refer to A-0398, Finding 4). E. Review of document titled “History & Physical - Short,” dated 10/17/25 at 1:36 am, indicated Patient 5 was in her late 70s, admitted on 10/16/25 for encephalopathy (disease process that alters brain function causing confusion, memory loss, personality changes, or seizures), fever, and shaking chills for two days. Other diagnoses included respiratory failure requiring sedation and mechanical ventilation (tube inserted into the airway to help patient breathe), septic shock (advanced, life-threatening stage of sepsis, an infection causing the body’s immune system to fail), urinary tract infection, acute kidney injury (sudden episode of kidney damage), and atrial fibrillation (irregular heart rhythm). Review of document titled “Two (2) RN/LVN Skin Assessment” by RN H and RN W, dated 10/26/25 at 1:09 am (nine days after admission), indicated the reason for skin assessment was “skin check not documented” (on admission per policy). Comments indicated Patient 5 had a small area of moisture breakdown on gluteal sulcus (skin crease between upper thigh and lower buttock) and redness to inner groin. “No other areas of concern.” Wound photos of Patient 5’s gluteal sulcus and inner groin were not provided. Review of document titled “Two (2) RN/LVN Skin Assessment” by RN X and RN Y, dated 11/7/25 at 12:05 am, indicated the presence of scabs on neck, labial redness, posterior scalp scab, redness on left abdomen, skin tag posterior left thigh, and redness under left breast. Review of photograph taken by WN B on 11/11/25 at 10:45 am indicated a “new finding” of wound to “occipital” (back of head), Present on Admission: “Clinically Undetermined.” WN B documented classification of the wound as “unstageable,” measuring 2 cm long, 2 cm wide, depth 0 (zero). During concurrent interview and review of Patient 5’s medical records with WN A and CSWC on 4/9/26 at 10:40 am, WN A and CSWC acknowledged a two-person skin assessment was not performed for nine days. WN A stated that it was facility policy for the bedside nurse to perform a full head-to-toe skin assessment within 24 hours of admission. WN A stated, “Basically, they dropped the ball on this patient” (Refer to A-0398, Finding 5). 2. Based on interview and record review, the facility failed to ensure nursing staff maintained updated nursing care plans for five of five sampled patients (Patients 1-5) who had urinary catheters placed during hospitalization (Refer to A-0396). A. Patient 5 was admitted 10/16/25 for encephalopathy (disease process that alters brain function causing confusion, memory loss, personality changes, or seizures), fever, and shaking chills for two days. Other diagnoses included respiratory failure requiring sedation and mechanical ventilation (tube inserted into the airway to help patient breathe), septic shock (advanced, life-threatening stage of sepsis, an infection causing the body’s immune system to fail), urinary tract infection, acute kidney injury (sudden episode of kidney damage), and atrial fibrillation (irregular heart rhythm). Patient 5 had a Foley catheter (thin flexible tube inserted into the bladder through the urethra to continuously drain urine into a collection bag) placed on 10/30/25. However, the care plan was not updated to include the insertion of a Foley catheter. On 11/2/25, a photograph of Patient 5’s “perineal area (labia)” (inner and outer folds on either side of the vagina) indicated a new wound was found and photographed by RN C. On 11/4/25, WN A documented classification of the wound as a “device-related pressure injury, acute” measuring 1 cm long and 2 cm wide (Refer to A-0396, Finding 1). B. Patient 2 was admitted 11/28/25 for “intractable (unrelenting) abdominal pain” with complaints of nausea and vomiting and decreased ostomy (a surgically created opening in the abdominal wall that allows urine/stool to exit the body) output. Patient 2 had a Foley catheter placed 11/29/25. However, the care plan was not updated to include the insertion of a Foley catheter. A new wound was found and photographed by WN A on 12/16/25 at 11:30 am, at the “meatal (natural opening) head of penis.” The wound measured 0.5 cm long and 1 cm wide. WN A classified the wound as a “device-related pressure injury” (Refer to A-0396, Finding 2). C. Patient 4 was admitted 9/11/25 for a large episode of bright red blood from the rectum and progressive generalized weakness. Patient 4 had a history of coronary artery disease, previous heart surgery, high blood pressure, severe peripheral artery disease (narrowed arteries in arms and legs due to fatty plaque), and narrowing of the spinal canal (causes pinched spinal cord and/or nerves) with back pain. Patient 4 had a Foley catheter placed 9/12/25. However, the care plan was not updated to include the insertion of a Foley catheter (Refer to A-0396, Finding 3). D. Review of document titled “Physical Assessment,” dated 2/24/26 at 8 am, indicated Patient 1 had a Foley catheter inserted on 2/22/26. However, the care plan was not updated to reflect the use of a catheter (Refer to A-0396, Finding 4). E. Patient 3 was admitted 2/24/26 for possible small bowel obstruction with complaints of “unbearable” pain associated with episodes of vomiting. Medical records indicated Patient 3 had a dry flow “wick” (external catheter placed against the body that uses low-pressure suction to draw voided urine away from the body into a collection canister) in place from 2/27/26 to 3/5/26; however, the care plan was not updated to reflect the use of an external catheter (Refer to A-0396, Finding 5). These deficient practices compromised patient safety, continuity of care, and informed decision-making by patients and care team members, with negative health outcomes for Patients 1-5 and potential negative health outcomes for all other patients hospitalized at the facility. The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality healthcare in compliance with the Condition of Participation for Nursing Services.”

“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: 49418 Based on interview and record review, the facility failed to ensure nursing staff maintained updated nursing care plans for five of five sampled patients (Patients 1-5) who had urinary catheters placed during hospitalization. These failures had the potential for patient care needs and goals to go unmet, with actual negative health outcomes for Patients 2 and 5 and potential negative health outcomes for Patients 1, 3, and 4 related to catheter placement. Findings: Review of Artificial Intelligence (AI) Overview on 4/17/26 indicated a nursing care plan for indwelling catheters is essential to prevent catheter-associated urinary tract infections (CAUTIs - one of the most prevalent hospital-acquired infections), to protect skin integrity from urine-related breakdown, reduce catheter-associated trauma and complications, to ensure urine flows and prevents blockage by maintaining patency, and to promote comfort and dignity. “Common Nursing Interventions” for catheter care included “at least daily” cleaning of perineal skin (area between anus and scrotum or vulva), stabilizing the device to prevent movement and friction, positioning to ensure proper drainage, and regular inspection of the skin for redness and breakdown. Review of the facility’s policy and procedure (P&P) titled “Process Plan (Plan of Care),” dated 9/2023, indicated that nursing staff were directed to formulate care plans in collaboration with the Interdisciplinary Team (IDT - a team with members from different disciplines who work together to set goals and make care decisions) at the time of the first assessment and review/revise “in cooperation with the patient, significant other(s), and members” of the IDT “at least every 12 hours” when reassessments are performed during the hospital stay. The P&P indicated nursing staff “shall revise/update expected outcomes, problems, interventions, supportive data, and reprioritize needs to coordinate care.” The P&P indicated the care plan should: a. identify patient problems, b. identify individualized patient-specific treatment goals and outcomes, c. list interventions provided to meet patient needs, including referrals, d. reassess and re-evaluate problems, and e. identify resolved problems based on outcome goals. 1. Review of document titled “History & Physical - Short,” dated 10/17/25 at 1:36 am, indicated Patient 5 was in her late 70s, admitted 10/16/25 for encephalopathy (disease process that alters brain function causing confusion, memory loss, personality changes, or seizures), fever, and shaking chills for two days. Other diagnoses included respiratory failure requiring sedation and mechanical ventilation (tube inserted into the airway to help patient breathe), septic shock (advanced, life-threatening stage of sepsis, an infection causing the body’s immune system to fail), urinary tract infection, acute kidney injury (sudden episode of kidney damage), and atrial fibrillation (irregular heart rhythm). Review of photograph of Patient 5’s “perineal area (labia)” (inner and outer folds on either side of the vagina) indicated a new wound was found and photographed by RN C on 11/2/25 at 10 am. The photo indicated a Foley catheter tube (thin flexible tube inserted into the bladder through the urethra to continuously drain urine into a collection bag) was present in the urethra. The labial tissue appeared to be reddened with a raw open area on the skin just above the Foley tubing. On 11/4/25 at 9:10 am, Wound Nurse (WN) A documented classification of the wound as a “device-related pressure injury, acute” measuring 1 centimeter (cm - a unit of measure) long and 2 cm wide. Review of document titled “Physical Assessment,” dated 11/6/25 at 10:55 pm, indicated Patient 5’s Foley catheter was inserted on 10/30/25 (three days prior to the wound finding). Review of document titled “Patient Plan of Care - Adult Respiratory Distress Syndrome,” initiated 10/18/25, indicated the care plan was not updated to include the insertion of a Foley catheter. During concurrent interview with WN A and Clinical Supervisor for Wound Care (CSWC) and record review on 4/9/26 at 10:40 am, WN A stated that the skin around Foley catheter tubing should be checked often, and nursing should make sure the patient is “aligned” (straight in bed) to avoid a pressure injury. WN A stated that if a patient was “squirmy” or moved around a lot, the patient should be checked more often. WN A stated that she recalled seeing Patient 5 for a wound assessment and noted “the Foley was pulled super, super tight” across her thigh. On review of the care plan, CSWC noted the Foley catheter was not documented, and WN A and CSWC acknowledged the Foley should have been added to the plan when it was inserted. 2. Review of document titled “Admission/Registration” indicated Patient 2 was in his late 60s, admitted 11/28/25 for “intractable (unrelenting) abdominal pain.” Patient 2 complained of nausea and vomiting with decreased ostomy (a surgically created opening in the abdominal wall that allows urine/stool to exit the body) output. Review of document titled “Wound, Ostomy, and Continence (WOC) - Wound Assessment,” dated 12/9/25, indicated Patient 2 had a history of irregular heart rhythm, coronary artery disease, high blood pressure, vascular disease, bowel obstruction, diverticulitis (inflammation of the intestines), chronic back pain, and a right above-knee amputation. The document indicated Patient 2 had a small bowel resection (surgery to remove damaged or diseased section of intestines) on 11/30/25, with another surgery 12/2/25 to create a new ostomy site. The document indicated Patient 2 had surgical wounds on the abdomen, lower back, coccyx (tailbone), and left heel. Review of document titled “Physical Assessment,” dated 12/14/25 at 8 am, indicated Patient 2 had “severe edema to scrotum,” with a Foley catheter placed on 11/29/25, the day after admission. Review of photograph of Patient 2’s “meatal (natural opening) head of penis” indicated a new wound was found and photographed by WN A on 12/16/25 at 11:30 am. The wound measured 0.5 cm long and 1 cm wide. WN A classified the wound as a “device-related pressure injury.” Review of document titled “Patient Plan of Care - Abdominal (Abd) Pain,” initiated 11/28/25, indicated Patient 2’s care plan was not updated to reflect the use of a Foley catheter. 3. Review of document titled “History & Physical,” dated 9/11/25 at 6:40 pm, indicated Patient 4 was in his late 80s, admitted for a large episode of bright red blood from the rectum and progressive generalized weakness. Patient 4 had a history of coronary artery disease, previous heart surgery, high blood pressure, severe peripheral artery disease (narrowed arteries in arms and legs due to fatty plaque), and narrowing of the spinal canal (causes pinched spinal cord and/or nerves) with back pain. Review of document titled “Physical Assessment,” dated 9/16/25 at 8 am, indicated Patient 4 had a Foley catheter inserted on 9/12/25. Review of document titled “Patient Plan of Care - Gastrointestinal (stomach and intestines) Bleeding,” initiated 9/11/25, indicated Patient 4’s care plan was not updated to reflect the use of a Foley catheter. 4. Review of document titled “Triage” (preliminary assessment to determine urgency of need for treatment and resources required), dated 2/1/26 at 11:42 pm, indicated Patient 1 was transferred from another hospital for altered level of consciousness (ALOC) following a non-ST-elevation myocardial infarction (NSTEMI or heart attack). The record indicated Patient 1 was sedated and intubated (a ventilation tube was inserted down the throat to help the patient breathe) on arrival and had “acute mental status changes.” Review of document titled “Physical Assessment,” dated 2/24/26 at 8 am, indicated Patient 1 had a Foley catheter inserted on 2/22/26. Review of document titled “Patient Plan of Care - Respiratory Failure,” initiated 2/2/26, indicated nursing diagnoses on 2/2/26 included ineffective breathing pattern, impaired gas exchange, anxiety, high risk for infection, knowledge deficit about respiratory failure, pain, mechanical ventilation, restraints placed due to confusion, altered/change in mental status, and on 2/3/26 of nutrition less than body requirements. The care plan was not updated to reflect the use of a urinary catheter. 5. Review of document titled “History & Physical,” dated 2/24/26 at 6:19 pm, indicated Patient 3 was in her late 90s, admitted for possible small bowel obstruction with complaints of “unbearable” pain associated with episodes of vomiting. Review of document titled “Physical Assessment,” dated 3/6/26 at 8:20 am, indicated Patient 3 had a dry flow “wick” (external catheter placed against the body that uses low-pressure suction to draw voided urine away from the body into a collection canister) in place from 2/27/26 to 3/5/26. Review of AI overview on 4/17/26 indicated common problems with external female catheters include skin irritation or breakdown, device leakage, and potential risk of urinary tract infection if not managed correctly. External catheters require frequent monitoring as they may also cause skin lesions due to improper suction and prolonged use. Review of document titled “Patient Plan of Care - Small Bowel Obstruction,” initiated 2/25/26, indicated the care plan was not updated to reflect the use of an external catheter.”

“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: 49418 Based on interview and record review, the facility failed to ensure nursing staff followed policies and procedures (P&Ps) for assessments and reassessments as well as care planning for five of five sampled patients (Patients 1-5) who developed healthcare-acquired pressure injuries (HAPIs) during hospitalization at the facility (Refer to A-0396). These deficient practices compromised patient safety, continuity of care, and informed decision-making by patients and care team members, with potential and actual negative health outcomes for all patients. Findings: Review of facility P&P titled “Process Plan (Plan of Care),” dated 9/2023, indicated nursing staff were to create and update patient care plans with the Interdisciplinary Team (IDT - a team with members from different disciplines who work together to set goals and make care decisions) at initial assessment and every 12 hours until discharge. Care plans were to identify and revise patient problems as they were reassessed, detail outcomes, list interventions, reprioritize needs, and document resolved issues based on outcome goals. Review of the facility’s P&P titled “Adverse Events (AEs) Reportable to [State Agency or SA],” dated 10/22/24, indicated AEs defined by California Health and Safety Code, Section 1279.1, must be reported within five days of detection or within 24 hours if it poses an ongoing emergent threat to health and safety. Reportable events included: 17. Stage 3 or 4 pressure ulcers and unstageable ulcers acquired after admission, except when Stage 2 ulcers progress and were identified on admission. Unstageable ulcers were only reported if acquired after admission (regulation specific to California). Unstageable ulcers present on admission and later revised to Stage 3 or 4 were not reportable. Review of the facility’s P&P titled “Skin Integrity,” dated 1/27/26, indicated its purpose was to establish guidelines for assessing patients’ risk of developing pressure injuries/ulcers (PI/PU) and for developing and maintaining care plans for PI/PU prevention and treatment. The policy indicated that wound care began with the primary registered nurse (RN) or licensed vocational nurse (LVN) and directed nursing staff to: A. Conduct a head-to-toe skin assessment on admission, each 12-hour shift, and at discharge. The policy recommended completing assessments at the bedside with two staff members (“four eyes” assessment). B. Initiate prevention protocols, wound care orders, and a wound care team consultation when an admission assessment identified a high risk for skin breakdown or the presence of a wound. C. Use the Braden Scale (a nursing tool used to predict a patient’s risk of developing PI/PU) on admission and each shift. D. Place patients on the most appropriate support surface available (for example, low air-loss surfaces or specialty beds) and consider nutritional status and other risk prevention factors. E. Because mucosal membranes were vulnerable to pressure injury from medical devices (for example, oxygen tubing and urinary catheters), nursing staff were directed to assess those areas each shift, initiate a care plan for prevention and treatment, photograph mucosal injuries, and notify the wound care team for consultation. Review of document titled “Braden Scale for Predicting Pressure Ulcer Risk,” (Addendum A in Skin Integrity P&P), dated 1/27/26, indicated: Risk Factors and Related Scoring/Points: - Sensory Perception (ability to respond to pressure-related discomfort): Completely limited (1), very limited (2), slightly limited (3), no impairment (4). - Moisture (degree to which skin is exposed to moisture): Constantly moist (1), often moist (2), occasionally moist (3), rarely moist (4). - Activity (degree of physical activity): Bedfast (1), chairfast (2), walks occasionally (3), walks frequently (4). - Mobility (ability to change and control body position): Completely immobile (1), very limited (2), slightly limited (3), no limitations (4). - Nutrition (usual food intake pattern - nothing by mouth, nutrition via tube in stomach or into a vein (IV), or by mouth): Very poor (1), probably inadequate (2), adequate (3), excellent (4). - Friction and Shear: Problem (1), potential problem (2), no apparent problem (3). When added together, total scores indicated 15-18 = mild risk; 13-14 = moderate risk; 10-12 = high risk; 9 or less = severe risk. Scores of 14 or lower required wound nurse consultation and physician notification. Review of an article published by the National Institutes of Health (NIH - the primary agency of the United States government responsible for public health research) titled “Impaired Wound Healing,” dated 8/28/23, indicated factors that hinder wound healing include: A. Diseases causing low oxygen, chronic inflammation, or tissue destruction (e.g., diabetes, heart disease, vascular disease, lung disease). B. Tobacco use-nicotine constricts blood vessels and lowers tissue blood flow. C. Poor nutrition-reduces essential nutrients for healing and immune function. D. Obesity-impairs blood and oxygen delivery, increases infection risk, and slows healing due to reduced mobility. E. Stress-raises stress hormones and weakens immunity. F. Medications-such as steroids, cancer drugs, anticoagulants (blood thinners), anti-inflammatories, vasopressors (pressors-constrict blood vessels), and beta-blockers (slows heart rate) can negatively impact healing. 1. Review of document titled “Triage,” (preliminary assessment to determine urgency of treatment needs and resources required), dated 2/1/26 at 11:42 pm, indicated Patient 1 was transferred to the facility and admitted for altered consciousness after a non-ST-elevation myocardial infarction (NSTEMI or heart attack) at another hospital. Patient 1 had been sedated and intubated (ventilation tubing is inserted in the throat to help the patient breathe) prior to arrival and exhibited “acute mental status changes.” Review of document titled “Progress Note,” dated 2/2/26, indicated Patient 1 was admitted with diagnoses of respiratory failure due to chronic obstructive pulmonary disease (constriction of the airways making it difficult to breathe), severe iron deficiency potentially from a gastrointestinal (GI - stomach and intestines) bleed, atrial fibrillation (atypical heart rhythm), pneumonia possibly leading to sepsis (life-threatening response to an infection), acute kidney injury, influenza, and a heart attack. Review of document titled “Two (2) Person Skin Assessment,” dated 2/2/26 at 5:43 am, indicated Patient 1 had “diffuse scabs and bruises” to forearms and shin with “no other areas of concern.” The document indicated a “prophylactic” Optifoam (soft padded bandage) had been placed on the coccyx (tailbone) to prevent skin breakdown. Review of “Care Trends - Integumentary” indicated: 2/21/26 at 8 pm and 2/22/26 at 8 am (bedside nurses): Braden score 14, generalized abrasions/bruising. 2/22/26 at 8 pm and 2/23/26 at 8 am (bedside nurses): Braden score 13, generalized abrasions/bruising, posterior spine pressure ulcer - reddened. 2/23/26 at 2:16 pm (by WN A): Midline lower spine pressure ulcer, purple, and left hip pressure ulcer, reddened. 2/23/26 at 8 pm (bedside nurse): Braden Score 11, dryness, redness, bruises; midline lower spine reddened, asymptomatic, open to air; and left hip abrasion, reddened, open to air. Review of photograph taken by RN D on 2/22/26 at 1 pm indicated “new finding” of left hip wound. Documentation on the wound form by WN A on 2/23/26 at 12 pm indicated the wound was “unstageable” and measured 1.5 centimeters (cm - a unit of measure) long and 1 cm wide, depth indeterminate. The wound appeared open with a moist yellow center and a pink-red “halo” around the wound extending approximately 0.5 to 1 cm from the wound edges. Review of document titled “Orders” indicated a wound care consult and “wound care bed type” (Arjo bed) were ordered on 2/22/26, after wounds were found by RN D. Review of document titled “Physical Assessment,” dated 2/23/26 at 8 am, indicated Patient 1 was intubated, arousable to light pain, on and off sedation, had “severe weakness,” had a percutaneous endoscopic gastrostomy (PEG tube - soft tube inserted through the abdomen into the stomach to deliver nutrition, fluids, and medications) inserted 2/12/26, a urinary catheter (tube inserted into bladder to continuously drain urine) inserted 2/22/26, generalized bruising and scabbing, and wounds including healing scabs to the left shin bone and a reddened “pressure ulcer” of the spine (discovered 2/22/26), Braden score 13 (moderate risk). The hip wound was not documented in the assessment. Review of document titled “Patient Plan of Care - Respiratory Failure,” indicated that Patient 1’s initial nursing diagnoses on 2/2/26 included ineffective breathing, impaired gas exchange, anxiety, risk for infection, knowledge deficit, pain, mechanical ventilation, restraints due to confusion, and altered mental status. Nutrition less than body requirements was added on 2/3/26. The plan instructed staff to monitor for infection (redness, pus, swelling), collaborate with a dietitian, turn and reposition the patient, monitor for skin changes, and assess the restraints. Although impaired skin integrity was noted at admission - alongside cardiac and respiratory issues, poor nutrition, and bed restraints - skin integrity was not included in the care plan until 2/12/26, ten days after admission. The care plan was not updated 2/22/26 to reflect the insertion of a urinary catheter. Review of document titled “WOC - Wound Assessment” by WN A, dated 2/23/26 at 8 pm, indicated Patient 1 was being seen for the Wound Team’s weekly skin check and left hip/spine check per nursing consult request. WN A documented wounds to (1) midline lower spine pressure ulcer staged as “suspected deep tissue injury (SDTI)/deep tissue injury (DTI)” and ordered “keep clean & dry, apply barrier ointment” and (2) an “unstageable” left hip pressure ulcer and ordered irrigation, topical medication, and a foam/hydrophilic (absorbs drainage) dressing. Review of document titled “Physical Assessment” by RN E, dated 2/23/26 at 8 pm, indicated wounds to midline lower spine, “reddened, asymptomatic, open to air,” and a left hip abrasion, “reddened, open to air.” Review of document titled “Self-Reported Adverse Event (AE),” received 2/26/26 at 12:54 pm, indicated “Patient [1] developed an unstageable pressure injury to his left hip,” detected after admission on 2/23/26 at 12:48 pm, with immediate corrective action being “Patient followed by wound care team.” The AE was categorized as a “care management event.” Review of document titled “Root Cause Analysis (RCA)/Intensive Case Analysis Tool” by the Director of Performance Improvement (DPI), completed 3/5/26, indicated: -RCA Findings Identified: Transferred intubated on 2/1/26 with altered consciousness, heart attack, GI bleed, influenza A (flu), pneumonia. Eventually “trached” (tube placed in windpipe through the neck to create an airway). “On the ventilator and multiple pressors for weeks.” Seen by wound care for low Braden since 2/12/26. -Action/Correction Plan: Continue monthly staff education events, skills fair (annual competency refresher/check), new hire orientation, work on individual binders for individual units, “continue to focus on wounds as a hospital performance improvement (PI) project, and per diem (Latin for “by the day” or “for each day”) meetings with wound care team regarding healthcare-acquired pressure injuries (HAPIs). During concurrent interview with Wound Nurse (WN) A and Clinical Supervisor of Wound Care (CSWC) and review of Patient 1’s medical record on 4/9/26 at 10 am, WN A noted Patient 1’s Braden scores were documented between 15 and 17 (mild risk for pressure ulcer) from admission 2/2/26 until 2/20/26. WN A stated she would expect Patient 1’s admission Braden score to be “between 6 and 8” (severe risk) due to sedation, limited mobility and activity (bedfast due to restraints), limited nutrition due to intubation, and potential friction/shear from frequent repositioning by nursing staff. WN A stated patients who were “trached” (on a ventilator) and required a wheelchair “should be low Braden.” WN A stated, “Nurses are not using Braden scores appropriately” and the facility was in the process of educating nurses. 2. Review of document titled “Admission/Registration” indicated Patient 2 was in his late 60s, admitted 11/28/25 for “intractable (unrelenting) abdominal pain,” nausea and vomiting, and decreased output from his ostomy. Review of document titled “Physical Assessment” by RN F, dated 11/28/25, indicated Patient 2 was alert, oriented, cooperative, with mild generalized weakness, right arm numbness, abdominal pain and nausea, and “left side colostomy, no output today.” The document indicated Patient 2 used crutches/cane/walker for impaired gait (manner of walking). Braden score was assessed at 14 (moderate risk). Review of admission “Two (2) RN/LVN Skin Assessment” by RN F and RN J, dated 11/28/25 at 5:45 pm, indicated “multiple healed scars on abdomen, healed scar on left AKA stump, dark discoloration of right lower extremity, left side colostomy.” Review of “Malnutrition Consultation,” dated 11/29/25, indicated the consult was ordered on admission due to patient-reported weight loss. A heart-healthy diet was ordered 11/28/25; however, Patient 2 was intubated on 11/30/25 (unable to eat/drink). Review of “Two (2) RN/LVN Skin Assessment” by RN G and RN H, dated 12/1/25 at 1:39 am, indicated skin assessment was performed due to transfer to another unit. The note indicated Patient 2 had an abdominal wound from surgery 11/30 “but no areas of skin breakdown.” Review of Registered Dietitian (RD) Reassessment by RD B, dated 12/4/25, indicated Patient 2 remained intubated, and total parenteral nutrition (TPN - nutrition provided through an IV) was being given “at goal rate for sole source of nutrition.” RD B noted Patient 2 was started on insulin (a hormone that regulates blood sugar) for high blood sugar levels. Review of photograph taken by WN A on 12/5/25 at 11 am indicated a surgical wound “present on admission” in Patient 2’s left abdomen measuring 2.7 cm long,4.5 cm wide, 5 cm deep. The wound was described as a “previous colostomy takedown site” (“reversal” surgery to close the ostomy site and reconnect the colon). Review of “Orders” indicated: A. Nutrition Consult ordered 12/2/25 at 10:17 am and again 12/7/25 at 10:28 am. B. Wound Care Consult ordered 12/8/25 at 5:19 pm. C. Wound Care Order for “Wound #3,” dated 12/9/25 at 11:10 am, indicated wound care of “coccyx unstageable” was to be performed every shift to include irrigation, pat dry, apply medicated ointment twice daily and as needed, and leave open to air. Review of photograph taken by WN A on weekly rounds 12/9/25 at 10 am indicated Patient 2 had a “DTI” to the coccyx (tailbone) measuring 5 cm long, 4 cm wide, depth indeterminate. Documentation indicated it was “clinically undetermined” if the wound was present on admission. The photo showed a large reddened area over both buttocks with a smaller dark purple/black area just above the anus. Review of document titled “RCA/Intensive Case Analysis Tool” by DPI, completed 12/18/25, indicated Patient 2 initially developed a DTI to coccyx on 12/11/25 which extended to an unstageable pressure injury on 12/16/25 and was reported to SA. -RCA Findings Identified: Patient admitted 11/28/25, on ventilator for extended period, progressively more ill, in the Intensive Care Unit (ICU) until discharge to long-term care facility. Patient “malnourished on tube feedings,” being seen regularly by wound care team. “Patient repositioned per policy.” -Action/Correction Plan: Continue with monthly staff education events, skills fair, new hire orientation. Work on informational binders for individual units. Continue to focus on wounds as a hospital PI project. Review of document titled “Turn and Position” by RN K, dated 12/14/25 at 7 am, indicated: Heels floated. Upper extremities up on pillows. Boney [sic] prominence padded. Left [sic]. Hydrophilic dressing to coccyx. Comments: Utilized pillows/wedges to offload pressure. Review of document titled “Physical Assessment” by RN K, dated 12/14/25 at 8 am, indicated Patient 2 had a urinary catheter placed on 11/29/25, the day after admission, was intubated, and at that time had “severe” edema of the scrotum. A surgical wound to the abdomen and “pressure ulcer” to the coccyx were documented. Wound comment for the coccyx indicated, “Skin sloughing off. No dressing applied due to (d/t) skin peeling off.” Braden score was 8. Review of document titled “Patient Plan of Care - Abdominal (Abd) Pain,” initiated 11/28/25, indicated Patient 2’s care plan was not updated to reflect the insertion of a urinary catheter. Review of photograph taken for weekly skin check on 12/14/25 at 10 am indicated the coccyx wound had expanded, now with large, dark red, open areas and blackened wound edges. WN A documented on the photograph form 12/16/25 at 12 pm that the wound previously classified as a DTI had “evolved to unstageable” and now measured 13 cm long, 14 cm wide, with indeterminate depth. Review of document titled “Physical Assessment” by RN K, dated 12/16/25 at 8 am, indicated Patient 2 had a urinary catheter placed on 11/29/25, the day after admission, was intubated, and currently had “severe” edema of the scrotum. A “midline abdominal incision with multiple drains,” after surgery and a “pressure ulcer” to the coccyx were the only wounds documented. The coccyx wound was described as reddened, purple, “open to air,” and “draining.” However, RN K also documented that a foam/hydrophilic dressing was in place and wound drainage amount was “None.” Braden score was 8. Review of photograph taken by WN A on 12/16/25 at 11:30 am indicated a “new finding” of DTI described as “device-related pressure injury” at Patient 2’s meatal (natural opening) head of penis measuring 0.5 cm long, 1 cm wide, depth indeterminate. A small bruise-like line was observed at the base of the penile head; urinary catheter tubing (approximately the same width as the wound) was observed in the urethra. Review of photographs taken 12/21/25 at 8:40 am for weekly assessment and 12/24/25 at 2:30 pm on discharge indicated the coccyx wound bed covered most of the left buttock from lower back to upper thigh with a black wound bed and open, yellow-pink wound edges. The right buttock wound was smaller, appeared bruise-like, skin sloughing from the wound, with an approximately 2 cm, open area with yellow-red, bleeding base. No measurements or wound classification were documented. Review of photographs taken 12/21/25 at 9:15 am for weekly assessment and 12/24/25 at 2:30 pm on discharge indicated thin, purple-black wounds surrounding the penile head with swelling of the scrotum. No measurements or wound classification were documented. During concurrent interview with WN A and CSWC and review of Patient 2’s medical record on 4/9/26 at 10:50 am, WN A stated Patient 2’s Braden scores were 14 on 11/28/25 and 11/29/25, 13 on 12/3/25, and 12 on 12/5/25, “the first low Braden.” WN A stated Patient 2 “should have been a low Braden before 12/5/25,” and stated the 12/1/25 two-person skin exam indicating no areas of skin breakdown was “likely not performed accurately.” On review of Patient 2’s wound photos of the coccyx, CSWC noted she had seen patients develop pressure injuries like that after lying on an operating room table for long periods of time. WN A stated a pressure injury can occur “in less than two hours.” 3. Review of document titled “History & Physical,” dated 2/24/26 at 6:19 pm, indicated Patient 3 was in her late 90s, admitted for possible small bowel obstruction with complaints of “unbearable” pain associated with episodes of vomiting. Review of document titled “Two (2) Person Skin Assessment” by RN L and RN M, dated 2/25/26 at 2:53 am, indicated “Findings: None.” Review of document titled “Physical Assessment” by RN N, dated 3/6/26 at 8:20 am, indicated Patient 3 was alert, oriented, cooperative, with “mild weakness.” RN N assessed mild edema (swelling) in the legs and noted the use of a dry flow “wick” (external catheter placed against the body that uses low-pressure suction to draw voided urine away from the body into a collection canister) from 2/27/26 to 3/5/26. Skin assessment indicated sacrum/coccyx “open area” and a left abdominal surgical wound. RN N documented that Patient 3’s skin was “occasionally moist,” she had slightly limited sensory perception, had a weak gait but walked occasionally with a cane or walker, “inadequate,” nutrition, and a “potential” friction and shear risk. Braden score was assessed at 16 (mild risk of PI/PU). Review of document titled “Patient Plan of Care - Small Bowel Obstruction,” initiated 2/25/26, indicated the care plan was not updated to reflect the use of an external catheter. Review of Artificial Intelligence (AI) Overview on 4/17/26 indicated common problems with external female catheters included skin irritation or breakdown, device leakage, and potential risk of urinary tract infection if not managed correctly. External catheters require frequent monitoring as they may also cause skin lesions due to improper suction and prolonged use. Review of photograph taken by RN N on 3/6/26 at 12:15 pm indicated “new finding,” Location: “coccyx,” Present on Admission: “No.” The photograph indicated an open wound to what appears to be a coccyx; no date, time, or patient identifiers were observed on the ruler, though Patient 3’s identification sticker was present at the bottom of the form. Review of photograph taken by WN A on 3/6/26 at 1 pm indicated “new finding,” Location: “coccyx,” Present on Admission: “Clinically undetermined.” WN A documented the wound as “acute on chronic,” unstageable, measuring 1.2 cm long, 0.5 cm wide, with depth of “0.4” [sic]. Review of document titled “RCA/Intensive Case Analysis Tool” by DPI, completed 3/19/26, indicated Patient 3 was admitted 2/24/26 and developed a Stage 2 injury to the sacrum (large bone at base of spine) and “unstageable injury” to coccyx on 3/6/26. -RCA Findings Identified: Patient 3 had lived independently at home, now very weak and “pretty much immobile due to bowel surgery,” malnourished with “poor nutritional intake,” and had incontinence. “Refusing care at times.” Patient had hernia repair surgery on 3/2/26 and “difficult and slow recovery.” -Action/Correction Plan: Continue with staff education via skills fair, orientation, floor binders. Meet with individual staff as needed to educate. Review of document titled “Two (2) Person Skin Assessment” by RN P and RN Q, dated 3/8/26 at 7 pm, indicated “Findings: None.” Review of document titled “Physical Assessment” by RN R, dated 3/9/26 at 8:47 am, indicated Patient 3 had worsening “mild” edema of the left leg and “moderate” edema of the right leg, was incontinent of urine, had a “reddened” sacrum/coccyx with Optifoam in place, a surgical wound to the abdomen, and “poor” nutrition. Braden score was assessed at 16 (mild risk). Review of document titled “WOC - Wound Assessment” by WN A, dated 3/9/26 at 1:26 pm, indicated Patient 3 had a Stage 2, reddened pressure ulcer at the sacrum with minimal drainage and an unstageable pressure ulcer at the coccyx. WN A documented the wound bed was 80 percent red, 20 percent yellow slough, and the tissues surrounding the wound were “bright red.” During a concurrent interview with WN A and CSWC and review of Patient 3’s medical records on 4/9/26 at 10:50 am, WN A noted that Patient 3 had a Braden score of 18 on admission and was “never on the low-Braden list according to nurses’ notes.” WN A and CSWC acknowledged the presence of wounds was documented 3/6/26 and RN P and RN Q “did not do a thorough two-person skin exam on 3/8/26.” WN A and CSWC agreed Patient 3 should have been a low Braden (12 or below) on admission. 4. Review of document titled “History & Physical,” dated 9/11/25 at 6:40 pm, indicated Patient 4 was in his late 80s, admitted for a large episode of bright red blood from the rectum and progressive generalized weakness. Patient 4 had a history of coronary artery disease (CAD), previous heart surgery, high blood pressure, severe peripheral artery disease (narrowed arteries in arms and legs due to fatty plaque), and narrowing of the spinal canal (causes pinched spinal cord and/or nerves) with back pain. Review of document titled “Two (2) Person Skin Assessment” by RN S and RN T, dated 9/11/25 at 11:01 pm, indicated Patient 4 had a wound on the left great toe, wound pictures in chart; bruising on the lower abdomen due to heparin (blood thinner) shots outpatient; and scabs on both legs. Review of document titled “Physical Assessment,” dated 9/16/25 at 8 am, indicated Patient 4 had a urinary catheter inserted on 9/12/25. Review of document titled “Patient Plan of Care - Gastrointestinal (stomach and intestines) Bleeding,” initiated 9/11/25, indicated: Fluid volume deficit: Maintain diet restrictions, monitor for dehydration. Altered tissue perfusion. Exhibit optimal tissue perfusion: Monitor for bleeding and shock. HIGH RISK: IMPAIRED SKIN INTEGRITY: Exhibit intact skin, monitor for impaired skin integrity (redness, tears, damage, “especially over bony prominences”) Knowledge deficit - GI bleeding. Patient 4’s Care Plan was not updated to reflect the use of a urinary catheter on 9/12/25. Review of admission photograph taken by RN T on 9/11/25 at 9:30 pm indicated wound Location: “Left big toe,” Present on Admission: “Yes.” WN A documented on the wound form 9/15/26 at 9 am indicating the wound was “acute,” of “unknown origin,” and measured 2 cm long, 2 cm wide, with indeterminate depth. The left big toe was observed to have a blackened area just below the toenail. The skin of the second toe appeared dry and peeling with a small (less than 1 cm) open area. Review of photograph taken by WN A on 9/15/25 at 8:30 am indicated “new finding,” Location: “Left heel,” Present on Admission: “Clinically undetermined.” WN A documented the wound as “acute” DTI measuring 3 cm long, 2 cm wide, with indeterminate depth. The left heel was not well seen in the photo but was observed to have pinkness with a darker red area in the center. Review of photograph taken by RN U on 9/15/25 at 4 am indicated “new finding,” Location: “Right heel.” WN A did not document on the photo form; therefore, no staging, classification, or measurements were present. In the photo, a reddened area approximately the size of a quarter was observed on the right heel. Review of photograph taken by WN A on 9/15/25 at 8:30 am indicated “new finding,” Location: “Right heel,” Present on Admission: “Clinically undetermined.” WN A documented the wound as “acute” DTI measuring 1 cm long, 1 cm wide, with indeterminate depth. The right heel was observed to have a small area of pinkness. On 9/15/25, Care Plan was updated to include: Impaired Skin Integrity: Exhibit optimal skin integrity, implement pressure-relieving devices (mattress overlay, therapeutic bed), collaborate with dietitian, turn and reposition (frequency not indicated), wound care pictures, and wound care orders as follows: -Left great toe (wound of unknown origin): Keep clean and dry, paint with betadine (antiseptic medication) daily/as needed, leave open to air. -Right heel DTI: Keep clean and dry, “keep medical boot in place,” and nursing to check placement of boot with each turn/reposition. -Left heel Stage III (3) Pressure Injury: Cleanse with normal saline, paint with betadine, ABD pad (thick, absorbent gauze), wrap with gauze roll, change daily/as needed. -Left leg fasciotomy (emergency procedure that cuts through connective tissue to relieve high pressure within a muscle): Cleanse, hydrogel (water-containing dressing that maintains a moist environment for wound healing) to wound bed, oil emulsion (sterile nonstick dressing with petrolatum-based emulsion) to bed, top with foam pad, wrap with roll gauze, change daily/as needed. “Do not use medical heel boot. Do not apply foam dressing to incision site.” -Wound photos weekly on Sundays. Review of document titled “Two (2) RN/LVN Skin Assessment” by RN N and RN V, dated 9/16/25 at 5:52 pm, indicated Patient 4 had a skin tear on the left forearm, surgical sites on right shoulder and right abdomen were well approximated (wound edges were aligned), wound to left great toe, blister on foot, bilateral heel pressure wounds, bruising on the left arm, scabs on both legs, fasciotomy on left lateral leg, PICO dressing (small disposable pump connected to an absorbent dressing that removes excess fluid from a wound) on bilateral groin, redness on coccyx, and swollen, edematous, bruised penis. Review of photograph taken by WN A on 9/17/25 at 11:30 am indicated the left heel wound was now classified Pressure Ulcer Stage III (3), “evolved from DTI on 9/15/25.” WN A documented the wound as measuring 1.5 cm long, 2 cm wide, with 0.2 cm depth. The left heel wound appeared to have opened, with a large bloody area observed across the bottom and back of the heel. Review of photograph taken by WN A on 9/17/25 at 11:30 am indicated “blisters” were present on the “left lower extremity.” Present on Admission: “Clinically undetermined.” Length and width were not measured; depth was documented as indeterminate. During concurrent interview and review of the 9/17/25 left lower extremity photograph with WN A and CSWC on 4/9/25 at 10:30 am, WN A stated she must have marked “Admission” in error as the patient was admitted 9/11/25. WN A stated she believed the blisters were a new finding on 9/17/25. On 9/17/25, Care Plan was updated to include impaired mobility. On 9/19/25, Care Plan was updated to include Nutrition - less than body requirements: Educate patient, collaborate with dietitian. Review of document titled “Progress Note,” dated 9/17/25, indicated Patient 4 was in the Cardiac ICU (CICU) awaiting placement in a rehabilitation facility. The note indicated Patient 4 had been working with physical therapy and had a “break with oozing of bloody fluid from the wound on his left heel,” and wound care had been reconsulted. Other diagnoses were as per History and Physical, with major surgery performed on 9/13/25 to improve blood flow to arteries of arms and legs. During concurrent interview and review of Patient 4’s medical records on 4/9/26 at 10:30 am with WN A and CSWC, WN A acknowledged Braden scores were 18 (minimal to no risk) on 9/11/25 and 9/12/25. WN A stated the first low Braden was documented on 9/15/25. WN A noted the heel wounds were charted on 9/14/25, and wound care saw Patient 4 the following day for the first time. WN A and CSWC agreed that Patient 4’s Braden score should not have been 18 on admission as he was unable to walk, which should have given him a low mobility score, and he came in with pre-existing wounds. WN A stated, “There’s definitely a breakdown in communication.” 5. Review of document titled “History & Physical - Short,” dated 10/17/25 at 1:36 am, indicated Patient 5 was in her late 70s, admitted 10/16/25 for encephalopathy (disease process that alters brain function causing confusion, memory loss, personality changes, or seizures), fever, and shaking chills for two days. Other diagnoses included respiratory failure requiring sedation and mechanical ventilation (tube inserted into the airway to help patient breathe), septic shock (advanced, life-threatening stage of sepsis, an infection causing the body’s immune system to fail), urinary tract infection, acute kidney injury (sudden episode of kidney damage), and atrial fibrillation (irregular heart rhythm). Review of document titled “Two (2) RN/LVN Skin Assessment” by RN H and RN W, dated 10/26/25 at 1:09 am (nine days after admission), indicated the reason for skin assessment was “Skin check not documented.” Comments indicated Patient 5 had a small area of moisture breakdown on gluteal sulcus (skin crease between upper thigh and lower buttock) and redness to inner groin. “No other areas of concern.” Wound photos of Patient 5’s gluteal sulcus and inner groin were not provided. Review of photograph taken by RN C on 11/2/25 at 10 am indicated a “new finding” of wound at the “perineal area (labia)” (inner and outer folds on either side of the vagina). The photo indicated urinary catheter tubing present in the urethra. The labial tissue appeared to be reddened with a raw open area on the skin just above the catheter tube. On 11/4/25 at 9:10 am, WN A documented classification of the wound on the wound form as a “device-related pressure injury, acute” measuring 1 cm long, 2 cm wide, depth indeterminate. Review of document titled “Physical Assessment,” dated 11/6/25 at 10:55 pm, indicated Patient 5’s urinary catheter was inserted on 10/30/25 (three days prior to the wound finding). Review of document titled “Patient Plan of Care - Adult Respiratory Distress Syndrome,” initiated 10/18/25, indicated the care plan was not updated to include the insertion of a urinary catheter. Review of document titled “Two (2) RN/LVN Skin Assessment” by RN X and RN Y, dated 11/7/25 at 12:05 am, indicated scabs on the neck, labial redness, posterior scalp scab, redness on left abdomen, skin tag on posterior left thigh, and redness under left breast. Review of photograph taken by WN B on 11/11/25 at 10:45 am, indicated a “new finding” of “occipital” (back of head) wound. Present on Admission: “Clinically Undetermined.” WN B documented classification of the wound as “unstageable,” measuring 2 cm long, 2 cm wide, depth 0 (zero). During concurrent interview and review of Patient 5’s medical records with WN A and CSWC on 4/9/26 at 10:40 am, WN A noted Patient 5 had a Braden score of 12 on admission, which would have automatically triggered a wound consult. WN A stated the skin around urinary catheter tubing should be checked often in the presence of a catheter-related injury, and nursing staff should make sure the patient is “aligned” in bed. WN A stated that if a patient was “squirmy” or moved around a lot, the patient should be checked more often. WN A stated she recalled seeing Patient 5 for a wound assessment and noted “the Foley (catheter) tubing was pulled super, super tight” across her thigh. On review of the care plan, CSWC noted the urinary catheter was not documented, and WN A and CSWC acknowledged the care plan should have been updated when it was inserted. WN A and CSWC also acknowledged a two-person skin assessment was not performed for nine days. WN A stated it is facility policy for the bedside nurse to perform a full head-to-toe skin assessment within 24 hours of admission. WN A stated, “Basically, they dropped the ball on this patient.” During an interview with Chief Nursing Officer (CNO) on 4/7/25 at 12:35 pm, CNO stated the Quality Safety Oversight Committee met weekly and talked about “focus needs. One is wounds.” CNO stated an increase in HAPIs at the facility was noted about six months ago, and the committee was trying to “streamline the process to decrease HAPIs.” CNO stated a subcommittee just for wounds was created last month. Members included herself, Wound Care Team nurses, and the Performance Improvement Manager (PIM). CNO stated, “As of today, we’ve decided we’ll meet with the RNs about their care” regarding what was documented and their opinions about what can be done to better help them. Regarding low-pressure beds to prevent skin breakdown, CNO stated they had an issue getting the beds at first, then nurses didn’t know how to operate the beds, then nurses were not putting the patients on the beds. CNO stated patients were to receive a two-person skin assessment within 24 hours of admission, and a report was printed daily indicating who was missing those assessments. CNO stated she had handed out two reports that morning for missing assessments. Meeting minutes were requested by this surveyor. Review of documents titled “Minutes [of] Quality Safety Oversight Committee” meetings between 2/2025 and 2/2026 indicated: 2/6/25 at 2:31 pm: Discussed having clinical supervisors sign off when (specialty wound prevention) bed delivered, making “tip sheet” for staff. [Staff name] found a patient on a fracture pan (smaller, tapered bedpan for patients with limited mobility) with the bed seat deflated. “Why do nurses not feel the urgency of placing these beds when they are ordered?” 5/15/25 at 2:30 pm: “Corporate” visited all floors last week. “Wants us to order wedges (soft pillow to eliminate pressure) and boots” (specialized device to prevent PUs to heels/ankles). 6/5/25 at 2:30 pm: Corporate upon visit “wants us to order wedges and boots.” Had second “Skin Champion” meeting. 2/5/26 at 2:31 pm: Visit from Corporate. Identified issues with documentation and efficiency. Will be implementing changes. Wound Care will do afternoon rounds to check on use of wedges, linen placement, and educate. Will begin a Wound Care Team to review all HAPIs before reporting in Verge (internal reporting system). Will consult on Braden less than 14 instead of 12. During an interview with DPI on 4/7/25 at 1:25 pm, DPI stated the wound nurses used to be notified for Braden of 12 or below, but “within the last 4-6 months” they had raised the auto-notification score to 14 or below. During concurrent interview with WN A and CSWC and medical record review for Patients 1-5 on 4/9/25 from 9:55 to 11 am, WN A stated she had been with the facility as a wound nurse for three years, and CSWC stated she had been a nurse for years but was new to the facility, having started her position this week. Asked about nursing education, CSWC stated a ‘skin integrity and assessment’ computer module was required during new-hire orientation. WN A stated “new grads” (nursing staff) did not do “hands-on” training in orientation but followed a wound nurse “for one hour” within six months of hire. CSWC stated she would be making changes to include hands-on training in future orientations. When a new wound was discovered by nursing staff, WN A stated the expectation was for the nurse to place a wound consult and document the wound with a photo on a wound form. The wound form was to include date, time, and nurse’s signature. WN A stated staff “must” use a ruler with patient’s medical record noted, the date (adding that she liked them to add the time), location of the wound, and the patient’s initials. “Those are the four required elements.” WN A stated it was her understanding that two-person skin assessments were to occur on admission by the floor nurses and once per shift (every 12 hours on day shift and night shift). WN A stated facility pressure-relieving devices included Arjo beds, wedges (“new in the last six months”), medical heel boots that lifted heels off the bed. Optifoam for heels, which wrapped around the heel and covered the foot, was also added in the last six months. WN A stated that if patients were not comfortable with pillows under their hips or knees, “then we suggest the Optifoam.” WN A stated medical boots did not require a physician order, adding, “It’s up to the nurse to use their best judgement” regarding patient need. WN A stated nurses could order an Arjo bed, and nurses caring for “anyone with a history of bedsores or pressure issues” who was staying two or more nights “need to request an Arjo.” WN A stated wound nurses have recently changed how they chart, new supplies have been added, and they were seeing patients more often. “We needed more help with HAPIs, so we’re targeting that.” WN A stated the wound nurses notified bedside nurses of their findings on rounds and were now updating charge nurses and the Wound Department as well. WN A stated they were also seeing higher-acuity (sicker) patients more often. WN A stated they found that patients were staying longer in the hospital (meaning more time in bed and increased risk of PI/PU). During an interview with CNO on 4/9/26 at 12:30 pm, CNO stated it had been their process for two months to print a “low-Braden report” every midnight. The Wound Care Team got the report, made sure patient pressure points were offloaded, heel dressings were on, and made sure the patient had a wound consult. CNO stated they had an average of 10 Arjo beds onsite in a day, noting the facility rents the beds, but “they are here within an hour” after they are requested. CNO stated her biggest concerns with wounds over the past six months was “the lack of communication with wound care.” CNO stated some nurses did not know they had to order a wound consultation, there was lack of photos, and many nurses did not know where offloading supplies were kept. CNO stated “probably a month ago” they created a centralized supply area on every floor. CNO stated one medical supply company was contracted to come out quarterly to provide staff education on their products, but “they weren’t coming out quarterly,” so she contacted them “about a month ago.” CNO stated she would try to coordinate that with monthly Skin Champion staff meetings in the future. CNO stated nurses were being educated about wounds, prevention, and treatment “by us, on the floor, in real time.” CNO stated new hires received Braden education and learned how to chart it; they also received education by the wound team on how to take photos, chart wound care assessments, and get a wound consultation. Nursing staff were also reeducated annually at Skills Fair. CNO stated she believed new hires also spent four hours with a wound nurse on their rounds. When informed that a wound nurse reported new hires only followed them for one hour, CNO stated she would check into that, noting, “That’s not enough.” Review of “Assignment Completion Report,” generated 4/9/26 at 5:13 pm, indicated the completion grid for “PHC Nurses & Nursing Assistants Skin Integrity & Wound Prevention” education module, date range 1/1/25 through 4/9/26, was completed by 98.15 percent of the 591 unique students (nursing staff) involved, with 73.83 percent completed on time, 24.33 percent late, and no “failed” modules. During an interview with RN B on 4/9/26 at 1 pm, RN B stated that if one of her patients was developing a pressure ulcer, she would request a wound consult because “we want more eyes on it.” RN B stated, “Working with a team is the best process.” Regarding Braden scoring, RN B stated, “If you’re answering the questions appropriately, the Braden is auto populated.” RN B stated nursing staff didn’t have to wait for a score, however, to determine if a new patient would be able to turn themselves and probably not be eating/hydrating well. RN B stated, “I’m paying more attention to them,” adding, “Even if there’s only redness, I’m putting in a consult.” During an interview with DPI on 4/9/26 at 3:20 pm, DPI acknowledged she was aware of issues with nursing care plans, nursing assessments, and nursing staff not following facility policies. DPI stated she presented quarterly to the Governing Board, and they were aware of the increased number of HAPIs at the facility.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 40204 Based on interview, and record review, the facility failed to administer medication according to their policy when Patient 1 was given pain medication, and was immediately discharged without an assessment of post medication pain relief. This failure created the potential for Patient 1 to have worsening, untreated pain following discharge from the facility, and undesirable patient outcomes. Findings: Patient 1’s medical record was reviewed. Patient 1 was admitted to the facility on 12/23/25, with a diagnosis that included colon cancer, nausea, and vomiting. On 12/26/25, Patient 1 had abdominal surgery to treat the cancer, and had a colostomy (creating an opening for the intestine on the outside of the abdomen to empty stool in to a collection bag). After the operation, Patient 1 also required to fed by a tube. Patient 1’s medical record indicated, that Patient 1’s, “hospital course was complicated by severe pain ... “ On 1/26/26, during a concurrent interview, and record review, with the Quality Manager (QM), the QM confirmed, that Patient 1’s pain, and pain management issues. Regarding the pain medications given immediately before discharge, the QM provided the facility’s policy titled, “Pain Management.” This policy indicated that reassessments after giving pain medication are required. The policy states, “Reassessments after interventions to lessen pain (e.g. administration of pain medications) should take place within a clinically appropriate time frame.” The QM reviewed Patient 1’s medication administration record for the date of discharge. Within less than four hours of discharge Patient 1 was given the following pain control narcotics (strong pain medication): Dilaudid two milligrams (mg) intravenously at 11:49 am, Norco 10/325 mg one tablet by mouth at 12 pm, Dilaudid one mg by mouth at 2:27 pm, and Norco 10/325 mg, two tablets by mouth at 3:01 pm. Patient 1 was discharged at 3:22 pm, twenty-one minutes after the last dose of medication. The QM confirmed, that facility’s policy that required pain reassessment could not have be performed so soon after giving the pain medication. This information was reaffirmed by the QM during an additional review, on 1/28/26 at 2 pm. On 1/29/26 at 2 pm, during a concurrent interview, and record review, with Charge Nurse (CN), the CN stated, there was not enough time to perform the required reassessment when Patient 1 was discharged. “There was no way to assess the pain because he was already gone.” The CN also said, that she would notify the doctor and make a note in the chart because Patient 1’s pain was not in control. A review, of Patient 1’s records did not reveal any such documentation. On 1/28/26 at 8:30 am, during a concurrent interview, and record review, the skilled nursing facility’s Administrator (FA) that received Patient 1 after being discharged, stated, “Patient 1 was in bad pain, and experiencing nausea when he arrived.” The FA provided medical records documenting the condition of Patient 1 on arrival and was transferred to Hospital 2. The skilled nursing facility’s Director of Nursing, and Assistant Director of Nursing also affirmed Patient 1’s condition as reflected in the medical record. On 1/28/26 at 10 am, the medical records from another local medical center (Hospital 2) were obtained from their Risk Manager (RM). The RM confirmed, that Patient 1 had continued having nausea, vomiting and pain control issues as reflected in the medical records. Post discharge medical records from the receiving skilled nursing facility and referral to another local hospital (Hospital 2) were reviewed. The records indicated that Patient 1 arrived at the skilled nursing facility and was having nausea, vomiting and severe uncontrollable pain. At 8:14 pm, Patient 1 was transferred to Hospital 2 for pain, and nausea control.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 39942 Based on interview, and record review, the facility failed to ensure that emergency medical services were provided in accordance with CFR §489.24, the regulations for the Emergency Medical Treatment and Active Labor Act (EMTALA) as evidenced by: 1. The facility failed to document that six of 22 patients (Patients 1, 3, 8, 11, 12, and 13) received ongoing monitoring while awaiting a medical screening exam. (Refer to A 2406) 2. The facility failed to obtain a patient signature on a transfer form for one of 22 patients (Patient 4). (Refer to A 2409)”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 49418 Based on observation, interview, and record review, this facility’s Emergency Department (ED) nursing staff failed to provide ongoing monitoring to assure patient stability when vital signs (VS - blood pressure, pulse, respirations, oxygen levels in the blood, temperature, pain level, and physical assessment) were not reassessed for six of 22 patients (Patients 1, 3, 8, 11, 12, and 13). These failures had the potential for Emergency Medical Conditions (EMCs) to go undetected and result in a decline in patient status with the potential for negative health outcomes. Findings: The Emergency Medical Treatment and Labor Act (EMTALA - known as the “Patient Anti-Dumping Law”) is a Federal law that ensures hospitals participating in Medicare programs provide Medical Screening Exams (MSEs) and stabilize patients with an EMC. A review, of the facility’s policy titled, “EMTALA - Compliance with the Emergency Medical Treatment and Active Labor Act,” dated 8/15/24, indicated that the facility must use its available resources to provide ongoing evaluation and stabilizing treatment as required by law. The policy indicated that any individual who presented to the ED requesting examination or treatment shall be provided with an appropriate MSE which would determine the presence or absence of an EMC. A review, of the facility’s policy titled, “Admission Policy/Emergency Medical Record,” dated 8/15/24, indicated that the facility shall comply with the emergency care obligations imposed by EMTALA. All patients presenting to the ED will be registered and receive an MSE by an ED provider. The policy indicated that the MSE was to be performed as soon as possible on patient arrival, and Triage/Intake (an initial assessment to determine the urgency of the presenting problem and treatment resources required) by a Registered Nurse (RN) is not an MSE. A review, of facility’s policy titled, “Triage and Treatment of Patients in the ED,” dated 6/25/24, indicated that patients were assessed using Emergency Severity Index (ESI) classifications: ESI Level 2: Patient with a high-risk situation or confused/lethargic/disoriented or severe pain/distress. Nursing staff were directed to reassess patients no less frequently than every hour for four hours, then every two hours if clinically stable. VS assessment was to be current within 30-minutes of discharge. ESI Level 3: Patients with normal VS but requiring many resources: labs, x-ray imaging, intravenous (into a vein), or intramuscular (into a muscle) medications, electrocardiogram (EKG - noninvasive testing that records the heart’s electrical activity), or repair of a laceration (cut). The policy directed nursing staff to reassess normal VS at their discretion but no less frequently than every four hours. Nursing staff were directed to reassess abnormal VS no less frequently than every two hours for four hours, then every four hours if clinically stable. VS assessment was to be current within 30-minutes of discharge. The policy indicated that the triage nurse had the primary responsibility for assessing and prioritizing patient needs and expediting patient care. A review, of facility’s policy titled, “Vital Signs (Temperature, Pulse, Respiration, Blood Pressure),” dated 5/23, indicated that VS were to be assessed at minimum once per shift or within the set monitoring frequency standard of the clinical unit within monitoring frequency set by physician order, or using a standing protocol. The policy indicated that all vital signs should be recorded in the electronic medical record (EMR). 1. Patient 1’s ED medical record was reviewed. Patient 1’s record indicated that he was seen in the ER on 1/23/25 at 11:41 am, with complaints of intermittent slurred speech, balance issues, and headaches for several months. The record indicated that Patient 1 reported an episode of slurred speech for one sentence that morning, witnessed by a family member, and she complained of headache, fatigue, and dizziness. Registered Nurse (RN) G triaged Patient 1 at ESI Level 3. VS taken at 11:42 am, and indicated a blood pressure (BP) of 182/89 (a “hypertensive crisis” per American Heart Association Guidelines, which if not treated could lead to stroke, heart attack, or kidney failure). The record indicated Patient 1 was placed in a room at 1:43 pm. A document titled, “Discharge Assessment,” documented by RN G on 1/23/25 at 4:34 pm, indicated that Patient 1 was waiting to see the provider, “all tests [were] back,” and RN G “Recommended patient wait to see if Dr. wants to run additional scans for mini TIAs,” (TIA or “mini stroke” - disruption of blood flow to the brain). The record indicated that Medical Doctor (MD) A went to Patient 1’s room at 4:29 pm (two hours and 46-minutes after being roomed), but Patient 1 was “gone,” and the EKG leads were on the bed. The record indicated that VS were “monitored;” however, VS were not documented between 11:42 am through 4:34 pm (four hours, and 52 minutes). A review, of “Emergency Room Provider Documentation” by MD A, dated 1/23/25 at 4:21 pm, indicated that Patient 1 had been “visually seen,” in triage; however, Patient 1 “did not receive re-evaluation as planned,” because the patient left the facility prior to completion of an MSE. The record indicated, “Plan was admission for TIA versus complex migraines.” The record indicated Primary Impression (diagnosis): TIA, Condition: “Guarded” (a serious medical situation where the outcome is uncertain). During a concurrent observational tour of the ED, and interview, with Director of Performance Improvement (DPI), Chief Nursing Officer (CNO), and ED Manager (EDM) on 6/18/25 at 11:04 am, it was observed that vital sign monitors were at the head of each bed. The CNO stated, that all VS, including BP, should be documented in the patient’s health record on reassessment. During an interview, with CNO, on 6/19/25 at 4:20 pm, the CNO stated a patient with “Monitor,” protocol ordered by a provider were to have BP, pulse, and blood oxygen levels continuously monitored using VS monitors at the bedside. The CNO stated, that the VS would be recorded on the monitor but data would not transfer to the electronic medical record, noting, “The nurse must chart the values.” During an interview, with DPI on 6/19/25 at 4:25 pm, DPI acknowledged Patient 1’s abnormal VS were not reassessed by nursing staff every two hours for four hours, then every four hours per facility policy for an ESI Level 3 patient. 2. A review, of Patient 3’s ED medical record, dated 1/24 to 1/25/25, indicated Patient 3 arrived by ambulance from another hospital for “Cardiology Transfer,” at 8:05 pm. RN H triaged Patient 3 in the ED as ESI Level 2 and documented initial VS at 8:22 pm, to include a pulse of 101 (normal 60 to 100), blood pressure of 138/62 (high normal), and blood oxygen levels of 94 percent (mildly low, normal 95 to 100 percent). The record indicated complete sets of VS were next performed on 1/25/25 at 3:05 am (six hours and 43 minutes later), 5:05 am, and 8:40 am. The record indicated Patient 3 was admitted and transferred to a hospital room on 1/25/25 at 2:07 pm, though VS were not reassessed after 8:40 am (five hours, and 27 minutes). A review, of “Emergency Room Provider Documentation” by MD B, dated 1/24/25, indicated Patient 3 was seen by MD B for an MSE at 8:46 pm. The record indicated Patient 3 was admitted to the hospital for acute diverticulitis (pouches in the colon lining become inflamed/infected) and non-ST-elevation myocardial infarction (NSTEMI - a heart attack that reduces blood flow to the heart). During an interview, with DPI on 6/19/25 at 4:25 pm, DPI acknowledged Patient 3’s VS were not reassessed by nursing staff no less frequently than every hour for four hours, then every two hours (if clinically stable) per facility policy for an ESI Level 2 patient. 3. A review, of Patient 8’s ED medical record, dated 2/23 and 2/24/25, indicated Patient 8 arrived in the ED at 9:52 pm, with complaint of abdominal pain. RN E triaged Patient 8 as ESI Level 3 and documented triage VS at 10:14 pm. A review, of records indicated VS were not reassessed after 10:14 pm, the patient waited in the lobby for a room from 9:52 pm, on 2/23/25 until 3:04 am, on 2/24/25 (six hours and 14 minutes), and an MSE was not performed. RN J documented that patient was not in the lobby on 2/24/25 at 3:04 am, 3:34 am, and 4:05 am. During an interview, with DPI on 6/19/25 at 4:25 pm, DPI acknowledged Patient 8’s VS were not reassessed by nursing staff every two hours for four hours, then every four hours per facility policy for an ESI Level 3 patient. 39942 4. A review of Patient 11’s clinical record indicated they came to the ED on 5/16/25, by ambulance with a complaint of high blood pressure. A review, of an Emergency Medical Services (EMS) Patient Care Report, dated 5/16/25, indicated at 2:34 pm, EMS staff documented Patient 11’s blood pressure as 188/124. EMS staff wrote that Patient 11 had lost their prescribed blood pressure medication and stopped taking it four days prior. A record review, of a nursing Triage Note, dated 5/16/25 at 3:08 pm, indicated RN A documented a blood pressure of 195/135. RN A also wrote that Patient 11 denied any headache or dizziness. Patient 11’s ESI Level was three. A record review, of a Nursing Note, dated 5/16/25 at 8:22 pm (over five hours after the triage assessment), indicated that RN B wrote that Patient 11 was, “Not in lobby,” and the patient had left without being seen (LWOBS) by a provider. 5. A review, of Patient 12’s clinical record indicated they came to the ED on 5/14/25 with a complaint of abdominal pain. A record review, of a nursing Triage Note, dated 5/14/25 at 6:35 pm, by RN C, indicated Patient 12 had right lower abdomen pain, level nine out of ten on a zero to ten scale (zero being no pain, ten being the worst pain) since the morning, relieved with vomiting. RN C also wrote that patient 12 was given a cup and instructed to provide a urine sample. Patient 12’s ESI level was three. A record review, of a Nursing Note, dated 5/14/25, at 11:11 pm (over four hours after the triage assessment) indicated that RN B wrote that Patient 12 was, “Not in lobby,” and the patient had LWOBS by a provider. 6. A review, of Patient 13’s clinical record indicated they came to the ED on 5/5/25, with a complaint of being short of breath at rest for one month. A record review, of a nursing Triage Note, dated 5/5/25 at 2:01 pm, indicated RN D wrote that Patient 13 complained of shortness of breath and was waiting for a heart monitor report from their doctor. Patient 13’s ESI Level was three. A record review, of a Nursing Note, dated 5/5/25 at 6:22 pm (over four hours after the triage assessment) indicated that RN E wrote that Patient 13 was, “Not in lobby,” and that Patient 13 had lab work and an x-ray done, but LWOBS by a provider. During a concurrent interview, and record review, on 6/20/25, at 9:45 am, DPI confirmed there were no nursing assessments, or vital signs documented after triage for Patients 11, 12 and 13.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 49418 Based on interview, and record review, the facility failed to ensure a Patient Transfer Acknowledgement (indicating patient had been informed of and understood the reasons/risks of transfer) was signed prior to transfer from the Emergency Department (ED) to another facility for one of 22 sampled patients (Patient 4). This deficient practice prevented Patient 4 from making an informed decision about whether to accept a transfer that could potentially endanger her health and safety. Findings: During a review, of the facility’s policy titled, “EMTALA - Compliance with the Emergency Medical Treatment and Active Labor Act,” dated 8/15/24, it indicated that: 1. Both stable and unstable patients may be transferred safely and systematically to another facility. 2. A Transfer Consent and Acknowledgement/Refusal Form 100-059 was required to be completed and signed by the individual or legally responsible adult. and was to be witnessed by an appropriate employee. A review, of Patient 4’s “ED Visit Summary,” dated 2/1/25 at 7:12 pm, indicated that Patient 4 arrived in the facility ED on 1/31/25 at 9:56 am, with “pregnancy complications.” Patient 4 complained of 8 out of 10 lower abdominal pain (0 to 10 pain scale, 10 being the worst pain), and cramping and bleeding after [positive] pregnancy test at home. A review, of Patient 4’s “Emergency Room Provider Documentation,” dated 1/31/25, indicated that a MSE and was found to have an acute surgical abdomen (abdominal condition requiring urgent surgery) with an acute ectopic pregnancy, (when a fertilized egg implants outside of the uterus), a life-threatening condition requiring immediate transfer to an outside hospital for emergent surgery and higher level of care. Patient 4’s diagnoses included ectopic pregnancy, complications of pregnancy, and anemia (a condition where red blood cells are low and adequate oxygen is not carried in the bloodstream to body tissues). A review, of a document titled, “Certification for Ambulance Transfer,” dated 1/31/25, and signed by Registered Nurse (RN) F, indicated that Patient 4 had been diagnosed with an ectopic pregnancy (left), and required transfer to an outside facility with LND (labor and delivery) triage. A review, of a document titled, “Acute Transfer Physician (Phys) Certification Form - Exhibit (Exh) B,” signed by Physician’s Assistant (PA) A on 1/31/25 at 1:37 pm, indicated that PA A deemed Patient 4 stable for transfer to a higher level of care/treatment not available at the facility for left ectopic pregnancy. The “Patient Transfer Acknowledgment,” portion of the form was blank, unsigned by the patient or a witness to indicate Patient 4 had been informed of, and understood the reasons/risks for transfer. During concurrent interview, with Director of Performance Improvement (DPI), and record review, of Patient 4’s medical records on 6/18/25 at 3:19 pm, the DPI acknowledged that the transfer consent for Patient 4 should have been signed by the patient prior to transfer.”

“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: 41567 Based on interview, and record review, the facility failed to ensure Patient 11 was consistently assessed in the Emergency Department (ED) while awaiting an available bed on an inpatient unit. This failure had the potential for a negative health outcome for Patient 11 . Findings: A review was made of a facility policy titled, “Triage,” revised 5/2022, which indicated that triage involved a rapid, directed patient assessment, and provided the assignment of an acuity or priority level for each patient based on the industry standardized Emergency Severity Index (ESI) algorithm. According to the acuity level definition outlined in the policy, a triage ESI level 3 indicated a potentially unstable patient that required two or more resources. A review was made of a facility policy titled, “Assessment/Reassessment of Patients,” revised 4/2021, which outlined that patients with ESI Level 3 required, at a minimum, reassessments and vital signs (VS: temperature, heart rate, respiratory rate, blood pressure, and the saturation of oxygen in blood) to be performed every 30 to 60 minutes. During an interview 7/18/24 10:16 am, Patient 11 recalled the events that led to her filing a complaint with California Department of Public Health and stated she was placed on a gurney late at night on 7/27/22 in a darkened room in the ED, the glass door shut, and unable to see a call bell button. Patient 11 stated she felt in a stupor from strong pain medications she had been given earlier in the evening. She stated, I was afraid of falling off the gurney if I tried to get off it, I looked around and didn’t see a way to get hold of a nurse. I can’t say I was in pain, but I was uncomfortable, there was pressure and I hurt. During the night I wet myself and was soaked from the neck down. I called out 2 or 3 different times at nurses passing by, but they didn’t notice me. A review of Patient 11’s medical record found that Patient 11 came to the ED with severe right flank pain, increased urinary frequency and burning with urination. In an Emergency Room Provider note dated 7/27/22, Physician’s Assistant (PA) 1 documented Patient 11 had a known history of chronic kidney disease and kidney stones (a mineral build-up that causes formation of stone-like material that accumulates in the kidney). After he reviewed the results of a CT (computed tomography, a scan that takes detailed images of bodily structures and organs), which indicated an ureteropelvic junction obstruction (a blockage preventing urine from releasing from the kidney into the bladder), PA 1 consulted Medical Doctor (MD) 1 at 7:42 pm, and admitted Patient 11 for intravenous (IV, ‘in the vein’) antibiotics (medications that destroy harmful bacteria that cause illness) due to the obstructing stone and a urinary tract infection. A review was made of a nursing triage note dated 7/27/22 12:17 pm, by Registered Nurse (RN) 12 who made a comment in the triage notes that Patient 11 was complaining of aching sharp pain in the right flank radiating to the right lower quadrant of the abdomen along with urinary frequency, burning and urgency and that she had a history of kidney stones. RN 12 documented that Patient 11 had a pain level of nine, with 10 being the maximum amount of pain conceivable on this pain scale. ESI was determined to be a level 3. A review was made of Patient 11’s ED Visit Summary. On 7/27/22 at 5:30 pm, Medic 1 documented a pain assessment of right flank pain, level four. A review was made of Patient 11’s History and Physical dated 7/27/22 8:30 pm, by Physician Assistant (PA) 1, who documented a kidney stone on the right side, and planned for IV antibiotics, an evaluation with urology (physicians who specialize in problems involving the urinary system), a medication to relax urinary bladder muscles, and nothing given to eat/drink by mouth. In Patient 11’s ED Visit Summary dated 7/27/22 at 8:47 pm, Patient 11 was designated an admit hold, then listed at 9:11 pm as an inpatient, awaiting an available bed. She remained in ED overnight and was admitted to a nursing unit on 7/28/22 at 4:26 pm. A review was made of Patient 11’s provider orders for medications and fluids dated 7/27/22 5:35 pm, by PA 1 who ordered: - Normal saline (a solution of sterile water and 0.9% salt, used for hydration) 1000 milliliters (mL, a unit of measure) IV, once; - Toradol (a pain reliever) inj (injectable - medication injected into the body via needle and syringe) 15 milligrams (mg, a unit of measure) IV, once; - Morphine (a potent narcotic pain reliever) inj 4 mg IV, once, for severe pain; and, - Zofran (an medication for nausea) inj 4 mg, IV, once. At 6:35 pm, MD 1 ordered a dose of an antibiotic, Rocephin, 2 grams (g, a unit of measure) in 50 mL of D5W (a solution in which medications are mixed and diluted) IV, once. A review was made of Patient 11’s medication administration record dated 7/27/22, for the administration of the medications ordered: the normal saline, Toradol, morphine, and Zofran were given as ordered by Medic 1 at 5:35 pm; the Rocephin was given as ordered by RN 13 at 6:35 pm. A review was made of Patient 11’s provider orders for medication and fluids dated 7/27/22 8:21 pm; MD 2 ordered morphine 1-2 mg IV every four hours as needed, normal saline 1000 mL IV, and Flomax (a medication to relax the bladder muscles) 0.4 mg by mouth at bedtime. In Patient 11’s ED Visit Summary on 7/27/22 at 10:06 pm, RN 6 documented a general assessment, a fall risk assessment, and VS. At 10:08 pm, RN 6 documented in the nursing note section that this was her first encounter with Patient 11 who was in the ED for flank pain and awaiting an inpatient bed and that Patient 11 was aware she was to eat or drink nothing after midnight. The next nursing note entry was made 11 hours later, on 7/28/22 at 9 am by RN 7, who documented, “Patient has been resting on stretcher with cardiac monitor (medical equipment that remains on patients to monitor/record VS) in place, and call bell within reach.” The last nursing note entries are by RN 7 and are in regard to Patient 11 being admitted to a nursing unit, at 2:29 pm and 3:53 pm. Between 7/27/22 at 10:06 pm, until her transfer out of the ED on 7/28/22 at 4:26 pm, over 18 hours later, there were no further nursing assessments or reassessments, no pain assessments, no documentation of urinary output. Vital signs were documented on 7/28/22 at 12:06 am, 2:30 am, 4:34 am, 6:25 am, 6:57 am, 8:32 am, 10 am, 11:46 am, 2:23 pm. The VS taken at 10 am and 11:46 am both include temperature readings, indicting these VS involve staff going into the room as temperatures, for a patient in this situation, would not be taken remotely. During a concurrent interview and record review conducted on 7/10/24 at 9:20 am, the Emergency Department Director (EDD) stated that a triage Level 3 patient should have been assessed with hourly vital signs, per policy in place in 2022. She stated a full general assessment is done upon arrival and thereafter a focused assessment, in this case a genitourinary-focused (sexual organs and urinary system) assessment, should have been done. EDD stated her concern is that Patient 11 was left alone all night; she could see in the medical record that vital signs were being reviewed but may have been done remotely with cardiac monitoring/automated blood pressure cuff; she could not determine whether or not Patient 11 went to the restroom, or urinated, or that pain was reassessed.”

“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: 40204 Based on interview and record review the facility staff failed to follow facility policies and procedures for one of 13 sampled patients after Patient number 11 fell. This failure created the potential for missing recognition of fall related injuries, delayed treatment of injuries, additional falls, increased pain and suffering. Findings: On 5/27/24 Patient 11 (P11) was admitted to the facility for Kidney Pain. P11 was treated in the Emergency Department (ED) and transferred to the Surgery Recovery Room (SRR) to await a urinary system procedure. While waiting for the procedure in the SRR P11 had an unwitnessed fall. On 7/11/2024 at 9:30 AM, during a concurrent interview and record review with the Director of Performance Improvement (DPI), the DPI stated, “It (P11’s fall) should be on an incident form if anything else.” An incident form was located, and the DPI arranged interviews with staff that provided P11 care around the time of the fall. The DPI provided a copy of the “Post Fall Assessment/Injury Prevention Huddle” and the facility policy titled, “Falls Reduction/Injury Prevention.” The DPI confirmed the policy refers to completion of the “Post Fall Assessment/Injury Prevention Huddle” which was not done. On 7/11/2024 at 10:00 AM, during a concurrent interview and record review with a Recovery Room Registered Nurse (RN9), RN9 stated, “He was in bed and called me over wanting to go to the bathroom to pee ... I told him that he couldn’t get up and that I would go him a urinal. I did and gave it to him and made sure he had the call light then pulled the curtain for his privacy. ...it was taking some time ...I went over to check and asked if he was ok. He said ‘yes’ and that he was still trying. I went back to the desk and then he is calling help help and is on the floor. RN9 was provided with a copy of a one-page facility document titled “Post Fall Assessment/Injury Prevention Huddle” having three pages of attachment. RN9 was given time to review the document and attachments to her satisfaction. When questioned RN9 was not aware of the document, attachments nor the requirement of completing the documentation after an incident such as this. RN9 stated she, “did not know about the forms.” The “Post Fall Assessment/Injury Prevention Huddle” was not completed as required by the facility policy titled, “Falls Reduction/Injury Prevention.” On 7/11/2024 at 11:00 AM, during a concurrent interview and record review with a Recovery Room Registered Nurse (RN10), RN10 stated, “He was an easy recovery. He didn’t complain of any pain the entire time. I heard he fell and that he got up on his own. I told him that he couldn’t get up and he was totally compliant. He didn’t try.” RN10 delivered P11 to the orthopedics unit after recovery. RN10 stated, “I took him to the floor, ortho and gave him to the nurse there. I did tell her in report that he had fallen but had no complaints. He never mentioned anything to me about pain from the fall.” RN10 was provided with a copy of a one-page facility document titled “Post Fall Assessment/Injury Prevention Huddle” having three pages of attachment. RN10 was given time to review the document and attachments to her satisfaction. When questioned RN10 was not aware of the document, attachments nor the requirement of completing the documentation after an incident such as this. RN10 responded to questioning stating, “I didn’t see this form, no. I didn’t know about it at all.””

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 39942 Based on interview and record review, the facility failed to ensure that emergency medical services were provided in accordance with CFR §489.24, the regulations for the Emergency Medical Treatment and Active Labor Act (EMTALA). The facility failed to provide a Medical Screening Examination (MSE) for one of 20 sampled patients (Patient 8) who came to the Emergency Department (ED) with a complaint of chest pain. This failure had the potential to put the patient at risk for potential life-threatening medical complications. (Refer to A2406)”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 39942 Based on interview and record review, the facility failed to provide a Medical Screening Examination (MSE) for one of 20 sampled patients (Patient 8) who came to the Emergency Department (ED) with a complaint of chest pain. This failure had the potential to put the patient at risk for potential life-threatening medical complications. Findings: A facility policy titled, “Admission Policy/Emergency Medical Record,” revised 2/1/20, was reviewed. Its purpose indicated to ensure that all patients who came to the hospital requesting emergency services received an appropriate MSE as required by the Emergency Medical Treatment and Active Labor Act (EMTALA). All patients who presented to the ED would have been registered and received an MSE by an ED Provider. The MSE was to have been performed as soon as possible after patient arrival. Triage/intake (evaluating a patient to determine the urgency of their need for care) by a Registered Nurse (RN) was not an MSE. Review of Patient 8’s Emergency Department (ED) record indicated they walked into the ED on 1/25/24 shortly after midnight with a complaint of chest pains. Patient 8’s triage priority was listed as “three,” which indicated the patient’s needs were urgent with the potential to increase, but not life-threatening. Under the Triage Vital Signs at 12:50 am, RN A documented a blood pressure value of 195/111 and a pain level of three out of 10 (on a zero to 10 scale, 10 being the worst pain, zero being no pain). Under Triage Comment RN A wrote: “left sided chest pressure onset few days, nonradiating (contained in one area), associated symptoms sob (shortness of breath).” A document from the American Heart Association titled, “Blood Pressure Categories,” dated 8/1/20 (available online at https://www.heart.org/en/health-topics/high-blood-pressure) was reviewed. The document contained a table of five blood pressure categories with corresponding numbers for systolic (upper number) and diastolic (lower number). A systolic number greater than 180 indicated a hypertensive (high blood pressure) crisis, and the reader was advised to consult a doctor immediately. A diastolic reading of 90 or higher indicated hypertension classified as “Stage 2.” An electrocardiogram (EKG- measures the electrical impulses of the heart to check for heart disease) result, dated 1/25/24 at 1:20 am, showed Patient 8 had an electronic atrial (top chambers of the heart) pacemaker, and Medical Doctor (MD) C reviewed and signed the EKG at 1:25 am. Review of a Patient Audit Trail for Patient 8, dated 1/25/24, showed RN D wrote that Patient 8 was, “awaiting MD, awaiting room” at 3:26 am. The next note written by RN B at 6:21 am, read, “not in lobby.” RN B documented three more checks for Patient 8, then, “Left Without Being Seen” at 6:51 am (six hours after arrival to the ED). There was no record of any MSE done for Patient 8. During a concurrent interview and record review, on 5/31/24, at 11:30 am, RN B stated they didn’t care for Patient 8 on 1/25/24, just did a roll call when they came on shift in the morning. RN A was triage nurse. It was unclear when Patient 8 left. RN B agreed a BP of 195/111 was high, and stated the triage nurse was always reassessing patients in the waiting room. RN B stated that when only one doctor worked on the night shift it was difficult for them to see all the patients without the help of a mid-level provider, such as a Physician’s Assistant. During a concurrent interview and record review, on 5/31/24, at 2:30 pm, the Director of Performance Improvement confirmed Patient 8 did not have an MSE documented and only had one BP reading documented on 1/25/24. MD C was the only doctor working on night shift from 10 pm 1/24/24 to 6 am 1/25/24. There was no surveillance camera footage available to determine what time Patient 8 left the ED lobby on 1/25/24.”

“MEDICAL STAFF CFR(s): 482.12((a)(8), (a)(9) [The governing body must:] (8) Ensure that, when telemedicine services are furnished to the hospital’s patients through an agreement with a distant-site hospital, the agreement is written and that it specifies that it is the responsibility of the governing body of the distant-site hospital to meet the requirements in paragraphs (a)(1) through (a)(7) of this section with regard to the distant -site hospital’s physicians and practitioners providing telemedicine services. The governing body of the hospital whose patients are receiving the telemedicine services may, in accordance with §482.22(a)(3) of this part, grant privileges based on its medical staff recommendations that rely on information provided by the distant-site hospital. (9) Ensure that when telemedicine services are furnished to the hospital’s patients through an agreement with a distant-site telemedicine entity, the written agreement specifies that the distant-site telemedicine entity is a contractor of services to the hospital and as such, in accordance with §482.12(e), furnishes the contracted services in a manner that permits the hospital to comply with all applicable conditions of participation for the contracted services, including, but not limited to, the requirements in paragraphs (a)(1) through (a)(7) of this section with regard to the distant-site telemedicine entity ’ s physicians and practitioners providing telemedicine services. The governing body of the hospital whose patients are receiving the telemedicine services may, in accordance with §482.22(a)(4) of this part, grant privileges to physicians and practitioners employed by the distant-site telemedicine entity based on such hospital’s medical staff recommendations; such staff recommendations may rely on information provided by the distant-site telemedicine entity. This Standard is not met as evidenced by: 48129 Based on interview and record review, the facility failed to have the Governing Board (GB) ensure the written agreement between the hospital and telemedicine intensivist physician group’s (Telehealth group) expanded services of covering non-critical care inpatient hospital units during the night shift. This failure had the potential for poor patient outcomes when hospital staff had no guidance or clear instructions for how contacting and/or interacting with the Telehealth group to obtain medical interventions and/or orders. Findings: During an interview, on 3/20/24 at 10:20 am, Office Coordinator 1 (Coordinator 1), stated that starting 3/1/24, the Hospitalist (a dedicated physician who works exclusively in a hospital) service on night shift was now covered by a remote Telemedicine group. Coordinator 1 stated, that it was the same group that covered the ICU. Coordinator 1 stated that one Telemedicine Doctor worked the night shift, from 7pm to 7am, and supervised two on-site facility Residents (a medical school graduate with a Doctor of Medicine (MD) degree who is taking part in a post-graduate training program). The Telemedicine Doctor was able to view and assess patients with the assistance of a Resident, through cameras and telehealth computer software. Coordinator 1 stated that the remote Telemedicine Doctor must electronically co-sign every order and progress note a Resident entered for a patient at the facility. Coordinator 1 stated, “they supervise the two residents.” During an interview with RN Manager 1 (RN 1) on 3/20/24, RN 1 stated that Residents were now supervised by a Telehealth Group doctor during night shift. RN 1 also stated during patient emergencies, an Emergency Room doctor came to the hospital units to assist Residents and perform invasive procedures (A medical procedure that enters the body, usually by cutting or puncturing the skin or by inserting instruments into the body) since the Telehealth Group doctor was not physically present. During a review of facility’s contract titled, “Telehealth Critical Care Professional Services Agreement”, dated 5/1/20, it indicated an agreement between the facility and Telehealth Group. The contract read, “[telemedicine] Group shall provide Qualified Physicians to provide critical care telehealth services for 24 hours a day, 7 days per week ....” The contract also outlined the term length of services contracted, “This Agreement shall commence on May 1, 2020 (“Effective Date”) and shall continue for a period of two (2) years, unless earlier terminated as provided in this Agreement. The Agreement will renew automatically for one (1) year terms unless terminated by either party in accordance with this Agreement. The Agreement may be modified upon mutual written agreement of the parties hereto. “The contract further indicated, “Any amendment to or modification of this Agreement shall be in writing, signed by [both parties] indicating the actual date signed, and attached hereto.” During an interview with Facility Chief Executive Officer (CEO) and three doctors (MD 1, MD2, MD3) on 3/26/24, the CEO and MD 1 verbally confirmed that the remote Telehealth group was now covering non-critical in-patients at the hospital during night shift. CEO and MD1 both stated that a new contract had not been created for the expanded new services. MD 1 also stated all Telehealth group doctors were privileged (when a facility gives credentials to a doctor to work and provide care there) by the facility to provide care to any patient. During an interview with a Telehealth Group Representative (Telehealth Rep 1) on 4/4/24, Telehealth Rep 1 stated, “We went live covering [the facility’s] ICU during the pandemic, roughly February 2021. That originally went until May 2022. Our services were paused in May 2022. The facility went back to us in March 2023, and reinstated services with us.” Telehealth Rep 1 also stated that Telehealth Group had other fields of service they provided, but that they (Telehealth group), “only has contract services for ICU at this time, only critical care.” Telehealth Rep 1 stated that Telehealth Group did not have a new contract with Facility to include expanded Hospitalist coverage services, and that a new updated contract has not been opened or talked about.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 39942 Based on interview and record review, the facility failed to follow nursing policies and procedures for patient safety for one patient (Patient 1) when: 1. Nursing staff left Patient 1 sitting on a bedpan on an unknown date, for an indeterminate length of time; 2. Nursing staff did not document any details about the incident involving the bedpan or when it happened; 3. Nursing staff did not photograph a new wound found on Patient 1’s skin after removing the bedpan; 4. Nursing staff did not complete an Occurrence Report about the incident; 5. Nursing staff did not notify Patient 1’s representative about the skin injury in a timely manner. These failures caused Patient 1 to suffer a deep tissue injury (DTI-a localized area of intact skin that was discolored due to damage of underlying tissue from pressure) and had the potential to lead to complications such as pain, infection, further skin breakdown leading to pressure sores, prolonged hospital stay, as well as emotional distress. This failure put Patient 1 at risk for further injury due to a lack of communication with other members of the healthcare team and administration about the incident. Findings: A facility policy titled, “Skin Integrity (health),” revised 11/1/23, was reviewed. The policy indicated that skin risk prevention techniques included repositioning the patient as frequently as the patient could tolerate; clarifying and documenting any limitations per physician or any patient refusal; avoiding direct pressure over bony areas or ulcer (sore) sites; and routinely checking the patient for any pressure ulcers from medical devices (e.g. wires . . tubing . . and bedpans). Nursing was instructed to photograph any new wound upon discovery, and if unable to obtain a photograph, to document the reason in the medical record. A facility policy titled, “Occurrence Reports,” revised 1/1/24, was reviewed. The policy indicated that completion of the Occurrence Report was the foundation of the risk/quality/safety management program and involved all departments within the facility. Occurrence Reports were to have been completed on all occurrences involving patients. The purpose of the Occurrence Report was to promote the improvement of quality and safety of patient care. A reportable occurrence was defined as an occurrence that was not consistent with the routine operation of the hospital or the routine care of a patient or patients. Injury did not have to occur. The potential for accident, injury or illness was sufficient for an occurrence to have been considered a Reportable Occurrence. The occurrence should have been reported to the Performance Improvement Department within 24 hours and included any follow up investigation. Review of Patient 1’s clinical record indicated the patient was admitted to the facility on 2/25/24 and discharged on 3/11/24, a total stay of 15 days. Patient 1’s conditions included falling at home, pneumothorax (a collapsed lung), atrial fibrillation (an irregular heart rhythm), arthritis, and dementia (a mental disorder that caused memory loss and confusion). An initial skin assessment documented on 2/26/24 indicated no skin issues, with a Braden Scale (a tool used to predict a patient’s pressure sore risk. A score of less than or equal to nine indicated severe risk; a score of 15-18, mild risk) score of 16, which indicated Patient 1 was at mild risk for developing a pressure sore. Patient 1’s subsequent Braden Scale scores were documented as 17 on 3/1/24 (day five) and 12 (high risk of developing pressure ulcer) on 3/11/24 (day of discharge). Record review on 3/20/24 at 9:56 am, showed photos of Patient 1’s DTIs. The first photo, dated 3/4/24 at 9:50 am, was taken eight days after admission to the facility. Descriptions written by Licensed Nurse (LN) C, the Wound Care Nurse, indicated, “site location: right sacrum (base of the spine) to hip 25 centimeters (cm), (approximately 10 inches) by three cm, (approximately 1.25 inches). Left sacrum to hip 25 cm by four cm.” The marks depicted in the photo were long and rectangular, medium to dark red in color. LN C documented the reason for the photo was “new finding,” and classified the wounds as “DTI,” with severity as “acute.” Record review of an Order Audit Trail showed a Wound Care Consult, entered on 3/1/24, at 10:39 pm, by RN G. There was no note explaining why the consult had been ordered. During a concurrent interview and record review, on 3/20/24, at 11:48 am, LN C and RN F, also a Wound Care Nurse, stated that the type of marks in the photos of Patient 1’s wounds were usually caused by pressure. LN C stated that the message wasn’t always clear about why a wound care consult was placed. LN C stated they had received a report about some skin breakdown but no one said what caused it. LN C stated the nurse should have photographed any wound and sent the photo with the consult order. During a telephone interview, on 3/22/24, at 4:48 pm, RN G stated they never saw the long wounds on Patient 1’s skin as depicted in the photos taken on 3/4/24. RN G stated the request for a wound consult placed on 3/1/24 at 10:39 pm was for slight redness on Patient 1’s coccyx (tailbone), not for the larger wounds. Record review of a nursing assessment, dated 3/11/24 (day of discharge), at 8 am, by LN E, indicated LN E had written, “pressure area to sacrum from bedpan.” During a concurrent interview and record review, on 3/20/24, at 11:48 am, LN C and RN F confirmed that LN E had written about a bedpan causing the pressure area on 3/11/24. During an interview, on 3/20/24, at 2:44 pm, with RN B, stated they were told by LN C that Patient 1 had been left on a bedpan and had a pressure wound. RN B was not sure what date or shift it was. Later that same week RN B claimed that Patient 1 had been found left on a bedpan a second time (date unknown). RN B put signs up in Patient 1’s room that read, “no bedpan” (date unknown). RN B was certain there was a sign posted in the room and addressed the issue verbally with Certified Nursing Assistants (CNAs) on the Unit. RN B stated that there should have been two Occurrence Reports completed for the two incidents, but RN B did not complete any Occurrence Reports. During a telephone interview, on 3/21/24, at 4:48 pm, CNA H stated they did not know when or how the marks occurred on Patient 1’s skin, but they did see a sign on the wall in Patient 1’s hospital room that indicated to not use a bedpan (date unknown). During a telephone interview, on 3/25/24, at 4:42 pm, RN A recalled that apparently on the night shift (date unknown) Patient 1 had been left on a bedpan for an extended period of time. RN A assumed care of Patient 1 in the morning of 3/3/24 and there was a red mark on Patient 1’s skin, but not as dark at first. It later developed and became more pronounced. The second morning 3/4/24 that RN A assumed care of Patient 1, RN A checked to make sure the Patient was not on a bedpan. RN A stated they received report from the night shift RN J, and they stopped putting the patient on a bedpan. Then LN C came in on 3/4/24, (in response to the wound care consult placed on 3/1/24), and took pictures of the wounds. No order was written to not use a bedpan; the message was passed on verbally to other staff. RN A did not recall any signs posted in the room. RN A thought the Wound Care Nurse would take over, so RN A did not submit an Occurrence Report for the wound/mark. During a telephone interview, on 3/26/24 at 4:36 pm, RN J stated they cared for Patient 1 during the weekend of 3/2/24 to 3/3/24. One morning early (date unknown) they went to turn the patient, with help from an unidentified CNA, and found Patient 1 was on a bedpan. RN J stated they removed the bedpan, and Patient 1’s skin was red. They couldn’t find the CNA who had placed Patient 1 on the bedpan. RN J confirmed the whoever placed the bedpan on Patient 1’s bottom should not be left unattended for extended period of time. RN J stated they reported it to the charge nurse, but did not document anything about it. RN J could not recall the name of the charge nurse. During a concurrent interview and record review, on 3/20/24, from 9:45 am to 3:07 pm, the Director of Performance Improvement (DPI) did not locate any documentation about the specific incident that caused the pressure injury on Patient 1’s skin, no Occurrence Report, no investigation into the root cause of the wounds, and no written order to not use a bedpan with Patient 1. DPI confirmed an Occurrence Report should have been completed for the injury to Patient 1’s skin. During a telephone interview, on 3/26/24, at 10:39 am, with RN I, indicated they were the Director of the Unit where Patient 1 had received care. RN I stated they had not completed the investigation into the origin of Patient 1’s wounds and did not know all the details. RN I had only been Director of the unit since 3/3/24. A facility policy titled, “Patient/Family Notification Procedure of Adverse Events,” approved 6/1/20, was reviewed. The Hospital Patient Safety Plan stated that patients and, when appropriate, their families should have been promptly informed about the outcomes of care, including unanticipated outcomes. The notification procedure should have been initiated as soon as possible after the appropriate level of care had been provided to the patient. Procedure should have included the staff member with the most knowledge of the unanticipated outcome immediately notifying the appropriate Department Supervisor. The Department Supervisor would have notified . . . the Director of Performance Improvement. If the patient was not competent, the team would have made reasonable efforts to locate an appropriate family member or other authorized representative identified in the medical record. All efforts to contact family members or representatives should have been documented in the medical record. The discussion was to have taken place within 24 hours of the unanticipated outcome. The patient/family should have been assured that the hospital and physician were taking the appropriate steps to reduce the likelihood of recurrence. These steps included an internal review of the unanticipated outcome. During a telephone interview, on 3/26/24, at 9:54 am, Patient 1’s Family Member (FM) A, who was also the patient’s Power of Attorney, stated that a female nurse informed them on 3/10/24, while at the bedside, that the patient had a bruise from the bedpan. FM A didn’t look at the wound at that time. That was the first time FM A had been notified of any skin irregularity or injury, and it was approximately seven days after the injury was discovered and documented by hospital staff.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 45757 Based on interview and record review, the facility failed to ensure a well-organized surgical services department, in accordance with acceptable standards of practice when: 1. The Operating Room Director (ORD) was unable to set-up or operate the cell saver device (a medical device that recovers blood lost during surgeries that pose a high-risk for blood loss, and reinfuses into the patient), when the facility’s Operating Room (OR) nursing staff required immediate assistance with cell saver set-up for Patient 9’s aorticbiliac bypass procedure (a surgery that redirects blood flow around a large blocked artery in the groin or abdomen). As a result, the facility’s contracted perfusionist (PERF, a contracted specialist who runs the heart-lung machine while patients are in open-heart surgery) had to be located in the facility, and requested to rapidly assist the OR nursing staff with cell saver set-up and operations (Refer to A-942, Finding 1). 2. The facility failed to ensure, that prior to surgery, one of two surgical patients’ (Patient 9) medical record contained a medical doctor (MD) order to properly execute an informed surgical consent and an MD attestation related to a discussion with the patient, or family, of the risks, benefits, alternatives and complications of the surgical procedures to be performed. As a result, Patient 9 was transported to the facility’s OR, and administered anesthesia, prior to MD 4 conducting an in-person surgical consultation with Patient 1, confirming Patient 1’s exact surgical procedure, or generating an MD order for a properly executed surgical consent. This failure resulted in the potential for Patient 9 to be misinformed on the exact surgical procedure the surgeon intended to perform, and the risks, benefits, and alternatives to the procedure (Refer to A-955). 3. The facility’s ORD was unable to provide direct surgical nursing services to patients receiving cardiovascular surgeries. As a result, the ORD was unable to provide nursing service relief, or support, to the cardiovascular OR (CVOR) nursing staff (Refer to A-942, Finding 2). 4. The facility failed to ensure that the scope of surgical services was staffed and organized to ensure that surgical personnel reported to qualified surgical clinical supervisors with knowledge and expertise in surgical service operations. (Refer to A- 941) The cumulative effects of these systemic problems resulted in the failure of the facility to ensure the provision of safe surgical services to patients in the hospital.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 26917 Based on interviews and document reviews, the hospital failed to meet the requirements related to identifying and reducing medical errors as part of its quality improvement program. Specifically, the hospital’s quality assessment and performance improvement efforts did not adequately “show measurable improvement in indicators for which there is evidence that it will identify and reduce medical errors” with regards to heparin medication (a high alert blood thinner) administration. Despite known issues with insulin (a high alert blood sugar medication) dose calculation errors, the hospital did not carefully review other high-alert medications like heparin drips to identify risks and opportunities for improvement in line with protocol adherence. Findings: During an interview and record review on 2/27/24 at 11:45 am, the Director of Pharmacy (DOP), Staff Pharmacist I, and the Director of Intensive Care Unit discussed the following medication errors: *Patient 1 received heparin (medication used to prevent blood clotting) therapy as a preventive measure against blood clots, with dosages adjusted based on Activated Partial Thromboplastin Time (aPTT a screening test that helps evaluate a person’s ability to appropriately form blood clots) levels. RN 1 administered a significant underdose (400 units instead of 4000 units), and RN 2 made dosage errors, including an underdose based on aPTT 35 and failure to follow protocol at aPTT 90. These deviations from protocol pose risks of compromised anticoagulation and violate hospital policy. *Patient 2, with a history of heart problems, had heparin dosages adjusted by protocol. RN 3 administered an excessive bolus (4000 units instead of 3500 units), risking potential bleeding complications. RN 4 failed to administer a prescribed bolus at aPTT 28, violating protocol. The ICU Director emphasized adherence to protocol even if Electronic Medical Record lacks information. *Patient 3 received heparin for clot prevention, with RN 5 administering a lower infusion rate (13 mL [milliliter] per hour instead of 14 mL per hour) at aPTT 29. This deviation could lead to suboptimal anticoagulation, increasing the risk of complications. Adherence to dosage protocols is crucial for patient safety and optimal treatment outcomes in heparin administration. During an interview on 2/28/24 at 8:00 am, with the DOP, he acknowledged that the hospital had a history of insulin medication errors like the heparin medication errors that occurred. He admitted that the hospital had not specifically examined heparin administration and was unaware of any reported errors or issues related to heparin. He also recognized that the root cause of the insulin medication errors was the complexity and confusion surrounding the orders and acknowledged that heparin orders shared similar challenges in terms of dose calculation. The DOP conceded that the hospital should have reviewed other high-risk medications, including heparin, to identify potential difficulties in calculating correct doses and reduce the risk of similar errors, as part of its quality improvement efforts in medication safety and prevention of errors. This resulted in the occurrence of multiple heparin dose calculation errors by nurses for three identified patients, with incorrect or missed administration of heparin doses. The hospital failed to “track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning”. Even when made aware of these heparin medical errors, the Director of Pharmacy admitted the hospital had not specifically examined risks relating to heparin administration as part of its quality improvement efforts. During an interview on 2/28/24 at 9:09 am, the Quality Director stated they did not proactively identify heparin dose administration and calculation as an area needing performance improvement focus to prevent medical errors. She acknowledged analysis of high-alert medication risk areas and implementing preventive actions could have identified issues with heparin dose protocols and calculations to avoid the medication errors that took place across multiple patients.”

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 41567 Based on interview, and record review, the facility failed to ensure the safety of Patient 6 when Registered Nurse (RN) 25, who had been floated to the Telemetry unit (a unit for patients requiring procedures or medications administered by nurses with advanced skills, but a lower level than Intensive Care, and that require cardiac monitoring/interventions) from a lower-acuity unit, administered a cardiac drip (a solution containing a medication that affects the rate/rhythm of the heart) to Patient 6 as RN 25 believed it was expected of him to do so, as he had had the training, but no return demonstration of competency. This failure exposed Patient 6 to possible negative health outcomes, up to and including death. Findings: A facility policy titled, “Patient Safety Plan,” revised on 11/2022, was reviewed. The policy indicated that the purpose of the patient safety plan is to “assure that a planned, systematic, coordinated approach exists to improve patient safety and reduce risk to patients.” “The leaders of the organization maintain responsibility for proper collection and dissemination of information for continuing education pertaining to the patient safety program to employees,” and, “the leaders will collaborate in decision making which affects the development of hospital wide patient care programs; policies and procedures that describe how patient care needs are met.” A facility policy titled, “IV Therapy: Administration of Intravenous Medications,” revised 10/2023, was reviewed. The policy indicated amiodarone, a cardiac medication given to stabilize irregular/rapid heart rhythms, is approved to be administered on the telemetry unit. Adverse effects include “hypotension (low blood pressure), especially with the loading dose.” Patient 6 was admitted to the facility on 10/5/23 with diagnoses which included cancer of the lung, coronary artery disease (reduced blood flow to the cardiac muscle due to build-up of plaque in the arteries of the heart), and diabetes (a chronic disorder that affects how the body converts food into energy). Patient 6’s discharge summary dated 10/10/23 by MD 7 was reviewed. MD documented that Patient 6 had developed rapid atrial fibrillation (a condition of the heart where both upper chambers beat too fast and irregularly) during the admission that required amiodarone. During an interview on 2/26/24 at 11:56 am, RN 28 stated she had been given some training on cardiac medications but was not a telemetry nurse, and won’t administer cardiac medications, and stated, “I refused, I’m not doing it”, and added that she had gotten some pushback for refusing. During an interview on 2/26/24 at 12:09 pm, RN 29 stated, they don’t give us the patients with drips when we float to telemetry. During an interview on 2/26/24 at 3:33 pm, RN 25 stated he was a Medical/Surgical nurse and had been floated occasionally to the Telemetry unit and had administered cardiac drips. RN 25 recalled there had been a “crash course” on cardiac medications in HealthStream (an online learning module) and later a power point presentation in a group educational course. There was no hands-on module nor a return demonstration in which RN 25 showed competence with administering cardiac medications before he began administering them. RN 25 stated, “I’m not a tele nurse,” and stated discomfort with administering cardiac drips, and had felt pressure to administer them. Patient 6’s physician’s order/medication administration record dated 10/8/23 at 7:15 am was reviewed. Medical Doctor (MD) 6 ordered a loading dose of amiodarone 150 mg (milligrams, a unit of measure) in 100 mL (milliliters, a unit of measure) of solution, at 600 mL/hour, to be infused over 10 minutes, to be followed by a maintenance/continuous dose of amiodarone 360 mg in 200 mL of solution, at 33 mL/hour. RN 25 administered the medications ordered, the initial dose at 10:33 am, and the maintenance dose at 10:42 am. RN 25’s “orientation checklist - registered nurse,” was reviewed. The checklist included instructions for completion as follows: nurses are required to complete a self-assessment of their clinical skills indicating if they are competent or require additional instruction or supervision; once the skill is completed in front of a preceptor and assistance is no longer needed, then the column “demonstrated independently” is completed. A competency titled Telemetry Addendum outlines “this portion is to be used for those nurses that will be trained in a telemetry/cardiac monitored unit.” Both orientation checklists were filled out by RN 25 on 1/17/23. The telemetry addendum included cardiac medications, including amiodarone. On this form, validation of competency instruction outlined that the preceptor was to initial and date the appropriate column when documenting the method of assessment. There were no initials nor dates nor method of assessment in the column below this instruction. In the next column, Self-Assessment by Employee, in the line specified for amiodarone, there was a pen mark under Needs Review/Practice, then a hand-drawn “x” under Competent. In the next column, Independent Demo (demonstration), the line specified for amiodarone is initialed. The initial resembles the handwritten signature for the Ortho/Neuro Director (OND), who was also the Director for the medical/surgical unit, and RN 25’s manager. RN 25’s competency transcript was reviewed. RN 25 completed a course titled “Telemetry Float class” on 11/2/23. During a concurrent interview and record review on 2/28/24 at 1:10 pm, the Clinical Educator reviewed RN 25’s orientation checklist and competencies and telemetry addendum, and stated “independent demo” meant the preceptor/trainer had watched a return demonstration by the employee, and as it was signed by the manager, it indicated RN 25 demonstrated knowledge in amiodarone infusion. During a follow-up concurrent interview and record review on 2/28/24 at 3:27 pm, RN 25 recalled hesitating marking an “x” for competence on the amiodarone drips and started to mark himself as needing review as he still did not feel comfortable starting or maintaining cardiac drips, but felt he had to, because he had had the training. When asked if the OND had confirmed his competence with a return demonstration, he stated he had not done a return demonstration. During a concurrent interview and record review, on 2/28/24 at 4pm, the OND stated that RN 25 did not do a return demonstration with him, and that OND’s initial under “Returned Demo” indicated that the nurse deemed himself competent with the knowledge about the medication, and not the direct administration of it. He stated, nurses that float from the Medical/Surgical unit would not be responsible for a cardiac drip because floating nurses are not given extensive education on drips, that if the floating nurse was given a patient who required a cardiac drip, then the charge nurse or a trained telemetry nurse should initiate and manage the drip. He stated, we gave everyone the education, but floating nurses are not deemed competent to hang the drug. If they get an order to start a drip, they are to contact another nurse to start and manage it. “I verbally told them this is the education component, you’re not responsible for the drip, it’s education only.” During a concurrent interview, and record review, on 2/28/24 at 5:03 pm, the Discharge Admission Resource and Transfer Registered Nurse (DART RN) confirmed that she had given an in-person PowerPoint instruction to a group of nurses that would be floating to the telemetry unit, in a course titled “Telemetry Float Class,” and provided a sample agenda which included a 60-minute presentation on eight cardiac and other drips, including amiodarone. She stated the presentation was to get them familiar with the medications, and that when this class was started in October 2023, they were not meant to be assigned these drips “right off the bat” after the training, but the class was to prepare them and they were expected to administer and manage cardiac medications. She stated, we strongly enforced that there were resources out there they could go to if they got an order for a drip, training materials available and policy, and a binder with resource data on the unit, and the assistance of the charge nurse or another competent nurse. She stated there was an exercise on heparin (an anti-clotting medication) infusion at the end of the presentation but there was no hands-on demonstration nor a return demonstration required on cardiac medication, from those who had been in the class. During an interview on 2/29/24 at 8:23 am, the Clinical Educator acknowledged that mock scenarios were not the best validation of competency, particularly in emergent settings, and that a lived experience was the best method to demonstrate proficiency. During an interview on 2/29/24 at 2:35 pm, the Corporate Chief Nursing Officer stated, our telemetry unit is our step-down unit so there are drips and if the nurse floating from medical surgical or ortho/neuro has completed the competency, I would expect them to administer the cardiac drips.”

“FORM AND RETENTION OF RECORDS CFR(s): 482.24(b) The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This Standard is not met as evidenced by: 45757 Based on interview and record review, the facility failed to ensure that Patient’s 11’s medical record was accurate and complete, in written or electronic form, when medical doctor (MD) 8 shredded a POLST (POLST, a record that identifies a patient’s wishes regarding medical treatment and must be signed by an MD) that was intimated and signed by Patient 11. As a result, Patient 11’s medical record had no documentation of his resuscitation wishes for a period of time that he remained in the facility. Findings: A review of the facility’s policy titled, “Resuscitation Status,” dated 6/22, indicated that the policy’s purpose was to recognize that the facility respected the rights of patients to make decisions about their care including resuscitation status. The policy further indicated that “differences of opinion and conflicts may arise with regard to appropriateness of resuscitation status. Every effort is make to comply with the patient’s wishes within the limits of the law.” A review of the facility’s policy titled “Medical Record Content,” dated 9/2020, indicated that every medical record shall contain specific elements that included Advance Directives, Durable Power of Attorney, or Living Will. A review of medical records indicated that Patient 11 was an 80 year old male admitted to the facility on 2/14/24 to undergo a planned coronary artery bypass graft surgery x 4 (CABG, a surgery that bypasses blocked heart vessels with healthy vessels removed from the leg or chest) scheduled for 2/16/24. On 2/14/24, at 7:08 pm, MD 8 conducted Patient 11’s surgical consultation and discussed the risks, benefits, and alternatives to surgery. The consultation indicated that Patient 11 agreed “to not be a Do Not Resuscitate Status” (DNR) for the duration of surgery, and 30 days after surgery, unless the situation is completely helpless.” On 2/14/24, at 4:00 pm, a Psychosocial Evaluation conducted by the facility’s Associate Clinical Social Worker (ACSW) indicated that Patient 11 requested to change his status from full code to DNR prior to surgery, with comfort-focused treatment, and no artificial means of nutrition. On 2/14/24, untimed, Patient 11 signed a POLST form that indicated Patient 11 desired to be a DNR, with comfort-focused treatment, and no artificial means of nutrition. During a concurrent interview and record review, on 2/26/24, at 8:20 am, the Director of Performance Improvement (DPI) was asked to provide a full and complete copy of Patient 11’s medical record, including a copy of Patient 11’s signed POLST. DPI stated that Patient 11 was currently admitted to the facility receiving postoperative CABG care. DPI audited Patient 11’s complete electronic health record and Patient 11’s current working hard copy chart and did not locate a patient signed POLST. DPI stated there was no evidence of a signed POLST in Patient 11’s medical record. During an interview on 2/27/24, at 10:57 am, RN 10 verified that she was assigned to provide nursing care to Patient 11 on the 2/14/24, day shift, when Patient 11 expressed a desire to change his resuscitation status from a full code to a DNR. RN 10 stated on 2/14/24, the day before surgery, the facility’s ACSW assisted Patient 11 with changing his resuscitation status, and spelling out his wishes, on the facility’s POLST form. The facility’s POLST forms were purposefully colored fluorescent pink, and placed on the front of Patient 11’s medical chart, so that it was easily recognizable to alert staff of Patient 11’s desire to change resuscitation status. During an interview on 2/27/24, at 10:17 am, ACSW stated that on 2/14/24, she assisted Patient 11 with documenting his resuscitation wishes on a POLST form the day prior to his CABG surgery, scheduled for 2/15/24. ACSW reported she left the original, bright pink, POLST that Patient 11 signed on the front of his medical record, awaiting MD signature. ACSW reported MD 8 wasn’t notified that Patient 11 desired to change his resuscitation status until the morning of surgery, after Patient 11 had already received a sedative (a medication used to relax patients prior to surgery). Since Patient 11 was not coherent to discuss the change in his resuscitation wishes, the CABG surgery was postponed. ACSW reported that MD 8 appeared surprised and agitated over the surgery being cancelled. MD 8 immediately made telephone contact with Patient 11’s friend on file and requested for the friend to rescind Patient 11’s DNR wishes while Patient 11 was sedated. ACSW stated that since Patient 11 was responsible for his own health care, and did not have a power of attorney (POA, a legal document that grants another person the authority to make health decisions on a patient’s behalf) on file, only Patient 11 could make decisions on his health care. After MD 8’s telephone conversation with Patient 11’s friend, ACSW observed MD 8 placing Patient 11’s signed POLST in the facility’s shredder bin. ACSW reported the only reason there was evidence of Patient 11’s signed POLST was because she happened to make a copy for her office files. ACSW stated five minutes prior to this interview, the facility’s DPI discovered that ACSW had proof of Patient 11’s signed POLST and requested a copy for the medical record. During a telephone interview on 2/26/24, at 6:46 pm, RN 18 stated she was the cardiovascular Operating Room (CVOR) nurse assigned to conduct the preoperative checks with Patient 11 and bring him up to the CVOR. RN 18 stated that she wasn’t made aware of Patient 11’s desire to change his resuscitation status, and newly signed POLST, until after Patient 11 received sedation. Since Patient 11 was not coherent to have an informed discussion on his resuscitation wishes, or the CVOR resuscitation requirements, Patient 11’s surgery was temporarily delayed until the facility’s administrators decided how to move forward. During this time, MD 8 placed telephone calls to Patient 11’s friend, who was not a listed family member or next of kin, to discuss rescinding the DNR and proceeding with surgery. RN 18 stated that after MD 8 spoke with Patient 11’s friend, he advised the OR RNs that surgery was back on because he “dealt with the issue and made the POLST disappear.” During an interview on 2/26/24, at 3:57 pm, the facility’s perfusionist (PERF, a specialist who operates the heart lung machine during open heart surgery) stated RN 18 reported to PERF that there appeared to be a patient-initiated, DNR / POLST that was initiated and signed by Patient 11 after MD 8 had conducted a surgical consultation confirming Patient 11 was a full code. PERF stated that if a patient initiated paperwork to become a DNR, the patient would have to be involved in rescinding the DNR. PERF reported that he, and the CVOR team, were waiting for the facility’s leadership team to decide how to proceed, when MD 8 presented to the OR and advised the CVOR staff to continue preparing for surgery because “he dealt with the POLST issue and made it disappear.” PERF stated, when he questioned MD 8 about the details of the POLST, MD 8 stated he shredded the document. PERF reported he had provided care to Patient 11 after this incidence, and confirmed that the Patient 11’s paper chart, and electronic record, had no evidence of a previously signed POLST. During an interview on 2/29/24, at 1:30 pm, the Chief Nursing Officer (CNO) reported that a POLST was not active until it was co-signed by an MD. However, if there was a discrepancy in understanding a patient’s wishes, the provider must discuss the contents of the patient’s POLST with the patient. CNO stated that he was aware of Patient 11’s missing POLST because MD 8 informed the CNO that he shredded Patient 11’s POLST document. CNO stated it was his expectations, and the facility’s policy, that original medical records were not to be shredded nor disposed. CNO reported that the issue was elevated to the facility’s peer-review board for a formal investigation.”

“CONTENT OF RECORD: ORDERS,NOTES,REPORTS CFR(s): 482.24(c)(4)(vi) [All records must document the following, as appropriate:] All practitioner’s orders, nursing notes, reports of treatment, medication records, radiology and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition. This Standard is not met as evidenced by: 22705 Based on interview and record review, the Emergency Department (ED) physician did not document a daily progress note for a mental health patient (Patient 25), who was in the ED overflow unit. This had the potential for a change in the patient’s condition to go unrecognized. Findings: A review of Patient 25’s record indicated she presented to the Emergency Department (ED) on 2/8/24 at 3:57 pm, with suicidal ideations. Mental health evaluated her and she was placed on a mental health hold. She was transferred to the ED overflow area to await disposition. She was transferred to another hospital on 2/10/24 at 8:43 am. There was one physician’s note by the ED physician on 2/8/24, but no further notes or physical assessments by a physician were in the record. During a concurrent interview and record review on 2/28/24 at 2:45 pm, the Director of Performance of Improvement (DPI) confirmed she was unable to find an interval progress note by the ED physician, in the record, but there should have been a daily note. She said the new nursing director of the ED has a new process started to prevent future occurrences. The Medical Staff Rules and Regulations indicated under progress notes: “The attending physician or an allied health professional with appropriate privileges, must ensure documentation of daily dated hospital visits and progress notes must reflect the condition of the patient and course of therapy, as the patient’s condition warrants, and such notes must provide continuity of care and transferability.””

“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: 26917 Based on interviews and record reviews, the facility failed to adequately develop or update and then implement policies and procedures to identify and minimize drug errors, the facility has had a history of high alert medication errors, and subsequently, heparin also a high alert medication was involved in multiple medication errors. The facility’s policy improvements were insufficient to effectively identify and prevent heparin-related medication errors. The absence of an effective response to these recurring medication errors indicates a significant oversight in the facility’s approach to patient safety as evidenced by: 1. There were six heparin continuous infusion medication errors identified for three of three patients (Patients 1, 2, and 3) receiving heparin drip. These errors can have severe consequences, including severe injury or even death, as heparin is an anticoagulant that thins the blood and affects the body’s ability to form clots. Inappropriate administration of heparin can lead to bleeding complications or inadequate anticoagulation, both of which pose significant risks to patient safety. 2. As a high-risk medication, heparin administration requires a double-check process, in which one nurse prepares and calculates the dose while a second nurse verifies the preparation and calculations before administration. However, this double-check system failed to function effectively at the hospital, as evidenced by the occurrence of multiple continuous infusion heparin medication errors that had been double-checked. Findings: 1. During an interview and record review on 2/27/24 at 11:45 am, the Director of Pharmacy (DOP), Staff Pharmacist I, and the Director of Intensive Care Unit (ICU)discussed the following medication errors: *Patient 1 received heparin therapy as a preventive measure against blood clots, with dosages adjusted based on aPTT levels. Registered Nurse (RN) 1 administered a significant underdose (400 units instead of 4000 units), and RN 2 made dosage errors, including an underdose based on aPTT 35 and failure to follow protocol at aPTT 90. These deviations from protocol pose risks of compromised anticoagulation and violate hospital policy. *Patient 2, with a history of heart problems, had heparin dosages adjusted by protocol. RN 3 administered an excessive bolus (4000 units instead of 3500 units), risking potential bleeding complications. RN 4 failed to administer a prescribed bolus at aPTT 28, violating protocol. The ICU Director emphasized adherence to protocol even if EMR lacks information. *Patient 3 received heparin for clot prevention, with RN 5 administering a lower infusion rate (13 mL per hour instead of 14 mL per hour) at aPTT 29. This deviation could lead to suboptimal anticoagulation, increasing the risk of complications. Adherence to dosage protocols is crucial for patient safety and optimal treatment outcomes in heparin administration. During an interview on 2/28/24 at 8:00 am, with the DOP, he acknowledged that the facility had a history of insulin medication errors like the heparin medication errors that occurred. He admitted that the facility had not specifically examined heparin administration and was unaware of any reported errors or issues related to heparin. He also recognized that the root cause of the insulin medication errors was the complexity and confusion surrounding the orders and acknowledged that heparin orders shared similar challenges in terms of dose calculation. The DOP conceded that the facility should have reviewed other high-risk medications, including heparin, to identify potential difficulties in calculating correct doses and reduce the risk of similar errors. He acknowledged that the policy needed to be improved to identify high risk medication errors. 2. During an interview on 2/27/24 at 4:00 pm, the DOP, Staff Pharmacist I, and the Director of Intensive Care Unit discussed the following medication errors and the nurses that double checked these errors. The nurses involved in the double-checking process for the heparin medication errors were as follows: *For Patient 1: RN 6, RN 7, RN 8, and RN 9 *For Patient 2: RN 10 and RN 11 *For Patient 3: RN 12 These nurses were responsible for verifying the heparin dose calculations and ensuring the correct amount was drawn up prior to administration. However, despite their efforts, errors still occurred, indicating a need to reevaluate and improve the double-check process. During an interview on 2/27/24 at 4:00 pm, the DOP, Staff Pharmacist I, and the Director of Intensive Care Unit discussed, and it was revealed that seven nurses were involved in double-checking the heparin dose calculations and verifying the correct amount drawn up prior to administration. Despite this double-check process, the calculations were incorrect, and the nurses inadvertently confirmed the errors. This situation highlights a critical breakdown in the double-check system, which was intended to serve as a safety net for catching and preventing medication errors. During an interview on 2/29/24 at 9:30 am, RN 12 reported that she double-checked and signed off on the heparin dosage for Patient 3, collaboratively calculating the dose and visually verifying the IV pump’s rate change to ensure its appropriateness. She mentioned that the computer system’s workflow for calculating heparin rate changes is challenging, and discrepancies exist between the protocol and the computer system. The presence of old file cabinets containing outdated protocols and policies contributes to this confusion. For instance, an insulin protocol from 2019 was recently replaced with an updated version from 2023, but the outdated paper protocol was still in circulation. This discrepancy between paper and computer-based protocols, along with the use of outdated paper protocols, often leads to confusion among the nursing staff. In many cases, nurses rely on paper protocols, which may not reflect the most current guidelines, resulting in potential medication errors. During an interview on 2/29/24 at 11:30 am, RN 10 stated that she double-checked and signed off on the heparin dosage for Patient 2, collaboratively calculating the dose and visually inspecting the medication. She mentioned that using separate protocols for cardiac and deep vein thrombosis (DVT) cases increases the potential for errors, as it is crucial to ensure that the correct protocol is used for each situation-she also mentioned she was not sure if this is what happened. RN 10 also acknowledged witnessing other nurses making similar errors due to the complexity of the process. She highlighted that there are multiple places to calculate the heparin dose, including the electronic medical administration record (eMAR) and paper protocols, which may lead to inconsistencies. Additionally, some of the paper protocols were outdated, further contributing to potential errors. To minimize confusion and enhance medication safety, RN 10 suggested separating the cardiac and DVT protocols and ensuring that each protocol was used appropriately for its intended purpose. This improvement can help reduce the risk of heparin medication errors and promote better patient outcomes. A total of 12 nurses were involved in the incorrect calculation of heparin bolus doses and infusion rate changes, resulting in medication errors. These 12 nurses, who were responsible for the administration and including the double-check process, unfortunately, did not catch the heparin medication errors.”

“ORGANIZATION OF SURGICAL SERVICES CFR(s): 482.51(a) The organization of the surgical services must be appropriate to the scope of the services offered. This Standard is not met as evidenced by: 45757 Based on observation, staff interviews and record reviews, the facility failed to ensure that the scope of surgical services was staffed and organized to ensure that surgical personnel reported to qualified surgical clinical supervisors with knowledge and expertise in surgical service operations. This failure had the potential to compromise the quality of nursing services delivered to all surgical patients, and result in adverse patient outcomes. Findings: A review of the facility’s document titled, “Provision of Patient Care Manual- Operating Room”, dated 10/23, indicated the facility’s Operating Room (OR) provided surgical nursing care 24 hours a day, seven (7) days a week to surgical patients and consisted of six (6) general surgery operating rooms and one (1) CVOR on the second floor. The CVOR (cardiovascular OR) was available and staffed 24 hours a day seven (7) days a week for the open-heart program and will be included in the three (3) or four (4) rooms used for surgery. Surgical procedures were performed in the following specialties with appropriate equipment available for procedures: General Surgery ,Orthopedics, Ear Nose and Throat, Plastics, Cardiovascular, Neuro & Ortho Spine, Podiatry, Urology,Thoracic, Gynecology, and da Vinci Robotic Surgery. The department is staffed with the Director of Perioperative Services, OR Supervisor, Clinical Supervisors, Registered Nurses, Relief Clinical Supervisors, Scheduler/Billers, Surgical Scrub Technicians, Bio-Med/Equipment/Anesthesia Tech, OR Attendants, and Case Facilitator. A review of the facility’s document titled, “Job Description Nursing Director Surgical Services”, dated 1/2014, indicated that the “Director of Surgical Services was responsible for direction of patient care in the operative environment.” Requirements for this position include, “At least 2 years experience in Surgical Nursing,” and “Current Certified Nurse OR (CNOR) (AORN) certificate(s) upon hire, preferred.” (AORN, Association of Operating Room Nurses). The job description’s Performance Accountability Section indicated ...”2. Performs all aspects of care in an environment that optimizes patient safety and reduces the likelihood of medical/health errors...” A review of the facility’s document titled, “Job Description Clinical Supervisor OR”, revised 1/2018, indicated that the OR Clinical Supervisor (ORCS) reported to the facility’s Nursing Director of Surgical Services. The Clinical Supervisor job summary indicated that ...”The clinical supervisor prepares, conducts, and/or oversees department(s) orientation and training of personnel....was responsible and accountable for the quality of staff and function during their shift. Assists the Department Director in the daily operation of the unit, directing, supervising, and evaluating personnel....The Clinical Supervisor’s knowledge and accountability requirements included...”Recognizes, evaluates, and responds appropriately to operational emergencies or unusual situations...Leadership responsibility and accountability was to ensure quality patient care and unit operations in the department...” The Job Duties and Responsibilities indicated that when the Clinical Supervisor was in charge they served as a resource to staff in their area of expertise. During a concurrent interview and record review, on 2/28/24, at 11:00 am , the facility’s Human Resource Generalist (HR) stated that RN 20 was hired as the facility’s ORCS on 10/25/23 and received her RN license on 1/01/1972. RN 20 had not worked as a Registered nurse since 11/2011. RN 20’s prior nursing experience included work an outpatient medical clinic from 1/2004 - 11/2011, and managing local “Surgery Center,” a small ambulatory surgery center with 2 ORs, from 2002 - 2004. RN 20’s resume did not include any perioperative nursing experience in the last 22 years. A review of a document titled the facility’s “Perioperative Services Department Orientation List”, dated 10/25/23, indicated that the purpose of the checklist was to provide new employees with an orientation to the OR to promote consistency and quality patient care and to acquaint the employee with the environment. The document indicated that “this form should be completed before access to the OR and kept in a file in the OR education office.” The Orientation packet further indicated that RN 20, who was hired and operating as the facility’s ORCS, did not receive training, or have proof of validated competencies, in the following perioperative areas: 1. End of case Process (processes in end of case completion) 2. Electrosurigcal Safety (safe use and operation of the Electrosurigcal unit) 3. Marking the surgical site procedure (knowledge requirements for marking of the surgical site) 4. Opening Sterile Supplies, 5. Patient Identification 6. Patient positioning (competency for positioning the surgical patient)- needs improvement, 7. Pyxis System (competency in operating the Pyxis system to obtain OR medication and narcotics) 8. Skin Preparation (preoperative hair removal with clippers and surgical skin preparation, 9. Specimen (handling of surgical specimens) 10. Sterile Processing/ Decontamination Room 11. Surgical Safety Checklist 12. Surgical Sharps Management 13. Time Out process 14. Tourniquet (use of pneumatic tourniquet) 15. Verification of Surgical Site, and 16. Wound classification. During an interview on 2/26/24, at 3:00 pm, OR Scrub Technician (ORST) 1 reported that the current ORCS, RN 20, had been the facility’s ORCS for several months and had continued difficulty with basic nursing skills. ORST 1 stated that RN 20 had no recent nursing experience, and was not up to speed with OR flow or practice. ORST 1 stated that RN 20 had transported surgical patients to incorrect OR rooms, made errors in verifying surgical consents, and was not confident assisting in the OR during surgery. ORST 1 stated since the facility frequently employed OR nurse travelers (RNs who accept a temporary assignment in a facility that is severely short staffed), it was important that the facility’s ORCS was a skilled expert in OR nursing, to ensure the travelers understood the facility’s nursing practice before they “hit the ground running.” ORST 1 stated there was no sense of leadership in the surgical services unit because RN 20 did not have any OR experience to gain respect or leadership. During an interview on 2/26/24, at 4:24 pm, RN 17 reported that the ORCS, RN 20, came out of retirement and had not worked in the health care industry for 13 years. RN 17 stated that ORCS, RN 20 had no idea how to deliver fundamental nursing services in the OR. ORCS, RN 20 could not assist with arterial line placement, circulating the OR (when a nurse assists the surgeon and OR team), or set-up or break down of an OR after use. RN 17 stated since the facility did not have a strong OR leader, various OR nurses attempted to “take over “ and change the facility’s nursing processes. During a telephone interview on 2/26/24, at 6:46 pm, RN 18 stated she had 7 years experience as a CVOR nurse and was hired to work in the facility’s CVOR as a traveler. RN 18 stated that the ORD relied on her to orient new OR RNs, and that the ORD requested for RN 18 to train RN 20. RN 18 declined to train RN 20 because RN 20 hadn’t worked as an OR nurse for approximately 20 years and lacked the basic building blocks of OR nursing. RN 18 stated that RN 20 was unsafe working in the facility’s OR. During an interview with 2/27/24, at 5:36 pm, MD 3 stated that the ORCS, RN 20 was incompetent in OR nursing, and was only being utilized to run the the OR board ( a posting of the daily OR patient schedule). MD 3 reported that he observed the ORCS receiving supervision from the OR nursing staff versus providing nursing supervision. MD 3 stated this was a very dangerous dynamic because the facility’s ORCS and ORD did not have the knowledge or experience to identify poor nursing practice. During an interview on 2/28/24, at 9:11 am, Certified Nursing Assistant (CNA) 1 stated that RN 20, the facility’s new ORCS, was unable to work independently and needed constant support from all of the OR staff. CNA 1 reported RN 20 continually requested assistance trying to locate different instruments for the surgeons and OR staff. CNA 1 reported he had to remind RN 20 of the same surgical instruments name and location multiple times. CNA 1 stated that although RN 20 was responsible for patient flow in the OR, he would assist her with transporting patients because she continually got confused on the patient’s location in the facility. During an interview on 2 /28/24, at 9:26 am, RN 21 stated that the ORCS, RN 20 did not know how to use the Pyxis (an automated medication dispensing system), despite being trained multiple times. RN 21 reported that she and RN 19 were orienting RN 20 on how to mix medications for ORSTs during surgery, however they stopped the orientation with RN 20 because she was having difficulty with the mathematics necessary to ensure medication safety. During an interview on 2/28/24, at 1:07 pm, MD 2 stated that the ORCS, RN 20, was unable to follow the basic nursing processes required to correctly obtain a patient’s surgical consent prior to transporting the patient to the OR (Refer to A - 955) . During an interview on 2/27/24, at 11:48 am, ORD reported that she hired RN 20 for the ORCS position because she met the minimum job description requirements and had a history of OR nursing experience. ORD verified that RN 20’s OR Orientation Checklist was incomplete and missing several dates and signatures that validated RN 20’s OR nursing competencies. ORD stated she had received some staff complaints regarding RN 20’s job performance and OR nursing skills, but ORD felt that those comments were based off of ageism and not RN 20’s job performance. ORD reported that RN 20 had not displayed any “direct incompetence”, but that RN 20 did have “room to grow.” ORD acknowledged that the facility’s job description required the ORCS to provide expertise and support to the OR staff. ORD stated that she depended on her more experienced OR nurses to provide expertise and support to the OR staff while RN 20 developed into her ORCS role, which was a process that did not align with the facility’s organizational structure, chain of command, or surgical services provision of care policy. During an interview on 2/29/23, at 1:30 pm, the Chief Nursing Officer (CNO) stated the expectation of the ORCS role was that the nurse be experienced and proficient in delivering OR nursing care, circulate OR cases when needed, assist with OR room turnovers, and run the OR board. CNO stated that it was his expectations that the ORCS be proficient and competent in OR nursing to assist with supervising and managing the team.”

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 45757 Based on interview and record review, the facility failed to ensure that prior to surgery, one of two surgical patients’ (Patient 9) medical record contained a medical doctor (MD) order to properly execute an informed surgical consent and an MD attestation related to a discussion with the patient, or family, of the risks, benefits, alternatives and complications of the surgical procedures to be performed. As a result, Patient 9 was transported to the facility’s operating room (OR), and administered anesthesia, prior to MD 4 conducting an in-person surgical consultation with Patient 1, confirming Patient 1’s exact surgical procedure, or generating an MD order for a properly executed surgical consent. This failure resulted in the potential for Patient 9 to be misinformed on the surgical procedure the surgeon intended to perform, and the risks, benefits, and alternatives to the procedure. Findings: A review of the facility’s policy titled, “Decision Making: Consent Requirements for Medical Treatment,” dated 2/2024, indicated that the policy’s purpose was to facilitate a consent process that reflects good practice, contributes to patient safety, and is in compliance with applicable legislation. The policy’s procedure indicated that “1. The physician performing the procedure and/or anesthesia/sedation is responsible to give the patient risks, benefits, and/or alternatives for the procedure.. which is necessary for the patient to make an informed consent decision....4.2 Consent form documentation. Name of specific treatment/procedure(s) filled in as physician ordered.” A review of the facility’s policy titled, “Consents-Preoperative Services”, dated 4/2020, indicated that the policy’s purpose was to establish guidelines for consents. The policy’s procedure indicated that ...”2. Consent shall be obtained from the surgeon’s order sheet, verbal order, or from the history and physical plan of care...” A review of a History and Physical, dated 2/25/24, at 11:31 pm, indicated that Patient 9 presented to the facility’s Emergency Department (ED) on 2/25/24, with complaints of a slight hardening of upper abdomen and purulent discharge from a previous surgical wound from a recent laparoscopic partial colectomy (the surgical removal of diseased colon). Patient 9 was subsequently admitted to the facility, and was awaiting a surgical and interventional radiology consult for abdominal wound draining on 2/26/24. The History and Physical did not indicate the exact surgical procedure Patient 9 was scheduled for, or the risks, benefits, and/or alternatives related to the surgical procedure. A review of the Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures, dated 2/26/24, indicated that Patient 9 consented on 2/26/24, at 4:59 pm, for MD 4 to perform an “Incision and drainage abdominal abcess; possible wound vac placement.” The consent was co-signed, and witnessed, by Registered Nurse (RN) 33. A review of the Anesthesia Record, dated 2/26/24, indicated that Patient 9 was transported to the OR 1, at 5:10 pm, and administered intravenous versed (a sedative that helps patients feel relaxed and sleepy before surgery) at 5:10 pm. A review of Progress Notes, dated 2/26/24, at 5:29 pm, indicated that MD 4 consulted with Patient 9, confirmed the intended surgical procedure, discussed the surgical procedure’s.. “risks, benefits, and alternatives...” , and obtained informed consent, 19 minutes after Patient 9 received sedation in OR 1. A review of an MD Order for Surgical Consent, dated 2/26/24, at 5:30 pm, indicated that MD 4 generated an MD order detailing the exact planned surgical procedure to be performed that was to be transcribed on Patient 9’s surgical consent prior to patient signature, 31 minutes after Patient 9 signed the nurse generated “Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures document.” During a concurrent record review and interview, on 2/27/24, at 3:50 pm, the OR Director (ORD) and Director of Performance Improvement (DPI) verified that MD 4 did not generate a surgical consent order, or conduct a surgical consultation, until after Patient 9 was transported to the OR and administered sedation. During an interview on 2/28/24, at 12:37 pm, OR Scrub Technician (ORST, a technician whose primary duties include preparing the operating room before surgery and working closely with the surgical team) 2 verified he was the ORST that assisted MD 4 with Patient 9’s surgery. ORST 2 stated that the OR Clinical Supervisor (ORCS, a RN who supervises the OR staff), RN 20, advised the OR team that MD 4 was on site in the facility, had seen Patient 9, and was “ready for the patient to go” to OR 1. ORST 2 stated when MD 4 entered OR 1, he was upset that Patient 9 was already transported to the OR, and administered sedation, because he hadn’t seen Patient 9 to conduct a surgeon consult, generate an MD order for surgical consent, or mark Patient 9’s surgical site. During an interview on 2/28/24, at 1:07 pm, MD 2, the anesthesiologist for Patient 9’s case, stated that the ORCS, RN 20, informed the OR team that MD 4 was onsite, had conducted a face-to-face MD visit with Patient 9, and was ready to proceed to the OR. MD 2 reported that he had covered his portion of the anesthesia informed consent, and verified that the surgical consent was signed and dated, because he had assumed nursing staff were operating off of MD orders. During an interview on 2/28/24, at 8:12 am, the ORCS, RN 20, stated that standard of practice, and facility policy, was that surgical consents were generated directly from an MD order. ORCS reported on 2/26/24, she spoke with Patient 9’s surgeon, MD 4, earlier in the day to confirm that surgery was “a go”, but she did not receive a verbal order for the surgical consent, nor did she document a verbal order for surgical consent in Patient 9’s medical record. ORCS stated she could not recall if she filled out the “surgical procedure to be performed” on Patient 9’s surgical consent, despite acknowledging that this portion should only be transcribed directly from an MD order. ORCS confirmed that she notified the OR staff, and MD 2, that Patient 9 was “good to go” to the OR. ORCS reported that this statement was referencing that MD 4 confirmed surgery was still “a go”, and not a confirmation that all of the preoperative procedures had been completed. During an interview on 2/27/24, at 3:30 pm, ORD stated that transporting a patient to the OR to begin a surgical procedure, without an MD ordered surgical consent or an MD consultation, was a serious nursing process violation. ORD reported that the facility’s policy, and her expectations, were that surgical consents are always generated from MD orders and transcribed “word for word, without abbreviations, with every work spelled out.” ORD reported that nursing staff should not transport a patient to the OR prior to a surgeon “getting eyes on patient, confirming the surgical procedure, and getting informed consent from the patient.” ORD stated she had serious concerns of a break in policy because these are basic OR nursing processes. During a telephone interview on 2/27/24, at 4:40 pm, MD 4 reported that when he entered the facility he was surprised that Patient 9 was already taken to OR 1 and sedated. MD 4 stated he had not conducted a face-to-face consultation with Patient 9, had not solidified the exact surgical procedure to be performed, and had not generated an order for a surgical consent prior to Patient 9 being transported to OR 1 and sedated. MD 4 stated that, luckily, he had a telephone consult with Patient 9 earlier in the day to discuss his anticipated plan for surgery and the procedure’s risks and benefits, however the facility nursing staff were not aware of this, and should not have transported Patient 9 to the OR until they verified that these components were completed and correct. MD 4 stated he had concerns with this “major break in protocol”, especially since the OR nursing staff generated a surgical consent off of “assumptions” and not MD order.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 45757 Based on interview and record review, the facility failed to protect and promote each patients’ rights when: 1. The Center for Behavioral Health unit (CBH,a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders) did not have adequate staff to provide continuous line of sight (LOS, a level of observation that requires a designated staff member to perform constant and continuous visual observation of a patient to prevent patients from harming themselves or others) observation for two of 17 CBH patients (Patient 2 and Patient 3) on legal holds (the involuntary detainment of an adult who is experiencing a mental health crisis and at risk for harming themselves or others). As a result, one nursing assistant (NA, an unlicensed staff member that provides basic nursing care and assists in maintaining a safe environment) was assigned to perform continuous LOS observations on Patient 2 and Patient 3, who were admitted into two separate rooms, and not simultaneously visible to the NA. This failure resulted in Patient 2, a high-suicide risk patient, being discovered unresponsive, with bluish-colored skin, and a pulse oximetry cord (SPO2 cord, a cable that connects to an oxygen measuring device) wrapped several times around her neck. Subsequently, a code blue was activated, the ligature cord was removed, and Patient 2 regained consciousness. An Immediate Jeopardy under A-0144 was issued on 12/01/23. The hospital submitted a plan to remove the immediacy on 12/01/23 and the Immediate Jeopardy was removed during onsite verification on 12/04/23. (Refer to A 144, Finding 1) 2. The CBH unit was not staffed with an adequate number of NAs or mental health technicians (MHTs, an unlicensed staff member that assists licensed nurses with behavioral interventions and maintaining a safe environment) to designate a staff member to conduct 15-minute patient safety rounds (a minimum level of observation required on every CBH patient to monitor patient safety. Each patient’s location, activity, and behaviors are observed and documented in 15 intervals. Safety rounds take the entire 15 minutes, before they are repeated for the next interval). As a result, a CBH clinical supervisor (CBHCS, a registered nurse who supervises the operations and nursing services of the CBH unit), a CBH registered nurse (RN)s, or a CBH licensed vocational nurse (LVN) was assigned to provide complete direct-care nursing services to six CBH patients while also being assigned to perform the unit’s 15-minute patient safety rounds, to all CBH patients, during the 10/01/23 day shift, 10/08/23 day shift, 10/12/23 night shift, 10/15/23 day shift, 10/18/23 day shift, 11/01/23 night shift, 11/11/23 night shift, 11/15/23 night shift, and 11/26/23 night shift. This failure potentially placed all CBH patients at risk for poor nursing care, compromised safety, and an unsafe environment. (Refer to A 144, Finding 2) 3. The CBH unit did not implement the facility’s Staffing Plan Policy, and utilize the facility’s Patient Classification System Matrix, to identify patient acuity levels and determine patient needs, which included: Patient hours in physical restraints, line of sight or 1:1 observation level, suicide risk, seclusion placement, oxygen tubing ligature risk, intravenous line (IV, a tube placed through the skin into a vein to deliver fluids or medication) placement/ ligature risk, fall risk or other higher acuity needs. As a result, the CBH unit was unable to determine appropriate staffing levels of licensed and unlicensed staff needed to meet the patients’ needs, and maintain a safe environment, from 10/01/23 - 11/30/23. This failure potentially placed all CBH patients at risk for poor nursing care, compromised safety, and an unsafe environment. (Refer to A 144, Finding 3) 4. The facility’s staff failed to ensure that the use of restraints for Patient 1 was in accordance with a physician (MD), or other licensed independent practitioner (LIP), order. This failure resulted in Patient 1 being placed in bilateral soft wrist restraints without an MD/LIP order. (Refer to A-0168) 5. Based on interview and record review, the facility failed to provide continuous monitoring of a patient in restraints when staff did not perform 15 minute Behavioral Health Restraint Assessments (BHRA, assessments conducted every 15 minutes that assesses a patient’s vital signs, hygiene and elimination needs, nutrition and hydration needs, and physical and psychosocial needs) when Patient 1 was placed in bilateral soft-wrist restraints. This failure resulted in Patient 1 remaining in restraints without his safety needs, physical needs, or psychosocial needs being frequently assessed and reevaluated. As a result, Patient 1 remained in restraints for 6 hours and 37 minutes without his vitals signs being measured, without being offered a lunch time meal tray, and without being reevaluated to determine if Patient 1 met criteria to discontinue restraint use. (Refer to A 0175) The cumulative effect of these systemic problems caused actual harm to one patient in the CBH and had the potential to compromise the safety and quality of care for all patients in the CBH and ED.”

“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: 45757 Based on interview and record review; 1. The facility failed to have an adequate number of registered nurses (RN) in the Emergency Department (ED) to provide immediate supervision of patient care provided to patients by licensed vocational nurses (LVNs) and prevent the medication administration error to one of one patients, by a LVN assigned to the patient’s care. (Refer to Finding A 392) 2. The facility’s registered nurses (RN) failed to perform initial and on-going patient assessments for 27 of 27 of patients assigned to licensed vocational nursing staff on the Center for Behavioral Health Unit (CBH, a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders). (Refer to Finding A 395) An Immediate Jeopardy under A-0392 was issued on 12/07/23. The hospital submitted a plan to remove the immediacy on 12/14/23 and the Immediate Jeopardy was removed during onsite verification on 12/15/23. As evidenced by: 1a. A RN was not immediately available to supervise LVN staff assigned in Emergency Department Overflow (EDOF, a 7-bed, contained section of the Emergency Department (ED) for patients on legal mental health holds or patients requiring psychiatric stabilization) and provide assistance with patient care and medication administration verification of insulin (a medication used to regulate the amount of sugar in the blood) administration. As a result, Patient 1 was administered an incorrect dose of 70 units of Humalog insulin (a short-acting insulin that last 2-4 hours), as opposed to the correct medical doctor (MD) ordered dose of 7 units. (Refer to A 392, Finding 1a) 1b. A RN was not immediately available to supervise the patient care and medication administration by LVN staff in EDOF and ensure the facility’s Blood Glucose (BG - blood sugar) Management and Hypoglycemia (low blood glucose) Protocol was implemented for Patient 1 in EDOF, who sustained a blood glucose of 50 milligrams (mg) per deciliter (dL) (normal range is 70 -100 mg/dL), following an insulin administration error. As a result, Patient 1 did not receive appropriate nursing services or care while he experienced lethargy, somnolence (excessive sleepiness and drowsiness), and a deterioration of neurological status (a decrease in brain function). (Refer to A 392, Finding 1b) 1c. A RN was not immediately available in EDOF to perform a registered nurse face-to-face evaluation or assessment that is required by facility Policy and Procedure to initiate a behavioral restraint order. As a result, LVN 1 placed Patient 1 in restraints, without RN evaluation or assessment, for approximately six hours. (Refer to A 392, Finding 1c) 1d. An RN was not immediately available in EDOF to provide RN patient care services, perform a physical health assessment, and change of condition assessment on Patient 1 in EDOF. As a result, Patient 1 did not receive a start of shift baseline physical health assessment or change of condition assessments when Patient 1 presented lethargic, somnolent, and was noted to have severe confusion and neurological deterioration following an incorrect insulin administration error. (Refer to A 392, Finding 1d) 1e. The EDOF unit did not utilize a patient classification system to determine that appropriate staffing levels, and staff classifications (RN, LVN), were followed to meet the patients’ needs. As a result, an LVN was assigned to nursing care for Patient 1 who was triaged (the sorting of patients according to the urgency of their need for care) as a Level II acuity (a method used to categorize ED patient needs. A Level II patient is considered unstable due serious acute injury and will become Level I without immediate attention) in the facility’s EDOF unit. These failures resulted in actual harm to Patient 1 due to a preventable medication error and could further result in potential medication errors, treatment errors, nursing care errors, patient injury, harm, impairment, and death. (Refer to A 392, Findings 1 a -e) 2. Registered nurses (RN) failed to perform initial and on-going patient assessments of 27 of 27 patients (Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, patient 25, Patient 26, Patient 27, and Patient 28) assigned to licensed vocational nursing (LVN) staff on the Center for Behavioral Health Unit (CBH, a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders). (Refer to Finding A 395) The cumulative effect of these systemic problems had the potential to compromise the safety and quality of care for patients in the CBH and ED, and caused actual harm to one patient in the CBH.”

“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: 45757 Based on observation, interview, and record review the facility failed to provide a safe environment, reduce ligature risk (an item that can be used for the purpose of hanging or strangulation), and protect patients admitted to the Center for Behavioral Health unit (CBH, a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders) from self-harm or harming others when: 1. The CBH unit did not have adequate staff to provide continuous line of sight (LOS, a level of observation that requires a designated staff member to perform constant and continuous visual observation of a patient to prevent patients from harming themselves or others) observation for two of 18 patients (Patient 2 and Patient 3) on legal holds (the involuntary detainment of an adult who is experiencing a mental health crisis and at risk for harming themselves or others). As a result, one nursing assistant (NA, an unlicensed staff member that provides basic nursing care and assists in maintaining a safe environment) was assigned to perform continuous LOS observations on Patient 2 and Patient 3, who were admitted into two separate rooms, and not simultaneously visible to the NA. This failure resulted in Patient 2, a high-suicide risk patient, being discovered unresponsive, with bluish-colored skin, and a pulse oximetry cord (SPO2 cord, a cable that connects to an oxygen measuring device) wrapped several times around her neck. Subsequently, a code blue was activated, the ligature cord was removed, and Patient 2 regained consciousness. 2. The CBH unit was not staffed with an adequate number of NAs or mental health technicians (MHTs, an unlicensed staff member that assists licensed nurses with behavioral interventions and maintaining a safe environment) to designate a staff member to conduct 15-minute patient safety rounds (a minimum level of observation required on every CBH patient to monitor patient safety. Each patient’s location, activity, and behaviors are observed and documented in 15 intervals. Safety rounds take the entire 15 minutes, before they are repeated for the next interval). As a result, a CBH clinical supervisor (CBHCS, a registered nurse who supervises the operations and nursing services of the CBH unit), a CBH registered nurse (RN)s, or a CBH licensed vocational nurse (LVN) was assigned to provide complete direct-care nursing services to six CBH patients while also being assigned to perform the unit’s 15-minute patient safety rounds, to all CBH patients, during the 10/01/23 day shift, 10/08/23 day shift, 10/12/23 night shift, 10/15/23 day shift, 10/18/23 day shift, 11/01/23 night shift, 11/11/23 night shift, 11/15/23 night shift, and 11/26/23 night shift. This failure potentially placed all CBH patients at risk for poor nursing care, compromised safety, and an unsafe environment. 3. The CBH unit did not implement the facility’s Staffing Plan Policy, and utilize the facility’s Patient Classification System Matrix, to identify patient acuity levels and determine patient needs, which included: Patient hours in physical restraints, line of sight or 1:1 observation level, suicide risk, seclusion placement, oxygen tubing ligature risk, intravenous line (IV, a tube placed through the skin into a vein to deliver fluids or medication) placement/ ligature risk, fall risk or other higher acuity needs. As a result, the CBH unit was unable to determine appropriate staffing levels of licensed and unlicensed staff needed to meet the patients’ needs, and maintain a safe environment, from 10/01/23 - 11/30/23. This failure potentially placed all CBH patients at risk for poor nursing care, compromised safety, and an unsafe environment. Findings 1. A review of the facility’s policy titled, “Suicide Risk Assessment”, dated 11/2019, indicated that the facility was committed to identifying the patient at risk for suicide and providing a safe environment. The policy further indicated patients who screened positive for suicide risk were further assessed to determine the degree of risk. Once risk was determined, the patient was placed on the corresponding level of observation. Patients at risk for suicide would maintain determined levels of observation and interventions until discontinued by the licensed independent mental health practitioner. An order by the licensed independent mental health practitioner was required to remove suicide levels of observation and interventions. A review of the facility’s policy titled, “Levels of Observation - Behavioral Health Program”, dated 6/2023, indicated that the policy’s purpose was to provide protection to patients and ensure that staff monitoring of patients was instituted to prevent patients from harming themselves or others. The policy further indicated there were three levels of staff monitoring. At a minimum, all CBH patients were to be monitored every 15 minutes and their location, activity, and behaviors were to be recorded at 15-minute intervals. The second level of observation, or LOS, required that a designated staff member always have the patient within visual view due to increased precautions for danger to self. When a patient on LOS observation showers, change clothes, or toilets, staff would remain outside, with the door slightly open, and visually check the patient every 30 seconds. The constant LOS observation was an alternative if the third level of observation, 1:1 constant observation (a designated staff member has constant visualization of a patient and is within arm’s length of the patient), would further agitate a patient. Any discontinuation of observation, or lessening of the level of observation, must be discontinued by a medical doctor (MD) order. A review of medical records indicated that Patient 2 was a 70-year-old female who arrived at the facility’s emergency department by ambulance, on 9/26/23, due to an intentional overdose (when a person deliberately takes drugs to harm themselves). Patient 2 was subsequently admitted to the facility’s intensive care unit and placed on mechanical ventilation (a machine that helps deliver oxygen into and out of the lungs) for acute on chronic respiratory failure (a sudden worsening of an ongoing lung condition). On 9/27/23, Patient 2 was extubated (breathing tube removed), transferred to the facility’s medical unit, and medically cleared to receive minimal medical services and intense psychiatric care on the facility’s CBH unit. Records indicated Patient 2 had been feeling suicidal and was severely depressed because her son, who was living with her, had been missing for more than two weeks. Patients 2’s diagnosis included severe depression, schizoaffective disorder, suicidal ideation, and chronic obstructive pulmonary disease. A review of Patient 2’s Columbia Suicide Risk Assessment, dated 9/26/23, at 1:00 pm, indicated that Patient 2 was at moderate risk, due to suicidal ideation without a plan, and required 15-minute safety rounds and LOS observation. A review of the facility’s hospitalist (MD 2) order, dated 9/27/23, indicated that Patient 2 was receiving daily respiratory therapy treatment, oxygen via nasal cannula to maintain oxygen saturations over 90% (a measurement of blood oxygen that is normally 97 -100 %), and oral prednisone (a steroid medication) to assist with respiratory distress. An interdisciplinary treatment plan, dated 10/02/23, indicated that Patient 2 was a danger to self, expressed suicidal ideation, and required line of sight observation due to ligature risk from the oxygen tubing and SPO2 cord. A review of RN 6’s nurse’s notes dated, 10/10/23, at 12:11 am, indicated that Patient 2 reported she had suicidal ideation, without a plan, and that she was hearing voices telling her to kill herself for being a “bad mom.” A review of RN 7’s nurse’s notes dated, 10/10/23, at 7:30 am, indicated that at the start of day shift, at approximately 6:30 am, Patient 2 was found unresponsive, with the SPO2 cord wrapped around her neck. Patient 2’s “LOS for night shift was reportedly checking on another patient at the time. Patient 2 was slightly blue, and a code blue was called. SPO2 cord was unwrapped and pt’s oxygen was increased to 10 liters/ nasal cannula.” Patient 2’s oxygen saturations increased to 97%, heart rate was 85 beats per minute (bpm), blood pressure was 162/86, and respiratory rate (RR, breaths per minute) was 18. “After approximately 10 minutes Patient 2 began responding to staff.” A review of RN 8’s Code Blue nurse’s notes, dated 10/10/23, at 7:15 am, indicated that RN 8 responded to an overhead code blue call for the CBH unit. “On arrival Patient 2 had a good carotid pulse ... was breathing spontaneously, had HR at 84 bpm, and O2 sats were in the mid-90s on 2/L of oxygen via nasal cannula.” Records indicated the CBH staff were at the patient’s bedside and stated Patient 2 had the SPO2 cord wrapped around her neck. Patient 2 was blue in the face when the CBH staff intervened, and removed the SPO 2 cord, prior to the code team’s arrival. RN 8 notified Patient 2’s psychiatrist, MD 3, of the strangulation attempt. MD 3 ordered a computed tomography scan (CT, an imaging test that detects injury) of Patient 2’s head and neck. A review of MD 3’s progress notes, dated 10/10/23, at 1:28 pm, indicated that, “apparently this patient was watched by partial line of sight, line of sight was also for patient in the next room, the patient was found by the nurse’s aide from the morning shift ... and discovered to have a pulse oximeter wrapped around her neck twice ... CODE BLUE was called ... CT of her head and neck was ordered which was reported to be within normal limits ....” When Patient 2 returned from the CT, she was alert, had a normal neurological exam, and was able to walk with assistance. MD 3 consulted with MD 2 and ordered arterial blood gases (ABG, a lab test that measures oxygen and carbon dioxide levels in the blood), electrocardiography (EKG, a recording of the hearts activity), a complete metabolic panel (CMP, a lab test that shows how well the kidney and liver are working), and troponins (TROP, a lab test that measures the troponin protein that is released in the blood during a heart attack). A review of the facility document titled, “Behavioral Health Staffing Sheet”, dated 10/09/23, indicated that the unit had one CBHCS, two RNs, two LVNs, one NA, and one MHT scheduled to work the 10/09/23, night shift, and provide care to 18 CBH patients. One RN was floated (removed from their home unit to work in an area that is short-staffed) off of the CBH unit to work in the Emergency Department. CBHCS was assigned to manage the unit and supervise two LVNs. One RN was working a double shift (24 hours) and was assigned to provide care to five CBH patients. Two LVNs were assigned to six CBH patients each. One NA was assigned to provide continuous LOS to Patient 2 (Room 326) and Patient 3 (Room 325). One MHT was assigned to perform the unit’s 15-minute patient safety rounds. During a concurrent observation and interview in the CBH unit, on 12/04/23, at 6:42 am, RN 4 reported she had been a relief Clinical Supervisor on the CBH unit for five years and verified she worked as relief clinical supervisor, on 10/09/23 night shift, when Patient 2 attempted to strangulate herself. RN 4 stated the event occurred at approximately 6:30 am, or at change of shift, while RN 4 was giving report in the unit’s secured conference room, so she was not present when Patient 2 was discovered with a SPO2 cord around her neck. RN 4 stated at the start of the 10/09/23, night shift, the CBH unit did not have enough NAs or MHTs scheduled to conduct safety rounds and LOS observations. RN 4 requested more NAs, but the facility was unable to provide the CBH unit with more staff. This resulted in NA 2 performing LOS on two patients at the same time. RN 4 stated the staff shortage created a situation where Patient 2 and Patient 3 did not receive constant LOS supervision, because, “one person cannot have eyes on two patients at all times, especially if the patients are in separate rooms.” RN 4 reported that LOS observation was initiated by an MD order and was intended for one staff member to always have continuous eyes on one patient. LOS was not intended to be a partial line of sight, which was what occurred when NA 2 was assigned LOS to more than one patient. RN 4 stated Patient 2’s strangulation attempt could have been prevented if the unit had enough staff to correctly implement the MD’s LOS order. During a concurrent interview and record review in the CBH unit, on 12/04/23, at 6:06 am, MHT verified he worked the 10/09/23 night shift, and was present on 10/10/23, at 6:30 am, when Patient 2 attempted to strangle herself. MHT stated that Patient 2 had been on LOS observation since being admitted to the unit because Patient 2 was suicidal and had medical tubing and cords that were a potential ligature risk. MHT reported that during the 10/09/23, night shift, the CBH unit was short-staffed and only had two staff members scheduled to perform 15-minute patient safety rounds and LOS observations. Since the CBH unit had two LOS patients (Patient 2 and Patient 3) MHT was assigned to perform safety rounds and NA 2 was assigned to provide LOS observation on both Patient 2 and Patient 3, at the same time. MHT stated that Patient 2 and Patient 3 were admitted to separate, private rooms, with exit doorways located right next to each other. NA 2 sat outside the doorways and attempted to continuously observe Patient 2 and Patient 3 as best as he could throughout the night shift. MHT stated that assigning NA 2 to perform LOS observation on both Patient 2 and Patient 3 was “extremely unsafe” because it was impossible for NA 2 to have both patients in his field of vision at the same time. During an interview in the facility’s conference room, on 12/11/23, at 6:09 pm, NA 2 reported he had worked as an NA at the facility’s CBH unit for approximately 6 years. NA 2 verified he worked on 10/09/23, night shift, and was assigned to provide LOS observation to Patient 2 and Patient 3. NA 2 stated that RN 4 requested more aide support for the night shift, but it was not provided, so the CBH staff had to do “the best they could with what they had.” NA 2 reported that both Patient 2 and Patient 3 were very high-risk patients and at risk for harming themselves or others. Since Patient 2 and Patient 3 were in separate, private rooms, located right next to each other, he (NA 2) opted to sit in the hallway, near their open doorways, to perform LOS observation. NA 2 stated it was not an “ideal situation” because he was unable to have a constant view of both patients. At approximately 6:20 am, near the change of shift, Patient 3 had increased agitation and was pacing in her room and yelling threats. NA 2 turned his chair toward Patient 3’s room, with his back toward Patient 2’s door, so he could prop his foot against Patient 3’s door to ensure she did not exit her room. NA 2 reported during this time, day shift staff members had entered Patient 2’s room and yelled for staff to initiate a Code Blue (an emergency code indicating a patient is in need of resuscitation due to respiratory or cardiac arrest). NA 2 stated he did not leave his post to assist the day shift staff with Patient 2’s Code Blue because Patient 3 was very triggered by the commotion and becoming a risk to harm herself or others. During a concurrent observation and interview in the CBH unit, on 12/04/23, at 8:03 am, NA 1 reported she worked the 10/10/23, day shift, and was the staff member that discovered Patient 2 with the cord wrapped around her neck. NA 1 reported she had a habit of saying good morning to the CBH patients prior to getting her day-shift assignment. When NA 1 approached Patient 2’s room, she noticed that NA 2 was sitting in a chair outside of Patient 2 and Patient 3’s room, providing partial LOS to both patients. NA 2 had his back to Patient 2’s door with his foot propped up on Patient 3’s door to secure it from being fully opened. NA 1 reported when she entered Patient 2’s room, the room was very dark, and Patient 2 had the bed sheet placed above her chin. When NA 1 approached Patient 2’s vital sign machine, that was connected to the SPO2 cord, NA 1 noticed the machine was completely “flatlined”, and not detecting Patient 2’s heart rate or oxygen levels. NA 1 began speaking to Patient 2 while she attempted to trouble shoot the machine. When Patient 2 did not respond NA 1 pulled down Patient 2’s sheet and discovered that Patient 2’s SPO2 cord was wrapped two times around Patient 2’s neck and cinched tightly across her throat. LVN 3 entered Patient 2’s room, turned on the light, and immediately assisted NA 1. Patient 2 was unresponsive, blue in the face, and had her hands clenched on the end of the cord. LVN 3 administered a sternal rub and yelled out for a staff member to call a Code Blue and bring the code cart, while NA 1 attempted to remove the cord from Patient 2’s neck. NA 1 stated that because the SPO2 cord was wrapped so tightly around Patient 2’s neck, LVN 3 had to break the cord from the vital signs machine to untangle and release the cord. NA 1 reported that the Code Blue team arrived while the CBH nurses were transferring Patient 2 to a CPR board and detected Patient 2’s pulse and respirations. CPR was not initiated and Patient 2 slowly regained consciousness and stabilized. NA 1 stated that Patient 2 was very disoriented, and did not know her name, date, or her location, hours after the suicide attempt. During an interview in the facility conference room, on 12/05/23, at 3:35 pm, LVN 3 verified she worked in the CBH unit, on 10/10/23, day shift, and assisted NA 1 when she discovered Patient 2 unresponsive with an SPO2 cord wrapped around her neck. LVN 3 stated when she entered the unit on 10/10/23 to receive report and begin her day shift, she noticed that NA 2 was seated in the hallway, in front of Patient 2 and Patient 3’s doors, attempting to perform LOS on both patients. LVN 3 stated that NA 2 could not visualize Patient 2 because he was positioned with his back to Patient 2’s door. LVN 3 entered Patient 2’s room because she heard a lot of commotion and observed NA 1 troubleshooting Patient 2’s vital sign machine. When LVN 3 turned on Patient 2’s light, she observed Patient 2 with her SPO2 cord wrapped several times around her neck. Patient 2’s was unresponsive, with peri-oral cyanosis (when the mouth and lips turn blue due to a lack of oxygen in the blood), and her hands were clenched tightly around the cord. LVN 3 administered a sternal rub (a firm rub on the chest to test for a patient’s consiouness), and yelled for staff to call a Code Blue and retrieve the code cart. LVN 3 stated that the cord was wrapped so tightly around Patient 2’s neck that she had to climb on top of Patient 2 to lift her head and neck and attempt to unwrap the cord. LVN 3 released the cord from Patient 2’s neck by breaking the SPO2 cord from the vital signs machine. LVN 3 stated the Code Blue team arrived quickly and assumed care of Patient 2. Since the Code Blue team detected that Patient 2 had a pulse stable blood pressure, they did not initiate CPR. During a concurrent interview and record review in the facility’s conference room, on 12/11/23, at 1:50 pm, MD 3 stated he had been the Medical Director of the CBH unit since it opened in 2015. MD 3 reported he initiated a full LOS observation order on Patient 2 because Patient 2 was severely depressed, expressed suicidal ideation, and had medical equipment that was a ligature risk. MD 3 stated that the facility’s policies, and his expectations, were that LOS observation required the attention of one single staff member on one single patient. MD 3 reported that the CBH unit observation levels were intentionally simple, and black and white, so there was no confusion with safe staffing expectations. MD 3 stated that the facility had on-going issues with insufficient staffing in the CBH unit, which led to Patient 2’s partial LOS, and compromised patient safety. 2. A review of the facility’s policy titled, “Safety Patient Rounds”, dated 6/2023, indicated that the policy’s purpose was to provide a minimum level of observation to continually monitor and supervise patient safety. The policy further indicated that the clinical supervisor would assign a staff member at the beginning of each shift to be responsible for conducting continual patient rounds. Patient rounds were to be completed every 15 minutes, on every patient, and documented on the Special Precautions/Observation Record in the patient’s medical record. A review of the facility’s policy titled, “Levels of Observation - Behavioral Health Program”, dated 6/2023, indicated that the policy’s purpose was to provide protection to patients and ensure that staff monitoring of patients was instituted to prevent patients from harming themselves or others. The policy further indicated there were three levels of staff monitoring. At a minimum, all CBH patients were to be monitored every 15 minutes and their location, activity, and behaviors were to be recorded at 15-minute intervals. During a concurrent record review and interview in the facility’s conference room, on 12/05/23, at 4:10pm, CBHCS stated patient safety rounds were critical in keeping CBH patients safe. The staff member conducting the rounds observed for escalating behaviors, potential triggers that may lead to harm, scanned the patients’ environment to identify potential safety risks, and engaged with patients to promote socialization. CBHCS verified that the CBH unit did not have sufficient staff scheduled to designate one staff member the responsibility of conducting 15-minute patient safety rounds on the following dates: 10/01/23 day shift, 10/08/23 day shift, 10/12/23 night shift, 10/15/23 day shift, and 10/18/23 day shift. CBHCS reported since the CBH unit was not provided with enough staff during these shifts, either the CBH LVNs, RNs, or CBHCS were assigned to perform 15-minute patient safety rounds on every patient in the unit while also being responsible for providing direct nursing care to six CBH patients. CBHCS reported it was impossible to perform both roles at the same time. When this occurred, safety round checks were frequently not conducted in 15-minute intervals, and the Special Precautions/Observation Record was not documented in real time, because the workload was unsustainable. During a concurrent interview and record review in the facility’s conference room, on 12/11/23, at 1:30 pm, RN 5 verified that the CBH unit did not have sufficient staff scheduled to designate one staff member the sole responsibility of conducting 15-minute patient safety rounds on the following dates: 11/01/23 night shift, 11/09/23 night shift, 11/11 night shift, 11/15/23 night shift, and 11/26/23 night shift. CBHCS reported since the CBH unit was not provided with enough staff during these shifts, either the CBH LVNs, RNs, or CBHCS were assigned to perform 15-minute patient safety rounds on every patient in the unit while also being responsible for providing direct nursing care to six CBH patients. RN 5 stated performing both assignments was very difficult and usually resulted in either nursing tasks or safety rounds not being completed timely. During an interview in the CBH unit, on 12/04/23, at 6:42 am, RN 4 stated 15-minute patient safety rounds must be performed by one designated staff member, who was not assigned to any other tasks, in order to conduct the rounds correctly. The staff member assigned to safety rounds must locate the patient, make eye contact with the patient, observe the patient’s current behaviors, and assess for any potential triggers. If a patient was sleeping, the staff member must get eyes on the patient’s face and observe that the patient’s chest was rising and falling to ensure the patient was breathing. RN stated that patient safety rounds take the entire 15 minutes to perform because the unit census (the number of patients admitted to a unit daily) was frequently 15-18 patients and CBH patients can be very active since they have the freedom to move around the unit. When one 15-minute patient safety round was completed, the next interval begins. RN 4 stated that the CBH unit frequently did not have enough NAs or MHTs scheduled to conduct safety rounds. When this occurred, a LVN, RN, or CBHCS would have to split time between their nursing care duties while attempting to conduct safety rounds on every patient in the CBH unit. RN 4 stated these assignments were unrealistic, and unsafe, because the licensed nurses had to rush through rounds in order to prevent a delay in their nursing care. During a concurrent interview and record review in the facility’s conference room, on 12/11/23, at 1:50 pm, MD 3 reported he had been the Medical Director of the CBH unit since it opened in 2015. MD 3 stated it was his expectation, and standard of practice, that the 15-minute patient safety rounds should be assigned to one staff member whose only job was to conduct patient safety rounds. MD 3 stated the CBH unit was rarely under census, and if the 15-minute safety rounds were done correctly, they would take the entire 15 minutes to complete before the process must be repeated. MD 3 stated it was unrealistic, and unsafe, to assign patient safety rounds to a LVN, RN, or CBHCS because it would completely take the licensed nurse away from the nursing services they should be delivering, or result in the 15-minute patient safety rounds not being completed properly. MD 3 reported that the unit’s Level of Observation Policy was intentionally clear to to mean that one staff member should be assigned to each level of observation (15-minute safety rounds, LOS, and 1:1 close contact), with no other responsibilities, to maintain a safe environment. During a concurrent interview and record review, on 12/13/23, at 3:45 pm, the Chief Nursing Officer (CNO), who was also acting as interim CBH Director (ICBHD), stated that the CBH unit had three levels of observation that included 15-minute patient safety rounds, LOS, and 1:1 “arms length” observation. CNO/ICBHD stated that his expectation was for one staff member to be assigned to each observation level, without any other patient assignments. If that was not possible, and absent no other resources, the 15-minute patient safety rounds would fall to the CBHCS. If the CBHCS could not perform the task, the staffing issue should be escalated to the nursing supervisor (a nurse responsible for overseeing staffing levels in a facility) or current unit director. 3. A review of the facility’s policy titled, “Staffing Plan- Center for Behavioral Health”, dated 5/2023, indicated, “A patient classification system shall be used on a day-to-day and shift-by-shift basis to determine the number of staff required to meet the needs of patients.” A review of the facility’s document titled, “Patient Classification Totals & Variance Reporting”, dated 5/2023, indicated that CBH patients were classified as Level I - Level V based on acuity needs that included: physical restraint hours, 1:1 or LOS observations, suicide risk, seclusion or isolation, oxygen use, IV placement, fall risk, and other. A review of the facility’s document titled, “Behavioral Health Acuity” (BHA), dated 10/01/23 through 11/30/23, indicated that only patients with LOS or 1:1 close contact observation were being measured to determine daily staffing needs. During a concurrent interview and record review in the facility’s conference room, on 12/05/23, at 4:10 pm, CBHCS 1 stated she had been employed as a CBHCS for five years. CBHCS reported she had never seen the facility’s “Patient Classification Totals & Variance Reporting” document and had not been instructed to utilize the matrix to determine appropriate staffing levels. CBHCS reported that the current Behavioral Health Acuity Form was created by the former CBH Director (FCBHD) and primarily used to determine how many patients require LOS or 1:1/Close Contact observation. The Behavioral Health Acuity form did not provide measures on CBH patient needs related to elopement risk, suicide risk, oxygen use, fall risk, or physical restraint hours. CBHCS stated measuring patient acuity levels would be very helpful because it would result in CBH staffing levels being based on clinical decisions and not on the number of staff available. During a concurrent interview and record review in the Nursing Supervisor’s (NS) office, on 12/05/23, at 5:40 pm, NS stated that the CBH clinical supervisors sent her a Behavioral Health Acuity report daily to help her determine the unit’s staffing levels, and decide if additional staff were required to meet the CBH patient needs. NS reported that the Behavioral Health Acuity report mainly identified the number of CBH patients on LOS or close contact observation. The report did not address other patient complexities that may require more licensed and unlicensed staffing to ensure patient safety. NS stated there was no process to “loop her in” on any other CBH patient needs to ensure she allocated enough staff to CBH. During a concurrent interview and record review, on 12/13/23, at 3:45 pm, CNO/ICBHD was asked to review the CBH Staffing Plan policy and Patient Classification & Variance Reporting document and compare it to the Behavioral Health Acuity Form that the facilty was currently utilizing. CNO/ICBHD stated that the current Behavioral Health Acuity form being implemented was not the correct form required by the CBH Staffing Plan Policy, and did not provide measures that indicated the intensity of care needed for each CBH patient to ensure safety.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 45757 Based on interview and record review, the facility staff failed to ensure that the use of restraints for Patient 1 was in accordance with a physician (MD), or other licensed independent practitioner (LIP), order. This failure resulted in Patient 1 being placed in bilateral soft-wrist restraints without an MD/LIP order. Findings: The facility’s policy titled, “Restraints: Violent Behavior or Seclusion,” dated 6/2023, was reviewed and indicated: “1. The policy and procedure is in effect for all departments and services in the acute care facility...3. Restraint may only be used when less restrictive interventions have been determined to be ineffective...15. If a Licensed Independent Provider (LIP, physicians, physician assistants, or advanced practiced registered nurses) are not able to issue an order, a Registered Nurse (RN) may initiate the use of restraints based on an appropriate assessment of the patient 15.1 If the initiation of the restraints is by the RN, the attending physician must be consulted as soon as possible and within one hour .... 16. Restraint is discontinued by a competent RN or LIP at the earliest possible time, regardless of the length of time identified in order.” The policy further indicated that, “all restraints are time limited as follows ... 4 hours for adults (18 years of age or older....” A review of Patient 1’s medical records indicated that Patient 1 was a 79-year-old male transported to the facility’s ED on 10/23/23, at 6:04 pm. Patient 1 was discovered at his home with hyperglycemia (high blood glucose), agitation, covered in urine and feces, and gravely disabled. Patient 1’s wife was unable to care for him due to his progression of moderate dementia with agitation, uncontrolled insulin dependent diabetes, and an increase in frequency of falls. Patient 1 was identified as being gravely disabled, not being able to meet his basic needs, and awaiting disposition to a memory care facility. Patient 1 remained on a prolonged patient hold in the facility’s Emergency Department, while receiving medical care and blood glucose management, and awaiting placement in a long-term living facility. A review of licensed vocational nurse (LVN)1’s nursing notes, dated 11/06/23, at 9:08 am, indicated LVN 1 applied soft wrist restraints on Patient 1 via an Emergency Department Clinical Supervisor’s (EDCS) verbal order, because Patient 1 had been, “getting out of bed for the past two hours”, was unsteady on his feet, and was becoming increasingly agitated. A review of LVN 1’s nursing notes, dated 11/06/23, indicated that LVN 1 continued to keep Patient 1 in two-point soft restraints while he slept from 12:54 pm to 3:55 pm. LVN 1 removed Patient 1’s restraints at 3:55 pm, for 6 hours and 47 minutes after LVN 1 placed Patient 1 in restraints. During a concurrent record review and interview, conducted in the Director of Performance Improvement’s Office (DPI), on 12/07/23, at 11:59 am, DPI stated, on 11/06/23, at 9:08 am, LVN 1 placed Patient 1 in bilateral soft-wrist restraints for a total of 6 hours and 47 minutes without an MD or LIP order. DPI stated that Patient 1 did not have an MD/ LIP order to initiate restraint use, or a second order for continued restraint use once Patient 1 remained in restraints beyond four hours. During a concurrent interview and record review, conducted in the facility’s conference room, on 12/12/23, at 2:14 pm, LVN 1 stated she requested that the EDCS provide a verbal order to apply restraints on Patient 1 because Patient 1 was getting increasingly agitated, not following commands, and was at risk for falling due to being unsteady on his feet. LVN 1 reported that she did not request for the EDCS to perform a face- to-face restraint assessment on Patient 1, or seek an MD/LIP order for restraint initiation and continued restraint use, because she was unaware that an MD/LIP order was required. During a concurrent interview and record review, conducted in the DPI’s office, on 12/13/23, at 10:10 am, the Emergency Department Director (EDD) reported that ED RNs can initiate restraint use, but they are required to get a MD/LIP order within 1 hour of the restraints being applied. EDD stated that LVN 1 kept Patient 1 in restraints, from 9:08 am to 3:55 pm, without obtaining an RN assessment or MD/LIP order. EDD stated that records indicated Patient 1 was asleep and cooperative while being restrained, which may have indicated that Patient 1 did not meet criteria for continued restraint use. EDD acknowledged that if LVN 1 notified an MD/LIP that Patient 1 was sleeping after bilateral soft-wrist restraints were applied, the MD/LIP may have denied restraint use and advised LVN 1 of less restrictive interventions. During a concurrent interview and record review, conducted in the DPI’s office, on 12/13/23, at 3:45 pm, the Chief Nursing Officer (CNO) stated that the facility’s restraint process was primarily intended to protect the patient. If a RN was unable to engage a provider for an order, the policy allowed an RN to emergently restrain a patient after performing a face-to-face patient evaluation. CNO stated if a RN initiated restraint use on a patient, an MD/LIP must be notified, and provide a written or verbal restraint order within one hour. CNO reported that if restraint use was on-going there were criteria for continuing orders, continuing use, and discontinuing restraints. CNO verified that medical records indicated Patient 1 did not receive a RN face-to- face restraint assessment and did not have an MD/LIP order that approved restraint initiation or continued restraint use.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 45757 Based on interview and record review, the facility failed to provide continuous monitoring of a patient in restraints when staff did not perform 15 minute Behavioral Health Restraint Assessments (BHRA, assessments conducted every 15 minutes that assesses a patient’s vital signs, hygiene and elimination needs, nutrition and hydration needs, and physical and psychosocial needs) on one of four patients (Patient 1). As a result, Patient 1 remained in bilateral soft-wrist restraints for 6 hours and 47 minutes, without vitals sign monitoring, blood glucose monitoring, food, hydration, or behavior reevaluation to determine if Patient 1 met criteria for continued restraint use. This failure resulted in Patient 1 being restrained without safety needs, physical health needs, or psychosocial needs being met. Findings: The facility’s policy titled, “Restraints: Violent Behavior or Seclusion”, dated 6/2023, was reviewed and indicated: “1. The policy and procedure is in effect for all departments and services in the acute care facility...3. Restraint may only be used when less restrictive interventions have been determined to be ineffective...” The policy further indicated that “A staff member who is trained and competent must assess the patient Every 15 Minutes: 1. Behavior, 2. Signs of injury associated with application of restraint or seclusion. 3. Physical and psychological comfort. 4. Circulation. “ Every two hours a staff member must assess the patients “5. Skin care and range of motion in the extremities. 6. Nutrient and hydration. 7. Hygiene and elimination. 8. Vital Signs...Document on available flow sheets...” A review of Patient 1’s medical records indicated that Patient 1 was a 79-year-old male transported to the facility’s ED on 10/23/23, at 6:04 pm. Patient 1 was discovered at his home with hyperglycemia (high blood glucose), agitation, covered in urine and feces, and gravely disabled. Patient 1’s wife was unable to care for him due to his progression of moderate dementia with agitation, uncontrolled insulin dependent diabetes, and an increase in frequency of falls. Patient 1 was identified as being gravely disabled, not being able to meet his basic needs, and awaiting disposition to a memory care facility. Patient 1 remained on a prolonged patient hold in the facility’s Emergency Department Overflow (EDOF, a 7-bed, contained section of the Emergency Department (ED) for patients on legal mental health holds or patients requiring psychiatric stabilization), while receiving medical care and blood glucose management, and awaiting placement in a long-term living facility. A review of licensed vocational nurse (LVN)1’s nursing notes, dated 11/06/23, at 9:08 am, indicated LVN 1 applied soft wrist restraints on Patient 1 via an Emergency Department Clinical Supervisor’s (EDCS) verbal order, because Patient 1 had been, “getting out of bed for the past two hours,” was unsteady on his feet, and was becoming increasingly agitated. A review of LVN 1’s nursing notes, dated 11/06/23, indicated that LVN 1 continued to keep Patient 1 in two-point (refers to two upper extremities) soft wrist restraints while he slept from 12:54 pm to 3:55 pm. LVN 1 removed Patient 1’s restraints at 3:55 pm, for 6 hours and 47 minutes after LVN 1 placed Patient 1 in restraints. During a concurrent interview and record review, conducted in the Director of Performance Improvement’s (DPI) office, on 12/07/23, at 11:59 am, DPI stated, on 11/06/23, at 11:33 am, LVN 1 administered one BHRA assessment to Patient 1 while Patient 1 was placed in bilateral soft-wrist restraints. DPI stated that since Patient 1 remained in restraints from 9:09 am - 3:55pm, or approximately seven hours, LVN 1 should have administered at least 25 BHRA assessments to ensure Patient 1’s needs were being met while restrained, assess Patients 1’s safety while restrained, and evaluate if continued restraint was appropriate. DPI reported that it is the facility’s policy, and standard of practice, for LVNs and RNs to evaluate restrained patients every 15 minutes. The evaluation assesses for changes in patient behavior to consider discontinuing restraint use, assesses for signs of injury or decreased circulation related to restraint use, and provides the patient with psychological support. DPI reported that LVNs and RNs are also required to assess restrained patients every two hours for skin breakdown related to restraint use, offer food and hydration, offer bathroom or elimination access, and monitor vital signs. All restraint assessments are required to be documented on the facility’s BHRA flowsheet. During a concurrent interview and record review, conducted in the facility conference room, on 12/12/23, at 2:14 pm, LVN 1 stated, on 11/06/23, she did not perform the required BHRAs while Patient 1 was restrained, from 9:08 am to 3:55 pm, because LVN 1 was the only nurse working in the contained EDOF unit, and was assigned a full patient load, without RN supervision or support. LVN 1 reported her workload was not manageable and that she had to prioritize her nursing services. LVN 1 stated she decided to not prioritize Patient 1’s BHRAs, and skip monitoring his vitals, blood glucose, restraint placement, or circulation, because she did not want to risk triggering Patient 1’s behaviors and cause him more agitation. LVN 1 reported once Patient 1 fell asleep in restraints, she did not wake him to perform the 15 minute BHRAs, or remove the restraints, because he was “sleeping peacefully.” LVN 1 acknowledged that “sleeping peacefully” was a behavior that did not meet criteria for restraint use. LVN 1 stated she continually observed Patient 1’s respirations from afar, and ensured his chest was rising and falling, while he slept in restraints. LVN 1 reported, at 3:55 pm, she woke Patient 1 from sleep, removed his restraints, checked Patient 1’s blood glucose, and offered food and drink because Patient 1 had not eaten since 9:08 am, when the restraints were placed. During a concurrent interview and record review, conducted in the DPI’s office, on 12/13/23, at 10:10 am, EDD stated, on 11/06/23, LVN 1 performed one BHRA while Patient 1 was restrained from 9:08 am to 3:55 pm. EDD reported that her expectations, and the facility’s policy, required LVNs and RNs to perform BHRAs every 15 minutes. EDD stated these assessments are required to ensure patient safety, to meet the patients’ physical health needs, and ensure restraint use is still warranted. EDD reported that Patient 1’s clinical records indicated Patient 1 was asleep and cooperative while being restrained, which did not meet criteria for continued restraint use. EDD stated that assigning LVN 1 to EDOF on 11/06/23, without an RN assigned to the EDOF unit to provide supervision and assistance, was an unsafe staffing assignment that compromised Patient 1’s health and safety. During a concurrent interview and record review, conducted in the DPI’s office, on 12/13/23, at 3:45 pm, the Chief Nursing Officer (CNO) stated that the facility’s restraint process was primarily intended to protect the patient. CNO reported that if restraint use was on-going, there were frequent assesments required to ensure patient safety, meet patient needs, and continue restraint use. CNO acknowledged that LVN 1’s lack of restraint assessments placed Patient 1 at risk for potential harm and unnecessary retraint use.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 45757 Based on observation, interview, and record review, the facility failed to have an adequate number of registered nurses (RN) to provide immediate supervision of patient care provided by Licensed Vocational Nurses (LVNs) and be immediately available to provide patient assessments, evaluations of patient care, safe and effective care as needed by patients, and implement its staffing polices in the Emergency Department when: 1a. A RN was not immediately available to supervise LVN staff assigned in Emergency Department Overflow (EDOF, a 7-bed, contained section of the Emergency Department (ED) for patients on legal mental health holds or patients requiring psychiatric stabilization) and provide assistance with patient care and medication administration verification of insulin (a medication used to regulate the amount of sugar in the blood) administration. As a result, Patient 1 was administered an incorrect dose of 70 units of Humalog insulin (a short-acting insulin that last 2-4 hours), as opposed to the correct medical doctor (MD) ordered dose of 7 units. 1b. A RN was not immediately available to supervise the patient care and medication administration by LVN staff in EDOF and ensure the facility’s Blood Glucose (BG - blood sugar) Management and Hypoglycemia (low blood glucose) Protocol was implemented for Patient 1 in EDOF, who sustained a blood glucose of 50 milligrams (mg) per deciliter (dL) (normal range is 70 -100 mg/dL), following an insulin administration error. As a result, Patient 1 did not receive appropriate nursing services or care while he experienced lethargy, somnolence (excessive sleepiness and drowsiness), and a deterioration of neurological status (a decrease in brain function). 1c. A RN was not immediately available in EDOF to perform a registered nurse face-to-face evaluation or assessment that is required by facility Policy and Procedure to initiate a behavioral restraint order. As a result, LVN 1 placed Patient 1 in restraints, without RN evaluation or assessment, for approximately six hours. 1d. An RN was not immediately available in EDOF to provide RN patient care services, perform a physical health assessment, and change of condition assessment on Patient 1 in EDOF. As a result, Patient 1 did not receive a start of shift baseline physical health assessment or change of condition assessments when Patient 1 presented lethargic, somnolent, and was noted to have severe confusion and neurological deterioration following an incorrect insulin administration error. 1e. The EDOF unit did not utilize a patient classification system to determine that appropriate staffing levels, and staff classifications (RN, LVN), were followed to meet the patients’ needs. As a result, an LVN was assigned to nursing care for Patient 1who was triaged (the sorting of patients according to the urgency of their need for care) as a Level II acuity (a method used to categorize ED patient needs. A Level II patient is considered unstable due serious acute injury and will become Level I without immediate attention) in the facility’s EDOF unit. These failures resulted in actual harm to Patient 1 due to a preventable medication error and could further result in potential medication errors, treatment errors, nursing care errors, patient injury, harm, impairment, and death. Findings: The facility’s manual titled, “Plan for Provision of Patient Care”, dated 10/2023, was reviewed and indicated: “The Emergency Department’s scope is to provide emergency care 24 hours a day, seven (78) days a week. The ED consists of 16 critical care beds, 10 Fast Track Beds, 3 RAP (Rapid Assessment Process) beds, 7 overflow beds (EDOF), for a total of 36 beds .... The ED’s progressive path of reporting is as follows: Patient Care Techs (PCT)/ Unit Secretary (US/ EMT/ Advanced ED Tech, Licensed Vocational Nurse (LVN), Registered Nurse (RN), Clinical Supervisor (CS), Director of Emergency Services (EDD), and Chief Nursing Officer (CNO) .... Licensed Vocational Nurses are utilized in the low acuity area as well as the arrival and lobby area to assist with monitoring of waiting patients and patient care tasks. They are also utilized to assist with patient holds and discharge as needed and any other task that is within their scope of practice. They are supervised by other RNs in the Emergency Department.” The facility’s policy titled, “Patient Classification Emergency Department”, dated 6/2023, was reviewed and indicated: “A Patient Classification System shall be used to determine the acuity of patients being cared for in the ED and the staffing level needs to meet the patients’ needs .... Patient acuity will be assigned during triage... Level I (Emergent) Immediate danger of loss of life, limb, or vision ... Level II (Unstable): Serious acute injury, will become level I without attention ... Level III (Potentially Unstable): Acute illness or injury, stable at his time, has the potential to become unstable ... Level IV (Stable) Patient is not in danger of losing life of limb, but has pain or discomfort ... Level V(Routine): Patient came in the ED for a routine visit, i.e. med refill, suture removal, etc., ....” The facility’s policy titled, “Scope of Vocational Nursing Practice/RN Supervision”, dated 10/2023, was reviewed and indicated: “The LVN is authorized to perform services which require the technical and manual skills acquired in an accredited vocational nursing school, and which are practiced under the direction of a licensed physician or Reregistered Nurse (RN). The responsible RN must delegate tasks within the LVN scope of practice and must oversee the performance to ensure high quality of care.” The policy further indicated the Nursing Process/Documentation procedures included, “5.6 Ongoing communication between the RN and LVN is required to ensure patient care needs are met. 5.7 Each patient must be evaluated on an individual basis for appropriate delegation of responsibilities. This evaluation must be based on patient condition/needs and LVN experience and competency .... 5.11 RN intervenes as necessary if tasks are being performed improperly. Supervision of the LVN: Provide direction and clear expectations of how a task is performed. Monitors performance to assure compliance with established practice, standards, policies, and procedures.” A review of Patient 1’s medical records indicated that Patient 1 was a 79-year-old male transported to the facility’s ED on 10/23/23, at 6:04 pm. Patient 1 was discovered at his home with hyperglycemia (high blood glucose), agitation, covered in urine and feces, and gravely disabled. Patient 1’s wife was unable to care for him due to his progression of moderate dementia with agitation, uncontrolled insulin dependent diabetes, and an increase in frequency of falls. Patient 1 was subsequently placed on a 5150 hold (involuntarily detaining an adult who is experiencing a mental health crisis). He was triaged by the facility’s ED, at 6:33 pm, as an acuity Level II. Patient 1’s vital signs at triage were: heart rate (HR) 81 beats per minute (bpm), respiratory rate 14, blood pressure (BP) 167/79, pulse oximetry (measurement of oxygen circulating in the blood) 98%, and a laboratory result showing that his blood glucose level of greater than 600 mg/dL. Laboratory results on 10/23/23, at 6:46 pm, indicated Patient 1’s BG level was 914 mg/dL, and was treated with subcutaneous Humalog, Novolog (a short-acting insulin that lasts 2-4 hours), and Lantus (a long acting insulin that gives a steady level of insulin over 24 hours) per the facility’s blood glucose management protocol. On 10/28/23, at 11:56 pm, Patient 1 was medically cleared for a mental health evaluation and treatment and placed in an EDOF bed pending a Psychotherapy Crisis Evaluation (PCE, an assessment to determine a patients mental health status). On 10/24/23, at 2:57 pm, MD 1 performed a PCE and determined Patient 1 did not meet the criteria for a 5150 hold. Patient 1’s 5150 was rescinded based on signs and symptoms that exhibited dementia (a decline in mental ability severe enough to interfere with daily life) and not a mental health disorder. Patient 1 was identified as being gravely disabled, not being able to meet his basic needs, and awaiting disposition to a memory care facility. Patient 1 remained in the facility’s EDOF on a prolonged patient hold, while receiving medical care and BG management, and awaiting placement in a long-term living facility. 1a. The facility’s policy titled, “High Alert Medications”, dated 10/2023, was reviewed and indicated: “High-Alert medications bear a heightened risk for causing significant patient harm when they are used in error ... Identified high alert medications used ... include Insulin .... Insulin is to be independently double-checked by a second nurse when a dose is prepared for administration ....” The facility’s protocol titled, “In-Patient Hyperglycemia Management”, dated 5/10/23, was reviewed and indicated that patients’ pre-prandial (before meals) blood sugar goal is 80-140 mg/dL. The corrective insulin to be used after meals was Humalog insulin and the dosage should be calculated by using the insulin adjustment tool. The facility’s document titled, “ER Daily Staffing”, dated 11/06/2023, was reviewed and indicated that LVN 1 and patient care technician (PCT)1 were assigned to provide patient care in the facility’s secured EDOF area. The EDOF area did not have an ED registered nurse or resource nurse staffed. The daily staffing sheet did not indicate the number of patients receiving care in the EDOF or identify what patients were assigned to LVN 1. A review of the Medication Administration Record (MAR), dated 11/06/23, at 9:27 am, was reviewed and indicated that Patient 1’s BG before breakfast was 287 mg/dL. The MAR indicated LVN 1 administered 7 units of Humalog insulin, per facility’s insulin adjustment tool, to correct the 287 BG. Patient 1 did not require insulin for carbohydrate correction because he only had 2 grams of carbohydrate intake during breakfast. A review of the MAR dated 11/06/23, at 6:19 pm, indicated that Patient 1’s BG before dinner was 194 mg/dl. Records indicated that LVN 1 administered 2 units of Humalog insulin, per facility’s insulin adjustment tool, to correct the 194 mg/dL BG. Patient 1 did not require insulin for carbohydrate correction for his dinner intake. During an interview conducted in the facility ED, on 12/05/23, at 6:03 pm, LVN 1 stated she had worked at the facility’s ED for approximately three months. LVN 1 reported she was employed as an LVN in a community medical clinic prior to being hired by the facility and had no previous hospital experience. LVN 1 verified she was the only licensed nurse assigned to the EDOF unit, on 11/06/23 day shift, and that she provided nursing care to four patients who were receiving medical and mental health services. LVN 1 stated that she was nervous about this assignment because she had never worked in the separated and contained EDOF unit, and she did not have a RN in the EDOF unit to provide supervision or assistance with patient care. LVN 1 stated during the 11/06/23, end of shift report with the EDOF night shift RN 1, RN 1 identified a Humalog insulin near miss (a medication error that is intercepted before the medication is administered) and an actual medication error that occurred when LVN 1 administered Humalog insulin to Patient 1 at 9:27 am. The medication errors were identified when LVN 1 requested RN 1 to provide a second verification of Patient 1’s dinner time, 2 unit Humalog insulin dose. LVN 1 stated RN 1 was “alarmed” and did not approve the nighttime insulin dose because LVN 1 incorrectly drew up 10 times the amount of insulin in a 1 cc (cubic centimeter a measurement of volume used for the dosing of medications.) tuberculin syringe (TB syringe, a 1 cc syringe that has graduated marks numbered 1-10. Each mark accounts for 0.1 cc of volume) instead of using a 50 unit insulin syringe (a 0.5 cc syringe that is marked with 50 marks for each unit of insulin. Each mark accounts for 0.01 cc of volume). LVN 1 stated since she had no experience with drawing up insulin in a syringe, she confused the TB syringe with an insulin syringe because the two syringes looked similar and were stored in the supply room next to each other. LVN 1 stated since the TB syringe had marks numbered from 1-10, she incorrectly assumed that the number two on the TB syringe was the equivalent of 2 units of insulin. Instead, the number two on the TB syringe was actually ten times the amount, or 20 insulin units. RN 1 prompted LVN 1 to waste the incorrect 20 unit insulin dose and RN 1 demonstrated the process for preparing an insulin dose using a correct insulin syringe. LVN 1 stated she immediately notified RN 1 that she used the same TB syringe, and same method, for Patient 1’s morning insulin dose of 7 units. LVN 1 demonstrated to RN 1 that she filled the TB syringe with insulin up to the number 7, or .7 cc, which was the equivalent of 70 units, and administered the 70 unit insulin dose to Patient 1 following his breakfast. LVN stated since there was not a RN available to verify the morning dose of insulin, she interrupted the ED Director (EDD) in her office and requested that she provide second verification of the “supposive” 7 unit insulin dose. LVN 1 stated the EDD looked up briefly, verified that the TB syringe plunger was pulled back to the number seven, and stated “yes that’s seven.” Since LVN 1 had no experience with administering insulin from a syringe and had never drawn up insulin into an insulin syringe, she depended on the EDD to identify her mistake through the second verification process. LVN 1 immediately notified the EDD of the morning insulin error at the change of shift. During a concurrent observation and interview conducted in the EDOF supply room with LVN 1 and ED Clinical Supervisor (EDCS) 1, on 12/05/23, at 6:33 pm, LVN 1 was asked to identify the syringe she used to draw up Patient 1’s Humalog insulin and demonstrate how much insulin she backfilled into the syringe. LVN 1 pulled a TB syringe from a storage bin that was located directly next to an insulin syringe storage bin. Both bins were correctly marked with clear labels that read ‘insulin’ and ‘TB’. LVN 1 stated the two syringes had similar colored caps and were located right next to each other, making it easy for her to confuse the syringes. LVN 1 and EDCS verified that the TB syringe was a 1 cc syringe with different markings than the 0.5 cc insulin syringe. LVN 1 identified that she used a TB syringe and pulled back the plunger to the “7” mark that indicated 0.7 cc of volume. EDCS was asked to take an insulin syringe and pull back the plunger to the mark that indicated a 7 unit insulin dose. EDCS reported that a 7 unit dose was equal to .07 cc on the insulin syringe. LVN 1 and EDCS 1 stated that 0.7 cc in the TB syringe equaled ten times the amount of insulin in the insulin syringe, or 70 units. During an interview on 12/04/23, at 7:11 am, RN 1 verified she was assigned to work at the facility’s EDOF unit during the 11/06/23 night shift. RN 1 stated when she arrived to work for her night shift, she noticed that LVN 1 was working in the EDOF unit alone, without any RN supervision or support. RN 1 stated during change of shift report LVN 1 requested that she verify a 2 unit Humalog insulin dose for Patient 1. RN 1 reported that LVN 1 accidentally drew up ten times the insulin amount, or 20 units of Humalog insulin, because she used a TB syringe and was measuring the volume incorrectly. RN 1 immediately corrected the near miss and provided LVN 1 with education and demonstration of correctly preparing an insulin dose. RN 1 stated that LVN 1 began crying and reported that she used the same TB syringe for Patient 1’s 7 unit morning dose. LVN 1 demonstrated to RN 1 that she back filled the TB syringe with insulin up to the 0.7 cc mark, or 70 units, and administered the 70 units to Patient 1 for his morning dose. RN 1 prompted LVN 1 to immediately report the insulin medication error to the EDD. During a concurrent interview and record review conducted in the EDD’s office, on 12/06/23, at 3:00 pm, EDD stated she was familiar with Patient 1’s insulin administration error that occurred on 11/06/23. EDD stated that RN 1 identified LVN 1’s morning insulin error retrospectively while she was performing a second verification with LVN 1 for Patient 1’s evening dose. EDD reported that LVN 1 requested for RN 1 to perform a second verification on an incorrect insulin dose that was draw up in a TB syringe. RN 1 identified the error, disposed of LVN 1’s incorrect dose, and provided LVN 1 with education on correctly drawing up insulin. EDD stated that LVN 1 immediately presented to her office and reported Patient 1’s morning insulin error. EDD reported that on 11/06/23 the EDOF unit was staffed unsafely, and that LVN 1 should have never been left alone to work in the EDOF unit without RN oversight and assistance. Since LVN 1 was alone in the EDOF, she approached the EDD in her office an asked for a second verification on Patient 1’s morning insulin dose. EDD was in the middle of processing administrative reports and hurriedly looked up at the syringe, verified that the plunger was pulled back to the number “7”, and replied “yes that is seven”. EDD stated if she had slowed down, and looked closely at the syringe, she would have recognized that LVN 1 was using a larger TB syringe and miscalculating the insulin dose. During a concurrent interview and record review conducted at the facility’s pharmacy, on 12/06/23, at 3:30 pm, the Director of Pharmacy (DOP), stated Patient 1 should have received 7 units on 11/06/23, at 9:27 am, for his 287 BG. DOP stated that a 1 cc TB syringe loaded with 0.7 cc Humalog insulin was the equivalent of 70 units of insulin, or ten times the amount of Patient 1’s indicated 7 unit dose. DOP stated that administering an insulin dose that is ten times the indicated amount could result in hypoglycemia, patient disorientation, unresponsiveness, somnolence (drowsiness, strong desire to fall asleep), lethargy (a decrease in consciousness), irritability, fast HR, diaphoresis (sweating), diabetic coma, and potential death. During an interview conducted in the EDOF, on 12/06/23, at 4:15 pm, Physician’s Assistant (PA) 1 reported he had worked at the facility’s ED as a Licensed Independent Provider (LIP, physicians, physician assistants, or advanced practiced registered nurses) for four years. PA 1 stated that LVNs were frequently assigned to higher acuity level patients (Level II and Level III) in the ED and EDOF unit without RN supervision or oversight. PA 1 stated that if a patient was administered an incorrect dose of insulin that exceeded the indicated amount the patient may become unarousable, experience lethargy, fatigue, disorientation, confusion, irritability, and ultimately death. During a concurrent interview and record review conducted in the Director of Performance Improvement’s (DPI) office, on 12/13/23, at 3:45 pm, the CNO verified that neither LVN 1 or EDD notified Patient 1’s provider that a medication error occurred. CNO stated it was the responsibility of all licensed nurses to notify providers of medication errors so that the MD can assess and treat the patient for harm related to the medication error and order any necessary diagnostics. 1b. The facility’s policy titled, “Blood Glucose Monitoring and Management”, dated 3/2023, was reviewed and indicated: “Nursing Alert! Only the RN may calculate the number of carbohydrates that the patient has eaten. This is because the RN will use the number of the carbohydrates eaten to determine the correct insulin coverage. The RN will follow the hospital’s glucose management policy and procedure.” A review of the facility’s document titled, “In-Patient Hyperglycemia Management”, dated 5/10/23, indicated that BG checks must be administered four times daily, and are to be scheduled before meals and before sleep. A review of the facility’s document titled, “Hypoglycemia-Adult”, date 5/10/23, indicated symptoms of low BG may include: “confusion, slurred speech, abnormal behavior, numbness, fatigue/sleepiness, convulsions/seizures, loss of consciousness”. The document further indicated that BG monitoring for hypoglycemia must occur “every 15 minutes treatment for hypoglycemia until the patient is stabilized and glucose value is above 70 mg/dl.” For mild to moderate hypoglycemia (BG value of 50-70 with alert patient) give one 60 ml bottle of Dex-4 solution (a sugar liquid used to treat very low blood glucose) every 15 minutes or four Dex 4 tablets (a sugar tablet used to treat very low blood glucose). If patient is unable to swallow administer Dextrose 50% (intravenous sugar solution used to treat very low blood glucose), 25 cc, IV solution every 15 minutes until BG is above 70 mg/dl. For sever hypoglycemia (glucose below 50 gm/dl, patient is conscious/alert, but may be disoriented) give 2 bottles of Dex 4 Solution every 15 minutes. or 8 Dex 4 tablets. If patient is unable to swallow administer Dextrose 50% 25 cc, IV every 15 minutes until BG is above 70 mg/dl. A review of MD 2’s notes dated, 10/28/23, at 11:10 pm, indicated that Patient 1 “exhibited altered mental status with a random glucose in the 60s” that improved with the administration of intravenous dextrose. A review of the Medication Administration Record dated 11/06/23, at 9:27 am, indicated that Patient 1’s BG before breakfast was 287 mg/dL. Records indicated LVN 1 administered 7 units of Humalog insulin, per the facility’s insulin adjustment tool, to correct the 287 BG. Patient 1’s 7 unit Humalog dose was later identified as a medication error that had an actual dosage of 70 units Humalog. A review of LVN 1’s nursing notes, dated 11/06/23, at 10:10 am, approximately 43 minutes after the insulin medication administration error, indicated that LVN 1 placed Patient 1 in soft wrist restraints because Patient 1 was becoming frustrated and restless. A review of LVN 1’s nursing notes, dated 11/06/23, at 12:54 pm, approximately 3 hours 27 minutes after the insulin medication administration error, indicated that Patient 1 was currently sleeping with no signs of distress. A review of LVN 1’s nursing notes, dated 11/06/23, at 1:45 pm, approximately 4 hours 17 minutes after the insulin medication administration error, indicated that LVN 1 did not want to wake the patient for vitals because he was resting peacefully after having a difficult time with remaining calm. A review of LVN 1’s nursing notes, dated 11/06/23, at 2:37 pm, approximately 5 hours 10 minutes after the insulin medication administration error, indicated that Patient 1 was continuing to rest peacefully. A review of LVN 1’s nursing notes, dated 11/06/23, at 2:44 pm, approximately 5 hours 17 minutes after the insulin medication administration error, indicated that LVN 1 did not perform a BG check on Patient 1 because he was finally resting peacefully and had not eaten anything since breakfast. A review of LVN 1’s nursing notes, dated 11/06/23, at 3:55 pm, approximately 6 hours 28 minutes after the insulin medication administration error, indicated that Patient 1’s BG was 50 gm/dL at 3:55 pm. LVN 1 offered Patient 1 a yogurt to increase BG levels. A review of LVN 1’s nursing notes, dated 11/06/23, at 4:05 pm, approximately 6 hours 38 minutes after the insulin medication administration error, indicated that LVN 1 woke Patent 1 to perform a BG check and offer yogurt for a BG of 50 gm/dL. Patient 1 fell while attempting to transfer to a chair to eat the yogurt. LVN 1 indicated Patient 1 went back to bed and was sleeping again. A review of LVN 1’s nursing notes titled, “Neuro Assessment Flow Sheet”, dated 11/0623, at 4:11 pm, indicated that Patient 1 had deteriorating Neuro changes. Patient 1 “did not seem to be getting better mentally and seemed to be extremely confused and unoriented ....” During a concurrent record review and interview, on 12/07/23, at 11:59 am, DPI stated that Patient 1’s clinical record indicated, on 11/06/23, that LVN 1 performed BG checks at 9:07 am, 3:55 pm, and 6:19 pm. DPI stated that LVN 1 did not check Patient 1’s BG for the required before-lunch-check, which followed LVN 1’s insulin medication administration error or wake Patient 1 for his lunchtime tray. DPI stated, when Patent 1’s BG measured 50 gm/dl, at 3:55 pm, LVN 1 did not administer Patient 1 Dex-4 oral solution, Dex-4 tablets, Dex 5% IV fluids, or recheck Patient 1’s BGs every 15 minutes, as required per protocol, to ensure Patient 1’s BG levels were increasing. During a concurrent interview and record review, on 12/12/23, at 2:14 pm, LVN 1 reported she had no experience with independently providing nursing services to an insulin dependent diabetic patient and had never implemented the facility’s In-Patient Hyperglycemia Management or Hypoglycemia protocols before. LVN 1 stated that Patient 1 had confusion, disorientation, and extreme sleepiness after she administered the incorrect insulin dose. Since LVN 1 had never worked in the EDOF unit, and was unfamiliar with Patient 1’s baseline, she thought these symptoms were behaviors related to Patient 1’s dementia. LVN stated that Patient 1 was extremely agitated and restless during the 11/05/23 night shift, so she opted to not wake Patient 1, on 11/06/23, for his lunchtime BG check or lunch tray so he could, “catch up on his sleep.” LVN 1 was asked if she was familiar with the nursing processes to treat a blood glucose of 50 gm/dl. LVN 1 stated that she was not familiar with the specific steps of the Hypoglycemia Protocol, and there was not a RN available to help LVN 1 detect Patient 1’s low BG symptoms or treat Patient 1’s low BG levels. LVN 1 confirmed she did not perform repeat BG level checks on Patient 1 following his 50 gm/dl BG. LVN stated that, “in general” she knew to offer Patient 1 food to increase his BG level. Patient 1 ate “some yogurt” so she thought he was “out of the woods.” Once RN 1 arrived at the EDOF unit for the 11/06/23 night shift, RN 1 notified LVN 1 that she did not treat Patient 1’s 50 gm/dL BG correctly or follow the facility’s Hypoglycemia protocol. LVN 1 stated it would have been nice have an RN present during day shift to “coach LVN 1 on BG management.” LVN 1 reported both her and RN 1 were relieved that Patient 1’s next BG check, at 6:19 pm, had increased to 194 gm/dL. During a concurrent interview and record review conducted in the EDOF unit, on 12/06/23, ED RN 2 reported that the facility’s In-Patient Hyperglycemia Management protocol required licensed nurses to check patients’ BG levels at a minimum of four times daily. These checks were always performed before meals and before bedtime. RN 2 stated there were no acceptable reasons for a licensed nurse to waive these routine checks. It was more common for ED and EDOF patients to require BG checks more than four times daily because these patients were typically unstable or their mental health behaviors may also mimic symptoms of low or high blood glucose levels. If patients were sleeping, licensed nurses should always wake their patient to perform the required BG checks and offer a meal tray. RN 2 reported that most experienced licensed ED nurses will frequently add an additional BG check after insulin administration to make sure their patient’s blood glucose levels were responding appropriately to the insulin as an “extra safety net.” During a concurrent interview and record review conducted at the facility’s pharmacy, on 12/06/23, at 3:30 pm, DOP stated the facility’s BG Management Policy and Hyperglycemia Protocol required licensed nurses to check patients’ BG levels at a minimum of four times daily. DOP reported that licensed nurses were always expected to wake up sleeping patients to check BG levels, especially if a patient was exhibiting unusual sleepiness, fatigue, or a sudden change in neurological status after a Humalog dose. Licensed nurses should be particularly aware of patients with mental health overlay, because the only absolute way of knowing if symptoms were related to blood glucose or dementia was by checking blood glucose levels. DOP stated that LVN 1 should have immediately notified an RN to implement the Hypoglycemia protocol and administer Dex 4 solution or tablets, or intravenous dextrose to quickly raise Patient 1’s blood glucose levels. DOP stated even though all licensed nurses attended the blood glucose management training at the facility’s skills fair, managing a patient with uncontrolled insulin dependent diabetes and dementia may require continual nursing assessments to ensure BG levels stay within safe parameters. During a concurrent interview and record review conducted in the DPI’s office, on 12/13/23, at 10:10 am, EDD stated that the facility’s Blood Glucose Management Protocol required licensed nurses to check patient’s BG four times daily, which included before meals and before sleep. EDD reported Patient 1’s clinical records indicated LVN 1 did not check Patient 1’s BG level before lunch because she did not want to wake Patient 1 from sleep. EDD stated this was an unacceptable reason to waive Patient 1’s BG check and that patients should always be aroused for BG monitoring and to be offered food. EDD stated that LVN 1 did not follow the facility’s Hypoglycemia Protocol when she opted to treat Patient 1’s 50 gm/dL BG with a yogurt. LVN 1 should have initiated the mild to moderate Hypoglycemia Protocol and consult with an ED RN to see if Patient 1 required an intravenous dextrose infusion. LVN 1 did not perform BG rechecks every 15 minutes on Patient 1 to ensure he received appropriate interventions until his BG increased to 70 mg/dL. EDD repeated that assigning LVN 1 to EDOF on 11/06/23, without an RN assigned to the EDOF unit for oversight and supervision was an unsafe staffing assignment. During a concurrent interview and record review conducted in the DPI’s office, on 12/13/23, at 3:45 pm, CNO reported that assigning an LVN to EDOF without the presence of an RN was an unsafe staffing plan. CNO stated that LVN 1 did not implement the BG Management Policy that required continuous BG monitoring or the Hypoglycemia protocol to rapidly treat Patient 1’s low BG. CNO stated he expected staff to speak up if they could not implement nursing services with the resources they have so, management could provide more support. CNO agreed that once RN 1 presented to the EDOF for the 11/06/23 night shift, Patient 1 received appropriate BG management nursing care. 1c. The facility’s policy titled, “When to Use Seclusion or Restraint”, dated 6/2023, was reviewed and indicated: “Restraint or seclusion is only used to protect a patient or others from harm when alternative methods (less restrictive) are determined to be ineffective.” The facility’s policy titled, “Restraints: Violent Behavior or Seclusion”, dated 6/2023, was reviewed and indicated: “1. This policy and procedure is in effect for all departments and services in the acute care facility .... 3. Restraint may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. ... 15. If a Licensed Independent Provider (LIP, physicians, physician assistants, or advanced practiced registered nurses) are not able to issue an order, a Registered Nurse (RN) may initiate the use of restraints based on an appropriate assessment of the patient .... 16. Restraint is discontinued by a competent RN or LIP at the earliest possible time, regardless of the length of time identified in order. 17. When restraint intervention is discontinued based on an assessment of a patient’s condition, a new order is required to reinstate the intervention.” The policy further indicated that, “all restraints are time limited as follow ... 4 hours for adults (18 years of age or older....” A review of MD orders dated 11/06/23, 5:30 am, indicated Patient 1’s night shift RN, RN 3, initiated a two-point (both upper extremities) soft restraint order on Patient 1 because Patient 1 assaulted RN 3 and was at risk for self-harm or harming others. Patient 1’s restraint order was co-signed by an MD at 6:30 am and, per policy, expired at 10:30 am. RN 3 removed Patient 1’s restraints at 6:35 am because, Patient 1 remained calm and cooperative. A review of LVN 1’s nursing notes, dated 11/06/23, at 9:08 am, indicated LVN 1 reapplied soft wrist restrains on Patient 1 via an EDCS verbal order, because Patient 1 had been, “getting out of bed for the past two hours”, was unsteady on his feet, and was becoming increasingly agitated. A review of LVN 1’s nursing notes, dated 11/06/23, indicated that LVN 1 continued to keep Patient 1 in two-point soft restraints while he slept from 12:54 pm to 3:55 pm. LVN 1 removed Patient 1’s restraints at 3:55 pm, or 6 hours and 47 minutes after EDCS initiated a verbal restraint order. During a concurrent record review and interview on 12/07/23, at 11:59 am, DPI stated, on 11/06/23, Patient 1 did not receive a RN face-to-face assessment that was required to determine if a patient met restraint criteria and to initiate a restraint order. DPI stated that Patient 1 did not receive any registered nursing care while LVN 1 kept Patient 1 in two-point soft wrist restraints for approximately 6 hours and 47 minutes. DPI stated that Patient 1 should have been removed from restraints when the order expired, at 1:08 pm, or when Patient 1’s behavioral condition began to improve. During a concurrent interview and record review, on 12/12/23, at 2:14 pm, LVN 1 stated she requested that the EDCS provide a verbal order to apply restrains on Patient because Patient 1 was getting increasingly agitated, not following commands, and was at risk for falling due to being unsteady on his feet. LVN 1 reported that there was no available ED RNs to perform the face-to-face restraint assessment, confirm that LVN 1 applied Patient 1’s restraints correctly, or determine if Patient 1 met criteria for ongoing restraint use. LVN 1 reported she kept Patients 1’s restraints applied while he was sleeping because she did not want to risk agitating him or waking him from his sleep. LVN 1 reported that she was unaware that a restraint order for adults was time limited and required to be renewed every four hours. During a concurrent interview and record review conducted in the DPI’s office, on 12/13/23, at 10:10 am, EDD reported that ED RNs can initiate restraint use, but they must conduct a face- to-face assessment to determine that restraints are necessary and can be utilized safely. After a RN initiates a restraint order they are required to get a MD order within 1 hour of the restraint being applied. EDD stated that the EDCS did not perform a face-to- face assessment on Patient 1 or request an MD to provide a restraint order within one hour of application. EDCS stated based on Patient 1’s records his restraint order expired at 1:08 pm and should have been renewed by an ED RN or MD. EDD confirmed that LVN 1 kept Patient 1 in restraints until 3:55 pm without obtaining an RN assessment or MD order. EDD stated that records indicated Patient 1 was asleep and cooperative while being restrained, which does not meet criteria for restraint use. During a concurrent interview and record review conducted in the DPI’s office, on 12/13/23, at 3:45 pm, CNO stated that the facility’s restraint process was primarily intended to protect the patient. If a RN was unable to engage a provider for an order, the policy allowed an RN to emergently restrain a patient after performing a face-to-face patient evaluation. CNO reported that if restraint use was on-going there were criteria for continuing orders, continuing use, and releasing restraints. CNO acknowledged that if an RN was available to supervise LVN 1 and assess Patient 1, then Patient 1 may have not met restraint criteria or had been placed in restraints for so long. 1d. The facility’s policy titled, “Patient Assessment/Reassessment” policy, dated 4/2021, was reviewed and indicated: “It is the policy of the ED to assess/reassess all patients according to the following classification criteria. Reassessment will continue through the patient’s stay in the ED based on the most recent acuity level .... Level 1 at least every 5-15 minutes ... Level 2 at least every 15-30 minutes with the understanding the more frequent assessment is often indicated and will be expected. If vital signs are stable, they may be measured every 30 minutes to every hour ... Level 3 at least every 30 to 60 minutes with the understanding the more frequent assessment is often indicated ... if vital signs are stable.” The facility’s policy titled, “Scope of Vocational Nursing Practice/RN Supervision”, dated 10/2023, was reviewed and indicated: The Nursing Process/Documentation procedures included “5.2 The RN must document on each patient at least once per shift. This assessment may include data, which is collected by the LVN, which the RN has reviewed and discussed with the LVN ... 5.6 Ongoing communication between the RN and LVN is required to ensure patient care needs are met. 5.7 Each patient must be evaluated on an individual basis for appropriate delegation of responsibilities. This evaluation must be based on patient condition/needs and LVN experience and competency ... 5.10 A registered nurse shall directly provide patient assessments and the findings will be documented in the patients record.” During a concurrent record review and interview on 12/07/23, at 11:59 am, DPI stated Patient 1’s records, dated 11/06/23, day shift, indicated that Patient 1 did not receive any registered nursing services. DPI stated an RN did not perform a start of shift physical health assessment, review or analyze LVN 1’s collected data on Patient 1 or perform a change of condition assessment when Patient 1 had a BG of 50 gm/dL and exhibited a decline in neurological status. DPI reported on 11/06/23, night shift, once RN 1 received report from LVN 1 and assumed care of Patient 1, RN 1 assessed Patient 1 with an altered mental status and notified MD 3 of a change of condition. On 11/06/23, at 11:35 pm, MD 3 ordered a computed topography (CT, a diagnostic imaging procedure) of the brain), a chest X-ray, a 12 lead EKG, troponin levels (a blood test that measure proteins that are released when there is heart damage) and a urinalysis, based on RN 1’s change of condition assessment. All tests and labs were determined to be within Patient 1’s normal limits. DPI acknowledged that if an ED RN was available to perform initial and on-going assessment on Patient 1, Patient 1’s altered mental status may have been evaluated earlier. During a concurrent interview and record review, on 12/12/23, at 2:14 pm, LVN 1 stated she was working alone in the separated EDOF unit on 11/06/23, day shift, without any RN support or supervision. LVN 1 confirmed that an ED RN never performed a start-of-shift physical assessment, change of condition assessment, or BG management evaluation on Patient 1 during the 11/06/23 day shift. LVN 1 stated she was provided a walky-talky to contact the EDCS, but the EDCS was too busy managing the main ED to provide support. During a concurrent interview and record review conducted in the DPI’s office, on 12/13/23, at 10:10 am, EDD stated a RN did not perform a start-of-shift physical health assessment, review or analyze LVN 1’s collected data on Patient 1, or perform a change of condition assessment when Patient 1 had a BG of 50 gm/dL and exhibited a decline in neurological status. EDD reported that the ED RNs were very aware of this requirement. EDD stated that Patient 1 did not receive registered nursing services on 11/06/23, day shift, because a RN was not assigned to supervise LVN 1. During a concurrent interview and record review conducted in the DPI’s office, on 12/13/23, at 3:45 pm, CNO stated he has made it abundantly clear that his expectations, and California/CMS regulations, required RNs to complete a physical health assessment on patients assigned to LVNs and validate the accuracy of the patient data that LVNs collected. CNO reported that RNs were responsible for reviewing the LVN’s data, completing an assessment, and confirming that the patient’s plan of care is unchanged. 1e. The facility’s policy titled, “Staffing Plan for Emergency Department”, dated 6/2023, was reviewed and indicated: “A Patient Classification System shall be used on a day-to-day, and shift-by-shift basis to determine the number of staff required to meet the needs of the patients .... When patient safety is at risk, i.e., due to confusion or suicidal ideation, the assignment of a Patient Care Tech, sitter or Security Guard shall be utilized to assist the Registered Nurse (RN) in providing a safe environment.” Refer to Findings 1a - 1d.”

“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: 45757 Based on interview and record review, the facility’s registered nurses (RN) failed to perform initial and on-going patient assessments of patients assigned to licensed vocational nursing (LVN) staff on the Center for Behavioral Health Unit (CBH, a secured 20-bed unit that provides intensive psychiatric treatment for patients suffering from acute psychiatric disorders and secondary substance abuse disorders). This failure caused, or contributed to a RN not supervising, reviewing, or performing independent physical health assessments on 26 of 26 patients (Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, patient 25, Patient 26, Patient 27, and Patient 28) assigned to LVNs. Findings: A review of the facility’s job description titled, “Job Description- Clinical Supervisor-CBH,” revised 2/18, indicated that the CBH Clinical Supervisor (CBHCS) was responsible and accountable for the quality of nursing functions during their shift, which included directing, supervising, and evaluating CBH staff. The CBH CS shall continually assess patient care and direct staff to make immediate changes to a patient’s plan of care when needed. A review of the facility’s job description titled, “Job Description - LVN- CBH Department,” revised 1/2014, indicated that the CBH LVN provided direct and indirect patient care services, within their scope of practice, and performed under the direction and supervision of a RN. The facility’s policy titled, “Scope of Vocational Nursing Practice/RN Supervision”, dated 10/2023, indicated: “ ...5.2. The RN must document on each patient at least once per shift ...The assessment must include data which is collected by the LVN, which the RN has reviewed and discussed, with the LVN ...5.8. A registered nurse shall directly provide patient assessments and the findings will be documented in the patient’s medical record, for each shift and upon receipt of the patient when he/she is transferred to another patient care areas ...” A review of patient physical assessments administered to LVN patients on the CBH unit, from 10/01/23 to 12/01/23, indicated that 26 of 26 patients (Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, patient 25, Patient 26, Patient 27, and Patient 28) assigned to LVNs did not include a registered nurse supervising, reviewing, or performing an independent physical health assessment as required by their licensure. During an interview on 11/28/23, at 10:32 am, LVN 2 stated that CBH RNs do not perform nursing assessments on the patients assigned to her or collaborate with the CBH LVNs throughout a shift. RNs are only involved with an LVN’s nursing care if they’re asked to administer an intravenous (IV, administering medication through a needle or tube inserted into a vein) medication. LVN 2 stated that RNs do not access her patients and that she provides all nursing care, and performs her own independent physical health assessments, on every patient she’s assigned to. During an interview on 11/28/23, at 10:59 am, RN 3 stated that she had worked in the CBH unit for approximately six years. RN 3 reported that CBH RNs do not perform nursing assessments or provide registered nursing services to patients assigned to LVNs. RN 3 stated she was aware that LVNs had a limited licensure prohibiting them from performing physical health assessments, assessing patient data, or formulating a patient care plan. The facility never had a formal meeting, or method of communication, that outlined procedures for RNs to collaborate with LVNs so that patients received the full scope of nursing services, including registered nursing physical health assessments. During an interview on 11/28/23, at 11:06 am, CBHCS 1 reported she has worked on the CBH unit for seven years and had been acting as a clinical supervisor for the past five years. CBHCS stated that the CBH RNs are not involved in performing nursing assessments, or providing nursing services to patients assigned to LVNs, because the LVNs work independently on the CBH unit. CBH RNs are only responsible for performing physical health assessments, and change of condition assessments, on their own patients. CBHCS 1 stated that the former CBH Director (FCBHD) informed the unit supervisors to review the LVN’s charts at the end of each shift for completeness to ensure that LVNs charted fully and to fulfill the “state requirement for LVN supervision”. CBHCS 1 stated the facility never informed the unit supervisors, or CBH RNs, that they were responsible to assess the LVN’s patient data or provide registered nursing assessments to the LVN’s patients. CBHCS reported if these were the facility’s expectations, the CBH unit would have to increase RN staffing to ensure that the CBH RNs had a sufficient amount of time to perform physical health assessments on patients assigned to LVNs. During a concurrent record review and interview on 12/07/23, at 2:24 pm, the Director of Performance Improvement (DPI) stated that the CBH patients listed above did not receive a RN physical health assessment or registered nursing services during the shifts that Patients 2 - 28 were assigned to LVNs. DPI reported that since an LVN’s licensure scope is limiting and prohibits independent patient assessments or the administration of IV medications, RNs are responsible for performinging a minimum of one physical health assessment per shift and administering all IV medications to the LVN’s patients. DPI stated that the facility depended on the former CBH unit Director (FCBHD) to communicate these nursing care requirements to the CBH unit nurses. DPI reported that the FCBHD resigned from his position approximately two weeks ago and that the new Chief Nursing Officer (CNO) was acting as the Interim CBH unit Director (ICBHD) while the facility recruited for the position. During an interview on ,12/13/23, at 3:45 pm, CNO/ICBHD reported he was acting as the ICBHD while the facility recruited for the open position. CNO/ICBHD stated that recently he made it “abundantly clear” to the CBH RNs and CBH clinical supervisors that RNs are responsible for reviewing the LVN’s data, completing an independent physical health assessment, and confirming that the patient’s plan of care is unchanged. CNO/ICBHD reported that, in most instances, it is expected that a RN “gets eyes on the patient” in order to fulfill this requirement and validate the LVN’s findings.”

“FORM AND RETENTION OF RECORDS CFR(s): 482.24(b) The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This Standard is not met as evidenced by: 45757 Based on interview and record review, the facility failed to ensure that Patient 1’s medical record was accurate and complete, in written or electronic form, when the facility did not have the factual documentation of an insulin administration medication error. This failure resulted in Patient 1’s medical record having no documentation that indicated Patient 1 was administered an incorrect dose of 70 units of Humalog insulin (a short-acting insulin that last 2-4 hours). Findings: A review of the facility’s policy titled, “Medication Safety Opportunities: Reporting,” dated 10/23, indicated that the facility encourages reporting of medication safety opportunities (MSOs), formerly known as medication errors, to assess and improve the medication use process and provide a safe environment. The policy’s process indicated that...”Staff will document the factual description of the MSO, and document notification of physician and subsequent monitoring in Meditech in the nursing notes for the patient.” A review of medical records indicated that Patient 1 was a 79-year-old male transported to the facility’s Emergency Department (ED), from his home, on 10/23/23, at 6:04 pm, for severe agitation, progressive dementia, and hyperglycemia (high blood glucose levels). Patient 1 was triaged by the facility’s ED with a blood glucose of 914 milligrams (mg) per deciliter (dL) and treated with subcutaneous Humalog, Novolog (a short-acting insulin that lasts 2-4 hours), and Lantus (a long-acting insulin that gives a steady level of insulin over 24 hours) per the facility’s blood glucose management protocol. Patient 1 was subsequently identified as being gravely disabled, not being able to meet his basic needs, and awaiting disposition to a memory care facility. Patient 1 remained in the facility’s Emergency Department Overflow (EDOF, a 7-bed, contained section of the Emergency Department (ED) for patients on legal mental health holds or patients requiring psychiatric stabilization) on a prolonged patient hold, while receiving medical care and BG management, and awaiting placement in a long-term living facility. A review of the Medication Administration Record (MAR), dated 11/06/23, at 9:27 am, and indicated that Patient 1’s BG before breakfast was 287 mg/dL. The MAR indicated Licensed Vocational Nurse (LVN) 1 administered 7 units of Humalog insulin, per facility’s insulin adjustment tool, to correct the 287 BG. Patient 1 did not require insulin for carbohydrate correction because he only had 2 grams of carbohydrate intake during breakfast. During a concurrent interview and record review, conducted in the ED Director’s (EDD) office, on 12/06/23, at 3 pm, EDD stated on 11/06/23, at 9:27 am, Patient 1 was exposed to an insulin medication administration error that was administered by LVN 1. EDD reported that LVN 1 incorrectly administered 70 units of Humalog insulin to Patient 1, instead of the 7 units that was MD ordered for Patient 1’s 287 mg/dL BG. After LVN 1 identified the medication administration error, LVN 1 immediately presented to the EDD’s office and reported the event. EDD stated she presumed that LVN 1 had updated Patient 1’s medical record to reflect the insulin administration error, and document that 70 units was the actual amount of Humalog insulin administered to Patient 1. During a concurrent interview and record review, conducted in the Director of Performance Improvement’s (DPI) office, on 11/29/23, at 2:15 pm, DPI stated that Patient 1’s complete clinical record did not indicate that an overdosed (a dose that is larger than the clinically required dosage) amount of insulin was flagged via the facility’s automatic insulin audit. DPI reported that the facility’s electronic health records (EHR) had an embedded feature that verified a patient’s blood glucose was treated with the correct amount of insulin per the facility’s protocol. DPI reported that the only flagged insulin administration events in Patient 1’s complete clinical record indicated that Patient 1 was actually underdosed (a dose that is less than the clinically required dosage) and not overdosed. During a follow up interview, conducted in DPI’s office, on 12/07/23, at 12:53 pm, with DPI, Chief Executive Officer (CEO), and Chief Nursing Officer (CNO), DPI restated that Patient 1’s complete clinical record had no documentation that Patient 1 was incorrectly administered 70 units of Humalog insulin, on 11/06/23, at 9:27 am, or that an insulin medication administration error had occurred. DPI reported she never received an occurrence report, (a confidential facility report that includes data to examine events that may cause patient harm) notifying her and the Director of Pharmacy (DOP), that Patient 1 was administered an incorrect dose of Humalog insulin. During a concurrent interview and record review, conducted at the facility’s pharmacy, on 12/06/23, at 3:30 pm, DOP stated that Patient 1’s complete clinical record had no documentation that an incorrect dose of 70 units of Humalog insulin was administered to Patient 1. Instead, Patient 1’s MAR, on 11/06/23, at 9:27 am, only had documentation that Patient 1 received 7 units of Humalog insulin, for a 287 mg/dl BG, opposed to the actual 70 units that were administered in error. DOP reported that it was critical for patients’ records to have documentation of every medication intervention, including medication administration errors, so that medical providers have a complete picture of a patient’s health, and can treat the patient accordingly. DOP stated that without complete and accurate documentation, pharmacy staff are unable to analyze the facility’s MSOs and suggest interventions to prevent future patient harm. During a concurrent interview and record review, conducted in the DPI’s office, on 12/13/23, at 3:45 pm, the CNO stated it was his expectation, and the facility’s policy, that licensed staff are required to document the following when a medication error is discovered: identify the medication and dosage that was administered in error, describe the chain of events that led up to the medication administration error, and explain what steps were taken to treat the patient following the medication administration error. CNO acknowledged that Patient 1’s medical record was not complete nor accurate because it had no documentation of the Humalog insulin administration error.”