Kaweah Health Medical Center

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 37797 Based on interview and record review, the facility failed to honor the advance directive (a legal document outlining a patient’s preference for medical care and treatments if they become incapacitated) of one of 30 sampled patients (Patient 1) when Patient 1 had an advanced directive indicating he did not want cardiopulmonary resuscitation (CPR) (emergency life-saving procedures performed when someone’s heartbeat or breathing has stopped comprising of chest compressions and forcing air into the lungs to manually pump blood and oxygen to the brain and vital organs) but hospital staff performed CPR on Patient 1 for two minutes when he became incapacitated. This failure resulted in a violation of Patient 1’s right to make decisions about his health care. Findings: During a review of Patient 1’s “Advance Health Care Directive Form” (AHCDF) dated 7/24/22, found in Patient 1’s medical record, the AHCDF designated Family Member (FM) 1 as his legal representative to make health care decisions for him and indicated “I direct that my health care providers and others involved in my care provide, withhold, or withdraw treatment in accordance with the choice I have marked below: (a) Choice Not to Prolong Life...” During a review of Patient 1’s “Physician Orders for Life-Sustaining Treatment” (POLST - a type of advance directive where the patient and physician agree on medical interventions if the patient’s heartbeat and breathing has stopped) dated 9/5/22, signed by FM 1 and Patient 1’s physician, and part of Patient 1’s medical record, the POLST indicated, “Cardiopulmonary Resuscitation (CPR): Do Not Attempt Resuscitation/DNR (Allow Natural Death).” During a review of Patient 1’s “History and Physical Report” (HPR) dated 6/9/26, the HPR indicated Patient 1 was admitted to the hospital on 6/9/26 with diagnosis including Altered Mental Status (AMS - a change in a person’s baseline awareness, cognition, or consciousness) and End Stage Renal Disease (ESRD - the final, irreversible stage of chronic kidney disease, when the kidneys can no longer filter blood) on Hemodialysis (a life-sustaining treatment for kidney failure where a machine pumps blood out of the body, filters toxins and excess fluids through an artificial kidney and returns the clean blood to the person). The HPR indicated, “CODE STATUS (a directive that tells medical staff what life-saving interventions patients want or do not want if their heart stops beating or they stop breathing): DNR/DNI [Do Not Resuscitate/Perform CPR/Do Not Intubate [inserting a breathing tube through the mouth or nose and down into the windpipe to keep the airway open and assist with breathing].” During a review of Patient 1’s “Orders” (undated), the Orders indicated physician order dated 6/9/26 indicating, “Do Not Resuscitate (Allow Natural Death).” During a review of Patient 1’s “Progress Note” (PN) dated 6/13/26 at 10:06 p.m., the PN indicated, “Patient reportedly broke a glass mirror and stabbed himself in the left arm... Patient received 1 round [2 minutes] of chest compressions despite a DNR order...” During a review of Patient 1’s “Cardiopulmonary Resuscitation Report” (CRR - a document indicating the use of CPR on hospital patients) dated 6/13/26, the CRR indicated CPR was performed on Patient 1 from 8:48 p.m. to 8:50 p.m. on 6/13/26. During an interview on 6/22/26 at 12:50 p.m. with the Director of Renal and Telemetry Services (DRTS), DRTS stated Patient 1 was admitted on 6/9/26 to the renal unit (for patients with kidney failure) and was receiving hemodialysis. DRTS stated Patient 1 was being continuously monitored by a TeleSitter (a staff member video-monitoring the patient 24 hours for safety) due to confusion, risk for falls and interfering with medical devices. DRTS stated on 6/13/26, during the night shift, Patient 1 broke a personal mirror in his possession and used glass chards to cut his left arm arteriovenous fistula (AV fistula - a surgically created access to the patient’s blood vessels used to remove and return blood during hemodialysis) causing bleeding. DRTS stated the TeleSitter noticed Patient 1 was bleeding and alerted the renal unit staff. DRTS stated staff responded to Patient 1’s room, rendered first aid, and activated the hospital’s Rapid Response Team (RRT- a specialized group of critical care clinicians who respond to life-threatening emergencies in the hospital). DRTS stated Patient 1 was transferred to the Intensive Care Unit (ICU) where he later died from his self-inflicted wounds. During an interview on 6/22/26 at 2:36 p.m. with Medical Doctor (MD) 1, MD 1 stated he was part of the facility’s RRT. MD 1 stated the RRT was activated to Patient 1’s room on 6/13/26 at night. MD 1 stated when he arrived in the renal unit Patient 1 was “bagged” (had a bag valve mask over his face to pump air into his lungs), had a cut on his left arm AV fistula and there was blood in his bed. MD 1 stated staff told him they had done chest compressions on Patient 1. MD 1 stated they took Patient 1 to the Intensive Care Unit (ICU) where Patient 1 later died from his wounds. During an interview on 6/22/26 at 3:10 p.m. with Certified Nursing Assistant (CNA) 1, CNA 1 stated he was working on the renal unit on 6/13/26 at night when he heard the TeleSitter alarm and rushed to Patient 1’s room. CNA 1 stated there was blood all over Patient 1’s bed and Patient 1 was holding a glass chard in his right hand. CNA 1 stated he put a towel in Patient 1’s left arm to stop the bleeding. CNA 1 stated then other staff came to Patient 1’s room. CNA 1 stated Patient 1 became unresponsive and a nurse started CPR on Patient 1. CNA 1 stated he also did CPR on Patient 1. During an interview on 6/22/26 at 3:30 p.m. with Registered Nurse (RN) 1, RN 1 stated she was working in the renal unit on 6/13/26 at night. RN 1 stated she heard the TeleSitter alarm she rushed into Patient 1’s room and saw blood on his bed. RN 1 stated a CNA was putting pressure on Patient 1’s left arm. RN 1 stated Patient 1 lost pulse (heartbeat) and stopped breathing and chest compressions were started until someone stated Patient 1 was DNR and they stopped chest compressions. During an interview on 6/22/26 at 3:35 p.m. with RN 2, RN 2 stated he was working in the renal unit on 6/13/26 at night when he was called to Patient 1’s room because he was bleeding. RN 2 stated there was blood in his bed and Patient 1 was unresponsive. RN 2 stated he performed chest compressions on Patient 1 and later a CNA also did chest compressions on Patient 1 until someone said Patient 1 was DNR and chest compressions ceased. During an interview on 6/22/26 at 3:50 p.m. with Patient 1’s Significant Other (SO), SO stated Patient 1 told her he did not want CPR. SO stated she was upset facility staff performed CPR on Patient 1 despite his refusal documented in his medical record. During an interview on 6/22/26 at 5:08 p.m. with FM 1, FM 1 stated she was distraught Patient 1 received CPR at the facility. FM 1 stated resuscitative efforts were contrary to Patient 1’s wishes, who wanted death to take its course in case his breathing or heartbeat stopped. During an interview on 6/23/26 at 2 p.m. with DRTS, DRTS stated Patient 1’s code status was DNR and he should not have received CPR. DRTS stated patients with DNR code status had a purple arm band indicating no resuscitative efforts. DRTS stated Patient 1 had a purple arm band and staff should have checked his arm band before starting CPR. During a review of facility policy and procedure (P&P) titled “Do Not Resuscitate (Resuscitation Status)”, dated 10/30/23, the P&P indicated, “[Facility] will ensure that a patient’s rights, preferences and decision to withhold resuscitative services, as permitted by law, are respected.” and “Each patient has the right to refuse recommended medical treatment.””

“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: 37797 Based on interview and record review, the facility failed to ensure one of 30 sampled patients (Patient 1) received care in a safe setting when the facility monitored Patient 1 using a TeleSitter (where a staff member continuously monitors a patient remotely via audiovisual equipment) who displayed delirium (a severe state of confusion and altered mental function causing drastic fluctuations in attention, awareness, and thinking) and psychosis (a collection of symptoms that affect the mind resulting in a loss of contact with reality where patients experience altered perceptions, unusual beliefs and disrupted thoughts), which were conditions that excluded the use of TeleSitters according to the facility’s policies and procedures. The facility also failed to document it considered the use of direct patient observation (where the patient is continuously monitored by a staff within line of sight of the patient instead of remotely via video by a TeleSitter) after Patient 1 displayed delirium and psychosis as required by its policies and procedures. These failures had the potential for Patient 1 not to be properly monitored for safety. Findings: During a review of Patient 1’s “History and Physical Report” (HPR) dated 6/9/26, the HPR indicated Patient 1 was admitted to the hospital on 6/9/26 with diagnosis including Altered Mental Status (AMS - a change in a person’s baseline awareness, cognition, or consciousness) and End Stage Renal Disease (ESRD - the final, irreversible stage of chronic kidney disease, when the kidneys can no longer filter blood) on Hemodialysis (a life-sustaining treatment for kidney failure where a machine pumps blood out of the body, filters toxins and excess fluids through an artificial kidney and returns the clean blood to the person). During a review of Patient 1’s “TeleSitter Initiation Form” (TSIF) dated 6/9/26, the TSIF indicated Patient 1 was admitted to TeleSitter monitoring on 6/9/26 for the following patient risk factors: poor short-term memory, impulsivity and distorted perception of reality. During a review of Patient 1’s “TeleSitter Communication Forms” (TSCFs) dated 6/11/26 (day shift), 6/11/26 (night shift), 6/12/26 (day shift) and 6/13/26 (night shift), the TSCFs indicated Patient 1 was being monitored for the following behaviors: fall risk, impulsive/confused, hard of hearing, medical device interference and distorted perception of reality. During a review of Patient 1’s “Care Management Form” (CMF), dated 6/12/26 at 2:13 p.m. and signed by Social Worker (SW) 1, the CFM indicated, “[staff] reviewed chart after being made aware during AM rounds that the patient was delusional (a fixed, false belief that is firmly held despite clear, contradictory evidence) with A/V [audio/visual] hallucinations (seeing, hearing, smelling, tasting, or feeling things that seem convincingly real, but are actually created by their own brain). Per RN, the patient thinks he is dead, thinks that staff are demons, and that staff is wanting to hurt him. Patient is not A/O [alert and oriented] at this time.” During a review of Patient 1’s “Neurological Assessment” (NA) dated 6/13/26 at 7:53 a.m., the NA indicated Patient 1 had “Disorganized Thought Process” and “Illogical Flow of Ideas.” During a review of Patient 1’s “Progress Note” (PN), dated 6/13/26 at 3:57 p.m., the PN indicated: “6/12/2026: Patient remains confused. Patient underwent emergent HD [hemodialysis]. still remains confused after HD... 6/13/2026: More awake sttill (sic) delirious...” During a review of Patient 1’s “Progress Note” (PN) dated 6/13/26 at 10:06 p.m., the PN indicated, “Patient reportedly broke a glass mirror and stabbed himself in the left arm...” During an interview on 6/22/26 at 12:50 p.m. with the Director of Renal and Telemetry Services (DRTS), DRTS stated Patient 1 was being continuously monitored by a TeleSitter due to confusion, risk for falls and interfering with medical devices. DRTS stated on 6/13/26, during the night shift, Patient 1 broke a personal mirror in his possession and used glass chards to cut his left arm arteriovenous fistula (AV fistula - a surgically created access to the patient’s blood vessels used to remove and return blood during hemodialysis) causing bleeding. DRTS stated the TeleSitter noticed Patient 1 was bleeding and alerted the renal unit staff. DRTS stated staff responded to Patient 1’s room, rendered first aid, and activated the hospital’s Rapid Response Team (RRT- a specialized group of critical care clinicians who respond to life-threatening emergencies in the hospital). DRTS stated Patient 1 transferred to the Intensive Care Unit (ICU) where he later died from his self-inflicted wounds. During an interview on 6/23/26 at 9:27 a.m. with SW 1, SW 1 stated she completed a psychosocial assessment of Patient 1 on 6/12/26 and found Patient 1 was having delusions and hallucinations. During an interview on 6/23/26 at 10 a.m. with RN 3, RN 3 stated he was Patient 1’s nurse in the renal unit on 6/12/23 and 6/13/23 during the day shift (6 a.m. to 6:30 a.m.). RN 3 stated during 6/12/23 and 6/13/23 Patient 1 was confused and having hallucinations of seeing dead cats and delusions that his girlfriend had died. RN 3 stated he reported the delusions and hallucinations to Patient 1’s physician. During a concurrent interview and record review on 6/23/26 at 11:50 a.m. with the DRTS, the facility’s P&P titled “Continuous Visual Monitoring for Patient Safety” (TeleSitter Policy) dated 2/3/23 was reviewed. The TeleSitter Policy indicated, “Patient conditions that exclude the use of TeleSitting:... B.2....delirium, psychosis.” The Telesitter Policy further indicated, “Consider direct observation (where the patient is continuously monitored by a staff within line of sight of the patient instead of remotely via video) by a PSA [Patient Safety Associate] if patient requires monitoring for the following conditions... delirium, psychosis.” DRTS stated the TeleSitter Policy did not exclude the use of TeleSitters for patients with delirium and psychosis. DRTS stated the TeleSitter Policy, instead, required the facility to consider the use direct observation for patients being “monitored” for delirium and psychosis. DRTS stated Patient 1 was not being monitored for delirium or psychosis and therefore this section of the TeleSitter policy did not apply to Patient 1. DRTS stated the consideration of whether a patient should be monitored by direct observation or TeleSitter was made by the patient’s licensed nurse at the beginning of each shift. DRTS was asked if Patient 1’s nurses made this consideration for Patient 1 and if it was documented in Patient 1’s clinical record. During an interview on 6/23/26 at 2 p.m. with DRTS, DRTS stated there was no documentation in Patient 1’s clinical record Patient 1’s nurses considered the use of direct observation by a PSA for Patient 1 because of his delirium and psychosis. DRTS stated the TeleSitter Policy’s indication to “Consider direct observation by a PSA if patient requires monitoring for... delirium, psychosis.” was a nursing intervention that did not require documentation in the patient’s clinical record. During a review of the facility’s TelleSitter policy, the P&P indicated: “To provide guidelines for decentralized continuous visual monitoring, referred to as “TeleSitting”, for patient safety using a mobile device. Centralized monitoring occurs by TeleSitter technician... in the monitor room.” “TeleSitting is considered a nursing intervention based on nursing assessment. Physician/provider order is not required to initiate continuous visual monitoring for patient safety.” “Patient need for continuous visual monitoring is assessed by the licensed nurse responsible for the patient’s care. If continuous visual monitoring is necessary, the TeleSitter Initiation Form is completed and faxed to the TeleSitter office.” “TeleSitting is attempted for patients who can respond to verbal redirection and... for the following patient conditions: A. Substance withdrawal; B. Medical device interference; C. Fall prevention; D. Confusion; E. Low risk for suicide; F. Protective Restraints; G. Elopement Risk (confused patients leaving the hospital); H. Potential aggressive/violent patients; and I. Safety issues identified by the licensed nurse.” “Patient conditions that exclude use of TeleSitting:... B. Consider direct observation by a PSA is patient requires monitoring for the following conditions: 2... delirium, psychosis.” During a review of the facility’s P&P titled, “Closed Monitoring for Patient Safety” dated 2/3/23 (the facility’s P&P on use of direct observation by PSA), the P&P indicated: “Close monitoring status may be indicated when one or more of the following patient conditions are present: 2. Medical Conditions that result in conscious or unconscious potentially self-injurious behaviors, such as but not limited to... impairment of reasoning or judgement.””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 39356 Based on interview and record review, the Hospital failed to implement its policy and procedure (P&P) titled “Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure (IC),” for one of 15 sampled patients (Patient 1) when a Physicians Order (PO) for a surgical procedure was not documented prior to licensed staff verifying and witnessing Patient 1’s IC. This failure had the potential for Patient 1 to not be informed of risk, benefits and alternatives prior to Patient 1’s surgical procedure and the potential for a wrong site surgery. Findings: During a review of Patient 1’s “IC,” dated 2/24/26 at 6:57 a.m., the IC indicated, “Fistulogram [minimally invasive x-ray procedure used to visualize a fistula (connection between two parts of your body which normally do not connect)] with possible intervention, with procedural sedation, possible declot [removing blood clots], possible insertion of a tunneled central venous dialysis access device (flexible tube placed into a large vein to provide immediate access for hemodialysis).” During an interview on 6/1/26 at 11:05 a.m. with Manager Cardiac Cath Lab, MCCL stated Patient 1 was scheduled for three procedures in the Cath (catherization) lab on 2/24/26. MCCL stated RN 2 was the preoperative nurse who confirmed the three procedures with Patient 1 prior to her procedures. MCCL stated RN 2 had Patient 1 sign her consent for “Fistulogram.” During an interview on 6/1/26 at 2:15 p.m. with MCCL, MCCL stated RN 2 had Patient 1 sign the IC without a documented PO from Interventional Radiologist (IR, specialized doctor who uses medical imaging to guide and treat conditions without the need for traditional open surgeries) . During a concurrent interview and record review on 6/2/26 at 2:30 p.m. with MCCL, the hospital’s “Common Consents (CC),” (undated) was reviewed. The CC indicated, “Fistulagram with possible intervention and procedural sedation.” MCCL stated the CC list were common procedures performed in the interventional radiology department. MCCL stated the nurse would fill in the IC from the CC list after a procedure was scheduled. MCCL stated this was not the correct process for filling out an IC form and the list was not a physicians order. During an interview on 6/3/26 at 8:30 a.m. with RN 2, RN 2 stated Patient 1 had been a patient multiple times at the facility and has had a fistulogram previously. RN 2 stated Patient 1 agreed with the procedure to be performed. RN 2 stated she did not fill out Patient 1’s informed consent for “Fistulogram” but she witnessed Patient 1 signing the informed consent. RN 2 stated RN 3 filled out the informed consent for “Fistulogram.” During an interview on 6/3/26 at 8:52 a.m. with Nurse Manager (NM), NM stated RN 3 informed NM that she had filled out the IC for Patient 1 which indicated “Fistulogram” NM stated Patient 1 was scheduled for an “IR declot” which is an umbrella term for “Fistulogram.” NM stated there was not a physicians order for “Fistulogram” and there should have been before RN 3 filled out the IC and before RN 2 witnessed the signing of the IC from Patient 1. During a review of the hospital’s P&P titled, “Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure” dated 11/23/21, the P&P indicated, “Purpose: [Hospital] adhere to the principles of Informed Consent. The purpose of this policy is to define the responsibilities of [Hospital] and its affiliated members of the medical staff and credentialed advance practice providers for obtaining and documenting the process of informed consent, based on statutory and legal requirements in the state of California, the Centers for Medicare & Medicaid Services and the Joint Commission. This policy is intended to provide guidance to assure patients receive sufficient information so that they have the opportunity to make knowledgeable and informed decisions about the course of their treatment related to surgical, diagnostic and other procedures that require informed consent. . . Policy: 2. The consent process consists of two important components: information disclosure and documentation. Except in limited circumstances, disclosure of certain information pertinent to the procedure, care or treatment rendered is always required. The Responsibility for disclosure rests with the healthcare provider performing the procedure or rendering the care/treatment and/or an equally credentialed member of the medical staff. 3. It is the provider’s responsibility to obtain informed consent and to document this consent in the patient’s hospital medical record before the provider is permitted to perform any procedure that requires consent. 4. The hospital’s role in the consent process is to verify the patient’s informed consent was obtained by the provider before the provider is permitted to perform the procedure. 5. The provider, not the hospital, has the duty to disclose all information relevant to the patient’s decision and to obtain the patient’s having perm consent for surgery and for special diagnostic or therapeutic procedures including blood transfusions. . .Procedure 5. e. How to complete the Informed Consent Form Procedures Section 1. a. This section is to be filled out by the provider in clear, legible writing. Abbreviations are not acceptable. b. The licensed staff may assist in completing this section based on the documented provider order. Section III. A. Patient’s signature The signature signifies that the patient’s acknowledgment of the discussion with his/her provider; that the information has been shared or read to him/her and consents to the procedure, and has no further questions. B. Witnessing the Signing of the Consent Form and Verification of Consent. Confirm that the patient has been given sufficient information by the provider regarding the procedure. The licensed staff will ask the patient to read the consent form and/or read the consent form to the patient if requested.””

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 47444 The facility failed to meet the regulatory requirements for the Condition of Participation: §482.22 Medical Staff as evidenced by: Based on interview and record review, the Hospital failed to ensure one of 31 sampled patients (Patient 1) was assessed timely and treated for left eye pain and decreased vision. This failure resulted in delayed treatment requiring a transfer to higher level of care, to prevent permanent loss of vision.( Refer to A-347) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure safe quality health care services, in compliance with Conditions of Participation for Medical 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: 39356 The facility failed to meet the regulatory requirements for the Condition of Participation: §482.51 Surgical Services as evidenced by: Based on interview and record review the hospital failed to ensure the surgical procedures performed were consistent with the documented informed consent (IC) obtained from four of 12 sampled patients (Patient 13, Patient 14, Patient 15, and Patient 20) when: 1. Patient 13’s signed an informed consent for a repeat cesarean (c-section - surgical procedure to deliver a baby through incisions in the mother’s abdomen and uterus) with bilateral tubal ligation (BTL - both fallopian tubes are blocked by tying, cutting or burning to prevent future pregnancy [sterilization] and may be reversible); a repeat cesarean section with bilateral salpingectomy (a permanent irreversible sterilization procedure which removes both fallopian tubes to prevent future pregnancies (sterilization) was performed. This failure resulted in Patient 13 being unable to have an option for a possible reversal of the sterilization procedure and had the potential to negatively affect Patient 13’s psychosocail well-being. 2. Patient 14’s physician’s orders (PO) and informed consent indicated a cesarean section procedure was to be performed; a repeat low transverse cesarean section with bilateral salpingectomy was performed. This failure had the potential for Patient 14 to to be unable to make an informed decision regarding irreversible sterilization. 3. Patient 15 and Patient 20’s POs indicated a cesarean section procedure was to be performed. Patient 15 and Patient 20 signed an informed consent for a cesarean section with bilateral tubal ligation; a low transverse (a surgical cut made across the thinnest, lower part of the uterus to deliver a baby) cesarean section with bilateral salpingectomy was performed. These failures resulted in Patient 15 and Patient 20 being unable to have an option for a possible reversal of the sterilization procedure and had the potential to negatively affect Patient 15 and Patient 20’s psychosocail well-being.(Refer to A-0955) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure safe quality health care, in compliance with Conditions of Participation for Surgical Services.”

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 47444 Based on interview and record review, the Hospital failed to ensure one of 31 sampled patients (Patient 1) was assessed timely and treated for her complaints of pain and decreased vision in her left eye. This failure resulted in delayed treatment requiring a transfer to higher level of care, to prevent permanent loss of vision in left eye. Findings: During a review of Patient 1’s “ED (Emergency Department) Note Physician (EDNP),” dated 9/30/25, the EDNP indicated Patient 1 arrived to the Hospital’s ED with complaints of weakness, nausea, vomiting and diarrhea. The EDNP indicated Patient 1 had a diagnosis of metastatic breast cancer (cancer in the breast that moved to other areas of the body). Patient 1 was admitted to the Hospital for inpatient medical care on 10/1/25. During an interview on 5/4/26 at 11:54 a.m. with Patient 1, Patient 1 stated ten days after being admitted to the Hospital, on the evening of 10/10/25, she started having black spots in her left eye vision. Patient 1 stated she informed the nurse and the physician but no specialist called. Patient 1 stated on 10/11/25 she woke up and her left eye was red, felt swollen and still had black spots in her vision. Patient 1 stated she reported the symptoms to the nurse and physician but no treatment was provided. Patient 1 stated on 10/12/25 her eye continued to be red, was painful, and was visibly swollen. Patient 1 stated she was told by a physician that the hospital did not have an eye specialist on staff. Patient 1 stated she woke on 10/13/25 with blood and pus draining from her left eye. Patient 1 stated she was transferred later that same day to a different hospital and recieved treatment for her left eye, but the damage was already done and she had permanent vision loss. During a concurrent interview and record review on 5/5/26 at 10:32 a.m. with Nurse Manager (NM), Patient 1’s “Provider Notification (PN),” dated 10/10/25 and 10/11/25 were reviewed. The PN indicated on 10/10/25 at 10 p.m. Registered Nurse (RN) 1 notified NP that Patient 1 was complaining of blurred vision in left eye. The PN indicated on 10/11/25 at 4:40 a.m. RN 1 notified NP that Patient 1 was complaining of continued blurred vision and dryness in left eye. RN 1 stated NP ordered lubricating eye drops as needed for Patient 1’s left eye. NM stated RN 1 documentation indicated the NP was notified of Patient 1’s vision changes in her left eye. During a concurrent interview and record review on 5/5/26 at 10:37 a.m. with NM, Patient 1’s “PN,” dated 10/11/25 was reviewed. The PN indicated on 10/11/25 at 8:29 p.m., RN 2 notified NP of Patient 1’s complaints of left eye pain, blurred vision, and seeing spots. The PN indicated Patient 1 had “large scleral edema [swelling of the white outer layer of eye, when left untreated can cause loss of vision and requires prompt treatment with anti-inflammatory medications] protruding outward from lateral [outer] side of left eye.” NM stated RN 2 documented notification of NP regarding Patient 1’s left eye vision loss and pain. During a concurrent interview and record review on 5/5/26 at 2:06 p.m. with Medical Doctor (MD) 1, Patient 1’s “Critical Care Progress Notes (CCPN),” dated 10/11/25 was reviewed. The CCPN indicated Patient 1 reported a headache and diarrhea. MD 1 stated he cared for Patient 1 during the day shift on 10/11/25. MD 1 stated he does a patient assessment each shift and documents any abnormal findings in a progress note. MD 1 stated he did not document any left eye related concerns for Patient 1. During a concurrent interview and record review on 5/5/26 at 2:08 p.m. with MD 1, Patient 1’s “CCPN,” dated 10/12/25 was reviewed. The CCPN indicated no left eye concerns were documented. MD 1 stated he cared for Patient 1 on 10/12/25 and did not document any eye related issues for Patient 1. MD 1 stated if NP had reported to him that Patient 1 was having eye and vision related issues, he would do an eye exam and document the findings. MD 1 stated the documentation of any eye or vision concerns would be important to help communicate identified concerns to other providers and what was being done to treat the identified concern. During a concurrent interview and record review on 5/6/26 at 8:38 a.m. with NP, Patient 1’s “PN,” dated 10/10/25 and 10/11/25 were reviewed. The PN indicated on 10/10/25 at 10 p.m. RN 1 notified NP that Patient 1 was complaining of blurred vision in left eye. The PN indicated on 10/11/25 at 4:40 a.m. RN 1 notified NP that Patient 1 was complaining of continued blurred vision and dryness in left eye. The NP ordered lubricating eye drops as needed for Patient 1’s left eye. NP stated she cared for Patient 1 on 10/10/25 during the night shift but did not document a progress note regarding the vision and dryness in Patient 1’s left eye. During a concurrent interview and record review on 5/6/26 at 8:43 a.m. with NP, Patient 1’s “PN,” dated 10/11/25 was reviewed. The PN indicated on 10/11/25 at 8:29 p.m. RN 2 notified NP of Patient 1’s complaints of eye pain, blurred vision and seeing spots in left eye. The PN indicated Patient 1 also had “large scleral edema protruding outward from lateral side of left eye.” NP stated she had noticed redness in Patient 1’s eye, but could not recall which eye. NP stated she should have documented Patient 1’s eye redness in a progress note but did not. NP stated it was important for her to document changes in patient condition, monitoring for worsening and treatment that was provided. NP stated she did not communicate with the day shift MD about Patient 1’s left eye redness. During a concurrent interview and record review on 5/6/26 at 8:48 a.m. with NP, Patient 1’s “CCPN,” dated 10/12/25 was reviewed. The CCPN indicated NP documented a review of lab results. NP stated she was aware of Patient 1’s swelling and redness of the eye. NP stated she did not document Patient 1’s eye condition in her progress note but should have. During a concurrent interview and record review on 5/6/26 at 12:30 p.m. with MD 3, Patient 1’s “Discharge Summary (DS),” dated 10/13/25 was reviewed. The DS indicated, “on 11 October MRI [magnetic resonance imaging - a noninvasive medical imaging that uses strong magnetic fields to produce images] was done because the patient [Patient 1] was complaining of vision changes and it showed a new right frontal lobe lesion consistent with metastasis. . . She [Patient 1] continued to complain of visual loss which initially started 2 days ago as black floaters in front of her left eye and today she is complaining of approximately 80% loss in her vision. . . Her eye exam is consistent with redness some swelling feeling of fullness not very tender and pus [thick fluid produced by the immune system during infections] in the anterior chamber [fluid filled space in the eye]. [Ophthalmology physician - specialist that diagnosis and treats conditions of the eye] was consulted urgently and recommended transfer to higher level of care where her vision loss could be addressed.” MD 3 stated she cared for Patient 1 on 10/13/25 during the day shift. MD 3 stated when she did her exam of Patient 1’s left eye, she saw pus in the anterior chamber and was concerned Patient 1 had an infection. MD 3 stated there was an urgent need for exam and care by an ophthalmology specialist. MD 3 stated Patient 1 was transferred to another facility since the Hospital did not have an ophthalmology specialist on staff. During a concurrent interview and record review on 5/6/26 at 1:23 p.m. with MD 2, Patient 1’s “Oncology (specialty that diagnosis and treats cancer) Progress Note (OPN),” dated 10/13/25 was reviewed. The OPN indicated, “Vision Loss patient [Patient 1] has had acute onset loss of vision over the last few days, needs urgent ophthalmology evaluation, being transferred to [hospital name] for the same.” MD 2 stated he was the Oncology specialist treating Patient 1’s metastatic breast cancer. MD 2 stated he was not made aware of Patient 1’s eye and vision concerns until he saw Patient 1 on 10/13/26 at 3:45 p.m. MD 2 stated he would have expected a call from a provider with any significant changes in Patent 1’s condition to collaborate for care and treatment of Patient 1’s eye and vision changes. During a review of Hospital’s “Medical Staff Rules and Regulations (R&R),” dated 12/17/25, the R&R indicated, “Medical Records 3.1 General Requirements: (a) Medical Record: . . . Each practitioner will be responsible for the timely, complete, accurate, and legible completion of the portions of the medical record that pertain to the care he or she provides.””

“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: 39356 Based on interview and record review the hospital failed to ensure the surgical procedures performed were consistent with the documented informed consent (IC) obtained from four of 12 sampled patients (Patient 13, Patient 14, Patient 15, and Patient 20) when: 1. Patient 13’s signed an informed consent for a repeat cesarean (C-section - surgical procedure to deliver a baby through incisions in the mother’s abdomen and uterus) with bilateral tubal ligation (BTL - both fallopian tubes are blocked by tying, cutting or burning to prevent future pregnancy [sterilization] and may be reversible); a repeat cesarean section with bilateral salpingectomy (a permanent irreversible sterilization procedure which removes both fallopian tubes to prevent future pregnancies [a sterilization/birth control procedure]) was performed. This failure resulted in Patient 13 having a permanent sterilization procedure which had the potential to cause psychological and financial harm. 2. Patient 14’s physician’s orders (PO) and informed consent indicated a cesarean section procedure was to be performed; a repeat low transverse cesarean section with bilateral salpingectomy was performed. This failure resulted in Patient 14 having a permanent sterilization procedure without her consent. 3. Patient 15 and 20’s POs indicated a cesarean section procedure was to be performed. Patient 15 and 20 both consented for a cesarean section with bilateral tubal ligation; a low transverse ( a surgical cut made across the thinnest, lower part of the uterus to deliver a baby) cesarean section with bilateral salpingectomy was performed. This failure resulted in 15 and 20 having a permanent sterilization procedure which had the potential to cause psychological and financial harm. Findings: 1. During a review of Patient 13’s “Orders (PO),” dated 3/22/24 at 5:09 p.m. the PO indicated, the procedure to be performed was “Cesarean Section with Salpingectomy.” During a review of Patient 13’s “Informed Consent for Surgical, Diagnostic Or Therapeutic Procedure (IC),” dated 3/12/24 at 3:29 p.m., the IC indicated, the procedure to be performed was “Repeat Cesarean with Bilateral Tubal Ligation.” During a review of Patient 13’s “Operative Report (OR - a detailed, official medical document that describes the surgical procedure performed by the surgeon),” dated 3/22/24 at 3:54 p.m., the OR indicated, the procedure performed by Surgeon 1 was “Repeat low transverse cesarean section with bilateral salpingectomy.” During an interview on 5/4/26 at 1:40 p.m. with Director of Maternal Child Health (DMCH), DMCH stated she completed a root cause analysis (RCA - structured systematic process for identifying fundamental causes of problems to prevent their recurrence) for Patient 13’s reported grievance (reported to the Hospital on 3/12/26) related to her fallopian tubes being removed without her consent following her c-section. DMCH stated she reviewed Patient 13’s medical record and Patient 13’s surgical IC indicated the procedure to be performed was a C-section with BTL. DMCH stated Patient 13’s OR dated 3/22/26 indicated Surgeon 1 documented and performed a C-section with bilateral salpingectomy. DMCH stated “surgeons” had informed her, BTL and bilateral salpingectomy were under the same umbrella as a “sterilization procedure [procedure to permanently prevent future pregnancies].” DMCH stated these two procedures (BTL and bilateral salpingectomy) were not the same procedure. DMCH stated bilateral salpingectomy removes the fallopian tubes and a BTL was the burning or use of clips on the fallopian tubes. DMCH stated there was a small possibility of reversing a BTL procedure to attempt to become pregnant again. DMCH stated the surgical IC should match the procedure documented on the surgeon’s OR. During an interview on 5/5/26 at 9:55 a.m. with Coding Supervisor (CS), CS stated a CPT code (current procedural terminology - standardized five-digit numeric system developed by the American Medical Association (AMA) used to act as a uniform language for communication between physicians, providers, and payers, ensuring accurate reimbursement and tracking of care) was for physicians to document their specific medical procedures for billing. CS stated the CPT code for c-section with BTL was 586811 and the CPT code for C-section with bilateral salpingectomy was 586661. CS stated they have different codes and are different surgical procedures. During an interview on 5/5/26 at 10:30 a.m. with CS, CS stated the importance of coding correctly is to maintain compliance, for proper reimbursement and for patient care. CS stated the physician’s documentation was referenced to determine the CPT code for billing purposes. During an interview on 5/5/26 at 2:05 p.m. with Surgeon 1, Surgeon 1 stated he informed patients that sterilization was a permanent process to prevent pregnancy and there was no going back. Surgeon 1 stated he informs patients of alternative pregnancy prevention options such as IUD and birth control. Surgeon 1 stated bilateral salpingectomy procedures had been recommended as the better option for sterilization due to preventing cancer and ectopic pregnancies (pregnancy located outside of the uterus). Surgeon 1 stated a BTL procedure utilizes clips being placed on the fallopian tubes or section of fallopian tube can be burned versus a bilateral salpingectomy procedure which the fallopian tubes are removed. Surgeon 1 stated he informed Patient 13 sterilization was permanent. Surgeon 1 stated Patient 13 PM 330 (a State of California Consent for Sterilization document was used to ensure patients provided fully informed, voluntary consent for permanent sterilization procedures) sterilization informed consent form erroneously stated bilateral tubal ligation and that was his error. Surgeon 1 stated a “culture change” was needed and the term “tubal ligation” should not be used as a blanket term to indicate sterilization. Surgeon 1 stated the medical record documentation should correctly state what surgical procedure was being performed. During a review of Patient 13’s “CONSENT FORM PM 330 dated 3/22/24 at 5:09 p.m. the PO indicated, “ I understand that I will be sterilized by an operation known as a Bilateral Tubal Ligation” Signed by Patient 13 on 1/2/24. “PHYSICIAN’S STATEMENT. . . Signature of Physician performing surgery” no signature documented. 2. During a concurrent interview and record review on 5/6/26 at 9:45 a.m. with DMCH, Patient 14’s “PO,” dated 11/11/25 at 5:16 a.m., Patient 14’s “IC” dated 11/11/25 at 7 a.m., and Patient 14’s “OR,” dated 11/11/25 at 8:44 a.m., were reviewed. The PO indicated, the procedure to be performed was a “Cesarean Section.” The IC indicated, “Cesarean Section.” The OR indicated, Surgeon 3 performed a “Repeat low transverse cesarean section with bilateral salpingectomy.” DMCH stated Patient 14’s PO and IC are not consistent with the procedure performed as indicated in the OR. DMCH stated Patient 14 had a sterilization procedure performed by the surgeon without her consent. 3. During a concurrent interview and record review on 5/6/26 at 9:48 a.m. with DMCH, Patient 15’s “PO,” dated 11/12/25 at 12:46 p.m., Patient 15’s “IC” dated 11/12/25 at 2:06 p.m. and Patient 15’s “OR,” dated 11/24/25 at 2:49 p.m., were reviewed. The PO indicated, the procedure to be performed was a “Cesarean Section.” The IC indicated, “Cesarean Section with Bilateral tubal Ligation.” The OR indicated, Surgeon 1 performed a “Repeat low transverse cesarean section with bilateral salpingectomy.” During a concurrent interview and record review on 5/6/26 at 10:02 a.m. with DMCH, Patient 20’s “PO,” dated 12/26/25 at 8:38 a.m., Patient 20’s “IC,” dated 12/26/25 at 8:09 a.m. and Patient 20’s “OR,” dated 12/26/25 at 8:44 a.m., were reviewed. The PO indicated, the procedure to be performed was a “Cesarean Section.” The IC indicated, “Cesarean Section with bilateral tubal ligation.” The OR indicated, Surgeon 2 performed a “Repeat low transverse cesarean section with bilateral salpingectomy.” DMCH stated Patient 20’s PO and IC are not consistent with the procedure performed as indicated in the OR. During an interview on 5/6/26 at 10:20 a.m. with DMCH, DMCH stated the process for obtaining informed consent should begin in the Surgeon’s office. DMCH stated the surgeon should clearly explain the difference between BTL and bilateral salpingectomy to the patients. DMCH stated once the patient arrives at the hospital, the physician orders should be placed in the electronic health record prior to the patient signing their informed consent and before entering the operating room. DMCH stated that the informed consent should indicate whether the patient consented for a BTL or Bilateral Salpingectomy and the procedure the patient consented should be documented consistently and accurately in the medical record. During a review of the hospital’s Policy and Procedure (P&P) titled, “Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure” dated 11/23/21, the P&P indicated, “Purpose: {Hospital} adhere to the principles of Informed Consent. The purpose of this policy is to define the responsibilities of [hospital] and its affiliated members of the medical staff and credentialed advance practice providers for obtaining and documenting the process of informed consent, based on statutory and legal requirements in the state of California, the Centers for Medicare & Medicaid Services and the Joint Commission. This policy is intended to provide guidance to assure patients receive sufficient information so that they have the opportunity to make knowledgeable and informed decisions about the course of their treatment related to surgical, diagnostic and other procedures that require informed consent. Policy: 1. Hospital] recognizes the fundamental right of each person (or authorized representative) to be reasonably informed in decisions involving the person’s healthcare. This patients right also include the patient’s participation in the care planning and treatment and being able to request or refuse treatment. This Right must not be construed as a mechanism to demand provision of treatment or services deemed medically unnecessary or inappropriate. 2. The consent process consists of two important components: information disclosure and documentation. Except in limited circumstances, disclosure of certain information pertinent to the procedure, care or treatment rendered is always required. The Responsibility for disclosure rests with the healthcare provider performing the procedure or rendering the care/treatment and/or an equally credentialed member of the medical staff. 3. It is the provider’s responsibility to obtain informed consent and to document this consent in the patient’s hospital medical record before the provider is permitted to perform any procedure that requires consent. 4. The hospital’s role in the consent process is to verify the patient’s informed consent was obtained by the provider before the provider is permitted to perform the procedure. 5. The provider, not the hospital, has the duty to disclose all information relevant to the patient’s decision and to obtain the patient’s having perm consent for surgery and for special diagnostic or therapeutic procedures including blood transfusions. 6. Discussion between a patient and health care providers regarding his/her value system and healthcare treatment preferences are encouraged and may include family members/surrogates in discussions as appropriate to the wishes of the patient. Whenever the word “person” or “patient” is used in this policy/procedure, one may substitute ‘or authorized representative.””

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 47444 The facility failed to meet the regulatory requirements for the Condition of Participation: §482.22 Medical Staff as evidenced by: 1. Based on interview and record review, the facility failed to ensure an X-ray esophagram barium swallow test (diagnostic imaging test that uses a contrast called barium to view the structure and function of the throat and esophagus [muscular tube that transports food and liquid to the stomach]) and CT (imaging using X-ray to create images of the body) of the abdomen and pelvis with contrast (dye used to highlight blood vessels, organs, and tissues) were accurately interpreted for one of 16 sampled patients (Patient 1). This failure resulted in the delay of Patient 1’s diagnosis and treatment for esophageal cancer and had the potential to contribute to an adverse health outcome. (refer to A-0347) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure safe quality health care, in compliance with Conditions of Participation for Medical Staff.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 51320 Based on interview and record review, the facility failed develop and implement a policy and procedure addressing appropriate behavior restraint to be utilized for one of two sampled patients (Patient 29)’s when a pillowcase was placed over Patient 29’s head when the patient spat on the staff. This failure had the potential to cause serious psychological trauma, injury, and/or death due to staff being unable to observe patient’s mouth for breathing and the potential for aspiration if the patient vomited. Findings: During an interview on 2/12/26 at 1:58 p.m. with Registered Nurse (RN) 2, RN 2 stated Patient 29’s behavior was known to staff because he had been on the floor for “several” days. RN 2 stated Patient 29 was in placed in behavioral four-point restraints (a type of physical restraint where both wrists and both ankles are secured simultaneously, to a bed or a restraint chair) because he had been pulling his medical equipment off. RN 2 stated he was also aware the patient had previously spit on other staff members. RN 2 stated on 12/22/25, he was called to Patient 29’s room because the patient was chewing on the telemetry leads (wires that attach to patient’s chest to monitors the heart). RN 2 stated he was adjusting Patient 29’s wrist restraint when Patient 29 spit on his left cheek. RN 2 stated he pushed Patient 29 on the face to divert Patient 29’s mouth away from his face. RN 2 stated he looked in a drawer the day before and he could not find spit masks (a loose mesh or fabric mask/restraint placed over a person’s head to prevent them from spitting or biting). RN 2 stated he instructed CNA 1 to obtain a pillowcase to put over Patient 29’s head. RN 2 stated CNA 1 placed the pillowcase on Patient 29’s head for two-three minutes until a spit mask was retrieved. RN 2 stated he was unsure if there was a specific P&P that addressed the use of spit masks. During an interview on 2/12/26 at 1:24 p.m. with Intern Chief Nursing Officer (ICNO), The ICNO stated the current restraint P&P does not address the use of spit masks. The ICNO stated a pillowcase should never have been used as a restraint. The ICNO stated the spit mask is a restraint and spit mask guidelines should have been included in the Facility’s restraint P&P. During a review of the facility’s policy and procedure (P&P) titled, “Restraint/Seclusion of Patients,” dated 8/20/25, the P&P indicated, “To provide guidelines to ensure that all . . .restraints for behavioral management is restricted to clinically appropriate and adequate justified situations in which less restrictive alternative methods have proven to be ineffective.””

“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: 51320 Based on interview and record review the facility failed to implement its “Restraints/Seclusion of Patient’s” Policy and Procedure (P&P) for two of six sampled patients (Patient 28, Patient 29) when the patients were not monitored as indicated on the P&P. This failure had the potential for Patient 28 and Patient 29’s circulatory (reduced blood flow to the arms or legs), motor, and sensory deficits or changes to go unnoticed and had the potential to cause unnecessary restraint application. Findings: During a review of Patient 28’s “History and Physical Report (H&P),” dated 2/6/26, the H&P indicates, Patient 28 was admitted for self destructive (harming self) injuries. During a review of Patient 28’s Physician Orders (PO), dated 2/9/26, the PO indicated, on 2/9/26 at 11:43 p.m. a four-point (a type of physical restraint where both wrists and both ankles are secured simultaneously, to a bed or a restraint chair) violent behavioral restraints were ordered. On 2/9/25 at 12:16 p.m the four point restraints were discontinued. During a concurrent interview and record review on 2/12/26 at 9:19 a.m. with Clinical Informatics Registered Nurse (CI), Patient 28’s “Restraint Information (RI)” dated 2/9/26 was reviewed. The RI indicated the staff did not document they conducted 15 minute checks on 2/9/26 at 11:43 p.m., 12 p.m., and 12:16 p.m. CI stated there should have been 15 minute checks documented for a four-point violent restraint order. During a review of Patient 28’s PO, dated 2/10/26, the PO indicated, on 2/10/26 at 12:13 a.m. four-point violent behavioral restraints were ordered. On 2/10/26 at 3:41 a.m. the four-point restraints were discontinued. During a concurrent interview and record review on 2/12/26 at 9:21 a.m. with CI, Patient 28’s RI dated 2/10/26 were reviewed. The RI indicated the staff did not document they conducted 15 minute checks on 2/10/26 at 12:15 a.m., 12:30 a.m. 12:45 a.m., 1 a.m., 1:15 a.m., 1:30 a.m., 1:45 a.m., 2 a.m., 2:15 a.m., 2:30 a.m., 2:45 a.m., 3 a.m., 3:15 a.m., 3:30 a.m., and 3:41 a.m. CI stated staff should have documented 15 minute checks for a four-point violent restraint order. During a review of Patient 29’s H&P, dated 12/14/25, the H&P indicates Patient 29 was admitted for cocaine (illegal drug) and ETOH (alcohol) use. During a review of Patient 29’s PO, dated 12/30/25, the PO indicated on 12/30/25 at 5:30 p.m. four-point restraints were ordered. On 1/30/26 at 12:04 a.m. the restraints were discontinued. During a concurrent interview and record review on 2/12/26 at 10:50 a.m. with CI, Patient 29’s RI dated 12/30/25 were reviewed. The RI indicated, there were no 15 minute checks documented on 12/30/25 at 5:45 p.m., 6:15 p.m., 6:30 p.m., 6:56 p.m. CI stated restraints are to be check every 15 minutes and documented. During a review of the facility’s P&P titled, “Restraints/Seclusion of Patients,” dated 8/20/25, the P&P indicated, “Patient placed in restraints or seclusion for violent or self-destructive behavior should be monitored at least every 15 minutes.” During a review of the facility’s P&P titled, “Restraints/Seclusion of Patients,” dated 2/5/26, the P&P indicated, “D. Minimum frequency of monitoring of a patient in restraints . . .patient placed in restraints. . .for a violent or self-destructive behavior should be monitored at least every 15 minutes . . .including the one hour face to face assessment for patients placed in response. . .for violent and disruptive behaviors.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(1) Training intervals. Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion- (i) Before performing any of the actions specified in this paragraph; (ii) As part of orientation; and (iii) Subsequently on a periodic basis consistent with hospital policy. This Standard is not met as evidenced by: 51320 Based on interview and record review, the facility failed to provide evidence four of four sampled staff (Registered Nurse [RN] 2, Certifed Nursing Assistant [CNA] 1, RN 4, RN 3) were trained on the Tranzport Hood (TTH)/spit mask (a device that goes over the head to reduce the risk of transmitting fluids like saliva and mucus) including training in the application, monitoring, assessment, and providing care prior to applying the TTH/spit mask on one two sampled patients (Patient 29). This failure resulted in inappropriate restraint use with the potential to cause harm while in restraints. Findings: During a review of Registered Nurse (RN) 2’s “Annual Training (AT),” dated 5/20/25, the AT indicated, RN 2 had no training on spit mask. During a review of Certified Nursing Assistant (CNA) 1’s AT, dated 5/20/25, the AT indicated, CNA 1 had no training on spit mask. During an interview on 2/9/26 at 3:04 p.m. with RN 4, RN 4 stated she is the charge nurse for the day. RN 4 stated she has no competencies on applying a spit mask. RN 4 stated she has not been trained on the guidelines for the spit mask that includes: order requirements, what staff are trained and allowed to place the spit mask, or the documentation that is required in the patient charting for monitoring. RN 4 reviewed the policy on restraints and could not find “spit mask” in the restraint policy. RN 4 stated as a charge nurse she does not have the training to guide the other staff. RN 4 stated as a charge nurse she should be educated on the spit mask or have a policy to references During an interview on 2/11/26 at 10:20 a.m. with Clinical Educator (CE), CE stated she was the educator that conducts the training on restraints for new employee orientation and that training does not it include the use of a spit mask. CE stated she teaches the restraint training as the policy is written. CE stated she did not train any staff on the spit mask because it was not part of the policy. CE stated staff has not had a return demonstration on applying the spit mask because the education department did not have a spit mask. CE stated the training that is given is not for CNAs. During a interview on 2/11/26 at 10:21 a.m. with CE, CE stated she was unable to provide documentation RN 2 had education or competency evaluation for the use of the spit mask. During a interview on 2/11/26 at 10:22 a.m. with CE, CE stated she was unable to provide documentation CNA 1 had education or competency evaluation for the use of the spit mask. During an interview on 2/11/26 at 1:36 p.m. with Mental Health Clinical Educator (MHCE), MHCE stated she conducts restraint training during the annual hospital training for all staff. MHCE stated the annual training for 2025 did not include a spit mask as a part of the restraint training so there was no return demonstration for competencies for any staff on the use of a spit mask. MHCE stated her expectations for the nurse that is caring for a patient that is spitting, is for the nurse to apply Personal Protective Equipment (PPE-refers to specialized clothing, goggles, or face shield to protect the body from mucus). MHCE stated the hospital has a spit mask that can be utilized and it is called the TTH. The TTH is found in the Emergency Room or in central supply. During an interview on 2/12/26 at 1 p.m. with Certified Nursing Assistant (CNA) 1, CNA 1 stated she was working on 12/22/25 when RN 2 asked CNA 1 to place a pillow case over Patient 29’s face. CNA 1 stated she placed the pillowcase on Patient 29’s face. CNA 1 stated she removed the pillowcase off Patient 29’s face and assisted RN 2 with applying a spit mask on Patient 29. CNA 1 stated she was never trained on a spit mask. During an interview on 2/12/26 at 1:24 p.m. with Intern Chief Nursing Officer (ICNO), ICNO stated a spit mask is a restraint and should be in the restraint policy. ICNO stated staff including RN’s, LVN’s, and CNA’s, have not been trained on the spit mask. During an interview on 2/12/26 at 1:58 with RN 2, RN 2 stated he was charge nurse when Patient 29 started to try to get out of his restraints (a leather material to hold someone down). RN 2 stated while he was in the room trying to fix the restraints, Patient 29 started to spit on him. RN 2 asked CNA 1 to place a pillowcase over Patient 29’s face. RN 2 stated CNA 1 placed the pillowcase over Patient 29’s face. RN 2 stated the pillowcase was removed by CNA 1 and RN 2 placed a spit mask on Patient 29. RN 2 stated he had no training on the spit mask. During an interview on 2/12/26 at 2:49 p.m. with RN 3, RN 3 stated on 12/29/25 she removed the spit mask that was placed on Patient 29. RN 4 stated she has had no training on spit mask that included the application, removal, or the monitoring that is required of the spit mask. During a review of the facility’s equipment, “The Tranzport Hood (TTH),” (undated), the TTH indicates, “Misuse of the transport hood can lead to severe harm or death.” During a review of the facility’s policy and procedure titled, “Restraints . . . of Patients,” dated 8/20/25, the P&P indicated, “All staff designated by the hospital as having direct patient care responsibilities. . .must demonstrate the competencies . . .application of restraints, implementation . . .monitoring, assessment, or care of a patient in restraint. . .Upon hire. . . before participating in the use of restraint. . . on an annual basis.””

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 47444 Based on interview and record review, Hospital 1 failed to ensure a computed tomography (CT - imaging using X-ray to create images of the body) of the abdomen and pelvis with contrast (dye used to highlight blood vessels, organs and tissues) and an X-ray of the esophagus (esophagram barium swallow test - diagnostic imaging test with contrast [barium] performed to view the structure and function of the throat and esophagus [muscular tube that transports food and liquid to the stomach]) were accurately interpreted by Medical Staff for one of 16 sampled patients (Patient 1). This failure resulted in the delay of Patient 1’s diagnosis and treatment of esophageal cancer and had the potential to contribute to adverse health outcome. Findings: During a review of Patient 1’s “[Hospital 1] Emergency Documentation (ED),” dated 11/4/25, the ED indicated Patient 1, age 51, was seen in the emergency department for complaints of dysphagia (difficulty swallowing) and unintentional weight loss of approximately 40 pounds over the last month. During a review of Patient 1’s “[Hospital 1] Radiology Orders (RO),” dated 11/4/25 at 9:07 a.m., the RO indicated, “CT Abdomen and Pelvis w [with]/Contrast . . . Reason: unexplained wt [weight] loss 40lbs [pounds] x 1 month.” During a review of Patient 1’s “[Hospital 1] RO,” dated 11/4/25 at 1:15 p.m., the RO indicated, “XR [x-ray] Esophagus Plan: Esophagram Barium Swallow. . . Reason: weight loss, Reason: poss [possible] stricture.” During a concurrent interview and record review on 2/10/26 at 10:49 a.m. with Radiologist 2, Patient 1’s “[Hospital 1] CT Abdomen and Pelvis Report (CTR),” and CT imaging, dated 11/4/25 were reviewed. The CTR indicated, “3. Distal esophageal wall thickening, which may reflect esophagitis (inflammation of esophagus).” Radiologist 2 stated Patient 1’s CT images showed nodular shapes around the outside of the gastroesophageal (GE-stomach esophagus) junction (where the esophagus connects to the stomach) which did not indicate esophagitis. Radiologist 2 stated based on the CT images, “I would have come down a little harder on the [GE junction] abnormality in my report.” Radiologist 2 stated his reported CTR findings would have included thickening of the esophagus which indicated a possible mass at the GE junction. Radiologist 2 stated he would have recommended a gastrointestinal physician consultation (specialist who diagnoses and treats conditions affecting the digestive system). Radiologist 2 stated Radiologist 3’s CTR did not raise enough concern for what he saw on Patient 1’s CT images. During a concurrent interview and record review on 2/10/26 at 11:25 a.m. with Radiologist 2, Patient 1’s X-ray of the esophagus’ (esophagram) “[Hospital 1] Diagnostic Radiology (DRR),” report and esophagram imaging, dated 11/4/25 were reviewed. The DRR indicated, “The preliminary radiograph demonstrates no significant abnormality. Prolonged transit through the gastroesophageal [GE] junction. No mucosal abnormality is seen. There are no masses. . . Impression: Presbyesophagus [age-related changes in the esophagus usually seen in adults aged 67 and up] with delayed motility [stomach muscles work poorly or not at all, causing food to stay in the stomach longer than normal].” Radiologist 2 reviewed Patient 1’s esophagram images. Radiologist 2 stated he had concerns about how the esophagram study was read and the results Radiologist 1 reported on the DRR report. Radiologist 2 stated, “That is esophageal cancer,” while pointing to Patient 1’s esophagram image. Radiologist 2 stated Patient 1’s esophagram images showed normal esophagus and then extreme narrowing at the GE junction. Radiologist 2 stated Patient 1’s DRR report impression of presbyesophagus would not be expected in a patient at the age of 51 as it was usually seen only in the elderly patient. During a concurrent interview and record review on 2/11/26 at 11:30 a.m. with Doctor of Osteopathic Medicine (DO), Patient 1’s “[Hospital 1] ED,” dated 11/4/25 was reviewed. The ED indicated, “Upon review of barium swallow study with GI, patient can discharge home with outpatient recommendation of outpatient EGD [Esophagogastroduodenoscopy a minimally invasive procedure where a Gastroenterologist uses a flexible tube with a camera to examine the upper digestive tract (esophagus, stomach, duodenum)]/manometry [procedure used to measure the strength and coordination of esophageal muscles].” DO stated she was not able to read radiology images and relied on Patient 1’s radiologist report results that she reviewed dated 11/4/25. During a concurrent interview and record review on 2/11/26 at 1:11 p.m. with Gastroenterologist, Patient 1’s “[Hospital 1] Consultation Notes (CN),” dated 11/4/25 were reviewed. The CN indicated, “Barium esophagram: There is delayed esophageal motility with tertiary contractions [abnormal, uncoordinated contractions of the esophageal muscles] Prolonged transit through the gastroesophageal junction. No mucosal [moist, inner lining] abnormality is seen. There are no masses.” The Gastroenterologist stated he was not good at reading radiology images and relied on the radiologist report results to develop his treatment plan. The Gastroenterologist stated if Patient 1’s imaging report results showed abnormal findings such as enlarged lymph nodes or mass like lesion, he would have admitted the patient to the hospital and performed additional studies including a biopsy (removing a sample of cells are removed to rule out cancer) if indicated. During a concurrent interview and record review on 2/12/26 at 2:31 p.m. with Radiologist 3, Patient 1’s “[Hospital 1] DRR” and barium esophagram imaging, dated 11/4/25 (report results by Radiologist 1) were reviewed. Radiologist 3 stated Patient 1’s barium esophagram imaging, indicated a significant narrowing (stricture) of the GE junction and suggested the tissue was abnormal. Radiologist 3 stated he would have reported the esophagram findings as “Distal esophageal stricture [narrowing of the lowest part of the esophagus that connects to the stomach], recommend endoscopic correlation [surgical procedure to visualize and biopsy tissue].” Requested an interview with Radiologist 1 on 2/12/26 at 9:22 a.m. On 2/12/26 at 4:55 p.m. PSM stated the medical staff office attempted to contact Radiologist 1 multiple times for an interview, but Radiologist 1 did not respond to the request for an interview. Radiologist 1 reviewed and provided Patient 1’s barium esophagram imaging results report dated 11/4/25. During a review of Patient 1’s “[Hospital 1] ED Discharge Instructions (DI),” dated 11/4/25, the DI indicated Patient 1 was discharged from the emergency department with diagnosis difficulty swallowing, throat swelling and unexplained weight loss. During a review of Patient 1’s “[Hospital 1] ED,” dated 1/4/26, the ED indicated Patient 1 was seen again (two months after the initial visit on 11/4/25) in Hospital 1’s emergency department with complaints of worsening symptoms including difficulty swallowing, additional unintentional weight loss, no bowel movement for two weeks and decreased urine output. The ED indicated Patient 1 was discharged and told to follow up with primary care physician and scheduled GI endoscopy procedure on 2/5/26 (one month later). During a review of Patient 1’s “[Hospital 2] ED Provider Note (EDPN),” dated 1/6/26, the EDPN indicated Patient 1 was seen in the ED of Hospital 2. The EDPN indicated Patient 1 had worsening symptoms including difficulty swallowing, unintentional weight loss, no bowel movement for two weeks and decreased urine output. The EDPN indicated Patient 1’s physical examination and overall health status was “cachectic [a severe wasting syndrome including significant loss of body weight, muscle mass, and fat, often linked to chronic diseases like advanced cancer].” The EDPH indicated, “Given the patient’s [Patient 1] severe symptoms of dysphagia, leading to weight loss and lab laboratoryy] abnormalities, he is unable to wait till scheduled endoscopy in 4 weeks. At this time, decision was made to admit patient for further management and GI evaluation.” During a review of Patient 1’s “[Hospital 2] Endoscopy Record (ESR),” dated 1/7/26, the ESR indicated, “Impression: Completely obstructing, likely malignant esophageal tumor was found in the lower third of the esophagus Biopsied. Malignant-appearing esophageal stenosis.” During a review of Patient 1’s “[Hospital 2] CT Chest Abdomen and Pelvis w contrast result (CTR),” dated 1/8/26, the CTR indicated, “Impression: 1. Questionable mild wall thickening of the distal esophagus. Questionable mildly masslike [sic] appearance at the gastroesophageal junction measuring 3.7 cm. . . Recommend correlation with endoscopy results.” During a review of Patient 1’s “[Hospital 2] Pathology Results (PR),” dated 1/9/26, the PR indicated, “Final Diagnosis (microscopic); Esophageal mass biopsies: Poorly differentiated adenocarcinoma with signet ring cell features [an aggressive cancer often originating in the stomach or gastrointestinal tract].” During a review of Hospital 1’s “Second Amended and Restated Exclusive Professional Services Agreement for Imaging Services,” dated 1/1/26, the service agreement indicated, “3.21 District Policies. Medical Group and each Physician shall comply with policies and directives of District and the Medical Staff Bylaws as shared with or made available to Medical Group in writing.” During a review of Hospital 1’s “Medical Staff Rules and Regulations (R&R),” dated 12/17/25, the R&R indicated, “Medical Records 3.1 General Requirements: (a) Medical Record: . . . Each practitioner will be responsible for the timely, complete, accurate, and legible completion of the portions of the medical record that pertain to the care he or she provides.””

“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: 36543 Based on interview, and record review, the hospital delayed care to one of one sampled pregnant patient (Patient 1) who came to the Emergency Department (ED) with complaints of vaginal bleeding and contractions (tightening and shortening of the uterine muscles during childbirth). This failure may have contributed to a pregnancy related miscarriage. Findings: During an interview on 11/5/25 at 12:30 p.m. with Patient 1, Patient 1 stated she went to the hospital ED on 9/4/25 around 12:55 p.m. for light bleeding and contractions every five to ten minutes. Patient 1 stated she told the staff she was having contractions, not cramps; they were stronger than cramps. During a concurrent interview and record review on 12/2/25 at 11:45 a.m. with CI 1, CI 1 reviewed Patient 1’s “Triage Record,” dated 9/4/25. CI 1 stated Patient 1’s “Triage Record,” indicated Patient 1 arrived at the ED, by private vehicle, on 9/4/25 at 12:41 p.m. with a chief complaint of vaginal bleeding and cramping at five minute intervals and she was 19 weeks and 3 days pregnant. During an interview on 12/3/25, at 1:16 p.m. with L&D Director, L&D Director stated a trained L&D nurse caring for a pregnant patient who said she was having cramps every five minutes would think labor. During a concurrent interview and record review on 12/3/25, at 2:18 p.m., with ED Director, the hospital provided MFTI was reviewed. The MFTI under criteria for Urgent 2 indicated examples of High-Risk Situations which included less than 34 weeks pregnant patients with complaints of/or detectable uterine contractions, less than 24 weeks with complaints of spontaneous rupture of membranes/leaking or spotting, and active vaginal bleeding (not spotting or show). ED Director stated the ED Triage did not use the MFTI and could not modify the triage score to account for the MFTI. During a record review of Patient 1’s Ultrasound Report, dated 9/4/25, The Ultrasound Report indicated: TECHNIQUE: Real-time transabdominal (through the stomach wall) sonography (ultrasound) through the uterus. FINDINGS Cervix Length: 4.0 cm Singleton pregnancy. Presentation Vertex. Placenta: posterior Fetal heart rate: 147 Fetal Movement: Yes IMPRESSION: Composite Ultrasound Age: 20 weeks, 0 days. During a concurrent interview, and record review, on 12/2/25, at 2:11 p.m. with CI 1, CI 1 reviewed Patient 1’s assessments and provider notes. CI 1 was unable to find documented evidence of fetal heart monitoring, contractions monitoring, bleeding assessments or other changes that indicated Patient 1’s progress in labor was monitored/assessed. During an interview on 12/3/25, at 1:03 p.m. with RN 4, RN 4 stated, Patient 1 arrived in L&D in active labor, the staff removed her pants, she was bleeding vaginally. RN 4 stated Patient 1 delivered the baby, still in the amniotic sac (fluid sac surrounding baby in the womb) almost immediately upon arrival to the L&D unit. RN 4 stated no attempt was made at resuscitation, there was no sign of life. During a review of Patient 1’s “Labor/Delivery/Newborn Data” (LDN Data), dated 9/5/25, at 4:58 a.m., the LDN Data indicated Fetal Death, heart rate and respirations were absent at 1 minute, muscle tone-limp, Color - pale or blue, Apgar (quick test given at 1 minute and 5 minutes after birth to evaluate immediate health and adaptation to life) Score at 5 minutes was 0 out of 10. During a review of Patient 1’s Pregnancy History, dated 9/5/25, The Pregnancy History indicated Delivery/Outcome date: 09/05/25 4:58 a.m. 19 4/7 (19 weeks and 4 days) Vaginal Birth; female; 277 grams (weight) Neonatal (newborn) outcome: Fetal Demise (death). On 12/2/25 at 11:40 a.m. a Policy and Procedure (P&P) on Triage of Pregnant Patients of 20 weeks or less was requested. On 12/2/25, at 11:48 a.m., P&Ps on triage of Pregnant Patient greater than 20 weeks was provided. Facility was unable to provide a P&P on Triage of Pregnant Patients at 20 weeks gestation or less. During an interview on 12/3/25 at 8:35 a.m., with Quality Safety (QS), QS stated the hospital did not have a P&P for pregnant patients 20 weeks or less who came to the ED in labor. During a review of the Guidelines for Perinatal Care, Eighth Edition (National Guidelines by the American Academy of Pediatrics [AAP] and The American College of Obstetricians and Gynecologists [ACOG]), dated 2017, the Guidelines indicated “Triage is followed by the complete evaluation of the woman and the fetus by a health care provider with skills and training appropriate to evaluate the issues identified during triage. The responsible obstetric care provider should be informed promptly if any of the following findings are present or suspected: Vaginal bleeding ...Any woman who is suspected to be in labor ...or has vaginal bleeding should be evaluated promptly in an obstetric service area. Whenever a pregnant woman is evaluated for labor, the following factors should be assessed and recorded in her permanent medical record ...frequency and duration of uterine contractions, Documentation of fetal well-being, Cervical [birth canal] dilation [opening] and effacement [thinning and shortening] or cervical length, as ascertained by transvaginal [through the vagina] ultrasonography unless contraindicated ...Fetal presentation [fetus orientation in the uterus] and station [how far down in the birth canal] of the presenting part, Status of the membranes (protective sac of fluid around fetus) ...Documentation Clinical information about the mother and fetus should be documented throughout the course of labor ...Documentation should occur concurrent with assessment when using intermittent auscultation as there is no other record of FHR [fetal heart monitoring] data in this situation.” During a review of the Guidelines for Perinatal Care, Eighth Edition, dated 2017, the Maternal Fetal Triage Index (MFTI) indicated Urgent Priority 2 Examples of High-Risk Situation included: Less than 34 weeks with complaints of/or detectable uterine contractions, Less than 24 weeks with complaints of spontaneous rupture of membranes/leaking or spotting, Active vaginal bleeding (not spotting or show).”

“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: 36543 Based on observation, interview, and record review, the hospital failed to document treatments and continuing assessments to one of one sampled pregnant patient (Patient 1) who came to the Emergency Department (ED) with complaints of vaginal bleeding and contractions (tightening and shortening of the uterine muscles during childbirth) at 5 minute intervals at 19 to 20 weeks pregnant (gestation) when: 1. Monitoring staff in ED lobby did not document pain level and notify Intake Coordinator (IC) of need for nurse assessment or pain interventions for one of one patient (Patient 1). 2. ED Registered Nurses (RN) did not document assessment of vaginal bleeding while in the waiting room for one of one patient (Patient 1). 3. Neither Advanced Practice Provider (APP, - Nurse Practitioner, Physician Assistant) 1 nor APP 2 documented one of one patient (Patient 1) informed of potential impending miscarriage or plan of care. 4. Neither APP 1 nor APP 2 documented regular assessments of signs and symptoms of premature labor such as cervical (birth canal) dilation (opening), tightening of abdomen (contractions), increase in the amount of vaginal bleeding or decreased fetal movement for one of one patient (Patient 1). 5. Neither APP 1 nor APP 2 documented ongoing assessments of active labor and fetal (unborn baby) well-being for one of one patient (Patient 1). These failures resulted in Patient 1’s pain to not be managed and not being unable to participate in care and decisions regarding an impending miscarriage due to lack of pregnancy related care management. Findings: 1. During an observation and interview on 12/2/25, at 9:50 a.m., with ED Director, while on a tour of the ED, ED Director stated patients’ with an Emergency Severity Index (ESI, prioritizes incoming patients and determine those who cannot wait to be seen) score of three to five go to the “Intake Zone.” While in the “Intake Zone” the provider (medical doctor, nurse practitioner, physician assistant) performs a Medical Screening Exam ( MSE) to determine if the patient had a medical emergency, the provider may order medication, labs, or medical diagnostic testing (x-rays, Magnetic Resonance Imaging [MRI], etc). ED Director stated the “Intake Zone” was for patients who did not need a bed. After seeing the provider, patient then returned to the lobby to wait for their labs, diagnostic testing or results. ED Director stated that the hospital always stationed either a Licensed Vocational Nurse (LVN) or an ED Technician (ED Tech) in the ED Waiting Room to monitor patients who returned from the “Intake Zone.” ED Director stated the ED Tech or LVN took patients’ vital signs (measurements of your body’s most basic, essential functions, like heart rate, breathing, temperature, blood pressure, and pain level) and notified the Intake Coordinator (IC) if a patient was getting worse. During a concurrent interview and record review on 12/2/25, at 12:20 p.m., with Clinical Informationist (CI) 1, Patient 1’s Vital Sign Record, dated 9/4/25 was reviewed. Patient 1’s Vital Sign Record indicated the following: 9/4/25 at 12:45 p.m., pain level of 8/10, in triage (pain of 0/10 is no pain, pain of 1-3/10 is mild pain, pain 4-6 is moderate pain, pain 7-9 is severe pain, pain 10/10 worst imaginable pain). 9/4/25 at 5:47 p.m., no pain level documented, in lobby 9/4/25 at 9:53 p.m., no pain level documented, in lobby 9/5/25 at 1:43 a.m., pain level of 10/10 documented in lobby CI stated that the ED Monitoring Staff took Patient 1’s vital signs three times while she was in the lobby. During a concurrent interview and record review on 12/2/25 at 12:48 p.m. with CI, Patient 1’s medication orders, dated 9/4/25 were reviewed. CI 1 stated APP 1 ordered Tylenol (mild pain medication) 500 milligrams (mg, unit of measurement), on 9/4/ 25 at 1:06 p.m. and the Tylenol was given 1:32 p.m. (Pain level assessed at 8/10 in triage on 9/4 at 12:45 p.m.). CI 1 stated APP 2 ordered Norco (strong opioid pain medication) on 9//25,5 at 1:27 a.m., and Norco was given at 1:41 a.m. (pain level assessed at 10/10 in the waiting room on 9/5/25, at 1:43 a.m. During a review of dailymed.nlm.nih.gov, the drug label NORCO-hydrocodone/apap tablet, dated 1/22/25, was reviewed. The drug label indicated, “Opioids cross the placenta and may produce respiratory depression (slow shallow breathing, causing a buildup of waste gas) and psycho-physiologic (how thoughts, emotions, and stress manifest physically) effects in neonates [newborn]. An opioid antagonist (reversal medication), such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Hydrocodone bitartrate and acetaminophen tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic(pain relief) techniques are more appropriate. Opioid analgesics, including hydrocodone bitartrate and acetaminophen tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation (sleepiness)and respiratory depression. During a concurrent interview and record review on 12/2/25 at 2:11 p.m., with CI 1, Patient 1’s “Person Mgmt [Management] Visit History [Location History]” dated 9/4/25 through 9/5/25 was reviewed. The “Location History” indicated Patient 1’s location in the hospital each time hospital staff treated her in a different area. CI 1 stated APP 1 saw Patient 1 in “Intake Zone.” CI 1 stated, after seeing APP 1, Patient 1 went to the waiting room. CI 1 stated except when having the ultrasound (medical diagnostic imaging scan using sound waves) and the MRI, Patient 1 was in the waiting room, between seeing APP 1 in “Intake Zone” on 9/4/25 and 4 a.m. on 9/5/25 when she was placed in a room in Zone 1. CI 1 stated Patient 1 remained in the ED lobby from 12:43.53 pm on 9/4/25 except when she was called to the lab, or out for medical imaging until 4:01 a.m. on 9/5/25 when she was moved to a room in ED Zone 1. During an interview on 12/3/25, at 9:10 a.m., with Obstetrician/Gynecologist (OBGYN, women’s reproductive health doctor) 1, OBGYN 1 stated the hospital could manage the patient’s pain during a miscarriage. During an interview on 12/3/25, at 10:39 a.m., with ED Manager (EDM) 1, EDM 1 stated he expected the Lobby Monitor (ED Tech or LVN) to document patient’s vital signs including pain, any bleeding or concerns. EDM stated the Lobby Monitor should escalate any concerns to the IC. During an interview on 12/3/25, at 2:18 p.m., with ED Director, ED Director stated the LVN or the ED Tech monitoring the waiting room should escalate problems to the IC. ED Director stated that pain was a vital sign, and staff should assess the patient’s pain level. During an interview on 12/4/25, at 9:55 a.m., with ED Tech 1, ED Tech 1 stated her job duties included taking patients’ vital signs as needed, including their pain level. ED Tech stated vital signs always include the patient’s pain level. ED Tech stated she scans her badge and the patient’s wrist band, the vital sign machine then transferred the vital signs directly to the patient’s chart. ED Tech 1 stated she tells the nurse the patients’ reported pain level each time. During an interview on 12/4/25, at 10:01 a.m., with ED Manager (EDM) 2, EDM 2 stated it was the hospital’s expectation for staff to take patients’ vital signs every four hours regardless of the patient’s location in the hospital and staff should record the patient’s pain score in the medical record. During an interview on 12/4/25, at 1:30 a.m., with RN 1, RN 1 stated she was IC on 9/4/25 until 6 p.m. RN 1 stated it was her expectation for vital signs to be taken every four hours and for the lobby monitoring staff to escalate concerns to the IC nurse. RN 1 stated if a patient requested something for pain, the request showed on the computer task bar. RN 1 stated the IC role included assessment of patients who may need to move to a higher level of care, facilitate re-evaluation with a provider, provide medication and provide discharge instructions. RN 1 stated she relied on the ED Tech reports for increased bleeding, product of conception discharge (miscarriage), and pain. RN 1 stated, as IC she would reassess a patient based on the ED Tech reports then report to the provider for further assessment. 2. During an interview with Patient 1 on 11/5/25, at 12:30 p.m., Patient 1 stated she went to the lobby bathroom, and she had active vaginal bleeding. Patient 1 stated she was in the lobby bathroom where she passed a lot of blood, Patient 1 stated she pushed the call light button repeatedly, but no one came, finally she went to the nurses’ station to get someone to come look at the amount of blood in the bathroom. Patient 1 stated once staff went to the bathroom and saw the amount of blood, the staff called for a wheelchair, and she was taken to an ED room. During a concurrent interview and record review on 12/2/25, at 11:45 a.m., with CI 1, Patient 1’s triage (determines order patients are seen) record, dated 9/4/25 were reviewed. Patient 1’s triage record indicated on 9/4/25 at 12:41 p.m., Patient 1 arrived at the ED, by private vehicle, with a chief complaint of vaginal bleeding and cramping at five minute intervals. CI 1 stated on 9/4/25 at 12:41 p.m., Patient 1 came to the ED complaining of vaginal bleeding and cramping at five minute intervals. During a concurrent interview and record review on 12/2/25, at 11:57 a.m., with CI 1, Patient 1’s “ED Note Physician” dated 9/4/25 at 12:53 p.m. in the “Intake Zone”, by APP 1 was reviewed. The ED Note Physician indicated on 9/4/25 at 12:41 p.m., Patient 1 arrived at the ED, by private vehicle, with a chief complaint of vaginal bleeding which began yesterday and cramping at five minute intervals. CI 1 stated Patient 1’s ED Note Physician indicated on 9/4/25 at 12:41 p.m. Patient 1 came in with complaints of vaginal bleeding which began on 9/3/25 and cramping at five minute intervals. During a concurrent interview and record review on 12/2/25, at 12:46 p.m., with CI 1, Patient 1’s nursing assessments, dated 9/4/25 were reviewed. CI 1 stated he did not see any nursing assessment indicating how heavy Patient 1 was bleeding, how many pads per hour were used, or any assessment of fetal heart rate by any ED RN. During a concurrent interview and record review on 12/2/25, at 2:08 p.m., with CI 1, Patient 1’s ED Documentation was again reviewed. CI 1 stated he was unable to find any nursing assessments regarding Patient 1’s vaginal bleeding. During a concurrent interview, and record review, on 12/2/25, at 2:11 p.m., with CI 1, Patient 1’s “Person Mgmt [Management] Visit History [Location History]” dated 9/4/25 through 9/5/25 was reviewed. The “Location History” indicated Patient 1’s location in the hospital each time hospital staff treated her in a different area. CI 1 stated Patient 1 remained in the ED lobby from 12:43.53 pm on 9/4/25 except when she was called to the lab, or out for medical imaging until 4:01 a.m. on 9/5/25 when she was moved to a room in ED Zone 1. During an interview with RN 2 on 12/3/25, at 9:39 a.m., RN 2 stated if a patient complained of vaginal bleeding, he would ask how many chux (disposable absorbent pad) the patient was going through, if the patient was feeling contractions, he would assess the quality of the contractions by feeling the patients belly and would inform the physician. During an interview on 12/3/25, at 10:39 a.m., with EDM 1, EDM 1 stated he would expect the nurse to conduct a full assessment, with a focused abdominal assessment which included checking bowel sounds, abdominal tenderness, assess for rupture of membranes (breaking of the fluid sac that surrounds the baby),spotting (spots of blood), or bleeding EDM 1 stated he would expect the nurse to ask the patient how many pads were used in an hour if bleeding is reported. EDM 1 stated it was the expectation for nurses to document patient assessments. During an interview on 12/3/25, at 1:16 p.m., with Labor and Delivery (L&D) Director, L&D Director stated the cervix (birth canal) can quickly go from closed to open in a mom who had given birth previously. L&D Director stated a trained L&D nurse who cared for a pregnant patient who said she was having cramps every five minutes would think labor. If the L&D nurse was notified, the L& D nurse would provide parameters (signs and symptoms) for the ED triage nurse to follow that could indicate labor may be progressing. During an interview on 12/3/25, at 1:37 p.m., with RN 3, RN 3 stated the nurse should ask if the patient was having contractions, how long were the contractions, and should consider if the contractions might indicate impending labor? The nurse should assess if the patient had any vaginal bleeding or an increase in bleeding. RN 3 stated to get a general idea of the amount of blood loss the patient should be asked how many pads were changed in the past hour due to blood saturation. 3. During a concurrent interview and record review on 12/2/25, at 11:45 a.m., with CI 1, Patient 1’s “Triage Record,” dated 9/4/25 was reviewed. CI 1 stated Patient 1’s “Triage Record” indicated Patient 1’s arrived at the ED, by private vehicle, on 9/4/25 at 12:41 p.m. with a chief complaint of vaginal bleeding and cramping at five minute intervals. The “Triage Record” indicated the triage nurse assigned Patient 1 an ESI level of 3 (urgent but stable, can likely wait for a short period, will require multiple resources such as labs and imaging and closer monitoring as condition may worsen). CI 1 stated the triage nurse assigned Patient 1’s ESI level of 3 The Triage Record indicated Patient 1 had a pain level of 8/10. During a concurrent interview and record review on 12/2/25. at 11:45 a.m.. with CI, Patient 1’s “ED Note Physician” dated 9/4/25 at 12:53 p.m. in the “Intake Zone”, by APP 1 was reviewed. Patient 1’s “ED Note Physician” indicated Patient 1 came in with complaints of vaginal bleeding which began on 9/3/25 and cramping at five minute intervals with right upper quadrant pain and right lower quadrant pain. CI 1 stated Patient 1’s “ED Note Physician” indicated Patient 1 also had right upper quadrant pain and right lower quadrant pain (no pain severity indicated). Patient 1’s “ED Note Physician” indicated five differential diagnoses (possible causes for complaint and symptoms) for Patient. CI 1 stated Patient 1’s “ED Note Physician” indicated the following differential diagnoses: Miscarriage (loss of baby before the 20th week of pregnancy), pancreatitis (inflammation of the pancreas, a gland that produces digestive enzymes and hormones), cholecystitis (inflammation of the gallbladder), appendicitis (inflammation of the appendix), and urinary tract infection (UTI). CI 1 stated APP 1 ordered labs (blood tests) and an ultrasound for Patient 1. Patient 1’s “ED Note Physician” indicated APP 1 reviewed the results of Patient 1’s lab work and determined although Patient 1’s had an elevated white blood cell count of 17.15 (normal 5.6 to 16.9, may indicate infection, inflammation, stress), there were no concerns with Patient 1’s electrolytes, kidney function, liver function and no UTI. Patient 1’s “ED Note Physician” indicated APP 1 reviewed Patient 1’s ultrasound results, dated 9/4/25, which indicated Patient 1’s had a single, live fetus at approximately 20 weeks and 0 days gestation, but the ultrasound did not determine a reason for Patient 1’s pain. APP 1 ordered an MRI to rule out appendicitis. During an interview on 12/3/25, at 9:10 a.m., with OBGYN 1, OBGYN 1 stated the patient should be counseled about the possibility of miscarriage. During a concurrent interview and record review on 12/3/25 at 10:17 a.m., with CI 2, Patient 1’s “ED Note Physician,” dated 9/4/25 were reviewed. CI 2 stated there was no documentation any provider had a discussion with Patient 1 regarding a potential miscarriage. CI 2 stated there was no documentation of spiritual support provided to Patient 1 prior to 9/5/25 at 5:55 a.m. (after the miscarriage). During an interview on 12/4/25 at 8:58 a.m. with APP 2, APP 2 stated he had reviewed Patient 1’s chart. APP 2 stated he updated Patient 1 about the potential of losing the baby. APP 2 was unable to provide documented evidence of a discussion with Patient 1 regarding the potential of a miscarriage. During an interview on 12/4/25 at 9:20 a.m., with APP 1, APP 1 stated she had reviewed Patient 1’s chart. APP 1 stated she had a discussion with Patient 1 that there was a potential of losing the baby. APP 1 stated she had this discussion with all pregnant patients that were bleeding, as well as the cause of the bleeding could be something else, such as an infection or a UTI. APP 1 stated she did not document this discussion with Patient 1. APP 1 stated she also would have documented the discussion in the discharge summary; however, she turned Patient 1’s care over to APP 2. During a review of the Guidelines for Perinatal Care, Eighth Edition, dated 2017, the Guidelines indicated “The U.S. Preventive Services Task force defines shared decision making as a process in which both the patient and physician share information, participate in the decision-making process, and agree on a course of action ...The American College of Obstetricians and Gynecologists recommends that care should always be patient centered; ie, it is focused on the health needs of the patient; respects the patient’s values, preferences, and goals; is based on an enduring personal relationship; and sees the patient as a partner in managing his or her health and making health care decisions ...These goals should be mutually decided upon by the patient, the family (according to patient preference), and the health care team.” During a review of the Medical Staff Rules and Regulations (R&R), Approved 7/23/25, the R&R indicated “3.1...(a)...Each practitioner will be responsible for the timely, complete, accurate, and legible completion of the portions of the medical record that pertain to the care he or she provides,...(e) Abbreviations: Only standardized terminology, definitions, abbreviations, acronyms, symbols and dose designations shall be used in the medical record. Abbreviations on the unapproved abbreviations and/or symbols list may not be used...In general, the use of abbreviation is discouraged in order to avoid is interpretation and confusion regarding the care of the patient...3.2 Content and Timeliness of Medical record Documentation:...(b) General Requirements All medical records for patients receiving care in the hospital setting or at an ambulatory care location will include the information outlined in this section as relevant and appropriate to the patient’s care...(5) records of communication with the patient regarding care, treatment...(19) relevant observations, diagnoses or conditions established during the course of care, treatment, and services; (20) reassessments and plan of care revisions...(c) Progress Notes (1) Clinically pertinent progress notes shall be recorded at the time of observation and must be legible, dated, and timed, shall be documented with a frequency consistent with the acuity of medical problems to reflect the patient’s condition and plans for management, and shall always be written in such a manner and with such clarity and frequency that another practitioner could quickly understand the patient’s status if care were transferred... (h) Obstetrical Records: (1) medical records of obstetrical patients will contain the information outlined below...(iv) observations and proceedings during labor...(p) Emergency Care: Medical records of patients who have received emergency care will contain the information outlined in this paragraph...(6) pertinent history of the injury or illness...(8) treatment given, if any...” 4. During a concurrent interview and record review on 12/2/25, at 12:30 p.m., with CI 1, Patient 1’s abdominal, genitourinary and cervical assessments dated 9/4/25 and 9/5/25 were reviewed. CI 1 stated Patient 1’s first vaginal exam occurred on 9/5/25 at 4:56 a.m. in the ED by a labor and delivery registered nurse. During a concurrent interview and record review on 12/2/25, at 12:37 p.m. with CI 1, APP 2’s Emergency Documentation “ED Note Physician,” dated 9/4/25, at 9:49 p.m., was reviewed. The “ED Note Physician” indicated “Gastrointestinal: Nondistended, lower abdominal ttp [tender to touch] ...Consultations discussed wotyh (sic) [OBGYN 1] and advises analgesia [pain medication] and observation in the ED and if pt [patient] starts passing tissue or still having pain at 7am should repage [notify the MD].” During a concurrent interview and record review on 12/2/25, at 12:44 p.m., with CI 1, APP 1’s Emergency Documentation, dated 9/4/25 at 12:55 p.m. was reviewed. The Emergency Documentation indicated under History of Present Illness, on examination she [Patient 1] had some right upper quadrant tenderness ...” and under Physical Exam “Gastrointestinal: the abdomen is soft, non tender and non distended.” CI stated the provider did not indicate a contraction was felt. During an interview on 12/3/25, at 9:10 a.m., with OBGYN 1, OBGYN 1 stated it was common for pregnant patients to come to ED with concerns about bleeding during pregnancy. The ED provider tells the attending OBGYN the results of the ultrasound. OBGYN 1 stated if the patient’s bleeding got worse, he would expect a call. OBGYN 1 stated he would expect an ongoing assessment to determine if patient’s condition was worsening. During an interview on 12/3/25, at 9:45 a.m. with EDM 2, EDM 2 stated the ED has a pelvic cart (contains equipment and supplies needed to inspect the female reproductive organs). EDM 2 stated the cart included sterile (germ free) speculums (device to open and widen the vagina to allow a visual inspection). During an interview on 12/4/25 at 8:58 a.m. with APP 2, APP 2 stated he had reviewed Patient 1’s chart. APP 2 stated he assumed care of Patient 1 after the ultrasound, on 9/4/25 at about 10 p.m. APP 2 stated he typically reevaluated patients at the time of hand-off (assumption of care). APP 2 was unable to provide a documented, time-stamped assessment of Patient 1 upon assumption of care. APP 2 stated during the OB consultation after the MRI results were available, the OBGYN asked for visual inspection without a speculum of Patient 1’s cervix. APP 2 stated Patient 1 was not actively hemorrhaging at that time, he could only see the membranes. APP 2 was unable to provide documentation he performed a visual cervical exam and what the results of the exam included. APP 2 stated OBGYN said to keep Patient 1 in the ED until morning when the new OBGYN came on shift. During an interview on 12/4/25 at 9:20 a.m., with APP 1, APP 1 stated she had reviewed Patient 1’s chart. APP stated cramping can mimic contractions, especially when a patient was having a miscarriage. APP 1 stated she could not feel Patient 1’s contractions. APP 1 stated she always asked the patients to describe how much bleeding they were having, such as how many pads per hour, or how large of a spot. APP 1 stated she documented Patient 1 reported at that time, she only had bleeding upon wiping. During a review of Emergency Documentation Medical Decision Making (MDM), undated, the MDM indicated “ED COURSE: Patient care handed over to myself pending MRI for lower abdominal pain at 19 weeks pregnant. Ultrasound actually shows patient measuring at about 20 weeks and discussed with OB triage otherwise fetal heart tones are noted feels patient should have completion of workup in the ED. MRI shows no evidence of acute appendicitis although patient’s symptoms increasing in the ED although given patient’s worsening condition and now active bleeding with possible rupture membrane and tissue discussed with OB triage who did agree to take the patient” During a review of the Medical Staff Rules and Regulations (R&R), Approved 7/23/25, the R&R indicated “Emergency Services 11.2 Medical Screening Examinations:...(b) Labor and Delivery Obstetrical medical screening exams, within the capability of the District, will be performed on all individuals who come to the District requesting examination or treatment to determine the presence of an emergency obstetrical condition.” 5. During an interview on 11/5/25 at 12:30 p.m. with Patient 1, Patient 1 stated she went to the hospital ED on 9/4/25 around 12:55 p.m. for light bleeding and contractions every five to ten minutes. Patient 1 stated she told the staff she was having contractions, not cramps; they were stronger than cramps. During a review of the Guidelines for Perinatal Care, Eighth Edition (National Guidelines by the American Academy of Pediatrics [AAP] and The American College of Obstetricians and Gynecologists [ACOG]), dated 2017, the Guidelines indicated “Triage is followed by the complete evaluation of the woman and the fetus by a health care provider with skills and training appropriate to evaluate the issues identified during triage. The responsible obstetric care provider should be informed promptly if any of the following findings are present or suspected: Vaginal bleeding ...Any woman who is suspected to be in labor ...or has vaginal bleeding should be evaluated promptly in an obstetric service area. Whenever a pregnant woman is evaluated for labor, the following factors should be assessed and recorded in her permanent medical record ...frequency and duration of uterine contractions, Documentation of fetal well-being, Cervical [birth canal] dilation [opening] and effacement [thinning and shortening] or cervical length, as ascertained by transvaginal [through the vagina] ultrasonography unless contraindicated ...Fetal presentation [fetus orientation in the uterus] and station [how far down in the birth canal] of the presenting part, Status of the membranes (protective sac of fluid around fetus) ...Documentation Clinical information about the mother and fetus should be documented throughout the course of labor ...Documentation should occur concurrent with assessment when using intermittent auscultation as there is no other record of FHR [fetal heart monitoring] data in this situation.” During a review of the Guidelines for Perinatal Care, Eighth Edition, dated 2017, the Maternal Fetal Triage Index (MFTI) indicated Urgent Priority 2 Examples of High-Risk Situation included: Less than 34 weeks with complaints of/or detectable uterine contractions, Less than 24 weeks with complaints of spontaneous rupture of membranes/leaking or spotting, Active vaginal bleeding (not spotting or show). During a concurrent interview and record review on 12/2/25 at 11:45 a.m. with CI 1, CI 1 reviewed Patient 1’s “Triage Record,” dated 9/4/25. CI 1 stated Patient 1’s “Triage Record,” indicated Patient 1 arrived at the ED, by private vehicle, on 9/4/25 at 12:41 p.m. with a chief complaint of vaginal bleeding and cramping at five minute intervals and she was 19 weeks and 3 days pregnant. During an interview on 12/3/25, at 1:16 p.m. with L&D Director, L&D Director stated a trained L&D nurse caring for a pregnant patient who said she was having cramps every five minutes would think labor. During a concurrent interview and record review on 12/3/25, at 2:18 p.m., with ED Director, the hospital provided MFTI was reviewed. The MFTI under criteria for Urgent 2 indicated examples of High-Risk Situations which included less than 34 weeks pregnant patients with complaints of/or detectable uterine contractions, less than 24 weeks with complaints of spontaneous rupture of membranes/leaking or spotting, and active vaginal bleeding (not spotting or show). ED Director stated the ED Triage did not use the MFTI and could not modify the triage score to account for the MFTI. During a record review of Patient 1’s Ultrasound Report, dated 9/4/25, The Ultrasound Report indicated: TECHNIQUE: Real-time transabdominal (through the stomach wall) sonography (ultrasound) through the uterus. FINDINGS Cervix Length: 4.0 cm Singleton pregnancy. Presentation Vertex. Placenta: posterior Fetal heart rate: 147 Fetal Movement: Yes IMPRESSION: Composite Ultrasound Age: 20 weeks, 0 days. During a concurrent interview, and record review, on 12/2/25, at 2:11 p.m. with CI 1, CI 1 reviewed Patient 1’s assessments and provider notes. CI 1 was unable to find documented evidence of fetal heart monitoring, contractions monitoring, bleeding assessments or other changes that indicated Patient 1’s progress in labor was monitored/assessed. During an interview on 12/3/25, at 1:03 p.m. with RN 4, RN 4 stated, Patient 1 arrived in L&D in active labor, the staff removed her pants, she was bleeding vaginally. RN 4 stated Patient 1 delivered the baby, still in the amniotic sac (fluid sac surrounding baby in the womb) almost immediately upon arrival to the L&D unit. RN 4 stated no attempt was made at resuscitation, there was no sign of life. During a review of Patient 1’s “Labor/Delivery/Newborn Data” (LDN Data), dated 9/5/25, at 4:58 a.m., the LDN Data indicated Fetal Death, heart rate and respirations were absent at 1 minute, muscle tone-limp, Color - pale or blue, Apgar (quick test given at 1 minute and 5 minutes after birth to evaluate immediate health and adaptation to life) Score at 5 minutes was 0 out of 10. During a review of Patient 1’s Pregnancy History, dated 9/5/25, The Pregnancy History indicated Delivery/Outcome date: 09/05/25 4:58 a.m. 19 4/7 (19 weeks and 4 days) Vaginal Birth; female; 277 grams (weight) Neonatal (newborn) outcome: Fetal Demise (death). On 12/2/25 at 11:40 a.m. a Policy and Procedure (P&P) on Triage of Pregnant Patients of 20 weeks or less was requested. On 12/2/25, at 11:48 a.m., P&Ps on triage of Pregnant Patient greater than 20 weeks was provided. Facility was unable to provide a P&P on Triage of Pregnant Patients at 20 weeks gestation or less. During an interview on 12/3/25 at 8:35 a.m., with Quality Safety (QS), QS stated the hospital did not have a P&P for pregnant patients 20 weeks or less who came to the ED in labor.”

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 32946 Based on interview and record review, the facility failed to ensure one of 30 Patients (Patient 19) was offered an opportunity to formulate an advance directive (a written statement of medical treatments to be carried out if patient is unable to communicate.) This failure had the potential for Patient 19’s health care decisions to not be followed. Findings: During a review of Patient 19’s “INPATIENT [IR],” record dated 9/2/25, the IR indicated Patient 19 was admitted to the facility on 9/2/25 as an in patient. During an concurrent interview and record review on 9/8/25 with Registered Nurse (RN) 3, Patient 19’s medical record was reviewed. RN was unable to provide documented evidence an Advance Directive was offered to patient 19. RN 3 stated, “They didn’t do it.” During a review of the facility policy and procedure(P&P) titled, “Advance Directives,” dated 10/26/22, the P&P indicated, “[facility name] honors the patient’s advanced health care directives. . .Patients. . . will be asked if they executed an Advanced Directive designating their health care wishes and/or health care decision maker. Any patients desiring to formulate an Advance Directives with capacity to do so will be assisted by being given a choice of an approved Advance Directive form.””

“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: 44134 Based on concurrent interview and record review, the facility failed to develop and implement an individualized fall prevention plan of care (plan to meet patient health care goals and needs) for one of 30 sampled patients (Patient 6). This failure had the potential for Patient 6 to fall resulting in harm or death. Findings: During a review of Patient 6’s “History and Physical Reports [H&P],” dated 8/27/25, the H&P indicated, Patient 6 was admitted to the hospital with an admission diagnosis of seizure disorder (uncontrolled jerking, loss of consciousness, or blank stares caused by abnormal electrical activity in the brain) and multiple falls. During a concurrent interview and record review on 9/9/25 at 9:57 a.m. with Registered Nurse (RN) 2, Patient 6’s “Plans of Care [POC],” dated 8/27/25 to 8/31/25 were reviewed. RN 2 stated she was unable to find documentation of a fall prevention POC. RN 2 stated Patient 6’s admitting diagnosis was multiple falls. RN 2 stated a POC should have been developed and implemented for Patient 6’s risk for fall. During a review of the facility’s policy and procedure (P&P) titled, “Interdisciplinary Pt Assessment, Reassessment & Care Planning for the Acute Setting,” dated 9/23/21, the P&P indicated, “D. Care Plan Development. . .The patient, their family, and/or their legal representative, whenever possible and appropriate, shall be included in all aspects of the development, review and revision of the care plan. The care plan shall be current and reflect all elements of the nursing process. . .The nursing process is. . .1. Assessment. . .2. Diagnosis (Nursing). . .3. Identification of outcomes (Goals). . .4. Planning. . .5.Implementation. . .6. Evaluation. . .7. Advocacy.””

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 44134 Based on interview, and record review, the facility failed to follow their policy and procedure (P&P) for the blood and blood components transfusion (whole blood or parts of blood are put into a patient’s blood stream through a vein) for one of four sampled patients (Patient 9). This failure had the potential for suspected transfusion reactions to be missed, a delay interventions, and compromised patient safety during the blood transfusion process. Findings: During a review of Patient 9’s “Physician Orders [PO],” dated 9/6/25, the PO indicated, one unit of red blood cells (RBC, blood) was ordered for transfusion on 9/6/25 at 2:07 a.m. During a review of Patient 9’s “Transfusion Medicine” Record (TMR), dated 9/6/25, the TMR indicated, Patient 9’s blood transfusion started on 9/6/25 at 4:17 a.m. and was completed on 9/6/25 at 6:41 a.m. During a review of Patient 9’s “Vital Signs” Log (VSL), dated 9/6/25, the VSL indicated, Patient 9 had vital signs checked on 9/6/25 at 4:16 a.m., 4:31 a.m., 4:58 a.m., 5:27 a.m., 5:48 a.m., 6:18 a.m., 6:43 a.m., and at 3:29 p.m. During a concurrent interview and record review on 9/9/25 at 10:55 a.m. with Registered Nurse (RN) 2, Patient 9’s VSL dated 9/6/25 was reviewed. The VSL indicated, there were no vital signs obtained one hour after Patient 9’s blood transfusion was completed. RN 2 stated she was unable to find documentation that Patient 9’s vital signs were checked after the blood transfusion was completed. RN 2 stated Patient 9 should have had his vital signs check one hour after the blood transfusion was completed. During a review of the facility’s P&P titled, “IV Therapy: Transfusion of Blood & Blood Components,” dated 11/1/24, the P&P indicated, “Licensed nursing staff who are competent in transfusion administration, identification of transfusion reactions, and/or complications associated with transfusion therapy and implementations of appropriate interventions, shall administer blood and blood components in accordance with the following procedures. . .C. Patient Monitoring for Routine and Emergency Transfusions: 1. The licensed nurse monitors for any change in VS [vital signs] and patient assessment throughout the transfusion. a) VS’s are obtained immediately prior to initiation of the transfusion, once the transfusion is initiated, at 5 and 15 minutes after infusion start, then every 30 minutes until the transfusion is completed, and then 1 hour after transfusion is completed.””

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the facility failed to ensure Food and Nutrition Services (FNS) department was organized, managed and effectively integrated into the hospital wide organizational structure to ensure consistent collaboration and interaction between different departments within the hospital for sharing of information, resources, and efforts to achieve common goals or solve problems that had the potential to impact patient care when: 1. The facility failed to ensure the facility’s diet manual (DM) was developed and implemented in accordance with current national standards for routinely ordered therapeutic dysphagia (difficulty swallowing) diets, and was not consistently used as guidance for ordering and preparing patient diets when the DM guided physician’s to order obsolete (out-of-date) dysphagia diets such as “chopped” and “ground” from a no longer recognized National Dysphagia Diet (NDD) system. Clinical Nutrition Manager (CNM) stated the facility’s information technology department informed her it was not possible to change the available diet order selections in the electronic health record (EHR) software to align with current standards of practice IDDSI (International Diet Standardization Initiative) dysphagia diet terminology. FNS department was not organized sufficiently when Director of Food and Nutrition Services (DFNS) nor CNM brought system level concerns and barriers to hospital leadership such as Medical Director and/or medical executive staff, and/or patient care policy committee and/or QAPI (Quality Assessment and Performance Improvement) for further discussion and review of standard of practices that warranted a systemic change for the health and safety of patients. (Cross Refer A-0618, A-0631) 2. Although DFNS/Registered Dietitian (RD) and CNM (an RD) provided IDDSI training to FNS staff, the FNS department RD leadership did not ensure sufficient organization into the hospital wide organizational structure when CNM was unaware as to whether the Speech Therapists (ST) or nursing was trained on IDDSI diets. In addition, CNM trained kitchen staff to prepare pureed rice and pureed scrambled eggs for the facility’s “chopped” diet (facility’s version of IDDSI Soft & Bite Sized diet/SB6 diet) based on one STs recommendation, however, that was not in accordance with the definition of that diet per the hospital’s DM. CNM had not discussed the systemic change interdepartmentally to collaborate and discuss whether the change was aligned with standard of practice, or whether additional support and resources was warranted to support development of appropriate recipes and skillset of the cooks to ensure IDDSI standards could be accomplished for improved quality of food service for patients on an SB6 diet . (Cross Refer A-0618, A-0631) 3. The facility failed to ensure FNS department was effectively organized into the hospital wide organizational structure and systems when the FNS policy and procedure (P&P) titled “Fluid Restrictions (FR)” that impacted patient care related to FR orders only required approval within the FNS department by the DFNS. In contrast, the facility’s P&P titled “Vital Signs, Intake & Output, Weights: (Adult)” that provided direction to nursing staff on FRs was reviewed and approved interdepartmentally by “Approvers: Medical Executive Committee, Patient Care Policy Approval Committee, Patient Care Policy Committee.” As a result, there was unclear direction provided to FNS staff on how menus and foodservice should be incorporated as related to standards of care per Nutrition Care Manual and lack of adequate guidance to the nutrition hosts and diet clerk’s who were responsible for checking patient menus for accuracy in accordance with a physician’s FR order and had the potential for negative medical complications for patients with a FR order. (Cross Refer A-0618, A-0621) Findings: 1. During a concurrent interview and record review on 6/9/25 at 2:05 p.m. with CNM, Patient 5’s “Order Desc [OD: description]”, dated 2/11/25, was reviewed. The “OD” indicated, “Chopped Diet.” CNM stated chopped diet was not an IDDSI (International Dysphagia [difficulty swallowing] Diet Standardization Initiative) diet but “it’s our house version for DDS SB6 diet (Level 6 Soft & Bite Sized).” CNM stated the physician’s ordered “chopped” and “ground” diet orders in a patient’s EHR from a pop down diet selection list in which those diets were available. CNM stated IDDSI diets were not available in the pop down diet list for physician’s to select from. CNM stated she asked the hospital’s information technology department to discontinue chopped and ground diet orders available from a pop down selection list in the EHR to IDDSI diet terminology to be consistent for standardization in accordance with current standard of practice but was told they could not change diet order options in the EHR. CNM stated she had not pursued the discussion further with hospital leadership such as via Chief Executive Officer, the medical executive or patient policy committee or via the hospital’s QAPI (Quality Assessment Performance Improvement) program to provide education on the importance of aligning the hospital’s physician prescribed diet orders with the only nationally recognized dysphagia IDDSI diets in accordance with standard of practice. During review of United States IDDSI Reference Group (USIRG), dated November 2021, USIRG indicated, “IDDSI has the full support of the Academy of Nutrition & Dietetics (AND) and the American Speech-Language & Hearing Association (ASHA) since May 2019. October 2021: IDDSI is now the only professionally recognized dysphagia diet standard in the Nutrition Care Manual of the AND for the United States.” During a review of IDDSI.Org titled “Guidelines For Use” (GFU), dated 2024, “GFU” indicated, “Supplementary Notice: Do not alter the elements of the IDDSI framework. Alterations may lead to confusion and errors in diet texture or drink selection for patients with dysphagia. Such errors have previously been associated with adverse events including choking and death.” During a review of IDDSI’s document titled “Standards of Practice Regulatory Information for Long Term Care Facilities, Hospitals, Critical Access Hospitals, Home Health Agencies and Hospice”, dated July 2021, indicated, “The National Dysphagia Diet (NDD) is now outdated and International Dysphagia Diet Standardization Initiative (IDDSI) will be the only professionally recognized texture modified diet framework as of October 2021. . .It is the only professionally- supported and evidence-based standard of practice.” 2. During a review of the facility specific diet manual titled, “[name of hospital] Health Diet Manual (DM)”, dated 2025, the “DM” indicated, “Dysphagia Diets: The International Dysphagia Diet Standardization Initiative (IDDSI) has become the professional standard for providing dysphagia diets. The goal is to ensure consistent and safe textures for patients with dysphagia. The names of the diet orders in [name of EHR software) have not changed but the interpretation of the diets are as follows: Diet Order: Chopped; interpretation-IDDSI Level 6 Soft & Bite Sized, Ground; IDDSI Level 5 Minced & Moist, Puree; IDDSI Level 4 Pureed, Blenderized; IDDSI Level 3 Liquidized. IDDSI Level 6- Soft & Bite Sized Indication: This diet is prescribed when patients are unable to safely bite off pieces of food but are able to chew the food into smaller pieces that can be safely swallowed. . .Food pieces should be no larger than 1.5 cm [centimeter] x [by] 1.5 cm (or the width of a dinner fork). Foods should be soft, tender and moist, for easier chewing and swallowing. Foods where sauce separates from the food should be strained or blended to ensure one consistency. Moisten foods with small amounts of gravy, sauce, juice or cooking liquids-but only if it can be absorbed into the food and does not separate. Food Groups. . .Protein - foods allowed: Cooked and soft proteins that are not on the restricted list, Foods Restricted: Poultry or fish with skin and/or bones, Natural casing on sausages, Breads and starches - foods allowed: Soft foods not on the restricted list, Foods Restricted: Crackers, biscuits, muffins, pancakes, waffles, bread dressing, sticky rice or rice that separates into individual grains. . .” During a concurrent observation and document review on 6/9/25 at 11:11 a.m. in the kitchen during lunch trayline (where prepared meals are assembled onto trays ), Patient 5’s lunch meal tray card indicated, “Diet: Chopped; Clerk Check [extra check process for meal tray accuracy]”, dated 6/9/25. Patient 5’s lunch meal tray was observed to have chopped chicken stirfry, pureed rice that was observed with liquid pooled on top with liquid separation coming out from the side of the thin appearing pureed rice that spread out on the plate, and a cup of gravy that had liquid separation. During an interview on 6/9/25 at 1:59 p.m. with CNM, CNM stated the kitchen staff always served pureed rice and pureed scrambled eggs for all “Chopped” (hospital’s version of SB6 diet) and “Ground” diets (hospital’s version of Level 5 Minced & Moist [MM5] diet). CNM stated there should not have been any liquid separation from the pureed rice or gravy served for the “chopped” diet, as that was not allowed per IDDSI SB6 diet standardization. CNM stated the hospital served pureed rice and pureed scrambled eggs for all “chopped” and “ground” diets across the board and was not dependent on patient-specific dysphagia assessment by an ST (Speech Therapist). CNM stated a ST that used to work at the hospital had told the FNS department to serve those food items in a pureed texture for the chopped and ground diet for patient safety. CNM was unable to provide documentation of that communication and/or the name of the previously employed ST or anyone else whom approved that to be implemented hospital wide without being based on an individualized ST assessment to demonstrate the required need for patient-specific safety. During a review of IDDSI.org, dated 2025, IDDSI indicated, “The risks associated with swallowing a mixed consistency item [such as when liquid separates out from a solid] are as follows:The liquid component of the item may separate and spill into the pharynx (throat) during oral preparation of the bolus (a mass of chewed food). This may represent an increased aspiration risk (when food or liquid enters the lungs instead of going down the esophagus/throat that could lead to health problems) in people with dysphagia. Solid particles may be washed into the pharynx with the liquid component, before they have been adequately chewed. If these particles enter the airway, there is an increased risk of choking and airway obstruction.” During a review of NCM under title, “IDDSI Level 6 Soft and Bite-Sized Nutrition Therapy (SB6 diet)”, dated 2022, the NCM for SB6 diet indicated, “Foods Recommended: Couscous, quinoa, or rice held together with smooth, thick sauce that keeps rice from separating into individual grains, Foods Not Recommended: Grainy, sticky, or glutinous rice. . .Level 6 Soft & Bite Sized Sample 1-Day Menu: Breakfast: 1 scrambled egg cut into 1.5 cm x 1.5 cm pieces.” During a review of IDDSI.org under “Frequently Asked Questions”, dated 2025, IDDSI indicated, “The average tracheal (a tube in the neck and chest that carries air to and from the lungs) size for adult males is 22 mm (millimeters) and for adult females is 17 mm (Brodsky et al., 1996). Particle sizes of 15 mm (i.e. 1.5cm) size are therefore more likely to pass through the trachea, than block it.” During an interview on 6/10/25 at 3:20 p.m. with ST, ST stated she was aware the kitchen provided pureed rice and pureed scrambled eggs for the chopped diet orders which was in place when she began working at the hospital 3 1/2 (three and a half) years ago. ST stated she did find that practice to be unusual and did question it but never received an answer that made sense and did not pursue it further. During a review of the facility’s planned “Chopped” menu that repeated every seven days, dated 6/9/25, the non-select chopped menu indicated pureed scrambled eggs were provided 7 out of 7 days, and pureed rice was provided for six meals during the weekly menu cycle. During a review of the facility’s DM, dated 2025, the DM for chopped and/or Soft & Bite Sized (SB6) diet provided no indication that pureed scrambled eggs or pureed rice was approved to be provided on an IDDSI SB6 diet. During a concurrent interview and record review on 6/10/25 at 3:30 p.m. with ST, Patient 5’s “Speech Therapy Forms (STF)”, dated 2/3/25 was reviewed. The “STF” indicated, “Recommendations: 1. chopped diet with thin liquids, 2. Strategies: 1:1 feeding assistance, upright with PO intake, single sips of liquid, slow rate, 3. oral care 3x daily, 4. ST for dysphagia management” signed by ST 2. ST was asked if she was aware that IDDSI was the only recognized dysphagia diets, and that “chopped” and “ground” diets was from an obsolete National Dysphagia Diet (NDD), and ST stated, yes. ST stated the ST’s at the hospital performed dysphagia tests, treatment and recommended dysphagia diets to physician’s for patients. ST stated ST’s provided recommendations on diet textures such as “chopped” and “ground” although she was aware it was an outdated term, but that was what the hospital used. ST was not able to explain why the hospital used out of date dysphagia diet terminology that was no longer nationally recognized. Further, ST stated she had not received training on IDDSI diets. During a review of “Patient List Chopped Diet (PLCD)”, dated 6/10/25, the “PLCD” indicated there were 8 additional patients prescribed a “chopped” diet (Patient’s 6, 7, 8, 9, 10, 11, 12, 13). Of those chopped diet orders, five specified thin liquids, and three had no liquid consistency specified. During a review of the facility’s DM, dated 2025, the DM indicated, “Due to the pathophysiology of dysphagia, the IDDSI framework requires that the liquid consistency be clarified by the physician and/or speech therapy prior to sending liquids to drink to the patient. Assumption that the patient can tolerate thin liquid cannot be made. Therefore, if the liquid consistency is not included with the diet order, the FNS department will not provide fluids to drink. It is highly encouraged prescribing physician to include liquid consistency in the diet order for safety and patient satisfaction with meals provided.” During an interview on 6/10/25 at 3:48 p.m. with CNM, CNM stated she had trained FNS staff on IDDSI diets and provided training to medical staff during a meeting a while back. CNM stated she did not know if STs or nursing received IDDSI training. During an interview on 6/10/25 at 4:40 p.m. with Director of Rehabilitation (DOR), DOR stated she was responsible for oversight of the rehabilitation department which included the STs. DOR stated she was aware the hospital fully transitioned to IDDSI at the end of year 2021. DOR stated at that time, the STs had received training on IDDSI diets, however, none of those STs were still employed at the hospital and the STs hired since then had not received IDDSI training. During a review of the facility’s job description (JD) titled, “Speech Pathologist (ST)”, dated 11/15/24, the JD indicated, “The Speech Pathologist assesses, treats, and helps to prevent disorders related to speech, language, cognitive-communication, voice, and swallowing problems. . .Job Responsibilities: Participates in continuing education to remain current in new treatment procedures, active in providing in-services to departmental staff.” During a review of the facility’s JD titled, “Clinical Nutrition Manager (CNM)”, dated 10/23/23, the “JD” indicated, “Identifies, reviews, and evaluates nutrition services through quality assurance and monitoring techniques to improve quality of care. Serves as a resource person to dietitians, physicians, house staff, nursing services, and food service personnel regarding clinical nutrition practices, development and trends. Approves nutritional adequacy of menus and writes special diet menus. While developing menus collaborates with purchasing, production, and patient service area. Collaborates on recipe development and views product evaluation with all necessary members of the department and hospital. Evaluates conformance to quality standards and diet orders. . .Serves as a liaison between nursing, medical personnel and other allied health personnel in relation to clinical nutrition. . .Additional: Upon request, plans and implements in-service training for physicians and nursing personnel.” During a review of the facility’s JD titled, “Director of Food & Nutrition Services”, dated 10/23/23, the JD indicated, “Oversees both the food service program as well as the clinical nutrition program. . ., Provides oversight of the clinical nutrition program. Provides guidance and direction to the Clinical Nutrition Manager.” During review of the NCM, dated 2022, the NCM indicated, “Treatment of dysphagia encompasses a multidisciplinary approach. Physicians and speech-language pathologists (SLPs) evaluate individuals with dysphagia through various procedures. The SLP may prescribe a texture-modified diet for foods and/or fluids and muscle-strengthening exercises and postural [sitting positions] maneuvers to increase swallow safety. The RDN supports the individual with dysphagia by encouraging adherence to texture-modified diet recommendations and recommending acceptable foods and fluids that meet the prescribed diet and nutrient needs. . .Often the entire health care team (including physicians and nurses) is involved in monitoring patients for difficulties related to chew/swallow; in reporting concerns per facility policy; monitoring diet texture effectiveness, adherence, and understanding; and evaluating needs related to patient education. . .The National Dysphagia Diet (NDD) and associated resources will no longer be included in the NCM after October 2021.” During review of United States IDDSI Reference Group (USIRG), dated November 2021, USIRG indicated, “IDDSI has the full support of the Academy of Nutrition & Dietetics (AND) and the American Speech-Language & Hearing Association (ASHA) since May 2019. October 2021: IDDSI is now the only professionally recognized dysphagia diet standard in the Nutrition Care Manual of the AND for the United States.” 3. During an observation on 6/9/25 at 10:17 a.m. during patients lunch trayline (an assembly line system where prepared food items are placed on trays) in the kitchen, Patient 1’s lunch meal tray had a meal tray card that indicated, “Diet: FR [fluid restriction] 1500 [ml: milliliters of fluid a (per) day was the maximum amount of fluids patient could consume in 24 hours]. . . Renal [diet for kidney disease], 60 g [grams] CC [carbohydrate per meal to manage diabetes]. . .” Patient 1’s lunch meal tray was observed with 8 ounces (oz.) of iced tea, a 4 oz. container of applesauce and 1/2 (half) a cup of diced peaches in a serving dish with a lid on it. During an observation on 6/9/25 at 10:27 a.m. during patients lunch trayline in the kitchen, Patient 2’s lunch meal tray had a meal tray card that indicated, “Diet: Renal, Dry Tray.” Patient 2’s lunch meal tray included a container of light & fit yogurt and a 4 oz. container of apple sauce. During a concurrent interview and record review on 6/9/25 at 2:21 p.m. with Clinical Nutrition Manager (CNM), Patient 2’s diet order in the electronic health record (EHR) was reviewed. CNM stated Patient 2’s diet order was a renal diet with a 1,200 ml FR per day. CNM used a software program (SP) utilized by FNS department that included specific foods and beverages provided to each patient on a meal tray. CNM stated the SP indicated Patient 2 was on a 1,200 ml FR. CNM stated the SP indicated Patient 2 was served 1 pkt (packet) graham crackers, 1 pkt lite mayonnaise, 2 pkt mustard, renal garden salad, 1/2 cup of applesauce, renal hamburger, one container of Light & Fit yogurt. CNM stated dry tray meant that kitchen staff should not provide any fluids on the meal tray. CNM stated, “We don’t count apple sauce and yogurt as part of the fluid restriction.” CNM stated FNS staff were trained to provide dry meal trays for 1,200 ml FR orders, as the 1,200 ml of fluids was “all given by nursing.” During a review of “Dialysis Patient Citizens Education Center (DPC)”, dated 2025, the “DPC” indicated, “Why Should I Care About Restricting My Fluids? Too much fluid gain between treatments can lead to: Cardiac arrest [heart attack], heart disease, vein damage, blood pressure-related issues, swelling, fluid build-up in the lungs, cramping during treatment. . .1 cup of yogurt = 7 oz. of fluid, 1 cup of applesauce = 8 oz. of fluid.” During an interview on 6/9/25 at 2:25 p.m. with CNM, CNM stated she did not know the fluid content of high-water foods like yogurt and therefore did not guide staff on counting fluids from certain foods toward FR orders. CNM stated, “Our hospital only wants liquids via beverages to be counted in a fluid restriction.” During a concurrent interview and record review on 6/9/25 at 2:26 p.m. with CNM, CNM stated she used the Nutrition Care Manual (NCM) from Academy of Nutrition and Dietetics (AND) as standards of practice. CNM accessed the NCM, the hospital had readily available for staff, and CNM stated standard of practice per NC for FR was to include foods with high water content and foods that melt. CNM stated it was the hospital that did not want to include foods with high water content as a liquid. CNM stated she did not discuss or clarify further with medical staff related to NCM’s guidance pertaining to FR, such as fluid-restriction diet order versus a no-free-water, fluid restriction diet order. During a review of the policy and procedure (P&P) titled, “Fluid Restrictions”, with a created date of 6/2/2008 and an approved date of 6/10/24, the P&P indicated, “Approvers: Director of Food & Nutrition Services, Policy: Physician orders for fluid restrictions will be implemented in conjunction with nursing. Procedure: 1. Fluid restrictions will be communicated via the diet order to the Food and Nutrition Services (FNS) Department. 2. The fluid restriction will be part of the diet order. 3. Fluid restrictions less than or equal to 1250 ml per day will be considered a dry tray. All other fluid restrictions will receive one liquid serving (i.e. soup, gelatin, ice cream, water, coffee, soda, juice, etc) of choice not to be more than 240 ml [8 oz.] per meal. 4. Oral nutrition supplements as ordered by the provider counts towards the liquids provided on each tray. 5. Nursing will record fluids & foods consumed into the patient’s medical record.” During an interview with CNM on 6/10/25 at 3:55 p.m., CNM stated she reviewed the above P&P and stated soup was included in FR per P&P and it was not just liquid beverages on a tray that should be counted toward FR. CNM was unclear on the hospital’s expectations related to FR orders. The hospital had only required the DFNS to approve the P&P without interdepartmental collaboration, review and approval in which concerns, questions, advice or improvement in the development of a P&P may take place to ensure clear, concise guidance related to FR orders in accordance with standard of care. During a review of the facility’s diet manual (DM), dated 2025, the DM contained a a full liquid diet described as “made up of only fluids and foods that turn to liquid at room temperature”, to provide an example of foods that may be considered liquids, which included “broths, strained cream soups, cooked refined cereal, farina, cream of rice, strained cereal, fruit and vegetable juices, milk, milkshake, yogurt, custard, and pudding.” During a review of the policy and procedure (P&IP) obtained from “Patient Care Manual” titled, “Vital Signs, Intake & Output, Weights: (Adult)”, dated 3/20/23, the P&P indicated, “Approvers: Medical Executive Committee, Patient Care Policy Approval Committee, Patient Care Policy Committee, Policy: All patients’. . .dietary intake & output will be consistently measured and documented as ordered. . .Each staff member is responsible for entering data that they obtain, reviewing entered data for completeness and accuracy. . .Fluid restrictions: 1. Inform and instruct patient/family on fluid restriction procedures including specific amounts of fluid that is allowed. 2. Remove water pitcher from patient room. 3. Carry forward to the next shift any fluids allowed but not consumed. . .” During a review of the policy and procedure (P&P) titled, “Diet Manual and Approval Acute Care”, dated 7/22/24, the P&P indicated, “Policy: The Nutrition Care Manual is the standard guide and reference for nutrition assessment and care. Policy: The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM) is the standard guide and reference for nutrition care. The NCM is online and available to all healthcare providers at [name of hospital] health.” During a review of Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2023, the “NCM” indicated, “Definition: The fluid-restriction diet order limits an individual’s daily fluid intake. Most foods are allowed in this diet, but extra planning is required to coordinate appropriate serving sizes of foods and liquids throughout the day. Note: items that are traditionally considered “foods” may be considered liquids in this diet. A no-free-water, fluid restriction diet order limits or eliminates liquids that are mostly composed of water, including plain water, coffee, tea, and tonic. Indication: A fluid restriction diet is indicated in individuals with congestive heart failure [the heart cannot pump enough blood to meet the body’s needs, leading to fluid buildup in the lungs and other tissues], hypertension [high blood pressure], fluid retention, pulmonary edema [excess fluid builds up in the lungs, making it difficult to breathe], hyponatremia [low sodium in the blood], and renal failure [kidneys are no longer functioning effectively to remove waste and excess fluid from the body]. Fluid restriction may be ordered in addition to a sodium restriction to help maintain fluid balance. A no-free water restriction diet order is often ordered for hyponatremia to provide a more liberalized approach. . .Counting Liquids and Foods for a Fluid Restriction Diet: A fluid is anything that is liquid or any foods that melt at room temperature. These foods and liquids must be counted as part of daily fluid intake. . .Examples of fluids include the following: Foods with High Water Content/Foods That Melt: Gelatin, Watermelon, Gravy, Ice cream sherbet, sorbet, Popsicles, Yogurt, Pudding, Soups.””

“THERAPEUTIC DIET MANUAL CFR(s): 482.28(b)(3) A current therapeutic diet manual approved by the dietitian and medical staff must be readily available to all medical, nursing, and food service personnel. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the facility failed to ensure the facility’s diet manual (DM) was developed and implemented in accordance with current national standards for routinely ordered therapeutic dysphagia (difficulty swallowing) diets, and was not consistently used as guidance for ordering and preparing patient diets when the DM guided physician’s to order obsolete (out-of-date) dysphagia diets such as “chopped” and “ground” from a no longer recognized National Dysphagia Diet (NDD) system. In addition, Food and Nutrition Services (FNS) department had not had the skillset to prepare rice and scrambled eggs in a safe manner and/or in accordance with current standard of practice IDDSI (International Dysphagia Diet Standardization Initiative) Level 6 Soft & Bite-Sized (SB6) standardized guidance (in which the facility was using an obsolete “chopped” diet as their version of SB6 diet) for one of one sampled patients (Patient 5) that had the potential to affect all patient’s prescribed a chopped diet since pureed rice and pureed scrambled eggs was on the chopped diet weekly cycle menu. During a review of the facility’s “Patient List Chopped Diet (PLCD)”, dated 6/10/25, the “PLCD” indicated there were 8 additional patients prescribed a “chopped” diet located in their electronic health record (EHR). (Patient’s 3, 6, 7, 8, 9, 10, 11, 12). (Cross Refer A-0618, A-0619) Facility failure to ensure full implementation of IDDSI diets, after the facility had indicated they had already fully transitioned to IDDSI at the end of year of 2021 with no further action plans for the implementation of IDDSI diets and/or interdisciplinary (IDT) staff education, resulted in the facility co-mingling obsolete therapeutic diet orders that was no longer nationally recognized with aspects of IDDSI diet implementation that had the potential to lead to confusion amongst staff, patients and family/caretakers and errors in diet texture for patients with dysphagia. Such errors have previously been associated with adverse events including choking. Findings: During a review of the policy and procedure (P&P) titled, “Diet Manual and Approval Acute Care”, dated 7/22/24, the P&P indicated, “Policy: To provide a reference for nutrition care, which will be used as a guideline for diet related information. The facility specific diet manual outlines all regular and therapeutic diets available for patients in the facility. The Nutrition Care Manual is the standard guide and reference for nutrition assessment and care. Policy: The facility specific diet manual is updated at least annually and reflects the current meals and therapeutic diet options available for providers to order for their patients. The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM) is the standard guide and reference for nutrition care. The NCM is online and available to all healthcare providers at [name of hospital] health. Procedure: 1. The facility specific diet manual is reviewed, updated and approved by the Food and Nutrition Services (FNS) Director, Clinical Nutrition Manager and a Medical Staff Representative. . .2. The NCM is kept current and updated at least annually by AND. (The NCM includes research-and evidence-based nutrition care information for more than 100 diseases, conditions, and topics.), 3. Both the facility specific diet manual and the NCM are located on [name of hospital] . . .and is accessible from all computers in the District.” During a review of the facility specific diet manual titled, “[name of hospital] Health Diet Manual (DM)”, dated 2025, the “DM” indicated, “Dysphagia Diets: The International Dysphagia Diet Standardization Initiative (IDDSI) has become the professional standard for providing dysphagia diets. The goal is to ensure consistent and safe textures for patients with dysphagia. The names of the diet orders in [name of EHR software) have not changed but the interpretation of the diets are as follows: Diet Order: Chopped; interpretation-IDDSI Level 6 Soft & Bite Sized, Ground; IDDSI Level 5 Minced & Moist, Puree; IDDSI Level 4 Pureed, Blenderized; IDDSI Level 3 Liquidized. IDDSI Level 6- Soft & Bite Sized Indication: This diet is prescribed when patients are unable to safely bite off pieces of food but are able to chew the food into smaller pieces that can be safely swallowed. . .Food pieces should be no larger than 1.5 cm [centimeter] x [by] 1.5 cm (or the width of a dinner fork). Foods should be soft, tender and moist, for easier chewing and swallowing. Foods where sauce separates from the food should be strained or blended to ensure one consistency. Moisten foods with small amounts of gravy, sauce, juice or cooking liquids-but only if it can be absorbed into the food and does not separate. Food Groups. . .Protein - foods allowed: Cooked and soft proteins that are not on the restricted list, Foods Restricted: Poultry or fish with skin and/or bones, Natural casing on sausages, Breads and starches - foods allowed: Soft foods not on the restricted list, Foods Restricted: Crackers, biscuits, muffins, pancakes, waffles, bread dressing, sticky rice or rice that separates into individual grains. . .” During a concurrent observation and document review on 6/9/25 at 11:11 a.m. in the kitchen during lunch trayline (where prepared meals are assembled onto trays ), Patient 5’s lunch meal tray card indicated, “Diet: Chopped; Clerk Check [extra check process for meal tray accuracy]”, dated 6/9/25. Patient 5’s lunch meal tray was observed to have chopped chicken stirfry, pureed rice that was observed with liquid pooled on top with liquid separation coming out from the side of the thin appearing pureed rice that spread out on the plate, and a cup of gravy that had liquid separation. During an interview on 6/9/25 at 1:59 p.m. with CNM, CNM stated the kitchen staff always served pureed rice and pureed scrambled eggs for all “Chopped” (hospital’s version of SB6 diet) and “Ground” diets (hospital’s version of Level 5 Minced & Moist [MM5] diet). CNM stated there should not have been any liquid separation from the pureed rice or gravy served for the “chopped” diet, as that was not allowed per IDDSI SB6 diet standardization. CNM stated the hospital served pureed rice and pureed scrambled eggs for all “chopped” and “ground” diets across the board and was not dependent on patient-specific dysphagia assessment by an ST (Speech Therapist). CNM stated a ST that used to work at the hospital had told the FNS department to serve those food items in a pureed texture for the chopped and ground diet for patient safety. CNM was unable to provide documentation of that communication and/or the name of the previously employed ST or anyone else whom approved that to be implemented hospital wide without being based on an individualized ST assessment to demonstrate the required need for patient-specific safety. During a review of IDDSI.org, dated 2025, IDDSI indicated, “The risks associated with swallowing a mixed consistency item [such as when liquid separates out from a solid] are as follows:The liquid component of the item may separate and spill into the pharynx (throat) during oral preparation of the bolus (a mass of chewed food). This may represent an increased aspiration risk (when food or liquid enters the lungs instead of going down the esophagus/throat that could lead to health problems) in people with dysphagia. Solid particles may be washed into the pharynx with the liquid component, before they have been adequately chewed. If these particles enter the airway, there is an increased risk of choking and airway obstruction.” During a review of NCM under title, “IDDSI Level 6 Soft and Bite-Sized Nutrition Therapy (SB6 diet)”, dated 2022, the NCM for SB6 diet indicated, “Foods Recommended: Couscous, quinoa, or rice held together with smooth, thick sauce that keeps rice from separating into individual grains, Foods Not Recommended: Grainy, sticky, or glutinous rice. . .Level 6 Soft & Bite Sized Sample 1-Day Menu: Breakfast: 1 scrambled egg cut into 1.5 cm x 1.5 cm pieces.” During a review of IDDSI.org under “Frequently Asked Questions”, dated 2025, IDDSI indicated, “The average tracheal (a tube in the neck and chest that carries air to and from the lungs) size for adult males is 22 mm (millimeters) and for adult females is 17 mm (Brodsky et al., 1996). Particle sizes of 15 mm (i.e. 1.5cm) size are therefore more likely to pass through the trachea, than block it.” During a concurrent interview and record review on 6/9/25 at 2:05 p.m. with CNM, Patient 5’s “Order Desc [OD: description]”, dated 2/11/25, was reviewed. The “OD” indicated, “Chopped Diet.” CNM stated chopped diet was not an IDDSI diet but “it’s our house version for IDDSI SB6 diet (Level 6 Soft & Bite Sized).” CNM stated the physician’s ordered “chopped” and “ground” diet orders in a patient’s EHR from a pop down diet selection list. CNM stated IDDSI diets were not available in the EHR’s pop down diet list for physicians to order for their patients. During an interview on 6/10/25 at 3:20 p.m. with ST, ST stated she was aware the kitchen provided pureed rice and pureed scrambled eggs for the chopped diet orders which was in place when she began working at the hospital 3 1/2 (three and a half) years ago. ST stated she did find that practice to be unusual and did question it but never received an answer that made sense and did not pursue it further. During a review of the facility’s planned “Chopped” menu that repeated every seven days, dated 6/9/25, the non-select chopped menu indicated pureed scrambled eggs were provided 7 out of 7 days, and pureed rice was provided for six meals during the weekly menu cycle. During a review of the facility’s DM, dated 2025, the DM for chopped and/or Soft & Bite Sized (SB6) diet provided no indication that pureed scrambled eggs or pureed rice was approved to be provided on an IDDSI SB6 diet. During a concurrent interview and record review on 6/10/25 at 3:30 p.m. with ST, Patient 5’s “Speech Therapy Forms (STF)”, dated 2/3/25 was reviewed. The “STF” indicated, “Recommendations: 1. chopped diet with thin liquids, 2. Strategies: 1:1 feeding assistance, upright with PO intake, single sips of liquid, slow rate, 3. oral care 3x daily, 4. ST for dysphagia management” signed by ST 2. ST was asked if she was aware that IDDSI was the only recognized dysphagia diets, and that “chopped” and “ground” diets was from an obsolete National Dysphagia Diet (NDD), and ST stated, yes. ST stated the ST’s at the hospital performed dysphagia tests, treatment and recommended dysphagia diets to physician’s for patients. ST stated ST’s provided recommendations on diet textures such as “chopped” and “ground” although she was aware it was an outdated term, but that was what the hospital used. ST was not able to explain why the hospital used out of date dysphagia diet terminology that was no longer nationally recognized. Further, ST stated she had not received training on IDDSI diets. During a review of “Patient List Chopped Diet (PLCD)”, dated 6/10/25, the “PLCD” indicated there were 8 additional patients prescribed a “chopped” diet (Patient’s 6, 7, 8, 9, 10, 11, 12, 13). Of those chopped diet orders, five specified thin liquids, and three had no liquid consistency specified. During a review of the facility’s DM, dated 2025, the DM indicated, “Due to the pathophysiology of dysphagia, the IDDSI framework requires that the liquid consistency be clarified by the physician and/or speech therapy prior to sending liquids to drink to the patient. Assumption that the patient can tolerate thin liquid cannot be made. Therefore, if the liquid consistency is not included with the diet order, the FNS department will not provide fluids to drink. It is highly encouraged prescribing physician to include liquid consistency in the diet order for safety and patient satisfaction with meals provided.” During an interview on 6/10/25 at 3:48 p.m. with CNM, CNM stated she had trained FNS staff on IDDSI diets and provided training to medical staff during a meeting a while back. CNM stated she did not know if STs or nursing received IDDSI training. During review of the NCM, dated 2022, the NCM indicated, “Treatment of dysphagia encompasses a multidisciplinary approach. Physicians and speech-language pathologists (SLPs) evaluate individuals with dysphagia through various procedures. The SLP may prescribe a texture-modified diet for foods and/or fluids and muscle-strengthening exercises and postural [sitting positions] maneuvers to increase swallow safety. The RDN supports the individual with dysphagia by encouraging adherence to texture-modified diet recommendations and recommending acceptable foods and fluids that meet the prescribed diet and nutrient needs. . .Often the entire health care team (including physicians and nurses) is involved in monitoring patients for difficulties related to chew/swallow; in reporting concerns per facility policy; monitoring diet texture effectiveness, adherence, and understanding; and evaluating needs related to patient education. . .The National Dysphagia Diet (NDD) and associated resources will no longer be included in the NCM after October 2021.” During review of United States IDDSI Reference Group (USIRG), dated November 2021, USIRG indicated, “IDDSI has the full support of the Academy of Nutrition & Dietetics (AND) and the American Speech-Language & Hearing Association (ASHA) since May 2019. October 2021: IDDSI is now the only professionally recognized dysphagia diet standard in the Nutrition Care Manual of the AND for the United States.” During a review of IDDSI.Org titled “Guidelines For Use” (GFU), dated 2024, “GFU” indicated, “Supplementary Notice: Do not alter the elements of the IDDSI framework. Alterations may lead to confusion and errors in diet texture or drink selection for patients with dysphagia. Such errors have previously been associated with adverse events including choking and death.” During a review of IDDSI’s document titled “Standards of Practice Regulatory Information for Long Term Care Facilities, Hospitals, Critical Access Hospitals, Home Health Agencies and Hospice”, dated July 2021, indicated, “The National Dysphagia Diet (NDD) is now outdated and International Dysphagia Diet Standardization Initiative (IDDSI) will be the only professionally recognized texture modified diet framework as of October 2021. . .It is the only professionally- supported and evidence-based standard of practice.””

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the hospital failed to: 1. Follow its policy and procedure on Basic Aseptic Technique (a procedure that healthcare providers use to prevent the spread of germs that cause infection) when a contaminated intravenous (IV-within the vein) spike (pointed end of the IV set that is inserted into the IV fluid bag or bottle to allow the fluid to flow from the bag into the tubing) was used during a surgical procedure for one of one sampled patient (Patient 18). 2. Ensure eight of eight sampled hinged instruments were sterilized in an open position. 3. Provide a weighing scale to ensure six of six sampled surgical instrument trays did not exceed the maximum weight of 25 pounds. These failures had the potential to result in post-operative surgical site infections due to the contaminated IV spike and surgical instruments not properly sterilized. Findings: 1. During a review of Patient 18’s “History & Physical (H&P),” dated 3/9/25, the H&P indicated, Patient 18 developed sciatica (nerve pain from an injury or irritation to the sciatic nerve caused by a herniated disc [the cushion-like cartilage between the bones of the spine] or an overgrowth of bone that puts pressure on the lower back nerve roots) in his right lower extremity with associated pain, numbness, tingling, and weakness. The recommended treatment was laminectomy (a surgical procedure to relieve pressure on one’s nerves by removing the arched back piece of the spinal bone), decompression (removal of pressure), and diskectomy (surgical removal of the damaged part of a disc [spongy cushions that separate the bones of the spine] of the L4-L5 (fourth and fifth vertebrae in the lumbar [L] spine) level. During an observation on 3/10/25 at 3:04 p.m. in Operating Room (OR) 1, Patient 18’s microdiscectomy (minimally invasive surgical procedure performed on patients with a herniated lumbar disc) was started with Surgeon 1 as the primary surgeon and Registered Nurse First Assist (RNFA) 1 as the surgeon’s assistant. At 3:07 p.m. the Circulating Registered Nurse (CRN) opened an IV spike set. The IV spike fell on the floor. CRN picked up the IV spike from the floor, wiped the IV spike with alcohol wipes, and inserted the IV spike into the 0.9% Normal Saline solution bag, and connected it to the aquamantys (medical device used by the surgeon to seal and control blood of an exposed tissue or bony surface) during the surgical procedure. It was noted CRN did not notify Surgeon 1 of the incident. Surgeon 1 continued to use the contaminated IV solution during Patient 18’s surgery. During an interview on 3/10/25 at 4:08 p.m. with CRN in the presence of the OR Nurse Manager (ORNM), CRN stated, “I made a mistake. I should have discarded and replaced the IV spike.” During an interview on 3/11/25 at 1:59 p.m. with Surgeon 1, Surgeon 1 stated he was not made aware CRN dropped the tip (referring to the IV spike) on the floor. Surgeon 1 stated CRN should have replaced it. Surgeon 1 stated he had not notified the patient nor the family. During an interview on 3/11/25 at 2:16 p.m. with Infection Prevention and Control Manager (IPCM), IPCM stated he was not informed CRN used a contaminated IV spike during the surgical procedure. IPCM stated there’s a potential risk for infection. IPCM stated anything that falls on the floor should not be used for the patient, and should be discarded. During a review of the hospital’s policy and procedure (P&P) titled, “Basic Aseptic Technique,” the P&P indicated, “Purpose: To ensure maximum protection from a postoperative wound infection through the practice of aseptic technique throughout the perioperative experience.” 44134 2. During a concurrent observation and interview on 3/11/25 at 10:37 a.m. with Sterile Processing Technician (SPT) 1 in the sterilization (process that eliminates all forms of germs through the use of high heat and pressure) supply room, staff packaged and sterilized one Ryder (brand name) needle holder (hinged surgical instrument) without ensuring the needle holder was in an open position. SPT 1 stated, “That individual did not follow the rules.” SPT 1 stated staff should ensure the instrument was in the open position prior to sterilization. During a concurrent observation and interview on 3/11/25 at 10:40 a.m. with ORNM in the sterilization supply room, staff had packaged and sterilized eight hinged instruments without ensuring the instruments were in an open position. The following hinged instruments were not sterilized in open position: one needle holder French eye two (Ryder) needle holders two Metzenbaum scissors one straight Kelly (type of forcep) one Demartel scissors one bulldog clip (type of forcep) ORMN stated the staff should have ensured the instruments were in an opened position during sterilization. During a review of the AORN Guidelines for periOperative Practice, dated 2019, the Guidelines indicated, “Items to be sterilized should be positioned within the packages to allow sterilant contact within all surfaces. . .Sterilant contact is necessary for sterilization to be achieved. . .Items to be sterilized should be placed in the package or tray in an open or unlocked position. . .The open or unlocked position facilitates sterilant contact of all surfaces of the item.” 3. During a concurrent observation and interview on 3/11/25 at 9:56 a.m. with Certified Lead Sterile Processing Technician (CLSPT) in the sterilization supply room, an open cart contained six open metal containers. Each container was filled with multiple surgical instruments. CLSPT stated the instruments were trauma “loaner boxes” that had been cleaned and the department was was waiting for the vendor to re-assess and restock, so staff can sterilize them. During an interview on 3/11/25 at 10:44 a.m. with CLSPT, CLSPT stated the Sterile Processing Department only had one scale and it broke last week. CLSPT stated the staff had not replaced the scale. CLSPT stated there were no records of surgical instrument tray weights being measured prior to the sterilization process. During an interview on 3/11/25 at 10:45 a.m. with Sterile Processing Manager (SPM), SPM stated the Sterile Processing Department should have a scale to weigh surgical instruments prior to the sterilization process. During a review of the facility’s P&P titled, “Loaner Trays,” dated 11/27/18, the P&P indicated, “All loaner instrument trays will be checked by the Sterile Processing technician or supervisor upon arrival in the department. The trays will be decontaminated, cleaned, sterilized, and documented properly. . .Procedure. . D. SPD [Sterile Processing Department] will weigh loaner trays to ensure they do not exceed the maximum weight of 25 pounds. E. If the loaner tray is over 25 pounds, the vendor must adjust or separate the tray to meet the 25 pound maximum requirement. F. Trays over 25 pounds will not be reprocessed.””

“SURGICAL PRIVILEGES CFR(s): 482.51(a)(4) Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner. This Standard is not met as evidenced by: 44134 Based on interview and record review, the hospital failed to ensure one of one sampled Registered Nurse First Assist ([RNFA 1], an advanced practice registered nurse that actively assists the surgeon during surgery) had an annual competency (knowledge and skills necessary to perform a job) completed. This failure had the potential to result in the facility not knowing if RNFA 1 was knowledgeable and had the skills to perform the role of a Registered Nurse First Assist. Findings: During a concurrent interview and record review on 3/12/25 at 2:52 p.m. with Director of Talent Acquisition (DOTA), RNFA 1’s employee file (EF) was reviewed. The EF indicated, RNFA 1 had a “RNFA Checklist-Initial Credentialing” completed on 10/3/19. DOTA stated this was RNFA 1’s competency completed upon hire. DOTA stated this document showed that four surgeons had signed off RNFA 1 on her skills. DOTA stated she was unable to find a current annual RNFA competency in RNFA 1’s EF. During an interview on 3/12/25 at 4:12 p.m. with Operating Room Nurse Manager (ORNM), ORNM stated a surgeon has not signed off a current annual competency for RNFA 1 to indicate that RNFA’s skills/competency had been reviewed. During a review of the facility’s policy and procedure (P&P) titled, “Performance Management and Competency Assessment Program,” dated 8/23/23, the P&P indicated, “It is the policy of [Facility Name] to assess, maintain, develop and improve employee performance and competence on an ongoing basis. Performance is formally evaluated on an annual basis. . .Competency is the demonstrated ability to integrate the knowledge, skills, and attitudes required in a designated role or setting. Competency is verified through utilization of techniques such as demonstration, review of policy/procedure, verbalization, and/or written testing. The performance evaluation and competency assessment process ensures that the requirements of the position are met.””

“POST-ANESTHESIA EVALUATION CFR(s): 482.52(b)(3) [The policies must ensure that the following are provided for each patient:] A post-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, no later than 48 hours after surgery or a procedure requiring anesthesia services. The post-anesthesia evaluation for anesthesia recovery must be completed in accordance with State law and with hospital policies and procedures, which have been approved by the medical staff and which reflect current standards of anesthesia care. This Standard is not met as evidenced by: 41035 Based on interview and record review, the hospital failed to ensure a post-anesthesia evaluation (assessment conducted by the anesthesiologist[doctor who gives medication to put patients to sleep for surgery so the patient does not feel pain] to evaluate a patient’s condition after receiving anesthesia [temporary loss of sensation or awareness caused by medications]) was completed after surgery for two of 30 sampled patients (Patient 12, Patient 14). This failure had the potential for anesthesia complications to negatively impact Patient 12 and Patient 14. Findings: 1. During a concurrent interview and record review on 3/11/25 at 3:50 p.m. with Clinical Informaticist (CI) and Assistant Nurse Manager (ANM), Patient 12’s Electronic Medical Record (EMR) was reviewed. The EMR indicated Patient 12 had an anterior cervical discectomy (removal of a damaged disc to relieve spinal cord or nerve pressure to alleviate pain) on 2/24/25. Surgeon 1 was the surgeon and Certified Registered Nurse Anesthetist (CRNA) administered the anesthesia. Patient 12’s EMR indicated Patient 12 was discharged on 2/25/25. CI and ANM were unable to find CRNA completed a post-anesthesia evaluation for Patient 12 and they both stated the evaluation should have been documented in the EMR. During a concurrent interview and record review on 3/12/25 at 1:35 p.m. with CRNA, Patient 12’s EMR was reviewed. CRNA stated he administered the anesthesia during Patient 12’s surgery on 2/24/25. CRNA stated he did not complete a post-anesthesia evaluation for Patient 12. CRNA stated it was an error on his side and stated he should have completed the post-anesthesia evaluation. CRNA stated the post-anesthesia evaluation should have been completed within 48 hours from the surgery. 2. During a concurrent interview and record review on 3/11/25 at 4:20 p.m. with CI and ANM, Patient 14’s EMR was reviewed. The EMR indicated Patient 14 had a left total knee replacement (a surgical procedure to replace the surface of the knee joint to relieve pain) on 2/24/25. Patient 14’s EMR indicated Surgeon 2 performed the surgery and MD 1 was the Anesthesiologist. Patient 14’s EMR indicated Patient 14 was discharged home on the same day of the surgery. CI and ANM were unable to find documentation MD 1 completed a post-anesthesia evaluation on Patient 14 and they both stated it should have been documented in the EMR. During a concurrent interview and record review on 3/12/25 at 9:30 a.m. with MD 1, Patient 14’s EMR was reviewed. MD 1 stated Anesthesia Resident Physician (ARP- physician in training in Anesthesia) provided anesthesia for Patient 14 under my supervision. MD 1 stated ARP should have completed the post-anesthesia evaluation for Patient 14. MD 1 stated there was no post-anesthesia evaluation in Patient 14’s EMR, and stated there should have been. MD 1 stated she normally completes the post-anesthesia evaluation two to three hours after surgery. During a review of the hospital’s “Medical Staff Bylaws (MSB),” dated 2020, the MSB indicated, “A post-anesthesia evaluation will be completed and documented by an individual qualified and credentialed to administer anesthesia no later than 48 hours after surgery or a procedure requiring anesthesia services.””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 35649 The hospital failed to meet the regulatory compliance for §482.12 Condition of Participation for Governing Body. The Governing Body was responsible for the conduct of the hospital operations, and carried out the responsibilities and the functions specific to the governing body as evidenced by: 1. Based on interview and record review, the governing body failed to exercise quality oversight responsibility to safeguard one of one sampled patient (Patient 2) with history of kidney transplant (replacing a diseased kidney or injured kidney with a healthy kidney from a donor) from complications resulting from injection of intravenous (IV-within the vein) contrast (iodine-based material injected into a vein to enhance x-ray and CT images) when the Nephrologist (MD 1- medical doctor who specializes in kidney care and treating diseases of the kidneys) was not consulted for medical care. (Refer to A-0053). 2. Based on interview and record review, the hospital failed to ensure the Registered Nurse (RN) 1 performed a nursing assessment for one of one sampled patient (Patient 3) follow a change in condition. (Refer to (A-0395). 3. Based on interview and record review, the hospital failed to ensure the Magnetic Resonance Imaging Technician (MRIT) activated the emergency system for one of one patient (Patient 1) who deteriorated during the MRI (a type of scan that uses strong magnetic fields and radio waves to produce detailed images of the inside of the body) procedure. (Refer to A-0547). 4. Based on interview and record review, the hospital failed to document and keep a record of the MRI Screening Form for one of one sampled patient (Patient 1) who had an MRI of the Brain without contrast. (Refer to A-0553) 5. Ensure the Director of Food & Nutrition Service (DFNS) effectively directed and provided oversight related to safe food handling and sanitary environment within the foodservice operation related to prompt elimination of harborage conditions that attract rodents. (Refer to A-0620, A-0622) 6. Ensure integration of the food and dietetic service into the hospital-wide QAPI (Quality Assessment and Performance Improvement) and Infection Control program related to on-going rodent problem in the kitchen. (Refer to A-0618, A-0620) 7. Ensure aspects of nutritional care were incorporated into the hospital’s structure for provision of nutrition care services to patients in accordance with standards of practice. (Refer to A-0621) a. Implement a system to order Registered Dietitian (RD) consults to provide Medical Nutrition Therapy (MNT) for patients with food allergies for one of five sampled patients (Patient 26). (Refer to A-0621) b. Ensure RD’s offered or provided therapeutic diet education to meet patient’s individualized nutritional needs in accordance with the hospital’s RD job description and standards of practice for one of five sampled patients (Patient 27). (Refer to A-0621) c. Ensure effective monitoring of oral nutrition supplement (ONS) for two of five sampled patients (Patient 26, Patient 21). (Refer to A-0629) d. Ensure an RD provided nutrition recommendations to one of five sampled patients (Patient 26) to ensure nutritional needs were met in accordance with standards of practice. (Refer A-0629) e. Ensure RD’s assessed and evaluated therapeutic diets for two of five sampled patients (Patient 27, Patient 29). who had multiple variations to select from, to determine whether nutrition recommendations to a patient’s physician were in order. (Refer to A-0629) 8. Based on observation, interview, and record review, the facility failed to implement nationally recognized organization Center for Disease Control (CDC-federal government agency that protects public health by preventing and controlling disease, injury, and disability) infection prevention and control practices) infection prevention and control practices when one of three sampled patients (Patient 4), who was diagnosed with Herpes Zoster (also known as Shingles, a painful rash caused by herpes virus), was not placed on Transmission-Based Precaution (used as second tier of basic infection control and are to be used in addition to Standard Precautions [includes hand hygiene and use of personal protective equipment such as gloves, masks, gowns, face shields, or goggles]). (Refer to A-0750). 9. Ensure the MRI technologist (MRIT) and Emergency Department Registered Nurse (EDRN) 1 activated the emergency response system and initiate cardiopulmonary resuscitation for one of one patient (Patient 1) during a life threatening event. (Refer to A1112). 10. Ensure EDRN 1 documented nursing assessment, placed one of one sampled patient (Patient 1) suffering from a life-threatening condition on the cardiac (heart) monitor, vital signs (includes temperature, heart rate, respiratory rate, blood pressure) machine, and pulse oximetry (measures oxygenation in one’s blood), and continued to monitor care upon return to the ED from Radiology Department (RD). (Refer to A1112). The cumulative effects of these systemic failures had the potential to negatively impact health and safety of all hospital patients and those patients seeking emergency care at the facility, in compliance with the Condition of Participation for Governing Body, Food and Dietetic Services, and Emergency Services.”

“FOOD AND DIETETIC SERVICES CFR(s): 482.28 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of Participation if the company has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment. This Condition is not met as evidenced by: 27157 Based on observation, interview, and record review, the hospital did not meet the requirements for Condition of Participation, CFR (Code of Federal Regulations) 482.28 Food and Dietetic Services when the hospital failed to: 1. Ensure the Director of Food & Nutrition Service (DFNS) effectively directed and provided oversight related to safe food handling and sanitary environment within the foodservice operation, and ensure prompt elimination of harborage conditions that attract rodents to avoid potential transmission of infection when there was a known rodent problem in the kitchen. (Cross Refer A-0620, A-0622) 2. Ensure integration of the food and dietetic service into the hospital-wide QAPI (Quality Assessment and Performance Improvement) and Infection Control program related to on-going rodent problem in the kitchen that had not been reported to the Infection Program Manager (IPM) nor to the Quality Committee responsible for organizational performance improvement for a multidisciplinary approach to promptly put in place effective measures to eliminate rodents presence within the foodservice operation, and provide awareness of the situation to medical staff responsible for care of the patients, as rodents are capable of transmitting disease to humans by contaminating food and food-contact surfaces. (Cross Refer A-0618, A-0620) 3. Ensure aspects of nutritional care were incorporated into the hospital’s structure for provision of nutrition care services to patients in accordance with standards of practice related to: a. Implement a system to order Registered Dietitian (RD) consults to provide Medical Nutrition Therapy (MNT) for patients with food allergies for one of five sampled patients (Patient 26). This failure placed patients at an increased risk of experiencing allergic symptoms ranging from mild to life-threatening. (Cross Refer A-0621) b. Ensure RD’s offered or provided therapeutic diet education to patients, patients families or caregivers to meet patient’s individualized nutritional needs in accordance with the hospital’s RD job description and standards of practice for one of five sampled patients (Patient 27). This failure had the potential to not fully utilize RD’s skill sets and expertise for therapeutic diet counseling which could impede a patient’s ability to minimize risks imposed by disease and/or comorbidities, decrease a patient’s quality of life and prevent a method toward reducing rates of re-admission of hospitalization. (Cross Refer A-0621) c. Effectively monitor of an oral nutrition supplement (ONS) when there lacked documentation of quantity consumed of ONS and failed to develop, update and/or revise an individualized nutrition plan of care with alternative nutrition approaches when two of five sampled patients (Patient 26, Patient 21) nutritional needs were not met. (Cross Refer A-0629) d. Ensure a RD provided nutrition recommendations to one of five sampled patients (Patient 26) physician regarding a discrepancy between Patient 26’s renal diet order in comparison with Patient 26’s individual assessed daily protein needs. This failure had the potential for Patient 26’s nutritional needs to not be met in accordance with standards of practice. (Cross Refer A-0629) e. Ensure the hospital’s overall system included RD’s to assess and evaluate therapeutic diets, such as consistent carbohydrate diet (for treatment of diabetes) that had multiple variations to select from, same for the variety of renal diets (for treatment of kidney disease), to determine whether nutrition recommendations to a patient’s physician were in order to ensure a patient’s individualized nutritional needs were met for two of five sampled patients (Patient 27, Patient 29). (Cross Refer A-0629) The cumulative effect of these systemic problems resulted in the inability of the hospital’s food and nutrition services to ensure the needs of the patients was met as required by the mandated Condition of Participation for Food and Dietetic Services. This had the potential to affect the hospital census of 494 highly susceptible patients. According to the FDA (Food and Drug Administration) Food Code 2022, “A “Highly susceptible population” means persons who are more likely than other people in the general population to experience foodborne disease because they are: (1) Immunocompromised; ... or older adults; and (2) Obtaining food at a facility that provides services such as...health care...hospital.””

“EMERGENCY SERVICES CFR(s): 482.55 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 35649 The hospital failed to meet the regulatory compliance §482.55 Condition of Participation Emergency Services as evidenced by: 1. Ensure the Emergency Department Registered Nurse (EDRN) 1 and MRI technologist (MRIT), activated emergency response system or initiated cardiopulmonary resuscitation for one of one patient (Patient 1) exhibiting a life threatening event during a Magnetic Resonance Imaging (MRI- [a type of scan that uses strong magnetic fields and radio waves to produce detailed images of the inside of the body]) procedure. This failure resulted in the delay of treatment in the management of a life-threatening condition. (Refer to A1112). 2. Ensure EDRN 1 documented nursing assessment, placed one of one sampled patient (Patient 1) suffering from a life-threatening condition on the cardiac (heart) monitor, vital signs (includes temperature, heart rate, respiratory rate, blood pressure) machine, and pulse oximetry (measures oxygenation in one’s blood), and continued to monitor care upon return to the ED from Radiology Department (RD). This failure decreased the patient’s chances of survival. favorable outcome, and had the potential to contribute to Patient 1’s death. (Refer to A1112).”

“CONSULTATION WITH MEDICAL STAFF CFR(s): 482.12(a)(10) [The governing body must:] §482.12(a)(10) Consult directly with the individual assigned the responsibility for the organization and conduct of the hospital’s medical staff, or his or her designee. At a minimum, this direct consultation must occur periodically throughout the fiscal or calendar year and include discussion of matters related to the quality of medical care provided to patients of the hospital. For a multi-hospital system using a single governing body, the single multi-hospital system governing body must consult directly with the individual responsible for the organized medical staff (or his or her designee) of each hospital within its system in addition to the other requirements of this paragraph (a). This Standard is not met as evidenced by: 35649 Based on interview and record review, the governing body failed to provide quality oversight responsibility to safeguard one of one sampled patient (Patient 2) with history of kidney transplant (replacing a diseased kidney or injured kidney with a healthy kidney from a donor) from complications resulting from injection of intravenous (IV-within the vein) contrast (iodine-based material injected into a vein to enhance x-ray and CT images) when the Nephrologist (MD 1- medical doctor who specializes in kidney care and treating diseases of the kidneys) was not consulted for medical care. This failure resulted in Patient 2’s MD 1 to not be informed of the plan to send Patient 2 for Computerized Tomography Scan (CT scan-diagnostic imaging procedure that uses a combination of X-rays and computer technology to produce images of the inside of the body) with IV Contrast of the chest, abdomen, and pelvis and resulted in a serious kidney complication of contrast-induced nephropathy (CIN- one of the major causes of hospital-acquired acute kidney injury [AKI], which led to Patient 2 undergoing Hemodialysis (a life-saving treatment for kidney failure that removes waste and extra fluids from the blood using a dialyzer [artificial kidney] when the kidneys can no longer work adequately). Findings: During a review of Patient 2’s “History & Physical (H&P) on 2/25/25 at 9:23 a.m. with Registered Nurse Clinical Informaticist (RNCI) and Patient Safety Manager (PSM), Patient 2’s “History & Physical (H&P),” dated 12/8/24, was reviewed. The H&P indicated, “Patient 2 was brought to the Emergency Department with complaints of pain to the right ribs and pelvis after a slip and fall at 4 a.m. Patient 2 has a history of kidney transplant in 2017 and no longer on dialysis. Patient 2 has diabetes mellitus (condition of high blood sugar) and a history of deep vein thrombosis (blood clot formation) of upper extremity in May 2024, for which she takes Eliquis, an anticoagulant (blood thinner). During a review of Patient 2’s “Emergency Documentation-ED Note Physician (ENP),” dated 12/8/24, the ENP indicated, “Primary survey indicated intact airway with bilateral breath sounds. Secondary survey indicated there was no obvious trauma to head. Chest was stable. No obvious signs of trauma along the right wall and no palpable deformities. No acute injuries noted. The CT of the chest, abdomen and pelvis with IV contrast indicated negative findings except for minimally non-displaced right rib fractures involving the 5th to the 10th ribs. During an interview on 2/26/25 at 8 p.m. with MD 1, MD 1 stated, “Nobody called me to notify me about my patient having a full body scan with IV contrast. I was notified five days later. I did not appreciate that, and I was not happy. Why did this patient have to get IV contrast with kidney transplant? They (the Resident and the attending physician) need to call me. Was the patient presented to the attending by the Resident? We do not treat by protocol medicine (a set of instructions which describe a process to be followed). I don’t think that is safe. I protested that decision. My patient [Patient 2] became anuric (no urine output). She had fluid overload. She became short of breath. Once she became anuric, no urine output, that became a good indication hemodialysis was necessary. The attending physician or the resident physician could have called me, and we could have developed a plan of care for the patient.” During a review of Patient 2’s “Intake and Output Record (IOR),” dated 12/8/24 to 12/16/24, the IOR indicated the following: 12/8/24 to 12/9/24: Urine voided: 800 ml 12/9/24 to 12/10/24: Urine voided:0 (zero) 12/10/24 to 12/11/24: Urine voided: 0 12/11/24 to 12/12/24: Urine voided: 450 ml 12/12/24 to 12/13/24: Urine Voided: 9 ml 12/13/24 to 12/14/24: Urine Voided: 0 12/14/24 to 12/15/24: Urine Voided: 0 12/15/24 to 12/16/24: Urine Voided: 0 12/16/24 to 12/17/24: Urine Voided: 0 During a review of Patient 2’s “Serum Creatinine Level (SCrL determines normal kidney function. The normal range of SCrL for female adult is 0.6 milligram per deciliter (mg/dl) to 1.1 mg/dl.” SCrL dated 12/8/24 to 12/21/24 were reviewed. The SCrL indicated the following: 12/8/24: 1.74 mg/dl 12/10/24: 1.8 mg/dl 12/11/24: 2.28 mg/dl 12/12/24: 2.68 mg/dl 12/13/24: 3.69 mg/dl 12/14/24: 3.02 mg/dl 12/15/24: 3.08 mg/dl 12/16/24: 3.11 mg/dl 12/17/24: 2.3 mg/dl 12/18/24: 3.51 mg/dl 12/19/24: 3.02 mg/dl 12/20/24: 3.98 mg/dl 12/21/24: 4.6 mg/dl During an interview on 2/27/25 at 10:27 a.m. with Surgery Program Director,also the Vice Chair of Surgery Services, SPD stated if a Resident Physician (RP) is assigned to see a patient, it is expected the supervising physician also sees the patient and depending upon the level of supervision of the resident physician. SPD stated RP’s judgment has limitations and so the RP must escalate the patient evaluation to the attending and make decisions together regarding the care of the patient. SPD stated if a patient with a history of kidney transplant is given an IV contrast, there is a potential to kill the kidney. SPD stated the patient should be hydrated prior to IV contrast injection and physicians should take extra precautions to prevent life-long dialysis. During a concurrent interview and record review on 2/27/25 at 1:50 p.m. with RP 1, Patient 2’s “Surgery Consultation Note, (SCN),” dated 12/8/24, was reviewed. The SCN indicated “History of deceased donor renal transplant on immunosuppressant therapy (treatment that reduces its ability to fight infections and other diseases. Injuries: non-displaced fx (fracture-break in the bone) R (right) 5th to 10th ribs. Recommend medicine admission for management of complex medical management. ACTS (surgical services) will follow for management of rib fractures. RP 1 stated he assumed he presented the case to his attending physician. RP stated he sees the patient, makes assessment, and have a verbal conversation with the attending /supervising physician. RP 1 stated he did not notify [Patient 2]’s nephrologist after he spoke with Patient 2’s daughter. During a review of the hospital’s “Governing Bylaws,” dated 12/21/23, the Bylaws indicated, “A. Quality Performance Responsibilities: This Board has the final moral, legal, and regulatory responsibility for everything that goes on in the organization, including the quality services provided by all individuals who perform their duties in the organization’s facilities pr under the Board sponsorship: 1. Understand and accept responsibility for the actions of all physicians, nurses, and other individuals who perform their duties in the organizations’ facilities ...11. Monitor programs and services to ensure they comply with policies and standards relating to quality.” During a review of the hospital’s “Medical Staff Rules and Regulations (MSRR),” dated 7/24/24, the MSRR indicated, “2.2 Responsibilities of Attending Physician: (a) the attending physician will be responsible for the following while in the District: (1) the medical care and treatment of the patient while in the District, including appropriate communication among the individuals involved in patient care (including personal communication with other physicians where possible. 5.1 Requesting Consultation: (a) The attending physician shall be responsible for requesting a consultation when indicated for contacting a qualified consultant. (b) Requests for consultation shall be entered in the patient’s medical record. In addition to documenting the reasons for the consultation request in the medical record, the attending practitioner will make reasonable attempts to personally contact the consulting practitioner to discuss the consultation request.””

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the facility failed to ensure: 1. The Director of Food & Nutrition Services and Food Service Manager followed the hospital’s “Quality Improvement Plan” when an on-going rodent problem in the kitchen was not reported to QAPI (Quality Assessment and Performance Improvement) program, nor Infection Prevention Manager (IPM), per the hospital’s “Quality Improvement Plan” to institute a PI project for prompt resolution of the rodent problem that was high risk, high volume and problem prone. (Cross Refer A-0620) 2. There was data collected to evaluate and review the hospital’s established time frames for Registered Dietitian (RD) follow-up for high nutrition risk patient’s to ensure provision of dietetic services to improve, and/or prevent or minimize nutritional decline, in a timely manner for one of five sampled patients (Patient 26), that had potential to affect other in- patients and/or future patients. (Cross Refer A-0629) 3. The hospital’s QAPI had not identified and ensured the RD’s assessed and evaluated the special therapeutic dietary needs of those patients requiring a therapeutic diet (ordered as part of a patient’s treatment for a disease or clinical condition) to determine if nutrition recommendations to a patient’s physician were in order pertaining to individualized nutrition needs for two of five sampled patients (Patient 27, Patient 29), that had potential to affect other in-patients and/or future patients. In addition, RD’s were not offering and providing therapeutic diet education to patients, patient’s families/caregivers in accordance with hospital’s RD job description and standards of practice for quality of care. (Cross Refer A-0629, A-0621) These failures had a potential for transmission of infection to patients, staff, and visitors and a decline in patient’s nutritional and medical status. Findings: 1. During an interview on 3/3/25 at 11:50 a.m. with Food Service Manager (FSM) and Director of Food & Nutrition Services (DFNS), FSM stated she had not reported the rodent problem in the kitchen and retail kitchen to anyone other than DFNS, Facilities staff, and EVS (environmental services/housekeeping). DFNS stated he had not reported the rodent problem in the kitchen and retail kitchen to the hospital-wide infection control program committee/IPM or to QAPI/Quality Committee (QComm). During an interview on 3/3/25 at 2:45 p.m. with Director of Quality & Patient Safety (DQPS), DQPS stated she was a part of the Quality Committee that had responsibility for oversight of organizational performance improvement. DQPS stated absolutely IPM and QComm should have been informed about rodents in the kitchen and we (both IPM and QComm) were not aware of that. DQPS stated rodents in the kitchen certainly qualified for a high risk, high volume, and problem prone performance improvement (PI) project. DQPS stated QComm could have ensured appropriate measures were in place for prompt resolution of the rodent problem. During a review of the facility’s P&P titled, “Quality Improvement Plan (QIP),” dated 1/26/22, the “QIP” indicated, “The Quality Council requires the. . .organization’s staff to implement and report on the activities for identifying and evaluating opportunities to improve patient care and services throughout the organization.” 2. During a review of Patient 26’s “Nutrition Note (NN)”, dated 2/2/25, the “NN” indicated, “Nutrition Risk Level: High (2/2/25), Assessment: RD consult for low Braden score (a tool used to assess a patient’s risk for developing pressure injury to the skin). Pt [patient] admitted for management of TB [Tuberculosis; a contagious bacterial infection that primarily affects the lungs]. Pt currently on Diabetic diet, eating limited amount. . .Pt had physical assessment completed previously given low bodyweight, though no malnutrition found. Pt previously reported early satiety (feeling of fullness), may benefit from snacks, supplements (products to provide additional calories and/or protein). Pt not fully meeting nutrition needs at this time. Nutrition Diagnosis: Inadequate nutrient intake. . .Nutrition Recommendations: Current order for Diabetic diet - BG [blood sugar] well controlled. Monitor phosphorous [a mineral]/potassium [an electrolyte] for possible Renal [kidney disease] diet restriction as needed. Trial Nepro [oral liquid supplement to add nutrients designed for kidney disease] 1/ [per] day and snacks 1/day - Proposed to MD. Continue renal multivitamin.” During a concurrent interview and record review on 2/28/25 at 12:00 p.m. with Clinical Nutrition Services Manager (CNSM), and DFNS, Patient 26’s “Orders,” dated 2/2/25 was reviewed. The order indicated, “Order: RDN [Registered Dietitian Nutritionist] F/U [follow up] Assessment, End-state Date/Time: 2/7/25 16:12 PST [Pacific Standard Time], entered and electronically signed by: [name of RD 1].” CNSM stated RD 1 assessed Patient 26 at nutritional high risk and not meeting nutrient needs, recommended nutrition interventions, and documented the RD follow up would occur five days later on 2/7/25. CNSM stated the hospital’s policy and procedure allowed patients identified as high nutrition risk to have a follow up RD evaluation up to five days later. CNSM stated, “I thought we just had to follow our policy.” During a concurrent interview and record review on 2/28/25 at 12:05 p.m. with CNSM and DFNS, CNSM was asked if the hospital’s system of allowing up to five days for an RD to follow up on a patient assessed as high risk for nutrition deficits had been meeting patient’s nutritional needs in a timely manner. CNSM and DFNS stated the hospital’s average length of patient hospital stay was 4.5 days. CNSM stated she had not collected data to track and analyze whether the RD follow up time frame up to five days for a high risk nutrition patient was meeting patient’s individualized nutritional needs, in a timely manner. CNSM stated she used ASPEN (American Society for Parenteral and Enteral Nutrition) and/or NCM (Academy of Nutrition & Dietetics [AND] Nutrition Care Manual[NCM]) as sources for nutrition care standards of practice to guide development of the hospital’s policies and procedures related to nutrition care of patients. During a review of the Hospital’s policy and procedure (P&P) titled, “Diet Manual and Approval Acute Care,” dated 7/22/24, the P&P indicated, “The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM) is the standard guide and reference for nutrition care.” During a review of ASPEN’s standards of care guidance titled “ASPEN Adult Nutrition Care Pathway (Age 18+ years) (ANCP)”, dated 9/14/22, the “ANCP” indicated once inadequate nutrient intake had been identified “Monitoring & Evaluation: Follow-up within 3 days, monitor parameters; tolerance of nutrient intake, oral intake including supplements, vitamins, minerals, anthropometric data (weight trends), functional status.” During a review of the facility’s P&P titled, “Adult and Pediatric Assessment (APA),” dated 6/12/24, the “APA” indicated, “Nutrition screening identifies patients who may have a nutrition diagnosis and may benefit from nutrition assessment and intervention by a Registered Dietitian. . .The Registered Dietitian will screen each patient for whom a notification is received. A comprehensive nutritional assessment will be completed if the patient is screened at moderate or high nutritional risk. If a patient is assessed at low risk, the screen and risk identification is documented. .Adult Nutritional Screening criteria; constipation, diarrhea, eating disorder, enteral [tube] feedings, loss of appetite/poor intake, lactation, nausea, skin breakdown or pressure injury, TPN [total parenteral nutrition; nutrition through a large vein], unplanned weight loss, vomiting, tube feeding [nutrition through a tube], stroke, length of stay of (5th day of hospital stay RD will receive a consult, and patient would be seen between the 5th and 7th day of hospital stay for a nutrition screen by RD per CNSM), BMI [body mass index; a tool to assess underweight, normal weight, overweight, obesity] <19 [underweight], Pressure injury stage II [partial-thickness skin loss] or higher, dysphagia [difficulty swallowing] alert, via malnutrition tracker via a software, and NPO [not eating or drinking through the mouth] x [for] 3 days.” 3a. During a concurrent interview and record review on 2/28/25 at 10:24 a.m. with CNSM and DFNS, Patient 27’s “Admission History Adult (AHA),” dated 2/26/25 was reviewed. The AHA indicated and CNSM stated the “AHA” included admission nutrition screening questions completed by nursing in which Patient 27 was determined not to meet facility’s criteria for nutrition risk that would have triggered an RD consult for further nutrition screening by an RD During an interview on 2/28/25 at 10:36 a.m. with CNSM, CNSM stated Patient 27’s therapeutic diet order was diabetic CC 60 g [consistent carbohydrate dispersed evenly over three meals with limit of a total of 60 grams of carbohydrate per day] and low potassium. CNSM stated the diabetic diet orders available to the physician’s to select from a drop down menu in the electronic health record (EHR) were 45 g CC [limit of 45 grams of consistent carbohydrate], 60 g CC or 75 g CC that corresponded with different total daily calories provided depending on the amount of CC ordered. In addition, CNSM stated the hospital had various renal diets as a drop down menu physicians selected from as follows: “Renal with an 80 g pro [protein]/d”, “High Protein Renal with 100 g pro/d”, “Low Protein- 60 g pro/d 2 gm [gram] Sodium [limit of salt intake]”, and a “Low Protein Renal- 60 g pro/d.” CNSM stated within the hospital’s nutrition care structure, if the hospital’s nutrition screening did not drive an RD to conduct a nutrition assessment for a patient, the hospital RD’s would not perform nutrition assessments for those patients that had specialized therapeutic dietary needs, simply due to a therapeutic diet in and of itself, to evaluate if the diet order was aligned with the patient’s daily calorie and protein needs, or if not, to provide nutrition recommendations to the physician regarding a patient’s therapeutic diet. 3b. During a concurrent interview and record review on 2/28/25 at 3:26 p.m. with CNSM, Patient 29’s “Inpatient” form, undated was reviewed. The Inpatient form indicated Patient 29 was 59 years old. Patient 29’s “Admission History Adult (AHA),” dated 2/21/25 was reviewed. The AHA indicated and CNSM stated the “AHA” included admission nutrition screening questions completed by nursing in which Patient 29 was determined not to have any of the facility’s criteria for nutrition risk to trigger an RD consult for RD to conduct further nutrition screening and/or complete a nutrition assessment. The “AHA” included a notation of “Home Diet: Diabetic, Renal.” During a review of Patient 29’s “Progress Note (PN),” dated 2/27/25, completed by RD 4, the “PN” indicated, “Nutrition Screen: Consult received as part of length of stay, pt meets criteria for low acuity (condition with low probability of progression); admitted with PD catheter (PD; Peritoneal [thin tissue that lines the abdominal cavity] dialysis [a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly] catheter dysfunction [malfunction of the tube used to access patient’s blood for dialysis], provided a renal, diabetic diet-po intake average of 72% [percent] x 9 meals, no trouble chewing or swallowing, BMI [body mass index] 27.2, skin intact, Braden score 20. Will monitor per policy, RD available sooner, prn [as needed].” During an interview on 2/28/25 at 3:30 p.m. with CNSM, CNSM stated within the hospital’s system RD’s were not required to perform a nutrition assessment for chronic diseases with comorbidities (a disease or medical condition that is simultaneously present with another) that required specialized dietary needs with a therapeutic renal, diabetic diet. CNSM stated it would require Patient 29 to have an RD complete a nutrition assessment to determine Patient 29’s daily calorie and protein needs in order to evaluate whether Patient 29 was prescribed the correct grams of carbohydrate diabetic diet and correct grams of protein renal diet to meet Patient 29’s individual nutritional needs. However, Patient 29 was screened by RD 4 to be low acuity after six days in the hospital with comorbidities of renal disease and diabetes and was assessed as continuing to be at low nutrition risk, per hospital P&P titled “Adult and Pediatric Assessment (APA)”, dated 6/12/24, the “APA” indicated “Low Risk. . .follow-up completed within 10 days.” CNSM stated RD 4 did not document an RD follow up date for monitoring as the hospital had established screening criteria during the hospital stay in which nursing screens for low appetite/poor po intake would trigger an RD consult, if that occurred. During an interview on 2/28/25 at 3:45 p.m. with CNSM, CNSM stated Patient 29 had not seen an RD since admission as she was assessed to be low nutrition risk, the RD’s do not evaluate whether the ordered therapeutic diet meets Patient 29’s specialized dietary needs due to comorbidities of diabetes and renal disease, and the hospital’s RD’s do not offer and conduct therapeutic diet education to in-patient’s, patient’s families or caregivers, nor do the RD’s review, update or revise interdisciplinary plans of care related to any type of diet education or readiness for therapeutic diet education. During a review of NCM, dated 2025, NCM indicated, “Registered dietitian nutritionists (RDN) must also receive referrals for nutrition problems other than malnutrition, such as the following: Knowledge deficits; For example, education focused on modification of sodium and fluid intake, in order to mitigate heart failure symptoms and reduce readmission rates.” During a review of The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2025, the NCM indicated, “. . .education handouts in the Nutrition Care Manual® (NCM®) are not intended to substitute for nutrition counseling with a registered dietitian nutritionist (RDN). The information is meant to serve as a general guideline and may not meet the unique nutritional needs of individual clients or patients. All medical professionals should consult with a RDN before providing handouts to clients or patients.” During a review of the facility’s job description (JD) titled, “Registered Dietitian,” dated 4/6/2017, the JD indicated, “Job Responsibilities Essential: Performs assessment and screening for patients designated as a high risk for optimal nutrition. Develops nutritional treatment plans in coordination with the interdisciplinary team and in collaboration with the patients and families as able. Follows up such patients to evaluate progress towards goals. . .Provides nutrition information and recommendations to physicians regarding patient’s nutritional status in a timely manner. . .Performs or coordinates nutrition education for patients and/or patient’s caregivers, and chart’s appropriately to the medical record. Tailors nutrition education to the needs of the patient and their family (ex: medical needs, cultural preferences, patient readiness, etc). . .Continuously looks for ways to improve nutritional care to patients. Acts with others to monitor current levels of service, plan new or improved services, implement the plan, and reassess, educate, and make changes necessary for excellent care of patients.” During a review of the Hospital’s P&P titled, “Quality Improvement Plan (QIP),” dated 1/26/22, the “QIP” indicated, “Purpose: The purpose of [name of hospital] Quality Improvement Plan is to have an effective, data-driven Quality Assessment Performance Improvement program that delivers high-quality, excellent clinical services and enhances patient safety.” During a review of the Hospital’s job description (JD) titled “Clinical Nutrition Manager,” dated 6/23/2020, the JD indicated, “In coordination with the Food and Nutrition Services Director establishes, enforces, and evaluates levels of productivity and performance standards for areas under the supervision of this position. This includes standards on recommendations for diet orders, documentation in the medical record system, nutritional assessments, patient follow-up and patient/family education and counseling. Identifies, reviews, and evaluates nutrition services through quality assurance and monitoring techniques to improve quality of care.” During a review of the Hospital’s job description (JD) titled “Director of Food & Nutrition Services,” dated 6/18/21, the JD indicated, “Provides oversight of the clinical nutrition program. Provides guidance and direction to the Clinical Nutrition Manager. . .Improve the Quality of Their Services; Responsible for quality and performance improvement activities in their department(s) and as they may affect other areas of [name of hospital]. . .Identifies, reviews, reports, and maintains indicators of sound clinical, service, and high quality practice. . .Researches industry ‘best practices’ for possible implementation in department(s).””

“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: 46958 Based on interview and record review, the hospital failed to ensure the Registered Nurse (RN) 1 performed a nursing assessment for one of one sampled patient (Patient 3) follow a change in condition. This failure had the potential to result in delayed or inadequate care and had the potential to result in serious health consequences. Findings: During a concurrent interview and record review on 2/26/25 at 1:10 p.m. with Director of Trauma (DOT), Patient 3’s “Pain” dated 12/12/25 was reviewed. The “Pain” indicated, pain assessment completed on 12/12/24 at 3:36 a.m., Patient 3 complained of sudden chest pressure. Patient 3 reported a 10 out of 10 pain level which indicated worst pain possible on the numerical pain scale (a widely used tool to assess pain intensity. It consists of a 0-10 point scale, where: 0: No pain, 1-3: Mild pain, 4-6: Moderate pain, 7-9: Severe pain,10: Worst possible pain). DOT was unable to provide documentation RN 1 performed a focused assessment following Patient 3’s report of chest pressure. DOT stated RN 1 should have completed a focused assessment on Patient 3. During a concurrent interview and record review on 2/26/25 at 2:03 p.m. with RN 1, Patient 1’s “Patient 3’s “Pain” dated 12/12/25 was reviewed. RN 1 stated when a patient complain of chest pain or chest pressure, a registered nurse is expected to perform a focused assessment (detailed assessment of specific body systems or areas related to presenting problem or current concern). RN 1 stated he complete a focused assessment for Patient 3 following the new complaint of chest pressure. During a review of the facility’s policy and procedure (P&P) titled, “Assessment and Documentation, Nursing: Acute Patient Care,” dated 3/20/23, the P&P indicated, “Focused assessments (assessments focused on a specific body system or systems) are performed with changes in patient condition or as a follow up to any unusual findings from a previous assessment. . . Nursing documentation reflects communications, observations, decisions, actions and outcomes related to patient-centered care. . .To record nursing actions and individual responses as soon after they occur. . .Changes in condition and follow up actions/responses to symptoms or condition changes. . .Nursing documentation reflects assessment findings and depicts both clinically significant normal findings as well as abnormal findings per the clinician’s clinical judgment. . . Documentation includes the status of the identified problems until they are resolved in the medical record or become inactive.””

“QUALIFIED STAFF CFR(s): 482.26(c)(2) Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures. This Standard is not met as evidenced by: 35649 Based on interview and record review, the hospital failed to ensure the Magnetic Resonance Imaging Technician (MRIT) activated the emergency system for one of one patient (Patient 1) who deteriorated during the MRI (a type of scan that uses strong magnetic fields and radio waves to produce detailed images of the inside of the body) procedure. This failure resulted in the delay of emergency intervention provided Patient 1 during a life-threatening condition. Findings: During a concurrent interview and record review on 2/24/25 at 1:59 p.m. with Director of Radiology (DR) and Imaging Service Manager (ISM), Patient 1’s MRI scan, dated 1/12/25, was reviewed. DR stated Patient 1 had an order for MRI of the brain without contrast on 1/12/25 at 10:48 p.m. DR stated Patient 1’s MRI scan was started but was aborted on 1/13 25 at 1:42 a.m. due to Patient 1’s change in condition during the MRI procedure. DR reviewed the documentation of the MRI technician (MRIT) which indicated, “Attempted exam. Patient became unstable towards the end of the exam. Unable to finish. Patient’s condition deteriorated.” DR was unable to find documentation the Rapid Response Team [RRT-hospital team that responds to patients who are deteriorating or have an emergency] or a Code Blue [designation for someone experiencing a life threatening medical emergency in need of immediate resuscitation to preserve life]) was called in MRI. ISM stated the staff had been educated and trained to call RRT or Code Blue when an emergency arise in MRI. ISM stated MRITs were trained to “Call RRT Alert Ext 44, Give Room Number, Call Primary Care Physician.” During an interview on 2/24/25 at 6:54 p.m. with MRIT, MRIT stated the emergency department registered nurse (EDRN 1), who was monitoring Patient 1 during the MRI scan, stated the scan needed to be stopped. MRIT stated EDRN 1 went inside the MRI room to check on the patient. MRIT stated the nurse informed him the patient did not look good and that the procedure could not be continued. MRIT stated EDRN 1 stated the patient needed to be taken back to the ED. MRIT stated there was no cardiopulmonary resuscitation performed on Patient 1 in MRI room. MRIT stated he did not call RRT or a Code Blue because EDRN 1 was in the room, and she took control of the situation. During a review of the facility’s policy and procedure (P&P) titled, “Rapid Response Team,” dated 11/22/24, the P&P indicated, “The system is designed to recognize at-risk adult and adolescent (age 14-17) non-critical care patients earlier in their course of deterioration and to rapidly mobilize appropriate institutional resources including but not limited to the Primary Care Practitioner and RRT. . . PROCEDURE: 1. RRT Activation and 10 SOV [signs of vitality] Assessment. . . D. Activation of the RRT alert and notification of the managing practitioner will occur simultaneously 1. If 2 or more of the weighted 10 SOV criteria are present and or any patient the staff is seriously concerned about. . . Call RRT Alert Ext 44, Give Room Number, Call Primary Care Physician.” During a review of the hospital’s P&P titled, “Code Blue,” dated 9/28/22, the P&P indicated, “ Procedure: I. First Responder A. Any district staff member witnessing an individual who is experiencing cardiac and/or respiratory arrest will immediately call for help either verbally and/or by dialing “44” within the main campus or “9-911” in satellite areas using any in-house telephone. The operator will page the code team.””

“RECORDS FOR RADIOLOGIC SERVICES CFR(s): 482.26(d), (d)(1), (d)(2) Records of radiologic services must be maintained. (1) - The radiologist or other practitioner who performs radiology services must sign reports of his or her interpretations. (2) - The hospital must maintain the following for at least 5 years: (i) Copies of reports and printouts. (ii) Films, scans, and other image records, as appropriate. This Standard is not met as evidenced by: 35649 Based on interview and record review, the hospital failed to document and keep a record of the MRI Screening Form for one of one sampled patient (Patient 1) who had an MRI of the Brain without contrast. This failure had the potential to result in adverse consequences from not having accurate information for Patient 1, which could negatively affect safe patient care. Findings: During an interview on 2/24/25 at 3:06 p.m. with Imaging Service Manager (ISM), ISM stated she was unable to find the final review of the MRI Screening by the MRI Technologist (MRIT). ISM stated the MRIT should review the MRI screening before the study. During an interview on 2/24/25 at 7:15 p.m. with MRIT, MRIT stated when an order for an MRI is received, an MRI screening form is filled out, first by the nurse obtaining information from the patient’s family. MRIT stated he reviewed [Patient 1]’s screening form, but he did not sign it. MRIT stated he normally completes the form once the MRI study is finished; unfortunately, the scan was stopped almost at the end of the procedure because the patient deteriorated. MRIT stated our policy states we review the screening tool, talk to the patient, and sign the form before the scan is started. MRIT stated if the scan was not completed, as in this case, the form does not get sent over to PACS (picture archiving and communication system. It stores, uploads, and transfers images to a secure network database). MRIT stated the MRI Screening was not completed and uploaded onto the PACS system; therefore, there was no record the MRI screening was done. During a review of the hospital’s policy and procedure titled, “MRI Patient Screening,” dated 6/11/24, the P&P indicated, “Policy: To assure patient safety, all patients will be screened twice prior to Magnetic Resonance Imaging (MRI). Procedure: B. The licensed MRI technologist will not start the MRI exam until the screening form is completed, reviewed, and the required signatures are obtained ...K. The licensed MRI technologist will perform a second review of the screening form with the patient as condition allows or a licensed nurse before the patient is taken into the MRI suite ...N. The screening form will be signed by a licensed MRI technologist and scanned into picture archiving communication system (PACS).””

“DIRECTOR OF DIETARY SERVICES CFR(s): 482.28(a)(1) The hospital must have a full-time employee who- (i) Serves as director of the food and dietetic services; (ii) Is responsible for daily management of the dietary services; and (iii) Is qualified by experience or training. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the hospital failed to ensure the Director of Food & Nutrition Service Director (DFNS) provided effective daily oversight related to the management of the foodservice operation, develop and implement policies and procedures to maintain safe food handling and a sanitary environment within the kitchen to avoid sources and potential transmission of infection when: 1. There was excessive moisture and condensation located in the dishmachine room due to a vent hood in disrepair where clean dishes were stored on drying racks. This failure had the potential for contaminating food equipment and the surrounding environment as excessive condensation could drip onto food equipment and create an environment to promote mold growth, and attract pests, such as rodents that could carry disease. 2. There were unsanitary conditions in the kitchen related to extensive build up of debris and grime along the baseboards, floors, walls, drains and lacked an air gap for a hose adjacent to a reach-in refrigerator, and did not repair holes in the wall promptly, especially with a known rodent problem in the kitchen. 3. Uncooked rice was not stored in a sanitary manner when the dry rice was located in an ingredient bin with extensive black colored scratches and was in disrepair. 4. Cold food was not maintained at 41 degrees F (Fahrenheit) or less while holding during the lunch trayline meal service. Failure to ensure cold food was not held within the temperature danger zone (42 degrees F to 134 degrees F) impeded the tracking of time to ensure the cold food was not in the danger zone for four or more hours, to include transportation, distribution, and potential for delay of consumption of food by patient at bedside, that could result in foodborne illness. 5. The dry food storage room had an open crevice in the wall, and extensive food debris underneath the shelving and milk crates with sugar granules on top of a food storage lid in which the lid contained a thick yellow colored substance. 6. The foodservice operation in the main kitchen had a known rodent problem for at least ten months during which time harborage conditions and unsanitary conditions remained. 7. The DFNS failed to report the extensive, on-going rodent problem to the hospital-wide infection control program and to the hospital-wide QAPI (Quality Assessment and Performance Improvement) program for a multidisciplinary approach and strategic planning to take effective measures to eliminate the rodents that are vectors of disease-causing microorganisms which may be transmitted to patient, staff or visitors by contamination of food and food-contact surfaces. These failures had the potential for growth of microorganisms and cross contamination which placed the patients at an increased risk for foodborne illness, and potential for rodent related infections in patients, staff and visitors. Findings: 1. During a concurrent observation and interview on 2/27/25 at 10:32 a.m. with DFNS and Director of Facilities Planning (DF) in the kitchen, there was an excessive amount of steam and condensation filling the large dishmachine room while the dishmachine was in use. Large drying racks stored clean dishes in the dishmachine room during the presence of excessive steam and condensation. DF stated the dishmachine was installed by an outside vendor per the dishmachine rental agreement about a year ago. DF stated although the dishmachine was newer the vent hood attached to the dishmachine was not. DF stated he observed the steam escaping form underneath the vent hood and filling the dishmachine room with excessive steam and condensation which was indicative of a improperly sized vent hood for that particular dishmachine. DF stated the improperly sized dishmachine vent hood caused the excessive steam and heat creating an unsafe and unsanitary environment as the moisture/condensation had the potential to support mold growth, attract rodents, and caused an uncomfortable work environment for staff. During a concurrent interview and record review on 2/27/25 at 2:41 p.m. with DFNS, DFNS stated the excessive moisture and condensation from the dishmachine was reported via a work order “a while ago.” During a review of “Work Order (WO),” dated 5/23/24, the “WO” indicated, “Problem: Please see if the vent hood in the kitchen dish room is operational. It is very hot. Can we put in a small swamp cooler? Building: Main campus, Location: Kitchen, Action: Repair - Completed.” During a concurrent interview and record review on 2/27/25 at 4:30 p.m. with DF, DF reviewed the “WO”, dated 5/23/24, DFP stated the repair was ineffective as the condition still exists. During a review of the Food and Drug Administration Food Code (FDAFC), dated 2022, the “FDAFC” indicated, “Exhaust ventilation hood systems in warewashing areas including components such as hoods, fans, guards, and ducting shall be designed to prevent. . .condensation from draining or dripping onto equipment.” During a review of the FDAFC Annex (FDAFCA), dated 2022, the FDAFCA indicated, “If a ventilation system is inadequate. . .condensate may build up on the floors, walls and ceilings of the food establishment, causing an unsanitary condition and possible deterioration of the surfaces of walls and ceilings. The accumulation of. . .condensate may contaminate. . .food-contact surfaces.” 2. During a concurrent observation and interview on 2/27/25 at 11:00 a.m. with DFNS and Director of DF in the kitchen, to the far back wall and right outside of the dish machine room, there was a large white fiber reinforced plastic (FRP) hanging up isolating an area behind the FRP from the rest of the kitchen. DFNS stated there used to be an old wooden type cabinet with a food contact surface counter top that was removed due to not able to clean it effectively and could harbor rodents. DF stated when the old cabinet was removed it accidentally caused part of the wall to come along with it leaving a hole in the wall which could be a harborage source for rodents. DF stated he placed the FRP to prevent entry of rodents into the food preparation area of the kitchen. DF stated he was still meeting with leadership to formulate a plan on how extensive of a project they want to do with that space, therefore, no notification to regulatory agencies had occurred yet. During a review of FDA Food Code (FDAFC), dated 2022, the FDAFC indicated, “Physical facilities shall be maintained in good repair.” During a concurrent observation and interview on 2/27/25 at 11:09 a.m. with DFNS and DF, in the kitchen, the rim of a floor sink drain was extensively covered with black and brown colored debris with brown and black round debris on the floor next to the rim of the floor sink drain that was adjacent to a reach-in refrigerator unit. There was a tube that was covered in black colored substance located directly on the bottom of the floor sink drain. DFNS stated the black colored substance was located on the outside of the tube. DFNS and DF stated the tube was not the waste water outlet for the reach-in refrigerator and they were unsure what the tube was for. DFP and DFNS verified the tube should not be located on the floor of the floor sink drain and had potential for cross-contamination from backflow should the drain back up. DFNS stated the drains, surrounding area of the floors and baseboards and lack of an air gap regarding the tube was unsanitary conditions in the kitchen. During a concurrent observation and interview on 2/27/25 at 11:14 a.m. with DFNS and DF, in the kitchen, the floors, baseboard and wall located behind, underneath and near the 3-compartment pot and pan sink had very thick build up of black grime in the corner of the wall along a raised baseboard, along the baseboard and up onto the wall. In addition, there was water dropping from a small gray colored hose in close proximity to a bottle of blue colored chemical at the 3-compartment pot and pan sink. The dripping water was pooling causing a small puddle of water on the floor. During a review of the FDA Food Code Annex (FDAA), dated 2022, FDAA indicated liquid wastes need to be quickly carried away to prevent pooling which could attract pests such as insects and rodents.” During a review of “FDA Food Code” (FDAFC), dated 2022, FDAFC indicated, “Non-food contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil residues.” During a review of “FDAFCA”, dated 2022, FDAFCA indicated, “The objective of cleaning focuses on the need to remove organic matter from food-contact surfaces so that sanitization can occur and to remove soil from nonfood contact surfaces so that pathogenic [capable of causing disease] microorganisms will not be allowed to accumulate and insects and rodents will not be attracted.” During a review of the facility’s “WO (Work Order),” dated 9/1/24 at 4:41 a.m., the “WO” indicated, “Pest removal from underneath pots and pans sink, repair completed 9/1/24 at 6:04 a.m.” During a review of the facility’s “WO,” dated 9/26/24 at 8:22 a.m., the WO indicated, “Mouse been caught on mouse trap needs to be picked up on the pots and pans station, repair completed on 9/26/24 at 9:20 a.m.” 3. During a concurrent observation and interview on 2/27/25 at 11:24 a.m. with DFNS and DF, in the kitchen, uncooked, white rice was stored directly in a food ingredient bin in which the inside of the bin had extensive black colored scratches and was in poor condition. DFNS stated the rice was not stored in a sanitary manner and that the ingredient bin needed to be replaced. DFNS stated the Food Services Manager (FSM) had not informed him about that. During a review of the facility’s policy and procedure (P&P) titled, “Chipped, Cracked, and Crazed China,” dated 5/21/24, the P&P indicated, “Policy: The use of cracked, crazed or damaged meal service equipment a safety hazard and is prohibited. . .Damaged items are immediately taken out of service. . .Procedure: Staff to notify management if/when replacement of equipment is needed.” 4. During a concurrent observation and interview on 2/27/25 at 12:15 p.m. with DFNS in the kitchen, lunch trayline meal service for patients was observed in which there were two reach-in refrigerators next to trayline with their doors propped opened. DFNS stated the lunch trayline service takes about two hours, sometimes more depending on the census (the number of in-patients). DFNS was asked if staff checked the cold food holding temperatures used for lunch meal service, and DFNS stated, yes, they do. DFNS was observed asking staff where the binder was for the trayline cold and hot holding temperatures, and staff replied that they only check the temperature of hot foods from the steamtable with a thermometer immediately prior to starting trayline, not the cold holding foods. During a concurrent observation and interview on 2/27/25 at 12:17 p.m. with DFNS in the kitchen, DFNS observed a food service worker (FSW)1 use a digital thermometer and inserted the thermometer into the middle of an eight ounce carton of milk obtained from one of the reach-in refrigerators used for trayline, and FSW 1 stated it’s 45. 1 degrees F (Fahrenheit). FSW 1 stated they were about 50% (percent) done plating patient lunches for meal service. During an interview on 2/27/25 at 12:25 p.m. with FSM, FSM stated they had not been checking the internal temperature of the cold foods being held for trayline meal service and the temperature should have been checked. During a review of the facility’s P&P titled, “Food Safety HACCP [Hazard Analysis of Critical Control Points],” dated 9/13/24, the P&P indicated, “Procedure: The HACCP monitoring system is in place throughout the food cycle including receiving, storage, production, holding, & serving process. Cold food must be maintained at 40 degrees F or below while holding and serving. Product temperature must be recorded on a specified log at 2 hour intervals during holding and serving. If a product is held and served for less than 2 hours, the product temperature must be recorded at the beginning and end of service. Cold food holding equipment (i.e., refrigerators, ice beds) must be kept clean, sanitized and in good working order (correctly calibrated).” 5. During a concurrent observation and interview on 2/27/25 at 3:10 p.m. with DFNS, FSM, and Dietary Stockroom Clerk (DSC) in the dry food storage room (DFSR) in the kitchen, DSC was using a mop on the floor toward the entrance of the dry food storage room. DSC stated he just finished cleaning the floors in the DFSR. During a review of the facility’s job description (JD) titled, “Dietary Stockroom Clerk”, dated 2/8/16, the “JD” indicated, “Maintains cleanliness of storage areas including the storeroom, walk-in coolers, and freezers.” During a concurrent observation and interview on 2/27/25 at 3:12 p.m. with DFNS and FSM in the DFSR, an opened crevice in the wall was observed that could allow entry of pests, with surrounding food debris on the floor. Upon further observation of the floor that was just cleaned by DSC, there was extensive food and food debris all along the baseboards and surface floor, and located under shelves and milk crates. During a concurrent observation and interview on 2/27/25 at 3:24 p.m. with DFNS in the DFSR, a food storage bin labeled “Granulated Sugar Prep 2/22/25; Must Use By 2/21/26” was observed to have an extensive amount of sugar granules on the top of the lid facing up with thick yellow colored substance along the corner of the lid. DFNS stated he did not know what the yellow colored substance was. DFNS stated the lid should have been washed and sanitized. In addition, there were multiple unused floor drains that had a cover to help prevent entry of pests into the kitchen. Surrounding the floor drains was a black colored substance and DFNS stated he thought that was some type of glue substance maintenance used to secure the drains flat so they could not be pushed up potentially by rodents, however, the thick amount of blackish colored glue could impede effective cleaning as it was not a smooth surface. During an interview on 2/27/25 at 3:29 p.m. with FSD, FSD stated he did not think it was necessary to remove the dry food stored in manufacturer packaging, such as plastic, and cardboard boxes and place into impermeable food grade containers with tight fitting lids despite knowing a there was a rodent problem in the kitchen for at least the past ten months. 6. During a review of the facility’s “WO (Work Order),” dated 8/7/24 at 5:24 a.m., the WO indicated, “Please reach out to [name of contracted pest control company]. We are in need of pest traps for the kitchen, vendor service 8/7/24 at 8:36 a.m.” During a review of the facility’s “WO (Work Order),” dated 8/14/24 at 5:55 a.m., the WO indicated, “Please reach out to [name of contracted pest control company]. We need our traps. . .in kitchen rest, vendor service 8/15/24 at 7:50 a.m.” During a review of the facility’s “kitchen (Work Order),” dated 8/23/24 at 2:26 p.m., the WO indicated, “Please remove dead rat from the trap in the utility closet. Repair completed 8/26/24 at 7:11 a.m.” During a review of the facility’s “WO (Work Order),” dated 9/1/24 at 4:41 a.m., the WO indicated, “Pest removal from underneath pots and pans sink, repair completed 9/1/24 at 6:04 a.m.” During a review of the facility’s “WO,” dated 9/26/24 at 8:22 a.m., the WO indicated, “Mouse been caught on mouse trap needs to be picked up on the pots and pans station, repair completed on 9/26/24 at 9:20 a.m.” During a review of the facility’s “WO (Work Order),” dated 10/08/24 at 7:31 a.m., the WO indicated, “There is a little mouse underneath trash cans in the main cafeteria, minor repair 10/8/24 at 12:51 p.m.” During a review of the facility’s “WO (Work Order),” dated 10/08/24 at 12:31 p.m., the WO indicated, “Can we get mouse traps put in underneath the trash cans, minor repair 10/08/24 at 3:48 p.m.” During a review of the facility’s “WO (Work Order),” dated 10/10/24 at 7:05 a.m., the WO indicated, “There is a mouse in the diet office. Repair completed 10/10/24 at 9:50 a.m.” During a review of the facility’s “WO (Work Order),” dated 10/21/24 at 4:32 p.m., the WO indicated, “Pest removal needed in cold food area, repair completed 10/22/24 at 3:02 p.m.” During a review of the facility’s “WO (Work Order),” dated 10/31/24 at 5:08 a.m., the WO indicated, “Please reach out to [name of contracted pest control company] to re-bait and reset traps, vendor service 10/31/24 at 8:21 a.m.” During a review of the facility’s “WO (Work Order),” dated 1/21/25 at 11:24 a.m., the WO indicated, “Multiple holes in walls, cracks in doors that need sealing to prevent pest entry.” During a review of the facility’s “WO (Work Order),” dated 1/23/25 at 3:15 p.m., the WO indicated, “Counter/cabinet and replace with our own worktables. Removed from service 2/12/25 at 11:49 a.m.” During a review of the facility’s “WO (Work Order),” dated 2/12/25 at 12:47 p.m., the WO indicated, “Rat underneath supplements need to be disposed of, minor repair 2/12/25 at 3:14 p.m.” During a review of the facility’s “WO (Work Order),” dated 2/17/25 at 8:12 a.m., the WO indicated, “Rat underneath sink in dish room. If we can get it removed, removed from service 2/17/25 at 1:13 p.m.” During a review of the facility’s “WO (Work Order),” dated 2/24/25 at 11:12 a.m., the WO indicated, “[Name of DFNS] is requesting a door seal on the walk in 1 [refrigerator] and outside double doors to prevent pest entry, incident evaluation 2/25/25 at 8:46 a.m.” During a review of the facility’s “WO,” dated 2/25/25 at 5:12 a.m., the WO indicated, “We have pests that are caught in traps if we can get them discarded, 2 in dish room and 1 in the cold food demo area, repair completed 2/25/25 at 7:46 a.m. During a review of the FDAFC, dated 2022, the FDAFC indicated, “The premises shall be maintained free of insects, rodents, and other pests. The presence of insects, rodents, and other pests shall be controlled to eliminate their presence on the premises by: (A) Routinely inspecting incoming shipments of food and supplies; (B) Routinely inspecting the premises for evidence of pests; (C) Using methods, if pests are found, such as trapping devices. . .and (D) Eliminating harborage conditions.” During a review of the FDAFC, dated 2022, the FDAFC indicated, “Insects and other pests are capable of transmitting disease to humans by contaminating food and food-contact surfaces. Effective measures must be taken to eliminate their presence in food establishments. . .dead or trapped. . .rodents, and other pests shall be removed from control devices and removed from the premises at a frequency that prevents their accumulation, decomposition, or the attraction of pests. . .dead rodents. . .must be removed promptly from the facilities to ensure clean and sanitary facilities and to preclude exacerbating the situation by allowing carcasses to attract other pests.” During an interview on 2/27/25 at 3:03 p.m. with FSM and DFNS, FSM stated facilities department manages the contracted pest control vendor. FSM stated the pest control vendor leaves a carbon copy of their report after each visit in her in-box which she reviews and then gives it to DFNS. During an interview on 3/3/25 at 11:50 a.m. with FSM and DFNS, FSM stated she had not reported the rodent problem in the kitchen and retail kitchen to anyone other than DFNS, facilities staff and EVS (environmental services/housekeeping). DFNS stated he had not reported the rodent problem in the kitchen and retail kitchen to the hospital-wide infection control program/committee/Infection Prevention Manager (IPM) or to the QAPI program/Quality Committee. During an interview on 3/3/25 at 2:45 p.m. with Director of Quality & Patient Safety (DQPS), DQPS stated she was a part of the Quality Committee (QComm) that had responsibility for oversight of organizational performance improvement. DQPS stated absolutely IPM and the Quality Committee (QComm) should have been informed about rodents in the kitchen and we (both IPM and QComm) were not aware of that. DQPS stated rodents in the kitchen certainly qualified for the criteria of high risk, high volume and problem prone for a performance improvement (PI) project. DQPS stated the QComm could have assisted DFNS by ensuring appropriate measures and allocation of resources were put in place to ensure resolution of the rodent problem. During a review of the facility’s P&P titled, “Quality Improvement Plan (QIP),” dated 1/26/22, the “QIP” indicated, “The Quality Council requires the. . .organization’s staff to implement and report on the activities for identifying and evaluating opportunities to improve patient care and services throughout the organization.” During an interview on 3/3/25 at 11:55 a.m. with a Cook (Cook 1), Cook 1 stated she started her shift on 3/3/25 at 4:45 a.m. Cook 1 stated when she arrived she turned on the foodservice equipment and then goes to the refrigerator and gets her cart to begin food preparation. Cook 1 stated she did not clean and sanitize when she arrived in the morning since that was done the night before. Cook 1 stated trayline (assembly to plate food) for breakfast meal service started at 6:00 a.m. During an interview on 3/3/25 at 12:01 p.m., with FSM and DFNS, FSM stated she had not modified the schedule for the a.m. opening cook position, or any other morning position, to provide extra time to clean and sanitize foodservice counter tops, and foodservice equipment including the steamtable used for breakfast trayline service, for example, during the known rodent problem in the kitchen that had been going on for at least ten months per FSM and DFNS. During an interview on 3/3/25 at 12:05 p.m. with DFNS, DFNS stated he was aware rodents were nocturnal and active at night and in the kitchen. DFNS stated he had not directed FSM to modify the morning crew’s schedule or tasks to accommodate cleaning and sanitizing of foodservice equipment in the mornings prior to food preparation, after being aware rodents are nocturnal and highly likely contaminating food contact surfaces during the night. DFNS stated when we see rodent droppings the staff sweep them up. During a review of Centers for Disease Control and Prevention (CDC) education material titled, “How to Clean Up After Rodents (CUR),” dated 4/8/24, the “CUR” document indicated, “Diseases are mainly spread to people from rodents when they [humans] breathe in contaminated air. Don’t vacuum or sweep rodent urine, droppings, or nesting materials. This can cause tiny droplets containing viruses to get into the air.” During a review of information (info.) provided by California Department of Public Health - Food and Drug Branch (CDPHFDB) titled “Vermin”, dated 5/7/24, the CDPHFDB info. indicated, “Diseases from rats and mice can spread to people directly through: handling of rodents, contact with rodent feces, urine, or saliva (such as through breathing in air or eating food that is contaminated with rodent waste), rodent bites, rodents can also spread disease indirectly by ticks, mites, lice, or fleas that can act as vectors to spread diseases between rodents and people. Foodborne illness and mouse-borne allergens are among the most common rodent-related human health hazards in urban environments.” During a review of the facility’s P&P titled, “Sanitation Program,” dated 9/13/24, the P&P indicated, “Policy: It is the policy of the Food and Nutrition Service Department to maintain a clean department through a comprehensive cleaning and sanitation program. The Food Service Director and/or designee monitors cleaning and sanitizing schedules and procedures. Equipment, walls, floors and storage areas are routinely cleaned with the appropriate cleaning and sanitizing solution.” During a review of the facility’s job description (JD) titled, “Food Service Manager,” dated 2/8/21, the “JD” indicated, “Oversees daily duties in the kitchen production: . . .Establishes and monitors cleaning schedule for proper sanitation, production and all food storage areas.” During a review of the facility’s job description (JD) titled, “Director of Food & Nutrition Services,” dated 6/18/21, the “JD” indicated, “Supervision of all production, food service and sanitation for patients, cafeteria and catering. . .Puts safety first, including speaking up respectfully when concerned or uncomfortable about a potential safety issue that is noticed or identified; steps in and works to correct this safety concern. Proactively address problems or defects; investigates, reports and corrects. Keep patients safe by preventing infections. . ., participates in meetings and carries out meeting responsibilities as assigned. . .Responsible for quality and performance improvement activities in their department(s) and as they may affect other areas of [name of hospital].”

“QUALIFIED DIETITIAN CFR(s): 482.28(a)(2) There must be a qualified dietitian, full-time, part-time, or on a consultant basis. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the facility failed to ensure nutritional aspects were implemented and supervised by a Registered Dietitian (RD) when: 1a. One of one sampled patient (Patient 26) with a latex allergy had potential for cross-reactivity (when an antibody reacts with a molecule that is similar to another molecule) with certain foods did not receive Medical Nutrition Therapy (MNT) in accordance with standards of practice. This failure had the potential for Patient 26’s latex allergy that may be associated with allergies to certain foods to go unrecognized and care plan needs unmet. 1b. The hospital’s system did not ensure RD’s provided MNT based on established standards of practice to patients, patient’s families or caretakers for those patients with food allergies. This failure placed patients at an increased risk of experiencing allergic symptoms ranging from mild to life-threatening. 2. RD 2 did not ensure dry weights were used for meaningful evaluation of weight changes for one of five sampled patients (Patient 26) who received hemodialysis (a medical procedure that filters waste products and excess fluid from the blood when the kidneys are unable to do so) three times a week, in accordance with nutrition assessment standards of practice. Clinical Nutrition Services Manager (CNSM) stated the pre dialysis weights and post dialysis weights were not available to the RD’s for patients receiving dialysis treatments. Failure to implement nutrition standards of care when assessing weight changes for patient’s receiving dialysis treatments could lead to unrecognized unplanned weight loss or weight gain with care plan needs not met. 3. A diet clerk interpreted a therapeutic low potassium diet order for one of five patient’s (Patient 27) without supervision from an RD to ensure the low potassium diet order was clarified with the physician to ensure Patient 27’s nutritional and safety needs were met. 4. The hospital’s structure did not ensure RDs provided individualized therapeutic diet education to patients and/or patient’s families or caregivers in accordance with the hospital’s RD job description for one of five sampled patient’s (Patient 27). Failure to fully utilize RDs skill sets and expertise for patient care could impede minimizing risks imposed by disease, comorbidities and/or not maximizing the impact of personalized patient therapeutic diet education in reducing rates of re-admission. Findings: 1a. During a concurrent interview and record review on 2/28/25 at 11:32 a.m. with CNSM and Director of Food and Nutrition Services (DFNS), Patient 26’s “Nutrition Note (NN),” dated 2/2/25 was reviewed. The NN indicated, “Allergies. . .Latex (Rash).” CNSM stated the NN was Patient 26’s admission nutrition assessment and the latex allergy listed was automatically populated from other areas of Patient 26’s electronic health record (EHR). CNSM stated the NN, dated 2/2/25, did not contain documentation by RD (Registered Dietitian) 1 addressing the latex allergy as it was listed as a drug allergy and did not have anything to do with nutritional care of Patient 26. DFNS stated latex allergy was listed as a drug allergy and FANS staff already used latex free gloves, otherwise the latex allergy did not have anything to do with food and nutrition services. During a review of Allergy & (and) Asthma Network on-line information titled, “Latex Allergy and Foods (LAF),” dated 2025, LAF indicated, “If you have a latex allergy, you can sometimes have reactions to certain fruits and vegetables. These reactions occur in 30-50% of people with latex allergy. Latex reactions to certain fruits and vegetables can happen because these foods share similarly structured proteins that the body mistakenly recognizes as latex. This, in turn, causes allergic reactions in latex-sensitive people. These allergic reactions can occur not only after eating these foods but also after touching or smelling them.” (https://allergyasthmanetwork.org/allergies/latex-allergy/latex-allergy-foods/) During a review of the facility’s policy and procedure (P&P) titled, “Adult and Pediatric Assessment,” dated 6/12/24, the P&P indicated, “Nutritional Assessment: To obtain, verify, and interpret data needed to identify nutrition-related problems, their causes, and significance. A Registered Dietitian (RD) conducts an in-depth assessment using comprehensive data, as well as interpretation of the data, to determine the presence and the degree of nutritional risk. Information on. . .food allergies will also be reviewed.” During a review of the facility’s P&P titled, “Diet Manual and Approval Acute Care,” dated 7/22/24, the P&P indicated, “Purpose: To provide a reference for nutrition care, which will be used as a guideline for diet related information. The facility specific diet manual outlines all regular and therapeutic diets available for patients in the facility. The Nutrition Care Manual is the standard guide and reference for nutrition assessment and care. Policy: The facility specific diet manual is updated at least annually and reflects the current meals and therapeutic diet options available for providers to order for their patients. The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM) is the standard guide and reference for nutrition care. The NCM is online and available to all healthcare providers at [name of hospital]. Procedure: The NCM is consistent with AND’s Evidence Analysis Library, AND’s position papers, and the Nutrition Care Process.” During a concurrent interview and record review on 2/28/25 at 11:38 a.m. with CNSM, the on-line NCM, dated 2025 was reviewed. The NCM indicated, “A nutrition consult should be ordered when a patient with latex allergy. . .is admitted to the hospital. Patients with latex allergy may need an allergen (a substance that causes an allergic reaction) free prescription.” CNSM stated RD 1 did not assess and evaluate nutritional aspects of care for Patient 26 latex allergy in accordance with standards of practice. 1b. During a concurrent interview and record review on 2/28/25 at 12:22 p.m. with CNSM, in the presence of DFNS, CNSM stated the hospital’s nutrition screening that should identify high risk nutrition patients who may benefit from a nutrition assessment and intervention by an RD did not capture patients with a food allergy. CNSM stated she used the NCM as established standards of care for guidance when developing the hospital’s diet manual. During a review of The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2025, the NCM indicated, “Food allergy: A nutrition consult should be ordered when a person with a food allergy is admitted to the hospital. Patients with food allergies must adhere to an allergen-free nutrition prescription, by avoiding their diagnosed allergens, during their entire hospital stay. A nutrition consult is indicated for all patients with food allergy to ensure the following: Successful elimination of the allergen, ensure adequate intake of nutrients that would normally be provided by foods that are eliminated. . . education handouts in the Nutrition Care Manual® (NCM®) are not intended to substitute for nutrition counseling with a registered dietitian nutritionist (RDN). The information is meant to serve as a general guideline and may not meet the unique nutritional needs of individual clients or patients. All medical professionals should consult with a RDN before providing handouts to clients or patients.” The NCM further indicated, “A cascade of symptoms, which usually occur within minutes after eating the offending food, involve the cutaneous (skin), respiratory (lungs), gastrointestinal (stomach and intestines), and/or cardiovascular (heart) systems. In the most severe cases, the airway closes off and the blood pressure drops rapidly, which could result in death. Once an anaphylactic reaction begins, there is no way to predict how serious it can become. Food-induced anaphylaxis is the most common cause of anaphylaxis in emergency rooms in the United States.” During an interview on 3/3/25 at 11:25 a.m. with CNSM, CNSM stated she needed to institute RD consult orders for food allergies into the hospital’s structure, including providing various food allergy guidance and sample menus into the hospital specific diet manual as it was currently excluded, to ensure patients with food allergies received MNT in accordance with standards of practice. During a review of the facility’s P&P titled, “Adult and Pediatric Assessment,” dated 6/12/24, the P&P indicated, “Nutrition Screening: Identifies patients who may have a nutrition diagnosis and may benefit from nutrition assessment and intervention by a Registered Dietitian. . .Nutritional Assessment: To obtain, verify, and interpret data needed to identify nutrition-related problems, their causes, and significance. A Registered Dietitian (RD) conducts an in-depth assessment using comprehensive data. . .information on. . .food preferences. . .and food allergies will also be reviewed.” 2. During a concurrent interview and record review on 2/28/25 at 12:22 p.m. with CNSM, Patient 26’s “Nutrition Follow-up (NFU)”, dated 2/7/25, completed by RD 2 was reviewed. The NFU indicated, “High nutrition risk follow up. . .Pt [patient] remains on a Renal diet (diet for kidney disease) with a PO [by mouth] intake averaging < [less than]25% last 9 documented meals. Pt has been consuming snacks that have been order. However, pt is likely not meeting estimated nutrition needs at this time. . .Weight trend within admission appears to show a weight gain from 52.8 to 53.5 to 55.5 kg [kilogram]--pt is at a negative fluid balance this admit, wt [weight] questionable but monitoring.” CNSM stated Patient 26 received hemodialysis three times a week due to ESRD [end stage renal disease]. CNSM showed Patient 26’s weights listed in the EHR under “Measurements” indicated, “1/31/25- 53.5 kg, 2/2/25- 53.5 kg, 2/3/25- 55.5 kg, and CNSM stated that was the only location where patients weights were recorded. CNSM stated comparing dry weight to dry weight post dialysis was the standards of practice when evaluating weight loss or weight gain for a patient with ESRD on HD (hemodialysis). CNSM stated the weights in the EHR under “Measurements” was not the dry weight post dialysis. CNSM stated she would need to work on ensuring RD’s have available, and use, dry weights pre and post dialysis treatment when conducting nutrition assessments for patients receiving dialysis for a meaningful evaluation of weight changes that may lead to an RD recommending nutrition interventions. During a review of the facility’s P&P titled, “Adult and Pediatric Assessment,” dated 6/12/24, the P&P indicated, “Nutritional Assessment: To obtain, verify, and interpret data needed to identify nutrition-related problems, their causes, and significance. During a review of The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2025, the NCM indicated, “In adults undergoing dialysis, assessments are best obtained after treatment when body fluid compartment levels are more likely to be balanced.” The NCM referenced “KDOQI Clinical Practice Guideline for Nutrition in CKD (CPG)”, dated 2020, the CPG indicated, “. . .percent change in usual body weight (dry weight in maintenance dialysis patients) may be a more reliable measure.” During a review of the facility’s job description (JD) titled, “Registered Dietitian,” dated 4/6/2017, the JD indicated, “Continuously looks for ways to improve nutritional care to patients. Acts with others to monitor current levels of service, plan new or improved services, implement the plan, and reassess, educate, and make changes necessary for excellent care of patients.” 3. During a concurrent observation and interview on 2/27/25 at 11:30 a.m. with DFNS in the kitchen, Patient 27’s lunch meal tray card indicated diet order was diabetic 60 g CC and 2 gm potassium with milk and broccoli observed on Patient 27’s meal tray. DFNS stated patients therapeutic diet select menus are screened by Diet Clerks. During a concurrent interview and record review on 2/28/25 at 10:36 a.m. with CNSM, CNSM stated Patient 27’s diet order in the EHR indicated 60 g CC, low potassium diet upon admission on 2/25/25 and remained that way as of 2/28/25. CNSM stated a “low potassium diet” was not a recognized diet order, as the hospital had 2 gm or 3 gm potassium diet orders readily available with menus and corresponding nutrient analysis to ensure patient’s received the diet order as intended, and defined in the hospital’s diet manual. During a concurrent interview and record review on 2/28/25 at 11:16 a.m. with CNSM, CNSM reviewed a software program (Computrition) the Diet Clerks utilized that contained pertinent patient specific dietary needs which generated individualized meal tray cards that provided direction to kitchen staff when assembling a patient’s meal tray, such as food allergies, and food preferences. CNSM reviewed Computrition for Patient 27 that listed, “Diet Order Restrictions: Consistent Carb (CC) 60 Diabetic, K 2000 mg.” Computrition had a tab titled “Diet Order History (DOH)”, dated 2/26/25 8:47 a.m., the DOH indicated, “Start Meal: 2/26/25- Breakfast, “Who” name of Diet Clerk listed (DC 1), “Menu Type” Renal, “Order Details” DB, 60g CC, K2gm.” CNSM stated DC 1 cannot write diet orders and cannot interpret what the correct low potassium diet order was for Patient 27, whether 2 gm K or 3 gm K. CNSM stated DC 1 should have communicated with an RD or RN (Registered Nurse) to clarify the diet order with the physician for Patient 27’s nutritional and safety needs. During an interview on 3/3/25 at 11:28 a.m. with CNSM, CNSM she did not find a 2 gm potassium diet, nor a 3 gm potassium diet in the hospital’s approved diet manual. CNSM stated those 2 gm K+ and 3 gm K+ diets are used by the hospital’s physician’s and she did provide directions and recipes to the kitchen staff on how to prepare patient meal trays to meet those diet orders. During a review of the facility’s policy and procedure (P&P) titled, “Diet Manual and Approval Acute Care,” dated 7/22/24, the P&P indicated, “Purpose: To provide a reference for nutrition care, which will be used as a guideline for diet related information. The facility specific diet manual outlines all regular and therapeutic diets available for patients in the facility. The Nutrition Care Manual is the standard guide and reference for nutrition assessment and care. Policy: The facility specific diet manual is updated at least annually and reflects the current meals and therapeutic diet options available for providers to order for their patients. During a review of the facility’s job description (JD) titled, “Diet Clerk,” dated 1/31/20, the JD indicated, “Job Responsibilities Essential: Receives diet orders from the electronic medical record and maintains current diet order in the automated diet office system (Computrition). Consults with patients, nurses, dietitians, and dietary personnel as needed concerning patient diets.” 4. During a concurrent interview and record review on 2/28/25 at 10:36 a.m. with CNSM, CNSM stated Patient 27’s diet order in the EHR indicated 60 g CC, low potassium diet upon admission on 2/25/25 and remained that way as of 2/28/25. During an interview on 2/28/25 at 10:55 a.m. with CNSM and DFNS, CNSM stated Patient 27’s therapeutic 60 g CC diet was prescribed for diabetes management and low potassium diet order was for renal disease and did not meet the facility’s nutrition screening criteria to warrant a RD to complete a nutrition assessment and/or provide therapeutic diet order education at anytime during the hospital stay based on diagnosis of chronic disease, chronic co-morbidities or therapeutic diet order in and of itself. CNSM stated teaching of therapeutic diets to patient’s was important and within the scope and expertise of a RD but “we have to manage the resources we have.” During a concurrent interview and record review on 2/28/25 at 11:25 a.m. with Director of Medical Surgical Services (DMSS), CNSM and DFNS, DMSS stated nursing staff have access to therapeutic diet education handouts located in Cerner (A software program) that a nurse could provide to a patient upon discharge “depending on the patient situation”, it was not automatic. DMSS stated nursing was responsible for initiating, updating and revising nutrition plans of care (Interdisciplinary/IDT nutrition care plans) that could include “Diet/Nutrition” with specifications such as “needs further teaching”, or “verbalizes understanding.” DMSS reviewed Patient 27’s Plans of Care and stated there was not a nutrition plan of care initiated for Patient 27. CNSM stated the hospital’s RDs do not access the plans of care for patients and therefore do not initiate, update or revise a patient’s IDT nutrition plans of care. CNSM stated she saw discharge orders for today for Patient 27. During an interview on 2/28/25 at 12:3 p.m. with Discharge Case Management (DCM), DCM stated she did not have anything to do with diets or therapeutic diet education for patients. DCM stated she did discharge planning for identified patient’s that needed case management but did not discuss or provide diet education, even in the form of therapeutic diet education handouts. During a review of the facility’s job description (JD) titled, “Registered Dietitian,” dated 4/6/2017, the JD indicated, “Job Responsibilities Essential: Performs assessment and screening for patients designated as a high risk for optimal nutrition. Develops nutritional treatment plans in coordination with the interdisciplinary team and in collaboration with the patients and families as able. . .Performs or coordinates nutrition education for patients and/or patient’s caregivers, and chart’s appropriately to the medical record. Tailors nutrition education to the needs of the patient and their family (ex: medical needs, cultural preferences, patient readiness, etc). . .Continuously looks for ways to improve nutritional care to patients. Acts with others to monitor current levels of service, plan new or improved services, implement the plan, and reassess, educate, and make changes necessary for excellent care of patients.” During a review of NCM, dated 2025, NCM indicated, “Registered dietitian nutritionists (RDN) must also receive referrals for nutrition problems other than malnutrition, such as the following: Vitamin intake; For example, ensuring consistent vitamin K intake for patients treated with vitamin K antagonists, Obesity; For example, diagnosis and documentation of obesity to support additional reimbursement to compensate for the increased costs of caring for morbidly obese patients; Knowledge deficits; For example, education focused on modification of sodium and fluid intake, in order to mitigate heart failure symptoms and reduce readmission rates.” During a review of the facility’s job description (JD) titled “Clinical Nutrition Manager”, dated 6/23/2020, the JD indicated, “In coordination with the Food and Nutrition Services Director establishes, enforces, and evaluates levels of productivity and performance standards for areas under the supervision of this position. This includes standards on recommendations for diet orders, documentation in the medical record system, nutritional assessments, patient follow-up and patient/family education and counseling. Identifies, reviews, and evaluates nutrition services through quality assurance and monitoring techniques to improve quality of care.””

“COMPETENT DIETARY STAFF CFR(s): 482.28(a)(3) There must be administrative and technical personnel competent in their respective duties. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the facility failed to ensure two of eight food service workers (Dietary Stockroom Clerk [DSC], Food Service Worker [FSW] 2) were competent in assigned duties related to: 1. DSC left extensive quantities of food debris alongside the walls and underneath shelving and crates after DSC just completed the task. Failure to adequately clean the floors in the dry food storage room allowed an environment to attract pests. 2. FSW 2 failed to immerse a chemistry (chem) test strip into a sanitizing solution located in a red bucket in accordance with manufacturer’s guidelines (MG) when determining if the sanitizing solution was at the correct concentration to effectively sanitize. Failure to use the chem test strip in accordance with manufacturer’s guidelines had the potential to give an inaccurate PPM (parts per million; a unit used to express the concentration of a substance in a solution) reading (color on chem strip that gets compared to a color coded graph with PPM labeled) and impede effective sanitizing of food contact surfaces. Findings: 1. During a concurrent observation and interview on 2/27/25 at 3:10 p.m. with Director of Food & Nutrition Services (DFNS), Food Service Manager (FSM), and Dietary Stockroom Clerk (DSC) in the dry food storage room (DFSR) in the kitchen, DSC was walking out of the “DFSR”with a mop as he had just finished mopping the floor in the DFSR. During a concurrent observation and interview on 2/27/25 at 3:12 p.m. with DFNS and FSM in the DFSR, an opened crevice in the wall was observed that could allow entry of pests, with surrounding food debris on the floor. Upon further observation of the floor that was just mopped by DSC, there was extensive food, such as individual size pack of crackers, and food debris all along the edge of the baseboards and the floor surface, as well as under shelves and milk crates. DFNS stated DSC did not demonstrate competency of assigned task of mopping the floors in the DFSR.. During a review of the facility’s job description (JD) titled, “Dietary Stockroom Clerk”, dated 2/8/16, the “JD” indicated, “Maintains cleanliness of storage areas including the storeroom, walk-in coolers, and freezers.” 2. During a concurrent observation and interview on 2/27/25 at 11:26 a.m. with Food Service Worker (FSW) 2, in the presence of DFNS and DFP in the kitchen, FSW 2 was standing at a food preparation counter with a red bucket filled with solution on the lower shelf underneath the counter top. FSW 2 stated he used a cloth from the red bucket filled with a sanitizer solution to sanitize the food preparation counter about thirty minutes earlier, and the sanitizer solution was still readily available for use. FSW 2 placed a large piece of chem test strip against the inside of the bucket while the lower part of the chem strip was immersed into the sanitizing solution located in the red bucket and left it there for approximately 30 to 60 seconds. FSW 2 then removed the chem test strip, compared the color to the color coded graph, and FSW 2 stated it was 400 PPM. FSW 2 stated he was supposed to immerse the chem test strip into the sanitizing solution for 30 seconds. During a concurrent interview and record review on 2/27/25 at 12:27 p.m. with DFNS, a poster with MG’s for the chem test strip and sanitizing solution, located on the wall above the 3-compartment pot and pan sink, was reviewed. The MG’s for the chem test strip indicated, “Withdraw and tear off approximately 2 inches of test paper from dispenser. Dip test paper for 10 seconds in sanitizing solution. Don’t shake. Compare colors immediately with colors on the test paper package to determine PPM.” During a review of the Food and Drug Administration Food Code (FDAFC), dated 2022, the “FDAFC” indicated a test kit or other device that accurately measures the concentration of sanitizing solutions shall be provided and used in accordance with the manufacturer’s label instructions.”

“THERAPEUTIC DIETS CFR(s): 482.28(b), (b)(1) §482.28(b) Menus must meet the needs of patients. (1) Individual patient nutritional needs must be met in accordance with recognized dietary practices. This Standard is not met as evidenced by: 27157 Based on interview, and record review, the facility failed to: 1. Effectively monitor nutrition intervention(s) when the quantity consumed of an oral nutrition supplement (ONS) was not documented and failed to develop, update and/or revise anindividualized nutrition plan of care with potential alternative nutrition approaches when two of five sampled patients (Patient 26, Patient 21) nutritional needs were not met. 2. A Registered Dietitian (RD) did not provide nutrition recommendations to the physician for one of five sampled (Patient 26) regarding a discrepancy between Patient 26’s renal diet order in comparison with Patient 26’s assessed daily protein needs to ensure individualized nutritional needs were met in accordance with standards of practice. 3. The hospital’s overall system did not ensure RD’s assessed and evaluated the appropriateness of prescribed therapeutic diets in which variations were available for a physician to select from to determine whether nutrition recommendations to a patient’s physician were in order to ensure the therapeutic diet met a patient’s individualized nutrition needs for two of five sampled patients (Patient 27, Patient 29). (Cross Refer A-0283) Failure to ensure patients nutritional needs are met in a timely manner could negatively impact the health status of medically fragile patients. Findings: 1a. During a review of Patient 26’s “Nutrition Note (NN),” dated 2/2/25, the NN indicated, “Nutrition Risk Level: High (2/2/25). . .Pt not fully meeting nutrition needs at this time. Nutrition Diagnosis: Inadequate nutrient intake. . .Trial Nepro 1/day and snacks 1/day - Proposed to MD [medical doctor]. Continue renal [kidney] multivitamin.” During a review of Patient 26’s “Orders”, dated 2/2/25, an order indicated, “Nepro 1 carton daily” and another order for a “snack” dated 2/2/25 were both electronically signed by a physician. During a review of Patient 26’s “Orders”, dated 2/2/25, an order indicated, “Order: RDN F/U [follow up] Assessment, End-state Date/Time: 2/7/25 16:12 PST, entered and electronically signed by: [name of RD 1].” During an interview on 2/28/25 at 12:00 p.m. with CNSM, CNSM stated RD 1 assessed Patient 26 at nutritional high risk and not meeting nutrient needs, recommended nutrition interventions, and documented the RD follow up would not occur until five days later on 2/7/25. During a concurrent interview and record review on 2/28/25 at 12:22 p.m. with CNSM, Patient 26’s “Nutrition Follow-up (NFU)”, dated 2/7/25 completed by RD 2 was reviewed. The NFU indicated, “High nutrition risk follow up. . .Pt remains on a Renal diet with a PO intake averaging <25% [less than 25 percent] last 9 documented meals. Pt has been consuming snacks that have been order. However, pt is likely not meeting estimated nutrition needs at this time. If pt’s PO intake remains poor within the next 2-3 days, pt may benefit from artificial nutrition support given it will be 7 days with a decreased PO intake.” CNSM stated there was no documentation by RD2 evaluating the effectiveness of the trial of Nepro 1 time a day. CNSM stated there was no documentation as to whether RD 2 spoke with Patient 26 related to acceptability and to encourage and discuss benefits of drinking the supplement, along with eating meals and the potential nutritional consequences on her health if she did not consume adequate nutrition. CNSM stated it was her expecation for the RD to document follow up on the previous nutrition recommendation related to the ONS. During a review of Patient 26’s “NN” completed by RD 3, dated 2/10/25, the NN indicated, “Recommendations: Continue with Nepro QD to document intake please. . .No documentation of supplement intake.” There was no documentation to indicate RD 3 had tried to speak with Patient 26 nor tried to speak with Patient 26’s family to collaborate with the patient and family to get input on potential new alternative nutrition approaches, as the care plan had remained the same since 2/2/25. During a concurrent interview and record review on 2/28/25 at 12:26 p.m. with CNSM and Director of Medical Surgical Services (DMSS), Patient 26’s “Nutrition ADLs (Activities of Daily Living),” dated 2/3/25 through 2/10/25 was reviewed. DMSS stated there was no documentation of the Nepro order for one time a day to show it was offered and/or consumed since ordered, and it should have been. CNSM stated the software program that the food and nutrition services staff used showed the Nepro supplement was scheduled to be provided to Patient 26 between lunch and dinner time. CNSM stated it was necessary to document quantity consumed of a nutrition supplement ordered as an intervention to monitor for effectiveness, compare to a patient’s daily nutritional needs in order to update and revise a patient’s nutrition plan of care in a timely manner, and or re-evaluate when to offer an alternative nutrition approach in a timely manner. 1b. During a concurrent interview and record review on 2/28/25 at 2:17 p.m. with CNSM and DMSS, CNSM stated Patient 21 was admitted to the facility on 2/19/25. Patient 21’s “Admission History Adult (AHA),” dated 2/19/25 was reviewed. The AHA indicated and CNSM stated the “AHA” included admission nutrition screening questions completed by nursing in which Patient 21 triggered for an RD consult within 48 hours due to loss of appetite/poor po intake prior to admission. During a review of Patient 21’s “Orders,” dated 2/20/25 at 1:12 p.m., the orders indicated, “Ensure Plus High Protein (EPHP) TID [three times a day] w[with]/Meals, Pt [patient] prefers Strawberry.” During a concurrent interview and record review on 2/28/25 at 2:25 p.m. with CNSM and DMSS, DMSS stated there was no documentation under “Intake and Output” located in Patient 21’s EHR (electronic health record) that “EPHP” was provided with the dinner meal on 2/20/25. DMSS stated the nursing staff were to document consumption of the EPHP on a line titled “Oral Supplement Amount”, and if there is not an “Oral Supplement Amount” line visible, or was left blank, then that meant there was no EPHP offered because nurses were trained to document refused or not available on the same “Oral Supplement Amount” line. During a review of the “Oral Supplement Amount” from 2/21/25 through 2/25/25 the EPHP was documented three out of 15 times. EPHP should have been offered and the consumption documented were 237 ml (mililiters-unit of measure), 160 ml and 300 ml. CNSM stated the EPHP came in a 8 oz (ounce-unit of measure) serving size which was 240 ml. DMSS stated the nurses’ needed more training and oversight over to ensure correct and consistent documentation of oral nutrition supplements for monitoring of acceptability by the patient. DMSS stated it may be time to revise the nutrition plan of care and offer an alternative nutrition intervention to meet nutritional needs of the patient. During a review of the facility’s job description (JD) titled, “Registered Dietitian,” dated 4/6/2017, the JD indicated, “Performs assessment and screening for patients designated as a high risk for optimal nutrition. Develops nutritional treatment plans in coordination with the interdisciplinary team and in collaboration with the patients and families as able. Follows up such patients to evaluate progress towards goals.” During a review of the facility’s policy and procedure (P&P) titled, “Vital Signs, Intake & Output, Weights: (Adult),” dated 3/20/23, the P&P indicated, “All patients’ vital signs, weight, and dietary intake & output will be consistently measured and documented. . .Procedure: Diet: Confirm physician order for diet and other supplements. . .Document percent consumed for every meal, snack and nutritional supplement. . .Do not leave documentation blank.” During a review of the facility’s policy and procedure (P&P) titled, “Adult and Pediatric Assessment,” dated 6/12/24, the P&P indicated, “Procedure: A comprehensive nutritional assessment will be completed if the patient is screened at moderate or high nutritional risk. If a patient is assessed at low risk, the screen and risk identification is documented. . .Follow up is assigned based on risk status as determined and documented by the RD. a. Follow up or rescreening is due as follows: i. High Risk - within 5 days, ii. Moderate Risk - within 7 days, iii. Low Risk -rescreen every 10 days.” During a review of the facility’s policy and procedure (P&P) titled, “Diet Manual and Approval Acute Care,” dated 7/22/24, the P&P indicated, “The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM) is the standard guide and reference for nutrition care.” During a review of ASPEN’s standards of care guidance titled “ASPEN Adult Nutrition Care Pathway (Age 18+ years) (ANCP)”, dated 9/14/22, the “ANCP” indicated once inadequate nutrient intake had been identified “Monitoring & Evaluation: Follow-up within 3 days, monitor parameters; tolerance of nutrient intake, oral intake including supplements, vitamins, minerals, anthropometric data (weight trends), functional status.” During a review of the facility’s job description (JD) titled “Clinical Nutrition Manager”, dated 6/23/2020, the JD indicated, “In coordination with the Food and Nutrition Services Director establishes, enforces, and evaluates levels of productivity and performance standards for areas under the supervision of this position. This includes standards on recommendations for diet orders, documentation in the medical record system, nutritional assessments, patient follow-up and patient/family education and counseling. Identifies, reviews, and evaluates nutrition services through quality assurance and monitoring techniques to improve quality of care.” 2. During a review of Patient 26’s NN, dated 2/2/25, the NN indicated, “Nutrition Risk Level: High (2/2/25). . .Pt not fully meeting nutrition needs at this time. Nutrition Diagnosis: Inadequate nutrient intake. . .Nutrition Recommendations: Current order for Diabetic diet - BG [blood glucose] well controlled. Monitor phosphorous[a mineral]/potassium [an electrolyte] for possible Renal diet [diet for kidney disease] restriction as needed. . .ESRD [end stage renal disease] on hemodialysis [a medical procedure that filters waste products and excess fluid from the blood when the kidneys are unable to do so] Process:. . . .Trial Nepro (ONS to add calories) 1/[per]day and snacks 1/day - Proposed to MD. Continue renal multivitamin.” During a review of Patient 26’s “Nutrition Assessment Information (NA)”, dated 2/2/25, located under “Nutritional” located in the EHR, the “NA” indicated, “Estimated Protein Needs Low g [grams]/day = 54, Estimated Protein Needs High g/day = 64 g.” During a review of patient 26’s “Orders”, dated 2/6/25, an order indicated, “Renal Diet” that was “entered and electronically signed” by a physician. During an interview on 2/28/25 at 3:04 p.m. with CNSM, CNSM stated RD 1 should have provided recommendations to the physician to address the discrepancy between the renal diet order that provided 80 grams of pro/day as compared to Patient 26’s assessed daily pro needs between 54 - 64 g pro/day (1-1.2 gm pro/kg [kilogram]) by recommending the renal diet be changed to a 60 g pro/d renal diet. During a review of the facility’s job description (JD) titled, “Registered Dietitian,” dated 4/6/2017, the JD indicated, “Job Responsibilities Essential: Performs assessment and screening for patients designated as a high risk for optimal nutrition. Develops nutritional treatment plans in coordination with the interdisciplinary team. . . Provides nutrition information and recommendations to Physicians regarding patient’s nutritional status in a timely manner.” During a review of the facility’s policy and procedure (P&P) titled, “Diet Manual and Approval Acute Care,” dated 7/22/24, the P&P indicated, “Purpose: To provide a reference for nutrition care, which will be used as a guideline for diet related information. The facility specific diet manual outlines all regular and therapeutic diets available for patients in the facility. The Nutrition Care Manual is the standard guide and reference for nutrition assessment and care. Policy: The facility specific diet manual is updated at least annually and reflects the current meals and therapeutic diet options available for providers to order for their patients. The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM) is the standard guide and reference for nutrition care. The NCM is online and available to all healthcare providers at [name of hospital]. Procedure: The NCM is consistent with AND’s Evidence Analysis Library, AND’s position papers, and the Nutrition Care Process.” During a review of the facility’s “Diet Manual and Approval Acute Care (DM),” dated 7/22/24, the DM indicated the facility had menus with corresponding nutrient analysis for renal diets providing 60 g pro/d, 80 g pro/d or 100 g pro/d. 3a.During a concurrent interview and record review on 2/28/25 at 10:24 a.m. with CNSM and DFNS, Patient 27’s “Admission History Adult (AHA)”, dated 2/26/25 was reviewed. CNSM stated the “AHA” included admission nutrition screening questions completed by nursing in which Patient 27 was determined not to have any of the facility’s criteria for nutrition risk that would in turn trigger an RD consult for further nutrition screening by an RD to determine if a nutrition assessment would be completed for Patient 27. During an interview on 2/28/25 at 10:36 a.m. with CNSM, CNSM stated Patient 27’s therapeutic diet order was diabetic CC 60 g [consistent carbohydrate dispersed evenly over three meals with limit of a total of 60 grams of carbohydrate per day] and low potassium. CNSM stated the diabetic diet orders available to the physician’s to select from a drop down menu in the electronic health record (EHR) were 45 g CC [limit of 45 grams of consistent carbohydrate], 60 g CC or 75 g CC that corresponded with different total daily calories provided depending on the amount of CC ordered. In addition, CNSM stated the hospital had various renal diets as a drop down menu physicians selected from as follows: “Renal with an 80 g pro [protein]/d”, “High Protein Renal with 100 g pro/d”, “Low Protein- 60 g pro/d 2 gm [gram] Sodium [limit of salt intake]”, and a “Low Protein Renal- 60 g pro/d.” CNSM stated within the hospital’s nutrition care structure, if the hospital’s nutrition screening did not drive an RD to conduct a nutrition assessment for a patient, the hospital RD’s would not perform nutrition assessments for those patients that had specialized therapeutic dietary needs, simply due to a therapeutic diet in and of itself, to evaluate if the diet order was aligned with the patient’s daily calorie and protein needs, or if not, to provide nutrition recommendations to the physician regarding a patient’s therapeutic diet. 3b.During a concurrent interview and record review on 2/28/25 at 3:26 p.m. with CNSM, Patient 29’s “Inpatient” form indicated she was 59 years old. Patient 29’s “Admission History Adult (AHA)”, dated 2/21/25 was reviewed. CNSM stated the “AHA” included admission nutrition screening questions completed by nursing in which Patient 29 was determined not to have any of the facility’s criteria for nutrition risk to trigger an RD consult for RD to conduct further nutrition screening and/or complete a nutrition assessment. The “AHA”, dated 2/21/25, included a notation of “Home Diet: Diabetic, Renal.” During a review of Patient 29’s “Progress Note (PN)”, dated 2/27/25, completed by RD 4, the “PN” indicated, “Nutrition Screen: Consult received as part of length of stay, pt meets criteria for low acuity (condition with low probability of progression); admitted with PD catheter (PD; Peritoneal [thin tissue that lines the abdominal cavity] dialysis [a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly] catheter dysfunction [malfunction of the tube used to access patient’s blood for dialysis], provided a renal, diabetic diet-po intake average of 72% [percent] x 9 meals, no trouble chewing or swallowing, BMI 27.2, skin intact, Braden score 20. Will monitor per policy, RD available sooner, prn [as needed].” During an interview on 2/28/25 at 3:30 p.m. with CNSM, CNSM stated within the hospital’s system RD’s were not required to perform a nutrition assessment for chronic diseases with comorbidities (a disease or medical condition that is simultaneously present with another) that required specialized dietary needs with a therapeutic renal, diabetic diet. CNSM stated it would require Patient 29 to have an RD complete a nutrition assessment to determine Patient 29’s daily calorie and protein needs in order to evaluate whether Patient 29 was prescribed the correct grams of carbohydrate diabetic diet and correct grams of protein renal diet to meet Patient 29’s individual nutritional needs. However, Patient 29 was screened by RD 4 to be low acuity after six days in the hospital with comorbidities of renal disease and diabetes and was assessed as continuing to be at low nutrition risk, per hospital P&P titled “Adult and Pediatric Assessment (APA)”, dated 6/12/24, the “APA” indicated “Low Risk. . .follow-up completed within 10 days.” CNSM stated RD 4 did not document an RD f/u date for monitoring as the hospital had established screening criteria during the hospital stay in which nursing screens for low appetite/poor po intake would trigger an RD consult, if that occurred. During an interview on 2/28/25 at 3:45 p.m. with CNSM, CNSM stated Patient 29 had not seen an RD since admission as she was assessed to be low nutrition risk, the RD’s do not evaluate whether the ordered therapeutic diet meets Patient 29’s specialized dietary needs due to comorbidities of diabetes and renal disease, and the hospital’s RD’s do not offer and conduct therapeutic diet education to in-patient’s, patient’s families or caregivers, nor do the RD’s review, update or revise interdisciplinary plans of care related to any type of diet education or readiness for therapeutic diet education. During a review of NCM, dated 2025, NCM indicated, “Registered dietitian nutritionists (RDN) must also receive referrals for nutrition problems other than malnutrition, such as the following: Knowledge deficits; For example, education focused on modification of sodium and fluid intake, in order to mitigate heart failure symptoms and reduce readmission rates.” During a review of The Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2025, the NCM indicated, “. . .education handouts in the Nutrition Care Manual® (NCM®) are not intended to substitute for nutrition counseling with a registered dietitian nutritionist (RDN). The information is meant to serve as a general guideline and may not meet the unique nutritional needs of individual clients or patients. All medical professionals should consult with a RDN before providing handouts to clients or patients.” During a review of the facility’s job description (JD) titled, “Registered Dietitian,” dated 4/6/2017, the JD indicated, “Job Responsibilities Essential: Performs assessment and screening for patients designated as a high risk for optimal nutrition. Develops nutritional treatment plans in coordination with the interdisciplinary team and in collaboration with the patients and families as able. Follows up such patients to evaluate progress towards goals. . .Provides nutrition information and recommendations to physicians regarding patient’s nutritional status in a timely manner. . .Performs or coordinates nutrition education for patients and/or patient’s caregivers, and chart’s appropriately to the medical record. Tailors nutrition education to the needs of the patient and their family (ex: medical needs, cultural preferences, patient readiness, etc). . .Continuously looks for ways to improve nutritional care to patients. Acts with others to monitor current levels of service, plan new or improved services, implement the plan, and reassess, educate, and make changes necessary for excellent care of patients.” During a review of the facility’s job description (JD) titled “Clinical Nutrition Manager”, dated 6/23/2020, the JD indicated, “In coordination with the Food and Nutrition Services Director establishes, enforces, and evaluates levels of productivity and performance standards for areas under the supervision of this position. This includes standards on recommendations for diet orders, documentation in the medical record system, nutritional assessments, patient follow-up and patient/family education and counseling. Identifies, reviews, and evaluates nutrition services through quality assurance and monitoring techniques to improve quality of care.” During a review of the facility’s job description (JD) titled “Director of Food & Nutrition Services,” dated 6/18/21, the JD indicated, “Provides oversight of the clinical nutrition program. Provides guidance and direction to the Clinical Nutrition Manager.””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 46958 Based on observation, interview, and record review, the facility failed to implement nationally recognized organization Center for Disease Control (CDC-federal government agency that protest public health by preventing and controlling disease, injury, and disability) infection prevention and control practices when:) infection prevention and control practices when one of three sampled patients (Patient 4), who was diagnosed with Herpes Zoster (also known as Shingles, a painful rash caused by herpes virus), was not placed on Transmission-Based Precaution (used as second tier of basic infection control and are to be used in addition to Standard Precautions [includes hand hygiene and use of personal protective equipment such as gloves, masks, gowns, face shields, or goggles]). This failure had the potential to transmit infection to patients, staff and visitors. Findings: During an interview on 2/26/25 at 11:05 a.m. with Assistant Emergency Department Nurse Manager, (AEDNM), AEDNM stated patient in room 52 was on isolation. During an observation on 2/26/25 at 11:10 a.m. in Emergency Department (ED) room 52, there was no infection control signage posted on the door, and there was no isolation caddy (contains personal protective equipment) outside the door. During a concurrent observation and interview on 2/26/25 at 11:16 a.m. with ED Technician (EDT) in front of ED room 52, EDT was posting the signage outside the door of room 52 for Contact Precaution (infection control measures used to prevent the spread of infectious diseases transmitted through direct or indirect contact with patients or their environment). EDT stated AEDNM asked her to post the Contact Precaution sign up in ED room 52’s door. During an interview on 2/26/26 at 11:25 a.m. with AEDNM, AEDNM stated, “If a patient is on isolation, there should be a sign with Stop Sign and the type of isolation the patient is on.” During an interview on 2/26/25 at 11:30 a.m. with Registered Nurse (RN) 2, RN 2 stated at shift change at 6 a.m. RN 2 was informed Patient 4 in room 52 has shingles. RN 2 stated Patient 4 should be on contact precaution and there should be signage on the door and there should be caddy front of the door with supplies. RN 2 stated Patient should have a contact precaution signage on the door, and there should be a caddy with isolation supplies outside Patient 4’s room. During a concurrent interview and record review on 2/26/25 at 3 p.m. with Director of Trauma (DOT), Patent 4’s “Physician Orders (PO),” 2/25/25 was reviewed. The PO indicated, Patient 4 was on Acyclovir (viral treatment) 800 mg (milligram) started on 2/25/25 for viral treatment. DOT stated Patient 4 was diagnosed with herpes zoster on 2/25/25. During a review of the facility’s policy and procedure (P&P) titled, “Standard and Transmission-Based Precautions,” dated 4/26/24, the P&P indicated, “To prevent the transmission of infection within the hospital by patients receiving care, staff and visitors. . .Contact Precautions: You must at a minimum wear gloves when entering the room. . .Place the caddy and appropriate transmission-based precautions signage in the caddy pocket. . .Some examples of illness requiring contact precaution include: herpes zoster (disseminated or in the Immunocompromised [having an impaired immune system]). RN initiates transmission-based precaution by placing the isolation caddy with appropriate PPE at the door to the patient’s room and enters an order for the type isolation in use into the electronic medical record.””

“QUALIFIED EMERGENCY SERVICES PERSONNEL CFR(s): 482.55(b)(2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. This Standard is not met as evidenced by: 35649 Based on interview and record review, the hospital failed to: 1.Ensure Emergency Department Registered Nurse (EDRN) 1) activated emergency response system or initiated cardiopulmonary resuscitation for one of one patient (Patient 1) exhibiting a life threatening event during a Magnetic Resonance Imaging (MRI- [a type of scan that uses strong magnetic fields and radio waves to produce detailed images of the inside of the body]) procedure. 2. Ensure EDRN 1 documented nursing assessment, placed one of one sampled patient (Patient 1) suffering from a life-threatening condition on the cardiac (heart) monitor, vital signs (includes temperature, heart rate, respiratory rate, blood pressure) machine, and pulse oximetry (measures oxygenation in one’s blood), and continued to monitor care upon return to the ED from Radiology Department (RD). These failures decreased the patient’s chances of survival. favorable outcome, and had the potential to contribute to Patient 1’s death. Findings: During a review of Patient 1’s “History & Physical (H&P),” dated 1/12/25, the H&P indicated, Patient 1 was brought to the hospital ED after a fall while getting off the toilet, fell on his side, and hit his head. Patient 1 had a past medical history of coronary artery disease (CAD-occurs when the arteries of the heart cannot deliver enough oxygen-rich blood to the heart due to narrowing or blockage) s/p (status post) coronary artery bypass graft (CABG- surgical procedure to treat a blockage or narrowing of one or more of the coronary arteries [blood vessels of the heart] to improve blood flow to the heart) and atrial fibrillation (irregular heart beat not anticoagulated [not on blood thinner]). Patient 1’s computerized tomography (CT-an imaging technique to obtain detailed image of the body) scan of the brain indicated subdural hematoma (blood collected in between the skull and the brain) following head injury. During a review of Patient 1’s “Neurosurgery Consultation Notes (NCN),” on 2/24/25 at 10:23 a.m. with Registered Nurse Clinical Informaticist (RNCI), the NCN, dated 1/12/25, indicated, “MRI of the brain to r/o (rule out) stroke (occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts (or ruptures).” During a concurrent interview and record review on 2/24/25 at 1:59 p.m. with Director of Radiology (DR) and Imaging Service Manager (ISM), Patient 1’s MRI scan, dated 1/12/25, was reviewed. DR stated Patient 1 had an order for MRI of the brain without contrast on 1/12/25 at 10:48 p.m. DR stated Patient 1’s MRI scan was started but was aborted on 1/13 25 at 1:42 a.m. due to Patient 1’s change in condition during the MRI procedure. DR and ISM were unable to locate the results of the partial MRI scan for Patient 1. DR reviewed the documentation of the MRI technician (MRIT) which indicated, “Attempted exam. Patient became unstable towards the end of the exam. Unable to finish. Patient’s condition deteriorated.” DR was unable to find documentation the Rapid Response Team [RRT-hospital team that responds to patients who are deteriorating or have an emergency] or a Code Blue [alert that someone is experiencing a life threatening medical emergency]) was called in MRI. ISM stated the staff had been educated and trained to call RRT or Code Blue when an emergency arise in MRI. ISM stated MRITs were trained to “Call RRT Alert Ext 44, Give Room Number, Call Primary Care Physician.” During an interview on 2/24/25 at 4:53 p.m. with Director of Critical Care Services (DCCS) who was the Interim Director of Emergency Services at the time of the incident, DCCS stated she was notified Patient 1 had concerns, coded, and died by way of MIDAS (hospital incident reporting system). DCCS stated she interviewed EDRN 1 and according to EDRN 1, Patient 1’s heart rate became bradycardic (slow heart rate) and that Patient 1 did not have a pulse. DCCS stated according to EDRN 1 Patient 1 was pulled out of the MRI scanner in the room and EDRN 1 was unable to obtain vital signs. DCCS stated according to EDRN 1, EDRN 1 made the decision to return Patient 1 to the ED instead of calling RRT or calling a Code Blue. DCCS stated there was no advanced cardiac life support implemented, thus a delay in the implementation of emergency intervention. During a review of the ED Documentation, dated 1/12/25 and 1/13/25, DCCS confirmed there was no EDRN 1 documentation of what transpired in MRI and upon return of Patient 1 to the ED until 2:27 a.m. DCCS stated the expectation was for the EDRN 1 to provide emergency intervention and call the RRT when Patient 1’s condition deteriorated in MRI and before moving the patient back to the ED. During an interview on 2/24/25 at 6:54 p.m. with MRIT, MRIT stated EDRN 1 came with the patient to MRI. Patient 1 was transported to MRI by the MRI aide via gurney accompanied by EDRN 1. MRIT stated Patient 1 was transferred to the MRI table for the procedure. MRIT stated the patient was on the portable monitor and was connected to the vital signs machine. MRIT stated when MRI scan was started the nurse, the MRI aide, and himself had to go to the control room (immediately outside the magnet room where the operator console, keyboard, communication devices, computer equipment that controls the scanner were located) for safety reasons. MRIT stated the nurse, the MRI aide, and himself could see the Patient 1 from the window. MRIT stated the patient’s vital signs and heart monitor wave form was visible from the window. MRIT stated near the end of the MRI scan, EDRN 1 stated the scan needed to be stopped. MRIT stated EDRN 1 went inside the MRI room to check on the patient. MRIT stated the nurse informed him the patient did not look good and that the procedure could not be continued. MRIT stated EDRN 1 stated the patient needed to be taken back to the ED. MRIT stated there was no cardiopulmonary resuscitation performed on Patient 1 in MRI room. MRIT stated he did not call RRT because the EDRN 1 was in the room, and she took control of the situation. During a review of the facility’s policy and procedure (P&P) titled, “Rapid Response Team,” dated 11/22/24, the P&P indicated, “The system is designed to recognize at-risk adult and adolescent (age 14-17) non-critical care patients earlier in their course of deterioration and to rapidly mobilize appropriate institutional resources including but not limited to the Primary Care Practitioner and RRT. . . PROCEDURE: 1. RRT Activation and 10 SOV [signs of vitality] Assessment. . . D. Activation of the RRT alert and notification of the managing practitioner will occur simultaneously 1. If 2 or more of the weighted 10 SOV criteria are present and or any patient the staff is seriously concerned about. . . Call RRT Alert Ext 44, Give Room Number, Call Primary Care Physician.” 2. During a concurrent interview and record review on 2/24/25 at 3:50 p.m. with RNCI, Patient 1’s ED Progress Notes, dated 1/12/25 and 1/13/25, were reviewed. RNCI was unable to find nursing documentation of when Patient 1 returned to the ED, nursing assessment of Patient 1 upon return to the ED, records of cardiac rhythm (record of one’s electrical activity), vital signs (includes temperature, heart rate, respiratory rate, blood pressure, pain) and pulse oximetry (measures blood oxygenation). RNCI stated there were no additional documentation until a Code Blue was called at 2:27 a.m. in the ED. RNCI stated Patient 1’s oxygen saturation was at 44% and Patient 1 was intubated, and placed on a ventilator at 2:59 a.m. During a review of Patient 1’s “Critical Care Progress Notes (CCPN),” dated 1/13/25 at 2:27 a.m., the CCPN documented by the Nurse Practitioner (NP) indicated, “I was across the patient’s room [Patient 1’s room in the ED] and noticed that patient [Patient 1] was pale and had a nasal cannula [a device that delivers extra oxygen through a tube and into one’s nose] and not connected to the cardiac monitor [a device that records the electrical activity of the heart]. We connected the patient to the cardiac monitor, rhythm was asystole [no movement or electrical activity in the heart)], no pulse, started CPR [cardiopulmonary resuscitation-emergency procedure used to restart a person’s heartbeat and breathing after one or both have stopped] called Code Blue.” During a review of Patient 1’s “Cardiopulmonary Resuscitation (CRR) Report,” dated 1/13/25, the CRR indicated,” Time code began: 2:27 a.m. Time code ended: 2:43 a.m. Rhythm: PEA (Pulseless Electrical Activity) Asystole 2:27 a.m. until 2:42 a.m. Ventricular Tachycardia (a heart rate higher than 120 beats per minute, major cause of sudden cardiac death) at 2:43 a.m. (responded to synchronized cardioversion (application of low-energy delivered between two consecutively conducted impulses of a cardiac cycle] at 200 joules (a unit of energy). At 1:10 a.m. return of spontaneous circulation (ROSC-resumption of a sustained heart rhythm that perfuses the body after cardiac arrest) was achieved and patient was transferred to Cardiovascular Intensive Care Unit (CVICU). During a review of the hospital’s P&P titled, “Assessment and Documentation, Nursing: Acute Patient Care,” dated 3/20/23, the P&P indicated, “PROCEDURE: 1 Nursing Assessment: A. A licensed nurse (within their scope of practice) assesses the patient’s needs for nursing care from admission through discharge in all settings where nursing care is provided. Assessments include both subjective and objective findings based on a body system (basic head-to-toe). . .II. Documentation Elements: Nursing documentation reflects the nursing care that occurs in a timely and ongoing basis. A. Nursing documentation reflects assessment findings and depicts both clinically significant normal findings as well as abnormal findings per the clinician’s clinical judgment. B. Documentation includes the status of the identified problems until they are resolved in the medical record or become inactive. . . Focused assessments (assessments focused on a specific body system or systems) are performed with changes in patient condition or as a follow up to any unusual findings from a previous assessment.” During a review of the hospital’s P&P titled, “Code Blue,” dated 9/28/22, the P&P indicated, “ Procedure: I. First Responder A. Any district staff member witnessing an individual who is experiencing cardiac and/or respiratory arrest will immediately call for help either verbally and/or by dialing “44” within the main campus or “9-911” in satellite areas using any in-house telephone. The operator will page the code team.””

“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: 47444 The facility failed to meet the regulatory requirements for the Condition of Participation: §482.51 Surgical Services as evidenced by: 1. Based on interview and record review, the hospital failed to ensure surgical mesh positioning system (scaffolding - flexible structure used to assist in placement of mesh [material used to repair hole in the abdominal wall] was removed at completion of surgical repair of a ventral hernia (when tissue or organs protrude through a weak spot in the abdominal wall). for one of three sampled patients (Patient 1). (refer to A-0951) 2. Based on interview and record review, the facility failed to follow its “Sponge, Instrument and Sharps Count,” policy and procedure (P&P) and national standards of practice for one of three sampled patients (Patient 1) when surgical mesh scaffolding was not removed at the conclusion of Patient 1’s ventral hernia repair.(refer to A-0951). These failures resulted in an additional abdominal surgical procedure to remove the retained surgical mesh scaffolding under general anesthesia (GA - medical treatment that uses medications to make patient unconscious) for Patient 1 and had the potential for infection and adverse health outcomes. 3. Based on interview and record review, the facility failed to follow its “Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure” and “Interpreter Services” P&Ps for five of 12 sampled patients (Patient 2, Patient 6, Patient 5, Patient 18 and Patient 17) when informed consent (the process in which a healthcare provider educates a patient about the surgery and the risks, benefits, and alternatives [RBAs]) was not provided in a language they could understand prior to surgical procedure. These failures resulted in Patient 2, Patient 6, Patient 5, Patient 18 and Patient 17, not being given the opportunity to make an informed decision based on RBAs of procedure. (refer to A-0955) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure safe quality health care, in compliance with Conditions of Participation for Surgical Services.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 47444 1. Based on interview and record review, the hospital failed to ensure surgical mesh positioning system (scaffolding - flexible structure used to assist in placement of mesh [material used to repair hole in the abdominal wall]) was removed at completion of surgical repair of a ventral hernia (when tissue or organs protrude through a weak spot in the abdominal wall) for one of three sampled patients (Patient 1). 2. Based on interview and record review, the facility failed to follow it’s “Sponge, Instrument and Sharps Count,” policy and procedure (P&P) and national standards of practice for one of three sampled patients (Patient 1) when surgical mesh scaffolding was not removed at the conclusion of Patient 1’s ventral hernia repair. These failures resulted in Patient 1 undergoing an additional abdominal surgical procedure to remove the retained surgical mesh scaffolding under general anesthesia (GA - medical treatment that uses medications to make patient unconscious) which had the potential for infection and adverse health outcomes. Findings: 1. During a review of Patient 1’s “General Surgery Consultation (GSC),” dated 10/29/24, the GSC indicated Medical Doctor (MD) 1 advised Patient 1 to undergo a ventral hernia repair surgical procedure. The GSC indicated Patient 1 had a history of coronary artery disease (CAD - arteries that supply blood to the heart become narrowed or blocked) and had a coronary artery bypass graft (CABG -surgical procedure to improve blood flow to the heart). During a review of Patient 1’s “Informed Consent for Surgical, Diagnostic or Therapeutic Procedure (IC),” dated 11/15/24 at 7:10 a.m., the IC indicated Patient 1 signed the IC for surgical procedure “laparoscopic [minimally invasive surgical procedure] possible open [incision in abdomen] Repair of Ventral Hernia with mesh.” During a review of Patient 1’s “Operative/Procedures (OP),” dated 11/15/24 at 9:53a.m.m, the OP indicated, “Operation Repair Hernia Ventral Laparoscopy, with mesh. . . Complications Scaffold of mesh left intraperitoneal [inside the abdomen].” was performed by MD 1 [primary surgeon] and MD 2 [surgical resident - a doctor who has completed medical school and is training in surgical specialty]. The OP indicated MD 1 documented an addendum at 9:57 a.m. MD 1’s addendum indicated, “I [MD 1] was present till the mesh was placed and then left the Room and was immediately available if the need arose. Electronically Signed [by MD 1] on 11/15/24 9:58 AM.” During a concurrent interview and record review on 1/2/25 at 10:41 a.m. with RN 1, Patient 1’s “Surgical Documentation (SD),” dated 11/15/24 was reviewed. The SD indicated MD 1 was in the operating room (OR) from 7:50 a.m. to 8:49 a.m. MD 2 was in the OR from 7:50 a.m. To 9:03 a.m. The SD indicated the procedure performed was “Repair Hernia Ventral Laparoscopy with mesh.” RN 1 stated MD 1 left the OR after the mesh was secured in Patient 1’s abdomen. RN 1 stated MD 2 closed the abdominal surgical incisions. During a concurrent interview and record review on 1/2/25 at 11:41 a.m. with MD 3, Patient 1’s “Preanesthesia Evaluation (PAE),” dated 11/15/24 at 7:33 a.m. was reviewed. The PAE indicated Patient 1 had a medical history of hypertension (high blood pressure), CAD, CABG, peripheral artery disease (PAD - arteries that supply blood to the legs and arms become narrowed or blocked), and ischemic cardiomyopathy (condition when heart muscle is damaged due to reduced blood supply). MD 3 stated every time a patient goes under GA there were risks and factors that needed to be considered including cardiac and respiratory instability and loss of airway. MD 3 stated administering GA was challenging when there was risk for cardiac instability. MD 3 stated there were many risk factors to consider prior to Patient 1’s return to surgery and beforeadministeringg GA which included the half life of medications (the time it takes the amount of a drug’s active substance to reduce by half strength) given in previous surgery, if a reversal medication (used to reverse sedatives or narcotics) was given and risks for the airway obstruction. MD 3 stated Patient 1’s cardiac status could become unstable and Patient 1 was a risk for forming blood clots post operatively. During an interview on 1/2/25 at 1:30 p.m. with MD 2, MD 2 stated he had used the surgical mesh with scaffold used on Patient 1, approximately 10 times in the last four years. MD 2 stated under the direct supervision of MD 1, he placed the mesh in Patient 1’s abdomen, tacks were used to secure the outer edge of the mesh, then he deflated the scaffolding to prepare for removal from Patient 1’s abdomen. MD 2 stated he started to remove the scaffolding through the trocar (a surgical instrument used in minimally invasive surgery) incision site, when MD 1 told him to stop and remove the scaffolding later. MD 2 stated the scaffolding was left in Patient 1’s abdomen while tacks were placed to secure the middle area of the mesh. MD 2 stated they closed the hernia incision, then went back into Patient 1’s abdomen through the trocars to check the mesh placement and placed more tacks. Once completed, MD 2 stated he was told by MD 1 to close the patient’s surgical incisions, then MD 1 broke scrub (removed sterile gown and gloves) and left the OR. MD 2 stated the routine process, when surgical mesh with scaffolding was used, included placement of the tacks around the edge of the mesh, deflate and then remove the scaffold from the abdomen through the trocar incision site. MD 2 stated once the scaffold was removed the center of the mesh was to be tacked. MD 2 stated he realized the scaffold had not been removed from Patient 1’s abdomen after Patient 1 had transferredd to post anesthesia care unit (PACU - nursing unit where patient starts to wake up from anesthesia). MD 2 stated he immediately notified MD 1 of the retained scaffolding and Patient 1 was returned to OR, placed under GA and a surgical procedure to retrieve the retained scaffolding (approximately one hour later) was performed. MD 2 stated if the scaffolding had remained in Patient 1’s abdomen the patient could have developed an infection, adhesions (scar tissue that forms between internal organs and tissue) or even a bowel obstruction (a serious condition when the small or large intestine is blocked, preventing food, liquid, gas, and stool from passing). During an interview on 1/2/25 at 1:50 p.m. with MD 1, MD 1 stated MD 2 reported, after Patient 1 was taken to PACU, that the mesh scaffold was not removed from Patient 1’s abdomen during the surgical repair of a ventral hernia. MD 1 stated as the attending surgeon, he was responsible for the outcome of the surgery, and for ensuring the scaffolding was removed from Patient 1’s abdomen. During a review of the “Ventralight ST [soft tissue] Mesh [used for Patient 1’s ventral hernia repair] with Echo PS [mesh positioning system] Instructions for Use (IFUs),” dated 11/2022, the IFUs indicated “Warnings. . . 11. Ventralight ST Mesh is the only permanent implant component of the device. The Echo PS Positioning System [used during Patient 1’s ventral hernia repair]. . . must be removed from the patient and appropriately discarded. It is not part of the permanent implant. . . Precautions. . . 4. Visualization must be maintained throughout the course of the entire procedure. Additionally, laparoscopic removal of the Echo PS Positioning System must be performed under sufficient visualization of the entire device and surrounding anatomy to ensure proper removal. Once the positioning system is verified to be fully intact, discard the Echo PS Positioning System appropriately.” During a review of the “Association of periOperative Registered Nurses [RN] [AORN] eGuidelines+ Guidelines for Perioperative Practice: Retained Surgical Items,” dated 1/9/25, the AORN guidelines indicated, “Surgeons and surgical first assistants should actively participate in safety measures to prevent RSIs [retained surgical items]. The surgeon and surgical first assistant should. . . maintain awareness of the location of items in the surgical wound during the course of the procedure; communicate placement of surgical items in the wound to the perioperative team for notation in a visible location (eg, the count board); . . . perform a methodical wound exploration before closing the patient, using both visualization and touch when feasible; notify the scrub person and RN circulator about surgical items returned to the surgical field to complete the final count; . . . participate in count reconciliation activities.” During a review of the hospitals “Medical Staff Rules and Regulations (R&R),” dated 7/24/24, the R&R indicated, “2.2 Responsibilities of Attending Physician: (a) The attending physician will be responsible for the following while in the District [hospital system]: (1) the medical care and treatment of the patient while in the District including appropriate communication among the individuals involved in the patient’s care.” 2. During an interview on 1/2/24 at 10:25 am with Surgical Technician (ST - assists during surgical procedure), ST stated he was in the OR for Patient 1’s ventral hernia repair procedure on 11/15/24. St stated MD 1 was the only surgeon who used the surgical mesh implant (medical item that stays inside the patient) with the scaffold. ST stated the scaffolding around the mesh was not part of the implant and was to be removed from the patient after use and before closing the surgical incisions. ST stated the mesh scaffold was not included in surgical counts. ST stated the mesh scaffold should have been included in the surgical count since the scaffold goes went into Patient 1’s abdomen during the procedure and was not to remain inside the abdomen permanently. ST stated if the scaffolding was included in the surgical count, the surgical team would have had to verify removal of the scaffold before closing Patient 1’s surgical incisions. ST stated he did not verify the scaffold was removed at the end of Patient 1’s surgical procedure. During a concurrent interview and record review on 1/2/25 at 10:52 a.m. with RN 1, Patient 1’s “SD Counts Verification - OR (CV),” dated 11/15/24 was reviewed. RN 1 stated the mesh scaffold was not included in the surgical counts for Patient 1’s procedure. RN 1 stated the mesh scaffold should have been included in Patient 1’s initial and final surgical count. During a review of the “Association of periOperative Registered Nurses eGuidelines+ Guidelines for Perioperative Practice: Retained Surgical Items,” dated 1/9/25, the AORN guidelines indicated, “Surgeons and surgical first assistants should actively participate in safety measures to prevent RSIs [retained surgical items]. The surgeon and surgical first assistant should. . . maintain awareness of the location of items in the surgical wound during the course of the procedure; communicate placement of surgical items in the wound to the perioperative team for notation in a visible location (eg, the count board); . . . perform a methodical wound exploration before closing the patient, using both visualization and touch when feasible. . .participate in count reconciliation activities.” During a review of the hospitals policy and procedure (P&P) titled, “Sponge, Instrument and Sharps Count,” dated 3/29/21, the P&P indicated, “A consistent multidisciplinary approach for preventing retained surgical items will be used during all surgical and invasive procedures. . . IV. Counting Procedure For Sharps & Other Miscellaneous Items. . . 2. Miscellaneous items includes, but is not limited to, the following items: a. Scalpels and scalpel blades b. Cautery tips c. Hypodermic needles d. White Clips e. Suture reels.””

“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: 47444 Based on interview and record review, the facility failed to follow its “Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure” and “Interpreter Services” P&Ps for five of 12 sampled patients (Patient 2, Patient 6, Patient 5, Patient 18, and Patient 17) when informed consent (the process in which a healthcare provider educates a patient about the surgery and the risks, benefits, and alternatives [RBAs]) was not provided in a language they could understand prior to surgical procedure. These failures resulted in Patient 2, Patient 6, Patient 5, Patient 18, and Patient 17, not being given the opportunity to make an informed decision based on RBAs of procedure Findings: a. During a concurrent interview and record review on 1/3/25 at 10:22 a.m. with Registered Nurse (RN) 5, Patient 2’s “Patient Information (PI),” dated 12/30/24 and “Informed Consent for Surgical, Diagnostic or Therapeutic Procedure (IC),” dated 12/31/24, were reviewed. The PI indicated Patient 2’s preferred language was Spanish. The IC indicated Patient 2 signed the IC (English version) on 12/31/24 at 12:53 p.m. for a “Laparoscopic [minimally invasive surgery] cholecystectomy [removal of gallbladder], possible open [incision in abdomen] possible umbilical [bellybutton] hernia [hole in the abdominal wall] repair, possible mesh [mesh - material used to repair hole in the abdominal wall]” surgical procedure. The IC indicated Medical Doctor (MD) 4 signed Patient 2’s IC on 12/31/24 at 8:37 a.m., no documentation of use of interpreter or declination. RN 5 stated MD 4 signed Patient 2’s IC and there was no documentation an interpreter was used to explain the surgical procedure or the RBAs. of the surgical procedure to Patient 2. RN 5 stated Patient 2’s IC form was in English and Patient 2’s preferred language was Spanish. RN 5 stated when the IC form was completed in the hospital, the nurse can choose from an English or Spanish version. RN 5 stated she routinely used the English IC form because she was unable to read Spanish. b. During a concurrent interview and record review on 1/3/25 at 10:44 a.m. with RN 5, Patient 6’s “PI,” dated 1/3/25 and “IC,” dated 1/3/25 were reviewed. The PI indicated Patient 6’s preferred language was Spanish. The IC indicated Patient 6 signed the IC (English version) on 1/3/25 at 8:59 a.m. for “Right breast Mastectomy [removal of breast], Sentinel lymph node [the first lymph node (small bean-shaped structure in the body) in the drainage pathway] biopsy [tissue removed from the body]” surgical procedure. RN 5 stated there was no documentation an interpreter was used to explain the surgical procedure or the RBAs of the surgical procedure to Patient 6. During an interview on 1/3/25 at 10:56 a.m. with RN 3, RN 3 stated a certified healthcare interpreter is required when the medical provider explained RBA’s of procedures and obtained informed consent for surgery from patients whose preferred language was not English. c. During a concurrent interview and record review on 1/3/25 at 11:05 a.m. with RN 4, Patient 5’s “PI,” dated 1/3/25 and “IC,” dated 1/3/25 were reviewed. The PI indicated Patient 5’s preferred language was Spanish. The IC indicated Patient 5 signed the IC on 1/30/25 at 10:09 a.m. for “L4 [lumbar level four (middle backbone)] - S1 [sacral level one (lower backbone)] Posterior [the back] Spinal Instrumentation [use of medical devices to stabilize and support the spine] and Fusion [permanently joins two or more bones in the spine] with Decompression [removing bone or tissue to take pressure off of nerve in the spine].” RN 4 stated MD 6 signed Patient 5’s IC on 1/3/24 at 10:41 a.m. and there was no documentation an interpreter was used to explain the surgical procedure or the RBAs of the surgical procedure to Patient 5. During a concurrent interview and record review on 1/3/25 at 3:13 p.m. with RN 3, the hospitals “IC” form, Section II, was reviewed. The IC form indicated, “The following has been read or explained to me [patient] in order for me to decide whether to give consent to the surgery or special procedure being recommended.” RN 3 stated in addition to explaining the proposed surgical procedure and the RBA’s, the provider was responsible for ensuring the patient had the opportunity to read and understand the information on the IC form (including consent for photographing or other imaging of the procedure, presence of observers in the operating room, disclosure of social security number if implant used). RN 3 stated a patient whose preferred language was Spanish or language other than English, would likely not be able to read and understand the IC form written in English. RN 3 stated in the hospital and in the providers office, patients with preferred language Spanish needed to be provided an IC form written in Spanish. During an interview on 1/3/25 at 3:42 p.m. with RN 3, RN 3 stated providers were required to use the hospital IC form when obtaining patient consent for surgical procedure. RN 3 stated providers (in the hospital and in the providers office) were expected to follow hospital policies and procedures for obtaining informed consent, including use of an interpreter. 44134 d. During a concurrent interview and record review on 1/3/25 at 3:32 p.m. with RN 3, Patient 18’s “PI,” dated 4/5/24 and “IC,” dated 4/5/24 were reviewed. The PI indicated Patient 18’s preferred language was Spanish. The IC indicated, Patient 18 signed the IC (English Version) on 4/5/24 at 8:29 a.m. for “Laparoscopic/ Open Repair of Recurrent Ventral [front or belly area] Hernia with Mesh.” The IC indicated, there was no documentation an interpreter was used to explain the surgical procedure or the RBAs. of the surgical procedure to Patient 18. RN 3 stated Patient 18 should have received the Spanish version of IC and an interpreter should have been provided. e. During a concurrent interview and record review on 1/3/25 at 3:44 p.m. with RN 3, Patient 17’s “PI,” dated 5/10/24 and “IC,” dated 5/10/24 were reviewed. The PI indicated Patient 17’s preferred language was Spanish. The IC indicated, Patient 17 signed the IC (English Version) on 5/10/24 at 5:49 a.m. for “Laparoscopic possible open Repair of Ventral Hernia with Mesh.” The IC indicated, there was no documentation an interpreter was used to explain the surgical procedure or the RBAs. of the surgical procedure to Patient 17. RN 3 stated Patient 17 should have received the Spanish version of IC and an interpreter should have been provided. During a review of the hospitals policy and procedure (P&P) titled, “Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure,” dated 11/23/21, the P&P indicated, “3. It is the provider’s responsibility to obtain informed consent and to document this consent in the patient’s hospital medical record. . . 3. Capacity: a person’s ability to understand the nature and consequences of a decision and to make and communicate a decision, and includes in the case of proposed health care, the ability to understand its significant benefits, risks and alternatives. Procedure: . . . 2. The provider is responsible to document that this discussion occurred by signing the “Informed Consent for Surgical, Diagnostic or Therapeutic Procedure” (Informed Consent form) form prior to the procedure. . . 5. Considerations when completing Informed Consent Form: a. Prior to the initiation of the procedure, the provider performing the procedure will ensure that documentation is completed using the approved Informed Consent Form and is placed in the patient’s medical record.” During a review of the hospitals P&P titled, “Interpreter Services,” dated 2/27/23, the P&P indicated, “A. [hospital name] recognizes that individuals and Health Care Providers must be able to communicate effectively. When language barriers exist between providers and patients, the quality of information is diminished and the outcome of the patient encounter may be unsatisfactory. This may lead to decreased patient compliance and increased potential for medical errors and misdiagnosis. . . C. . . The following types of encounters and procedures which are performed by providers who do not speak the primary language spoken by the patient/surrogate decision-maker, and which require the use of healthcare interpreter services, including, but not limited to: . . . f. Explaining any medical procedures, tests or surgical interventions; . . . i. Obtaining informed consent.” During a review of the hospitals “Medical Staff Rules and Regulations (R&R),” dated 7/24/24, the R&R indicated, “3.2. Content and Timeliness of Medical Record Documentation . . . (f) Informed Consent: Informed consent is required prior to surgery and prior to special diagnostic or therapeutic procedures, including blood transfusion, in accordance with District [hospital system] policy. . . It is the responsibility of the practitioner ordering blood or performing the procedure to discuss with the patient or responsible party the risks, benefits, and alternatives of the procedure, and document this discussion in the patient’s medical record before performing any procedure that requires consent. The consent form is used to document this discussion.””

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 42344 The facility failed to meet the regulatory requirements for the Condition of Participation: §482.22 Medical Staff as evidenced by: Based on interview and record review, the facility failed to ensure one of three sampled patients (Patient 1) had the correct central line catheter (CL-an IV [intravenous] line inserted into a large blood vessel near the center of the body) for hemodialysis (remove waste products and excess fluid from the blood when the kidneys stop working properly) inserted. This failure resulted in Patient 1 having a second procedure to remove the incorrect central line and for the insertion of the correct CL for dialysis, which had the potential for delayed emergency dialysis. (Refer A-0347) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure safe quality healthcare in compliance with Conditions of Participation for Medical Staff.”

“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: 47444 The facility failed to meet the regulatory requirements for the Condition of Participation: §482.23 Nursing Services as evidenced by: Based on interview and record review, the hospital failed to ensure one of four sampled patients (Patient 14) was provided safe, competent nursing care when licensed nursing staff were not trained and evaluated for competency prior to inserting and using the post pyloric tube (PPT - tube inserted through the nose past the stomach to deliver nutrition and medications). This failure resulted in Patient 14 having an unintentionally retained stylet/guidewire which has the potential for significant negative health outcomes. (Refer to A-0385) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure safe quality health care, in compliance with Conditions of Participation for Nursing Services.”

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 42344 Based on interview and record review, the facility failed to ensure one of three sampled patients (Patient 1) had the correct central line catheter (CL-an IV [intravenous] line inserted into a large blood vessel near the center of the body) for hemodialysis (HD - remove waste products and excess fluid from the blood when the kidneys stop working properly) inserted. This failure resulted in Patient 1 having a second procedure to remove the incorrect central line and for the insertion of the correct CL for dialysis, which had the potential for delayed emergency dialysis. Findings: During an interview on 12/2/24 at 3:30 p.m. with Patient 1, Patient 1 stated he did not know why he had to have the catheter in his neck replaced. Patient 1 stated he did not recall the hospital telling him that they had made a mistake. During a review of Patient 1’s “INFORMED CONSENT FOR SURGICAL, DIAGNOSTIC OR THERAPEUTIC PROCEDURE (REV[ISED] 5/2024” the consent indicated, “I, [Patient 1], authorize and request (Post Graduate Year [PGY] 1 - a recent graduate from medical school in his/her 1st year of training) and associates of his/her choice and appropriate hospital personnel, including Advanced Practice Providers, to assist in performing the following medical/surgical procedure(s) on me: Vas-cath insertion [Vascular Catheter is a flexible tube inserted into a large vein typically in the neck or groin in situations requiring temporary dialysis for patients in kidney failure]” insertion, dated and signed by Patient 1 on 10/14/24 at 8:21 PM. During a review of PGY 1’s “ED Procedure Note” dated 10/14/24 at 10:28 PM, the note indicated under the procedure subheading, “Right IJ [Internal Jugular vein located on the side of the neck] Vas Cath Central Line Procedure Note. . .Indication: Emergent dialysis. . .Site: Internal Jugular Vein. . .Catheter type: Triple lumen [three channels and lumens] 7F [French - a unit of measurement for catheter size] vas cath. . .” During a concurrent interview and record review on 12/2/24 at 3:40 p.m. with the Chief Nursing Officer (CNO), Nurse Practitioner (NP) 1’s “Critical Care/Intensivist Procedure (CCIP)” note dated 10/15/24 at 3:15 a.m., indicated “Noticed Central Line 7F triple lumen 16cm [centimeters - length of catheter] was inserted in the RIJ instead of HD [hemodialysis] cath[eter]. Patient [1] has Emergency HD for uremia [buildup of waste products in your blood that occurs as a result of untreated kidney failure, without treatment uremia is fatal] and acidosis [build up of acid in the body as result of kidney failure]. . . Emergent catheter exchange was needed. . .Procedure Performed: central line exchange to Trialysis/Hemodialysis Line Placement R [Right] IJ. . .Pre-procedure diagnosis: urosepsis [life-threatening medical condition that occurs when a urinary tract infection spreads to the bloodstream and causes sepsis which is a dangerous response by the body to an infection that can lead to death] metabolic acidosis. . .Post-procedure diagnosis: urosepsis metabolic acidosis. . .Informed consent: Implied Emergent. . .” Patient 1 was informed about risks, benefits, and alternatives prior to signing the consent for the exchange of the CL’s. The CNO stated the disclosure of the error to the patient was not documented. During an interview on 12/3/24 at 11:30 a.m. with PGY 1 and Doctor of Osteopathy (DO) 1, PGY 1 stated she was asked to put in a Vas Cath for Patient 1. PGY 1 stated she removed a kit that she believed was a Vas Cath kit from the CL cart. PGY 1 stated the team did a time-out (a short pause prior to a procedure to confirm the correct patient, procedure and site) , but no one noticed the kit was not a Vas Cath kit. PGY 1 stated the procedure went well but she was not aware the incorrect catheter was inserted. DO 1 stated he was supervising PGY 1. He stated during the time out, he did not realize PGY 1 had the wrong CL kit. During an interview on 12/4/24 at 2:30 p.m. with the Director of Critical Care (DCC), the DCC stated she was involved in the investigation of the placement of the incorrect CL. DCC stated a CL not designed for hemodialysis was inserted into Patient 1 instead of a Vas Cath. DCC stated the facility had kits for both CL and hemodialysis that looked alike and the CL cart was not labeled effectively. During a review of Patient 1’s “Preprocedure [sic] Time-Out Universal Protocol (TOUP),” dated 10/14/24, the TOUP indicated, “Procedure Category ... Line Insertion, Other: vas cath insertion ... Product verified by proceduralist ... yes ... Name of Product Read Aloud ...Yes.” During a review of Patient 1’s “ED Procedural Note (EDPN),” dated 10/14/24, the EDPN indicated, “Procedure: Right IJ (Internal Jugular - a vein that collects blood from the brain and delivers it to the heart) Vas Cath Line Procedure ... Catheter type: Triple lumen 7 fr vas cath ... a ‘time out’ was completed to ensure correct patient ... The CVL [central venous line] was inserted ... the guidewire was removed ... A portable CXR [chest x ray] was ordered.” During a review of Patient 1’s “Critical Care / Intensivist Procedure (CCIP),” dated 10/15/24, the CCIP indicated, “Noticed Central Line 7F triple lumen 16 cm [centimeter] was inserted in the R [right] IJ instead of HD [hemodialysis -dialysis using blood in the veins] cath. Patient has Emergent HD for uremia [build up of toxins in blood] and acidosis [blood is acidic] ...Emergent catheter exchange was needed ...Procedure Performed: central line exchange to [brand name]/Hemodialysis Line Placement R IJ.” During a review of the facility’s policy and procedure (P&P) titled, “Surgical/Procedural Site Verification (Universal Protocol),” approval date 1/10/20, the P&P indicated, “Procedure: I. Conduct a preoperative/pre-invasive procedure verification process in all settings ... B. A preoperative/preprocedure [sic] verification checklist (hard copy or electronic) is used to review and ensure availability of the following items prior to the start of the procedure. The electronic verification checklist is retained as part of the medical record ... 4. Confirming the on-site availability of any required implants, devices, and/or special equipment for the procedure.” During a review of the facility’s P&P titled, “Sentinel Event and Adverse Event Response and Reporting,” approval date 11/20/23, the P&P indicated, “PROCESS for Sentinel/Adverse events and near-misses ... G. The RM [Risk Management] Director (or designee) in collaboration with the patient’s physician, Chief of Staff (or designee) will ensure that an apology is offered and notice of the SE/AE [sentinel event/adverse event] is given to the patient involved, or the party responsible for the patient, of the nature of the Event by the time the initial report is made to CDPH [California Department of Public Health].””

“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: 47444 Based on interview and record review, the hospital failed to ensure one of four sampled patients (Patient 14) was provided safe competent nursing care when licensed nursing staff were not trained and evaluated for competency prior to inserting and using the post pyloric tube (PPT - tube inserted through the nose past the stomach to deliver nutrition and medications). This failure resulted in Patient 14 having an unintentionally retained stylet/guidewire which has the potential for significant negative health outcomes. Findings: During a review of Patient 14’s “History and Physical (H&P),” dated 10/4/24, the H&P indicated Patient 14 was brought to the emergency department (ED) with concerns of altered mental status. Patient 14 had a history of cerebral palsy (abnormal brain development disorder affecting movement), developmental mental delay, upper and lower extremity contractures (tightening of muscles), seizure disorder (abnormal electrical activity of the brain causing uncontrolled movements or loss of conciousness) and was non-verbal. A Computed Tomography (CT x-ray images of the body) of Patient 14’s abdomen was done and indicated concern for possible rectal cancer. During a review of Post Graduate Year ([PGY] 2 - a recent graduate from medical school in his/her 3rd year of training) “ED (Emergency Department) Note Physician *Final Report*”, dated 10/4/24 at 2:03 PM, the note indicated, “. . . I have assumed care of this patient. . .Workup thus far reveals sepsis (life threatening medical condition due to an extreme response to an infection). . .Dx’d (diagnoses) with a “tia [Transient Ischemic Attack - mini stroke] yesterday was discharged from the floor. Anticipated disposition is admit. . .” During a review of the “ORDER SHEET”, the Order Sheet dated 10/5/24 at 9:02 a.m., indicated, “Post Pyloric Feeding Tube Insertion.” On 10/5/24 at 9:02 a.m., the Order Sheet indicated, “Post Pyloric Feeding Tube Care. . .Confirm Placement with XR [x-ray] abdomen 1 view (KUB [Kidney Ureters Bladder]). . .After KUB confirmation remove metal stylet [guidewire] and keep at bedside. . .Ensure metal stylet is removed prior to sending patient to MRI. . .May reinsert metal stylet if tube gets slugglish/clogged. . .” During a review of the “[GI Tube] Flowsheet (GITF),” dated 10/6/24 through 10/19/24, the GITF indicated on 10/6/24 at 1 p.m., Registerd Nurse (RN) 1 inserted a small gauge tube (PPT) through Patient 14’s right nare (opening of nose). During a review of the “XR Abdomen KUB 1 View *Final Report*” dated 10/6/24 4:18 PM, indicated, “HISTORY. . .POST PYLORIC PLACEMENT. . .FINDINGS: There is a Dobbhoff tube seen, tip projecting over the left upper quadrant. . .” During a review of Patient 14’s Order Sheet dated 10/6/24, the OS indicated, “Tube Feeding Continuous. . . Nasogastric [PPT], Jevity [type of liquid nutrition] 1.2 Cal [calories], 24 hours, Start at 20 mL [milliliters]/hr [hour] and advance 10 mL q [every] 10 hr to goal rate of 50 mL x 24 hr/day.” During a review of the 10/16/24 at 11:59 a.m. “Adult Systems Assessment”, the Assessment indicated, “Unexpected Event. . .Other: guidewire in place since 10/6/24. . .” During a review of the “GITF,” dated 10/17/24 at 9:34 a.m., the GITF indicated, “Gastrointestinal Tubes. . . Unexpected Event Other: guide wire [sic] in place since 10/6/24.” During an interview on 12/2/24 at 3:04 p.m. with Registerd Nurse (RN) 1, RN 1 stated she inserted Patient 14’s PPT on 10/6/24. RN 1 stated she was able to insert the PPT but not in the correct position and informed the oncoming nurse but Physician (MD) was not notified. On 10/7/24, RN 1 received report the PPT was not advanced to place in the correct position. RN 1 notified MD who indicated to start the nutrition. She was aware the stylet (guidewire) was still in the PPT. On 10/8/24, RN 1 gave report to the night shift nurse informing the nurse of the need to remove the stylet if the patient was required to go for an Magnetic Resonance Imaging (MRI is a non-invasive imaging technique that uses radio wave and a powerful magnet to create detailed pictures of the inside of the body). RN 1 did not recall having training on insertion or use of the PPT product. RN 1 stated she did not notify MD of the guidewire remaining in the PPT when the nutrition was started. During an interview on 12/2/24 at 3:20 PM, with Licensed Vocational Nurse (LVN) 1, LVN 1 stated on 10/17/24, he was preparing to administer Patient 14’s medication through the PPT, when he prepared to flush with a syringe the stylet came back into the syringe. LVN 1 stated he discovered the guidewire still in Patient 14’s PPT on 10/17/24. LVN 1 stated he received assistance from RN 3, who successfully removed the guidewire. During an interview on 12/2/24 at 3:48 p.m. with Nurse Manager (NM) 1, NM 1 stated stated the guidewire was not to be left in the PPT while being used. NM 1 stated the guidewire was left in place in Patient 14’s PPT for 11 days. During an interview on 12/2/24 at 3:50 p.m. with Director of Medical Surgical Unit (DMS), DMS stated the PPT product is part of our new hire orientation, but not part of our annual competencies. During a concurrent interview and record review on 12/3/24 at 4:29 p.m. with Director of Talent Acquisition (DTA), RN 1’s personnel file (PF) was reviewed. The PF indicated RN 1 had a discussion for PPT insertion on 8/5/24. DTA stated the new hire competency checklist did not include documentation of training for guidewire removal and no demonstration of competency. During an interview on 12/3/23 at 10:09 a.m. with RN 2, RN 2 stated she assumed care of Patient 14 and did not recall having training for this type of PPT and had not inserted a PPT before. During a concurrent interview and record review on 12/3/24 at 4:37 p.m. with DTA, RN 2’s PF was reviewed. DTA stated the medical surgical core competencies are different since RN 2 was a traveler. DTA stated travel nurses come from their company with a checklist of competencies and the hospital has an abbreviated competency check list for travelers. DTA stated RN 2 did not have training for use of the PPT. During a concurrent interview and record review on 12/3/24 at 1:55 p.m. with Director of Clinical Education (DCE), the hospital’s “Medical Surgical Orientation Competency Checklist: Licensed Nurse and Student Nurse Intern (MSCC),” (undated) was reviewed. The MSCC indicated training for PPT insertion. DCE stated the checklist did not include guidewire removal before use. During a concurrent interview and record review on 12/3/24 at 2:33 p.m. with DCE, the hospital’s “Annual Competency 2024 3 South Medical Surgical (AC),” dated 2024, was reviewed. DCE stated training for PPT use was not included in the AC. During an interview on 12/4/24 at 9:05 a.m., with Physician (MD), he stated he did not recall being notified the stylet was retained and had not been removed when the nutritional feeding was started. When he placed the order (10/5/24) to start the feeding, he would have expected the stylet to have been removed due to possible occlusion, improperly functioning tube and aspiration. During a review of the hospital’s P&P titled, “Nutrition: Enteral Nutrition,” dated 10/30/23, the P&P indicated, “General Enteral Nutrition Management: . . . II. . . B. Small bowel/post-pyloric tubes: 1. Ensure that the metal stylet [guidewire] is removed after placement has been verified via radiograph [x-ray]. . . Tube Patency and Flushing Management: I. Prior to instilling nutrition/medications or flushes into any enteral tube the following will be considered: . . . C. Ensure metal stylet has been removed from small bowel/post-pyloric tubes prior to administering nutrition . . . Small Bowel - Post Pyloric Tube Monitoring: II. Insertion of a small bowel/post-pyloric feeding tube will be completed only by licensed staff. A. The metal stylet will be removed immediately after placement has been confirmed via radiograph. 1. . . a. Ensure metal stylet has been removed prior to administering nutrition. . . Potential Complications Non patent/blocked tube. . . F. Stylet still in place. . . E. Discontinue tube and call practitioner for orders.””

“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: 48901 Based on interview and record review, the hospital failed to ensure nurses followed national standards for the care of obstetric (OB- relating to pregnancy, labor, and delivery) patient for two of six sampled patients (Patient 1[mother] and Patient 2 [fetus baby still in the mother’s womb]) when: 1. Labor and Delivery (L&D- nursing unit caring for pregnant patients during labor and childbirth) Registered Nurse (RN) 1 did not follow the hospital’s policy and procedure (P&P) titled, “Oxytocin [Pitocin- used to cause or speed up labor contractions] Induction [start]/Administration for Induction/Augmentation [speed up].” When RN 1 started, maintained, or increased Pitocin infusion when the fetal heart rate (FHR) had minimal variability (range of changes is detectable but is less than or equal to 5 beats per minute [bpm]). and during signs of fetal distress (fetus not tolerating labor and/or delivery process, due to not receiving sufficient oxygen). (Refer A-398) 2. L&D RN did not follow the hospital’s P&P titled “Fetal Distress, management of,” when the OB Physician (doctor specializing in the care of women during pregnancy and delivery) 1 was not notified when the fetal heart rate (FHR) tracing (continuous method of recording the fetus’ heart rate and mother’s uterine (womb) contractions (tightening and relaxing of the womb muscles to cause labor to progress to delivery) (UCs) indicated fetal distress. (Refer A-398) 3. RN 1 did not monitor and record the FHR tracing (Category I- Normal tracing with a baseline rate of 110-160 beats per minute, moderate variability (variation in time between a fetus’s heartbeats), and possibly early decelerations. This category indicates a lack of fetal acidosis (serious condition that occurs when there is too much acid in the body’s fluids), and no intervention is required. Category II- Vaguely defined tracing that can indicate normal or rapidly developing acidosis. This category is present in most laboring patients. Key factors that make a Category II tracing non-reassuring include absent variability and increased depth and frequency of decelerations. Category III- Abnormal tracing that indicates a high risk of fetal acidosis. This category is characterized by absent variability, recurrent late (smooth, shallow dips in the FHR that can indicate the fetus is not getting enough oxygen) or variable decelerations, bradycardia, or a sinusoidal pattern. If immediate interventions don’t improve the tracing, delivery should be sped up) or UCs (strength, frequency, and duration) every 15 minutes when Patient 1 was receiving Pitocin. (Refer A-398) These failures resulted in Patient 1 undergoing an emergency cesarean section (surgical method of delivering a baby) and the “unexpected neonatal [newborn] death” of Patient 2. The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure nursing services were provided in a safe manner, patient care need were being met, and had the potential to contribute to Patient 2’s death.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 39356 Based on interview and record review, the hospital failed to follow their policy and procedures (P&P) titled, “Radiology-Pregnant Patient” and “Patients’ Rights and Responsibilities, and Non-Discrimination” for one of three sampled patients (Patient 3) when Medical Staff did not inform Patient 3 of a positive pregnancy test or provide the risk, benefits or alternatives prior to having a radiological procedure while pregnant. This failure resulted in hospital staff performing a computed tomography (CT, medical imaging technique) on Patient 3 without Patient 3 knowing her pregnancy diagnosis, and being informed of the risks, benefits, and alternatives of exposure to radiation to an unborn child. Findings: During a review of Patient 3’s “ED Note Physician Final Report” (EDPN), dated 5/31/24 at 11:51 a.m. the EDPN indicated, on 5/13/24, at 10:27 am, Patient 3, a 34 year old female) came to the emergency department (ED) because of pain and possible abscess (painful swollen lump filled with pus) or cyst (cavity filled with fluid). The physician ordered a CT exam for further evaluation. During a review of Patient 3’s EDPN, the EDPN indicated, “Sensitive Lab Results Latest Results Beta HCG [beta-human chorionic gonadotropin - hormone that can be detected in the blood or urine during pregnancy] Serum Qualitative [blood test that gives result pregnancy as a positive or negative] 5/31/24 14:49 [2:29 p.m.] Weak Pos [positive for pregnancy].” During a review of Patient 3’s “CT” results dated 5/31/24 at 8:30 p.m. the CT indicated, “Report Exam: CT Pelvis Indication: concern for left perineal abscess, concern for left perineal abscess [sic]” During a concurrent interview and record review on 10/29/24 at 10:15 a.m. with Assistant Nurse Manager Emergency Department (ANMED), Patient 3’s electronic health record (EHR) was reviewed. ANMED stated Patient 3’s physician notes did not have documentation of a Patient 3’s positive pregnancy test. ANMED stated the process was a patient should not be taken for a CT scan until the pregnancy test has been confirmed. During a concurrent interview and record review on 10/29/24 at 10:30 a.m. with ANMED, and Imaging Service Manager of Radiology (ISMR), Patient 3’s EHR was reviewed. ISMR stated the process was to confirm pregnancy status for any female up to age 55 prior to a CT exam for the pelvis or abdomen. ISMR stated the provider should review the risks and benefits and alternatives of having a CT performed while pregnant. ISMR reviewed Patient’s EHR and stated Patient 3 had not signed an informed consent. ISMR stated the informed consent should have been completed prior to Patient 3’s CT scan. ADMED stated the expectations would be the results of the positive pregnancy test be communicated to Patient 3. During an interview on 10/29/24 at 2:15 p.m. with Patient 3, Patient 3 stated no one from the hospital informed her of her positive pregnancy test. Patient 3 stated she was concerned she might be pregnant when she arrived at the emergency department and she notified her (unidentified) provider. Patient 3 stated when she was being transferred to the CT exam, she had asked the (unidentified) technologist, if her pregnancy test results were available. Patient 3 stated, the unidentified technologist responded “Oh, you thought you were pregnant?” Patient 3 stated the unidentified technologist then assured her results of the pregnancy test were negative. During a concurrent interview and record review on 10/29/24 at 2:30 p.m. with Medical Doctor (MD) 3, MD 3 reviewed Patient 3’s EHR. MD 3 stated multiple providers took care of Patient 3 on 5/31/24. MD 3 stated any patient of child-bearing age would be checked for positive pregnancy prior to a CT. MD 3 stated the risks and benefits would be discussed by the provider, then the patient could make a decision as to whether or not to have the CT exam. MD 3 stated the Radiology department had a form for the patient to sign if they were pregnant before they proceed with the CT exam. MD 3 stated it was safe to say the physicians providing care to Patient 3 were not aware Patient 3 was pregnant as it had not been documented in the EHR. MD 3 stated if he was aware of Patient 3’s pregnancy then he would have ordered a quantitative pregnancy test (measures the amount of hormone HCG in your blood). During a review of the hospital’s P&P titled, “Patients’ Rights and Responsibilities, and Non- Discrimination,” dated 9/6/23, the P&P indicated, “1. Patient Rights A. . . . 4. Receive information about their health status, diagnosis, prognosis, course of treatment, prospect for recovery and outcomes of care (including unanticipated outcomes) in terms the patient can understand. The patient has the right to effective communication and to participate in the development and implementation of their plan of care. The patient has the right to participate in ethical questions that arise in the course of their care, including issues of conflict resolution, withholding resuscitative services, and foregoing or withdrawing life-sustaining treatment.” During a review of the hospitals P&P titled, “Radiology - Pregnant Patient” dated 1/10/24, the P&P indicated, “Policy: Prior to administering any imaging study which includes exposure to radiation (diagnostic radiology), Computed Tomography (CT), Radioisotopes (Nuclear Medicine) or Magnetic Resonance Imaging (MRI), staff will follow the following guidelines to assure potential risks are reviewed. This will include ALARA, (as low as reasonably achievable) standards are taking place on patients who may be pregnant. II. Procedure for CT Pregnant Patients: A. For female patients ranging in age from puberty, 12 years to 50 years, prior to administering any contrast or ionizing radiation, the technologist will ask if the patient is or could be pregnant. B. If patient can confirm they are not pregnant, technologists will note this on the ordering requisition and document the electronic health record (EHR) in Cerner when completing the order. C. If patient is unable to confirm or deny pregnancy, ordering LIP must obtain a urine or blood pregnancy test ONLY if the X-ray beam goes through the abdominal and pelvic area. Consult with LIP for risk versus benefit. IF LIP determines to move forward, LIP will document in EHR. . . E. If results are negative, the technologist may proceed with scan/procedure. F. If results are positive for pregnancy, the technologist must consult a radiologist or the LIP... If the radiologist or LIP decide to proceed with the exam, the patient must sign the Pregnancy Consent for Abdominopelvic CT during Pregnancy form when able (see Appendix B). If patient is unable to sign pregnancy declaration form and physician feels the benefits outweighs the risk to the fetus, physician may decide to move forward. CT technologist will document decision and physician name in EHR.””

“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: 48901 Based on interview and record review, the hospital failed to ensure nurses followed national standards for the care of obstetric (OB- relating to pregnancy, labor, and delivery) patient for two of six sampled patients (Patient 1[mother] and Patient 2 [fetus baby still in the mother’s womb]) when: 1. Labor and Delivery (L&D- nursing unit caring for pregnant patients during labor and childbirth) Registered Nurse (RN) 1 did not follow the hospital’s policy and procedure (P&P) titled, “Oxytocin [Pitocin- used to cause or speed up labor contractions] Induction [start]/Administration for Induction/Augmentation [speed up].” When RN 1 started, maintained, or increased Pitocin infusion when the fetal heart rate (FHR) had minimal variability (range of changes is detectable but is less than or equal to 5 beats per minute [bpm]). and during signs of fetal distress (fetus not tolerating labor and/or delivery process, due to not receiving sufficient oxygen). 2. L&D RN did not follow the hospital’s P&P titled “Fetal Distress, management of,” when the OB Physician (doctor specializing in the care of women during pregnancy and delivery) 1 was not notified when the fetal heart rate (FHR) tracing (continuous method of recording the fetus’ heart rate and mother’s uterine (womb) contractions (tightening and relaxing of the womb muscles to cause labor to progress to delivery) (UCs) indicated fetal distress. 3. RN 1 did not monitor and record the FHR tracing (Category I- Normal tracing with a baseline rate of 110-160 beats per minute, moderate variability (variation in time between a fetus’s heartbeats), and possibly early decelerations. This category indicates a lack of fetal acidosis (serious condition that occurs when there is too much acid in the body’s fluids), and no intervention is required. Category II- Vaguely defined tracing that can indicate normal or rapidly developing acidosis. This category is present in most laboring patients. Key factors that make a Category II tracing non-reassuring include absent variability and increased depth and frequency of decelerations. Category III- Abnormal tracing that indicates a high risk of fetal acidosis. This category is characterized by absent variability, recurrent late (smooth, shallow dips in the FHR that can indicate the fetus is not getting enough oxygen) or variable decelerations, bradycardia, or a sinusoidal pattern. If immediate interventions don’t improve the tracing, delivery should be sped up) or UCs (strength, frequency, and duration) every 15 minutes when Patient 1 was receiving Pitocin. These failures resulted in Patient 1 undergoing an emergency cesarean section (surgical method of delivering a baby) and the “unexpected neonatal [newborn] death” of Patient 2. Findings: 1. During a review of the hospital’s “Risk Management Report” (RMR), undated, the RMR indicated Patient 1 presented to the L&D Triage (method to determine which patients need to be seen and treated first) on 9/6/24 at 4:42 a.m. During a review of Patient 1’s Physician Orders (PO), dated 9/6/24 at 10:48 a.m. the PO indicated start Pitocin solution augmentation intravenously (through the vein) at 2 mU/minute and increase by 2 mU/minute every 30 minutes until regular UCs achieved. During a review of Patient 1’s FHR tracing (FHRT), the FHRT indicated the following: 9/6/24 at 11:36 a.m. RN 1 started Pitocin augmentation. FHR had minimal variability from 11:35 a.m. to 11:51:20 a.m. 9/6/24 at 12:10 p.m. Variable deceleration (decrease in heart rate) of FHR to 80 bpm taking 50 seconds to return to baseline of 140 bpm. 9/6/24 at 12:13:20 p.m. Variable deceleration of FHR to 110 taking 50 seconds to return to baseline of 140 bpm. 9/6/24 at 12:15 p.m. RN 1 increased Pitocin to 4 mU/minute. 9/6/24 at 12:24 p.m. Late deceleration of FHR, taking 90 seconds to return to baseline of 140 bpm. 9/6/24 at 2:36 p.m. to 2:48 p.m. FHR had minimal variability. 9/6/24 at 2:39 p.m. RN 1 increased Pitocin to 6 mU/minute. 9/6/24 at 3:07:10 p.m. UC started and lasted 120 seconds (UC during labor typically lasts between 30 and 70 seconds and may be around 45 to 90 seconds long and occur every 3 to 5 minutes as labor progresses) and ended at 3:09:10 p.m. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 3:09:40 p.m. UC started and lasted 120 seconds and ended at 3:11:40 p.m. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 3:12 p.m. UC started and lasted 120 seconds and ended at 3:14 p.m. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 3:22:30 p.m. to 3:51 p.m. FHR tracing sinusoidal (rare, ominous sign of severe fetal distress and impending death). Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 4:33:30 p.m. FHR variable deceleration. 9/6/24 at 4:53:30 p.m. FHR variable deceleration. 9/6/24 at 5:01:30 p.m. FHR variable deceleration. 9/6/24 at 5:06:50 p.m. FHR variable deceleration. 9/6/24 at 5:07:30 p.m. FHR prolonged deceleration began, return to baseline 140 bpm at 5:15:50 p.m. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 5:22:10 p.m. FHR variable deceleration. 9/6/24 at 5:24:30 p.m. FHR variable deceleration. 9/6/24 at 5:27:50 p.m. FHR variable deceleration. 9/6/24 at 5:30:50 p.m. FHR late deceleration. 9/6/24 at 5:33:30 p.m. FHR late deceleration. 9/6/24 at 5:35:30 p.m. FHR late deceleration. 9/6/24 at 5:40:20 p.m. FHR late deceleration. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 5:43:10 p.m. FHR variable deceleration. 9/6/24 at 5:47:20 p.m. FHR variable deceleration. 9/6/24 at 5:53:50 p.m. FHR variable deceleration. 9/6/24 at 5:57:30 p.m. FHR variable deceleration. 9/6/24 at 5:58:20 p.m. FHR late deceleration. 9/6/24 at 6:00:30 p.m. FHR late deceleration. 9/6/24 at 6:10:10 p.m. FHR late deceleration. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 6:13:20 p.m. FHR late deceleration. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 6:15:20 p.m. FHR late deceleration. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 6:18:10 p.m. Absent FHR variability. Recurrent variable and late decelerations. Category III. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 6:33 p.m. Absent FHR variability. Recurrent variable and late decelerations. Category III tracing continued. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 6:43 p.m. Oxytocin off. 9/6/24 at 6:18:10 p.m. Absent FHR variability. Recurrent variable and late decelerations. Category III. Oxytocin remained infusing at 6 mU/minute. 9/6/24 at 6:52 p.m. Emergency cesarean section called. 9/6/24 at 6:54 p.m. Patient 1 taken to L&D operating room. 9/6/24 at 6:56 p.m. Patient 1 in L&D operating room. 9/6/24 at 7:04 p.m. Infant delivered (Patient 2). During a review of Patient 1’s “Gynecology-Obstetrics” (GO) dated 9/6/24, the GO indicated, “Result Comments Resuscitation at Birth: Resuscitation record completed. 20 minutes of resuscitation done. Cooling measures [methods used to lower a newborn’s head or whole-body temperature to prevent further brain damage in newborns who were deprived of sufficient oxygen in the womb] initiated per provider, awaiting transport to tertiary care [specialized care delivered in a hospital or similar care setting].” During an interview on 10/28/24 at 9:40 a.m. with RN 2, RN 2 stated, “Patient [Patient 2] went into category two a few times; when a patient goes into category two, we need to intervene and notify the physician. We can also turn off the Pitocin.” During a review of the hospital’s P&P titled, “Oxytocin Induction /Administration for Induction/Augmentation” dated 10/2/24, the P&P indicated, “Policy: The Labor and Delivery RN will initiate and maintain Oxytocin infusions while monitoring patients for possible adverse reactions/results. Procedure. . . X. If Category II tracing and tachysystole, assist patient to lateral position and administer IV bolus. If unresolved consider the following: A. Discontinue if fetal distress or hypertonus and notify OB provider within 5 minutes that Oxytocin was discontinued. . . XI. Notify OB Provider should any of the following occur. . .C. Category III tracing, bradycardia, or tachycardia.” 2. During a review of Patient 1’s FHR tracing (FHRT), the FHRT indicated the following: 9/6/24 at 11:36 a.m. RN 1 started Pitocin augmentation. FHR had minimal variability from 11:35 a.m. to 11:51:20 a.m. The “Clinician Notification” (CN) dated 9/6/24 indicated Physician 2 was not notified of the Category II FHR tracing. 9/6/24 at 12:24 p.m. Late deceleration (smooth, shallow dips in the FHR that can indicate the fetus is not getting enough oxygen) of FHR, taking 90 seconds to return to baseline of 140 bpm. The CN dated 9/6/24 indicated Physician 2 was not notified of the FHR late deceleration. 9/6/24 at 2:36 p.m. to 2:48 p.m. FHR had minimal variability. The CN dated 9/6/24 indicated Physician 2 was not notified of the Category II FHR tracing. 9/6/24 at 3:07:10 p.m. UC started and lasted 120 seconds and ended at 3:09:10 p.m., followed by a UC which started at 3:09:40 p.m. and lasted 120 seconds and ended at 3:11:40 p.m. followed by a UC which started at 3:12 and lasted 120 seconds and ended at 3:14 p.m. The CN dated 9/6/24 indicated Physician 2 was not notified of UCs abnormal frequency and duration. 9/6/24 at 3:22:30 p.m. to 3:51 p.m. FHR tracing sinusoidal (rare, ominous sign of severe fetal distress and impending death) and indicated a Category III FHR tracing. The CN dated 9/6/24 indicated Physician 2 was not notified of the Category III FHR tracing. During an interview on 10/28/24 at 1:38 p.m. with RN 1 and RN 2, RN 2 stated variable decelerations, minimal variability, or absent variability can indicate fetal distress. RN 2 stated Patient 2’s FHR tracing went into Category II a few times. RN 2 stated the expectation is for the nurse intervene first, and then notify the physician, and try to document as events occur. RN 2 stated she did not talk to Physician 2 about every single Category II, and she should have had according to the facility policy. RN 1 stated the importance of notifying Physician 2 of these category changes is for Physician 2 to make a change to the plan of care if needed. RN 2 stated she reported to RN 3 during handoff and told RN 3 Physician 2 was aware of variables. RN 2 stated Physician 2 ordered for Patient 1 keep pushing. RN 2 stated her biggest concern was the Patient 1’s bleeding and pain and that had resolved. During an interview on 10/28/24 at 2:19 p.m. with Charge Nurse (CN) 2, CN 2 stated she remembers that she was told that Patient 1 had been bleeding in triage, and the strip did not look the best. CN 2 stated she looked at the fetal monitoring strip when there were variability and when there was none. CN 2 stated Physician 2 was in the unit, and she assumed Physician 2 was aware of Patient 1’s FHR variables. During a concurrent interview and record review on 10/28/24 at 3:59 p.m. with Nurse Manager Labor and Delivery (NMLD) Patient 1’s Clinician Notification “Flowsheet Print Request” (FPR) was reviewed. The FPD indicated there were no clinician notifications from 8:04 a.m. to 4:29 p.m. NMLD stated during a review of the medical record there is no documentation that RN 1 or RN 2 contacted Physician 2. NMLD stated the nurses should always communicate and document Category IIs to the MD and MD’s responses. During an interview on 10/29/24 at 12:27 p.m. with Physician 2, Physician 2 stated around 6:30 p.m. RN 3 called him that Patient 1 was fully dilated. Physician 2 stated he was not aware of the decelerations when Patient 1 was pushing, and he became aware after RN 3 called out for him. Physician 2 stated looking at the FHR tracing if at around 5:15 p.m. he was notified of the tracing he would have watched the tracing very closely and had ordered to stop the Pitocin and if no improvement he would have done an emergency C-Section. Physician 2 stated variable decelerations can indicate that Patient 2 is being deprived of oxygen. Physician 2 stated if Patient 1 had a C-Section sooner maybe Patient 2’s APGAR would have not been “as bad”. Physician 2 stated it seems Patient 1’s ruptured uterus happened late, possibly when pushing and when Patient 1 was screaming, but he is not sure. Physician 2 stated when Patient 1 is having variable decelerations, pushing needs to stop, Pitocin stopped, hydrate patient, give oxygen if needed, and if interventions are not working then a vaginal operative technique or C-Section. During an interview on 10/30/24 at 4:41 p.m. with Chief Medical Officer (CMO), CMO stated any change in patient condition needed to be communicated to the physician, the physician should understand changes that occur with patients to decide what the plan of care will be. During a review of the facility’s P&P titled, “Fetal Distress, Management of,” dated 7/3/24, the P&P indicated, “Policy: Nursing intervention during fetal distress will attempt to correct indeterminate and/or abnormal fetal heart rate patterns and support fetal physiological stability. Procedure: I. The RN will notify the obstetrician and the lead RN of any changes in maternal or fetal heart rate (FHR) status (i.e.: unstable maternal vital signs, FHR characteristics consistent with Category II or III tracings as defined by National Institute of Child Health and Human Development (NICHD) terminology. II. Nursing interventions will be to maximize uteroplacental blood flow, increase fetal oxygenation, and minimize hypoxic insult to the fetus. IV. For patients with persistent Category II tracing as defined by NICHD, where the RN has utilized all appropriate interventions and has notified the provider and the provider, and the provider indicates to continue with plan of care. If the tracing does not resolve to Category I and the RN remains concerned and has contacted the provider a 2nd time and either the provider does not respond or no change in the plan of care, then initiate the “Code EFM” algorithm [steps to guide RN of who to contact when concerned of patient].” 3. During a review of Patient 1’s FHR tracing (FHRT), dated 9/6/24 at 11:36 a.m., the FHRT indicated RN 1 started Pitocin augmentation. During a review of Patient 1’s Vital Signs, Labor Assessment, and Electronic Fetal Monitoring flow sheet (FS), dated 9/6/24, the FS indicated entries at 12 p.m., 12:30 p.m., 1 p.m., 1:30 p.m., 2 p.m., and 2:30 p.m. During a review of Patient 1’s Electronic Fetal Herat Rate Annotations (EFHRA), the EFHRA indicated Patient 1’s vital signs (blood pressure and maternal heart rate) were recorded every 30 minutes from 3:02 p.m. to until 6:22 p.m. No FHR tracing or UC assessments were documented. During a review of the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN- National organization which provides nursing guidelines for the care of obstetric patients and newborns) guidelines for induction and augmentation of labor, the guidelines indicated, “Frequency of Fetal Heart Monitoring Assessment Using Continuous Electronic Fetal Monitoring With oxytocin or risk factors every 15 min [minutes] with oxytocin. AWHONN supports development of interprofessional institutional policies, procedures, and protocols that outline responsibility for ongoing FHM documentation. Documentation should contain streamlined, factual, and objective information and should include but should not be limited to the following: A systematic admission assessment of the woman and fetus; Ongoing assessments of the woman and fetus, including FHR and uterine activity data; Interventions provided and evaluation of responses; Communication with the woman and her family or primary support person; Communication with providers; and Communication related to escalation of concerns” Retrieved from: https://ilpqc.org/ILPQC%202020+/PVB/Toolkit/FI/AWHONN%20Position%20Statement%20FH.pdf”

“CONTENT OF RECORD CFR(s): 482.24(c) The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient’s progress and response to medications and services. This Standard is not met as evidenced by: 48901 Based on interview and record review, the facility failed to ensure documentation was accurate and complete for two of 37 sampled patients (Patient 1 and Patient 2). This failure had the potential to miss important information for patient 1’s continuum of care due to inadequate documentation. Findings: During a review of Patient 1’s “Discharge Summary” (DS), dated 9/7/24 at 4:04 p.m. the DS indicated, Patient 1 admitted for induction of labor, at term with diagnosis of gestational HTN. Patient 1 progressed to complete dilatation (10 cm) and pushed [trying to deliver baby vaginally] for one hour. Patient 2 experienced sudden fetal distress without recovery, Patient 1 was taken to emergent cesarean section confirming uterine rupture. Baby [Patient 2] born with poor APGARS [medical assessment to evaluate the health of newborn] with need of prolong resuscitation. Baby transfer to [Facility 2]. Patient had 1000 ml [milliliters] of blood loss, she received 2 units of RBC [red blood cells - blood].” During a concurrent interview and record review on 10/29/24 at 9:27 a.m. with Nurse Manager for Labor & Delivery (NMLD), Patient 1 and Patient 2’s electronic fetal monitoring strips (FMS) and “Timeline of Events” (TOE), dated 9/6/24, were reviewed. The FMS had no annotations indicating the different variables [abnormal baby heart rates] and MD notifications. NMLD stated the FMS and TOE indicated the following on 9/6/24: a. Minimal variability (MV - low amplitude rage of less than or equal to 5 beats per minute [bpm]): 11:40 a.m. to 11:51 a.m. (11 minutes) Minimal variability. 12:44 p.m. to 12:48 p.m. (4 minutes) minimal variability. 1:32 p.m. to 1:35 p.m. (3 minutes) minimal variability. 2:37 p.m. to 2:48 p.m. (11 minutes) Minimal variability. b. Variable deceleration (VD - a sudden, noticeable decrease in the fetal heart rate of at least 15 bpm that lasts at least 15 seconds): 9:23 a.m. Variable deceleration. 9:26 a.m. Variable deceleration 9:30 a.m. Variable deceleration. 9:32 a.m. Variable deceleration. 12:10 p.m. Variable deceleration. 12:13 p.m. Variable deceleration. 12:25 p.m. Variable deceleration. 12:28 p.m. Variable deceleration. 1:20 p.m. Variable deceleration. 1:31 p.m. Variable deceleration. 2:36 p.m. Variable deceleration. 4:08 p.m. Variable deceleration c. Late deceleration (LD - a gradual decrease in a fetus’s heart rate that occurs after a uterine contraction): 10:44 a.m. Late deceleration. 1:01 p.m. Late deceleration. 1:04 p.m. Late deceleration. During a review of Patient 1’s “LABOR RECORD” (LR), dated 9/6/24, the LR indicated Registered (RN) 1 and RN 2 documented Variable Decelerations at 10 a.m. and 2:30 p.m. and Late Decelerations at 11 a.m. and 12:30 p.m. During an interview on 10/28/24 at 1:38 p.m. with Registered Nurse (RN) 1 and RN 2, RN 2 stated variable decelerations, minimal variability, or absent variability can indicate fetal distress. RN 2 stated Patient 1 went into Category 2 (an indeterminate tracing that is neither reassuring nor non-reassuring) a few times. RN 2 stated the expectation was for nurses to intervene first, then notify MD, and try to document as we (nurse) go. RN 2 stated she did not speak with MD 2 about every single Category 2. RN 2 stated, according to the facility policy she should have spoken to MD 2 every time Patient 1 had a Category 2 tracing. RN 1 stated the importance of notifying MD 2 of these category changes was for MD 2 to make a change to the plan of care if needed. During a concurrent interview and record review on 10/28/24 at 3:59 p.m. with NMLD Patient 1’s Clinician Notification “Flowsheet Print Request” (FPR) was reviewed. The FPD indicated there were no clinician notifications from 8:04 a.m. to 4:29 p.m. NMLD stated during a review of the medical record there is no documentation that RN 1 or RN 2 contacted the MD. NMLD stated the nurses should always communicate and document category 2s to the MD and MD’s responses. During a review of the facility’s policy and procedures (P&P) titled “Assessment and Documentation, Nursing: Acute Patient Care,” the P&P indicated, “Procedure: II. Principles of Documentation. . . Nursing documentation reflects communications, observations, decisions, actions, and outcomes related to patient-centered care. Information reflecting the nursing process, patient plan of care and other pertinent information are documented in the individual patient record in an ongoing, accurate, timely and legible manner. . . B. What to Chart. . . 6. Contacts with and outcomes of interactions with primary care providers. . . II. Documentation Elements. . . B. Documentation includes the status of the identified problems until they are resolved in the medical record or become inactive.””

“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: 47444 The facility failed to meet the regulatory requirements for the Condition of Participation: CFR §482.51 Surgical Services as evidenced by: 1. Based on interview and record review, the Hospital failed to follow their policy and procedure, “Surgical/Procedural Site Verification [a pause before a procedure to confirm the correct patient, procedure, and site],” for one of 32 sampled patients (Patient 32) when the signed informed consent (IC - process for health care provider to educate patient about the risks, benefits, and alternatives of a procedure) did not match the procedure performed. (Refer to A-0951) This failure resulted in Patient 32’s wrong site surgical procedure and had the potential for development of infection due to untreated abscesses (pockets of pus in tissues). 2. Based on interview and record review, the Hospital failed to ensure the correct informed consent (process for health care providers to educate patient about the risks, benefits, and alternatives of the planned procedure) was obtained for one of 32 sampled patients (Patient 32)’s prior to surgical procedure. (Refer to A-0955) This failure resulted in Patient 32 being unable to make informed medical decisions regarding the surgical procedure. The cumulative effect of these systemic problems resulted in the hospitals inability to ensure safe quality health care, in compliance with Conditions of Participation for Surgical Services.”

“PATIENT RIGHTS: EXERCISE OF RIGHTS CFR(s): 482.13(b) Patient Rights: Exercise of Rights This Standard is not met as evidenced by: 39356 Based on observation, interview, and record review, the hospital failed to ensure one of 32 sampled patients (Patient 27) was provided pain medication for a pain level of 8 out of 10 on the pain scale (pain assessment tool to measure pain level from 1-10, with 8-10 indicating severe pain). This failure resulted in Patient 27’s right to have pain managed to not be upheld. Findings: During a review of Patient 27’s “Emergency Documentation (EDT)” dated 8/19/24 at 7:01 p.m. the EDT indicated, “This patient is a 16 Years Old Male, with no reported past medical history, who is brought in by mother to the [ED] complaining of infection of left knee and antibiotic reaction. Patient reports that last week on 8/11/24 a car hit the front of his left quad. [quadriceps-leg muscle] He noticed on 8/15/24 an infection started and he had a fever, episode of emesis [vomiting], and no appetite.” During a review of Patient 27’s “ED (Emergency Department ) Triage Part 1 (EDT)” dated 8/19/24 at 4:37 p.m. the EDT indicated, “Numeric Pain Score (0-10): 8.” During a review of Patient 27’s “Orders (O),” dated 8/19/24, the “O” indicated, “ibuprofen )Motrin-pain medication) 400 mg [milligram - unit of measure] + 20 ml [milliliter-unit of measure], Oral [by mouth], Susp (suspension), every 6 hours, for 45 days, PRN [as needed], First Dose: 08/19/24 10:52 p.m.” During a review of Patient 27’s “Pain (P)” dated 8/19/24 at 11:45 p.m. the “P” indicated oral analgesic (pain relief) was given (over 7 hours after pain level assessment of 8). During a concurrent observation and interview on 8/28/24 at 10:50 a.m. with Patient 27 and Family Member (FM) 1, in Patient 27’s room, Patient 27 was lying in his bed with a large wound noted on left upper leg. Patient 27 stated he had been in a lot of pain. FM 1 stated the hospital could improve on providing pain medication and [Patient 27] was not provided pain medication until he was in his hospital room. During an interview on 8/28/24 at 2:05 p.m. with Assistant Nurse Manager (ANM), ANM stated the triage nurse would assess the pain level, and the physician would review the triage note and could implement an order for pain medication. ANM stated, severe pain (level 8-10) should be treated. During an interview on 8/29/24 at 10:45 a.m. with Triage Registered Nurse (TRN), TRN stated patient pain level is assessed when patient assessments are completed. TRN stated if a patient is in pain, a physician’s order can be obtained for a pain medication to be administered to the patient. TRN stated, once a pain medication order has been obtained, the patient would be administered the pain medication. During a review of the hospital’s policy and procedure (P&P) titled, “Pain Assessment and Reassessment, Standards for,” dated 10/20/22, the P&P indicated, “[Hospital] recognizes and upholds the rights of patients to have pain safely and effectively managed and to include the patient the family and/or the patient’s legal representative in the planning of the patient’s care. The patient has the right to request or reject the use of any or all modalities to relieve their pain. The presence and intensity of pain will be based on the patient’s self-report, physical examination and behavioral indicators in order to balance the need for pain control with the risk of over sedation. Patients will receive the best level of pain control that can be safety provided.” During a review of the hospital’s P&P titled, “Patients’ Rights and Responsibilities, and Non-Discrimination” dated 9/6/23, the P&P indicated, “1. Patient Rights . . . 9. Appropriate assessment and management of their pain, information about pain, pain relief measures and to participate in pain management decisions. The patient may request or reject the use of any or all modalities to relieve pain, including opiate medication, if they suffer from severe chronic intractable pain. The physician may refuse to prescribe the opiate [powerful pain reducing medication].” medication, but if so, the physician must inform the patient that there are physicians who specialize in the treatment of severe chronic pain with methods that include the use of opiates”

“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: 47444 Based on interview and record review, the hospital failed to develop and update individualized plans of care (IPOC- a plan to meet patient health care goals and needs) for one of 32 sampled patients (Patient 19). This failure had the potential for unmet care needs. Findings: During a review of Patient 19’s “History and Physical (H&P),” dated 7/13/24, the H&P indicated Patient 19 was admitted to the hospital on 7/13/24 for an “acute hip fracture [break] requiring urgent surgical intervention.” During a review of Patient 19’s “ OPERATIVE NOTE (ORTHOPEDIC SURGERY) [OPN],” dated 7/14/24, the OPN indicated “OPERATION: Right proximal femur closed reduction and fixation [procedure to fix a broken thigh bone].” During a review of Patient 19’s “Encounter Tracking Sheet (ETS - dates and timespatients areetransferredd between departments),” undated, the ETS indicated Patient 19 was admitted as in patient to “1 E [east] on 7/13/24 at 4:02 a.m. and to “4 S [south]” (medical surgical unit) on 7/13/24 at 12:09 p.m. Patient 19 was transferred to pre operative unit on 7/14/24 at 8:36 a.m. and returned to 4 south on 7/14/24 at 12:24 p.m. post operatively. During a concurrent interview and record review on 8/29/24 at 9:14 a.m. with Nurse Manager (NM), Patient 19’s “H&P,” dated 7/13/24 was reviewed. The H&P indicated Patient 19 was admitted to the hospital on 7/13/24 for an “acute hip fracture [break] requiring urgent surgical intervention.” NM was unable to provide an IPOC for fall risk and pain management implemented on 7/13/24. NM stated an IPOC for fall risk and pain management should have initiated on 7/13/24 following her admission assessment on the medical surgical floor. NM was unable to provide an IPOC for impaired skin integrity implemented on 7/14/24. NM stated an IPOC for impaired skin integrity should have been initiated following Patient 19’s surgery on 7/14/24. During an interview on 8/29/24 at 9:25 a.m. with Director of Medical Surgical unit (DMS), DMS stated the policy stated Registered Nurses (RN) must initiate the IPOC by the end of their shift. DMS stated the IPOC’s should be initiated at time of the patient’s admission assessment or within four hours of the patient arrival to the unit. During a review of the hospital’s policy and procedure (P&P) titled “Assessment and Documentation, Nursing: Acute Patient Care” dated 3/20/23, the P&P indicated, “Procedure: I. Nursing Assessment. . . D. Initial assessment and Admission History. . . 1. The function of the initial nursing assessment is to identify the assessment parameters and responsibilities needed to plan and deliver appropriate, individualized care to the patient. 2. Each patient undergoes an initial assessment by an RN [registered nurse] as soon as possible upon admission to the assigned unit, transfer from a higher level of care or post anesthesia care unit (PACU). 3. The admission history is completed within 24 hours upon admission to the assigned unit unless otherwise specified by department procedure. . . 5. The RN analyzes the data collected from the initial assessment and admission history to formulate a nursing diagnosis and individualized plan of care (IPOC) in collaboration with the patient and the interdisciplinary team. . . C. Shift Assessment and Interdisciplinary Plan of Care (iPOC): minimum frequencies. . . 2. Minimally, the plan of care is reviewed and revised as needed with documentation of outcomes conducted each shift.””

“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: 39356 Based on interview and record review, the Hospital failed to ensure their procedure titled, “Wound Care RN [Registered Nurse] [WN] Consult Priority Workflow (WCWF)” was implemented for one of 32 sampled patients (Patient 21) when WN consultation orders were not implemented timely. This failure had the potential for Patient 21’s pressure injuries to worsen. Findings: During a review of Patient 21’s “History and Physical (H&P),” dated 7/18/24, the “H&P” indicated Patient 21 was brought to the hospital due to unresponsive altered mental status. The assessment included sepsis (infection in the blood), hypothermia (low body temperature), hypoglycemia (low blood sugar), toxic metabolic encephalopathy (alteration in consciousness due to brain dysfunction), sacral decubitus ulcer (pressure ulcer that appear on skin over a bony region of the spine), stage III (wound to the lower back), history of CVA (cerebral vascular accident - stroke). During a review of Patient 21’s “Order Information (OI),” dated 7/18/24, the “OI” indicated, “Consult to Wound Care RN with follow up as needed.” During a review of Patient 21’s “Wound Care Progress Notes (WCPN),” dated 7/26/24 at 12:33 p.m. (six business days after initial wound care consultation order was placed) the WCPN indicated, “2. Sacrococcygeal (buttock) - Left Buttock Stage 4 [a full skin thickness skin loss that may extent to the muscle, bone, tendon, or joint].” During an interview on 8/27/24 at 1:04 p.m. with Wound Nurse (WN), WN stated She identified Patient 21’s stage 4 pressure injuries during the WN consultation on 7/26/24. WCN 1 stated the process for prioritization of wound care patients was coordinated each morning from a list of patients with wound care consultant orders. WN stated there are two to three wound nurses at the facility, therefore we must prioritize which patients are seen by the WN each day. WN stated patients with pressure injuries on admission should be seen within one to two days. WN stated patients with pending discharges or patients with urgent needs would be seen as next priority. WN stated patients with any wound care orders should be seen within five days. During a concurrent interview and record review on 8/27/24 at 1:30 p.m. with WN, the hospitals “Multiple Patient Task List - Wound Care (MPLWC)” dated 7/19/24 was reviewed. The MPLWC indicated, 54 patients were on the list to be seen for wound care and 32 patients were overdue for their wound care consultations. WN stated the MPLWC identified which patients had wound care consultant orders and through this list the WN prioritized which order patients would be seen. During a review of the Hospital’s procedure titled, “Wound Care RN Consult Priority Workflow” dated 7/19/24, the WCWF indicated, “1. Orders received for a wound consult. 2. Patients are auto placed on multi-task list. 3. Wound consults are reviewed on the Wound team’s multi-task list 4. Depending on priority selected on the wound consult order, the wound care RN will respond to wound consult orders in the following order: a. ASAP orders b. Pending discharge/Pressure injuries c. Urgent/Emergent phone calls/messages received d. Oldest consult date on multi-task list e. Requests while rounding on floors. 5. Wound Care RNs will attempt to consult on patients within 1-5 business days depending on the priority established in # 4.” During a review of the hospital’s policy and procedure (P&P) titled, “Wound: Prevention & Treatment of Wounds,” dated 4/05/24, the P&P indicated, “I. All patients are screened by a Licensed Nurse to determine the risk potential for pressure injury development and/or the presence of an existing pressure injury(s) and/or wound(s).””

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 47444 Based on interview and record review, the Hospital failed to follow their policy and procedure, “Surgical/Procedural Site Verification [TO - a pause before a procedure to confirm the correct patient, procedure, and site],” for one of 32 sampled patients (Patient 32) when the signed informed consent (IC - process for health care provider to educate patient about the risks, benefits, and alternatives of a procedure) did not match the procedure performed. This failure resulted in Patient 32’s wrong site surgical procedure and had the potential for development of infection due to untreated abscesses (pockets of pus in tissues). Findings: During a concurrent interview and record review on 8/28/24 at 11:32 a.m. with Surgeon, Patient 32’s “Surgical Progress Note” (SPN), dated 8/22/24 was reviewed. The SPN indicated Patient 32’s computed tomography (CT - special x-ray that produces 3D images) of abdomen and pelvis showed fluid in abdominal wall. Surgeon stated there were two suspected abscesses (pocket of pus in tissues or spaces inside the body), one in the left abdominal wall and one in the pelvis. Surgeon stated after reviewing the CT results, the surgical team decided to prioritize treatment of the left abdominal wall abscess. Surgeon stated she placed an order for a left abdominal wall abscess CT guided drain placement to be performed by an interventional radiologist (IR - a doctor who performs minimally invasive procedures guided by x-ray imaging). During a review of Patient 32’s “Order Information” (OI), dated 8/22/24 at 5:46 a.m. the OI indicated Surgeon placed an order for “stat [now] CT Percutaneous [through the skin] Drain of left abdominal wall abscess.” During a concurrent interview and record review on 8/28/24 at 11:49 a.m. with Registered Nurse (RN) 1, Patient 32’s “Informed Consent for Surgical, Diagnostic or Therapeutic Procedure” (IC) was reviewed. The IC indicated the procedure to be performed was “Imagining [sic] Guided Percutaneous Left abdominal wall abscess drain placement with procedural sedation [medications given to relax and calm the patient].” The IC indicated Patient 32 signed the IC on 8/22/24. RN 1 witnessed Patient 32’s signature and signed the IC on 8/22/24. IR 1 signed Patient 32’s IC on 8/22/24. RN 1 stated she created the IC form based on the order that was placed by the Surgeon. RN stated IR 1 did not inform her of any changes to the ordered procedure. During a concurrent interview and record review on 8/28/24 at 11:49 a.m. with RN 1, Patient 32’s “Preprocedure Time-Out Universal Protocol” (PTO), dated 8/22/24 at 12:15 p.m., was reviewed. The PTO indicated IR 1, RN 1, RN 2 and Certified Radiological Technologist (CRT) were present for the procedure time out. The PTO indicated: “Procedure Category Other: Abdominal drain” “Full Procedure Team Present for Timeout Yes” “Correct Patient Name and Date of Birth Yes” “Spoken Procedure Matches Written Cons [Consent] ... Yes” “Procedure SIDE Verified Yes” “Procedure SITE Verified Yes” “Procedure Site Marked & Visible PostDrape [after surgical field is prepared] Yes” “Relevant documentation reviewed Yes” “Proc. [procedure] Consent accurate/complete/Signed Yes” “Correct Patient Position Yes” “Diagnostic or radiology studies reviewed Yes” “All members involved in the proc [procedure] agree Yes” “Procedure Comments Site marked, draped and cleansed” RN 1 stated she read the procedure from the order (CT Percutaneous Drain Left Abdominal Wall Abscess). RN 1 stated IR 1 was present during the TO but was preparing for the procedure and not giving his full attention during the TO. During an interview on 8/28/24 at 2:58 p.m. with CRT, CRT stated he recalled the TO during Patient 32’s procedure was read as “left abdominal wall mass” thought it was odd, but did not think he (CRT) needed to clarify. During a concurrent interview and record review on 8/29/24 at 1:30 p.m. with IR 1, Patient 32’s “CT Percutaneous Drain Exam Report” (CTER) was reviewed. The CTER indicated reason for exam was “left abdominal wall abscess . . . Impression: Successful CT guided right transgluteal [buttock] approach perirectal [tissue around the buttocks] abscess drainage catheter placement . . .” signed by IR 1 on 8/22/24. IR 1 stated after he reviewed Patient 32’s CT results, IR 1 decided Patient 32’s pelvic abscess was of more concern. IR 1 stated he did not contact the ordering surgeon to discuss the change in planned procedure and did not place a new order for the perirectal drain placement. IR 1 stated he did not review the IC form prior to signing. IR 1 stated he did not notify RN 1 of change to Patient 32’s planned procedure (from left abdominal wall abscess drain placement to perirectal abscess drain placement) During an interview on 8/28/24 at 12:10 p.m. with Imaging Services Manager (ISM), ISM stated during the TO process, the procedure should be read from the IC form signed by the patient and the physician performing the procedure. ISM stated any member of the team should stop and ask questions when something does not seem right. ISM stated she had observed the TO process and there were opportunities for improvement. Team members should be “present”, use actively listening, and communicate during procedure time outs. During a review of the hospital’s policy and procedure (P&P) titled, “Surgical/Procedural Site Verification (Universal Protocol)” dated 1/10/20, the P&P indicated, “Procedure: . . . IV. Conduct final “Time Out” verification immediately before starting the procedure. A. . . Note: this includes at a minimum; a review of the patient (using two identifiers), signed informed consent, verifying the correct procedure(s), laterality [right or left], and site(s). . . C. Interactive verbal communication between all team members includes a verbal statement of “I agree” at the end of the Time Out. If anyone on the team is not in agreement with the information stated during the time out, or if there is a concern or question, the team member must express their concerns without hesitation. D. Any discrepancy is discussed and reconciled prior to starting the intended surgery or procedure. E. During the “Time Out,” other activities are suspended and all members of the team are focused on the active verification of the correct patient, procedure, site, and other critical elements. . . All areas within Surgical Services will also include the following elements in the time-out: 1. Reading from a verified, accurate procedure consent form.””

“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: 47444 2. Based on interview and record review, the Hospital failed to ensure the correct informed consent (process for health care providers to educate patient about the risks, benefits, and alternatives of the planned procedure) was obtained for one of 32 sampled patients (Patient 32)’s prior to surgical procedure. This failure resulted in Patient 32 being unable to make informed medical decisions regarding the surgical procedure. Findings: During a review of Patient 32’s “ED [emergency department] Note Physician” (EDNP), dated 8/11/24, the EDNP indicated Patient 32 was brought to the ED after a motor vehicle accident on 8/11/24, where he received an abdominal contusion (bruise due to direct blow or impact). During a concurrent interview and record review on 8/28/24 at 11:32 a.m. with Surgeon, Patient 32’s “Surgical Progress Note” (SPN), dated 8/22/24 was reviewed. The SPN indicated Patient 32’s computed tomography (CT - special x-ray that produces 3D images) of abdomen and pelvis showed fluid in abdominal wall. Surgeon stated there were two suspected abscesses (pocket of pus in tissues or spaces inside the body), one in the left abdominal wall and one in the pelvis. Surgeon stated after reviewing the CT results, the surgical team decided to prioritize treatment of the left abdominal wall abscess. Surgeon stated she placed an order for a left abdominal wall abscess CT guided drain placement to be performed by an interventional radiologist (IR - a doctor who performs minimally invasive procedures guided by x-ray imaging). During a review of Patient 32’s “Order Information” (OI), dated 8/22/24 at 5:46 a.m. the OI indicated Surgeon placed an order for “stat [now] CT Percutaneous [through the skin] Drain of left abdominal wall abscess.” During a concurrent interview and record review on 8/28/24 at 11:49 a.m. with Registered Nurse (RN) 1, Patient 32’s “Informed Consent for Surgical, Diagnostic or Therapeutic Procedure” (IC) was reviewed. The IC indicated the procedure to be performed was “Imagining [sic] Guided Percutaneous Left abdominal wall abscess drain placement with procedural sedation [medications given to relax and calm the patient].” The IC indicated Patient 32 signed the IC on 8/22/24. RN 1 witnessed Patient 32’s signature and signed the IC on 8/22/24. IR 1 signed Patient 32’s IC on 8/22/24. RN 1 stated she created the IC form based on the order that was placed by the Surgeon. RN stated IR 1 did not inform her of any changes to the ordered procedure. During a concurrent interview and record review on 8/29/24 at 1:30 p.m. with IR 1, Patient 32’s “CT Percutaneous Drain Exam Report” (CTER) was reviewed. The CTER indicated reason for exam was “left abdominal wall abscess . . . Impression: Successful CT guided right transgluteal [buttock] approach perirectal [tissue around the buttocks] abscess drainage catheter placement . . .” signed by IR 1 on 8/22/24. IR 1 stated after he reviewed Patient 32’s CT results, IR 1 decided Patient 32’s pelvic abscess was of more concern. IR 1 stated he did not contact the ordering surgeon to discuss the change in planned procedure and did not place a new order for the perirectal drain placement. IR 1 stated he did not review the IC form prior to signing. IR 1 stated he did not notify RN 1 of change to Patient 32’s planned procedure (from left abdominal wall abscess drain placement to perirectal abscess drain placement) During an interview on 8/28/24 at 12:10 p.m. with Imaging Services Manager (ISM), ISM stated the expectation was for IR 1 to discuss the changes made to the procedure with the ordering physician and change the IC to reflect procedure to be performed. During an interview on 8/29/24 at 1:00 p.m. with IR 2, IR 2 stated the expectation was for IR 1 to contact the ordering physician and discuss the proposed changes to the procedure, have the ordering physician change the order and obtain a new IC form for the planned procedure. During a review of the hospital’s policy and procedure (P&P) titled, “Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure,” dated 11/23/21, the P&P indicated “Policy: . . . 3. It is the provider’s responsibility to obtain informed consent and to document this consent in the patient’s hospital medical record before the provider is permitted to perform any procedure that requires consent. 4. The hospital’s role in the consent process is to verify the patient’s informed consent was obtained by the provider before the provider is permitted to perform the procedure. . . Procedure: . . . 2. The provider is responsible to document that this discussion occurred by signing the “Informed Consent for Surgical, Diagnostics or Therapeutic Procedure” (Informed Consent form) form prior to the procedure. 3. The hospital’s role is to verify that the informed consent discussion occurred.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 35649 The hospital failed to meet the regulatory compliance for §482.13 Condition of Participation: Patient’s Rights as evidenced by: 1. Based on observation, interview, and record review, the hospital failed to: Provide one of one sampled patient (Patient 2) information and direction in Spanish, the language Patient 2 understands, before the insertion of a Vascular Catheter (Vas Cath - a large vein access device) for Dialysis (a mechanical process to filter waste and water from the blood when the kidneys can no longer function) into Patient 2’s right jugular vein (large neck vein). Provide three of three non-English speaking sampled patients (Patient 31, Patient 32, Patient 33) the appropriate light blue-colored patient wristband indicating the patient’s preferred language to communicate. These failures resulted in a violation of Patient 2’s right to be informed and had the potential to result in staff being unaware of the patients’ (Patient 31, Patient 32, Patient 33) preferred language and the need for interpreter services. (Refer to A-0117) 2. Based on interview and record review, the facility failed to ensure three of 36 sampled patients (Patient 1, Patient 14, Patient 22), Informed Consents (the process in which a healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention) for “Central Line Insertion Procedure” were completed in accordance with the hospital policy and procedure. This failure resulted in Patient 1, Patient 14, and Patient 22 not being given the opportunity to weigh the risks and benefits of the procedure prior to the procedure. (Refer to A-0131) 3. Based on observation, interview, and record review, the hospital failed to ensure one of one sampled patient (Patient 35) was provided physical privacy in the Emergency Department (ED) Triage area (area used to assess patients’ severity of illness/injury within a short time and assigning priorities) when he verbalized his health issues to the Emergency Department Registered Nurse/Start Nurse (EDRN 5). This failure had the potential for other patients, family member, hospital staff and visitors to overhear the health issues of Patient 35. (Refer to A-0143) 4. Based on observation, interview, and record review, the facility failed to ensure one oxygen e-tank was stored safely and securely. This failure had the potential to result in injures to patient, staff, and visitors. (Refer to A-0144) 5. Based on interview and record review, the facility failed to ensure two of two sampled patients’ (Patient 17 and Patient 19) restraints (measure keep someone under control or within limits) were monitored every two hours, according to the facility’s policy and procedure. This failure had the potential to compromise the safety and comfort of Patient 17 and Patient 19 while on restraints. (A-0167) The cumulative effect of these systemic failures resulted in the hospital’s inability to ensure the provision of quality health care, in compliance with the Condition of Participation for Patient Rights.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 35649 The hospital failed to meet the regulatory compliance for §482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs as evidenced by the following: 1. Based on observation, interview, and record review, the hospital failed to have an effective infection prevention and control program to provide a sanitary environment and minimize the sources of infections for 346 admitted patients, and all emergency room patients as evidenced by: One of one sampled medical staff (Resident 2) did not use aseptic technique (methods used to prevent or reduce bacteria that cause disease on skin, tissue or surfaces) during the insertion of a Vascular Catheter (Vas Cath, large vein access device) for one of one sampled patient (Patient 2). Two of two sampled medical staff (MD 3 and Resident 2) contaminated the sterile (germ free) field during one sampled patient’s (Patient 2) Vas Cath insertion. One of one sampled medical staff (MD 3) did not use sterile water to clean the Vas Cath access site for one sampled patient (Patient 2). One of one sampled clean linen cart was uncovered, and additional items were stored on top of the clean linen cart. One of one sampled sink in Zone 6 had patient care items in the splash zone (area around sink which can be contaminated from water splash from drains and faucets). One of one sampled Registered Nurse (RN) 9 did not disinfect the medication vial’s (small bottle) septum (seal) prior to injecting the needle and drawing medication for one of one sampled patient (Patient 30). Medical supplies were stored on the floor. One of one sampled patient treatment chair was not cleaned between patients. Outside food was stored on the Central Line Cart. One of one sampled sharp (used needles, syringes, vials) container was maintained in a safe and sanitary manner and was properly disposed of. These failures had the potential to transmit infections to patients, staff and visitors. (Refer to A-0749) 2. Based on interview and record review, the hospital failed to ensure the Infection Preventionist provided Infection Prevention and Control Training to the Medical Staff. This failure has the potential to result in the Medical Staff unaware of current infection prevention and control practices. (Refer to A-0775) The cumulative effect of these systemic failures resulted in the hospital’s inability to adhere to infection control practices for the provision of a safe and sanitary environment for all patients, staff, and visitors in compliance with the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs.”

“EMERGENCY SERVICES CFR(s): 482.55 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 35649 The hospital failed to meet the regulatory compliance for §482.55 Condition of Participation: Emergency Services as evidenced by: Based on interview and record review, the hospital failed to: 1. Ensure one of one resident (Resident 1) in the first year of Emergency Medicine Residency Program (post-graduate training for physicians going for their specialty), under direct supervision, followed the procedure for central line (a flexible tube inserted into a large blood vessel that goes directly to the heart) insertion. This failure resulted in the guidewire to be retained in the right jugular vein (large neck vein) for one of one sampled patient (Patient 1). (Refer to A-1112) 2. Based on observation, interview, and record review, the hospital failed to provide Registered Nurses to function as Triage (process to prioritize the order in which patients will be treated based on the types of disease and severity) Nurses in the Emergency Department (ED) for patients seen on 4/29/24. This failure had the potential to result in these patients to not receive proper triage assessment and appropriate Emergency Severity Index (ESI - sorts patients into five groups from 1 [emergent] to 5 [least urgent] based on predicted acuity and resource needs) designation. (Refer to A-1112). 3. Ensure ED Registered Nurse (EDRN) 5 provided immediate triage assessment for one of one sampled patient (Patient 34) who presented to the ED with mid-sternum chest pain. This failure resulted in a delay of physician examination. (Refer to A-1112). 4. Ensure two of two EDRNs (EDRN 6 and EDRN 7) were familiar with the “Resident Directory” to determine whether the ED Residents possess the skills, knowledge, and training to perform certain procedures in the ED. This failure had the potential to result in adverse consequences if resident physicians perform procedures they were not competent and trained in. (Refer to A-1112). 5. Ensure EDRN 1 received adequate training when assigned to assist and monitor during insertion of a Vas Catheter (large vein access device) for one of one sampled patient (Patient 2). This failure resulted in EDRN 1 not recognizing the need to notify the physician when changes occurred during a procedure. (Refer to A-1112). The cumulative effects of these systemic failures had the potential to negatively impact health and safety of all patients seeking emergency care at the facility, in compliance with the Condition of Participation for Emergency Services.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the hospital failed to: a. Provide one of one sampled patient (Patient 2) information and direction in Spanish, the language that Patient 2 understands, before the insertion of a Vascular Catheter (Vas Cath - a large vein access device) for Dialysis (a mechanical process to filter waste and water from the blood when the kidneys can no longer function) into Patient 2’s right jugular vein (large neck vein). This failure resulted in a violation of Patient 2’s right to be informed. b. Provide three of three non-English speaking sampled patients (Patient 31, Patient 32, Patient 33) the appropriate light blue-colored patient wristband indicating the patient’s preferred language to communicate. This failure had the potential to result in staff being unaware of the patients’ preferred language and the need for interpreter services. Findings: a. During a review of Patient 2’s “Face Sheet (FS - a document that contains a summary of a patient’s personal and demographic information),” dated 4/29/24, the “FS” indicated, Patient 2 is a 58-year-old male, Hispanic/Latino, preferred Spanish language. During an interview on 4/29/24 at 2:15 p.m. with Resident 2 (first year doctor in Residency Program [training for doctors to go into their specialization]) and Emergency Department Physician (MD 3), they both stated they did not speak Spanish. During an observation on 4/29/24 at 2:16 p.m. with Resident 2 and MD 3 in Patient 2’s room, Patient 2 was on a gurney with the head of the gurney in an upright position. Resident 2 stated she was going “to lay him down.” Resident 2 did not speak to Patient 2 in Spanish to explain what she was going to do and laid the head of the gurney down. Resident 2 repositioned Patient 2’s head and turned his neck toward the left side, cleansed the right side of the neck with chlorhexidine (antiseptic - substance that inhibits the growth of microorganism) and covered Patient 2 with a full body drape without speaking with Patient 2 in Spanish. During a concurrent observation and interview on 4/29/24 at 2:50 p.m. with Resident 2 and MD 3 in Patient 2’s room, Resident 2 secured the placement of the triple lumen catheter with sutures (a stitch used to sew up a cut in a person’s body) without communicating in Spanish with Patient 2. Resident 2 ripped the plastic sheet from Patient 2’s neck and removed the full body drape from the patient without informing Patient 2 the procedure was over. There was no staff interpreter in the room nor a language line in Spanish to inform Patient 2 of what to expect during the procedure or asked Patient 2 how he was during the procedure. Resident 2 and MD 3 confirmed they did not speak in Spanish while providing treatment to Patient 2. During an interview on 4/30/24 at 10:25 a.m. with Emergency Department Registered Nurse (EDRN) 4, EDRN 4 stated when she had a Spanish-speaking patient, she would call an interpreter especially if she needed to ask more detailed questions to meet the patient’s needs. EDRN 4 stated during a procedure sometimes there is a need to keep the interpreter in the room or use the language line which is available 24/7. During a review of the hospital’s policy and procedure (P&P) titled, “Interpreter Services,” the P&P indicated, “It is the policy of the facility to provide, to the extent possible, the use of qualified interpreters or assistive devices whenever a language or communication barrier exists...A. The facility recognizes that individuals and Healthcare Providers must be able to communicate effectively. b. During a concurrent observation and interview on 5/1/24 at 9:46 a.m. with Patient 31 and Director of Emergency Department (DED), in Patient 31’s room, Patient 31 was in bed with his eyes closed. Patient 31 did not open his eyes when greeted and when Interpreter (IS) 1 explained the purpose of the visit. Patient 31’s family member was at the bedside and stated Patient 31 speaks Spanish and he was not at his best today. Patient 31 appeared lethargic and responded yes to every question asked by IS 1. Patient 31’s arm band was observed and DED stated Patient 31’s wristband was white in color with the patient’s name, birthdate, account number, and medical record number. DED stated there was no interpreter service contact information on the ID band. DED stated there was no light blue-colored patient wristband. During a concurrent observation and interview on 5/1/24 at 9:55 a.m. with Patient 32 and DED, in Patient 32’s room, Patient 32 was in bed, awake and responsive to questions. Patient 32’s family member was at the bedside. With IS 1 interpreting in Spanish, Patient 32 stated he speaks Spanish. Family member stated she was there to assist to interpret for the nurses when they come to the room. Patient 32 stated he was admitted today, and no one informed him about the availability of interpreter services. Patient 32 stated he was not provided with a number to contact for interpreter services if he needed one. DED checked Patient 32’s wristband and stated Patient 32 had a white-colored ID band with the patient’s name, date of birth, account number, and medical record number. DED stated there was no interpreter service contact information on the ID band. DED stated there was no light blue-colored patient wristband. During a concurrent observation and interview on 5/1/24 at 10 a.m. with Patient 33, DED, and IS 1 in Patient 33’s room. Patient 33 was in her bed and spoke in Spanish. With IS 1 interpreting in Spanish, Patient 33 stated she was not feeling well. Patient 33 stated, “Nobody really speaks Spanish here. I had to yell for the nurses to come and help me. They did not give me a call light to use. I just yell for them.” DED checked Patient 33’s wristband and stated Patient 33 had a white-colored ID band with the patient’s name, date of birth, account number, and medical record number. DED stated there was no interpreter service contact information on the ID band. DED stated there was no light blue-colored patient wristband. During a review of the hospital’s P&P, titled, “Interpreter Services,” dated 2/27/23, the P&P indicated, “...H. A patient is not required or expected to use friends or family members as interpreters because the use of such individuals may result in breach of confidentiality and reluctance from the patient to reveal personal information critical to the services to be provided...III. Inform Patients of their Right to Have Interpreter Services: a. If the patient speaks a language other than English at home, the statement informing patients of their rights to interpreter services will also be provided to patients in written form in their primary language. IV. Patient Wristbands: a. The wristband is light blue with the message: Dial ext. 8989 for Interpreter...b. To ensure that the preferred communication preferences follow the patient from department/facility to department/facility, a light blue wristband will be placed on the patient’s wrist (dominant arm) and secured to identify and visually communicate to all staff that the patient has requested interpreter services be provided during his/her stay. The procedure is applicable to all staff that initially register/admit the patient, as well as staff who provide patient care.””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 47734 Based on interview and record review, the facility failed to ensure three of 36 sampled patients (Patient 1, Patient 14, Patient 22), Informed Consents (the process in which a healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention) for “Central Line Insertion Procedure” were completed in accordance with the hospital policy and procedure. This failure resulted in Patient 1, Patient 14, and Patient 22 not being given the opportunity to weigh the risks and benefits of the procedure prior to the procedure. Findings: 1. During a concurrent interview and record review on 5/1/24 at 1:44 p.m. with Quality Manager (QM), Patient 14’s “Critical Care/Intervention Procedure Note (CC/IP),” dated 4/11/24 was reviewed. The CC/IP indicated, on 4/9/24, a Central Line Insertion Procedure (the insertion of a tube through the neck and into a large vein that connects to the heart) was performed on Patient 14. QM stated the medical records were reviewed and there was no informed consent found for Patient 14 prior to the procedure. 35649 2. During a concurrent interview and record review on 5/1/24 at 2:38 p.m. with Clinical Informaticist (CI) 2, Patient 1’s “History and Physical (H&P),” dated 3/14/24, was reviewed. The H&P indicated, Patient 1 had a central line inserted into the right jugular (large blood vessel in the neck connected to the heart) vein. CI 2 was unable to find a signed informed consent. During an interview on 5/2/14 at 8:30 a.m. with Risk Management Manager (RMM), RMM stated and validated Patient 1 did not have a signed informed consent for the central line insertion prior to the insertion. 32946 3. During a concurrent interview and record review on 4/30/24 at 4:06 p.m. with Clinical Risk Management Specialist (CRMS) and CI 2, Patient 22’s “Final Report (FR),” dated 2/1/24, was reviewed. The FR indicated, “Procedure: Central Line Placement & Ultrasound Guidance. . . Informed consent: Obtained from the surrogate decision maker.” The documentation regarding informed consent was not found for the Central Line Placement & Ultrasound Guidance. CI 2 was not able to provide documented evidence of a signed patient consent form for Patient 22. During a review of the hospital’s policy and procedure (P&P) titled, “Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure,” dated 11/23/21, the P&P indicated, “Policy:...3. It is the provider’s responsibility to obtain informed consent and to document this consent in the patient’s hospital medical record before the provider is permitted to perform any procedure that requires consent. 4. The hospital’s role in the consent process is to verify the patient’s informed consent was obtained by the provider before the provider is permitted to perform the procedure.” During a review of the facility’s policy and procedure titled, “Informed Consent for Surgical, Diagnostics, or Therapeutic Procedure,” dated 11/23/21, the P&P indicated, “Procedure: 1. The provider performing the procedure is responsible to conduct the informed consent discussion with the patient...2. The provider is responsible to document that this discussion occurred by signing the “Informed Consent for Surgical, Diagnostics, or Therapeutic Procedure,”...4. On behalf of the hospital, it is licensed staff who conducts the verification process, as a witness to the patient’s signature, and as a patient advocate.””

“PATIENT RIGHTS: PERSONAL PRIVACY CFR(s): 482.13(c)(1) The patient has the right to personal privacy. This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the hospital failed to ensure one of one sampled patient (Patient 35) was provided physical privacy in the Emergency Department (ED) Triage area (area used to assess patients’ severity of illness/injury within a short time and assigning priorities) when he verbalized his health issues to the Emergency Department Registered Nurse/Start Nurse (EDRN 5). This failure had the potential for other patients, family member, hospital staff and visitors to overhear the health issues of Patient 35. Findings: During a concurrent observation and interview on 4/30/24 at 8:40 a.m. with Patient 35 and EDRN 5, in the ED Triage check-in area, Patient 35 approached the ED glass-covered window where EDRN 5 was sitting. Patient 35 spoke to EDRN 5 in Spanish. EDRN 5 handed Patient 35 an ED complaint form but did not speak to Patient 35. EDRN 5 stated she did not speak Spanish and did not understand what Patient 35 said. EDRN 5 was trying to get someone on the phone who could interpret for Patient 35. EDRN 5 handed the phone to Patient 35 as Patient 35 discussed his presenting problem. It was noted there were several ED employees, including registration clerks, patients, and visitors in the triage area. At 8:48 a.m., Interpreter Service (IS) 1 arrived and personally spoke with Patient 35. Patient 35 talked about his health issues, audible to approximately five to six patients in line, and by patients/family members/visitors waiting and seated in the lobby/waiting area. During a concurrent observation and interview on 4/30/24 at 9:01 a.m. inside the triage area and by the counter where ED physician (MD 4) stays and examines the patients, two patients and two family members were seated, separated by a cloth folding screen, but not enclosed where everyone passing through the hallway could hear and see MD 4 interviewing and examining the patient. During an interview on 4/30/24 at 9:02 a.m. with Patient 36, Patient 36 and his family member stated they could hear everything the patient and the doctor were saying. During an observation and interview on 4/30/24 at 9:14 a.m. with Director of Facilities and Planning (DFP), using the facility’s measuring tape, DFP measured the distance from where Patient 35 was standing by the glass window to the next person in line, and stated the distance was three feet. DFP measured the distance from Patient 35 standing by the glass window to the patient/family seated on the right side of the wall. DFP stated the distance was six feet. DFP measured the distance from one patient to another separated by the folding screen in the medical screening area, DFP stated the distance was eight feet. During an interview on 4/30/24 at 9:45 a.m. with MD 4, MD 4 stated the triage area is not an “ideal set up.” During a review of the document Office for Civil Rights (OCR) HIPAA Privacy titled, “Incidental Uses and Disclosure,” dated 12/3/02, the document indicated, “Many health care providers and professionals have long made a practice to ensure reasonable safeguards for individuals’ health information - for instance: By speaking quietly when discussing a patient’s condition with family members in a waiting room or other public area...” During a review of the article of the US Department of Health and Human Services titled, “Does the HIPAA Privacy Rule require hospitals and doctor’s offices to be retrofitted, to provide private rooms, and soundproof walls to avoid any possibility that a conversation is overheard?,” dated 12/28/22, the article indicated, “Covered entities must implement reasonable safeguards to limit incidental and avoid prohibited, uses and disclosures. Covered entities must review their own practices and what steps are reasonable to safeguard their patient information. In determining what is reasonable, covered entities should assess potential risks to patient privacy, as well as consider such issues as the potential effects on patient care...””

“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: 32946 Based on observation, interview, and record review, the facility failed to ensure one oxygen e-tank was stored safely and securely. This failure had the potential to result in injures to patient, staff, and visitors. Findings: During a concurrent observation and interview on 4/29/24 at 10 a.m. in the Emergency Department (ED) ED nurses’ station with Clinical Risk Management Specialist (CRMS) and Emergency Department Assistant Manager (EDAM) 1, an oxygen e-tank was stored freestanding outside of an oxygen storage rack. EDAM 1 acknowledge the finding and stated, “They (oxygen e-tank) are supposed to be stored in the rack, that e-tank is not stored in the rack. Staff are trained on proper storage of e-tanks.” During a review of the hospital’s policy and procedure (P&P) titled, “Compressed Gas and Oxygen Use,” dated 4/01/2010, indicated, “PROCEDURE: 1. Cylinder must be secured by two restraints in order to reduce the chance of falling . . .OXYGEN USE; Oxygen and other gases are potentially dangerous. Special safety precautions shall be followed at all times while using or storing oxygen.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 47734 Based on interview and record review, the facility failed to ensure two of two sampled patients’ (Patient 17 and Patient 19) restraints (measure keep someone under control or within limits) were monitored every two hours, according to the facility’s policy and procedure. This failure had the potential to compromise the safety and comfort of Patient 17 and Patient 19 while on restraints. Findings: a. During a concurrent interview and record review on 5/1/24 at 4:11 p.m. with Quality Manager (QM), Patient 17’s “Flowsheet for Restraints (FR),” dated 4/10/24 through 4/15/24 was reviewed. Patient 17’s FR indicated the restraint monitoring was not conducted every two hours. The following FR documentation: 4/10/24 5 p.m. “Restraint Episode Activity: Initiate episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: No adverse Response...” 4/11/24 5 a.m. “Restraint Monitoring Attestation: No adverse Response...” 4/11/24 6:30 p.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Restless/Agitated. Restraint Monitoring Attestation: No adverse Response...” 4/12/24 4 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: No adverse Response...” 4/12/24 6 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation].” 4/12/24 5 p.m. “Restraint Monitoring Attestation: No adverse Response...” 4/12/24 5:13 p.m. “Restraint Observation Behavior: Calm...Restraint Monitoring Attestation: [no documentation].” 4/13/24 6 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation].” 4/13/24 3:04 p.m. “Restraint Observation Behavior: Calm...Restraint Monitoring Attestation: [no documentation].” 4/13/24 5 p.m. “Restraint Monitoring Attestation: No adverse Response...” 4/14/24 7 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation].” 4/14/24 4 p.m. “Restraint Monitoring Attestation: No adverse Response...” 4/15/24 3 a.m. “Restraint Observation Behavior: Calm...Restraint Monitoring Attestation: [no documentation].” 4/15/24 6:30 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: No adverse Response...” 4/15/24 1:15 p.m. “Restraint Episode Activity: Discontinue episode...Restraint Monitoring Attestation: No adverse Response...” QM stated these were the dates and times restraints were documented and monitored; there were no documentation the restraints were monitored every two hours. b. During a concurrent interview and record review on 5/1/24 at 4:42 p.m. with QM, Patient 19’s FR, dated 4/25/24 through 5/1/24 were reviewed. Patient 19’s FR indicated monitoring was not conducted every two hours. The following FR documentation: 4/25/24 p.m. “Restraint Episode Activity: Initiate episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: [no documentation].” 4/25/24 6 p.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: [no documentation].” 4/25/24 7:41 p.m. “Restraint Observation Behavior: Calm... Restraint Monitoring Attestation: [no documentation].” 4/26/24 4:55 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: [no documentation]. Restraint Monitoring Attestation: No adverse Response...” 4/27/24 6:11 am “Restraint Observation Behavior: Calm... Restraint Monitoring Attestation: [no documentation].” 4/27/24 7 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation].” 4/27/24 7 p.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation].” 4/28/24 5 a.m. “Restraint Monitoring Attestation: No adverse Response...” 4/28/24 5:32 a.m. “Restraint Observation Behavior: Calm...Restraint Monitoring Attestation: [no documentation].” 4/28/24 7 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation].” 4/28/24 5 p.m. “Restraint Monitoring Attestation: No adverse Response...” 4/28/24 5:33 p.m. “Restraint Observation Behavior: Calm.” 4/28/24 7 p.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation].” 4/29/24 4:05 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: Calm. Restraint Monitoring Attestation: [no documentation].” 4/29/24 5 a.m. “Restraint Monitoring Attestation: No adverse Response...” 4/29/29 7 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: [no documentation].” 4/29/24 5 p.m. “Restraint Monitoring Attestation: No adverse Response...” 4/30/24 7 a.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: No adverse Response...” 4/30/24 6 p.m. “Restraint Episode Activity: Continue episode...Restraint Observation Behavior: disoriented/confused. Restraint Monitoring Attestation: No adverse Response...” 4/30/24 6:29 p.m. “Restraint Observation Behavior: Calm.” QM stated restraints were not monitored every two hours. During a review of the facility’s policy and procedure (P&P) titled, “Restraints/Seclusion of Patients,” dated 11/1/19, the P&P indicated, “. . . 6. Protective Restraints shall be subject to ongoing monitoring and assessment as specified in the patient’s plan of care. Monitoring and assessments shall occur at least every 2 [two] hours and be documented in the patient care record every shift.””

“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: 47734 Based on interview and record review, the hospital failed to develop and update individualized, person-centered care plans for two of two sampled patients (Patient 12 and Patient 15). This failure had the potential for unmet care needs. Findings: During a concurrent interview and record review on 4/30/24 at 4:39 p.m. with Quality Manager (QM), Patient 12’s “History and Physical (H&P),” dated 3/30/24 was reviewed. The H&P indicated, “[Patient 12] developed chest pain/difficulty breathing...send patient [12] to the ED [Emergency Department]...ongoing Medical diagnosis Chest pain...SOB (shortness of breath)” QM stated there were no care plans for respiratory, impaired gas exchange, and pain management. During a concurrent interview and record review on 4/30/24 at 4:56 p.m. with Clinical Informaticist (CI) 1, Patient 12’s “Medical Records (MR),” were reviewed. CI 1 stated she did not see discontinued or current care plans for respiratory, impaired gas exchange, and pain management in the medical record. During a review of Resident 12’s “Flowsheet for Pain (FP),” dated 4/1/24, the FP indicated, Resident 12 had a CPOT (Critical Care Pain Observation Tool - used for patients who cannot express a numerical pain scale) score of 7 (Scores: Mild =2-3, Moderate = 4-6, Severe = 7-8). During a review of Resident 12’s “Orders” dated 4/1/24, the orders indicated, Resident 12 had an order for use of ventilator (a device used medically to assist with breathing). During an interview on 5/2/24 at 9:50 a.m. with Registered Nurse (RN) 8, RN 8 stated care plans are done every shift and on admission. RN 8 stated as soon as she gets the patient she writes the care plan. RN 8 stated if a patient complains of pain she will write a care plan for pain. During a concurrent interview and record review on 5/1/24 at 3:57 p.m. with QM, Resident 14’s H&P, dated 3/22/24 was reviewed. The H&P indicated, “History of Present Illness:...Patient [14] presented to emergency department for chief complaint of right upper quadrant pain and nausea for the last week.” QM stated Patient 14 does not have a plan of care for the right upper quadrant pain. During a review of Resident 14’s FP dated 3/23/24, the FP indicated, Resident 14 had a pain scale of “5 = Moderate pain”. During a review of the hospital’s policy and procedure (P&P) titled, “Interdisciplinary Pt Assessment, Reassessment & Care Planning for the Acute Setting,” dated 9/23/21, the P&P indicated, “V. Care decisions will be based upon data and information gathered in assessments and reassessments. This data will be utilized in prioritizing patient care needs and selecting appropriate interventions...VI. Prioritizing patient care needs will be as follows: A. Emergent/Urgent B. Actual C. Potential D. Education.””

“CONTENT OF RECORD: INFORMED CONSENT CFR(s): 482.24(c)(4)(v) [All records must document the following, as appropriate:] Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent. This Standard is not met as evidenced by: 35649 Based on interview and record review, the hospital failed to ensure the physician and the supervising attending physician for nine of 36 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, and Patient 9) who performed the procedure and signed the informed consent (the process in which a healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention) forms could be identified. This failure resulted in illegible medical records. Findings: During a concurrent interview and record review on 5/1/24 at 2:38 p.m. with Clinical Informaticist (CI) 2, Patient 1’s Informed Consent, dated 3/15/24, was reviewed. The informed consent indicated “Bilateral Radial and Femoral Arterial Line Placement, (procedure to obtain more accurate measurement of blood pressures for critically ill patients receiving vasoactive drugs [powerful drugs that work quickly to narrow one’s blood vessels and raise one’s blood pressure]).” The Informed Consent Form had signatures, but the signatures of the physician who performed the procedure and the signature of the supervising attending physician could not be identified. CI 2 stated the physician signatures on the Informed Consent Form could not be identified. During a concurrent interview and record review on 5/1/24 at 2:45 p.m. with CI 2, Patient 2’s Informed Consent, dated 4/29/24, was reviewed. The informed consent indicated, “Dialysis Catheter in right internal jugular vein, or left internal jugular vein, or right femoral vein, or left femoral vein (insertion of a large bore tube into a large blood vessel for hemodialysis [process of removing waste and fluid for someone whose kidneys can no longer function normally]). The Informed Consent Form had signatures, but the signature of the physician who performed the procedure and the signature of the supervising attending physician could not be identified on the form. CI 2 stated the physician signatures could not be identified on the form. During a concurrent interview and record review on 5/2/24 at 9 a.m. with CI 2, Patient 3’s Informed Consent, dated 2/27/24, was reviewed. The informed consent indicated, “Image guided Percutaneous Left-sided Thoracentesis with possible Chest Tube Placement with Procedural Sedation (a procedure to remove fluid or air from around the lungs with possible insertion of a tube to remove fluid from the space between the lungs and the wall of the chest, and using a medication that would induce depression of consciousness during a procedure). The Informed Consent Form had the signature of the name of the physician who performed the procedure, but the signature was not identifiable. CI 2 stated the physician signature could not be identified on the form. During a concurrent interview and record review on 5/2/24 at 9:10 a.m. with CI 2, Patient 4’s Informed Consent, dated 3/12/24, was reviewed. The informed consent indicated, “Arteriogram (an imaging test that uses x-rays and a special dye to see inside the arteries) with possible Embolization (blockage of the blood vessel ) under Procedural Sedation (giving a medication to the patient to depress consciousness during the procedure). The Informed Consent Form did have a signature of the physician who performed the procedure, but the signature was not identifiable. CI 2 stated the physician signature could not be identified on the form. During a concurrent interview and record review on 5/2/24 at 9:15 a.m. with CI 2, Patient 5’s Informed Consent, dated 3/12/24, was reviewed. The informed consent indicated, “upper endoscopy (involves insertion of a long, flexible tube called an endoscope down one’s throat and into the esophagus [organ that food travels through to reach the stomach for further digestion]) with all the necessary intervention.” The Informed Consent Form had a signature of the physician who performed the procedure, but the signature was not identifiable. CI 2 stated the physician signature could not be identified on the form. During a concurrent interview and record review on 5/2/24 at 9:25 a.m. with CI 2, Patient 6’s Informed Consent, dated 3/12/24, was reviewed. The informed consent indicated, “Bilateral Internal Jugular and Femoral Central Venous Catheter Placement (insertion of a large bore tube into a large blood vessel).” The Informed Consent Form had a signature of the physician who performed the procedure and a signature of the supervising attending physician, but the signatures were not identifiable. CI 2 stated the physician signatures could not be identified on the form. During a concurrent interview and record review on 5/2/24 at 9:30 a.m. with CI 2, Patient 7’s Informed Consent, dated 3/17/24, was reviewed. The informed consent indicated, “Left or right internal jugular central venous catheter insertion, Left or right radial arterial line placement, and Bronchoscopy (a procedure that lets doctors look into one’s lungs and air passages). The Informed Consent Form did have the signature of the physician who performed the procedure and the signature of the supervising attending physician, but the signatures were not identifiable. CI 2 stated the physician signatures could not be identified on the form. During a concurrent interview and record review on 5/2/24 at 9:35 a.m. with CI 2, Patient 8’s Informed Consent, dated 3/17/24, was reviewed. The informed consent indicated, “Arterial line of left or right radial artery.” The Informed Consent Form did have the signature of the physician who performed the procedure and a signature of the supervising attending physician but the signatures were not identfiable. CI 2 stated the physician signatures could not be identified on the form. During a concurrent interview and record review on 5/2/24 at 9:45 a.m. with CI 2, Patient 9’s Informed Consent, dated 3/19/24, was reviewed. The informed consent indicated, “Central venous access, Arterial access.” The Informed Consent Form had the signature of the physician who performed the procedure and the signature of the supervising attending physician but the signatures were not identifiable. CI 2 stated the physician signatures could not be identified on the form. During a review of the hospital’s “Medical Staff Rules and Regulations (MSRR),” dated 9/27/23, the MSRR indicated, “2.2 Responsibilities of Attending Physicians:...b. At all times during a patient’s hospitalization, the identity of the attending physician will be clearly documented in the medical record...Medical Records 3.1 General Requirements:...c. Authentication: Authentication means to establish authorship by signature or identifiable initials and may include computer entry using unique electronic signatures for electronic entries...Written signatures must include the responsible practitioner’s identification numbers.””

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the hospital failed to have an effective infection prevention and control program to provide a sanitary environment and minimize the sources of infections for 346 admitted patients, and all emergency room patients as evidenced by: 1. One of one sampled medical staff (Resident 2) did not use aseptic technique (methods used to prevent or reduce bacteria that cause disease on skin, tissue or surfaces) during the insertion of a Vascular Catheter (Vas Cath, large vein access device) for one of one sampled patient (Patient 2). 2. Two of two sampled medical staff (MD 3 and Resident 2) contaminated the sterile (germ free) field during one sampled patient’s (Patient 2) Vas Cath insertion. 3. One of one sampled medical staff (MD 3) did not use sterile water to clean the Vas Cath access site for one sampled patient (Patient 2). 4. One of one sampled clean linen cart was uncovered, and additional items were stored on top of the clean linen cart. 5. One of one sampled sink in Zone 6 had patient care items in the splash zone (area around sink which can be contaminated from water splash from drains and faucets). 6. One of one sampled Registered Nurse (RN) 9 did not disinfect the medication vial’s (small bottle) septum (seal) prior to injecting the needle and drawing medication for one of one sampled patient (Patient 30). 7. Medical supplies were stored on the floor. 8. One of one sampled patient treatment chair was not cleaned between patients. 9. Outside food was stored on the Central Line Cart. 10. One of one sampled sharp (used needles, syringes, vials) container was maintained in a safe and sanitary manner and was properly disposed of. These failures had the potential to transmit infections to patients, staff and visitors. Findings: 1. During an observation on 4/29/24 at 2:16 p.m. in Patient 2’s room, with Resident 2 and MD 3, during the preparation of Patient 2 for the insertion of the Vas Cath on the right jugular (large neck vein) vein, Resident 2 cleaned the right side of Patient 2’s neck using a chlorhexidine (antiseptic-substance inhibits the growth of microorganism) swab in a circular motion moving from inside and extending outwards of the access site but returned back to the access site using the same contaminated swab. During an interview on 4/30/24 at 3:23 p.m. with Resident 2, Resident 2 stated she used chlorhexidine swabs and cleaned Patient 2’s access site from center outwards but did not realize she went back to the access site after. During an interview on 4/30/24 at 3:01 p.m. with MD 3, MD 3 stated she was an attending physician in the Emergency Department and provided direct supervision to Resident 2 during the insertion of the Vas Cath for Patient 2. MD 3 acknowledged the breaches in aseptic technique when Resident 2 used the chlorhexidine swab starting inward and then outward and then went back inward. During a review of the manufacturer’s instructions for use (MIFU), dated 2009, the MIFU indicated “maximal treatment area for one applicator is approximately 2.5 in. [inches] x [by] 2.5 in ...Place the foam flat side down on the treatment area. Completely wet treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds. Allow the area to air dry for approximately 30 seconds ...Discard the applicator after a single use ...” 2. During an observation on 4/29/24 at 2:16 p.m. in Patient 2’s room, during the insertion of Patient 2’s Vas Cath, MD 3 and Resident 2 contaminated the sterile field when: 2a. MD 3 did not wear a mask, while standing over the sterile field, 2b. MD 3’s sterile gown exposed her back and the waist ties were not secured to prevent accidental touch onto the sterile field. 2c. MD 3, while wearing a sterile gown, reached under Patient 2’s sterile drape, to check Patient 2’s arm band during the time-out (assures the correct procedure is performed on the correct patient) process. 2d. MD 3 positioned herself behind Resident 2’s back, close enough for the front of MD 3’s sterile gown, to touch Resident 2’s gown. 2e. MD 3 assisted Resident 2 in inserting the dilator (an instrument used to expand the puncture hole), into Patient 2’s access site, without changing her gown. 2f. During an observation on 4/29/24 at 2:56 p.m. in Patient 2’s room, during the insertion of Patient 2’s Vas Cath, Resident 2 stepped out of Patient 2’s room, still wearing a contaminated gown and a bloody glove on her left hand, to wait for the portable chest x-ray to be completed. During an interview on 4/30/24 at 3:23 p.m. with Resident 2, Resident 2 stated she did not realize she stepped out of the room while wearing her contaminated gown and gloves. During a review of the hospital’s policy and procedure (P&P) titled, “Basic Aseptic Technique,” 3/17/14, the P&P indicated, “1. Scrubbed persons will wear sterile gowns and gloves...III. All items used in the sterile field should be sterile. IV. All items introduced into a sterile field will be dispensed by methods that maintain sterility of the item and integrity of the sterile field.” During a review of the Centers for Disease Control and Prevention (CDC, national health organization) guideline titled “Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011, updated 2017, the guideline indicated “4. * Maximal Sterile Barrier Precautions 1. Use maximal sterile barrier precautions, including the use of a cap, mask, sterile gown, sterile gloves, and a sterile full body drape, for the insertion of CVCs, [central vein catheters ...” During a review of the article in the Association of periOperative Nurses (AORN, national nurse association provides evidence-based recommendations) Journal, titled, “Recommended Practices for Maintaining a Sterile Field,” dated 7/7/06, the Article indicated, “The front of a sterile gown is considered sterile from the chest to the level of the sterile field. The sterile area of the gown front extends to the level of the sterile field. The back of the gown is not considered sterile, because it cannot be observed by the sterile team member.” During a review of the “AORN Guidelines for periOperative Practice,” dated 2019, the Guidelines indicated: Perioperative personnel should select and wear surgical gowns that wrap around the wearer’s body and completely cover the wearer’s back...The part of the surgical gown that should be considered contaminated or unsterile include the neckline, shoulders, and axillary region, the gown back, and the sleeves cuffs after the scrubbed team member’s hands pass through and beyond the cuff...Personnel should move within or around a sterile field in a manner that prevents contamination of the sterile field.” 3. After Patient 2’s Vas Cath procedure, MD 3 wet a piece of gauze with tap water from the room’s sink. MD 3 cleansed Patient 2’s neck using tap water from the room’s sink. During a review of the CDC guideline titled “Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011, updated 2017, the guideline indicated, “2. Maintain aseptic technique for the insertion and care of intravascular catheters.” During a review of the CDC guideline titled “Healthcare-Associated Infections (HAIs), dated 9/11/2019, the guideline indicated “Tap water meets stringent safety standards in the United States, but it is not sterile. Certain numbers and types of bacteria and other microbes may be present when water leaves the tap ...in healthcare settings, the ways we use water are more varied and patients might be more vulnerable to infection. Certain conditions within healthcare plumbing systems can even encourage microbial growth. This can lead to dangerously high levels of potential pathogens. Moreover, the risk does not stop at the tap-every use of water in patient care settings must be scrutinized and evaluated for its risk to harbor and transmit healthcare-associated pathogens . . .” 47734 4. During a concurrent observation and interview on 4/29/24 at 10:20 a.m. with Emergency Department Assistant Manager (EDAM) 1, in Zone 5 hallway, a clean linen cart had its cover pulled to the top. On top of the uncovered linen cart were two waffle mattresses, one pillow, and one bag of paper blankets. EDAM 1 stated the linen cart should be closed and there should not be anything on top of the cart. EDAM 1 stated, two waffle mattresses, one pillow, one bag of paper blankets were observed on top of the clean linen cart. 5. During a concurrent observation and interview on 4/29/24 at 10:40 a.m. with EDAM 1 in Zone 6 sink area, a folded gown with a syringe and gauze were in the sink’s splash zone (on the side of the sink). EDAM 1 stated patient care supplies should not have been placed on the side of the sink. During a review of the CDC guideline titled “Healthcare-Associated Infections (HAIs), dated 9/11/2019, the guideline indicated “Recent evidence indicates sinks and other drains, such as toilets or hoppers, in healthcare facilities can become contaminated with multidrug-resistant organisms (MDROs). These pathogens [organism that causes disease] can stick to the pipes to form biofilms [colony of germs and microbes], which allow the organisms to persist in drains for long periods of time and are often difficult to impossible to fully remove. Because different types of bacteria may contaminate the same drain, drains can serve as sites where antibiotic resistant are transferred between bacterial species. Patients may be exposed to organisms in drains when water splashes from the drain.” 6. During an observation on 4/30/24 at 9:22 a.m. in the Interventional Radiology Procedure Room (IRPR), RN 9 uncapped a new medication vial for and inserted the needle without disinfecting the rubber septum with alcohol. During an observation on 4/30/24 at 10:45 a.m. in IRPR, RN 9 uncapped a new medication vial and inserted the needle without disinfecting the rubber septum with alcohol. During an interview on 4/30/24 at 11:03 a.m. with RN 9, RN 9 stated he should have cleaned the rubber top (septum) with alcohol pads before drawing the medication. During a review of the Centers for Disease Control and Prevention (CDC) guideline titled, “FAQs regarding Safe Practices for Medical Injections: Medication Preparation Questions” dated 6/20/19, the guideline indicated, “the rubber septum should be disinfected with alcohol prior to piercing it.” 32946 7. During an observation on 4/29/24 at 10:10 a.m. in the ED patient triage area, in a small alcove, a green plastic bag with multiple white items inside, a square white plastic bucket, and a paper bag on top of the square white plastic bucket were on the floor. During a concurrent observation and interview on 4/29/24 at 10:11 a.m. with Clinical Risk Management Specialist (CRMS) and EDAM 1 in the ED triage area, EDAM 1 removed the green plastic bag from the floor to discover a second green plastic bag underneath the first green plastic bag. CRMS stated, “Looks like blood pressure cuffs, approximately 40.” EDAM 1 stated, “It’s just overstock.” EDAM 1 stated the white plastic bucket contained used pulse Oximeters (used to measure the level of oxygen in the blood) and the paper bag contained multiple specimen bags with a specimen cup inside each bag. During a concurrent observation and interview on 4/29/24 at 10:15 p.m. with RN 12, in the ED triage area. RN 12 noted two green plastic bags, the white bucket and the paper bag. RN 12 stated, nothing should be stored on the floor. The facility policy and procedure regarding storing items on the floor was requested; none were provided. 8. During a concurrent observation and interview on 4/29/24 at 10:11 a.m. with EDAM 1, in the Fast Track area, an eggplant-colored treatment chair, was in the reclined position for patient observation. Under the treatment chair was a used elastic wrap and a used emesis (nausea) bag. EDAM 1 stated there was used elastic wrap and a used emesis bag under the treatment chair. During a review of a facility document titled, “Recommendation III”, [undated] the facility document indicated, “A clean environment should be reestablished after the patient is transferred from the area.” 9. During a concurrent observation and interview on 4/29/24 at 2:18 p.m. outside Patient 2’s room, was a six-drawer “Central Line Cart.” On the top of the Central Line cart, a plastic bag labeled “Biohazard [contaminated items]” contained several round orange fruits (cumquats). The Central Line cart was currently in use in an active procedure for Patient 2. Director of Emergency Department (DED) stated there were approximately 15 - 20 cumquats stored inside the biohazard bag. DED stated, “Outside food is not allowed.” During a concurrent observation and interview on 4/29/24 at 3:06 p.m. with MD 3, MD 3 stated, “Someone put them down for me on the cart, another provider handed them to me. He [other provider] placed them (the cumquats) on the cart.” The facility policy and procedure regarding food on Central Line Carts was requested; none was provided. 10. During a concurrent observation and interview on 4/29/24 at 3:06 p.m. in the ED hallway with CRMS, a Sharps storage container (storage for used needles, syringes, and other used medical devices) mounted on the wall at the nurses’ station was overflowing with used IV (intravenous into vein) tubing, used needles, and used dressings sticking out of the top of the full Sharps storage container. Two patients were seen seated across the hall from the Sharps storage container. CRMS stated the sharps container was overflowing in a patient care area. During an interview on 4/29/24, at 3:43 p.m. with Environmental Services (EVS) 1, EVS 1 stated she should have changed the Sharps container; the Sharps container was full, and patients could remove items from the Sharp storage container. During a review of the facility’s policy and procedure (P&P) titled, “Biohazard Waste/Sharps Waste,” dated 11/8/2023, indicated, “Procedure: . . .B. Sharps Waste 1. Sharps waste, i.e.., fistula needles, hypodermic needles and syringes are contained for disposal in a puncture resistant rigid plastic red container. 2. The container comes equipped with a lid that can close and permanently lock when it is three quarters full and discarded . . .B Sharps Waste 1. The sharps containers are used until they are three quarters full.””

“IC PROFESSIONAL TRAINING CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (iv) Competency-based training and education of hospital personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the hospital, on the practical applications of infection prevention and control guidelines, policies, and procedures. This Standard is not met as evidenced by: 35649 Based on interview and record review, the hospital failed to ensure the Infection Preventionist provided Infection Prevention and Control Training to the Medical Staff. This failure has the potential to result in the Medical Staff unaware of current infection prevention and control practices. Findings: During an interview on 4/30/24 at 4:15 p.m. with Director of Medical Staff Services (DSS), DMSS stated the Medical Staff did not have training on infection prevention and control. During an interview on 5/1/24 at 1:47 p.m. with Medical Director 1, Medical Director 1 stated the Medical Staff did not receive formal hospital training on infection control. Medical Director 1 stated the Medical Staff had no infection control training. During a concurrent interview and record review on 5/2/24 at 10:20 a.m. with Infection Preventionist (IP) and Infection Prevention Manager (IPM), IPM stated Infection Control education materials were provided to the Medical Staff Office. The Medical Staff infection control education materials included Hospital Acquired Infections (infection a patient gets while in the hospital), hand hygiene, masking, COVID-19 (serious lung infection), measles (highly contagious disease), and others. IP was unable to provide evidence of infection control training for the Medical Staff. IP stated she had not provided a formal education/training on infection control for the Medical Staff. During a review of the hospital’s policy and procedure (P&P) titled, “Infection Prevention Department Plan,” the P&P indicated, “Policies: Develop communication systems with independent practitioners, staff, students, volunteers...visitors, patients, families and the community about infection prevention and control issues, including their responsibilities in preventing the spread of infection within the hospital...9. Provide education to employees, staff, patients, and visitors on current disease trends, infection prevention and control practices and other patient safety topics as appropriate...11. Coordinate and integrate infection prevention and control activities with medical staff to encourage collaborative and consistent infection control practice with other health care disciplines.””

“QUALIFIED EMERGENCY SERVICES PERSONNEL CFR(s): 482.55(b)(2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. This Standard is not met as evidenced by: 35649 Based on observation, interview, and record review, the hospital failed to: 1. Ensure one of one resident (Resident 1) in the first year of Emergency Medicine Residency Program (post-graduate training for physicians going for their specialty), under direct supervision, followed the procedure for central line (a flexible tube inserted into a large blood vessel that goes directly to the heart) insertion. This failure resulted in the guidewire to be retained in the right jugular vein (large blood vessel) for one of one sampled patient (Patient 1). 2. Provide Registered Nurses to function as Triage (process to prioritize the order in which patients will be treated based on the types of disease and severity) nurses in the Emergency Department (ED) for patients seen on 4/29/24. This failure had the potential to result in patients not receiving proper triage assessment and appropriate Emergency Severity Index (ESI- sorts patients into five groups from 1 [emergent] to 5 [least urgent] based on predicted acuity and resource needs) designation 3. Ensure the ED Registered Nurse (EDRN) 5 provided immediate triage assessment for one of one sampled patient (Patient 34) who arrived to the ED with mid-sternum chest pain. This failure resulted in a delay of physician examination. 4. Ensure two of two EDRNs (EDRN 6 and EDRN 7) were familiar with “Resident Directory” to determine whether the ED Residents possess the skills, knowledge, and training to perform certain procedures in the ED. This failure had the potential for adverse consequences if resident physicians were allowed to perform procedures they were not competent and trained in. 5. Ensure EDRN 1 received adequate training when assigned to assist and monitor during insertion of a Vas Catheter (large vein access device) for one of one sampled patient (Patient 2). This failure resulted in EDRN 1 not recognizing the need to notify the physician when changes occurred during a procedure. Findings: 1. During an interview on 5/1/24 at 8:39 a.m. with Resident 1, Resident 1 stated Patient 1 was hemodynamically unstable (low blood pressure that leads to insufficient blood flow to the body), and already hit the threshold for Levophed (medication to raise blood pressure). Patient 1 could not continue the medication using the peripheral line (intravenous fluid administered through the hands/arms) as it would cause damage to the peripheral veins. Resident 1 stated the need to establish a central line was necessary to continue medications to increase blood pressure support. Resident 1 stated he performed the insertion of central line on Patient 1’s right jugular vein under direct supervision from the ED Physician (MD 2). Resident 1 stated, “It was towards the end of the procedure when I was threading the catheter over the guidewire and advancing the catheter when I realized the guidewire did not stick out of the ‘brown port’ (used for infusion).” Resident 1 stated the guidewire must stick out of the port before the catheter is inserted. Resident 1 stated, “I was rushing through the procedure. It was a high stress environment. I did not withdraw the guidewire.” Resident 1 stated, “I realized I did not have the guidewire. I tried to remove the catheter hoping the guidewire would come out with the catheter, but when I pulled only the catheter came out. I knew something was wrong. The guidewire remained inside the patient.” During an interview on 5/1/24 at 9:33 a.m. with MD 2, MD 2 stated Resident 1 inadvertently advanced the triple lumen catheter (multi-lumen flexible tube which allows for several different infusion with only one access site) with the guidewire. MD 2 stated he provided direct supervision, standing about two to three feet away, behind Resident 1’s right shoulder. During a review of Patient 1’s “Interventional Radiology Foreign Body Retrieval Report,” dated 3/15/24 at 6:18 a.m., the retrieval report indicated, “Initial images demonstrate the guidewire within the region of the right internal jugular vein and extending to loop in the region of the right atrium.” During a concurrent interview and record review on 5/2/24 at 8:13 a.m. with MD 2 and Risk Management Manager (RMM), Resident 1’s Central Line Checklist, dated 4/2024, was reviewed. The central line checklist indicated, “Advance the catheter over the wire. Ensure the guidewire exits the distal lumen enough to be grasped. Advance the catheter into the vessel, again, NEVER LETTING GO OF THE WIRE...” MD 2 stated Resident 1 did not “walk-back” the guidewire, meaning Resident 1 needed to draw back the guidewire before advancing the catheter, but Resident 1 did not “walk-back” the catheter in time. During a review of the article of “the National Institute of Health Library of Medicine” titled, “Central Line Placement,” dated 12/21/22, the article indicated, “1. While holding the guidewire in place, remove the introducer needle hub. 2. Advance the Central Venous Line (CVL) over the guidewire. Ensure the distal lumen of the central line is uncapped to facilitate the passage of the guidewire. 3. Once the CVL is in place, remove the guidewire. Next, flush and aspirate all ports with sterile saline.” 2. During a concurrent observation and interview on 4/29/24 at 9:39 a.m. with Director of Emergency Department (DED) and RMM, in the ED waiting room, inside a closed glass window was EDRN 3 and a registration clerk. A patient approached the glass window and EDRN 3 handed the patient a form to fill out. DED stated the registered nurse at the window was the “Start Nurse,” whose role was to obtain patient’s chief complaint. DED stated once the chief complaint was received, EDRN 3 would hand the form to the registration clerk for a quick registration. DED stated the patient would be sent back to the waiting room until the ED Technician calls the patient for vital signs. Once vital signs were entered into the computer, EDRN 3 would complete the triage note and would assign the patient his/her ESI designation. DED stated, “We do not have a triage nurse.” During an interview on 4/29/24 at 3:50 p.m. with EDRN 3, EDRN 3 stated Start Nurse or Triage Nurse were used fairly frequently and interchangeably to identify us (registered nurses) in the triage area. EDRN 3 stated, “There are no other nurses here to assess the patients. If we have enough staffing, then we would have a triage nurse.” EDRN 3 stated her role at triage was to visually observe the patients who come to the window. EDRN 3 stated she just looked at airway, breathing, and circulation. EDRN stated once the vital signs of the patients were inputted in the computer, EDRN 3 would assign the patients’ ESI levels based upon the quick assessment from the window when patients first present themselves in the department. EDRN 3 stated, “Most often than not, we do not have a triage nurse.” During an interview on 4/29/24 at 4:18 p.m. with DED, DED stated Administration realized the need for a triage nurse in August 2023. DED stated there was a work group consisted of the Medical Director, Director of Emergency Department, Chief Nursing Officer, Director of Quality, Director of Risk Management, and Emergency Physicians, that investigated the ED throughput and assigning a triage nurse at Triage. DED stated the project was scheduled to go live in November 2023, but the ED did not have enough registered nurses to take on the duties and responsibilities of a triage nurse. DED stated it’s been since August that the ED had no triage nurse. During an interview on 4/30/24 at 10:25 a.m. with EDRN 4, EDRN 4 stated as the start nurse you are the triage nurse; however, just looking at the patient coming in is not triage. EDRN 4 stated there is a better way to do it. EDRN 4 stated, “As the triage nurse I must lay my hands on the patients and do a full assessment of the patient.” EDRN 4 stated visual observation of the patient was not adequate. EDRN 4 stated unless the ED has an extra nurse then the nurses could take the patient to a triage room and conduct full assessment of the patient and assign an accurate ESI level. During a concurrent interview on 5/1/24 at 10:52 a.m. with Chief Nursing Officer (CNO), the CNO stated the intent is for a safe and effective care when patients come to the ED. CNO stated there was a work group and one of the goals was to have a triage nurse at triage. CNO stated it went live on 11/15/23. There were parts of the plan that did not move forward because of staffing challenges. CNO stated without a triage nurse, it would impact how the nurses score and determine the number of resources needed for an accurate ESI designation. CNO stated some patients were over triaged, which meant some patients were assigned an ESI of two or an ESI of three because the nurses could not properly identify accurate an ESI level. CNO stated she was not aware there was no triage nurse assigned at ED Triage. During a review of the document titled, “Kaizen Action Plan: Safe, Efficient and Effective Care of the ED Patients,” dated 8/18/23, the document indicated,” QI Strategy: 1. Design workflow from patient entry to assessment which results in the safe care of ED patients. Safe care defined as vital signs obtained, assessments completed, action on change of condition executed. Action Step: The system shall reallocate resources to assign complete care team for all ED patients.” During a review of the ED Staffing Assignment, dated 3/2/24 to 3/10/24 and 4/22/24 to 4/29/24, there were no triage nurses assigned in the ED for the above dates, during both day and night shifts. During a review of the “Emergency Nurses Association (ENA) Position Statement,” dated 5/2017, the Position Statement indicated, “Triage is the process of collecting pertinent information about patients who are seeking emergency care and initiating a decision-making procedure that uses a valid and reliable triage acuity designation system. Rapid and accurate triage decisions are important for successful emergency department (ED) operations and optimal patient outcomes. This process includes collecting pertinent patient information, performing a focused assessment, assigning an acuity level, and prioritizing the needs of the patient seeking emergency care, all in a time-sensitive manner. Accuracy in problem identification is a crucial component of clinical decision making, especially in the triage encounter, and requires the nurse to establish boundaries of physiological and psychological stability as well as predict the potential trajectory of the patient’s condition ...” 3. During an interview on 5/1/24 at 10:19 a.m. with EDRN 5, EDRN 5 stated she was assigned as the triage nurse for today. EDRN 5 stated there was one patient (Patient 34) who she had to call, but because there was no room available in the triage area, EDRN 5 stated she had not seen the patient. During a concurrent interview and record review on 5/1/24 at 10:22 a.m. with EDRN 5, Patient 34’s “ED Intake Form,” dated 5/1/24, was reviewed. The intake form indicated Patient 34 was registered at 9:24 a.m. with complaints of “intermittent mid-sternum chest pain, tingling sensation on both hands since Monday, and worse today.” EDRN 5 stated Patient 34 had an electrocardiogram (electrical tracing of the heart) completed at 9:31 a.m. EDRN 5 stated she had not seen [Patient 34] because there was no room available in the triage area. EDRN 5 stated she had not assigned an ESI for Patient 34. EDRN 5 stated as the triage nurse her role was to assess the patient and assign the acuity (a measurement of the level of care a patient needs based on the severity of either an illness or mental condition). EDRN 5 stated [Patient 34] had not been seen for almost an hour and patients with chest pain should be taken in right away. During an interview on 5/1/24 at 10:24 a.m. with DED, DED stated [EDRN 5] could have taken the patient to another room in the ED. During a review of Patient 34’s Emergency Documentation, dated 5/1/24, the emergency documentation indicated, Patient 34 was evaluated by the emergency physician at 10:27 a.m. The ED Start Nurse (EDRN 11) documented “ED Triage Part 1” to indicate Patient 34’s chief complaint, allergies, and fall risk screening. The ED MSE (medical screening examination-to determine if an emergency medical condition exists) was performed and completed at 10:42 a.m. There was no documentation that EDRN 5 completed a triage assessment for Patient 34. During a review of the facility’s policy and procedure (P&P) titled, “Standards of Care: Nursing,” dated 12/19/23, the P&P indicated, “RN Assessment: The RN is responsible for completing and documenting an assessment based on patient’s chief complaint. Assessment contributes to determination of patient acuity or classification and assist in determining staffing needs...” 4. During an interview on 4/30/24 at 2:47 p.m. with Chief of Medical Education (MD) 6, MD 6 stated the Resident Directory was rolled out to the nurses and physicians regarding the level of resident physicians’ supervision and expectation. MD 6 stated it was important to revise the Resident Directory and update it monthly. During a concurrent interview and record review on 4/30/24 at 3:50 p.m. with EDRN 6 and Risk Management Manager (RMM), Resident Directory was reviewed electronically. EDRN 6 was unable to locate the Resident Directory and EDRN 6 was not familiar on how the nurses verify whether the resident physician could perform certain procedure in the ED. EDRN 6 stated, “I do not know.” RMM verified the findings. During a concurrent interview and record review on 4/30/24 at 3:53 p.m. with EDRN 7 and RMM, Resident Directory was reviewed in the computer. EDRN 7 stated resident physicians are with the attending physician during the procedure. EDRN 7 stated she would go to the attending physician to ask if the resident physician could perform the procedure. EDRN 7 stated she was not aware about the Resident Directory in the computer. 5. During an observation on 4/29/24 at 2:24 p.m. in Patient 2’s room, EDRN 1 entered the room with his Work-On-Wheels (WOW) computer and fixed the electrodes (electrical conductor) and lead placement (view of electrical activity of the heart) to ensure proper heart monitoring of Patient 2’s heart rhythm. During an observation on 4/29/24 at 2:31 p.m. in Patient 2’s room, ED Physician (MD) 3 called for “Time Out,” (a surgical pause conducted before the procedure to ensure right patient, right site, right consent signed for patient safety). EDRN 1 stood by his computer and did not go to the bedside to check for the patient’s identification and EDRN 1 did not review Patient 2’s record for accuracy of the Informed Consent and whether Informed Consent was obtained and signed. During an observation on 4/29/24 at 2:35 p.m. in Patient 2’s room, MD 3 was not wearing a mask during a sterile procedure. EDRN 1 did not recognize the need for MD 3 to be completely garbed with a cap, mask, gown, gloves, and face shield to maintain a maximum barrier for the sterile procedure. During an observation on 4/29/24 at 2:46 p.m. in Patient 2’s room, Patient 2’s heart monitor displayed a heart rate of 30, bradycardia (slow heart rate), but EDRN 1 did not inform MD 3. During an interview on 4/29/24 at 3:09 p.m. with EDRN 1, EDRN 1 stated he entered Patient 2’s room and while he was in the room, he made sure the timeout process was done before the procedure and he observed, [MD 3]’s gown waist ties were not completely tied, and [MD 3] was not wearing a mask during the early part of the procedure. EDRN 1 stated, “I am supposed to document when the line was placed and monitor Patient 2’s vital signs, but I did not. I was not sure what I was supposed to document for Vas Cath insertion. I was always (sic) used to monitor during a procedure under conscious sedation (an induced state of sedation characterized by a minimally depressed consciousness), but not familiar with procedures performed not under conscious sedation.” EDRN 1 stated he identified Patient 2’s heart rhythm was bradycardia, but he was waiting to see how long it would last. EDRN 1 stated, “I did not notify the doctor. I was supposed to let the doctor know of Patient 2’s vital signs during the procedure, but I did not do that.” EDRN 1 stated he also did not document anything during the procedure. During a review of Patient 2’s Vital Signs, dated 4/29/24 at 2:02 p.m., the vital signs indicated, “Respiratory Rate: 22.” The vital signs record did not have documentation of Patient 2’s heart rate, blood pressure, or oxygen saturation (measures the percentage of oxygen in the blood).” During a review of the facility’s policy and procedure (P&P) titled, “Standards of Care-Adult” dated 8/16/19, the P&P indicated, “The RN is responsible for assessment and surveillance: initial and ongoing assessment for changes in patient’s condition and/or concerning vital signs. The RN is responsible for documenting changes in patient’s condition and/or vital signs including ED Provider notified.” During a review of the facility’s P&P titled, “Surgical/Procedure Site Verification (Universal Protocol),” dated 1/10/20, the P &P indicated, “V. Documentation: The completed components of the Universal Protocol (provides guidance for health care professionals key steps: conducting a pre-procedure verification process, marking the procedure site, and performing a time-out), and Time-Out are clearly documented by the Registered Nurse in the electronic medical record.: correct patient identity, correct die and site, an accurate procedure consent form...””

“ON CALL PHYSICIANS CFR(s): 489.20(r)(2) and 489.24(j)(1-2) §489.20(r)(2) [The hospital (including both the transferring and receiving hospitals), must maintain] a list of physicians who are on call for duty after the initial examination to provide further evaluation and/or treatment necessary to stabilize an individual with an emergency medical condition. §489.24(j)(1) Each hospital must maintain an on-call list of physicians on its medical staff in a manner that best meets the needs of the hospital’s patients who are receiving services required under this section in accordance with the resources available to the hospital, including the availability of on-call physicians. §489.24(j)(2)(i) The hospital must have written policies and procedures in place to respond to situations in which a particular specialty is not available or the on-call physician cannot respond because of circumstances beyond the physician’s control. §489.24(j)(2)(ii) The hospital must have written policies and procedures in place to provide that emergency services are available to meet the needs of patients with emergency medical conditions if it elects to permit on-call physicians to schedule elective surgery during the time that they are on call or to permit on-call physicians to have simultaneous on-call duties. This Standard is not met as evidenced by: 42148 Based on interview and record review, the facility failed to ensure one of 21 sampled patients (Patient 21) was provided care within the hospital’s specialized capabilities when Physician 1 refused to accept a transfer requiring trauma and orthopedic services. This failure resulted in delay of care causing the patient to be transferred to a trauma center over 2 hours away. Findings: During a review of Patient 21’s “Emergency Room Note (EN),” from Hospital A, dated 1/27/24, the “EN” indicated, “Trauma Narrative: 19 year old otherwise healthy male with isolated GSW [gunshot wound] to the left thigh resulting in an open comminuted [multiple fragments] femur [long bone in the thigh] fracture. Review of Systems: Extremities: . . . Positive GSW to the left thigh. . . Left leg is externally rotated with a shift at the midline [deformed]. . . Patient will require Ortho [Orthopedic] and trauma services. X-ray done with 4 views of the left femur. Impression: 1. Acute Comminuted fracture of the mid to distal femur. 2. Bullet fragments peripheral to the fracture. 3. Soft tissue emphysema [air sacs in tissue], suspicious for infection. Consultations: Consultation #1: Spoke with [Hospital B] transfer center. Declined the patient for transfer. Consultations #2: Spoke with [Hospital C] transfer center. [Physician] from [Hospital C] accepts the patient for transfer. Trauma Differential Diagnosis: Femur fx [fracture], hip fx, GSW.” During a review of Hospital B’s “Transfer Log (TL),” dated 1/27/24, the “TL” indicated, there was a request for ED (Emergency Department) to ED incoming transfer. Status indicated “DECLINED” on 1/27/24 3:16 a.m.- “Services not available at sending facility [Hospital A].” Services requested- Trauma. Diagnosis- Left Femur Fracture. Reason Declined- (Hospital B Physician) declined. “[Physician 1] said did not need transfer.” During a concurrent interview and record review on 2/27/24 at 12:18 p.m. with Director of Case Management (DCM), the “TL” dated 1/27/24 was reviewed. The TL indicated, trauma services was the requested from Hospital A for Patient 21. DCM stated trauma services should have been involved and contacted in this case. DCM stated Hospital B had Trauma Physicians on-call on 1/27/24. DCM confirmed only the Orthopedic Surgeon was contacted and declined the transfer without consulting the Trauma Physician. During an interview on 2/27/24 at 9:38 a.m. with Risk Manager (RM), RM stated Hospital B had capacity on 1/27/24 to take Patient 21. RM stated Physician 1 was the Orthopedic Surgeon on call 1/27/24 and that Trauma Services had two physicians on call 1/27/24. During an interview on 2/27/24 at 12:30 p.m. with RM, RM stated, “I reached out to Hospital A about this case, they told me that their [Hospital A’s] Orthopedic Surgeon that was on call 1/27/24 did not handle traumas. During an interview on 2/27/24 at 6:15 p.m. with Physician 1, Physician 1 stated he was the Orthopedic Surgeon on-call for Hospital B on 1/27/24 and was contacted by Hospital B’s transfer center stating Hospital A wanted to transfer a patient with a GSW to the thigh that caused a femur fracture. Physician 1 stated that he requested x-ray images and was told there was not a radiologist report yet so Hospital A sent the x-ray image to his cellphone. Physician 1 stated the x-ray “was a very simple fracture that any orthopedic surgeon could handle and was told that [Hospital A] had an orthopedic Surgeon on call, and felt that he should handle it. There was no reason for the patient to be transferred.” Physician 1 stated there was not a doctor-to-doctor conversation done with Hospital A because one wasn’t requested. Physician 1 stated he did not consult trauma services because the only diagnosis the patient had was a Femur Fracture and Patient 21 did not require trauma services. During a Review of “Transfer Center Documentation (TCD),” dated 1/27/24, the “TCD” indicated, “Case number 8655. 1/27/24 at 3:16 am. Indicated, “Sending location Case Type: ED to ED incoming. Sending hospital: [Hospital A] Receiving hospital [Hospital B]. Patient Type- Emergency. Transfer Reason- (EMTALA) Services not available at sending facility. Diagnosis: Trauma; Femur Fracture. Disposition: Declined/Time: 1/27/24 0432am Decline Reason: [Hospital B Physician] Declined. Physician (Declining) [Physician 1] Note: 0255- R/C [received call] from [Hospital B] requesting to initiate a transfer request for trauma requiring ortho [Orthopedic] services as [Patient 21] has a long bone fracture. 0258- S/W [spoke with] HS [house Supervisor] informing her of request. 0315- S/W [Hospital A] at which time he answered the above EMTALA Questions. After stating both trauma and orthopedic services needed and agreeing to speak to orthopedic on call first, attempted to connect both physicians yet [Physician 1] stated no need to discuss case as the only injury was to the femur. In fact, [Physician 1] requesting images to be sent to his cell number. [Hospital A] informed of [Physician 1’s] request, at which time verbalizing understanding. In addition, I let [Hospital A] know we would await orthopedics decision before calling trauma physician, as [Physician 1’s] decision would determine. 0324- R/C from [Physician 1] who reported after viewing images there was no need for HLOC [Health Locus of Control] as patient’s femoral shaft fracture was requiring a nail repair, which could be done by any orthopedist. 0327- S/W [Hospital A] and updated him on [Physician 1’s] decision, at which time he reported he would have to reach another trauma facility. 0329- S/W HS at which time was updated, with [house supervisor] stating she would reach out to on call director.” During a review of “Agreement for On-Call Coverage (AOC),” dated 10/31/23, the “AOC” indicated, Physician 1 signed the agreement. “. . . 5. Call Responsibility. During the term of this Agreement, . . . Participating physician shall provide call coverage to the Hospital in the Specialty for all Emergency Department patients and any request for EMTALA compliance-required transfers of patients to Hospital from outlying emergency departments requiring specialty evaluations, treatment, consultations, or admission . . . in accordance with the medical staff bylaws, rules/regulations, clinical protocols, and policies/procedures. During a review of “On-Call Schedule (OCS),” dated 1/27/24, the “OCS” indicated, Physician 1 was on-call for Orthopedic Surgery. Physician 2 and Physician 3 was on call for Trauma Services. During a review of “Medical Staff Rules and Regulations (MSRR),” dated 9/27/23, the MSRR indicated, on page 44, 11.3 On-Call Responsibilities: (a) At a minimum, participants in the on-call roster are expected to follow all applicable laws and regulations, including EMTALA, and respond in accordance with the time frames outlined in Section 2.3 (b) of these Rules and Regulations. Page 49- 13. 1 EMTALA Transfers: (a) The transfer of a patient with an emergency medical condition from the Emergency Department to another hospital will be made in accordance with the districts applicable policy and in compliance with all applicable state and federal laws, such as EMTALA. During a review of the facility’s policy and procedure (P&P) titled, “Compliance with EMTALA,” dated 2/27/23, the P&P indicated, “A. Compliance: It is the policy of [Hospital B] to comply with EMTALA regulations. These regulations are mandated. . . III. General Policies: C. On-Call Response: [Hospital B] shall maintain a schedule of on-call physicians available to respond to consult or provide treatment necessary to stabilize a patient with an emergency medical condition. On-Call physician responsibilities to respond, examine, and treat emergency patients are defined in the med staff bylaws and or within the physician on call agreement. The Emergency department shall be prospectively aware of physicians who are on call to the department. The notification of an on-call physician shall be documented in the medical record and any failure or refusal of the on call physician to respond to call shall be reported to the medical staff office and the executive team member/chief medical officer.””