Kaiser Foundation Hospital - Oakland/Richmond

“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: 26674 The Condition of Participation- Nursing Services was not met as evidenced by the Hospital’s failure to: Based on interview and record review, for one of thirty sampled patients (Patient 1), the facility failed to follow pharmacy national guidelines when two of three physician orders for hydromorphone (an opioid pain killer) were inconsistently recorded and interpreted, resulting in an ambiguous medication order. The facility then failed to administer the hydromorphone according to the interpretation of the physician orders supported by the preponderance of evidence. Refer to A-405. The deficient practices resulted in Patient 1 showing signs of opioid overdose, placing Patient 1 at risk for respiratory arrest and requiring an opioid reversal agent (naloxone) to be administered to Patient 1. The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe environment.”

“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: 26674 The Condition of Participation- Surgical Services was not met as evidenced by the Hospital’s failure to: Based on interview and record review, the facility failed to ensure surgical services were provided according to standards of practice. For one of thirty sampled patients (Patient 1), the facility failed to follow pharmacy national guidelines when two of three physician orders for hydromorphone (an opioid pain killer) were inconsistently recorded and interpreted, resulting in an ambiguous medication order. The facility then failed to administer the hydromorphone according to the interpretation of the physician orders supported by the preponderance of evidence. The facility failed to ensure its pediatric intensive care unit (PICU) capabilities included continuous renal replacement therapy (CRRT, a treatment for kidney failure which is an alternative to intermittent dialysis), peritoneal dialysis (PD, a type of dialysis using fluid placed in the patient’s abdomen rather than a hemodialysis machine), and charcoal hemofiltration (a form of CRRT using charcoal to absorb toxins) as required by national guidelines for post-operative care of cardiac surgery patients. The deficient practices resulted in Patient 1 showing signs of opioid overdose, placing Patient 1 at risk for respiratory arrest and requiring an opioid reversal agent (naloxone) to be administered to Patient 1. The deficient practices also had the potential to require post-operative cardiac surgery patients to be transferred to another facility while critically ill, increasing their risk for a poor outcome. Findings: 1. Review of Patient 1’s medical record indicated a “Long Operative Note” dated 5/7/25 at 2:46 p.m. was present describing that Patient 1 had just underwent cardiac surgery at the facility. Refer to A-405 regarding hydromorphone orders and medication administration within the first 24 hours after surgery. 2. Refer to A-957 regarding the facility’s PICU capabilities.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 26674 Based on interview and record review, for one of thirty sampled patients (Patient 1), the facility failed to follow pharmacy national guidelines when two of three physician orders for hydromorphone (an opioid pain killer) were inconsistently recorded and interpreted, resulting in an ambiguous medication order. The facility then failed to administer the hydromorphone according to the interpretation of the physician orders supported by the preponderance of evidence. The deficient practices resulted in Patient 1 showing signs of opioid overdose, placing Patient 1 at risk for respiratory arrest and requiring an opioid reversal agent (naloxone) to be administered to Patient 1. Findings: Review of two medication history reports for Patient 1 dated 7/7/25 indicated both reports included the medication order and administration history for hydromorphone. One report addressed a lower dose, 0.11 mg (milligrams); the other report addressed a higher dose, 0.165 mg. The reports indicated Patient 1 had a physician order dated 5/7/25 for hydromorphone 0.11 mg IV (intravenously, within a vein) every 1 hour as needed for moderate pain (4-6 on a 10 point scale). Patient 1 also had a physician order dated 5/7/25 for hydromorphone 0.165 mg IV every 1 hour as needed for severe pain (7-10 on a 10 point scale). Both orders stated to call the physician if pain is inadequately controlled after 2 consecutive doses. The reports stated each hydromorphone order was part of a linked group, and to “See attached printout for full Linked Orders Report”. No linked orders report was present. The reports did not specify whether Patient 1’s hydromorphone orders should be interpreted such that either the low dose or the high dose could be given each hour, or such that both doses could be given each hour. The reports indicated Patient 1 received the following hydromorphone doses on 5/8/25: 0.165 mg at 1:12 a.m., 0.11 mg at 1:56 a.m., 0.165 mg at 2:27 a.m., 0.11 mg at 3:11 a.m., 0.165 mg at 4:18 a.m., 0.11 mg at 4:57 a.m. The report for each dose of hydromorphone indicated to “See Alternative” at dates and times when a different dose was given. In a concurrent interview and record review on 7/7/25 at 10:59 a.m., Nurse Manager 1 (NM 1) stated the nurse should administer one or the other of the alternative linked hydromorphone orders every hour as needed, and nodded yes when the surveyor stated it appeared each of the linked orders had been given within an hour. NM 1 acknowledged the higher dose of hydromorphone had been given at 4:18 a.m., and the lower dose had been at 4:57 a.m. When the surveyor asked where there was documentation of the expectation that either the high dose or the low dose of hydromorphone should have been given, NM 1 stated, “We generally have stuck with what the order says,” unless there is documentation that the physician is at the bedside. NM 1 reviewed Patient 1’s “Critical/Event Notification Flowsheet”, Patient 1’s vital signs, pain, and PICU (pediatric intensive care unit) flowsheets, and Patient 1’s nursing notes and did not locate entries regarding Patient 1’s hydromorphone order. NM 1 stated there was no documentation regarding communication with the physician regarding the hydromorphone order on 5/8/25 in Patient 1’s critical event notification flowsheet, vital signs/pain/PICU flowsheet, or the nursing notes. In an interview on 7/7/25 at 12:00 noon, the Assistant Physician in Chief stated Patient 1 was not adequately managed with one hydromorphone order, so the other hydromorphone order was used. Review of Patient 1’s “Orders History” dated 5/7/25 to 7/7/25 indicated no other hydromorphone orders were issued for Patient 1 until 4:49 a.m. on 5/8/25, when Medical Doctor 1 (MD 1) issued an order for a hydromorphone drip, 50 mg hydromorphone in 50 mL (milliliters) normal saline (a type of IV fluid), rate of administration unspecified. At 4:58 a.m. on 5/8/25, the hydromorphone drip order was discontinued, and MD 1 issued a replacement order for hydromorphone in normal saline 0.2 mg/mL, rate unspecified. Review of Patient 1’s medication administration record dated 5/8/25 indicated there was no documented administration of either hydromorphone drip through 5:13 a.m. on 5/8/25. In an interview on 7/9/25 at 10:03 a.m., Registered Nurse 1 (RN 1) stated on the overnight shift the morning of 5/8/25, Patient 1 needed more medication, it was too soon to give another high dose of hydromorphone, but the orders also gave the option of giving a smaller dose. RN 1 stated the bedside nurses had interpreted the orders for the different doses of hydromorphone as two separate orders. RN 1 stated the staff had been thinking of a hydromorphone drip for Patient 1, but they didn’t get to it before MD 1 ordered naloxone because he wanted lighter sedation. Review of Patient 1’s medication history for naloxone dated 7/7/25 indicated MD 1 administered naloxone to Patient 1 on 5/8/25 at 5:13 a.m. In an interview on 7/10/25 at 12:00 noon, MD 1 stated he was the physician caring for Patient 1 for the overnight shift including the early morning hours of 5/8/25, but he did not write the order for the hydromorphone which Patient 1 received. MD 1 stated since there had already been discussion with other staff regarding contradictory interpretations of the hydromorphone order, he would defer to the nurse on that topic. Review of an undated screen shot of Patient 1’s medication administration record indicated the word “or” was present in the left hand margin between entries for hydromorphone 0.11 mg and hydromorphone 0.165 mg. Review of a report titled “Linked Group” dated 7/10/25 indicated Patient 1’s two hydromorphone orders (0.11 mg last administered 5/8/25 at 4:57 a.m. and 0.165 mg last administered 5/8/25 at 4:18 a.m.) were separated by the word “Or”. Review of “PICU Cardiovascular Surgery Post Op Orders” dated 4/23/25, without patient identifiers, indicated the order set (a template of physician orders suggesting common physician orders for a specific situation) included a section labeled “PRN [as needed] OPIOIDS IV for Breakthrough Pain”. One of the choices for prn opioids was hydromorphone 0.01 mg/kg (milligrams of the medication per kilogram of the patient’s body weight) every three hours as needed for moderate pain or hydromorphone 0.015 mg/kg every three hours as needed for severe pain. Check boxes were available which would allow modifications of the parameters for the low and high doses of hydromorphone; no choices were present which would allow modifying the word “or” to “and”. In an interview on 7/10/25 at 3:57 p.m., the Director of Accreditation Regulation & Licensure (DAR&L) stated the document dated 4/23/25 was an order set, not orders for a specific patient. In an interview on 7/11/25 at 9:42 a.m., DAR&L stated the facility did not have an ambiguous orders policy, she wouldn’t know which national guideline the facility followed on the topic, but she would ask. DAR&L stated the expectation is to call and clarify, but only if an order is ambiguous to you. DAR&L then stated the facility follows Lippincott (name of a nursing textbook) regarding ambiguous orders and that she would provide a copy. In an interview on 7/11/25 at 10:35 a.m., the Regional Director of Inpatient Pediatrics (RDIP) stated the order sets needed to be tailored to each patient, but some orders on the set were pre-checked because most patients have those orders. When asked whether the two hydromorphone orders should be interpreted as allowing either the low dose or the high dose to be given each hour, or as allowing both the low dose and the high dose to be given each hour, RDIP stated, “I would go with or.” RDIP then stated assessment of the patient is required, and there is also the option of giving an additional dose. The Chief Nurse Executive stated Patient 1 was in pain so was being medicated, the order set does allow medicating the patient, and there typically is a dialog when the provider is in the room. RDIP stated if the patient was in pain a few minutes before another dose of pain medication was due, the nurse could call the physician. RDIP stated he did not know about the documentation, but that communication happens in such situations. In an interview on 7/11/25 at 11:15 a.m., DAR&L stated Patient 1’s hydromorphone was administered within the parameters of the existing order. In an interview on 7/11/25 at 4:58 p.m., DAR&L stated Lippincott applies to medication administration, she did not have anything regarding ambiguous orders, and the expectation was to call the physician if something was unclear. Review of the ASHP (American Society of Health-System Pharmacists) Guidelines on Preventing Medication Errors in Hospitals dated 11/8/17 indicated, “Care should be taken to ensure that the intent and indication of medication orders is clear. Prescribers should adhere to the following guidelines... Do not use vague or blanket instructions... specific directions can help differentiate among intended medications and clarify instructions for other clinicians... Limit the number of as-needed orders for the same therapeutic indication, and provide clear directions regarding the order and symptom hierarchy in which as-needed medications are to be used... All unclear orders should be regarded as potential errors, as staff should not have to interpret what the physician is ordering. The hospital’s patient safety culture should require nursing and pharmacy staff to stop processing the order until clarification is provided by the prescriber... Verbal or telephonic medication orders should be reserved for situations in which it is impossible or impractical for the prescriber to write the order or enter it into the computer (e.g., during an emergency situation, if prescriber is involved in a sterile procedure).” Review of a “PEDIATRIC ICU EVENT NOTE” dated 5/9/25 indicated Patient 1 had been discharged 5/8/25, and an adhesive note attached to the document indicated it was a “5/8 EVENT NOTE”. The document indicated, “The patient had also received a PRN dose of Dilaudid [brand name of hydromorphone] approximately 30 minutes prior, had constricted pupils, and did not wake fully to painful stimuli and so naloxone was ordered and diluted 10:1... 1 mL [milliliter] of the 10:1 dilution of naloxone was provided... The patient awoke with these interventions...” Review of the UpToDate LexiDrug (an online database of drug information) prescribing information for hydromorphone indicated, “Serious, life-threatening or fatal respiratory depression may occur with use of hydromorphone, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydromorphone are essential.””

“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: 26674 Based on observation and interview, the facility failed to ensure the design and implementation of its environmental cleaning policies was sufficient to ensure one of two observed surgical staff changing areas was visibly clean, as required by national infection control guidelines. The deficient practice had the potential to increase the risk of health care associated infections. Findings: In an observation and interview on 7/8/25 at approximately 10:15 a.m., the men’s staff changing area outside the main operating room (OR) suite had black stains on the floor and brown stains on two chairs. The Clinical Nursing Director of Perioperative Services (DPS) stated the locker room was a high traffic area and was about to be cleaned. An unidentified member of the janitorial staff approached the men’s staff changing area with a cart containing janitorial supplies. In an observation and interview on 7/8/25 at approximately 12:00 noon, the men’s staff changing area outside the main OR had black stains on the floor and brown stains on two chairs, all in the same locations as had previously been observed at approximately 10:15 a.m. The DPS stated there was an opportunity for more cleaning. The OR Manager wiped the stain on one chair with a used surgical mask, examined the portion of the stain which transferred to the mask, and stated he didn’t think the stain was blood, but probably was coffee. In an interview on 7/11/25 at 2:17 p.m., the Director of Accreditation, Regulation, & Licensure (DAR&L) stated she would check regarding a housekeeping policy. DAR&L stated there was no national guideline the facility followed, but the expectation was the hospital needed to be clean. In an interview on 7/11/25 at 2:26 p.m., DAR&L stated the facility did not have a housekeeping policy specific to the locker room. Review of the CDC Guidelines for Environmental Infection Control in Health-Care Facilities (revised July 2019) indicated, “Keep housekeeping surfaces (e.g., floors, walls, and tabletops) visibly clean on a regular basis and clean up spills promptly.” Review of the AORN (Association of periOperative Registered Nurses) Guideline for Environmental Cleaning (effective 1/13/20) indicated, “Determine a cleaning schedule (eg, weekly, monthly) for areas that are not terminally cleaned, including... locker rooms... Areas and equipment that are not cleaned according to a schedule may be missed during routine cleaning procedures and become environmental reservoirs for dust, debris, and microorganisms... Establish a process for evaluating cleaning thoroughness... Measure cleaning practices using qualitative methods (eg, visual observation of cleaning process, visual inspection of cleanliness, fluorescent marking) and quantitative methods (eg, cultures, adenosine tri-phosphate [ATP] monitoring)... Provide feedback of assessment findings to personnel and leaders.””

“POST-OPERATIVE CARE CFR(s): 482.51(b)(4) There must be adequate provisions for immediate post-operative care. This Standard is not met as evidenced by: 26674 Based on interview and record review, the facility failed to ensure its pediatric intensive care unit (PICU) capabilities included continuous renal replacement therapy (CRRT, a treatment for kidney failure which is an alternative to intermittent dialysis), peritoneal dialysis (PD, a type of dialysis using fluid placed in the patient’s abdomen rather than a hemodialysis machine), and charcoal hemofiltration (a form of CRRT using charcoal to absorb toxins) as required by national guidelines for post-operative care of cardiac surgery patients. The deficient practice had the potential to require post-operative cardiac surgery patients to be transferred to another facility while critically ill, increasing their risk for a poor outcome. Findings: Review of Patient 1’s medical record indicated a “Long Operative Note” dated 5/7/25 at 2:46 p.m. was present describing that Patient 1 had just underwent cardiac surgery at the facility for repair of a congenital heart defect. Review of a slide deck titled “Kaiser Foundation Hospital Oakland Pediatric Cardiovascular Surgery Program” dated 7/25 indicated the facility had performed 20 pediatric cardiovascular surgeries in 2024 and 10 so far in 2025. In an interview on 7/8/25 at 1:56 p.m., the Regional Director of Inpatient Pediatrics (RDIP) stated the facility had been working on meeting the 2019 AAP (American Academy of Pediatrics) guidelines regarding PICU (pediatric intensive care unit) levels of care. RDIP stated the facility did not offer CRRT, but would in the next few years. RDIP stated the facility was not a CCS (California Children’s Services, a state government program which pays for some medical care and publishes requirements for payment) cardiac center, but intended to be in the future, and was not presently performing cardiac surgery on CCS patients. RDIP stated the facility was following AAP guidelines instead, had a tertiary PICU (a specific category of PICU in the AAP guidelines), but had small gaps it was in the process of closing. RDIP stated he would provide a crosswalk of (a table comparing) the facility’s PICU capabilities to AAP guidelines. Review of an undated “Kaiser Foundation Hospital (KFH) Oakland AAP PICU Crosswalk” indicated CRRT, PD, and charcoal hemofiltration all had a status of “In Progress”. In an interview on 7/11/25 at 10:35 a.m., RDIP stated the facility’s hemodialysis capability mostly covered situations which would require PD. RDIP stated there was a small gap and a regional workgroup was addressing it, otherwise the facility had a tertiary PICU. The Chief Nurse Executive stated the facility would transfer out patients who needed CRRT and had an agreement to provide CRRT. When the surveyor asked to see the agreement, RDIP stated the agreement was not specifically for CRRT, but the facility could transfer a patient needing CRRT to another PICU, and that transfers were rare. Review of the AAP “Executive Summary: Criteria for Critical Care of Infants and Children: PICU Admission, Discharge, and Triage Practice Statement and Levels of Care Guidance” dated 10/19 indicated the document discussed types of patients seen in, and capabilities of, three types of PICU: community, tertiary, and “quaternary or specialized.” The document indicated, “Pediatric patients requiring specialized service interventions such as cardiac, neurologic, or trauma related surgery have improved outcomes when cared for in a quaternary or tertiary ICU, and early interfacility transfer to the appropriate regional facility should be the standard of care...” The guideline indicated CRRT, PD, and charcoal hemofiltration were “Essential” in a tertiary PICU.”

“OPERATING ROOM REGISTER CFR(s): 482.51(b)(5) The operating room register must be complete and up to date. This Standard is not met as evidenced by: 26674 Based on observation, interview, and record review, the facility failed to maintain a readily retrievable operating room (OR) register which included all required data elements. The facility instead generated custom reports which extracted data from its electronic medical records when desired, but which did not include seven of thirteen required data elements. The deficient practice sidestepped a regulatory requirement. Findings: Review of the facility’s listing of OR cases indicated the document was titled “Master Daily Schedule - Temporary Report (5/7/2025 - 5/14/2025) and was dated 7/7/25. The document did not include total time of the operation, the names of assistant surgeons, the names of nursing personnel, the type of anesthesia used, the name of the person administering the anesthesia, or the pre- and post-operative diagnoses. In an observation and interview on 7/11/25 at 3:53 p.m., the Quality Nurse Consultant showed a screen allowing data elements to be selected for a custom report and stated the facility could pull in whatever data is required from the “uptime report” which was “part of EPIC” (the hospital’s electronic medical record). The Director of Accreditation, Regulation, & Licensing stated any user can select the information that’s required. The QNC stated the record for each patient had detailed time stamps, and a report could be generated showing the actual case length. The QNC reviewed a list of available data and stated she didn’t know what the assistant surgeons would be called. The QNC located data elements for all staff and all surgeons and stated the nursing personnel would be included in all staff. The QNC searched additional variables and stated, “There’s a lot of anesthesia details: events, equipment, duration, location, procedures.” The QNC eventually located data elements for anesthesia type and anesthesia provider. The QNC stated diagnoses would be in the patient’s medical record, but she could search for it. The QNC located data elements for pre- and post-operative diagnosis codes and stated the name of the diagnosis would also be spelled out. The QNC stated, “All these fields are charted in the medical record.” When the surveyor asked if an OR register including all the elements discussed was already available or would need to be generated, the QNC responded, “I think it’s been done, but not in this manner. If we needed to keep it this way, we could.””

“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: 44823 Based on observation, interview and record review, the facility failed to provide an appropriate and complete medical screening exam (MSE) for one of 22 sampled patients (Patient 22). Refer to A-2406. This deficient practice resulted in Patient 22 not receiving a complete MSE for a developing emergent medical condition to go unrecognized and untreated, and was not in compliance with the Emergency Medical Treatment and Labor Act (EMTALA) requirement. EMTALA requires hospitals with emergency departments to provide a MSE to any individual who comes to the emergency department (ED) and requests such an examination and prohibits hospitals with emergency departments from refusing to examine or treat individuals with an emergency medical condition (EMC - emergency medical condition manifested by acute [severe and sudden] symptoms of sufficient severity [including severe pain ...] is such that the absence of immediate medical attention could reasonably be expected to result in any or all of the following: placing the patient’s health in serious jeopardy, serious impairment to bodily function, serious dysfunction to any bodily part organ or part). Findings: During a review of the facility’s policy and procedure (P&P) titled, “Basic Unit Care Standards - Emergency Services,” dated 3/2021, the P&P indicated, “4.4 Triage: an initial evaluation completed by a licensed provider including Registered Nurse, Physician, or Allied Health Provider in order to prioritize patients to be seen by a Physician or Allied Health Provider. The initial evaluation includes an assignment of an Emergency Severity Index (ESI - a five-level system that assigns severity of illness to patients in order to assign priority for assessment by a healthcare provider from 1 [most urgent] to 5 [least urgent]) level to each patient) ... 4.6 Qualified Medical Professional (QMP) - healthcare professional designated in the Professional Staff Bylaws, Rules & Regulations (and consistent with state licensure) to perform medical screening examinations ... 4.7 Focused System Assessment: a Registered Nurse (RN) performs a focused chief-complaint based system assessment and evaluation upon assuming care of the patient ... 5.2 A triage is promptly initiated by an RN, Physician or Allied Health Provider for all patients requesting care in the ED, regardless of arrival modality. An ESI level is assigned for all patients ... 5.3 The medical screening exam is completed by the Physician or Allied Health Provider ... 5.5.1 Reassessment will include vital signs, pain assessment and any change in ESI level ... 5.6 The triage nurse(s) are responsible to visually monitor patients in the waiting room and intervene immediately when clinical and/or safety concerns are identified ... 5.10.2 Frequency of vital signs will adjust as warranted by patient’s condition or physician order.” During an interview on 11/9/23, at 11:40 a.m., with Chief of Emergency Department (CED), CED stated, Patient’s 22 MSE was not completed, and every patient needed an MSE. 5.1.1 This policy is mandated by Section 1867 (“Medical screening requirement ... if any individual ... comes to the emergency department and a request is made on the individual’s behalf for examination or treatment for a medical condition, the hospital must provide for an appropriate medical screening examination”) of the Social Security Act, as amended, regulations adopted by Center for Medicare and Medicaid Services (CMS) ... 5.1.4 The hospital will provide a MSE by a QMP to any individual who comes to the hospital seeking emergency medical treatment (or requested on their behalf) to determine if the individual seeking care has an EMC; and, if an EMC exists, provide the individual with further medical examination and treatment as required to stabilize the EMC or arrange for transfer of the individual to another facility ...” During a review of hospital’s, “Professional Staff Bylaws (regulations and rules established by an organization for internal management) (Name of Hospital),” dated 2021, did not include any references to comply with EMTALA regulations or 489.20 (l) ( ... “required under EMTALA to do the following: provide an appropriate MSE to any individual who comes to the emergency department”) and 489.24(a) (“ ...provide an appropriate medical screening examination ... to determine whether or not an emergency condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations ...).””

“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: 44823 Based on observation, interview, and record review, the facility failed to provide an adequate and appropriate medical screening examination (MSE-process to determine if an emergency medical condition exists and is an ongoing process until patient is stabilized or transferred), for one of 22 sampled patients (Patient 22). Patient 22 had a severely, elevated blood pressure (BP) and severe abdominal pain. Staff failed to maintain assessments while Patient 22 waited for care in agony. These failures resulted in Patient 22 not receiving the appropriate triage level (preliminary assessment of patients in order to determine the urgency of care and treatment) for Patient 22’s condition and need for a complete MSE. Patient 22 became unresponsive in the waiting room and subsequently died after cardiopulmonary resuscitation (CPR- rescue breathing and chest compressions) efforts were unsuccessful. Findings: A review of the ambulance record titled, “Patient Care Report” indicated Patient 22, age 55 years old, was transported from home to the emergency department (ED), on 8/29/23 at 12:22 p.m. for abdominal pain. Further review of the ambulance record indicated at 12:00 noon, Patient 22’s pain level was 9/10 (pain scale 0-10 and 10 being the worst). At 12:10 p.m., his O2 sat was 97% (normal 95% or higher) on room air. At 12:11 p.m., Patient 22’s blood pressure (BP) was 220/112 (normal 120/80), pulse 112 (normal 60-100 beats per minute), and respiration rate (RR) 15 (normal 12-20 breaths per minute). At 12:21 p.m., Patient 22’s BP was 208/95 and pulse 104. At 12:22 p.m., Patient 22’s pain level continued to be severe at 9/10. A review of Patient 22’s “Intake” in the ED dated 8/29/23 at 12:26 p.m., indicated the ambulance triage nurse, Registered Nurse (RN) 1, recorded Patient 22’s BP of 208/95, temperature 97.5 degrees Fahrenheit (F-normal 97.5 F- 98.9 F), RR 16, pulse 104, O2 sat 97% on room air and pain 9/10. RN 1’s assessment of Patient 22’s general appearance-distress level was documented as mild. During an interview on 11/7/23, at 2:30 p.m., RN 1 stated, Patient 22’s V/S at the time of his ED arrival, BP 208/95, pain level 9/10, and his presentation, RN 1 assigned Patient 22’s Emergency Severity Index (ESI) of 3. ESI 3 represented Urgent - patients that do not have immediate life or limb threatening illnesses or injuries. When Patient 22 was in the waiting room, a full set of V/S were not retaken. RN 1 stated she saw missed V/S happening all the time and full V/S included BP, pulse, O2 sat, pain, and RR. During an interview on 11/7/23, at 2:50 p.m., with ED Registered Nurse (RN) 2, RN 2 stated she was talking to another patient in the ED waiting area when she heard Patient 22 moaning. RN 2 went back to her triage desk area and when she returned, Patient 22 was quiet. RN 2 noticed Patient 22’s head leaned back and called for Patient 22’s attention. Patient 22 was unresponsive. Per RN 2, she checked Patient 22’s neck pulse and could not recall if he had a pulse. RN 2 called for assistance. RN 2 and ED Registered Nurse (RN) 3 transferred Patient 22 from his seat to a wheelchair and took Patient 22 to the code room (room where life-sustaining efforts are initiated). RN 2 stated the ED was extremely busy and the lobby was packed. During an interview on 11/8/23, at 9:00 a.m., with ED Nurse Manager (NM), NM stated when doing triage, a visual presentation of the patient was needed. A pain level of 9 may be considered for a higher acuity (priority). NM further stated full V/S will include the heart rate, BP, RR, O2, and pain levels. The ambulance triage nurse was supposed to inform the triage nurse of the patient’s condition for reassessment. The (P&P) titled, “Basic Unit Care Standards - Emergency Services,” dated 3/2021 indicated, “Reassessment will include vital signs, pain assessment and any change in ESI level. The triage nurse(s) are responsible to visually monitor patients in the waiting area and intervene immediately when clinical and/or safety concerns are identified. Frequency of vital signs will adjust as warranted by patient’s condition or physician order.” During an interview on 11/8/23, at 9:45 a.m., with ED Assistant Nurse Manager (ANM) 1, ANM 1 stated the elevated BP and pain level were concerning. ANM stated Patient 22’s 208/95 and pain of 9, indicated the ESI would have been ESI 2 and the patient closely monitored. The policy and procedure (P&P) titled, “Basic Unit Care Standards - Emergency Services,” dated 3/2021 indicated, “ESI Priority Levels: Priority 2 - Emergent - patients with illnesses or injuries that place them at a high risk and/or in severe pain or distress or present with unstable vital signs and require prompt intervention. Priority 3 - Urgent - patients with illnesses or injuries that are not immediately life or limb threatening but require prompt medical attention.” During an interview on 11/8/23, at 10:10 a.m., with Registered Nurse (RN) 3, RN 3 stated while in the waiting room, Patient 22 complained of shortness of breath, and took his O2 level and RR. RN 3 stated there was nothing alarming about Patient 22’s condition. Per RN 3, Patient 22 complained of belly pain and stood out because he used a louder voice when he asked when he would be seen and that he had shortness of breath. RN 3 stated he did not check Patient 22’s BP. Furthermore, RN 3 stated Patient 22 kept complaining of belly pain and shortness of breath. RN 3 also stated the ED was hunting (looking) for a room for Patient 22 but there was no sense of urgency. A review of the V/S flowsheet for Patient 22 indicated, on 8/29/23 at 12:26 p.m., Patient 22’s BP was 208/95, RR 16, O2 sat 97% on room air and pain score 9/10. At 1:50 p.m., RR 20, and O2 sat was 100%. However, no BP or pain level was documented. During an interview on 11/8/23, at 12:09 p.m., with ED Assistant Nurse Manager (ANM) 2, ANM 2 stated that day (8/29/23) was busier in the ED. Patient 22’s elevated BP and pain level were concerning; ANM 2 stated pain is whatever the patient says and the triage nurses are to keep an eye on patients in the waiting area. During a review of the hospital’s videotape (no audio) of the ED waiting room lobby, on 11/9/23 at 10:30 a.m., with the Inpatient Adult Care (IACM) Manager, Clinical Quality Director (CQD), and Quality Leader (QL), the videotape taken on 8/29/23 showed the following ED events of Patient 22: -At 12:33 p.m., An ill appearing, Patient 22 arrived in the ED waiting area in a wheelchair brought in by an EMT (emergency medical technician) and transferred himself onto a seat. Patient 22 was observed not being able to sit still, had facial grimacing, clenched teeth, and frequently looked towards the triage nurses desk area. -At 1:41 p.m., Patient 22 moved to another seat closer to the triage desk, unable to sit still, and hunched over. -At 1:49 p.m., RN 3 brought out the V/S machine equipped with a BP cuff to the waiting room area and took Patient 22’s O2 level on the right finger and no BP check. - At 1:53 p.m., Patient 22 hit the seat’s armrest twice with his right palm and took deep breaths. -At 1:57 p.m., Patient 22 touched his abdominal area with his right hand with facial grimacing. At 1:58 p.m., RN 3 walked past in front of Patient 22 and did not stop to assess. -At 1:59 p.m.to 2:01 p.m., Patient 22 continued to touch his abdomen and took deep breaths. -At 2:02 p.m., RN 2 was about to hand Patient 22 ice packs. RN 2 placed her left hand on Patient 22’s right upper abdomen, then went back to her desk to get gloves. As RN 2 was putting on gloves in front of Patient 22, Patient 22 took deep breaths, and was slouched in his seat, placing both hands on his abdomen. -At 2:03 p.m., Patient 22’s head and body tilted back in the chair and RN 2 pulled Patient 22’s torso forward. RN 2 gave a few chest compressions before summoning help and transferred Patient 22 into a wheelchair with assistance from RN 3 and took Patient 22 to the code room (resuscitation treatment room). During an interview on 11/9/23, at 11:40 a.m., with Chief of Emergency Department (CED), CED stated the normal BP reading is 120/80 and a BP reading of 208/95 is elevated. CED, further stated, Patient’s 22 MSE (process to determine if an emergency medical condition exists and is an ongoing process, until patient is stabilized or transferred) was not completed. CED stated, he was not aware of Patient 22’s BP and pain level. CED further stated there was a lag (delay) time between triage and the change of condition regarding Patient 22’s unresponsiveness. Review of the ED physician’s provider notes dated 8/29/23 indicated the physician received Patient 22, “unresponsive when I assumed care.” ...”Cardiac arrest.” Record review of the ED nurse’s notes, dated 8/29/23 at 3:58 p.m., showed CPR was started in the code room at 1405 (2:05 pm) and time of death pronounced by the physician at 1434 (2:34 pm). During a review of the P&P titled, “Basic Unit Care Standards - Emergency Services,” dated 3/2021 indicated, “An emergency medical condition manifested by acute symptoms of sufficient severity (including severe pain) is such that the absence of immediate medical attention could reasonably be expected to result in any or all of the following: placing the patient’s health in serious jeopardy, serious impairment to bodily function, serious dysfunction to any bodily part organ or part.” During a review of the P&P titled, “Emergency Medical Screening Examination, Treatment and Transfer,” dated 06/2023, the P&P indicated, “Medical Screening Exam (MSE) - the process required to determine within reasonable clinical confidence whether an emergency medical condition exists. It is an ongoing process, including monitoring of an individual until the individual is either stabilized or transferred.””