Madison Medical Center

“EMERGENCY SERVICES CFR(s): The CAH provides emergency care necessary to meet the needs of its inpatients and outpatients. This Condition is not met as evidenced by: 36473 Based on observation, interview and review of the Malignant Hyperthermia Association of the United States (MHAUS), the hospital failed to ensure the required life-saving medications were readily accessible when administering Succinylcholine (a muscle relaxant/paralytic) in the emergency department (ED). The facility census was one Acute Care patient, two Swing Bed patients and two Observation (Observation - outpatient services provided to a patient while the patient’s physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five. The severity and cumulative effects of these failed practices resulted in the hospital’s non-compliance with 42 CFR 485.618 CoP of Emergency Services. Please refer to C-0884 for details.”

“EQUIPMENT, SUPPLIES, AND MEDICATION CFR(s): Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. The items available must include the following: This Standard is not met as evidenced by: 36473 Based on observation, interview and review of the Malignant Hyperthermia Association of the United States (MHAUS), the hospital failed to ensure the required life-saving medications were readily accessible when administering Succinylcholine (a muscle relaxant/paralytic) in the emergency department (ED). This failure had the potential to affect all patients that presented to the ED and given Succinylcholine in an emergency. The facility census was one Acute Care patient, two Swing Bed patients and two Observation (Observation - outpatient services provided to a patient while the patient’s physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five. Findings included: 1. Observation on 04/02/24 at 9:40 AM, showed the Malignant Hyperthermia box was in a locked room in the surgical services area. 2. During an interview on 04/02/24 at 9:45 AM, Staff B, Registered Nurse (RN), stated the Malignant Hyperthermia box was located in the locked anesthesia room. Staff B stated the Charge nurse on the Medical Surgical unit had access. 3. During an interview on 04/02/24 at 10:34 AM, Staff H, Emergency Department Operations Coordinator, acknowledged ED physicians utilized the medication Succinylcholine (a skeletal muscle relaxant used to relax muscles either during surgery or while on a breathing tube) when a patient required intubation (a tube inserted through a person’s mouth or nose, down into their trachea [airway/windpipe], that kept the trachea open so air can get through and connected to a machine that delivers air or oxygen to the patient). Staff H stated the ED did not have a Malignant Hyperthermia kit/cart and Staff H was unsure if another department in the hospital had a Malignant Hyperthermia kit/cart. Staff H stated if another department did have a Malignant Hyperthermia kit/cart, ED staff did not have access to the kit/cart. 4. During an interview on 04/02/24 at 11:24 AM, Staff I, ED Physician, stated if a patient needed to be intubated either Versed (medication used to help a patient relax or sleep before a procedure) or Succinylcholine (paralytic) medication would be administered. Staff I stated the ED did not have a Malignant Hyperthermia kit/cart available. 5. During an interview on 04/02/24 at 11:30 AM, Staff J, ED RN, stated ED staff was unaware if the facility had an in-house Malignant Hyperthermia kit/cart available. 6. During an interview on 04/02/24 at 12:48 PM, Staff F,Medical-Surgical Charge Nurse, stated: - If the ED staff notified the Medical-Surgical Unit that a patient in the ED required the Malignant Hyperthermia kit/cart, the Medical-Surgical Unit staff would notify pharmacy that a patient in ED needed the Malignant Hyperthermia kit/cart. - The Charge Nurse on the Medical-Surgical Unit had keys to the Operating Room (OR) that allowed access to the Malignant Hyperthermia kit/cart in OR. - It would take Staff F a long time to get the locked key for OR to access and retrieve the Malignant Hyperthermia kit/cart. - The facility had not conducted any drills with staff for either retrieval or the process/procedure to utilize for Malignant Hyperthermia signs and symptoms. 7. During an interview on 04/02/24 at 12:57 PM, Staff A, OR Manager, stated: - They were not sure if other departments in the hospital knew about the Malignant Hyperthermia kit located in the OR. - Keys were available per the Medical-Surgical Unit’s Charge Nurse with access to the OR and the locked key to access/retrieve the facility’s Malignant Hyperthermia kit. - If ED staff needed the Malignant Hyperthermia kit, ED staff would have to retrieve the key from the Medical-Surgical Unit’s Charge Nurse. - Unsure if the ED had a Malignant Hyperthermia kit in the department. - They had discussed the kit and procedure to perform treatment with OR staff but had not provided education/training to other departmental nursing staff. 8. Review of the MHAUS recommendations, dated 2016, showed that when patients were given Malignant Hyperthermia (a life-threatening, but treatable reaction of the inhalation anesthetics and Succinylcholine triggering anesthetics), medication, the only antidote used to reverse the reaction was the medication Dantrolene (medication that uncouples the heat generating mechanism in the muscles). 18018”

“RECORDS SYSTEM CFR(s): For each patient receiving health care services, the CAH maintains a record that includes, as applicable-- (i) Identification and social data, evidence of properly executed informed consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient; This Standard is not met as evidenced by: 36473 Based on observation, record review, interview and nationally-recognized standards review, the facility failed to perform four (#2, #3, #4 and #5) out of reviewed for fire-risk assessments prior to surgical procedures. These failures placed the surgical patients and staff at an elevated fire risk.The hospital census was one Acute Care patient, two Swing Bed patients and two Observation (Observation - outpatient services provided to a patient while the patient’s physician decides whether to admit the patient to Acute Care services or discharge the patient) patients for a total patient census of five. Findings included: 1. Observation on 4/02/24 at 9:25 AM, for surgical Patient #5, in Operating Room Suite #1, showed no surgical staff performed a fire-risk assessment prior to a cystoscopy. 2. Review of Patient #2’s medical record on 03/19/24, showed no documentation of a fire-risk assessment prior to a prostate ultrasound and biopsy. 3. Review of Patient #3’s medical record on 12/07/23, showed no documentation of a fire-risk assessment prior to a colonoscopy with biopsy. 4. Review of Patient #4’s medical record on 02/27/24, showed no documentation of a fire-risk assessment prior to a left mini-open carpal tunnel release. 5. During an interview on 04/03/24 at 12:40 PM, Staff A, Operating Room Manager, stated staff had not performed fire-risk assessments verbally prior to surgical procedures and subsequently document them. 6. Review of the Association of PeriOperative Registered Nurses (AORN) “Guideline for Fire Prevention Practices,” dated 2023, showed the direction for staff to: - Perform a fire-risk assessment as part of the preprocedural briefing process, to include ignition, fuel, and oxidizer sources present in the OR. - Include cognitive aids (eg, algorithms, checklists). - Collaborate on and implement interventions based on the fire-risk assessment. - Document the fire-risk and the actions taken to address them. - Prevent contact between fuel sources (eg, drapes, skin antisepsis agents) and ignition sources (eg, electrosurgical devices). - Prevent pooling of flammable skin antiseptic agents under, on, or near the patient. - Prevent the pooling of flammable antiseptic agents by: o placing sterile or clean towels near the surgical preparation site to absorb excess solution from pooling; o using sterile towels to absorb excess solution from the prepped site; o removing materials (eg, sterile or clean towels) that become wet with the skin preparation solution before draping; and o moving flammable antiseptic soaked materials away from ignition sources and outside of the patient care vicinity (ie, at least 6 ft away). - Allow the skin antiseptic agent to dry before applying surgical drapes. Follow the manufacturer’s IFU for dry time. - Use a water-soluble gel for the patient’s head and hair when performing procedures that involve the head of neck. - Use moistened radiopaque sponges near oxidizer and ignition sources during airway procedures. The operating room contains several elements of the fire triangle, including oxygen (oxidizer), lasers and electrosurgical devices (ignition sources), and alcohol-based skin antiseptics and surgical drapes (fuel). The perioperative team can help reduce the risk of fire by performing a fire risk assessment and implementing interventions (eg, preventing contact between fuel sources and ignition sources) based on that assessment.”

“INFECTION PREVENT SURVEIL & CONTROL OF HAIs CFR(s): The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 36473 Based on observation, interview, policy review and nationally-recognized standards review, the hospital failed to ensure staff followed infection control policies and infection prevention standards of practice when staff failed to: - Maintain maintenance and repairs in the surgical areas. - Maintain cleaning and repairs in the Central Sterile rooms. - Remove all paper products (particle shedding) from the Central Sterile Clean room. - Provide maintenance and a rust (reddish-brown oxidation of metal that can harbor bacteria) -free kitchen. - Remove expired food items from the kitchen. These failed practices had the potential to expose all patients, visitors and staff to cross-contamination and increased the potential to spread infection. The facility census was one Acute Care patient, two Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and two Observation (Observation - outpatient services provided to a patient while the patient’s physician decides whether to admit the patient to Acute Care services or discharge the patient) patients for a total patient census of five. Findings included: Surgery and Central Sterile 1. Observation on 04/02/24 at 8:20 AM, in Operating Room #2 (OR #2), showed: - Two rusted vents; - Chipped paint with exposted drywall (particle shedding that harbors bacteria) between the floor and wall; and - Two rusted doorframes with chipped paint. 2. Observation on 4/02/24 at 9:30 AM, in the Endoscopy Cabinet/Sterilizer room, showed behind, under and to the side of the sterilizer, wall damage and door frame damage. Also rust with wall damage around the corner into OR #1. 3. Observation on 4/02/24 at 8:30 AM, in the Central Sterile Clean room, showed: - Wall damage in four areas; - Multiple papers and one tissue box (particle shedding) on a desk; and - Open drywall area under the sink between the pipe and the wall. 3. Review of the hospital’s policy titled, “Infection Control Central Sterile,” last reviewed on 03/2024, showed the direction for staff to clean the Central Sterile areas daily. 4. Review of three months of the surgery department cleaning logs, failed to show the cleaning of the Central Sterile areas. 6. During an interview on 4/03/24 at 12:40 PM, Staff A, OR Manager, stated staff were expected to turn in maintenance work requests for repairs needed and expected staff to remove all paper products from the Central Sterile clean room. 7. During an interview on 4/03/24 at 3:30 PM, Staff O, Infection Preventionist, stated their hospital followed AORN guidelines and they rounded in the surgical area monthly. They also stated staff was expected to complete a work order for repairs and follow the protocol for a sterile environment in the Central Sterile areas. 8. Review of the APIC “Infection Preventionists Guide to the Operating Room,” dated 2018, showed the OR environment requires surfaces which are smooth, cleanable, non-absorptive, and capable of withstanding cleaners and disinfectant solutions. There should be no cracks and crevices where dirt can become trapped. Other materials (e.g., vinyl) can rip or wear in ways which create environmental reservoirs for microorganisms. 9. Review of the AORN “Guideline for Environmental Cleaning,” dated 2023, showed the Sterile Processing Areas were to be terminally cleaned each day the areas were used. Kitchen 10. Observation on 4/01/24 at 2:30 PM, in the kitchen, showed: - Rusted sink legs; - Unclean grout behind the sink; - Unclean ceiling vent and ceiling tiles above the dishwasher; - One unclean fluorescent light cover; - Rusted shelving that housed clean dishes; - Unclean ceiling tiles with cracks and unclean sprinklers in the stove area; - Four unclean stained ceiling tiles in the cleaning hallway; - One rusted mixer spindle and base; - Rusted hanging pots; - Unclean knife holder; - Scraped, open drywall near the cook’s refrigerator; - Unclean baseboards; - Unclean wall with holes and grout separated above the handwashing sink; - Unclean tubing for the juice machine; - Cracked wall around a clock; - Damage on the bottom of the microwave cabinet; and - Soiled ceiling tiles around the air conditioner. 11. During an interview on 4/01/24 at 2:55 PM, Staff C, Dietary Manager, stated staff was expected to remove the valve of the juice concentrate box, place into hot water and run hot water through the tubing. 12. Observation on 4/01/24 at 2:40 PM, in the kitchen refrigerator, showed the following expired foods: - Five whipped toppings with expiration dates of 10/2020; - Five heavy whipping cream with expiration dates of 07/2020; - One ranch dressing with expiration date of 07/2022; and - One italian dressing with expiration date of 10/13/23. 13. Observation on 4/01/24 at 2:50 PM, in storage room, 10 honey thickners, with expiration dates of 02/07/22. 14. During an interview on 4/03/24 at 3:30 PM, Staff O, Infection Preventionist, stated they do not perform environmental rounds in the kitchen, they followed the Missouri Food Code and expected staff to complete work orders for repairs needed. 15. Review of the Missouri Food Code for the Food Establishments of the State of Missouri, dated 06/03/13, chapter 6, showed surface characteristics of floors, walls and ceiling surfaces should be smooth, durable, and easily cleanable for areas where food establishment operations were conducted and nonabsorbent for areas subject to moisture such as food preparation areas, walk-in-refrigerators, washing areas, toilet rooms, mobile food establishment servicing areas, and areas subject to flushing or spray cleaning methods. Food in unmarked containers or packages, or marked with a time that exceeded six hours shall be discarded.”

“COMP ASSESSMENT, CARE PLAN & DISCHARGE CFR(s): §485.645(d)(5) Comprehensive assessment, comprehensive care plan, and discharge planning (§483.20(b), and §483.21(b) and (c)(2) of this chapter), except that the CAH is not required to use the resident assessment instrument (RAI) specified by the State that is required under §483.20(b), or to comply with the requirements for frequency, scope, and number of assessments prescribed in §413.343(b) of this chapter). “ §483.20(b) Comprehensive assessments- (1) Resident assessment instrument. A facility must make a comprehensive assessment of a resident’s needs, strengths, goals, life history and preferences, using the resident assessment instrument (RAI) specified by CMS. The assessment must include at least the following: (i) Identification and demographic information. (ii) Customary routine. (iii) Cognitive patterns. (iv) Communication. (v) Vision. (vi) Mood and behavior patterns. (vii) Psychosocial well-being. (viii) Physical functioning and structural problems. (ix) Continence. (x) Disease diagnoses and health conditions. (xi) Dental and nutritional status. (xii) Skin condition. (xiii) Activity pursuit. (xiv) Medications. (xv) Special treatments and procedures. (xvi) Discharge planning. (xvii) Documentation of summary information regarding the additional assessment performed on the care areas triggered by the completion of the Minimum Data Set (MDS). (xviii) Documentation of participation in assessment. The assessment process must include direct observation and communication with the resident, as well as communication with licensed and nonlicensed direct care staff members on all shifts. (2) When required. Subject to the timeframes prescribed in §413.343(b) of this chapter, a facility must conduct a comprehensive assessment of a resident in accordance with the timeframes specified in paragraphs (b)(2) (i) through (iii) of this section. The timeframes prescribed in §413.343(b) of this chapter do not apply to CAHs. (i) Within 14 calendar days after admission, excluding readmissions in which there is no significant change in the resident’s physical or mental condition. (For purposes of this section, “readmission” means a return to the facility following a temporary absence for hospitalization or for therapeutic leave.) (ii) Within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident’s physical or mental condition. (For purposes of this section, a “significant change” means a major decline or improvement in the resident’s status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident’s health status, and requires interdisciplinary review or revision of the care plan, or both.) (iii) Not less often than once every 12 months. “ §483.21(b) Comprehensive care plans. (1) The facility must develop and implement a comprehensive person-centered care plan for each resident, consistent with the resident rights set forth at §483.10(c)(2) and §483.10(c)(3), that includes measurable objectives and timeframes to meet a resident’s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment. The comprehensive care plan must describe the following: (i) The services that are to be furnished to attain or maintain the resident’s highest practicable physical, mental, and psychosocial well-being as required under §483.24, §483.25, or §483.40; and (ii) Any services that would otherwise be required under §483.24, §483.25, or §483.40 but are not provided due to the resident’s exercise of rights under §483.10, including the right to refuse treatment under §483.10(c)(6). (i) Any specialized services or specialized rehabilitative services the nursing facility will provide as a result of PASARR recommendations. If a facility disagrees with the findings of the PASARR, it must indicate its rationale in the resident’s medical record. (ii) In consultation with the resident and the resident’s representative(s)- (A) The resident’s goals for admission and desired outcomes. (B) The resident’s preference and potential for future discharge. Facilities must document whether the resident’s desire to return to the community was assessed and any referrals to local contact agencies and/or other appropriate entities, for this purpose. (C) Discharge plans in the comprehensive care plan, as appropriate, in accordance with the requirements set forth in paragraph (c) of this section. (2) A comprehensive care plan must be- (i) Developed within 7 days after completion of the comprehensive assessment. (ii) Prepared by an interdisciplinary team, that includes but is not limited to- (A) The attending physician. (B) A registered nurse with responsibility for the resident. (C) A nurse aide with responsibility for the resident. (D) A member of food and nutrition services staff. (E) To the extent practicable, the participation of the resident and the resident’s representative(s). An explanation must be included in a resident’s medical record if the participation of the resident and their resident representative is determined not practicable for the development of the resident’s care plan. (F) Other appropriate staff or professionals in disciplines as determined by the resident’s needs or as requested by the resident. (iii) Reviewed and revised by the interdisciplinary team after each assessment, including both the comprehensive and quarterly review assessments. (3) The services provided or arranged by the facility, as outlined by the comprehensive care plan, must- (i) Meet professional standards of quality. (ii) Be provided by qualified persons in accordance with each resident’s written plan of care. (iii) Be culturally-competent and trauma-informed. “ §483.21(c)(2) Discharge summary. When the facility anticipates discharge a resident must have a discharge summary that includes, but is not limited to, the following: (i) A recapitulation of the resident’s stay that includes, but is not limited to, diagnoses, course of illness/treatment or therapy, and pertinent lab, radiology, and consultation results. (ii) A final summary of the resident’s status to include items in paragraph (b)(1) of §483.20, at the time of the discharge that is available for release to authorized persons and agencies, with the consent of the resident or resident’s representative. (iii) Reconciliation of all pre-discharge medications with the resident’s post-discharge medications (both prescribed and over-the-counter). (iv) A post-discharge plan of care that is developed with the participation of the resident and, with the resident’s consent, the resident representative(s), which will assist the resident to adjust to his or her new living environment. The post-discharge plan of care must indicate where the individual plans to reside, any arrangements that have been made for the resident’s follow up care and any post-discharge medical and non-medical services. This Standard is not met as evidenced by: 18018 Based on policy review, record review and interview the facility failed to develop a comprehensive activity care plan that provided specific individualized activity interest and interventions to stimulate the patient’s physical and mental well-being for two current Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients (#6 and #7) and for two discharged Swing Bed patients (#20 and #21) reviewed for a comprehensive quality of life activities care plan. This failed practice had the potential to affect all Swing Bed patients by failing to stimulate their minds, body, and social interests. The facility census was one Acute Care patient, two Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and two Observation (Observation - outpatient services provided to a patient while the patient’s physician decides whether to admit the patient to Acute Care services or discharge the patient) patients for a total census of five. Findings included: 1. Review of the facility’s policy titled, “Basics and Standards of Care Planning,” dated 09/2023, showed in part staff directives: - To ensure evidence of implementation of an individualized plan of care is contained within the patient’s record the outline process will require routine documentation of patient assessment, orders, patient care, and discharge planning as evidenced of care planning within the facility. - To ensure care planning process included patient assessment, goal setting, intervention(s), referrals to other health care professionals, evaluations of patient responses to treatment. Additionally, this included revision of care and treatment in order to meet the patient’s needs as needed. - To ensure documentation of the patient care plan was embedded in the patient record. - To ensure the patient’s nursing care needs were determined through the patient assessment process. - To ensure a Registered Nurse (RN) would determine specific patient care needs and the plan for meeting patient needs, to include patient assignments and specific delegation of patient care activities. 2. Review of Patients’ Electronic Medical Health Records (EMHR) showed: - Patient #6 was admitted to the facility’s Swing Bed program on 03/17/24, for complaints of weakness; - Patient #7 was admitted to the facility’s Swing Bed program on 03/26/24, for complaints of cerebrovascular accident (CVA - stroke), weakness and respiratory failure; - Patient #20 was admitted to the facility’s Swing Bed program on 03/14/24, for complaints of weakness; and - Patient #21 was admitted to the facility’s Swing Bed program on 03/20/24 for complaints of status post left hip fracture and weakness. Patient #6’s, #7’s, #20’s, and #21’s EMHR showed staff failed to develop a comprehensive activity plan of care for the patients during their stay in the facility’s Swing Bed program. 3. During an interview on 04/03/24 at 3:35 PM, Staff O, Director of Nursing, acknowledged the Swing Bed patients did not have an activity plan of care included in the patients’ EMHR.”

“Subdivision of Building Spaces - Smoke Barrie CFR(s): NFPA 101 Subdivision of Building Spaces - Smoke Barrier Construction 2012 EXISTING Smoke barriers shall be constructed to a 1/2-hour fire resistance rating per 8.5. Smoke barriers shall be permitted to terminate at an atrium wall. Smoke dampers are not required in duct penetrations in fully ducted HVAC systems where an approved sprinkler system is installed for smoke compartments adjacent to the smoke barrier. 19.3.7.3, 8.6.7.1(1) Describe any mechanical smoke control system in REMARKS. This Standard is not met as evidenced by: 16639 Based on observation and interview the facility failed to ensure all smoke barriers were maintained in a manner to resist smoke. The hospital census was one Acute Care Patients, two Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and two Observation (Observation - outpatient services provided to a patient while the patient’s physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five. Findings included: 1. During observation on 04/03/24 of the area above the ceiling the smoke wall near the emergency department was noted to have three open areas around joists and the wall near the laboratory entrance had a 12 inch by 18 inch area which were open. During interview upon the observation Staff D, Maintenance Director, confirmed the open areas in the smoke wall.”

“Gas and Vacuum Piped Systems - Inspection and CFR(s): NFPA 101 Gas and Vacuum Piped Systems - Inspection and Testing Operations The gas and vacuum systems are inspected and tested as part of a maintenance program and include the required elements. Records of the inspections and testing are maintained as required. 5.1.14.2.3, B.5.2, 5.2.13, 5.3.13, 5.3.13.4 (NFPA 99) This Standard is not met as evidenced by: 16639 Based on observation, record review, and interview, the facility failed to ensure areas where medical gasses were stored were maintained as required by code. The hospital census was one Acute Care Patients, two Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and two Observation (Observation - outpatient services provided to a patient while the patient’s physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of five. Findings included: 1. Observation on 04/03/24 at 8:50 AM showed an outdoor enclosure for liquid oxygen and oxygen tanks. There was no overhead protection for the tanks. The containers were on a concrete pad. During an interview upon the observation Staff D, Mainteance Director, stated they had contacted the inspection company to provide the needed protection but had not heard back from them. 2. Review of a report on the medical gas system dated 06/20/22 showed the following conditions needed to be addressed, cylinders stored outside must be protected as follows, from the ground beneath to prevent rusting, from the accumulation of snow and ice in winter, and from exosure to direct sunlight during the summer.”