Ray County Memorial Hospital

“PROVISION OF SERVICES CFR(s): §485.635 Condition of Participation: Provision of Services This Condition is not met as evidenced by: 48359 Based on interview, medical record review and policy review, the hospital failed to: - Ensure staff verified medications prior to administration for all patients cared for in the Emergency Department (ED). - Perform a two-nurse verification for high alert medications for two (#10 and #16) of seven records reviewed. - Prevent a medication error when one patient (#24) was given the wrong medication dose of 24 medical records reviewed. - These failures placed all patients at risk for medication errors. The hospital census was five. This failed practice resulted in a system failure and noncompliance with 42 CFR 485.635 Condition of Participation (CoP): Provision of Services. The severity and cumulative effect of this practice had the potential to place all patients at risk for their health and safety, also known as an Immediate Jeopardy (IJ). As of 08/07/24, the hospital provided an immediate action plan sufficient to remove the IJ when the hospital implemented corrective actions that included educating all current and oncoming staff on medication administration verification. All remaining staff were to complete education prior to the start of their next shift.”

“NURSING SERVICES CFR(s): §485.635(d)(3) All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. This Standard is not met as evidenced by: 48359 Based on interview, medical record review and policy review, the hospital failed to: - Ensure staff verified medications prior to administration for all patients cared for in the Emergency Department (ED). - Perform a two-nurse verification for high alert medications for two (#10 and #16) of seven records reviewed. - Prevent a medication error when one patient (#24) was given the wrong medication dose of 24 medical records reviewed. - These failures placed all patients at risk for medication errors. Findings included: Review of the hospital’s policy titled, “High Alert Medications,” revised 04/2024, showed: - High alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. The purpose of this policy is to identify said high-alert medications and provide instructions for use to minimize risk of adverse events. - All high alert medications should undergo a double nurse verification of the medication and dose before administration whenever possible. - Lovenox (a medication used to help prevent the formation of blood clots [clumps that occur when blood hardens from a liquid to a solid]) treatment doses will have a second nurse verification on the electronic medical record (EMR). - Tenecteplase (TNK, medication to treat blood clot) is a high alert medication and the ordering, dispensing and administration is delineated in a separate policy. Review of the hospital’s policy titled, “Stroke Policy and Process,” revised 03/2024, showed: - If TNK is to be given the Stroke Team will assist in the administration of TNK per protocol. - Stroke dosing for TNK is 0.25 milligrams (mg) per kilogram (kg). - The TNK dose was not to exceed 25 mg. - The dose for a weight of 98 kg was 24.5mg. Review of the hospital’s policy titled, “Automated Dispensing Machines,” reviewed 12/2023, showed: - Override is a process of bypassing pharmacist review of the medication order to obtain a medication when assessment of the patient indicates that a delay in medication administration would harm the patient. - Overrides are restricted to urgently needed medications. - The override removal of medication from an automated dispensing machine should be limited at all costs. - Pharmacy reviews the overrides each day to ensure orders exist, trends are noted, and brought forward. Review of the hospital’s document titled, “Occurrence Report Summary,” dated 04/16/24, showed: - Patient #24 was given a heart attack dose of TNK instead of a stroke dose. - This was an error and could have necessitated monitoring and/or intervention to preclude harm. - The patient received the heart attack dose of 50 mg of TNK instead of the stroke dose of 24.5 mg. The maximum dose for a heart attack is 50mg and the maximum dose for a stroke is 25 mg. - TNK was administered before the ED provider entered the order into the EMR. - TNK was administered without a pharmacist, provider or second nurse verification. Review of Patient #24’s medical record dated 04/16/24, showed: - At 11:55 AM, she was a 68-year-old female who presented to the ED with a complaint of chest pain. The left side of her face was tingling. Her cardiologist (a physician who is an expert in the care of your heart and blood vessels) recommended she go to the ED for a complaint of “head pain.” - Her weight was 98 kilograms. - At 1:10 PM, a Code Stroke was activated. - At 1:56 PM, a note showed the ED provider spoke with cardiology and the patient again and found out she was experiencing left sided weakness and left facial “tingling.” - At 2:04 PM, a verbal order was placed to administer TNK 50 milligrams IV (in the vein). - At 2:05 PM, TNK 50mg was given IV. There was no two-nurse medication verification documented. - At 2:21 PM, she had left sided weakness. Review of Patient #16’s medical record dated 07/27/24 through 07/29/24, showed: - On 07/28/24 at 12:14 PM, Lovenox was given. - On 07/29/24 at 9:34 AM, Lovenox was given. - There were no second nurse medication verifications completed for either Lovenox administration. Review of Patient #10’s medical record dated, 08/07/24 showed at 9:38 AM, Lovenox was given. There was no second nurse medication verification completed. During an interview on 08/07/24 at 10:54 AM and 12:20 PM, Staff S, Chief Nursing Officer (CNO), stated that she agreed patients were at risk of harm without a medication verification process in place. Scanning medication in the ED created a billing discrepancy. Patients were charged twice because they were charged when the order was written and again when the medication was scanned. She agreed patient safety was a priority to patient billing. The previous on-site pharmacist requested the ED nurses did not scan the medication because they walked the medications to the nurse to verify the correct medication and dose was administered. The current EMR system did not communicate with the medication dispensing machine. Every medication administered in the ED was retrieved via override. The previous on-site pharmacists reviewed the medication dispensing machine reports printed after medications were administered and compared them to the physician orders to ensure the correct medications and doses were administered. She agreed it was not the best practice to review medication administration for errors after the medication was administered. When the hospital transitioned to the virtual pharmacists on 07/30//24 she became responsible for reviewing the medication dispensing machine reports and comparing them to the patient orders to ensure accurate medication and dose administration. She did not have time to review the reports. During an interview on 08/06/24 at 2:30 PM and 08/07/24 at 1:15 PM, Staff F, ED Manager, stated that she agreed patients were at risk of harm without a medication verification process. The EMR did not communicate with the medication dispensing machine and the ED nurses did not scan medications prior to medication administration. She believed medication documentation could not be completed for high alert medications without a second nurse verification. She expected a second nurse verification was completed for high alert medications as indicated by the policy. The pharmacy never communicated any medication errors to her. The wrong dose of TPK was given to Patient #24. The heart attack dose was given instead of the stroke dose. The nurse who made the error was an agency nurse and she was not familiar with the medication. She had never administered TPK.”

“PATIENT CARE POLICIES CFR(s): [The policies include the following:] (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. This Standard is not met as evidenced by: 36473 Based on observation, interview, and review of the United States Pharmacopoeia (USP) Chapter 797 and Chapter 795, when the hospital failed to provide an admixture log for sterile compounding to ensure correct beyond use dates (BUD). These failures had the potential to affect the quality of the medications administered to patients and the ability to track them for potential recalls for patients that received care at the hospital. The hospital census was one Acute Care Patient, five 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 zero 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 six. Findings included: Observation on 04/25/24 at 9:30 AM, in Sterile Compounding Room #1, showed Staff B, Pharmacy Technician, mixed 2 milliliter (ml, system of measurement for one thousandth of a liter) of thiamine with 100 cubic centimeter (cc, a system of measurement equal to ml) of normal saline (NS) without documenting the admixture on a log. During an interview on 04/25/24 at 10:00 AM, Staff A, Pharmacist, stated they did not have a way to track the time of the admixtures and never logged the mixing times for immediate use compounding. Review of the United States Pharmacopoeia (USP) Chapter 797 and Chapter 795 showed beyond-use date (BUD) is the date or time after which administration of a CSP shall not be initiated. As described in previous ASHP guidelines and in USP chapter 797, the BUD is determined from the date or time the preparation is compounded, its chemical stability, and the sterility limits described later in these guidelines. Both the stability of the components and the sterility limits described above must be taken into consideration when determining BUDs. Information regarding stability dating procedures and defaults can be found in USP chapter 795, Pharmaceutical Compounding. USP chapter 795 requirements for documentation showed all CSPs must have a compounding record to permit traceability of all components in case of recall or quality issues.”

“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, interview, record review and nationally-recognized standards review, the facility failed to perform fire-risk assessments prior to surgical procedures. These failures placed the surgical patients and staff at an elevated fire risk.The hospital census was two Acute Care patients, 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) patient for a total patient census of six. Findings included: 1. Observation on 1/31/24 at 9:05 AM, for surgical Patient #8, in the Gastrointestinal Operating Room Suite, showed no surgical staff performed a fire-risk assessment prior to a colonoscopy. 2. During an interview on 1/31/24 at 1:50 PM, Staff K, Director of Surgical and Outpatient Services, stated staff were expected to perform fire-risk assessments verbally prior to surgical procedures and document them. 3. Review of Patient #5’s medical record on 10/25/23, showed no documentation of a fire-risk assessment prior to a colonoscopy with lesion removal. 4. Review of Patient #6’s medical record on 08/07/23, showed no documentation of a fire-risk assessment prior to a left knee scope with menicotomy. 5. Review of Patient #7’s medical record on 11/13/23, showed no documentation of a fire-risk assessment prior to a laporoscopy chole. 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. 7. Review of the facility’s policy titled, “Fire In The Operating Room,” dated 09/2023, showed the direction for staff to perform fire-risk assessments before each operative or other invasive procedures.”

“ADMINISTRATION OF ANESTHESIA CFR(s): In those cases in which a CRNA administers the anesthesia, the anesthetist must be under the supervision of the operating practitioner except as provided in paragraph (e) of this section. An anesthesiologist’s assistant who administers anesthesia must be under the supervision of an anesthesiologist. This Standard is not met as evidenced by: 16639 Based on record review and interview the facility failed to ensure physicians who supervise Certified Registered Nurse Anesthetists (CRNA) had approved privileges.The facility census was two 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 discharge the patient) patients for a total patient census of six. Findings included: 1. Review of the credentialing packets for Physician #1 and #10 showed privileges requested for surgery. The privilege for supervision of the CRNA did not appear on the sheet as an option. 2. Review of the facility’s undated policy titled, “Scope of Services for Anesthesia,” showed anesthesia administered by a CRNA is done under the supervision of the operating practitioner. 3. During an interview on 01/31/24 at 9:30 AM, Staff I, Chief Nursing officer confirmed the privilege sheet lacked an option to select supervision of the CRNA and neither physician had that on the privilege sheet.”

“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: - Provide a separation between the clean laundry and dirty laundry to ensure containment to prevent cross-contamination; - Maintain cleanliness in the Endoscope cabinet; - Maintain repairs and cleanable drop ceilings in the Central Sterile rooms; and - Provide maintenance and a rust (reddish-brown oxidation of metal that can harbor bacteria) -free 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 two 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 discharge the patient) patients for a total patient census of six. Findings included: Laundry Separation 1. Observation on 1/31/24 at 8:10 AM, in the laundry department, showed no door between the dirty laundry and the clean laundry failing to keep the laundry contained. 2. During an interview on 1/31/24 at 8:10 AM, Staff H, Environmental Services Manager, stated the dirty side is a negative pressure room and hadn’t had a door for 23 years. 3. Review of the AORN “Guidelines for Laundry,” dated 2023, showed handling contaminated laundry with a minimum of agitation avoids contamination of air, surfaces and personnel. 4. Review of the facility’s policy titled, “Infection Prevention and Control - Laundry,” undated, showed clean linen and soiled linen shall be strictly separated and contact between clean linen and soiled linen shall not occur at any time. Endoscope Storage 5. Observation on 1/31/24 at 9:40 AM, in the Endoscope storage room, showed inside the Endoscope cabinet multiple tape (harbors bacteria) labels on the back wall of the cabinet, two sticky notes (harbors bacteria) on the side wall and an unclean towel in the bottom of the cabinet. 6. Review of the AORN “Guideline for Flexible Endoscopes,” dated 2023, showed visible soil in the storage cabinet may contaminate endoscopes stored in the cabinet. 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. Central Sterile and Surgical Hallway 7. Observation on 1/31/24 at 9:45 AM, in the surgical hallway, showed six scrapes on the wall with exposed drywall (particle shedding that harbors bacteria). 8. Observation on 1/31/24 at 9:50 AM, in the Central Sterile Clean room, showed: - A drop uncleanable ceiling; - Two paper calendars (particle shedding); and - Multiple papers and tissue box (particle shedding) on a desk. 9. Observation on 1/31/24 at 10:00 AM, in the Instrument Decontamination room, showed: - A drop uncleanable ceiling; - A floor seam cracked, open and unclean; and - Two wall seams broken away from the wall leaving unclean areas. 10. Observation on 1/31/24 at 10:15 AM, in the Endoscope Decontamination room, showed a drop uncleanable ceiling. 11. 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. 12. 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 13. Observation on 1/29/24 at 2:00 PM, in the kitchen, showed: - Four holes in the wall to the left of the window; - Ceiling cracks with drywall exposed above the cook stove; - Rust under the dishwasher; - Rust under the lid of the ice machine; - Rust on legs below the ice machine; and - One hole in the wall to the left of the café door. 14. During an interview on 1/31/24 at 1:50 PM, Staff K, Director of Surgical and Outpatient Services, stated they expected staff to place work orders for any repairs needed, remove all paper products and terminally clean the Central Sterile area. 15. During an interview on 1/31/24 at 2:10 PM, Staff J, Infection Preventionist, stated they expected: - Dirty laundry to be contained; - Paper products to be removed from the Central Sterile Clean room; - The central sterile staff to keep the endoscope cabinet clean; - Ceilings in the Central Sterile rooms to be cleanable; and - Staff in the kitchen and surgical areas to report any needed repairs to maintenance and Infection Control. 16. Review of the facility’s policy titled, “Infection Prevention and Control Program Policy,” last reviewed on 3/03/14, showed environmental rounding was to be performed monthly of patient care units and ancillary departments by the Infection Preventionist. 17. Review of the facility’s log titled, “Quality Assurance Monitoring Evaluation - Walk Around Hospital Cleanliness,” for the last six months, showed no observation of the kitchen or surgery areas.”

“LEADERSHIP RESPONSIBILITIES CFR(s): (1) The governing body, or responsible individual, must ensure all of the following: (i) Systems are in place and operational for the tracking of all infection surveillance, prevention and control, and antibiotic use activities, in order to demonstrate the implementation, success, and sustainability of such activities. This Standard is not met as evidenced by: 36473 Based on interview and record review and nationally-recognized standards review, the facility failed to provide a current Infection Control Plan approved by the Governing Body. This failure had the potential to effect all patients and staff that presented to the hospital for treatment.The hospital census was two 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 discharge the patient) patients for a total patient census of six. Findings included: 1. During an interview on 1/31/24 at 2:10 PM, Staff J, Infection Preventionist, stated they didn’t have an Infection Control Plan approved by the Governing Body. 2. Although requested, the facility failed to provide a current Infection Control Plan approved by the Governing Body. 3. Review of the Centers For Disease Control and Prevention (CDC), titled, “Core Infection Prevention and Control Practices for Safe Healthcare Delivery”, dated 11/29/22, showed the required ensurance of the Governing Body’s accountability for the success of infection prevention activites in a health care facility.”