Adventhealth Castle Rock

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 49541 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §416.51 INFECTION CONTROL was out of compliance. A-0749 (a)(2) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, document reviews, and interviews, the facility failed to ensure a functional and sanitary environment for surgical services to avoid sources and transmission of infections and communicable diseases. Specifically, the facility failed to ensure surgical instruments were processed in accordance with facility policies and manufacturer instructions for use (IFU) in one of one observations in the emergency department (ED).”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 49541 Based on observations, document reviews, and interviews, the facility failed to ensure a functional and sanitary environment for surgical services to avoid sources and transmission of infections and communicable diseases. Specifically, the facility failed to ensure surgical instruments were processed in accordance with facility policies and manufacturer instructions for use (IFU) in one of one observations in the emergency department (ED). Findings include: Facility policy: The Sterile Processing Procedures policy read, items to be sterilized must be cleaned, inspected, decontaminated, sterilized, and stored in a controlled environment. For instrument cleaning and decontamination, the following steps must be followed: Refer to the manufacturer ’ s instructions or guidelines for specific care instructions for each instrument prior to proceeding. All objects to be sterilized must first be thoroughly cleaned to remove all bioburden and other residue. Soiled objects shall be placed in a designated covered container and sprayed with an enzymatic foam or gel at the point of use. The items will then be taken to the Sterile Processing Department for reprocessing or cleaned in the OR decontamination room if applicable. References: According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Manufacturer ’ s Instructions; the manufacturer ’ s written IFU for the cleaning and sterilization of surgical instruments should be read, understood, and followed by those responsible for processing the instrument. The cleaning process should be audited to ensure that the procedures being used comply with the manufacturer ’ s written IFU and that the personnel performing cleaning procedures have received documented training and have demonstrated competency in the cleaning process. According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Precleaning: instruments should be precleaned immediately following use. Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water as recommended by the manufacturer. The instruments should be maintained in a moist state before cleaning in order to prevent the drying of surgical debris onto or within them. According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Transport of Instruments; during transport of instruments from the point of use to the decontamination area, appropriate precautions (e.g., use of a closed transport container) should be taken to avoid personnel exposure to blood-borne pathogens, contamination of the work environment, and further contamination of the instruments. The time between using instruments and cleaning them should be kept to a minimum. The BD MEDICAL/ CAREFUSION / V. MUELLER General Surgical Instrument IFU read, Point of Use Pre-processing Instructions: Initiate cleaning of device within two hours of use. Remove excess gross soil as soon as possible after use by rinsing or wiping the device. Disassembly Pre-processing Instructions: All devices must be processed in the completely open position (i.e. flushports, jaws, etc.) to allow solution contact of all surfaces. Warnings: device shall be used in accordance with these IFU. Improper use of these devices may cause serious injury. In addition, improper care and maintenance of the devices may render the devices non-sterile prior to patient use and may cause serious injury to the health care provider or the patient. The KARL STROZ Surgical Instrument IFU read, failure to follow the instructions, cautions, and warnings presented in this manual may result in serious consequences to the patient. Pre-cleaning: Potable water may be used for pre-cleaning and rinsing a device immediately after patient use to remove gross contamination. Water temperature should not exceed 113°F (45°C) to prevent coagulation of blood and other proteins. Pre-Cleaning Preparation: Immediately after a procedure, at the point of use (e.g. operating room), wipe the instruments with a soft, lint-free, disposable cloth, moistened with water to remove all heavy soiling. Contain and transport the contaminated instruments with a soft, lint-free, disposable cloth, moistened with water or cleaning detergent to remove all heavy soiling. The Prepzyme® Forever Wet IFU read, the enzymatic humectant spray which promotes the long lasting retention of moisture on all soiled instruments and scopes, helping to prevent the adhesion of bio-burden. Spray directly on the soiled instruments and scopes immediately after use. Apply product in five to six sweeping sprays across the tray. Allow the instrument or scope to set in Prepzyme® Forever Wet until ready for cleaning. As long as all surfaces have been completely covered, it is not necessary to reapply as moisture is retained. Rinse thoroughly before cleaning. 1. The facility failed to pre-clean all surgical instruments prior to sterilization in accordance with the instruments’ IFU. Additionally, the facility failed to place contaminated surgical instruments in a designated covered container and spray them with an enzymatic foam or gel at the point of use in accordance with the facility policies. A. Observations i. On 9/30/24 at 12:05 p.m., observations were conducted in the ED. Observations revealed a soiled utility closet that contained biohazardous (waste that contains infectious or potentially infectious substances) materials with the door latch taped closed, which prevented the door from closing and locking. The soiled utility closet was located across from three treatment rooms designed for psychiatric patients. Additional observations revealed soiled hinged surgical instruments in a closed position placed directly on the counter. Sterile processing technician (Tech) #1 stated the surgical instruments should have been placed in a rigid biohazard container with a lid for safety. Tech #1 stated the instrument’s hinges were visibly soiled. Tech #1 stated the instruments were dry and not sprayed with the enzymatic cleaner with the hinges in an open position. Tech #1 was unable to state how long the soiled surgical instruments had been sitting there. Tech #1 stated when surgical instruments were not cleaned per the IFU, there could be bioburden left behind, increasing the patient ’ s risk of infection. The observations on 9/30/24 were in contrast to AAMI guidelines which read, instruments were to be precleaned immediately following use. Gross debris was to be removed, and instrument lumens were to be flushed with sterile distilled water as recommended by the manufacturer. The instruments were to be maintained in a moist state before cleaning to prevent the drying of surgical debris onto or within them. The observations on 9/30/24 were in contrast to AAMI guidelines which read, during transport of instruments from the point of use to the decontamination area, appropriate precautions (e.g., use of a closed transport container) were to be taken to avoid personnel exposure to blood-borne pathogens, contamination of the work environment, and further contamination of the instruments. The time between using the instruments and cleaning them was to be kept to a minimum. The observations on 9/30/24 were in contrast to the BD MEDICAL/ CAREFUSION / V. MUELLER General Surgical Instrument IFU which read, initiation of cleaning of the device was required within two hours of use. Excess gross soil was to be removed as soon as possible after use by rinsing or wiping the device. All devices had to be processed in the completely open position (e.g., flushports, jaws) to allow solution contact on all surfaces. The observations on 9/30/24 were in contrast to the KARL STORZ Surgical Instrument IFU which read, potable water was to be used for pre-cleaning and rinsing a device immediately after patient use to remove gross contamination. Pre-cleaning preparation required, immediately after a procedure and at the point of use (e.g., operating room), the instruments be wiped with a soft, lint-free, disposable cloth moistened with water to remove all heavy soiling. Contaminated instruments were to be contained and transported with a soft, lint-free, disposable cloth moistened with water or cleaning detergent to remove all heavy soiling. The observations on 9/30/24 were in contrast to the Prepzyme® Forever Wet IFU which read, spray directly on the soiled instruments and scopes immediately after use and apply the product in five to six sweeping sprays across the tray. The instrument or scope was to be allowed to set in Prepzyme® Forever Wet until ready for cleaning. As long as all surfaces were completely covered, reapplication was not necessary, as moisture was retained. The instruments were to be rinsed thoroughly before cleaning. B. Interviews i. On 9/30/24 at 12:12 p.m., an interview was conducted with emergency department charge nurse (RN) #2. RN #2 stated the emergency department staff was responsible for cleaning and storing the equipment before transporting it to the sterile processing department (SPD). RN #2 stated the surgical instruments were visibly soiled and the hinges were left in a closed position. RN #2 stated the instruments were dry and had not been sprayed with the enzymatic humectant spray. RN #2 said they were not aware when the surgical instruments had been pre-cleaned or how long they had been sitting there. RN #2 stated the soiled surgical instruments should have been placed in a biohazard container and not directly on the counter. RN #2 stated instruments not secured in a biohazard container put the staff at risk of injury and potential infection. RN #2 stated surgical instruments not cleaned correctly put both the staff and patients at risk of infections. Upon request, RN #2 was unable to provide or locate the surgical instruments’ IFUs. This was in contrast to the AAMI Sterile Processing guidelines, which stated those responsible for processing surgical instruments read, understand, and follow the manufacturer’s written IFU for cleaning and sterilization. They recommended auditing the cleaning process to ensure compliance with the manufacturer’s IFU and verifying personnel performing the cleaning had received documented training and demonstrated competency in the procedures This was in contrast to the BD MEDICAL/CAREFUSION/V. MUELLER General Surgical Instrument IFU, which stated device cleaning must begin within two hours of use, with excess soil removed by rinsing or wiping as soon as possible. All devices had to be processed in a fully open position to ensure solution contact with all surfaces. The warnings highlighted improper use, care, or maintenance of the devices could cause serious injury and may render the instruments non-sterile, posing risks to both health care providers and patients. This was in contrast to the KARL STORZ Surgical Instrument IFU, which stated failure to follow instructions, cautions, and warnings could result in serious consequences for the patient. For pre-cleaning, potable water was recommended to rinse and remove gross contamination immediately after use, with the water temperature not exceeding 113°F (45°C) to prevent coagulation of blood and proteins. After a procedure, instruments had to be wiped with a soft, lint-free cloth moistened with water to remove heavy soiling, and contaminated instruments were to be contained and transported with a similar cloth moistened with water or cleaning detergent. ii. On 9/30/24 at 12:23 p.m., an interview was conducted with infection prevention program manager (Manager) #3. Manager #3 stated the Prepzyme Forever Wet was an enzymatic humectant spray used to prevent bioburden from drying on the surgical instruments, which would make them harder to clean. Manager #3 said the enzymatic humectant spray was colored blue, making it easy to detect whether the instruments had been sprayed correctly. Manager #3 stated untreated soiled instruments found on the counter were not best practice and went against the facility’s policies. Manager #3 stated the facility followed AAMI guidelines for processing surgical instruments. Manager #3 stated surgical instruments not processed according to the IFU put patients at risk for infection. iii. On 9/30/24 at 12:15 p.m., an interview was conducted with emergency department director (Director) #4. Director #4 stated the emergency department staff was responsible for cleaning and storing the surgical instruments before transporting it to SPD. Director #4 stated the soiled surgical instruments should not have been placed directly on the counter. Director #4 stated the soiled surgical instruments should have been pre-cleaned and sprayed with the enzymatic humectant spray according to the facility’s policy. Director #4 stated when surgical instruments were not cleaned correctly, it placed patients at risk for surgical infection.”

“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: 44751 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES was out of compliance. A-0395 RN SUPERVISION OF NURSING CARE A registered nurse must supervise and evaluate the nursing care for each patient. Based on interviews and document review, the facility failed to ensure the nursing care provided met the continuous care needs of patients and was in accordance with facility protocol, policy, and national guidelines. Specifically, the facility failed to ensure registered nurses (RNs) assessed detox patients on Clinical Institute Withdrawal Assessment (CIWA) protocols (clinical assessment used to diagnose the severity of alcohol withdrawal) and ensure patients were assessed after medication was administered in three of four medical records reviewed (Patient #2, #3, and #4). Additionally, nursing staff failed to identify and respond to changes in the patient’s condition, implement timely interventions, and inform medical providers when the patient’s condition worsened in one of four medical records reviewed (Patient #3).”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 44751 Based on interviews and document review, the facility failed to ensure the nursing care provided met the continuous care needs of patients and was in accordance with facility protocol, policy, and national guidelines. Specifically, the facility failed to ensure registered nurses (RNs) assessed detox patients on Clinical Institute Withdrawal Assessment (CIWA) protocols (clinical assessment used to diagnose the severity of alcohol withdrawal) and ensure patients were assessed after medication was administered in three of four medical records reviewed (Patient #2, #3, and #4). Additionally, nursing staff failed to identify and respond to changes in the patient’s condition, implement timely interventions, and inform medical providers when the patient’s condition worsened in one of four medical records reviewed (Patient #3). Findings include: Facility policies: The Assessment, Reassessment, Vital Signs, and Documentation of Patient Care policy read, reassessment of the hospitalized patient is a continuous, ongoing process based upon department-specific assessment parameters as well as in response to changes in diagnosis, treatments, procedures, and the plan of care. Patient condition and ongoing changes in status warrant more frequent reassessment and documentation of specific system changes as determined by the caregiver. A registered nurse (RN) supervises and evaluates the nursing care for each patient. The Medication Administration policy read, before the administration of any medication, the health care professional administering the medication will ensure the following information: the indications for which they are prescribed, the clinical situations in which they are administered, and the needs of the patient receiving the medication. Facility order sets: The Provider Order Set: Alcohol Withdrawal CIWA Less Than 19 read, CIWA nursing assessments should be completed as follows: For CIWA greater than 19, every 30 minutes times 2, then every 2 hours. For CIWA between 8-19, every 2 hours times 2 then every 4 hours. For CIWA less than 8, every 4 hours. Always check CIWA within 1 hour after medications. Notify the provider if CIWA does not decrease by at least 3 points after medication administration. The provider should be notified if the CIWA score is greater than 19, if there is any seizure activity, and/or if there is new onset delirium and/or hallucinations. The Provider Order Set: Alcohol Withdrawal Intensive Care Unit (ICU) read, the following interventions were to be provided only within the ICU and the Alcohol Withdrawal CIWA Less Than 19 order set and the Alcohol Withdrawal ICU order set must be used in conjunction with one another for CIWA scores greater than 19. CIWA nursing assessments should be completed as follows: For CIWA greater than 19, every 30 minutes times 2, then every 2 hours for patients not receiving a sedating infusion. For patients sedated with dexmedetomidine (a medication used to sedate non-intubated patients and reduce the severity of alcohol withdrawal), concurrent administration of intravenous (IV) lorazepam (a medication used to treat alcohol withdrawal) was to occur for the prevention of alcohol withdrawal seizures. Additionally, for patients receiving dexmedetomidine infusions nursing staff were to reassess the patient’s CIWA score every hour. References: The Elsevier Clinical Skills - Alcohol Withdrawal reference, provided by the facility, read, delirium tremens (DTs) is a potentially fatal condition occurring 24 to 72 hours after cessation or reduction of prolonged and heavy alcohol use. Reassess signs and symptoms of alcohol withdrawal symptoms (AWS) including assessing for DTs using standardized assessment tools such as CIWA. Assess the patient’s response to medications and other treatments or interventions. Monitor the patient’s vital signs, orientation, sleep, and emotional status, including suicidal thoughts. Monitor a patient receiving pharmacotherapy for signs of oversedation and respiratory depression. Continue to reassess the patient’s condition until an assessment is no longer clinically indicated per the organization’s practice regarding alcohol withdrawal. 1. The facility failed to ensure nurses identified and responded to changes in the patient’s condition, implemented timely interventions, informed medical providers when the patient’s condition worsened, and conducted CIWA assessments for patients who were undergoing alcohol detoxification per facility protocol, policy, and national guidelines. a. A review of Patient #3’s medical record revealed on 2/5/24 at 6:14 p.m., Patient #3 was admitted for alcohol withdrawal and pancreatitis (inflammation of the pancreas). Further record review revealed the provider had ordered CIWA assessments to be completed and for Patient #3 to receive nothing by mouth (NPO). i. A review of the CIWA flowsheet for Patient #3 revealed on 2/5/24 at 6:02 p.m. Patient #3’s CIWA score was 7. Patient #3’s next CIWA assessment was performed five hours and 42 minutes later at 11:44 p.m. This was in contrast to the Alcohol Withdrawal CIWA Less Than 19 Provider Order Set which read, for CIWA scores less than 8 the patient should be assessed every 4 hours. ii. On 2/6/24 at 3:46 a.m., RN #6 completed a CIWA assessment for Patient #3. Patient #3’s CIWA score at the time was 15. At 3:53 a.m. RN #6 administered a one milligram (mg) tablet of lorazepam to Patient #3. The administration of the lorazepam tablet contradicted the NPO order entered on 2/5/24 at 6:14 p.m. Furthermore, there was no indication Patient #3 had been reevaluated within one hour of receiving the medication to assess its effectiveness. Further review of Patient #3’s medical record revealed at 5:35 a.m., one hour and 49 minutes after Patient #3 had been administered lorazepam, RN #7 conducted a CIWA assessment. Patient #3’s CIWA score was 14, despite having a continued elevated score, no additional medication had been administered to the patient. Additionally, no communication had been initiated with Patient #3’s medical provider regarding an elevated CIWA score greater than 11 or that Patient #3’s CIWA score had not decreased by at least three points. Lastly, there was no evidence Patient #3 had been administered medication for alcohol withdrawal when their CIWA score was 14. At 6:02 a.m., twenty-three minutes after Patient #3 had a CIWA score of 14, RN #7 and a phlebotomist entered Patient #3’s room and found the patient unresponsive. At 6:03 a.m. a code blue (a code used to indicate a patient requiring resuscitation) was called and CPR (cardiopulmonary resuscitation) was initiated. CPR was terminated at 6:23 a.m. and the patient subsequently died. These events were in contrast to the Alcohol Withdrawal CIWA Less Than 19 Provider Order Set which read, always check CIWA within one hour after medications have been administered. Notify the provider if the CIWA score does not decrease by at least three points after medication administration or if there are additional concerns. In addition, notify the medical provider for CIWA scores greater than 11. iii. A review of the safety event for Patient #3 revealed Patient #3’s death was unexpected. On 4/15/24 at 3:48 p.m., an interview was conducted with patient safety program manager (PSPM) #5. PSPM #5 stated they had interviewed nursing staff and the medical provider (Provider #3) who had cared for Patient #3 on the morning of 2/6/24. However, this interview was in contrast to an interview conducted on 4/16/24 at 9:30 a.m. with Provider #3. During the interview Provider #3 stated they had not spoken to PSPM #5 or quality and patient safety leadership after Patient #3 had expired. PSPM #5 stated they had reviewed Patient #3’s medical record on 2/7/24 and a critical event analysis (CEA) had been performed on 2/12/24. PSPM #5 stated after interviews, medical record review, and the CEA were conducted no inconsistencies or concerns in the care provided to Patient #3 had been identified. This was in contrast to Patient #3’s medical record review which had identified, nursing staff failed to identify and respond to changes in Patient #3’s condition and implement timely medical interventions. Additionally, nursing staff failed to inform Patient #3’s medical provider Patient #3’s medical condition worsened, and the patient expired. Additionally, on 4/10/24 at 3:49 p.m., 4/11/24 at 3:58 p.m., and 4/15/24 at 5:00 p.m. surveyors requested evidence of the corrective actions and preventive measures implemented by the facility after the facility investigated and evaluated the care provided to Patient #3. However, the facility was unable to provide this evidence. b. A review of Patient #2’s medical record revealed on 3/30/24 at 11:16 p.m. Patient #2 was directly admitted to the ICU for acute alcohol withdrawal and management of alcohol withdrawal symptoms. Patient #2’s medication administration record revealed on 3/31/24 at 12:37 a.m. a dexmedetomidine continuous infusion was initiated and the continuous infusion was not discontinued until 4/3/24 at 2:15 a.m. Review of the CIWA assessments for Patient #3 revealed nursing staff had not performed hourly CIWA assessments in accordance with the Provider Order Set: Alcohol Withdrawal Intensive Care Unit while Patient #2 received the dexmedetomidine continuous infusion. Examples included: i. On 3/31/24 between 12:30 a.m. and 12:00 p.m. (a duration of 11 hours and 30 minutes), nursing staff performed six CIWA assessments for Patient #2. The CIWA assessments were performed at,12:30 a.m., 1:57 a.m., 4:00 a.m., 6:00 a.m., 10:00 a.m., and 12:00 p.m. Additionally, from 2:18 p.m. to 11:00 p.m. (a duration of 8 hours and 42 minutes), four CIWA assessments were performed for Patient #2. The CIWA assessments were performed at 2:18 p.m., 6:00 p.m., 8:58 p.m. and 11:00 p.m. ii. On 4/1/24 between 4:00 a.m. and 10:00 p.m. (a duration of 18 hours), there were six CIWA assessments performed for Patient #2. The CIWA assessments were performed at, 4:00 a.m., 9:40 a.m., 3:00 p.m., 6:00 p.m., 8:00 p.m., and 10:00 p.m. iii. On 4/2/24 between 2:00 a.m. and 7:00 p.m. (a duration of 17 hours), nursing staff performed six CIWA assessments for Patient #2. The CIWA assessments were performed at, 2:00 a.m., 6:00 a.m., 11:00 a.m., 6:00 p.m., 6:36 p.m., and 7:00 p.m. c. Review of Patient #4’s medical record revealed Patient #4 was directly admitted to the ICU on 3/11/24 at 11:55 p.m. after the patient had a witnessed alcohol withdrawal seizure. According to Patient #4’s medication administration record on 3/12/24 at 12:14 a.m. Patient #4 was placed on a dexmedetomidine continuous infusion. The continuous dexmedetomidine infusion was not stopped until 3/22/24 at 5:46 p.m. Upon review of the CIWA assessments performed for Patient #4, hourly CIWA assessments had not been performed while Patient #2 was administered the dexmedetomidine. Additionally, Patient #2’s medical record showed no evidence of CIWA assessments being performed prior to 3/22/24. The events for Patient #2 and Patient #4 were in contrast to the Provider Order Set: Alcohol Withdrawal Intensive Care Unit (ICU) which read, nursing staff were to perform CIWA assessments every hour for patients receiving dexmedetomidine in the ICU. Additionally, these events were in contrast to the Elsevier Clinical Skills - Alcohol Withdrawal reference and the Assessment, Reassessment, Vital Signs, and Documentation of Patient Care policy which read, the medical condition of alcohol withdrawal patients and their response to medical treatment should have been assessed until no longer clinically indicated. d. On 4/10/23 at 2:25 p.m., an interview was conducted with registered nurse (RN) #2. RN #2 stated it was important to follow CIWA protocol to prevent seizures and possible death. RN #2 stated it was important to reassess patients after medication administration to ensure the medication was working to treat the patient’s symptoms. RN #2 further stated if the medication was not effective, they would notify the provider. e. On 4/11/24 at 4:56 p.m., an interview was conducted with RN #1. RN #1 stated lorazepam was often used to treat withdrawal symptoms. RN #1 further stated the patient needed to be assessed one hour after medication administration. RN #1 stated if a CIWA patient was not assessed or treated with medication, there was a risk that the patient would have a seizure or possible death. f. On 4/16/23 at 9:15 a.m., an interview was conducted with Provider #3. Provider #3 stated it was important to reassess a patient after medication administration to ensure the medication was working and to ensure the patient was not going through alcohol withdrawal. Provider #3 stated they expected to be notified when CIWA scores increased for patients with a prior history of alcohol withdrawal. Provider #3 stated they relied on the nursing staff to notify them when alcohol withdrawal patients exhibited changes in behavior and began experiencing alcohol withdrawal symptoms regardless of whether or not medication had been administered to the patient. Additionally, Provider #3 stated alcohol withdrawal could have been deadly for patients.”