Parkview Medical Center, Inc.

“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: 48269 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs, was out of compliance. A-0749 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 follow manufacturers’ instructions for use (IFU), national guidelines, and facility policy to ensure methods were in place to prevent and control the transmission of infections. Specifically, the facility failed to ensure staff reprocessed surgical instruments according to the manufacturers’ IFUs in three of three observations of the instrument decontamination process.”

“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: 48269 Based on observations, document reviews, and interviews, the facility failed to follow manufacturers’ instructions for use (IFU), national guidelines, and facility policy to ensure methods were in place to prevent and control the transmission of infections. Specifically, the facility failed to ensure staff reprocessed surgical instruments according to the manufacturers’ IFUs in three of three observations of the instrument decontamination process. Findings include: Facility policy: The Sterile Processing policy read, all medical devices requiring specific methods of decontamination, sterilization, transportation, and storage will follow all current manufacturer’s instructions for use, current standards and practice including but not limited to the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of periOperative Registered Nurses (AORN), federal and state regulations, evidence based practice or facility specific policies and procedures. References: According to the American National Standards Institute (ANSI)/AAMI Sterile Processing - Knowledge, Skills, Competencies, cleaning is the most important step in sterile processing; thorough cleaning removes most microorganisms and other organic material from contaminated items. Unless an item is clean, it cannot be effectively disinfected or sterilized. Any soil, no matter how little or visible, can prevent disinfectant or sterilant from contacting the surface of an item. The best resource for determining how to best manage an item is the manufacturer’s IFU. The V Mueller IFU read, 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. Only the cleaning and sterilization processes which are defined within these IFUs have been validated. Rinse the device by completely immersing it in treated water for a minimum of 30 seconds to remove any residual detergent or debris. The Arthrex IFU read, sonicate (high-frequency ultrasonic energy used to break apart particles) for 10 minutes at a minimum of 40+5 kilohertz (kHz). Remove instruments from the cleaning solution and rinse at least one minute with utility water. The Smith and Nephews IFU read, sonicate for a minimum of 15 minutes in an ultrasonic cleaner containing enzymatic detergent and deionized water. Rinse thoroughly with warm deionized water for a minimum of two minutes, making sure to irrigate any lumens and/or crevices. 1. The facility failed to manually clean surgical instruments in accordance with facility policy, national guidelines, and manufacturers’ IFUs. A. Observations i. On 12/1/25 at 12:19 p.m., observations were conducted in the sterile processing department (SPD). Observations revealed orthopedic surgical instruments from a small bone set being cleaned and reprocessed by sterile processing technician (Tech) #1. Tech #1 cleaned and brushed the instruments in an enzymatic solution for five minutes, placed the instruments in a tray, and rinsed them with tap water. Tech #1 then placed the instruments in an ultrasonic cleaner (a device that uses high-frequency sound waves to clean objects submerged in a liquid solution) for five minutes. After Tech #1 removed the tray of instruments from the ultrasonic, Tech #1 rinsed the instruments by dipping the tray into deionized (DI) water (water with dissolved mineral ions, such as sodium, calcium, and chloride, removed through a process called deionization) for approximately one to five seconds. The instruments were placed into the automatic washer once they had been rinsed. This was in contrast to the V Mueller IFU, which did not indicate ultrasonic cleaning was a validated cleaning process for the devices. According to the V Mueller IFU, only the cleaning and processes which were defined within the IFUs had been validated. This was also in contrast to the V Mueller IFU, which instructed staff to thoroughly rinse instruments by completely immersing them in treated water for a minimum of 30 seconds to remove any residual detergent or debris. ii. On 12/1/25 at 12:19 p.m., additional observations at a separate work station in SPD revealed orthopedic surgical instruments from a shoulder repair set being cleaned and reprocessed by Tech #2. Tech #2 cleaned and brushed the instruments in an enzymatic solution, placed the instruments in a tray, and rinsed them with tap water. Tech #2 then placed the instruments in the ultrasonic for five minutes. After Tech #2 removed the tray of instruments from the ultrasonic, Tech #2 rinsed the instruments by dipping the tray into DI water for approximately one to five seconds. This was in contrast to the Arthrex IFU, which instructed staff to sonicate the instruments for 10 minutes, and then remove the instruments from the cleaning solution and rinse them for at least one minute with utility water. iii. On 12/2/25 at 10:58 a.m., observations were conducted in the SPD. Observations revealed orthopedic surgical instruments from a shoulder repair set being cleaned and reprocessed by Tech #1. Tech #1 cleaned and brushed the instruments in an enzymatic solution for five minutes, placed the instruments in a tray, and rinsed them with tap water. Tech #1 then placed the instruments in the ultrasonic for 10 minutes. After Tech #1 removed the tray of instruments from the ultrasonic, Tech #1 rinsed the instruments by immersing them in DI water for 30 seconds. These observations were in contrast to the Smith and Nephews IFU, which instructed staff to sonicate the instruments for a minimum of 15 minutes, and then rinse the instruments thoroughly with warm DI water for a minimum of two minutes, making sure to irrigate any lumens or crevices. Additionally, observations on 12/1/25 and 12/2/25 were in contrast to the Sterile Processing policy, which instructed staff to decontaminate surgical instruments according to the manufacturer’s IFU. Further, these observations were in contrast to the ANSI/AAMI Sterile Processing - Knowledge, Skills, Competencies, which read, the manufacturer’s IFU was the best resource to determine how to manage instruments. B. Interviews i. On 12/2/25 at 10:58 a.m., an interview was conducted with Tech #1. Tech #1 stated, on 12/2/25, they changed the reprocessing of the shoulder repair instruments to a 10 minute ultrasonic cycle (five minutes previously), followed by a 30 second immersion rinse in DI water (instruments were dipped in DI water for one to five seconds previously). Tech #1 stated these processes had changed because their SPD supervisor had reviewed the IFU for the shoulder instruments. This was in contrast to the Smith and Nephews IFU, which instructed staff to sonicate the instruments for a minimum of 15 minutes, and then rinse the instruments thoroughly with warm DI water for a minimum of two minutes. Additionally, Tech #1 stated IFUs for reprocessing instruments were followed to ensure proper cleaning of bioburden (blood, tissue, and microorganisms) from the instruments and to prevent the spread of infections in patients. ii. On 12/3/25 at 11:16 a.m., an interview was conducted with the central services manager (Manager) #3. Manager #3 stated the IFUs were available to SPD staff at all times online and on paper. Manager #3 stated it was important to follow the IFUs because all instrumentation, even from the same vendor, could have different instructions for proper sterilization. Manager #3 stated when IFUs were not followed, it caused ineffective sterilization of the instruments. Manager #3 stated improper sterilization of instruments created risks to patient safety, such as delays in surgery or infections. iii. On 12/3/25 at 12:04 p.m., an interview was conducted with the infection prevention program manager (Manager) #4. Manager #4 stated SPD staff were expected to follow IFUs because following instrument manufacturers’ specifications prevented unintended outcomes. Furthermore, Manager #4 stated not following IFU caused patient safety risks up to, and including, death.”

“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: 49541 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 observations, interviews, and document review, the facility failed to provide nursing services in accordance with facility protocol and policy. Specifically, the facility failed to ensure patients with respiratory concerns received continuous pulse oximetry monitoring (a non-invasive way to monitor a person’s blood oxygen levels) in accordance with facility policy and provider orders to ensure the safety of patients in two of three patients observed (Patients #4 and #5). Additionally, nursing staff failed to implement preventive measures to prevent a new pressure injury, or monitor and prevent further pressure injury once it was identified in three of five medical records reviewed (Patients #1, #2, and #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: 49541 Based on observations, interviews, and document review, the facility failed to provide nursing services in accordance with facility protocol and policy. Specifically, the facility failed to ensure patients with respiratory concerns received continuous pulse oximetry monitoring (a non-invasive way to monitor a person’s blood oxygen levels) in accordance with facility policy and provider orders to ensure the safety of patients in two of three patients observed (Patients #4 and #5). Additionally, nursing staff failed to implement preventive measures to prevent a new pressure injury, or monitor and prevent further pressure injury once it was identified in three of five medical records reviewed (Patients #1, #2, and #3). Findings include: Facility policies: The Clinical Alarm Policy read, this policy is to provide guidance for the management of clinical alarms to include alarm settings, response, regular preventative maintenance and testing of clinical alarms. Soft or customized alarm settings within the hard limits may be modified by Healthcare Professionals based on an individual patient’s condition and assessed risks. Clinical alarm parameters are also set to minimize false and nuisance/artifact alarms. Verify clinical alarm parameters are appropriate and audible on initiation and throughout care episodes. Suspend or silence options are used temporarily to assess the patient’s condition and/or the cause of the alarm. A clinical alarm system may only be discontinued upon physician order, or when a patient is made end-of-life or comfort care. The A.S.K.I.N. Bundle for Prevention of Pressure Injury Policy read, assessment of risk: perform head-to-toe skin and risk assessment upon admission, transfer, and change of condition. Complete a head-to-toe skin assessment each shift with focus on bony prominences. Perform the BRADEN scale each shift. Keep Patient Moving. For patients unable to reposition themselves adequately or verbalize their needs: Turn and reposition on an individualized basis (every 2-4 hours). Use 30-degree turns to offload sacrum. For safety, use turn teams if available. Offload heels, ensure heels are free from the bed. Utilize lift sheet or assistive device to reposition patient. References: The 2 East Vital Sign Monitor Education read, pay careful attention to what “setting” the monitor is in. If you see a check box, the monitor is in “quick check mode” and will not alarm to abnormal readings. The Lippincott Procedures read, pressure injuries result when pressure-applied with great force for a short period or with less force for a long period-impairs circulation, depriving tissues of oxygen and other life-sustaining nutrients. This process damages skin and underlying structures. Untreated, resulting ischemic lesions can lead to serious infection. Successful pressure injury treatment involves relieving pressure, restoring circulation, promoting adequate nutrition, and (if possible) resolving or managing related disorders. Prevention is the key to avoiding extensive therapy. Preventive measures include off-loading pressure, maintaining adequate nourishment, and ensuring mobility to relieve pressure and promote circulation. Perform a comprehensive skin assessment using a facility-approved skin assessment tool. A comprehensive skin assessment may be the first step in pressure injury prevention. Comprehensive skin assessment shouldn’t be a one-time event that occurs only on admission. You must repeat it regularly to determine any changes in skin condition. Perform a comprehensive skin assessment on a patient’s admission to the unit, daily, and on transfer or discharge. Documentation associated with pressure injury prevention includes: updating of care plan (as required), complete skin assessment findings, interventions used to prevent pressure injuries, pressure injury, changes in its condition or size, date and time of practitioner notification of pertinent observations of abnormalities, and prescribed interventions. The NDNQI (National Database of Nursing Quality Indicators) read, positioning and mobility: Change patient positions frequently, at least every two hours in bed and every hour while seated, use proper body alignment techniques to minimize pressure point, encourage active movement and exercise when appropriate. 1. The facility failed to ensure patients received continuous pulse oximetry monitoring in accordance with recognized standards and provider orders. Specifically, staff failed to ensure monitor alarms were audible to alert staff of changes in the patient’s condition. A. Observations i. On 1/7/25 at 2:32 p.m., observations were conducted in the 2 East Medical Surgical Unit. Further observations revealed Patient #4’s checkmark profile had been selected on the continuous pulse oximetry monitor. Registered nurse (RN) #2 stated the checkmark profile should not have been selected on the monitor. RN #2 stated if the checkmark profile was selected, the monitor would not alarm if the patient’s pulse oximetry dropped below 90%. ii. On 1/7/25 at 2:35 p.m., observations were conducted in the 2 East Medical Surgical Unit. Further observations revealed Patient #5’s checkmark profile had been selected on the continuous pulse oximetry monitor. Observations on 1/7/25 were in contrast to the Clinical Alarm Policy which read, healthcare professionals modified soft or customized alarm settings within the hard limits based on individual patient conditions and assessed risks. They verified that clinical alarm parameters were appropriate and audible during initiation and throughout care episodes. They used suspend or silence options temporarily to assess the patient’s condition or determine the cause of the alarm. A physician ordered the discontinuation of a clinical alarm system, or it was discontinued when a patient transitioned to end-of-life or comfort care. Observations on 1/7/25 were also in contrast to the 2 East Vital Sign Monitor Education which read, staff were to pay careful attention to the monitor’s settings. If staff saw a checkmark, the monitor was in “quick check mode,” and would not alarm for abnormal readings. B. Document Review i. Medical record review revealed, Patient #4 was admitted to the hospital on 12/31/24 for Pneumonia (inflammation of the lungs, usually caused by an infection) due to an infectious agent. Further review of the medical record review revealed, on 12/31/24 at 11:33 p.m., Patient #4’s provider had placed an order for continuous pulse oximetry monitoring. Further review of the medical record review revealed, on 1/6/25 at 12:30 p.m., Patient #4 had a chest tube inserted for an empyema (collection of pus in the cavity between the lung and the membrane that surrounds it). ii. Medical record review revealed, Patient #5 was admitted to the hospital on 1/6/25 for COPD exacerbation (a sudden worsening of lung diseases that make it hard to breathe). Further review of the medical record review revealed, on 1/6/25 at 1:33 p.m., Patient #5 chest x-ray showed the patient had several small-to-moderate-sized peripheral perfusion defects (an area of the lung where blood flow is reduced) in both lungs. Further review of the medical record review revealed, on 1/6/25 at 6:50 p.m., Patient #5 ‘s provider had placed an order for continuous pulse oximetry monitoring. The provider orders for Patient #4 and Patient #5 were in contrast to the observations which revealed their checkmark profiles had been selected and would not alarm for abnormal oxygen levels. C. Interviews i. On 1/13/25 at 1:30 p.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated the unit had wall-mounted monitors that were not centrally monitored by staff. RN #3 stated the alarms for the monitors would only sound in the room if the patient’s vital signs dropped below the limit setting. RN #3 stated the nurses should have verified the alarm settings at the beginning of every shift. RN #3 stated the monitors should only be set on profiles one and two. RN #3 stated if the monitor was set to the checkmark profile, the alarms would not sound, and the staff would not be able to monitor the patients. RN #3 stated it was important for the alarms to be audible to alert the staff of any changes in the patient’s condition. RN #3 stated if the alarms were turned off, the staff would not be alerted to a drop in the patient’s oxygen level, and they could go into respiratory distress, CODE (a life-threatening medical emergency), and subsequently die. ii. On 1/13/25 at 1:46 p.m., an interview was conducted with nurse manager (Manager) #4. Manager #4 stated the unit had wall-mounted monitors that were not centrally monitored by staff, and only alarmed in the patients’ rooms. Manager #4 stated the staff should only use the number one and two profiles. Manager #4 stated there was a third profile that was labeled as a checkmark. Manager #4 stated the staff should not use the checkmark profile as it would silence all alarms, and the staff could not monitor their patients. Manager #4 stated it was important for the staff to hear the alarms and be alerted of any changes in condition. Manager #4 stated if the staff could not hear the alarms, the patient could be in respiratory distress, and if untreated, could result in cardiac arrest leading to death. iii. On 1/13/25 at 2:30 p.m., an interview was conducted with acute care director (Director) #5. Director #5 stated 21 of the 28 monitors on 2 East had the capability to turn off all of the alarms by selecting the checkmark profile. Director #5 stated the staff had been educated they were not permitted to use the checkmark profile for patient safety. Director #5 stated if the staff were not able to hear the alarms, the staff were not able to monitor the patients effectively. Director #5 stated if the alarms were not audible, the patient could go into respiratory distress and not receive appropriate care, leading to respiratory arrest and death. 2. The facility failed to ensure nursing staff turned and repositioned patients who were at risk of developing pressure related injuries. A. Observations i. On 1/6/25 at 11:49 a.m., observations were conducted on 2 East. Observations revealed a blank pink mobility sheet posted outside Patient #2’s room dated 1/5. Manager #1 stated the sheet was used as a visual reminder to turn the patients who were at high risk for developing pressure injuries. Manager #1 stated it was the nursing staff’s responsibility to fill out the sheet every two hours when the patient was turned. Manager #1 stated the pink mobility sheet had not been filled out for the last 12 hours. Further observations revealed the patient was supine (lying on their back). Patient #2 stated they were uncomfortable and needed to be repositioned. Patient #2 stated the last time they were repositioned was at 7:00 a.m., approximately five hours earlier. ii. On 1/6/25 at 12:56 p.m., observations were conducted on 2 East. Observations revealed Patient #1 was in a supine position. Further observations revealed the call light was not within reach. iii. On 1/6/25 at 1:03 p.m., observations were conducted at the nursing station on 2 East. Observations revealed RN #2 on the phone with Patient #1’s family member. RN #2 stated the family received a call from Patient #1, who stated they could not reach their call light and requested to be repositioned. RN #2 stated they would notify the staff to reposition the patient and give them their call light. B. Document Review i. Medical record review revealed, Patient #1 was admitted to the hospital on 12/29/24 for diabetic ketoacidosis (life-threatening complication from severe insulin deficiency). Further review of the medical record revealed, Patient #1’s Braden Score (numerical value used to assess a patient’s risk of developing pressure ulcers) consistently fell between 14 and 16, which placed the patient at a mild risk for developing pressure injuries. Further review of the medical record revealed the Braden Score interventions were to reposition the patient every two hours. Further review of the medical record revealed on 1/3/25 at 9:00 p.m., Patient #1 was placed in a supine position. Further review of the medical record revealed on 1/5/25 at 11:17 p.m., 50 hours and 17 minutes after the patient was placed in a supine position, the staff repositioned the patient to their right side. Further review of the medical record revealed, on 1/3/25 at 5:00 p.m., four days after Patient #1 was admitted to the facility, wound nurse (RN) #6’s nursing note revealed a blister to the left heel that was not identified on admission. RN #6 stated the blister was blanchable (occurs when the redness or discoloration disappears with pressure) and erythematous (reddened skin). RN #6 stated Patient #1 informed the staff the wound to the left heel was there prior to admission. Further review of the medical record revealed, on 1/6/25 at 6:43 a.m., three days after the wound was identified, a nursing note was entered by RN #7. The nursing note indicated there was a change in condition and the wound to the left heel was black and purple. ii. Medical record review revealed, Patient #2 was admitted to the hospital on 1/8/25 for multiple injuries after a motorcycle versus automobile collision. Further review of the medical record revealed, Patient #2’s Braden Score consistently fell between 13 and 17, which placed the patient at a mild to moderate risk for developing pressure injuries. Further review of the medical record revealed the Braden Score interventions were to reposition the patient every two hours. Further review of the medical record revealed on 1/4/25 at 2:00 a.m., Patient #2 was placed in a supine position. Further review of the medical record revealed on 1/6/25 at 8:00 a.m., 54 hours after the patient was placed in a supine position, the staff repositioned the patient to their left side. Further review of the medical record revealed, on 1/3/25 at 10:10 a.m., a nursing note was entered by wound care RN #8. The nursing note indicated Patient #2 was at high risk for pressure injuries due to traumatic injuries and limited mobility. Medical record reviews were in contrast to the A.S.K.I.N. Bundle for Prevention of Pressure Injury Policy which read, staff were to keep patients moving. Patients unable to reposition themselves adequately or verbalize their needs were to be turned and repositioned on an individualized basis (every 2-4 hours). 30-degree turns were to be used to offload the sacrum and offloaded heels, which ensured patients were free from the bed. To ensure safety, staff were to utilize turn teams if available and used lift sheets or assistive devices to reposition patients. Medical record reviews were also in contrast to the Lippincott Procedures which read, staff could have treated pressure injuries successfully by relieving pressure, restoring circulation, promoting adequate nutrition, and resolving or managing related disorders when possible. Preventive measures included offloading pressure, maintaining adequate nourishment, and ensuring mobility to relieve pressure and improve circulation. Staff should have performed comprehensive skin assessments using a facility-approved skin assessment tool. A comprehensive skin assessment served as the first step in preventing pressure injuries. These assessments should have been conducted regularly rather than as a one-time event at admission and repeated during patient admission to the unit, daily, and at transfer or discharge. Staff should have documented pressure injury prevention by updating care plans as required, recorded skin assessment findings, listed interventions to prevent pressure injuries, noted changes in pressure injuries or their size, documented the date and time of practitioner notification about abnormalities, and recorded prescribed interventions. Additionally, medical record reviews were in contrast to the NDNQI indicators which read, staff should have frequently changed patient positions, at least every 2 hours in bed and every hour while seated. They used proper body alignment techniques to minimize pressure points, and encouraged active movement and exercise when appropriate. C. Interviews i. On 1/13/25 at 1:30 p.m., an interview was conducted with RN #3. RN #3 stated it was the nurse’s responsibility to perform a full head-to-toe skin assessment every shift. RN #3 stated if the Braden Scale determined the patient was at risk for pressure injuries, the staff were to turn the patient every two hours. RN #3 stated it was important to turn the patient every two hours to prevent skin breakdown. RN #3 stated if the patient was not turned every two hours, the patient could develop a pressure injury. ii. On 1/13/25 at 1:46 p.m., an interview was conducted with Manager #4. Manager #4 stated patients with a Braden Score below 16 were considered at risk for pressure injuries and should be repositioned at least every two hours. Manager #4 stated the staff should document the patient’s change in position in the medical record. Manager #4 stated it was important to turn the patient every 2 hours to prevent pressure injuries, decrease the risk of urinary tract infections (UTI), and prevent pneumonia. iii. On 1/13/25 at 2:30 p.m., an interview was conducted with Director #5. Director #5 stated patients who scored 18 or lower on the Braden Scale needed to be repositioned every two hours. Director #5 stated patients who scored 16 or lower on the Braden Scale would be repositioned every two hours by the turn team assigned to the unit. Director #5 stated it was important to turn patients at high risk of skin breakdown to prevent wounds, increase the patient’s comfort, and prevent other complications such as pneumonia.”