Milbank Area Hospital/Avera Health

“EMERGENCY AND SUPPLIES CFR(s): Equipment and supplies commonly used in life-saving procedures, including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters. This Standard is not met as evidenced by: 45683 Based on observation, interview, and policy review the provider failed to ensure outdated supplies were removed in one of one obstetrical (OB) (mother/baby room) overflow room. Findings include: 1. Observation on 12/29/25 at 3:45 p.m. in room 207 revealed: *A desk drawer with obstetric supplies. -Two Amnihooks (amniotic membrane perforators) with expiration dates of 5/1/22. -Four pairs of Sensicare brand surgical gloves with expiration dates of 1/28/25. -Two Medichoice brand lubricating jelly packets with expiration dates of 10/22/23. -Five SensiCare brand medium powder free synthetic exam gloves with expiration dates of 8/16. -One SensiCare brand medium powder free synthetic exam glove with an expiration date of 9/15. -Three SensiCare brand large powder free synthetic exam gloves with an expiration date of 9/14. 2. Interview on 12/30/25 at 2:40 p.m. with registered nurse (RN) C regarding supplies revealed: *Monthly checklists were completed for medication carts, crash carts, and the medication room to check for outdated supplies. *Staff were to sign off the checklist when that task was completed. *There was no checklist for supplies in the patients’ rooms because all supplies were to be brought into the patients’ rooms as each patient needed them. *Garbage bags were the only supplies that were kept in a desk drawer in each patient’s room. 3. Observation and interview on 12/31/25 at 9:00 a.m. with director of nursing (DON) B of room 207 revealed: *Room 207 was used as an obstet:ric (OB) overflow room if the emergency department rooms were occupied. *She acknowledged OB supplies were kept in that room’s desk drawer. *She expected the staff to check the expiration dates of those supplies and discard them if they were past their expiration date. *She stated she thought the supplies were overlooked because room 207 was rarely used for OB purposes. *She confirmed the supplies in the drawer in room 207 were expired. 4. Interview on 12/31/25 at 12:15 p.m. with administrator A regarding supplies revealed: *The nurses were to check supplies for expiration dates. *She expected that all expired supplies would be discarded by the staff. *She agreed the expired OB supplies in room 207 should have been discarded. Review of the provider’s 1/1/25 Outdates and Obsolescence policy revealed: *”Purpose: To establish guidelines based on industry standards so all staff recognize the necessity for the rotation and periodic inspection of supplies. This is necessary to ensure patient safety and to minimize the loss of product from expiration dates and obsolescence.” *”1. Expiration dates are normally expressed as a month and year, ex. 6/2025. If that is the case, the last day of the month shall be considered the actual expiration date.” *”3. A visual inspection for expiring product of all stock supplies should be conducted monthly and be documented as being completed.: *”8. Remove expired products immediately. They should be properly disposed of by one of these identified methods. It is important to process expired supplies immediately, never leave unattended. -“a. Dispose of the product per your specific department procedure. --“i. Place products in a designated area to be disposed of and/or destroyed.” --“ii. Donate products to approved medical charities.” -“b. Return expired products to Supply Chain for proper disposal and donation.””

“DRUGS AND BIOLOGICALS ARE APPROPRIATELY STORE CFR(s): (3) Drugs and biologicals are appropriately stored; This Standard is not met as evidenced by: 46511 Based on observation, interview, record review, and manufacturer’s instructions for use (IFU) review, the provider failed to ensure contrast dye was stored in one of one contrast dye warmer at a safe temperature range for patient use. Findings include: 1. Observation and interview on 12/29/25 at 2:00 p.m. in the computerized tomography (CT) scan room with radiology technician (RT) K revealed: *There was a contrast dye warming cabinet stored on top of the counter. *The contrast dye warming cabinet contained four bottles of contrast dye with a date of 12/23/25. *The dates on the contrast dye bottles indicated when they were placed in the warming cabinet. *The contrast was stored in the warming cabinet for up to two weeks. *The contrast warming cabinet temperature was set at 27.7 degrees Celsius (C). *The temperature of the contrast warming cabinet was recorded daily. 2. Interview on 12/30/25 at 9:30 a.m. with RT L revealed: *The safe temperature to store the contrast dye was from 20 degrees C to 25 degrees C per the manufacturer’s IFU. *There was no documentation to support if any corrective actions were taken to address the out-of-range temperatures of the contrast warming cabinet. 3. Interview on 12/30/25 at 11:00 a.m. with director of nursing (DON) B revealed: *She was aware that the contrast warming cabinet temperatures were out of range. *They did not have a policy that addressed safe storage of contrast dye in the warming cabinet. *The contrast dye should have been stored according to the manufacturer’s IFU, which indicated the safe storage temperature range was from 20 degrees C to 25 degrees C. 4. Review of the provider’s daily contrast warming cabinet temperature log from 10/1/25 through 12/30/25 revealed: *The contrast warming dye cabinet was not maintained per the manufacturer’s IFU of 20 degrees C to 25 degrees C for all 76 days reviewed. *There was no documented temperature corrective action or additional monitoring for those dates. Review of the contrast dye manufacturer’s December 2024 IFU revealed: *Contrast dye was to be stored from 20 degrees C to 25 degrees C. A contrast dye storage policy was requested to RT K on 12/29/25 at 2:15 p.m. and was not provided by the end of the survey process.”

“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: 32355 Based on observation, interview, and policy review, the provider failed to ensure medications were securely stored and had been properly monitored and secured to prevent access from unauthorized staff in: *One of one utility and equipment room located in the obstetrical (OB) unit (mother and newborn). *One of one nursery. *One of two operating rooms (OR #1). Findings include: 1. Observation and interview on 12/29/25 at 2:27 p.m. of the obstetrical (OB) unit revealed: *A utility/equipment room within the OB unit required an access code for entry. The director of nursing (DON) B provided access to the surveyor and then exited the room. *Inside the room were multiple medical supplies, clean linens, newborn bassinets, delivery balls, and a metal cart with several drawers. *The drawers on the metal cart were unlocked and allowed easy access to their contents. *Multiple vials of Naropin (an anesthetic administered only by trained healthcare professionals such as anesthesia staff), multiple vials of Sensorcaine (a long-acting local anesthetic), and Xylocaine (an injectable numbing med for surgical procedures) were stored in the top drawer of the metal cart. *The medications were stored in the cart without documentation that indicated: -The quantity of medications that were stored in the cart. *At 2:45 p.m., the housekeeping/laundry director (G) and a laundry service worker (N) entered the utility/equipment room to deliver clean linens. They placed the clean linens on several shelves in the room. -They were allowed access to the room because that was where the clean linens had been stored. Continued observation and interview on 12/29/25 at 3:00 p.m. of the OB unit and the newborn nursery room with the housekeeping/laundry director G revealed: *The nursery was locked and could be unlocked by swiping a badge to allow entry. -The housekeeping/laundry director G accessed the room using her badge. *Housekeeping staff had access to the nursery to clean the floors and wipe down the infant radiant warmers. *Two infant radiant warmers were present, each with a large canvas pack attached to them that had supplies and medications for infant resuscitation. The following meds had been attached to the canvas packs: -Two single-dose vials of epinephrine (stimulate the heart activity and increase circulation). -A vial of naloxone (life-saving med used to reverse the effects of a pain med rapidly). -Two vials of lidocaine (numbing med). *These medications could only be administered by trained healthcare professionals such as certified registered nurse anesthetiss (CRNA)s or nurses. *Housekeeping/laundry director G was unaware that she was considered unauthorized where medications were stored and available. 2. Interview and observation on 12/29/25 at 3:10 p.m. with registered nurse (RN) D revealed RN D: *Was unaware that housekeeping and laundry staff members had access to the nursery. *Confirmed medications were stored in the nursery beyond the locked door and should be accessible only to authorized professional staff. *Stated that the metal cart in the utility/equipment room was used by the anesthesia department, and thought it should have been located in the surgical area. *Agreed that the medications stored in the nursery were unsecured and accessible to unauthorized staff. 3. Interview on 12/29/25 at 3:45 p.m. with RN F regarding the anesthesia cart located in the OB utility/equipment room revealed that the anesthesia department was responsible for the security of that cart, and it should have been located in the surgical area. She was unsure why it was left in there and unsecured. 4. Observation on 12/30/25 at 9:10 a.m. in the OB utility/equipment room revealed the anesthesia cart remained in that room and was unsecured from unauthorized access by staff. 5. Observation and interview on 12/30/25 at 1:10 p.m. with the director of nursing (DON) in the OB unit about the security of the medications in the nursery and the utility/equipment room revealed: *She was unsure why the anesthesia cart was in that room, unless the anesthesia department put it there for ease of access should it be needed during a delivery. *She agreed the medications in the anesthesia cart were not secured from access by unauthorized staff and should have been. *She confirmed: -That housekeeping, laundry, and maintenance staff were all unauthorized to have access to the utility/equipment room and the nursery where medications were stored. -Only licensed staff should have had access to the medications stored in both of those rooms. -It was the anesthesia department’s responsibility to ensure the medications stored inside those carts were secured and not accessible to unauthorized staff. *She reported that the provider did not have a policy regarding the security and an ccountability process for the medications stored in the anesthesia carts. 46511 6. Observation and interview on 12/30/25 at 1:00 p.m. with surgery director M in the OR unit revealed: *The OR unit was secured, requiring badge access for entry. *Housekeeping staff and maintenance staff had access to the unit. *In OR #1, there was a metal cart with several doors. *The drawers on the cart were unsecured, allowing staff access to the contents. *The top drawer contained multiple vials of ketamine (medication used as an anesthetic and for pain). *Confirmed the cart should have been locked. *Confirmed anesthesia department was responsible for the security of the cart. 7. There were no surgeries scheduled for the week of 12/29/25. The anesthesia staff were not available for interview regarding if there was a process in place to ensure medications were accounted for and secured from access by unauthorized staff. 8. The pharmacist was not available on 12/31/25 for interview regarding the processes that she followed to ensure: -Anesthesia medications were accounted for and not accessible to unauthorized staff. -Medications in the nursery were securely stored and not accessible to unauthorized staff. Review of the provider’s November 2024 Medication Security in Facility policy revealed: *”Precautions have been made to ensure that the medications located in the facility are secure and unavailable to unauthorized persons, or employees. *The Pharmacy Director is responsible for the overseeing and control of this system. A sign out system is used in the OR by the anesthesiologist, which is also overseen by the Pharmacy Director. *All medications within the facility are in locked drawers or have a numbered cinch lock verifying the integrity of the cart or cabinet. A cinch lock is used where a key lock is considered unsafe or inappropriate (i.e., crash cart). A numbered card is used to record any opening of the cart (who and when).” Review of the provider’s 10/25 Crash Cart policy revealed: *”Carts are locked with breakaway, number locks. *Integrity of the locks is checked one time daily. *Immediately after use, the cart is restocked .””

“PROTECTION OF RECORD INFORMATION CFR(s): The CAH maintains the confidentially of record information and provides safeguards against loss, destruction, or unauthorized use. This Standard is not met as evidenced by: 32355 Based on observation, interview, and policy review, the provider failed to ensure that two sampled patients’ (11 and 21) health information was protected from view by visitors and unauthorized staff on two of two observed computer monitors in the medical-surgical unit’s nurses’ station . Findings include: 1. Observation on 12/31/25 at 12:55 p.m. of the nurse’s station in the medical-surgical unit revealed: *Two computer monitor screens were each displaying eight distinct squares. *One square displayed Patient 11’s full name and the status “Standby.” *Another square displayed Patient 21’s full name, a current oxygen saturation level (percentage of oxygen in the blood), pulse rate, and heart rhythm. *The information on both monitors was clearly visible from the desk counter, approximately 10 feet away. *The patient’s names and health information was visible to any staff member or visitor near or who passed by the nurse’s station. *The monitors were positioned in an area frequently accessed by visitors and ancillary staff for communication with the staff. 2. Interview on 12/31/25 at 1:00 p.m. with registered nurse (RN) F regarding the visibility of patient information on the above-observed monitors revealed: *RN F confirmed that patient names and health information were visible on those computer monitors. *She stated that she felt, from her vantage point during the interview, the patient’s names appeared blurry. *RN F expressed uncertainty regarding how patient names were displayed on the monitors, noting that she typically entered only medical record numbers into the computer system. *She explained that the nursing staff utilized the monitors to continuously monitor patient statuses. *RN F reported that she was closely monitoring patient 21’s oxygen saturation levels due to the patient’s use of continuous oxygen therapy. 3. Interview on 12/31/25 at 1:08 p.m. with director of nursing (DON) B regarding the visibility of patient information on the two observed monitors located in the medical-surgical unit revealed that she: *Acknowledged the privacy concerns associated with the visibility of patient information on those monitors. *Stated that the monitors were used by staff to observe patient status in real time. *Reported that she had explored options for relocating the monitors to a more private area; however, she had not identified a suitable alternative location or solution, such as privacy screens that would maintain the monitors’ intended functionality and privacy. Review of the provider’s April 2025 Technology Facility Access Control policy revealed: *”Avera Health Information Technology will create, coordinate, and maintain a plan that manages the physical security controls to all rooms, systems, and equipment used to store electronic Confidential Information against unauthorized physical access...” *There was no documentation to indicate a process was in place for the staff to follow that ensured the patients’ health information was visibly secured from visitors’ or ancillary staff’s view.”

“INFECTION PREVENT & CONTROL POLICIES CFR(s): The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings; This Standard is not met as evidenced by: 32355 Based on observation, interview, and policy review, the provider failed to ensure gloves had been available for use in one of one isolation room to ensure one of one registered nurse (RN) F could have changed them when necessary during medication administration for one of one sampled patient (21) on transmission-based precautions for a diagnosis of Influenza A that required the staff to use personal protective equipment such as gloves, gowns, and masks to minimize exposure to the infection (PPE). Findings include: 1. Interview on 12/29/25 at 3:45 p.m. with RN F revealed that patient 21 was admitted and placed on transmission-based precautions for Influenza A, a highly infectious communicable disease requiring precautions to prevent transmission. 2. Observation on 12/29/25 at 3:55 p.m. of patient 21’s room revealed: *There was an alcove approximately five feet in length located before the room’s entrance. *Inside the alcove: *PPE supplies (gloves, gowns) were stored inside the alcove on a rack hanging on the outside of the entrance door, goggles were on a countertop, and a bottle of sanitizer was stored inside the alcove. *Two covered bins used for dirty laundry and garbage. 3. Observation and interview on 12/30/25 at 8:15 a.m. with RN F in patient 21’s room revealed: *RN F put on a pair of goggles, a gown, and gloves before she entered the patient’s room to administer individually packaged medications. *The patient was lying in bed, alert, talkative, wearing oxygen, and had a moist cough. *With those same gloves on RN F: -Placed the individually wrapped medications on the counter near the laptop. -Opened individually packaged medications and placed them in a medication cup. -Touched the computer keypad and mouse to double check the medications were the correct dose. -Activated the patient’s call button to request a spoon, opened the window curtains, turned on the television, adjusted the patient’s bed covers, and applied chapstick to the patient’s lips after touching all of those dirty surfaces with the same pair of gloves. *The PCT brought RN F a spoon to help administer the medications to patient 21. *Without changing her dirty gloves, RN F opened each individually packaged medication and administered the medications using the spoon provided by a PCT. *One of the pills was to large for the patient to swallow and required RN F to cut it in half. *RN F: -Opened a small box that was on the counter by the laptop and took out a pill cutter from it. -Handled the medication with her dirty gloves and cut it in half with the pill cutter. -Administered the medication to the patient. -Then placed medication in the patient’s nebulizer (a device that converts liquid medication into an inhalable mist) chamber, connected the nebulizer tubing to oxygen, and gave the chamber with the medication to the patient. -Rinsed the nebulizer chamber in the sink and placed it on a drying towel after the treatment was completed. -Then exited the room wearing those same gloves, disposed of PPE in designated bins, and sanitized her hands after she removed her soiled gloves outside of the patient’s room. *There were no gloves available for use observed in the patient’s room or bathroom. *RN F stated that she was aware her gloves were soiled after touching multiple dirty surfaces, but was unable to change them because there were no gloves or hand sanitizer available inside the patient’s room. She acknowledged that the observed process was unsanitary and reported that the isolation room did not have gloves or sanitizer in them available for use for some time. 4. Interview on 12/30/25 at 10:40 a.m. with patient care technicians (PCT) H and I regarding patient 21 revealed they previously assisted the patient with a bed bath and oral care. They confirmed there was a lack of supplies inside the room, such as gloves and hand sanitizer. PCT I stated they could have left the room to obtain clean gloves, but was unsure of other options. 5. Interview on 12/30/25 at 12:30 p.m. with the director of nursing (DON) B revealed she was unaware that gloves and hand sanitizer were not available inside patient isolation rooms and agreed that the above staff members performed patient care tasks according to policy. 6. Interview on 12/30/25 at 12:40 p.m. with administrator A revealed that she stated that during COVID-19, gloves were intentionally excluded from isolation rooms, the process had not been revised, and that there were cost concerns regarding the need to dispose each patient’s unused PPE supplies from the isolation rooms after the patient discharged. Review of the provider’s March 2023 Donning/Doffing [putting on/taking off] Personal Protective Equipment (PPE) for Transmission-Based Precautions (Isolation) and Standard Precautions policy revealed: *”Prevent transmission of microorganisms to hands and clothing by proper donning of clean and doffing of contaminated personal protective equipment.: *Gloves: -“Change gloves as often as necessary, when grossly contaminated with excretions, or when torn.” Review of the provider’s 8/12/25 Avera Hand Hygiene policy revealed: *”Hand hygiene (HH) continues to be the primary means of preventing the transmission of infection. -To clean hands to prevent the spread of infection. -To provide a clean and healthy environment for patients, staff, and visitors.” Review of the provider’s 6/11/25 Avera Transmission-Based Precautions (Isolation) revealed: *”Isolation room self-awareness: -Work from clean to dirty. -Limit opportunities for “touch contamination” - protect yourself, others, and the environment. -Do not touch environmental surfaces (including privacy curtains) except as necessary during patient care.” *”Personal protective equipment is not worn by employees outside the patient’s room...””

“Hazardous Areas - Enclosure CFR(s): NFPA 101 Hazardous Areas - Enclosure Hazardous areas are protected by a fire barrier having 1-hour fire resistance rating (with 3/4 hour fire rated doors) or an automatic fire extinguishing system in accordance with 8.7.1 or 19.3.5.9. When the approved automatic fire extinguishing system option is used, the areas shall be separated from other spaces by smoke resisting partitions and doors in accordance with 8.4. Doors shall be self-closing or automatic-closing and permitted to have nonrated or field-applied protective plates that do not exceed 48 inches from the bottom of the door. Describe the floor and zone locations of hazardous areas that are deficient in REMARKS. 19.3.2.1, 19.3.5.9 Area Automatic Sprinkler Separation N/A a. Boiler and Fuel-Fired Heater Rooms b. Laundries (larger than 100 square feet) c. Repair, Maintenance, and Paint Shops d. Soiled Linen Rooms (exceeding 64 gallons) e. Trash Collection Rooms (exceeding 64 gallons) f. Combustible Storage Rooms/Spaces (over 50 square feet) g. Laboratories (if classified as Severe Hazard - see K322) This Standard is not met as evidenced by: 18087 Based on observation and interview, the facility failed to maintain one randomly observed hazardous area (garages) as required. The garages had internal combustion equipment kept inside without a carbon monoxide monitor and the corridor door was held open with a magnet. Findings include: 1. Observations on 12/30/25 at 9:33 a.m. revealed the triple stall garage was approximately 1500 square feet in area containing internal combustion equipment (a four-wheeler, snow removal equipment, and lawn mowing equipment). The garages also had the 90-minute fire-rated door to the egress corridor held open with a magnet tied into the fire alarm system. The garage was not equipped with a carbon monoxide (CO) gas detector that would open a garage door when high levels of CO were detected. The magnet door hold-open device would not provide any protection for the corridor from carbon monoxide gas coming in from the garage. Interview with the maintenance director at that same time confirmed that finding. He stated he was unaware of the noted requirements for that location. The deficiency had the potential to affect all occupants of the smoke compartment.”

“Cooking Facilities CFR(s): NFPA 101 Cooking Facilities Cooking equipment is protected in accordance with NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, unless: * residential cooking equipment (i.e., small appliances such as microwaves, hot plates, toasters) are used for food warming or limited cooking in accordance with 18.3.2.5.2, 19.3.2.5.2 * cooking facilities open to the corridor in smoke compartments with 30 or fewer patients comply with the conditions under 18.3.2.5.3, 19.3.2.5.3, or * cooking facilities in smoke compartments with 30 or fewer patients comply with conditions under 18.3.2.5.4, 19.3.2.5.4. Cooking facilities protected according to NFPA 96 per 9.2.3 are not required to be enclosed as hazardous areas, but shall not be open to the corridor. 18.3.2.5.1 through 18.3.2.5.4, 19.3.2.5.1 through 19.3.2.5.5, 9.2.3, TIA 12-2 This Standard is not met as evidenced by: 18087 Based on record review and interview, the provider failed to maintain documentation that supported the kitchen hood exhaust ductwork in one of one kitchen was inspected twice a year. Findings include: 1. Record review on 12/30/25 at 2:17 p.m. revealed there was no documentation of the required twice-yearly kitchen commercial range hood exhaust ductwork inspections for cleanliness regarding grease buildup. The inspections were to be performed from the rooftop ventilator down to the grease filters in the range hood. Interview with the maintenance director at that same time confirmed that finding. He stated he was unaware of the noted requirements for that equipment. The deficiency had the potential to affect all occupants of the smoke compartment.”

“Fire Alarm System - Testing and Maintenance CFR(s): NFPA 101 Fire Alarm System - Testing and Maintenance A fire alarm system is tested and maintained in accordance with an approved program complying with the requirements of NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm and Signaling Code. Records of system acceptance, maintenance and testing are readily available. 9.6.1.3, 9.6.1.5, NFPA 70, NFPA 72 This Standard is not met as evidenced by: 18087 Based on record review and interview, the facility failed to document smoke detection information as required. Findings include: 1. Record review on 12/30/25 at 2:11 p.m. revealed the annual fire alarm report dated 1/23/25 did not show smoke detector sensitivity values, just pass/fail conditions. Interview with the maintenance director at that same time confirmed that finding. He stated he was unaware of the noted requirements for that report. The deficiency had the potential to affect all occupants of the facility.”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 18087 Based on record review and interview, the provider failed to continuously maintain automatic sprinklers in reliable operating condition (quarterly flow testing and 5-year internal obstruction inspection was not done). Findings include: 1. Record review on 12/30/25 at 2:22 p.m. revealed there was no documentation that quarterly sprinkler flow testing (every three months testing) or a 5-year internal obstruction inspection had been done since the facility was built in 2016. Interview with the maintenance director at that same time confirmed that finding. He stated he was unaware of the noted requirements for that equipment. He stated he did not have a copy of NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems. The deficiency had the potential to affect 100 percent of the building occupants.”