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Based on document review and interview, the Hospital failed to comply with the Condition of Participation 42 CFR 482.21 Quality Assessment and Performance Improvement Program.

Findings include:

1. The Hospital failed to ensure an ongoing Quality Assurance & Performance (QAPI) Plan/Program was in place to monitor the effectiveness and safety of services and quality of care, including readmissions and patient safety, with designated timeframes, frequency and detail of data collection, and measure, analyze and track data collected. See A-273.

The Life Safety Code portion of a Full Survey Due to a Complaint survey was conducted August 4 - 6 , 2025. The requirements of 42 CFR Subpart 482.41 Physical Environment are NOT MET as evidenced by the deficiencies cited under the K-Tags.

Based on document review and interview, the hospital failed to comply with the Condition of Participation 42 CFR 482.42 Infection Prevention Control Antibiotic Stewardship.

Findings include:

1. The hospital failed to ensure infection control surveillance and maintenance a clean and sanitary environment, and addressing any infection control issues identified by the hospital, including temperature/humidity levels in the operating rooms (OR) and stains on ceiling in patient care areas related to lack of ventilation system cleaning/preventive maintenance. See A-750 A.

2. The Hospital failed to evaluate and analyze infection control data for the infection prevention and control program, per hospital's infection and control plan. See A-750 B.

Based on document review and interview, for all hospital contracted services the Hospital failed to ensure the governing body evaluated the contracts to ensure that services are provided in a safe and effective manner.

Findings included:

1. A list of hospital contracted vendors was reviewed on 8/6/2025. The hospital was unable to provide an evaluation of the services provided for any contract.

2. During an interview on 8/6/2025 at approxiamtley 2:30 PM , the Executive Director of Operations (E#25). E#25 stated, "Contracts are not evaluated to ensure quality service is provided. The list of vendors has not been reviewed and I'm unsure if the list is current."

Based on observation, document review, and interview, for 2 of 4 patients (Pt's. #24 and #25) observed with all four side rails up, the Hospital failed to ensure that hospital devices used to prevent a patient from voluntarily getting out of bed was considered a restraint.

Findings include:

1. During a tour of the Progressive Care Unit (PCU) on 08/04/2025, between approximately 11:00 AM and 1:00 PM, two patients (Pt's. #24 and #25) were observed to be laying in bed with all 4 bed side rails up.

2. The Hospital's policy titled, "Restraint Management Policy" (revised 04/2022), was reviewed and required, "...Manual Restraint: Any manual method, physical or mechanical device, material, equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely and cannot be removed by the patient. These may include: ...Soft Restraint Devices... Enclosure beds or net beds are considered a restraint if: It is used to prevent the patient from exiting the bed..."

3. The clinical records of Pt's. #24 and #25 were reviewed on 08/04/2025 and indicated that both patients needed assistance with ambulation and activities of daily living but were not completely immobile (unable to get out of bed on their own). The records lacked orders to use all 4 side rails up.

4. An interview was conducted with Nurse (E#10) on 08/04/2025, at approximately 1:05 PM. E#10 stated that they use side rails up to prevent the patients from getting up and falling out of the bed. E#10 stated that some of their patients experience sun downing (dementia that occurs at dusk through the night) and don't want them getting out of the bed when they are confused as they may potentially fall. E#10 stated that they do not obtain orders for using 4 side rails.

Based on document review and interview, for 2 of 5 patients (Pts. #28 and #29) reviewed for restraint use, the Hospital failed to ensure that less restrictive measures were attempted prior to restraint use.

Findings include:

1. The Hospital's policy titled, "Restraint Management Policy" (revised 04/2022), was reviewed and required, "...It is the objective of our hospitals to limit and/or eliminate the use of restraint. Conversely, clinically and developmentally appropriate alternatives to restraint are to be attempted, documented and found to be ineffective prior to use of restraint if possible..."

2. Restraint Logs from July and August 2025 were reviewed and indicated the following:

- Pt. #28 was placed in non-violent wrist restraints on 07/30/2025 from 5:00 AM to 6:00 AM due to being impulsive and taking off monitoring and pulling IV (intravenous access).

- Pt. #29 was placed in non-violent wrist restraints on 07/30/2025 starting around 5:00 AM due to being very confused and pulling out lines.

3. The clinical records of Pts. #28 and #29 were reviewed on 08/04/2025 and lacked documentation of less restrictive measures attempted prior to use of restraint.

4. An interview was conducted with Nurse (E#10) on 08/04/2025, at approximately 12:10 PM. E#10 stated that attempts to redirect and reorient the patient should be attempted and documented prior to resorting to restraints.

Based on document review and interview, for 2 of 5 patients (Pts. #28 and #29) reviewed for restraint use, the Hospital failed to ensure that restraints were utilized in accordance with a physician's order and that the orders included the type of restraints to utilize.

Findings include:

1. The Hospital's policy titled, "Restraint Management Policy" (revised 04/2022), was reviewed and required, "...Each episode of restraint or seclusion must be ordered by a physician or an authorized licensed practitioner responsible for the patient's ongoing care. The order shall include the type of restraint... For the restraint applied for non-violent or non-self-destructive behavior... Physician's order: If the physician or authorized licensed practitioner is not present a verbal/telephone order must be obtained and entered into the patient's medical record as soon as possible but not more than 12 hours after the initiation of non-violent, non-self-destructive restraints..."

2. Restraint Logs from July and August 2025 were reviewed and indicated that Pts. #28 and #29 were placed in non-violent wrist restraints on 07/30/2025 starting around 5:00 AM.

3. The clinical record of Pt. #28 was reviewed on 08/04/2025 and lacked orders for restraint use.

4. The clinical record of Pt. #29 was reviewed on 08/04/2025 and included orders for non-violent restraints, dated 07/30/2025 at 5:35 AM with a discontinuation date of 07/31/2025 at 5:35 AM. The orders lacked the specific type of restraints to use (i.e. bilateral soft wrist, ankle, mittens, side rails, etc.).

5. An interview was conducted with Nurse (E#10) on 08/04/2025, at approximately 12:10 PM. E#10 stated that all non-violent restraints should have an order placed. E#10 stated that typically they need a new order every 24 hours. E#10 stated that the type of restraint needs to be entered in manually by the doctor or nurse entering a verbal order, as the system doesn't have a selection to choose from. E#10 stated that the order should include the exact type/location (i.e. mitt, wrists, ankle, etc.) of the restraint to use.

Based on document review and interview, for 1 of 5 patients (Pt. #29) reviewed for restraint use, the Hospital failed to ensure that the patient was monitored every 2 hours as required by policy while in restraints.

Findings include:

1. The Hospital's policy titled, "Restraint Management Policy" (revised 04/2022), was reviewed and required, "...Non-Violent, Non-Self Destructive: ... The patient shall be monitored at regular intervals, not to exceed every 2 hours interval, to be determined consistent with physician orders and/or patient condition and will have documented assessments to assure patient is free from adverse events and to determine if restraint shall be continued..."

2. The clinical record of Pt. #29 was reviewed on 08/04/2025 and included orders for non-violent restraint use with every 2 hour monitoring, dated 07/30/2025 at 5:35 AM. Restraint flow sheets indicated that the patient remained in restraints from 07/30/2025 at 5:36 AM until 07/31/2025 at 2:19 PM. The record lacked every 2 hour assessments as follows:

- Between 07/30/2025 at 5:00 PM to 07/31/2025 at 4:20 AM (over 11 hours)
- Between 07/31/2025 at 4:20 AM to 8:14 AM (nearly 4 hours)
- Between 07/31/2025 at 8:14 AM to 12:16 (about 4 hours)

3. An interview was conducted with Nurse (E#10) on 08/04/2025, at approximately 12:10 PM. E#10 stated that patients in restraints should be monitored minimally every 2 hours for condition and offering of tilting, hydration, and nutrition. E#10 stated that the nurses should document these checks in the medical record. E#10 confirmed there were gaps in the documentation of the restraint checks.

Based on document review and interview, the Hospital failed to ensure an ongoing Quality Assurance & Performance (QAPI) Plan/Program was in place to monitor the effectiveness and safety of services and quality of care, including readmissions and patient safety, with designated timeframes, frequency and detail of data collection, and measure, analyze and track data collected.

Findings include:

1. The Hospital's "Quality Assurance & Performance Improvement (QAPI) plan" (not dated, Board of Directors' meeting minutes included that this plan was presented during 1/2025 meeting), was reviewed and included, "The purpose of the QAPI program at [Hospital] is to take a continuous and proactive approach to establish a systemic, data driven decision making to ensure the delivery of high-quality patient care, improving organizational performance, and meeting regulatory and accreditation standards...Feedback, Data Systems, and Monitoring: The QAPI committee at [Hospital] will decide on the data that will be monitored routinely. This data provides the foundation for identifying opportunities for improvement, tracking progress and ensures that the intervention['s] effectiveness and is continuously improving the quality of care and safety for the patients and staff satisfaction. Some key performance indicators are: Clinical care areas (Door to needle, Door to EKG [electrocardiogram], Door to CT [computerized tomography], Door to TNK [Tenecteplase - medication used to treat stroke], ED throughput, HAI [hospital aquired infection], VTE [venous thromboembolism - blood clot], STK [streptokinase - medication to treat blood clots], STEMI-door to balloon time [treatment of type of sever heart attack], Sepsis, Fall with injury, Opioid on discharge); Patient Safety Incidences; medication incidences; Lab result time; Patient demographics, social determinants of health (SDOH). Data will be collected from electronic health records, incident reporting software, and financial systems. The QAPI team will regularly review data to identify trends and patterns. The team will set targets for the measures based on internal criteria and state and national averages... Performance Improvement Projects (PIPs): A robust QAPI plan helps to identify gaps or patterns in the system of care and thus pointing at opportunities for improvements. Considerations for PIPs: When selecting a measure and running a PIPs, it is important to ensure that the decision is data driven, in an area tha is at high risk, high volume or problem prone, evidence based, has a measureable goal, can be monitored regularly and is sustainable... Systemic Analusis and Systemic Action: this is a crucial component of a QAPI plan as it involves a structured approach to identify problems, understand the root causes, and implement sustainable solutions while addressing the underlying issue. [Hospital name] adopted the Lean Six Sigma approach for its PIPs thereby reducing waste and variation and improving workflow and quality... Systemic actions: ...Creating, updating and revising policies and procedures... process improvement... continuous data monitoring and identifying trends... Documentation and Communication of Performance Improvement and Trends in Performance Measures: To ensure transparency, alignment, and sustained progress in performance improvement efforts it is imperative that there is effective documentation and communication... Maintain detaled records for each PIPs... Sharing information in board of directors' meetings. Monitoring trends in Performance Measures: Data analysis-trend analysis... Benchmarking-comparing performance against internal target, historical data and state and national averages..." Under the section " Performance Improvement Projects (PIPs)", there were no PIPs listed. The plan did not include designation of whom would be responsible for data collection or types of data to be collected and did not include frequency of quality data collection or review. The key performance indicators did not include hospital readmissions.

2. On 8/5/2025, the Hospital presented the Quality Council Meeting monthly minutes from 2025 (dated 5/7/2025, 6/4/2025, and 7/2/2025). There was no meeting minutes provided/available prior to 5/7/2025. The meeting minutes were reviewed and indicated the team members from various departments were present and the topics discussed. The 5/7/2025 meeting included 2 topics (electronic medical record/EMR concerns and infection prevention concerns). The 6/4/2025 meeting included discussion on complied dashboard data from various departments. The 7/2/2025 meeting included discussion on the Nursing Quality dashboard and discussion on infection prevention. The meeting minutes lacked any action or performance improvement plans. There was no documentation of evaluation of the indicators, in order to measure and trend the outcomes of the data collected. The meeting minutes lacked frequency of review of the collected data, and did not include any improvement activities.

3. On 8/6/2025 at 1:15 PM, an interview was conducted with the Executive Director of Quality (E #13). Electronic data compiled from different departments, that is submitted to the Quality department, was reviewed with E #13 on the computer. The data included areas from infection control; hospital acquired pressure ulcers; stroke, and emergency department. E #13 stated that the data from the different departments are discussed during the leadership departmental meetings. When asked how data and frequency of collection from each department was determined, E #13 stated that each department collects data related to their department, but E #13 does not assign/designate data collection to the departments. When asked to show how data is analyzed and tracked to determine improvements, E #13 stated that no goals or benchmarks had been determined based on hospital or national standards yet. When asked to see patient safety quality indicators, such as falls and hospital incidents, E #13 could only show that a list of falls and incidents was maintained. However, E #13 could not show any review, analysis, or trending/tracking of this data. When asked to show data for readmissions, E #13 could not provide any data collection or review. E #13 stated that however, the topics that have been actually discussed and incorporated into the monthly QAPI meeting minutes at this point, includes only infection prevention dashboard and concerns with the new EMR system. E #13 stated that there has only been one established quality indicator that has a performance improvement plan (PIP) approved. E #13 stated that the performance improvement plan developed is related to infection prevention (CLABSI) and has just been approved/initiated as 8/2025. E #13 stated that a PIP related to hospital length of stay is being drafted due to information that was received verbally from the discharge department. E #13 stated that E #13 generally gathers and receives areas of concerns from department leaders and then decides if this information will be shared during the Quality meetings. E #13 acknowledged that there were no PIPS developed related to patient safety events or any other areas beside than infection control, and no quality improvement measures had been identified or implemented, based on data collected.

Based on document review and interview, for 6 of 12 records (Pts. #8-#11, #32 and #33) reviewed for pain management, the Hospital failed to ensure that pain assessments were completed as required by policy.

Findings include:

1. The Hospital's policy titled, "Pain Management" (dated 01/2025), was reviewed and required, "...Inpatients will be reassessed for the presence of pain no less frequently than the minimum requirements for the taking of vital signs (5th vital sign) in the are setting... Patients seen in the Emergency Department shall receive a screen during the triage or initial assessment process to identify the presence of pain..."

2. The clinical record of Pt. #33 was reviewed on 08/04/2025 at approximately 12:49 PM, with Charge Nurse (E#10). Pt. #33 was admitted on 08/01/2025 at 5:06 PM to the Progressive Care Unit/PCU with a diagnosis of hematuria (blood in the urine). Pain assessment flow sheets from 08/01/2025-08/04/2025 were reviewed and indicated that only one pain assessment was completed on 08/02/2025 at 2:35 PM. The record lacked any other assessments of pain during this admission.

3. The clinical record of Pt. #32 was reviewed on 08/04/2025 at approximately 1:25 PM, with E#10. Pt. #32 was admitted on 06/17/2025 with a diagnosis of altered mental status and desaturation. Pain assessment flow sheets from 07/29/2025-08/04/2025 were reviewed and indicated that the last pain assessment was completed on 07/29/2025 at 4:18 PM. No further assessments of pain had been documented in the record since. The record indicated that Pt. #32 had been on the PCU since 07/19/2025.

4. On 08/05/2025, at approximately 10:50 AM, four current Emergency Department (ED) patient medical records were reviewed and 3 of the 4 records reviewed (Pts. #8, #10, and #11) lacked a pain assessment completed on initial assessment.

5. An interview was conducted with the PCU Charge Nurse (E#10) on 08/04/2025, at approximately 1:00 PM. E#10 stated that they should assess for pain every time they assess for vital signs, which is every 4 hours on the Progressive Care Unit.

6. The E#4 (ED Charge Nurse) was interviewed on 08/05/2025 at 11:10 AM. E#4 said it is an expectation that all patients receive a pain assessment on presentation to the ED.



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Based on document review, observation and interview, it was determined that for 2 of 4 patients with IV (intravenous) access sites observed, the hospital failed to ensure that the IV accesses were labeled and dated with the insertion date, in accordance with policy.

Findings include:

1. The Hospital's policy titled, "Peripheral Intravenous Catheter Placement and Management" review date 1/2025 included "... IV Procedure: Intravenous cannula/needle: ...document date and time of insertion ..."

2. During an observational tour of the 4 North Medical Surgical Unit on 8/4/2025 between 10:00 AM and 11:00 AM, 2 patients (Pt.#4 and Pt.#5) had IV access sites that were not labeled with date of insertion.

3. An interview was conducted with the 4 North Medical Surgical Unit Charge Nurse (E#3) during the tour. E#3 stated that all IV access sites should be dated and labeled when it was inserted.

Based on document review and interview, it was determined that for 3 of 3 clinical records (Pts.#4-6) reviewed, on the 4 North Medical Surgical Unit, the hospital failed to ensure that a general informed consent was obtained upon admission.

Findings include:

1. The Hospital's policy titled, "Informed Consent" Reviewed Dates: June 2025 included, "... II. Policy: Any health care relationship, treatment or refusal with a known or appreciable risk to the patient requires documented evidence of an informed consent form executed by the patient or legally authorized representative..."

2. The clinical records of Pts. #4-6 was reviewed on 8/4/2025.
-Pt.#4 was a 59 year-old who was admitted on 8/3/2025 for chest pain.
-Pt.#5 was a 65 year-old who was admitted for post fall and hematoma (bruising) on right hip.
-Pt.#6 was a 77 year old who was admitted for dementia and Parkinson's disease.
All clinical records reviewed lacked the general informed consent for treatment upon admission to the Hospital.

3. On 8/4/2025 at approximately 10:45 AM, an interview was conducted with the 4 North-Charge Nurse (E#3). E#3 stated that Consents should be in the patient's medical record either scanned or paper copy.

Based on document review and interview, the Hospital failed to ensure that patient medical records are completed within 30 days of discharge.

Findings include:

1. The Hospital's "Medical Staff Rules and Regulations" - effective 4/2/2025 included, "... Section 1.8 Medical Records - Accurate, timely, and complete medical records shall be maintained in accordance with the Health Information Management Policies approved by the MEC..."

2. An attestation letter was provided on 8/7/2025 that included the hospital currently has 2,540 delinquent medical records.

3. On 8/7/2025 at approximately 9:45 AM, an interview was conducted with the executive director of nursing (E#9). E# 9 stated that the records should be completed within 30 days. E#9 stated, "I was informed that we have delinquent records because of the way Paragon [computer system] requires physicians to cosign orders."

Based on document review, observation, and interview, for 1 of 3 patient rooms observed for respiratory supplies, the Hospital failed to ensure that medications were secured and not left unattended.

Findings include:

1. The Hospital's policy titled, "Storage of Medications in Patient Care Areas" (dated 01/2025), was reviewed and required, "...Medications that are not securely locked must be under constant surveillance... Medications removed from a medication storage area must remain with the individual at all times and are not to be left unattended... If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only or discarded after use..."

2. During a tour of the Progressive Care Unit on 08/04/2025, at approximately 10:55 AM, 3 vials of acetylcysteine (mucolytic agent) were noted in a plastic bag with a nebulizer kit in patient room #4430. The vials were not attended to or secured by a staff member at all times.

3. An interview was conducted with Respiratory Therapist (E#21) on 08/04/2025, at approximately 11:05 AM. E#21 stated that each vial contains enough medication for two nebulizer treatments so E#21 saves the rest of the medication for the next treatment. E#21 stated that the vial cannot be returned to the Pxyis (medication storage machine) once it's entered the patient's room and stated that there is no secure cabinet in the patient room to store the left over medication.

Based on document review, observation, and interview, for 1 of 1 urine specimen observed in the emergency department (ED), the Hospital failed to ensure that lab specimen was labeled in accordance to laboratory services policies.

Findings include:

1. The Hospital's policy titled, "Labeling of Specimens" (dated 01/2025), was reviewed and required, "...Specimen Labeling: ... Date and Time of Draw, Initials of the Person Drawing Specimen..."

2. During a tour of the ED on 08/05/2025, at approximately 10:32 AM, a urine specimen was observed in the point of care testing room. The urine cup had a patient label on it; however, lacked the date/time it was collected and the initials of the person that collected the specimen.

3. An interview was conducted with the ED Manager (E#16) and the EMS (emergency medical services) Coordinator (E#17) on 08/05/2025 at approximately 10:33 AM. E#16 stated that any specimen should be labeled with the date, time, and who collected at the time it is collected. E#17 stated that ED staff collect lab specimens for ED patients and bring it down to the lab. E#17 stated that specimens should not just be left in the room.

4. An interview was conducted with the Lab Supervisor (E#22) on 08/05/2025, at approximately 2:30 PM. E#22 stated that laboratory staff collect specimens for the inpatient units and will bring them back to the lab for testing. E#22 stated that lab orders in the ED are collected by the ED staff and they are responsible for bringing them to the laboratory for testing. E#22 stated that the specimens must be labeled with the date and time it was collected as some tests are time sensitive and may affect the results of the tests.

Based on document review, observation, and interview, the Hospital failed to ensure that Dietary staff adhered to appropriate hair covering and glove guidelines during food preparation, in accordance with hospital policy.

Findings include:

1. The Hospital's policy titled, "Uniform Policy" - Revision dates: 9/2024 included, "... III. All food handlers must wear a clean hat with appropriate hair covering underneath said hat or use other appropriate hair coverings. This includes individuals who are bald when: IV. Prepping food, V. Working in prep areas... VII. Note: Food handlers with facial hair must also wear a beard restraint ..."

2. The Hospital's policy titled, "Personal Hygiene & Attire" - Revision Dates: 9/2021 included, "... 6. Gloves will be always used and will be changed often ... "

3. During an observational tour of the Food and Dietetic Services on 8/5/2025 from 10:30 AM to 12:15 PM, 2 dietary staff were observed in the food preparation area - 1 dietary staff with facial hair (E#6) was observed with no hair covering and and no beard restraint; another 1 dietary staff (E#7) with facial hair was observed at the end of the food preparation tray line handling food trays without wearing gloves.

4. During the observational tour on 8/5/2025 at approximately 12:00 PM, an interview was conducted with the Director of Dietary Services (E#5). E#5 stated that all staff should wear appropriate hair covering and beard restraint (if with facial hair) and must always wear gloves when handling food trays.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety code portion of the Full Survey Due to a Complaint conducted on August 4 - 6, 2025. the surveyors find that the facility does not comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags.

Based on document review, observation, and interview, for 2 or 3 inpatient units and 1 of 1 emergency department (ED) toured, the Hospital failed to ensure that emergency/crash carts were maintained with the supplies/equipment necessary in case of medical emergencies.

Finding include:

1. On 08/05/2025, the Hospital presented educational material on crash cart contents (dated 05/2023) which indicated that each crash cart should contain a full oxygen tank, defibrillator, and portable suction machine. The Hospital did not have a policy regarding crash cart use and management.

2. During tours of the Progressive Care Unit and the 4 North Medical Surgical Unit on 08/04/2025, at approximately 10:00 AM, there was one crash cart located on each of these units; however, the crash carts did not have portable suction machines.

3. During a tour of the ED on 08/05/2025 at approximately 10:00 AM, there were 5 adult crash carts, 1 pediatric crash cart, and 1 neonatal crash cart present; however, only 3 of the adult crash carts had a defibrillator, only 2 of the adult crash carts had an oxygen tank, and none of the crash carts had a portable suction machine. The pediatric and neonatal crash carts did not have defibrillators or oxygen tanks. In addition, the only portable suction machine that was set up and ready to use in the ED, was sitting on the wall of the nurse's station plugged into the electrical outlet (not directly associated with any of the crash carts). To note, each patient room did have a built-in suction apparatus on the wall. Additionally, it was noted that one drawer of the pediatric crash cart (for patients between 30-36 kilograms) had a supply expiration date of 08/01/2025.

4. An interview was conducted with the ED Manager (E#16) and EMS (emergency medical services) Coordinator (E#17) on 08/05/2025, at approximately 10:00 AM. E#16 stated that they should be checking the crash carts daily and completing the logs that check for defibrillator functioning, suction machine functioning, oxygen tank levels, and outdates of supplies. E#17 stated that a while ago they used to have more defibrillators but many of them broke after being pulled with the crash cart and dropping on the ground.

A. Based on document review, observation, and interview, the hospital failed to ensure infection control surveillance and maintenance a clean and sanitary environment, and addressing any infection control issues identified by the hospital, including temperature/humidity levels in the operating rooms (OR) and stains on ceiling in patient care areas related to lack of ventilation system cleaning/preventive maintenance.

Finding include:

1. On 8/4/2025, the Hospital's Infection and Control Plan (dated 2025) was reviewed and required, "purpose is to promote safe and quality care to our patients, healthcare workers and visitors through the prevention and control of infections ...The purpose of the Infection Control Committee is to evaluate the data and provide input into the Infection Prevention and Control Program. The Committee is responsible for: Review and approve all policies and procedures related to infection surveillance, prevention and control activities in all department/services. Review the infection surveillance data and recommend methods for the preventions and control of infections in the hospital. The Infection Control Committee meets quarterly unless the committee determines otherwise. Will maintain minutes of findings, proceedings, and action."

2. On 8/4/2025, the Staff Rules & Regulations (dated 4/2/2025) was reviewed and required, "...The duties of the Infection Control Committee shall be to: 1) Maintain surveillance over the Hospital Infection Control program... 4) Develop, evaluate and revise preventive, surveillance and control policies and procedures relating to all phases of the Hospital's activities, including, but not limited to: operating rooms, delivery rooms, special care units; central service, housekeeping and laundry; prevention of cross-infection by anesthesia apparatus or inhalation therapy equipment; testing of Hospital personnel for carrier status; disposal of infectious material; food sanitation and waste management; select community acquired infections and, when appropriate, employee infections; and other situations as requested... 7) Maintain a record of all activities relating to Infection Control and report to the MEC (Medical Executive Committee), CEO, and Performance Distinction Council..."

3. On 8/4/2025, the Hospital's policy titled, "Temperature and Humidity Control" (dated 7/2024) was reviewed and required, "This policy describes the requirement and procedures for maintaining proper ventilation, temperature, and humidity control in procedural suites. The purpose of this policy is to provide basic guidelines and criteria for keeping the ventilation, temperature and humidity within acceptable range which will promote a safe and functional environment for our patients following recommended guidelines...If any area is 10 degrees plus or minus the acceptable range, the finding will be escalated immediately up the chain of command with the potential to close the area and move equipment, supplies and procedures to a different room within acceptable ranges...acceptable normal ranges: temperature 68-76 degrees; humidity: 30-60%..."

4. On 8/4/2025, the maintenance "daily temperature/humidity log" (dated July 2025 and August 2025) was reviewed. The ranges and directives on the log included, "*Readings must be taken between 4:00 AM - 6:00 AM daily. **Acceptable ranges = 68-73 degrees F. [Fahrenheit] & 30-60% RH [relative humidity] *** Unacceptable ranges must be reported to the House Manager and/or Department Manager." The only dates where the temperature and humidity were within acceptable ranges in the OR rooms [OR-1 - OR-8] were the following:7/7/2025 (OR-3, OR-4 and OR-7), 7/8/2025 (OR-6), 7/10/2025 (OR-OR-6), 7/11/2025 (OR-6), 7/12/2025 (OR-6 and OR-7), 7/13/2025 (OR-6), 7/27/2025 (OR-6), 7/27/2025 (OR-6), 7/29/2025 (OR-6), 7/31/2025 (OR-6), 8/5/2025 (OR-6), and 8/6/2025 (OR-6). Of note, the temperature/humidity was not documented for any of the ORs on 7/30/2025. The log included that on July 4th, OR #5 (OR #5 was the location where Pt. #7 has surgery) humidity -73% (normal range is 20 % - 60%) and temperature 70 degrees (within range).

5. On 8/6/2025, the surgery schedule was reviewed for June through August 2025. The schedules indicated that surgeries were cancelled on all dates where the temperature and/or humidity levels were out of range, except for an emergency surgery which was performed in OR- 5 on 7/4/2025 when humidity levels were out of range.

6. On 8/4/2025, Pt. #7's clinical record (dated 7/3/2025 through 7/4/2025) was reviewed and indicated: "Pt. #7 came to the ED (Emergency Department) on 7/3/2025 for persistent worsening right knee pain. Aspiration (the act of withdrawing the fluid, tissue, or other substance through a needle) completed in the ED. Nonoperative versus operative options were discussed. Pt. #7 acknowledged understanding and wished to proceed with operative intervention. Pt. #7's "intraoperative case report) dated 7/4/2025 noted that Pt. #7's surgery was performed by MD #2 (surgeon) at 9::11 AM. Pt. #7's pre-operative and post-operative diagnosis dated 7/4/2025 was right septic knee, advanced tricompartmental OA (osteoarthritis). Brief description of procedure - knee arthroscopic (a minimally invasive procedure used to diagnose and treat knee problems) extensive synovectomy/debridement (a surgical procedure to remove the synovium, the lining of the knee - debridement removes dead, damaged or infected tissue from a wound to promote healing and knee aspiration)."

7. A tour of the Emergency Department (ED) was conducted on 08/05/2025, at approximately 9:45 AM. During the tour, it was noted that there was a black substance (in a speck like pattern) around each of the ceiling air vents by the nurses' stations, in the medication preparation areas, and in some of the unoccupied patient rooms (i.e. #5, #20, #23). There were also some stains which appeared to be dried liquid marks (black and/or brown in color) by the nurses' station in the fast-track area and in unoccupied patient rooms #3 and #21.

8. On 8/5/2025 at 2: 10 PM, an interview was conducted with the MD #1 (Surgeon - partner/associate of MD #2). MD #1 stated that the Hospital is not a safe place to perform surgery. MD #1 wasn't told about the humidity until after surgery had started [Referencing July 4, 2025 - this surgery was performed by MD #1's partner/associate, MD #2.]. MD #1 stated that MD #1 doesn't schedule anything at the Hospital anymore. [MD #2 was not available for interview during dates of this survey.]

9. On 8/6/2025 at 10:00 AM, an interview was conducted with the Interim PeriOperative Director/Manager (E #14). E #14 stated that the temperature/humidity is checked in each OR room by OR staff at 6:00 AM and 1:00 PM, and if the humidity/temperature is out of range, the surgery is cancelled. E #14 stated that MD #2 [surgeon who actually performed the surgery referenced in the allegation on 7/4/2025] was informed by the OR staff that the humidity was out of range on 7/4/2025, but MD #2 proceeded to do the surgery for Pt. #7. E #14 stated that when E #14 asked MD #2 why MD #2 did Pt. #7's surgery, MD #2 stated that Pt. #7's case was emergent. [Of note, E #14 was not working on 7/4/2025. Therefore, E #14 did not inform MD #2 of the out-of-range humidity.]

10. On 8/7/2025 at 10:15 AM, an interview was conducted with the OR Registered Nurse (E #24) who was working on 7/4/2025. E #24 stated that E #24 was the OR Circulating Nurse on 7/4/2025 during the surgery for Pt #7. E #24 stated that E #24 was not aware that the humidity was out of range on 7/4/2025. E #24 stated that E #24 did not know how MD #2 (surgeon) knew that the humidity was out of range.

11. On 8/4/2025 at 11:00AM and 8/6/2025 at approximately 10:00 AM, interviews were conducted with the Infection Control Nurse (E #1). E #1 stated that E #1 has had this position since October 2024. E #1 stated that E #1 has the infection control oversight over the entire hospital. E #1 stated that E #1 has not had any Infection Control Meetings yet [since October 2024]. E #1 stated that there was an Infection Control Meeting scheduled for July, but the meeting was cancelled. E #1 stated that E #1 monitors infection control in the surgical area. E #1 stated that E #1 works with E #14 (Interim PeriOperative Director/Manager) and monitors patients who had surgery with out-of-range humidity. However, E #1 does not review the temperature/humidity logs to ensure that they are being monitored or track when surgeries were cancelled due to temperature/humidity. E #1 stated that E #14 informed E #1 after Pt #7 had surgery while the humidity level was out of range. E #1 stated that EVS and maintenance report any issues with the physical environment, including stains on ceiling tiles. E #1 stated that work orders are submitted, and E #1 does rounds to check the status of work orders/maintenance. E #1 stated that the stains on the ceiling tiles are likely from the ventilation system, as they appear to be in a pattern of air flowing outward from vents onto ceiling tiles. When asked to provide the preventive maintenance schedule and date of last vent cleaning and documentation of rounds regarding the status of work orders/maintenance, E #1 stated that maintenance was responsible for that and could not provide a schedule of cleaning, last date of ventilation system cleaning by survey exit date on 8/7/2025.

12. On 8/7/2025 at approximately 10:00 AM, during an interview with the Executive Director of Operations (E #25), E #25 stated that there were no records of the last cleaning of the ventilation system. E #25 stated, "I know they haven't been cleaned since I started here in 2021."

13. On 8/7/2025 at approximately 10:30 AM, an interview was conducted with the Executive Director of Nursing (E #9). E #9 stated that when the temperature and/or humidity is out of range, E #14 calls E #9, and E #9 directs E #14 to cancel/reschedule surgeries on those dates in effected OR rooms. E #9 stated that E #9 does not relay this information to E #1 to ensure E #1 receives this information. E #9 stated that E #9 had sent daily reports of the temperature/humidity in the OR to the Department for a while [6/28/2025 - 7/7/2025], which included which surgeries were performed. However, E #9 stated that other than these reports, they do not keep specific records/tracking of when surgeries were cancelled due to temperature/humidity levels and could not provide this information. E #9 stated that they would have to go through all the surgery schedules, and see which surgeries were marked as cancelled.

B. Based on document review and interview, the Hospital failed to evaluate and analyze infection control data for the infection prevention and control program, per hospital's infection and control plan.

Findings include:

1. On 8/4/2025, the Hospital's Infection and Control Plan (dated 2025) was reviewed and required, "purpose is to promote safe and quality care to our patients, healthcare workers and visitors through the prevention and control of infections ...The purpose of the Infection Control Committee is to evaluate the data and provide input into the Infection Prevention and Control Program. The Committee is responsible for: Review and approve all policies and procedures related to infection surveillance, prevention and control activities in all department/services. Review the infection surveillance data and recommend methods for the preventions and control of infections in the hospital. The Infection Control Committee meets quarterly unless the committee determines otherwise. Will maintain minutes of findings, proceedings, and action."

2. On 8/4/2025, the Staff Rules & Regulations (dated 4/2/2025) was reviewed and required, "Section 5.7 Infection Control Committee - Composition - The Infection Control Committee shall consist of a Chairperson and five (5) members appointed from the Department of Family Medicine, Internal Medicine, Obstetrics and Gynecology, Pediatrics and Surgery. The following non-medical staff members shall serve as adjunct members: the Infection Control nurse and one (1) representative each from Hospital Administration, Microbiology, Pharmacy and Patient Care Services, one of whom may be delegated to keep the minutes of the Committee meetings. The duties of the Infection Control Committee shall be to:
1) Maintain surveillance over the Hospital Infection Control program.
2) Develop a system for reporting, identifying and analyzing the incidence and cause of selected infection.
3) Implement a preventive and corrective program designed to minimize infection hazards, including establishing, reviewing and evaluating aseptic, isolation and sanitation techniques.
4) Develop, evaluate and revise preventive, surveillance and control policies and procedures relating to all phases of the Hospital's activities, including, but not limited to: operating rooms, delivery rooms, special care units; central service, housekeeping and laundry; prevention of cross-infection by anesthesia apparatus or inhalation therapy equipment; testing of Hospital personnel for carrier status; disposal of infectious material; food sanitation and waste management; select community acquired infections and, when appropriate, employee infections; and other situations as requested;
5) Coordinate action on findings from the Medical Staff's review of the clinical use of antibiotics.
6) Act upon recommendations related to Infection Control received from the President of the Medical Staff, Medical Executive Committee, Departments and other Medical Staff and Hospital Committees.
7) Maintain a record of all activities relating to Infection Control and report to the MEC (Medical Executive Committee), CEO, and Performance Distinction Council; and
8) Promote educational endeavors on infection control for the medical and nursing staffs and other appropriate personnel."

3. On 8/4/2025, an interview was conducted with the Infection Control Nurse (E #1). E #1 stated that E #1 reviews culture reports. E #1 stated that there have not been any Infection Control meetings since they started in October 2024, and E #1 has yet to evaluate and analyze infection control data.





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C. Based on document review, observation, and interview, for 2 of 2 staff (E#20 and E#21) observed on the Progressive Care Unit, the Hospital failed to ensure that medications were handled in a manner to prevent cross-contamination.

Findings include:

1. The Hospital's policy titled, "Storage of Medications in Patient Care Areas" (dated 01/2025), was reviewed and required, "...The medication should not be left on or in any area exceeding 77 degrees Fahrenheit, including an individual's pocket or in any carrying apparatus (i.e. fanny packs or pouches) that remains in contact with the person... Multi-dose vials are dated with the beyond use date in accordance with facility policy..."

2. The Hospital's policy titled, "Medication Administration" (dated 06/2025), were reviewed and required, "...Personnel authorized to administer medications receiving training during orientation and ongoing education about topics related to safe medication handling, preparation, administration, and patient monitoring..." The policy did not specifically outline infection control practices expected when administering medications.

3. The Hospital's policy titled, "Transmission Based Precautions" (revised 2023), was reviewed and required, "... Droplet Precautions - used to prevent spread of infections by droplets... Dedicated patient care equipment will be used for all patients on precautions. Disposable items... will be used whenever possible... Avoid bringing carts and equipment into the room whenever possible..."

4. During a tour of the Progressive Care Unit on 08/04/2025, the following was observed:

- At approximately 9:52 AM, a Nurse (E#20) was observed administering some IV (intravenous) medications to a patient that was on droplet precautions. E#20 did not wipe the top of the vials (single-dose) prior to withdrawing the medications with a syringe. Additionally, E#20 had an oral medication for the patient left by the sink in the room. E#20 did not administer the medication, and put it back into E#20's pocket which also contained common supplies such as alcohol wipes and saline syringes.

- At approximately 10:55 AM, 3 opened vials of acetylcysteine (mucolytic agent) were noted in a plastic bag with a nebulizer kit in patient room #4430. The manufacturer's label on the vials included to discard the medication within 96 hours after opening. The vials were not labeled with the date opened.

5. An interview was conducted with Nurse (E#10) on 08/04/2025, at approximately 11:07 AM. E#10 stated that the oral medication is best to given with a meal so E#10 will come back to give it later when the lunch tray arrives. E#10 stated that E#10 was taught in nursing school that the vials do not have to be wiped if it's a brand new vial.

6. An interview was conducted with Respiratory Therapist (E#21) on 08/04/2025, at approximately 11:05 AM. E#21 stated E#21 only uses each vial two times and discards the vial after that. E#21 stated that they should label the vials with the date/time so that know when it was opened/used.

7. An interview was conducted with the Executive Director of Nursing (E#9) on 08/05/2025, at approximately 3:30 PM. E#9 stated that they do not have a policy that medication vials (whether single or multi-dose) need to be disinfected prior to use, as this should be general infection control knowledge.

Based on document review and interview, it was determined that the hospital failed to demonstrate periodic assessment of the discharge planning process, including an internal audit of closed medical records and review of patients admitted within 30 days of previous admission were conducted.

Findings include:

1. On 8/07/2025, the hospital's policy titled, 'Case Management Discharge Planning' (revised 1/27/2025) was reviewed and did not include a process for review of discharge plans or readmissions within 30 days.

2. On 8/07/2025, the hospital's 2025 Utilization Review Committee meeting minutes were reviewed and included readmission data (January 2024-June 2025), however the data was combined with the hospital's sister/affiliated hospital. No readmission assessment to ensure discharge planning needs were met was available for this hospital.

3. On 8/07/2025 at approximately 9:45 AM, any documentation or data collected to indicate that the hospital conducted an internal audit of closed medical records and patients admitted within 30 days of previous admission was requested of the Director of Patient Access (E #26). However, no documentation was provided.

4. On 8/07/2025 at approximately 10:00 AM, an interview with the Director of Patient Access (E #26) was conducted. E #26 stated that utilization meetings are conducted and include metrics including readmissions, and chart audits of closed medical records including readmissions have been conducted. However, E #26 was unable to provide documentation of this.

5. On 8/07/2025 at approximately 10:35 AM, an interview with the Executive Director of Nursing (E #9) was conducted. E #9 stated that after communication between E #9 and E #26, it was confirmed that utilization review has not conducted audits of readmissions nor closed medical records. E #9 stated that readmissions within 30 days are not triggered in the hospital's new EMR (electronic medical records) system, so discharge planner would have to review each patient's admission history to identify if they had been admitted within the last 30 days, for purposes of tracking/trending readmissions.

A. Based on document review, observation, interview, for 2 of 2 nebulizer kits observed on the Progressive Care Unit/PCU, the Hospital failed to ensure that nebulizer kits were labeled to ensure that the kits were changed every 48 hours as required.

Findings include:

1. The Hospital's Respiratory Care Policy titled, "Infection Control" (dated 06/2025), was reviewed and required, "...Handheld Nebulizer Set-Ups: Replace complete neb circuit at least every 48 hours..."

2. During a tour of the PCU on 08/04/2025, between approximately 10:00 AM and 11:00 AM, nebulizer kits kept in patient rooms #4430 and #4443 were not labeled with the date used/changed.

3. An interview was conducted with Respiratory Therapist (E#21) on 08/04/2025, at approximately 11:05 AM. E#21 stated that they do not typically label the nebulizer kits with a date opened or changed. E#21 stated that nebulizer kits are changed weekly on Fridays. E#21 stated that without a date, E#21 does not know when the kits were last changed.


B. Based on document review and interview, for 1 of 2 records (Pt. #32) reviewed for respiratory treatments, the Hospital failed to ensure that respiratory treatments were completed as ordered.

Findings include:

1. The Hospital's policy titled, "Chest Physio Therapy [CPT] Procedure (Percussion & Vibration)" (dated 06/2025), was reviewed and required, "...Check patient's chart for complete physician's orders. A complete order shall include: Type of therapy... frequency... A descriptive entry shall be made in the Respiratory Progress Notes sheet in the patient's chart following each treatment..."

2. The clinical record of Pt. #32 was reviewed on 08/04/2025 at approximately 1:25 PM, with E#10. Pt. #32 was admitted on 06/17/2025 with a diagnosis of altered mental status and desaturation. Physician orders for CPT were placed on 07/23/2025 to start on 07/24/2025 at 12:00 AM with a frequency of 3 times a day. CPT flowsheets from 07/24/2025 were reviewed and indicated that 1-3 treatments were missed everyday except for on 7/29/2025 and 08/01/2025. The record lacked any respiratory progress notes indicating CPT was completed as ordered.

3. An interview was conducted with the Respiratory Therapy Supervisor (E#18) on 08/05/2025, at approximately 3:00 PM. E#18 stated that when CPT is ordered, respiratory staff will document performance of the CPT in the medical record in the CPT flowsheets.