Fmc - Pensacola

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 52621 Based on observations, staff interviews, record review and facility policies, it was determined that the facility failed to implement and maintain effective infection control precautions. The facility failed to adhere to infection control standards including offering a patient hand hygiene after applying pressure to access site (Refer to V113); failed to ensure only items dedicated to the patient were brought to the dialysis station, failed to ensure proper cleaning of stethoscopes between patients (Refer V116); failed to clearly separate clean and dirty equipment (Refer V117); and failed to use only dedicated instruments in HBV+ patients in isolation (Refer V130). The cumulative effect of this systemic problem resulted in the facility being out of compliance with the Condition for Coverage 42 CFR 494.30 Infection Control.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 52621 Based on observations, interviews, and policy review, the facility failed to offer hand hygiene for 1 out 1 patient discharged home after wearing a gloved hand for fistula care to prevent contaminant transmission. (Patient #11) The findings include: On 09/02/25 at approximately 1:55 PM, during an observation of discontinuation of dialysis and post dialysis care for Arteriovenous (AV) Fistula, Patient #11 was observed with a left gloved hand to apply pressure to her AV fistula site. Upon completion of the task, the patient removed the glove. The patient was escorted out of the facility for discharge without being offered hand hygiene. On 09/02/25 at approximately 2:10 PM, an interview was conducted with Staff P, Registered Nurse who escorted Patient #11 out of the facility after completion of her treatment. He acknowledged discharging the patient without offering hand hygiene and explained that he forgot. He further indicated that it is the facility expectation to offer hand hygiene to patients upon discharge to prevent cross-contamination. On 09/04/25 at approximately 4:15 PM, during the QAPI (Quality Assurance Performance Improvement) review, the Clinical Manager explained that the facility was trending up in regard of Infection Control and as of 07/09/25 she identified staff and patients not performing hand hygiene as a concern. She further indicated that she identified a need for patient education on washing their hands after applying pressure to their AV fistula site. She acknowledged this as a concern but has not yet developed a plan, at least regarding offering patient hand hygiene. According to the Center for Disease Control and Prevention website titled: “2001 Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients” at https://www.cdc.gov/mmwr/PDF/rr/rr5005.pdf, see page 17, “Contact transmission can be prevented by hand hygiene (i.e., hand washing or use of a waterless hand rub), glove use, and disinfection of environmental surfaces. Of these, hand hygiene is the most important. In addition, nonsterile disposable gloves provide a protective barrier for workers ’ hands, preventing them from becoming soiled or contaminated, and reduce the likelihood that microorganisms present on the hands of personnel will be transmitted to patients. However, even with glove use, hand washing is needed because pathogens deposited on the outer surface of gloves can be detected on hands after glove removal, possibly because of holes or defects in the gloves, leakage at the wrist, or contamination of hands during glove removal.” A review of the facilty’s policy titled: “Hand Hygiene”, published 11/06/2023, Reference Number: 47664, Version indicates, the purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. The responsibility includes all staff, patients, patient care givers, physicians and non-physician practitioners, social workers, dietitians, and any other indirect care staff must follow the same requirements for hand hygiene. Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub immediately after removing gloves. The section: “Hand Hygiene Patients” states: “Gloves must be provided to patients when performing procedures which risk exposure to blood or body fluids, such as holding access sites post treatment to achieve hemostasis. To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed”.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 37965 Based on observations, staff interviews and review of the facility’s policies, the facility failed to ensure that items taken to a dialysis station were either disposed of, dedicated for use on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient for observations made on 3 of 3 days of the survey. (9/2-4/25). The findings include: On 9/3/25 at approximately 11:35 AM, an interview was conducted with staff member U, a Personal Care Technician (PCT) and staff member V, PCT. During the interview they were asked about the cleaning of stethoscopes used to assess patient access sites. They both reported that their stethoscopes were very expensive and if they cleaned them every time they used them it would ruin them. Staff member U, stated she keeps her stethoscope at the nurses station and is the only staff member who uses it. She stated that the stethoscope is “dirty” while at the nursing station which is why she cleans the diaphragm with alcohol before she uses it. When asked if she cleans the entirety of the stethoscope she stated “no” again stating that would ruin it. At this time staff member V, PCT demonstrated how she keeps her personal stethoscope clean by placing it into a clean glove, so the diaphragm never touches the patients. She offered that her stethoscope was expensive and cleaning it would ruin it so she only uses it with a glove. On 9/3/25 at approximately 11:45 AM, an observation was made of a stethoscope laying on top of dialysis supplies at the nursing station. On 9/3/25 at approximately 11:50 AM, an observation of staff member U, PCT, was observed to obtain the stethoscope from the nursing station and take it to station number 7 where she was initiating dialysis treatment for a patient. She was observed to use a small alcohol wipe to clean the diaphragm of the stethoscope prior to assessing the patient’s dialysis access site. She was then observed to return the stethoscope to its original location at the nursing station on top of dialysis supplies, she was not observed to clean the stethoscope. On 9/03/25 at approximately 11:55 AM an observation was made of staff member T, Registered Nurse (RN), during which she was observed to enter the facility’s hepatitis B positive isolation dialysis station room. She was wearing a visor on top of her head that had a face shield attached and there was a stethoscope noted hanging around her neck. As she was observed to talking to the patient she removed the stethoscope from around her neck and began to assess the patient’s lung sounds. She returned the stethoscope to her neck upon completion of the assessment. She was not observed to clean the stethoscope prior to assessing the patient or after she completed the assessment. She removed the gown, washed her hands and exited the isolation room, the stethoscope was hanging from around her neck. On 9/03/25 at approximately 12:00 PM, an interview was conducted with staff member T, RN, during which she was asked about cleaning the stethoscope before use on the patient and she stated “I did not clean it” when asked about the visor upon her head and the use of the stethoscope on the isolation patient she stated she would have to ask the charge nurse as she was not sure if the visor could be worn in the isolation room or not. She clarified that she cleans her stethoscope after every other use. On 9/3/25 at approximately 12:15 PM, an interview was conducted with the charge nurse who stated that stethoscopes should be cleaned at the end of the day and he cleans his with either alcohol wipes or if he has sanitizer on his hands he will run his hands over the tubing. On 9/3/25 at approximately 12:25 PM, an interview was conducted with the Clinic Manager who stated that she did not think staff were required to clean the stethoscopes between patients because they are usually placed on intact skin or over clothing. She stated she thought it was a good idea to clean them but was not aware of the facility’s policy for cleaning. On 9/4/25 at approximately 8:40 AM, a telephone interview was conducted with the Medical Director who stated that it is the job of the leadership on the floor to ensure staff follow infection control protocol and isolation precautions. A review of the facility’s policy “Access Assessment and Cannulation”, reference number 45178, version 5, states “The purpose of this procedure is to provide guidance for assessing patency and placement of needles in an AV (arteriovenous) Fistula (an abnormal connection between an artery and a vein) or AV Graft (a surgical procedure that creates a connection between an artery and a vein) to obtain access to the circulatory system for hemodialysis.” Item #6 on page 3 states “Clean stethoscope after assessing a patient.” A review of the faciility’s policy “General Cleanliness and Infection Control Guidelines” reference number 47685 version 9 indicates, “The purpose of this policy is to provide guidance for (the dialysis center) staff on preventing the spread of infectious disease and maintaining a clean, safe and aesthetically pleasant environment for patients, staff and visitors.” “Noncritical medical equipment, which includes equipment that touches only intact skin (e.g. stethoscope, blood pressure cuffs), must be disinfected with 1:100 bleach or an EPA (Environmental Protection Agency) registered disinfectant.” 52621 On 09/04/25 at approximately 10:25 AM an observation was made in the treatment area of Patient #14 at Dialysis Station 8 during initiation and dressing change of her Central Venous Catheter (CVC) access. A black rectangle trash can was observed under the side tray of the dialysis chair by the dialysis machine. (Photographic evidence obtained). Staff L was observed performing a CVC dressing change and disposal of the contaminated dressing into the trash can. After initiation of dialysis, the contaminated trash can was returned to the common area. On 09/04/2025 at approximately 10:42 AM an interview was conducted with Staff L, Registered Nurse. He explained that for CVC dressing change he brings a trash can by the dialysis chair for easy disposal of supplies. The trash can was not disinfected prior to being brought to Station 8 and is not a dedicated item for the patient. He further explained that after completion of his task, the trash is then returned to the common area for everyone to use. On 09/04/25 at approximately 10:45 AM an interview was conducted with the Charge Nurse. He explained that while bringing a trash can closer is acceptable for easily disposal of supply, common trash should not be brought to the patient’s station for infection prevention. His expectations are only items dedicated to the patients to be brought to the station. A review of Patient #14 positive blood culture results dated 08/28/2025 and 08/30/2025 from specimen draw date 08/26/2025, revealed suspected source of positive blood culture from vascular access. A review of the faciility’s policy titled “General Cleanliness and Infection Control Guidelines”, published 09/02/25, Reference Number 47685, Version 9 was reviewed. The purpose of this policy is to provide guidance to the staff on preventing the spread of infectious diseases. The policy included the statement, “All non-disposable containers, baskets, pails, etc., that are to be reused and have a reasonable likelihood of becoming contaminated, must be inspected and disinfected immediately.” The Center for Disease Control and Prevention (CDC) Morbidity and Mortality Recommendations and Reports dated 04/27/2001/Vol. 50/No. RR-5 was reviewed, https://www.cdc.gov/mmwr/PDF/rr/rr5005.pdf. According to the CDC, any item taken to a patient’s dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination from the hands of personnel. Items taken to a patient’s dialysis station including those items placed on the top or sides of dialysis machines and on dialysis chairs, should either be disposed of, dedicated for use only on a single patient, cleaned and disinfected before being returned to a common clean area or used for other patients.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 52621 Based on observations, staff interviews and review of the CDC (Center for Disease Control and Prevention) website, the facility failed to ensure that clean areas were clearly separated from contaminated areas, specifically for 3 out 5 biohazards containers in the common area. The findings include: On 09/02/2025 at approximately 10:41 AM, during the flash tour of the in-center treatment area, 3 out 5 biohazards containers were observed placed adjacent to the clean sink area (Photographic evidence obtained). On 09/03/2025 at approximately 11:58 AM, during an observation, 1 out of 5 biohazard containers were observed adjacent to the clean sink area (Photographic evidence obtained). On 09/04/2025 at approximately 2:53 PM, during an observation, 1 out 5 biohazard containers were observed adjacent to the clean sink area. A floor staff was observed disposing of the contaminated circuit line into the biohazard container. Additionally, 1 biohazard container was observed next to the clean supply cart (Photographic evidence obtained). On 09/04/2025 at approximately 3:00 PM, an interview was conducted with the Charge Nurse. He explained that each station has a biohazard container, and it should be next to the dirty sink for potential contamination. On 09/04/2025 at approximately 4:16 PM, an interview was conducted with the Clinical Manager. She explained that she doesn’t agree with the idea of having both clean and dirty areas, including biohazards containers, in close proximity. From her perspective as a manager, this is not considered standard practice. She acknowledged the possibility of a splash from contaminated bloodlines into the clean area and stated that this creates a conflict between maintaining clean and dirty separation in regard to infection prevention. The Center for Disease Control and Prevention (CDC) Morbidity and Mortality Recommendations and Reports dated 04/27/2001/Vol. 50/No. RR-5 was reviewed with a webpage link as follow: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm. According to the CDC, measures to prevent contamination of clean or sterile items include; not handling, cleaning, or storing potentially contaminated (i.e., used) supplies, equipment, blood samples, or biohazard containers in areas where medications and clean (i.e., unused) equipment and supplies are handled. The patient treatment area should have designated “clean” and “dirty” areas. The CDC defines a “dirty” area as an area where there is potential for contamination with blood or body fluids and areas where contaminated or “used” supplies, equipment, blood supplies or biohazard containers are stored or handled. A “clean” area is an area designated only for clean and unused equipment and supplies and medications. Staff must remain aware of the separation of clean and dirty areas to prevent cross-contamination protection of clean areas and items from cross contamination.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 37965 Based on observation, interviews and review of the facility’s policy and procedurrd reviews and interviews, the facility failed to ensure staff, providing care to a hepatitis B positive patient receiving dialysis treatment in the isolation room, removed Personal Protective Equipment (PPE) (face shield/visor) when exiting the isolation room and failed to utilize dedicated equipment for the assessment of lung sounds. (Staff Member T, Registered Nurse) The findings include: On 9/03/25 at approximately 11:55 AM an observation was made of staff member T, Registered Nurse (RN), during which she was observed to enter the facility’s hepatitis B positive isolation dialysis station room. She was wearing a visor on top of her head that had a face shield attached and there was a stethoscope noted hanging around her neck. She was observed to don a gown, wash her hands at the sink in the room, don clean gloves, and lower the visor from the top of her head which allowed the shield to cover her face. She then was observed to talk to the patient as she removed the stethoscope from around her neck and began to assess the patient’s lung sounds. She returned the stethoscope to her neck upon completion of the assessment. She was not observed to clean the stethoscope prior to assessing the patient or after she completed the assessment. She removed the gown, washed her hands and exited the isolation room, still wearing the visor which had been pushed up to the top of her head and the stethoscope was hanging from around her neck. On 9/03/25 at approximately 12:00 PM, an interview was conducted with staff member T, RN, during which she was asked about cleaning the stethoscope before use on the patient and she stated “I did not clean it” when asked about the visor upon her head and the use of the stethoscope on the isolation patient she stated she would have to ask the charge nurse as she was not sure if the visor could be worn in the isolation room or not. She clarified that she cleans her stethoscope after every other use. On 9/3/25 at approximately 12:15 PM, an interview was conducted with the charge nurse who stated that there are dedicated supplies in the isolation room that should be utilized during care. He offered that the visor and stethoscope should not have been used in the isolation room. On 9/3/25 at approximately 12:25 PM, an interview was conducted with the Clinic Manager who stated that staff should not bring anything into the isolation room as there is dedicated equipment. On 9/4/25 at approximately 8:40 AM, a telephone interview was conducted with the Medical Director who stated that it is the job of the leadership on the floor to ensure staff follow infection control protocol and isolation precautions. A review of the facility’s policy “Dialyzing Patients with Positive Hepatitis B “ reference number 70789, version 1, indicates, “Caring for HBsAg (Hepatitis B Surface Antigen) positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infection because the concentration of virus particles in the blood is very high and the hepatitis B virus can live outside the body on surfaces for at least (7) seven days. Outbreaks of hepatitis B has been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for hepatitis B.” Equipment and Supplies “Separated dedicated supplies and equipment, including blood glucose monitors, must be used to provide care to the HBsAg positive patient”. Hand Hygiene and PPE (Personal Protective Equipment), “Personal protective equipment (PPE) must be removed and discarded or left in the isolation room/are if not soiled.” A review of the facility’s policy “General Cleanliness and Infection Control Guidelines,” reference number 47685 version 9, indicates, “The purpose of this policy is to provide guidance for (the dialysis center) staff on preventing the spread of infectious disease and maintaining a clean, safe and aesthetically pleasant environment for patients, staff and visitors.” “Noncritical medical equipment, which includes equipment that touches only intact skin (e.g. stethoscope, blood pressure cuffs), must be disinfected with 1:100 bleach or an EPA (Environmental Protection Agency) registered disinfectant.” A review of the facility’s policy “Access Assessment and Cannulation,” reference number 45178, version 5, indicates, “The purpose of this procedure is to provide guidance for assessing patency and placement of needles in an AV (arteriovenous) Fistula (an abnormal connection between an artery and a vein) or AV Graft (a surgical procedure that creates a connection between an artery and a vein) to obtain access to the circulatory system for hemodialysis.” Item #6 on page 3 states “Clean stethoscope after assessing a patient.””

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 37965 Based on patient record review, staff interview and review of the facility’s policy and procecure, the facility failed to ensure patients identified as unstable had comprehensive assessments performed monthly and a revision to the plan of care by the Interdisciplinary Team (IDT) for 1 of 1 patient deemed unstable (Patient #7). The findings include: A review of the facility’s policy “Comprehensive Patient Assessment and Plan of Care (POC),” reference number 45283 version 6, revealed that “unstable patients must be reassessed by the IDT monthly. Monthly reassessment and any POC updates related to the reason the patients is consider “unstable” must be documented until the issues have been resolved or the IDT (including the patient if possible) determines that the condition is chronic.” The policy goes on to state on page 7 “If the patient and or designee is unable or unwilling to attend the Plan of Care meeting or if the patient attends via telehealth/virtual: The registered nurse may review the Plan of Care as developed by the IDT at the meeting with the patient and obtain the patient’s signature and any comments. If the patient is not physically present at the meeting, or is remoted at the time of review tsignature (electronic signature) may be obtained at a later date.” On 9/4/25 at approximately 12:30 PM, an interview was conducted with staff member I, a Social Worker (SW) during which she stated, Patient #7, a home hemodialysis patient, was determined to be “unstable” in December 2024 for non-compliance with treatment orders. The patient’s physician was notified on December 3, 2025 of the facility’s concerns related to the patient’s non-compliance. In October 2024 the patient was sent a certified letter stating that there were concerns for his health and safety. She stated the patient was hospitalized in December for a wound infection and had been transferred to a specialty hospital where he was receiving dialysis while also receiving treatment for his wounds. She was not sure of the exact date he was discharged but stated he was readmitted in April 2025, and was still deemed unstable due to his extended hospitalization. She offered that she had seen the patient monthly since he was admitted but was unsure if the IDT had met regarding this patient. On 9/4/25 at approximately 1:10 PM, an interview was conducted with the Home Therapy Manager during which she stated that the IDT does meet monthly however was unable to find documentation that patient #7 had been reviewed by the IDT for the months of April and May but had documentation he had been reviewed by the team in June, July and August. She clarified that April and May had been “missed”. She also stated the patient and his wife had attended these meetings via telehealth. A review of the “Comprehensive Assessment and Plan of Care” for Patient #7, dated 6/11/25 revealed the last POC meeting and the POC meeting/admit date were held on 12/18/24 and that the next POC type was “unstable”. Under “Marked deterioration in health status: Change in ambulation severe enough to interfere with the patient’s ability to follow aspects of the treatment plan.” Under “Significant change in psychosocial needs: Change in mentation or psychosocial needs severe enough to interfere with the patient’s ability to follow aspects of the treatment plan and may include situation related to immediate family members. (Any patient considered at risk for involuntary discharge or transfer must be considered “unstable” under this category).” Review of the signature pages for those who attended the meeting were electronically signed by the Medical Doctor, a Registered Nurse, Social Worker and the Registered Dietitian; however the section for Patient Approval Signature was blank. There was no indication the patient had attended remotely or that the POC had been reviewed with the patient or their family. A review of the “Comprehensive Assessment and Plan of Care” for Patient #7, dated 7/23/25 revealed the last POC meeting and the POC meeting/admit date were held on 6/11/25 and that the next POC type was “unstable”. Under “Marked deterioration in health status: Change in ambulation severe enough to interfere with the patient’s ability to follow aspects of the treatment plan.” Review of the signature pages for those who attended the meeting were electronically signed by the Medical Doctor, a Registered Nurse, Social Worker and the Registered Dietitian; however, the section for Patient Approval Signature was blank. There was no indication the patient had attended remotely or that the POC had been reviewed with the patient or their family. A review of the “Comprehensive Assessment and Plan of Care” for Patient #7 dated 8/21/25 revealed the last POC meeting and the POC meeting/admit date were held on 7/23/25 and that the next POC type was “unstable”. Under “Marked deterioration in health status: Change in ambulation severe enough to interfere with the patient’s ability to follow aspects of the treatment plan.” Review of the signature pages for those who attended the meeting were electronically signed by the Medical Doctor (attended remotely), a Registered Nurse, Social Worker and the Registered Dietitian; however, the section for Patient Approval Signature was blank. There was no indication the patient had attended remotely or that the POC had been reviewed with the patient or their family. On 9/4/25 at approximately 2:00 PM, a follow up interview was conducted with the Home Therapy Manager during which she verified that there was no documentation that the family had attended the meeting remotely or that the nurse had reviewed the information with the family.”