Fmc - Elkton

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, the facility’s Governing Body, Administration, and the Medical Director failed to meet Based on the overall findings of the survey, the facility’s Governing Body, Administration, and the Medical Director failed to meet the Conditions for Coverage (CfC: 494.60) for Physical Environment as evidenced by: Based on the overall findings of the survey, the facility’s administration and the Medical Director failed to ensure the clinical staff conduct safety checks of the dialysis machines per the manufacture’s recommendation and its own policy, before initiating patient treatments. The facility failed to meet the minimum requirements for Conditions for Coverage (CfC: 494.60) for Physical Environment. This failure placed all patients at an increased risk of harm and or injury as evidenced by the following regulation that was violated: Physical Environment - Equipment Maintenance (V0403)”

“Policies/Procedures for Medical Documentation CFR(s): §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This Standard is not met as evidenced by: 44367 Based on observations, staff interview, and record review, the facility’s administration and the Medical Director failed to ensure that the patient’s health records remained confidential and protected from unauthorized access. This failure denied the patients their rights to privacy and confidentiality of their health information. Findings Included: Review on 04/24/2025 of the facility’s policy entitled “Guidelines for Emergency Preparedness” revealed “The facility must develop a communication plan for all patients (in-center and home). This plan includes the following: Current copy of the emergency lists must: Be kept locked in the emergency supply boxes, or cart.” 1. On 04/24/2025 at 11:49 a.m., during the inspection of the home program emergency equipment, the surveyors observed the facility’s “Emergency Disaster Contact List - Verified” was placed on top of the crash cart, making it accessible for unauthorized access. The list included patient demographics 2. On 04/25/2025 at 12:00 a.m., during the inspection of the in-center emergency equipment, the surveyors observed the facility’s “Emergency Disaster Contact List - Verified” was placed on top of the crash cart, making it accessible for unauthorized access. The list included patient demographics. The Director of Operations was informed of the findings on 04/24/2025 and 04/25/2025.”

“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: 44367 Based on clinical observations, the facility’s administration failed to ensure that the standards of care related to hand hygiene and glove use requirements were followed by all staff who encounter dialysis patients in the facility. This failure placed the patients and staff at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Staff: #5 Findings included: According to the Centers for Disease Control and Prevention (CDC), infection can be spread in a dialysis center through the passing of microorganisms from one patient to another by the hands of the caregiver; or if the environmental surfaces are contaminated and touched by a caregiver or patient. Even with glove use, hand hygiene is necessary before gloves are put on and after gloves are removed because hands can become contaminated through small defects in gloves and from the outer surface of the gloves during glove removal. According to the facility’s policy entitled, “Changing the Catheter Dressing Procedure” Page 4 states, “Inspect and remove old dressing...Discard dressing and remove gloves. Perform hand hygiene. Prepare dressing supplies...Perform hand hygiene and don gloves...” Observations of the clinical treatment area on 04/28/2025 revealed that during treatment initiation of a Central Venous Catheter (CVC)patient at Station 10, Staff #5 removed the dirty dressing and then removed gloves. Staff #5 did not perform hand hygiene before putting on clean gloves to clean the CVC exit site. (Cross-referenced with V0147) The Director of Operations was informed of the findings on 04/28/2025.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies, the governing body failed to ensure that personal protective equipment (PPE) is worn in the treatment area where there is potential for contact with body fluids, hazardous chemicals, contaminated equipment, and environmental surfaces. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to other staff members, as well as patients. Staff: #2 and #3 Findings included: Personal protective equipment (PPE) is defined by the Occupational Safety and Health Administration (OSHA) as “specialized clothing or equipment, worn by an employee for protection against infectious materials.” Review on 04/23/2025 of the facility’s policy entitled “Personal Protective Equipment” page 1 states, “Personal protective equipment including a full-face-shield or mask and protective eyewear with full side shield, fluid-resistant gowns, and gloves, must be worn to protect employees from blood or other potentially infectious materials (OPIM). PPE is used to protect employees who are occupationally exposed to blood or OPIM when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination, cleaning of dialyzer, and centrifugation of blood).” 1. During observations of the clinical treatment area on 04/23/2025 at 11:40 a.m. revealed Staff #2 did not have on protective eyewear/face shield or gown during treatment termination of the patient at station #1. 2. During observation of the clinical treatment area on 04/24/2025 at 11:27 a.m. revealed Staff #3 was speaking with a patient in close proximity at station #18, during the treatment initiation process without wearing a gown or protective eyewear/face shield. 3. During observation of the clinical treatment area on 04/25/2025 at 10:15 a.m. revealed Staff #4 was discontinuing the patient’s treatment at Station #16 with the sleeves of the gown pushed up to the elbow. The Director of Operations was informed of the findings on 04/23/2025, 04/24/2025 and 04/25/2025.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies, the governing body failed to ensure that the clinical staff inspected the dialysis machine’s external transducer and changed it when wet. This failure placed the patient at risk for infection and harm. Findings include: Transducer protectors are used in Hemodialysis blood lines to keep the blood side of the circuit separated from the machine side and to prevent contamination of the machine by the blood flowing through the circuit. According to the “National Institute of Health (NIH)”, “Wet external transducer protectors must be changed immediately, and the machine side of the protector should be inspected for contamination or wetting.” Review on 04/25/2025 of the facility’s policy entitled “Patient Assessment and Monitoring” stated, “Observe and ensure that: That the transducer protectors are dry, unclamped and pressure lines are free of fluid.” Observation of the clinical treatment area on 04/25/2025 at 11:11 a.m. revealed that the venous external transducer and the pressure line on machine #19 at Station #8 were wet (filled with blood). The Director of Operations was informed of the findings on 04/25/2025.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #1 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” According to the facility’s policy entitled, “Changing the Catheter Dressing Procedure” page 2 states, “2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds.” Page 4 states, “Inspect and remove old dressing...Discard dressing and remove gloves. Perform hand hygiene. Prepare dressing supplies...Perform hand hygiene and don gloves...” According to the facility’s policy “Initiation of Treatment Using a Central venous Catheter and Optiflux Single Use Ebeam Dialyzer” page 4 states, “Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) for 10-15 seconds and any time caps are removed, or bloodlines are disconnected (i.e. end of treatment or treatment interruption) to reduce risk of contamination.” 1. Observation of the clinical treatment area on 04/23/2025 at 11:23 a.m. revealed that during initiation of treatment at station 12, Staff #1 cleaned the arterial hub and the venous hub for 1 second each with the same alcohol pad. 2. Observation of the clinical treatment area on 04/24/2025 at 10:32 a.m. revealed that during termination of treatment at station 16, Staff #1 disconnected the bloodlines from the catheter and cleaned the arterial hub and the venous hub for 6 seconds with the same alcohol pad. 3. Observation of the clinical treatment area on 04/24/2025 at 11:05 a.m. revealed that during termination of treatment at station 18, Staff #1diconnected the bloodlines from the hubs and cleaned the arterial hub and the venous hub for 6 seconds at the same time with the same alcohol pad. 4. Observations of the clinical treatment area on 04/28/2025 at revealed that during treatment initiation of a CVC patient at Station 10, Staff #5 removed the dirty dressing and then removed gloves. Staff #5 placed new gloves on and did not perform hand hygiene. Staff #5 continued to clean the patient’s exit site. (Cross-referenced with V0113) The Director of Operations was informed of the findings on 04/23/2025, 04/24/2025 and 04/25/2025.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 44367 Based on observation, the Facility’s Administration and the Medical Director failed to ensure that the water room remained secure and restricted from unauthorized access. This failure placed the water system at risk for possible contamination and placed the patients at potential risk of harm. Findings included: Unauthorized access to the system could lead to tampering, which could have serious consequences for the safety and quality of the water supply. To maintain the quality and safety of the water supply, it is essential to make sure that the water purification and storage systems are secure and only accessible by authorized personnel. 1. On 04/23/2025 at 10:00 a.m., during the flash tour, the surveyors observed that the water room did not have a door or gate in place, leaving the system accessible to unauthorized. 2. On 04/23/2025 at 10:05 a.m. during the flash tour, the surveyor observed that the room where the Bicarbonate tank and supplies are kept, is placed on the treatment floor in front of Station #7. The Bicarbonate room does not have a door or gate in place, leaving the system accessible to unauthorized access. The Biomedical Technician and the Director of Operation corroborated that the water system and the Bicarbonate tanks were not secure.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 44367 Based on observations and interviews with the facility’s administration, the governing body failed to ensure that the physical structure of the dialysis facility and the components of the water treatment room were clean, and the system was secure. This failure placed the patients, staff, and visitors at potential risk of harm including exposure to hazardous or infectious material from a potentially contaminated water system. Findings included: According to the “American Journal of Kidney Diseases” on 06/12/2024, “Physical environment requirements of the CfC address building safety, equipment maintenance, the patient care setting, emergency preparedness, and fire safety. This includes the ensurance of proper maintenance and repair of such items as the dialysis equipment, operating systems, water treatment systems, and physical building and grounds.” On 04/23/2025 at 12:00 p.m., the inspection of the water treatment room revealed the following: “ The water treatment system did not have a door or gate in place, allowing access to unauthorized personnel. “ A moderate amount of brown and white substance on the floor behind the Multimedia tank. “ Small black dots covering the entire surface of the drain behind the Water Heater Tank. The Biomedical Staff was informed of the findings on 04/23/2025.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 44367 Based on observations, record reviews, and staff interviews, the facility’s governing body failed to ensure that the clinical staff conducted safety checks of the dialysis machines in accordance with the manufacturer’s instructions and its own policy before initiating patient treatments. This failure placed patients at risk for harm. Patient: #6 Staff: #1 and #2 Finding Include: On 04/24/2025 at 06:10 a.m., during review of the Fresenius 2008T Machine Operator’s Manual, page 74 stated: “Warning! ...If the machine fails this or any of the pressure, alarm, and diasafe tests and the cause cannot be corrected, or if it fails subsequent tests, do not use it for treatment. Remove the machine from service and have it inspected by a qualified technician to correct the problem.” Review on 04/24/2025 of the facility’s policy “Priming an Optiflux Single Use E-Beam Dialyzer” page 5 number 14 revealed, “If the AUTOMATIC TESTING FAILS, repeat the test. If the cause of the failure cannot be corrected, or if it fails subsequent tests, the machine should not be used.” On 04/24/2025 at 11:32 a.m. the surveyor observed that machine #14 located at station #17 failed the safety tests (pressure test and alarm test) one time. The surveyor observed that Staff #2 retested the alarm test portion only. The surveyor asked PCT #1 to explain the testing procedure if the automatic test fails. According to PCT #1. stated that because the machine failed the alarm portion “we were told to only retest the alarm portion.” The surveyor asked if this was the policy and PCT #1 stated that “the previous Biomed told us.” The Charge Nurse was also unable to verbalize the testing procedure per the policy. On 04/24/2025 at 11:46 a.m., during random machine safety checks, Patient #6 was receiving treatment on Machine #5 at Station #5. The surveyor noted that the machine failed testing at 11:28 am, PCT #2 retested the alarm portion only at 11:32 am. The surveyor asked PCT#2 why only the alarm portion was retested and PCT #2 stated “that is what education told us to do.” At 11:29 a.m. the Director of Operations and the Facility were informed of the findings. The DO immediately instructed PCT #2 to end Patient #6 treatment, reassemble the machine and conduct the safety checks. Patient #6 treatment was initiated at 11:36 a.m. At 11:55 a.m., Staff #2 discontinued Patient #6’s treatment. At 12:23 p.m., Patient #6 treatment was resumed after machine #5 was reassembled tested according to the facility’s policy. At 11:45 a.m., after receiving the surveyor’s findings the Director of Operations and the Facility administrator immediately checked the testing portion of each occupied and unoccupied assembled machines and initiated education and training to the entire staff regarding the machine safety check testing process per the facility’s policy.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44367 Based on review of medical records, and interviews with the facility’s administrative staff, the governing body failed to ensure that a registered nurse (RN) completed an initial nursing assessment prior to the patients’ initial dialysis treatment when being admitted to the facility. This failure placed the affected patients at risk for harm. Patients: #2, #3 and #8 Findings included: Review on 04/25/2025 of the facility’s policy entitled “Comprehensive Interdisciplinary Assessment and Plan of Care” revealed that “A registered nurse must perform an assessment on patient new to dialysis before initiation of their first treatment to determine immediate needs.” During a review of ten selected patients’ medical records on 04/25/2025, the surveyor noted that three (3) or 30% out of the ten of the selected patients did not have an initial nursing assessment documented in their paper or electronic charts. The assessment should have been completed prior to the patient being placed on the dialysis machine on the day of admission. The Director of Operations was given the opportunity to provide the missing initial nursing assessments; However, the Director of Operations corroborated that the initial nursing assessments were not completed.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44367 Based on review of the dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions were the same as what the patients received. Failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm, injury, and denied the patients their rights. Patients: #1, #8 and #10 Findings included: The treatment flowsheet is the form used to record the patient’s care during dialysis. Recorded information includes the patient’s blood flow rates (BFR) and the dialysate flow rate (DFR), the patient’s blood pressure, administration of medications, visual observations of the patient and any patient complaints. This information may be handwritten or computer generated. According to the facility’s policy entitled “Patient Assessed and Monitoring” page 6 revealed, “check prescribed blood flow is being achieved, or reason is documented in medical record if unable to meet prescribed flow. Check dialysate flow rate setting in correct, and the prescribed flows are being delivered.” A review of ten (10) selected patients’ treatment flowsheets on 04/25/2025, revealed that three (3) or 30% of the selected patients did not receive the correct dialysis prescription as ordered by the Nephrologist. On treatment date 03/15/2025, Patient #1’s BFR was prescribed for 400 ml/min. However, the BFR was set at 350 ml/min from 07:05 a.m. to 08:01 a.m. There was no documentation found explaining why Patient #1’s BFR was not set on the dialysis machine as prescribed. On treatment date 04/18/2025, Patient #8’s BFR was prescribed for 400 ml/min. However, the BFR was set at 350 ml/min for the entire treatment. There was no documentation found explaining why Patient #8’s BFR was not set on the dialysis machine as prescribed. On treatment date 04/15/2025, Patient #10’s BFR was prescribed for 450 ml/min. However, the BFR was set at 440 ml/min from 11:00 a.m. to 01:23 p.m. There was no documentation found explaining why Patient #10’s BFR was not set on the dialysis machine as prescribed. The Director of Operations was informed of the findings on 04/25/2025.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 44367 Based on the patient record review and interviews with the facility’s administration, the governing body, and interdisciplinary team (IDT) failed to ensure that an initial comprehensive assessment has been conducted on all new patients within the latter of 30 calendar days, or 13 treatments beginning with the first outpatient dialysis session for both in-center and home dialysis. This failure placed the affected patients at potential risk of harm and denied the patients their rights. Patients: #2 and #5 Findings included: Review on 04/25/2025 of the facility’s policy entitled “Comprehensive Assessment and Plan of Care” revealed that “An initial comprehensive assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.” On 04/25/2025, review of the ten selected patients’ charts revealed two (2) or 20% of the selected patients’ charts did not contain an Initial Comprehensive Assessment (30-day). The charts revealed the following: 1.Patient #2 was admitted to the facility on 07/12/2022; However, there was no initial Comprehensive Assessment found in Patient 2’s paper or electronic chart. 2.Patient #5 was admitted to the facility on 08/05/2020; However, there was no initial Comprehensive Assessment found in Patient #5’s paper or electronic chart. The Director of Operations corroborated that Patient #2 and Patient #5 did not have an initial comprehensive assessment.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the facility’s administration failed to ensure that the clinical staff complied with the appropriate procedures when assessing the patients’ vascular access prior to and during the cannulation process. This failure placed the safety and well-being of the patients at potential risk of harm in maintaining their vascular access and/or infection. Staff: #4 Findings included: Review on 04/23/2025 of the facility’s policy entitled “Access Assessment and Cannulation” revealed that the staff must clean their “stethoscope with alcohol. Listen: Bruit high pitch/whistle; Do not touch cannulation sites after skin disinfection.” 1. Observation of the clinical treatment area on 04/23/2025 at 11:41 a.m. revealed that during treatment initiation at station 11, Staff #4 did not use a stethoscope to listen to the patient’s access prior to cannulation. Staff #4 touched the arterial portion of the access after the disinfection process and did not disinfect the access again prior to cannulation. The Director of Operations was informed of the findings on 04/23/2025.”