Fmc-Surratts Jv

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(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:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[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. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 44367 Based on inspection of the emergency evacuation box and binder, the facility’s administrative staff failed to maintain a current list of all its patients and staff for the purpose of tracking in the event of an emergency evacuation. The failure to provide an updated patient list could potentially result in a patient’s injury or harm in the event of an evacuation. Patients: All Patients Findings include: Review on 08/28/2025 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.” On 08/28/2025 at 11:00 a.m., the inspection of the facility’s emergency evacuation kit revealed that the kit did not contain a contact list for the in-center or home dialysis patients and did not have a contact list of its employees. The Charge Nurse corroborated that the kit did not contain any contact list of patients or employees.”

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(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:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. 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 enough supplies were available to provide care during an emergency evacuation. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency. Findings included: Review on 08/28/2025 of the facility’s policy entitled Emergency Medication, Equipment and Supplies” page 1 stated “Emergency Evacuation Box: An emergency evacuation box contains supplies primarily needed to emergently remove needles, cap catheters, and provide saline as needed for every licensed station once the patient is in a secure location.” On 08/28/2025 at 11:00 a.m., during inspection of the facility’s evacuation kit, the surveyor noted that the kit did not contain enough supplies to provide care for every licensed station. There were only four (4) packs of fistula needles, which will accommodate four (4) stations, but the facility has 18 stations. The emergency evacuation kit did not contain any supplies for the four (4) home training rooms. The Charge Nurse corroborated that the emergency evacuation kit did not have enough supplies for every licensed station or the home program rooms.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility 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. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44367 Based on observations, staff interviews, and record review, the facility’s administration and the Medical Director failed to ensure the home dialysis program had an emergency evacuation kit for its patients. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency evacuation. Findings included: Review on 08/28/2025 of the facility’s policy entitled Emergency Medication, Equipment and Supplies” page 1 stated “Emergency Evacuation Box: An emergency evacuation box contains supplies primarily needed to emergently remove needles, cap catheters, and provide saline as needed for every licensed station once the patient is in a secure location.” On 08/28/2025, an interview with the Home Dialysis Program Manager revealed that the emergency supplies for peritoneal dialysis patients and home hemodialysis patients are “supposed” to be kept in the in-center emergency evacuation kit. According to the in-center Clinical Manager, he/she is unaware that the home program supplies were to be kept with the in-center supplies. The In-center Clinical Manager and the Home Dialysis Program Manager both corroborated that the emergency evacuation kit did not contain supplies for home dialysis patients.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 44367 Based on review of the facility’s personnel files, and interviews with the facility’s administration, the governing body, medical director and facility’s administration failed to ensure that all the facility’s clinical staff maintain the Basic Life Support/Cardiopulmonary Resuscitation (BLS/CPR) card; and that fire drills were conducted per the facility’s policy. These failures denied patients their rights and posed a potential risk of harm to patients. Staff: #2 Findings include: Staff must maintain current CPR (Cardiopulmonary Resuscitation) certification for healthcare providers through a CPR provider whose training includes hands-on practice and in-person skills assessment; online-only certification is not acceptable. Occupational Safety and Health Agency (OSHA), institutions, and States, have determined that online-only certification is not acceptable. Review on 09/02/2025 of the “National CPR Foundation” revealed “Online training is a legal and acceptable form of training, however, NCPRF (Trademark) does not offer in-person training...Therefore, we cannot guarantee that our certification will be accepted in every situation.” Review of the facility’s personnel files on 09/02/2025 revealed that Staff #2 did not have an acceptable BLS/CPR certification. Staff #2 provided a card that stated “Certificate: Healthcare CPR/AED, Date: 8/30/2024, Renew: 8/30/2026. The surveyor asked Facility Administrator if the course was taken online only or online and in-person. The Clinical Manager informed the surveyor that they realized that Staff #2 did not possess an acceptable BLS/CPR card and removed Staff #2 from the schedule on 08/21/2025. The surveyor noted that Staff #2 has worked at the facility as a Patient Care Technician from 10/14/2024 until 08/21/2025 providing direct patient care without acceptable BLS/CPR training. The Clinical Manager corroborated that Staff #2 did not possess an acceptable BLS/CPR certification and Staff #2 was removed from the schedule until an updated BLS/CPR card is obtained. Review on 09/02/2025 of the facility’s policy entitled “Comprehensive Emergency/Fire Drill and Evaluation” revealed that “A fire drill is required to be conducted quarterly. Fire drills are conducted to ensure that the facility’s staff and patients are prepared in the event of a fire.” During review of the emergency preparedness binder on 09/02/2025, the surveyor noted that the binder did not contain evidence of quarterly fire drills. During an interview with the Clinical Manager, the surveyor was informed that the facility has not conducted fire drills and that they are working to correct the situation. The Clinical Manager corroborated the findings that facility did not conduct fire drills quarterly per facility’s policy.”

“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. Staff: #1 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 08/26/2025 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 08/26/2025 at 11:46 a.m. revealed that the venous external transducer and the pressure line on machine #19 at Station #9 were wet (filled with blood). Staff #1 did not clear the pressure line or replaced the transducer. The Clinical Manager was informed of the finding on 08/26/2025.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 44367 Based on clinical observations, the governing body failed to ensure that the clinical staff followed the standard regulations in the cleaning and disinfection of contaminated equipment being used in the facility. This failure put patients at risk for possible cross-contamination. Staff: #6 Findings included: Review on 08/27/2025 of the facility’s policy entitled “Prime Bucket Disinfection “ page 1 stated, “Dispose of saline solution down any marked dirty sink...Clean all surfaces of the prime bucket or approve receptacle, with 1:100 bleach solution or an approval 1:100 bleach disinfect wipe.” On 08/27/2025 at 11:34 a.m., observation of the clinical treatment area revealed that Staff #4 did not clean the prime bucket during the machine disinfection process at station #11. The Clinical Manager was informed of the findings on 08/28/2025.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 44367 Based on interviews with the Clinical Manager and review of the facility’s employee records, the governing body failed to ensure all its clinical staff were screened for hepatitis B virus and offered the vaccine if warranted. This failure placed the patients and staff at risk of acquiring hepatitis B virus. Staff: #1, #2, #3, #4, #5, #6, #7, #8, #9, and #10 Findings: Review on 09/02/2025 of the facility’s policy entitled, Employee Requirements for Testing and Vaccination for Hepatitis B” revealed, “The Hepatitis B vaccine shall be offered to all employees upon hire and rehire. Prior to vaccine administration, draw the hepatitis B antibody (anti-HBs) to determine susceptibility ...If susceptible, offer vaccine.” Review on 09/02/2025 of the facility’s Personnel File revealed that 10 out of the 15 employees or 67% did not have hepatitis B antibodies drawn to determine susceptibility upon hire or rehire. The staff without documented antibodies are: · Staff #2’s hire date was 10/14/2024 · Staff #3’s hire date was 11/04/2002 · Staff #4’s hire date was 05/07/2001 · Staff #5’s hire date was 01/12/2025 · Staff #6’s hire date was 07/26/2021 · Staff #7’s hire date was 06/01/2020 · Staff #8’s hire date was 7/13/1998 · Staff #9’s hire date was 12/20/2012 · Staff #10’s hire date was 03/03/2025 Three (3) out of the 15 employee’s hepatitis B antibodies were <10 (less than10) and resulted on 08/26/2025. No documentation was provided showing that the staff was offered the vaccine. The staff less than 10 were: · Staff #1’s hire date was 04/01/2024 · Staff #11’s hire date was 04/12/2009 · Staff #12’s hire date was 08/19/2024 The Clinical Manager corroborated that the facility has not checked staff hepatitis B antibodies and did not offer the hepatitis B vaccine to staff who were <10.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 44367 Based on clinical observations and interviews with the administrative staff, the facility’s governing body failed to ensure that the medications being administered to patients were handled medication according to its own policy. This failure placed the patients at potential risk. Findings Included: Review on 08/28/2025 of the facility’s policy entitled “Medication Preparation and Administration” stated “When preparing medications, if the vial is not used immediately in its entirely, the nurse or PCT (if allowed by state regulations), must place the date and time the vial was open on the medication label along with their initials ...Label any open multi-dose vial that is not used immediately and store vial accordingly.” The policy also states, “Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol.” On 08/28/2025, during observation of the clinical treatment area, the surveyor noted that Staff #1 drew up four syringes from a multidose vial of Heparin; However, Staff #1 did not clean the diaphragm with alcohol before each needle insertion. Staff #1 did label the approximately half full opened multidose vial of Heparin once he/she had finished drawing up the four syringes. The Clinical Manager was informed of the findings.”

“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: #4 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 “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.” Observation of the clinical treatment area on 08/27/2025 at 11:16 a.m. revealed that during initiation of treatment at station 13, Staff #4 cleaned catheter exit site for eighteen (18) seconds and only allowed the site to dry for 30 seconds before placing a clean dressing. Staff #1 scrubbed the arterial hub for six (6) seconds and the venous hub for six (6) seconds. The Clinical Manager was informed of the findings on 08/27/2025.”

“IC-MONITOR CATH-RELATED BSI RATES/SURV CFR(s): 494.30(a)(2) Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. I. Surveillance A. Conduct surveillance ...to determine CRBSI rates, monitor trends in those rates, and assist in identifying lapses in infection-control practices. C. Investigate events leading to unexpected life-threatening or fatal outcomes. This includes any process variation for which a recurrence would likely present an adverse outcome. This Standard is not met as evidenced by: 44367 Based on review of the facility’s National Healthcare Safety Network (NHSN) reports and patient medical records, the medical director and the governing body failed to include all information regarding the use of antibiotics for effective surveillance. The failure place patients at risk for ineffective care related to infections. The Dialysis Module of the National Healthcare Safety Network (NHSN) is reported monthly and should contain detailed information on individual patients for effective surveillance and tracking of infections and infection control practices. On 09/02/2025, review of the NHSN event reports revealed the following: · The report for February 2025 revealed a “continuation of antimicrobial” showing both Gentamicin Sulfate and Vancomycin HCI was given on 02/25/2025, 02/27/2025, 03/01/2025, 03/04/2025, 03/06/2025, 03/08/2025, 03/11/2025 (only Vancomycin HCI was given), 03/13/2025, 03/15/2025, and 03/18/2025. The section labeled “was blood sample collected for culture”, the response was “no”; The section labeled “Problem(s) to be reported”, the response was “none”; The section that labeled “Pathogen”, the response box was left blank. · The report for February 2025 revealed a “continuation of antimicrobial” showing both Gentamicin Sulfate and Vancomycin HCI was given on 02/17/2025, 02/19/2025 and 02/21/2025.The section labeled “was blood sample collected for culture”, the response was “no”; The section labeled “Problem(s) to be reported”, the response was “none”; The section that labeled “Pathogen”, the response box was left blank. · The report for July 2025 revealed a “new antimicrobial Start” showing Vancomycin was given 07/26/2025, 07/29/2025 and 07/31/2025. The section labeled “was blood sample collected for culture”, the response was “no”; The section labeled “Problem(s) to be reported” the response was “none”; The section labeled “Pathogen”, the response box was left blank. · The report for July 2025 revealed a “new antimicrobial Start” showing Cefazolin was given on 06/02/2025, 06/04/2025, 06/06/2025, 06/09/2025, 06/11/2025, 06/13/2025, 06/16/2025, 06/18/2025, 06/20/2025, 06/23/2025, 06/25/2025, and 06/27/2025. The section labeled “was blood sample collected for culture”, the response was “no”; The section labeled “Problem(s) to be reported”, the response was “none”; The section labeled “Pathogen”, the response box was left blank. · The report for July 2025 revealed a “continuation of antimicrobial” showing Ceftazidime was given on 06/13/2025, 06/16/2025, 06/18/2025, 06/20/2025, 06/23/2025, and 06/25/2025. The section labeled “was blood sample collected for culture”, the response was “no”; The section labeled “Problem(s) to be reported”, the response was “none”; The section that labeled “Pathogen”, the response box was left blank. There was no justification for the given antibiotics provided for the NHSN reporting. The Surveyor asked the Clinical Manager why the documentation was incomplete, the response was “I don’t know.” The Clinical Manager corroborated that the NHSN reports were incomplete. (Cross-referenced with V0637)”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 44367 Based on observations of the facility’s brine tank and a review of the facility’s policies and procedure, the facility’s administration and the medical director failed to ensure that the salt level of the brine tank was maintained according to its policy. This failure placed the patients at potential risk for harm. Findings include: Review on 08/26/2025 of the facility’s policy entitled “Water Softener Policy” page 4 stated, “At a minimum, the facility staff will monitor and document water softener(s) for the following each operational day: Check the brine tank daily to be sure the tank is at least half filled with salt, adding salt pellets if necessary.” On 08/26/2025 at 10:30 a.m. during the flash tour it revealed that the brine tank was less than half full. On 09/02/2025 at 12:00 p.m., inspection of the water room revealed that the brine tank was less than ¼ full. The Clinical Manager observed and corroborated that the brine tank was less than ¼ full.”

“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 water treatment room components were free of defects. 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: Review on 08/26/2025 of the “American Journal of Kidney Diseases” revealed, “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.” During inspection of the water treatment room on 08/26/2025, the surveyor observed: “ An active drip appeared to be coming from a component of the water system. The drip created a large amount of water pooling on the floor. The water had a thick black and brownish colored border. According to the Clinical Manager, the component has been dripping for “at least a week.” During an interview with the Biomedical Technician the surveyor was informed that the leak was coming from the “Diaphragm Valve” and that they just learned about the drip one day ago (08/25/2025). The Clinical Manager and the Biomedical Technician both corroborated that the diaphragm valve was leaking.”

“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, and a review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the facility was free of expired supplies. This failure placed the patients at potential risk of harm. Findings include: When supplies are no longer needed, they should be disposed of promptly. Healthcare providers should remove expired medications and supplies as quickly as possible to help reduce the chances that others accidentally receive or intentionally misuse them. Review on 08/26/2025 of the facility’s policy entitled “Storage of Supplies” page 1 states “Appropriately dispose of items that have reached the expiration date.” Observations of the supply room on 08/26/2025 revealed the following expired supplies: · Twelve (12) bottles of Step 1 Isopure, lot number 24EC001, expired 05/2025. · Three (3) bottles of Step 2 Isopure, lot number 24GC002, expired 07/2025. · One (1) box of 200 count of Cotton Tipped applicators, lot number 94367, expired 11/07/2024. · One (1) box of 22-gauge TB Safety Syringe with fixed needle, lot number 05003003, expired 03/05/2025. · Seven (7) Suture Removal kits, lot number 23BBC732, expired 02/28/2025. Observation of the Home dialysis PD room #1 revealed: · Four (4) Yellow top test tubes, lot number 4011426, expired 07/31/2025 · Four (4) Wound swabs, lot number 3F23A, expired 06/23/2025. Observation of the Home dialysis PD room #1 revealed: · One (1) 21-gauge Vacutainer Blood Collection set, lot number 2E1311, expired 05/31/2025. · One (1) Suture Removal Tray, lot number 23BBL735, expired 02/28/2025 On 08/28/2025, observation of the facility’s clinical treatment area revealed: · Five (5) Transparent Dressings, lot number 948998, expired 12/2024. · Two (2) 16-gauge Hemodialysis Fistula Needles Sets, lot number 210220F8, expired 02/29/2024. · One (1) 17-gauge Hemodialysis Fistula Needle Sets, lot number 181226371, expired 12/26/2023. · One (1) Hemodialysis Fistula Needle Sets, lot number 130902641, expired 09/2018. · Fifteen (15) Crit-line Blood Chamber, lot number 215R0113, expired 12/03/2024. · One (1) 15-guage Hemodialysis Fistula Needle Sets, lot number 210705F3, expired 07/01/2023. · One (1) 16-guage Hemodialysis Fistula Needle Sets, lot number 180701381, expired 07/01/2023. On 08/28/2025, observation of the facility’s lab area revealed: · Five (5) lime green top C&S Boric Acid Tube, lot number 3160420, expired 12/31/2024. · Ten (10) lime green top C&S Boric Acid Tube, lot number 3191175, expired 01/31/2025. · Nineteen (19) lime green top C&S Boric Acid Tube, lot number 3227753, expired 02/25/2025. · Sixteen (16) Urine Analysis Preservative Tubes, lot number 3289186, expired 04/30/2025. · Two (2) Dialysis Center Transplant blood tubes, lot number 7485, expired 02/28/2025. · Two (2) Dialysis Center Transplant blood tubes, lot number 7485, expired 02/28/2025. The Clinical Manager and the Home Program Manager were informed of the findings on 08/26/2025 and 08/28/2025.”

“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’ first dialysis treatment when being admitted to the facility. This failure placed the affected patients at risk for harm and/or death. Patients: #6, #7, #9, #10, and #11 Findings included: Review on 08/28/2025 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 eleven (11) selected home and in-center hemodialysis patients’ medical records on 08/28/2025, the surveyor noted that four (4) out of the eleven (11) or 37% of the selected patients’ paper or electronic charts did not contain an initial nursing assessment or the assessment was incomplete or late. The assessment should have been completed prior to the patient being placed on the dialysis machine on the day of admission. Patient #6 was admitted to in-center dialysis on 2/25/2025. An initial nursing assessment was done on 02/25/2025; however, the assessment was incomplete. Patient #7 was admitted to in-center dialysis on 02/07/2024. An initial nursing assessment was done on 02/07/2024; however, the assessment was incomplete. Patient #9 was admitted to home dialysis on 11/06/2017. An initial nursing assessment was not found in Patient #9’s paper or electronic chart. Patient #10 was admitted to home dialysis on 11/06/2017. An initial nursing assessment was not found in Patient #9’s paper or electronic chart. Patient #11 was admitted on home dialysis on 12/02/2024. An initial nursing assessment was done on 12/18/2024 which is 16 days after Patient #11 was admitted. The Home Program Dialysis Manager and the In-center Clinical Manager were given the opportunity to provide additional information. Both corroborated that some patients did not have an initial nursing assessment completed, the assessment was late, or the assessment was incomplete.”

“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: #2, #3, #5, and #8 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 eleven (11) selected patients’ treatment flowsheets on 08/27/2025 revealed that four (4) of the selected patients did not receive the correct dialysis prescription as ordered by the Nephrologist. On treatment date 07/30/2025, Patient #2’s BFR was prescribed for 350 ml/min. However, the BFR was set at 365 ml/min from 07:04 a.m. to 07:22 a.m. There was no documentation found explaining why Patient #2’s BFR was not set on the dialysis machine as prescribed. On treatment date 07/30/2025, Patient #2’s BFR was prescribed for 350 ml/min. However, the BFR was set at 300 ml/min from 07:01 a.m. to 07:52 a.m. There was no documentation found explaining why Patient #2’s BFR was not set on the dialysis machine as prescribed. On treatment date 08/25/2025, Patient #3’s BFR was prescribed for 450 ml/min. However, the BFR was set at 350 ml/min from 06:06 a.m. to 07:09 a.m. There was no documentation found explaining why Patient #3’s BFR was not set on the dialysis machine as prescribed. On treatment date 08/25/2025, Patient #5’s BFR was prescribed for 400 ml/min. However, the BFR was set at 350 ml/min from 06:37 a.m. and then 340 ml/min from 09:28 a.m. to 10:26 a.m. There was no documentation found explaining why Patient #5’s BFR was not set on the dialysis machine as prescribed. On treatment date 08/09/2025, Patient #8’s BFR was prescribed for 400 ml/min. However, the BFR was set at 325 ml/min from 11:51 a.m. to 12:38 p.m.; 300 ml/min from 01:34 p.m. to 02:08 p.m.; 250 ml/min from 02:08 p.m. to 03:08 p.m.; and then 265 from 03:36 p.m. to 04:08 p.m. There was no documentation found explaining why Patient #8’s BFR was not set on the dialysis machine as prescribed. On treatment date 08/07/2025, Patient #8’s BFR was prescribed for 400 ml/min. However, the BFR was set at 350 ml/min from 01:03 p.m. to 01:30 p.m. and then 350 ml/min from 02:33 p.m. to 03:23 p.m. There was no documentation found explaining why Patient #8’s BFR was not set on the dialysis machine as prescribed. The Clinical Manager was informed of the findings on 08/27/2025.”

“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 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. This failure placed the affected patient at potential risk of harm and denied the patients their rights. Patients: #5, #7 and #11 Findings included: Review on 08/28/2025 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 08/28/2025, review of the eleven (11) selected home dialysis and in-center patients’ charts revealed three (3) of the selected patients did not have an Initial Comprehensive Assessment or the assessment was completed late. The charts revealed the following: Patient #5 was admitted to in-center dialysis on 01/13/2025. Patient #5 initial Comprehensive Assessment was completed on 04/02/2025. The assessment was not completed within 30 days or 13 treatments. Patient #7 was admitted to the facility on 02/07/2024; However, no initial Comprehensive Assessment was found in Patient 7’s paper or electronic chart. Patient #11 was admitted to in-center dialysis on 12/02/2024. Patient #11 initial Comprehensive Assessment was completed on 03/21/2025. The assessment was not completed within 30 days or 13 treatments. The home dialysis Program Manager and the in-center Clinical Manager were given the opportunity to provide additional information. Both corroborated that some patients did not have a initial nursing assessment completed, the assessment was late, or the assessment was incomplete.”

“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 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. This failure placed the affected patient at potential risk of harm and denied the patients their rights. Patients: #5, #7 and #11 Findings included: 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: #1 and #3 Findings included: Review on 08/27/2025 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.” Observation of the clinical treatment area on 08/27/2025 at 11:02 a.m. revealed that during treatment initiation at station 7, Staff #3 did not use a stethoscope to listen to the patient’s access prior to cannulation. Staff #3 touched the arterial portion of the access after the disinfection process and did not disinfect the access again prior to cannulation. Observation of the clinical treatment area on 08/27/2025 at 11:05 a.m. revealed that during treatment initiation at station 9, Staff #1 did not use a stethoscope to listen to the patient’s access prior to cannulation. The Clinical Manager was informed of the findings on 08/27/2025.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 44367 Based on in-center and home dialysis patient records review and interviews with the facility’s staff, the interdisciplinary team (IDT) members (physician, nurse, dietician and social work); facility administration, medical director, and governing body failed to ensure that all patients were invited to participate in their plan of care (PoC) meetings. This failure denied patients’ rights and placed the patients at risk for receiving insufficient and ineffective care. Patients: #3, #9 and #10 Findings included: Review on 08/28/2025 of the facility’s policy entitled “Comprehensive Interdisciplinary Assessment and Plan of Care” stated, “Notify the patient in writing of the time and date of the Plan of Care review ...The patient must sign the plan of care meant to acknowledge the information in the plan. If the patient chooses not to sign their plan of care, the reason for refusal must be documented on the patient’s medical record.” On 08/28/2025, review of PoC for the eleven (11) selected patients revealed that three (3) of the patients were missing the patients’ signatures acknowledging active participation in their own individual care. The missing signatures are as follows: · Patient #3’s 90-day PoC dated 02/07/2025 was not signed by Patient #3. There was no documentation stating why the patient did not sign. · PD Patient #9’s annual PoC dated 04/11/2025 was not signed by Patient #9. There was no documentation stating why the patient did not sign. PD Patient #10’s 30-day PoC dated 03/25/2025 was not signed by Patient #10; Patient #10’s 90-day PoC dated 07/25/2025 was not signed by Patient #10. There was no documentation stating why the patient did not sign the 30-day and the 90-day PoCs. The Clinical Manager and the Home Program Manager were given the opportunity to provide additional documentation. Clinical Manager and the Home Program Manager both corroborated that the patients did not sign their PoCs.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 44367 Based on review of the Quality Assessment and Performance Improvement (QAPI) meeting minutes and data, and review of the agency’s policies and procedures, the governing body and the Medical Director failed to ensure the facility’s interdisciplinary team (IDT) analyze, track and create action plans related to infections. This failure denied patient effective and safe dialysis which placed the patients at risk for harm. Findings include: The facility is responsible for recording and following up on all patient infections and serious adverse events. The occurrence of these events should be recorded using a centralized logbook or other tracking mechanism and regularly reviewed, with documentation of actions taken. Surveillance information available for review should include, but not be limited to, bacteremia episodes; pyrogenic reactions; vascular access infections; and vascular access loss due to infection. Surveillance information must include at a minimum, the date of infection onset, site of infection, full identification of infecting organism(s), and antimicrobial susceptibility results. The Dialysis Module of the National Healthcare Safety Network (NHSN) is reported monthly and should contain detailed information of individual patients (unidentified) for effective surveillance and tracking of infections and infection control practices. Review on 09/02/2025 of the facility’s QAPI documentation from January 2025 to August 2025 revealed the facility had insufficient documentation for Infections. There was a lack of documentation for a root cause, developed action plan and evidence of tracking patient data for infections. Review on 09/02/2025 of the facility’s NHSN reports revealed that the facility administered antibiotics in the months of February 2025, March 2025, June 2025, and July 2025; However, the reports did not contain pertinent information to efficiently track infections which are used for QAPI reporting. There was no justification for the given antibiotics provided on the NHSN reports. The Surveyor asked the Clinical Manager why the documentation was incomplete, the response was “I don’t know.” The Clinical Manager corroborated that the facility did not track and trend to create action plans related to infections. (Cross-referenced with V0148)”

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. This Standard is not met as evidenced by: 44367 Based on review of the governing body and Quality Assessment and Performance Improvement (QAPI) meeting minutes and data, interviews with the facility’s administrative staff, the governing body and the Medical Director failed to ensure that the facility had its own full-time Nurse Manager (Registered Nurse) to be responsible for nursing services. This failure placed patients at risk for receiving insufficient and ineffective care and denied the patients their rights. Findings include: The nurse manager must be a Registered Nurse and is Responsible for nursing services provides oversight and direction to all direct care staff that provide dialysis and nursing care in the facility. This includes input into hiring, evaluating, and terminating these staff. Two or more qualified nurses may share this responsibility, but the facility must designate one of these nurses as primarily responsible. Review on 09/02/2025 of the Maryland state COMAR 10.30.02.04C (1) (a) revealed, “(1) Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility that: (a) Is a full-time employee of the facility ...” 09/02/2025, an interview with the Clinical Manager revealed that he/she serves as the only Nurse Manager for two facilities. The Clinical Manager stated that he/she is currently covering for the facility because they do not have a clinical manager. The facility does not have a second nurse to share responsibility at either clinic. The Clinical Manager and the Director of Operations corroborated that the Clinic does not have a full-time Nurse Manager assigned to the facility to oversee the patient population.”