Fresenius Kidney Care Germantown

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to reassess the facility and community based all-hazards risk assessment. This failure placed the patients and staff at potential risk of harm in case of an emergency. Findings Included: On 09/13/2024 at 12:00 p.m., review of the facility’s policy titled “Guidelines for Emergency Preparedness” (Reference Number: 25907) page 2 under Disaster Risk Assessment stated, “The Interdisciplinary Team (including the Medical Director) led by the Director of Operations will annually complete the Hazard Vulnerability Assessment (HVA) spreadsheet identifying hazardous events that may affect clinic operations.” On 09/12/2024 from 11:30 a.m. -12:30 p.m., during review of the facility’s emergency preparedness binder and agreements binder. The surveyor observed that the last facility and community based all-hazards risk assessment was completed on 06/25/2021. Interviews with the Clinical Manager confirmed the information above.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 47759 Based on observations and record review, the facility’s governing body failed to provide a community based emergency preparedness training related to the facility’s risk assessments as well as conduct an effective facility based emergency preparedness training. This failure placed the patients and staff at potential risk of harm in case of an emergency. Findings Included: On 09/13/2024 at 12:00 p.m., review of the facility’s policy titled “Guidelines for Emergency Preparedness “ (Reference Number: 25907) page 3 stated, “Annually, each facility must participate in a community-based disaster drill. In addition to the community drills, facilities must select an event of high likelihood and conduct a table-top drill. It is recommended a different drill be completed annually.” On 09/12/2024 from 11:30 a.m. -12:30 p.m., during review of the facility’s emergency preparedness binder and agreements binder.The surveyor observed that (1) the emergency preparedness training conducted on 01/12/2024 did not have information that discussed the evaluation of the effectiveness of the training. (2) Of the 19 full time clinical staff members disclosed, only 7 attended the training. (3) The facility could not present a community based disaster drill.”

“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: 47759 Based on observations and a staff interview, the facility’s governing body failed to provide a clean area for medication preparation.This failure increased the risk of cross contamination and placed patients at potential risk for exposures to infectious diseases. Findings Included: Clean supplies should not be near areas of splashing water (e.g., within 3 feet of a sink). According to the American Society for HealthCare Engineering (ASHE) in partnership with the Centers for Disease Control and Prevention, “Best practices related to the design of hand hygiene facilities include: Ensure adequate space between areas used for medical preparation and use splash guards where appropriate.” On 09/10/2024 at 10:05 a.m., during observations of the treatment floor, the surveyor observed that the Medication preparation area was set up adjacent to the hand wash sink. The Clinical Manager stated that the medication preparation area adjacent to the hand wash sink posed a cross contamination concern.”

“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: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures the facility put in place to prevent intravascular catheter-related infections. This failure placed patients at potential risk of infection. Findings Include: On 09/13/2024 at 12:00 p.m., review of the facility’s policy titled “Initiation of Treatment Using a Central Venous Catheter (CVC)” (Reference Number: 45651) page 3 number 9 step numbers 3 to 4 states “Using a sterile alcohol pad scrub the sides and end of the hub thoroughly with friction...using the same sterile alcohol pad applying friction to remove any blood or residue, move from the hub at least several centimeters towards the body of the catheter (Steps 3 and 4 should take 10-15 seconds). “ On 09/10/2024, during observations of the treatment floor, the surveyor observed the following: 1. At 11:45 a.m., during CVC termination of Patient D, the surveyor observed Staff #1 failed to disinfect the hub before attaching the CVC cap back on. 2. At 12:30 p.m., during CVC initiation of Patient E, the surveyor observed Staff #1 failed to disinfect the hub before starting treatment”

“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: 47759 Based on observations, review of facility’s policy, and interviews with the home program manager, the facility’s governing body failed to ensure that all patient supplies used for dialysis treatment were maintained in a manner that provided for patient safety. This failure denied patients their rights to a minimum standard of medical care Findings included: According to the Food and Drug Administration (FDA), Drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality and purity when it is stored according to its labeled storage conditions. On 09/10/2024 at 10:45 a.m., during observations of the home program training rooms, the surveyor observed the following: 1. Inside treatment room number 3 (three), 1(one) set of next stage fluid warmer disposable line tube sets with lot number 20979285 with an expiration date of 08/20/2024 was found inside the cabinets. This finding was witnessed by the Home Program Manager. 2. Inside treatment room number 4 (four), 4 (four) sets of next stage fluid warmer disposable line tube sets with lot number 20979285 with an expiration date of 08/20/2024 were found inside the cabinets. This finding was witnessed by the Home Program Manager.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 47759 Based on observation and staff interviews, the facility’s governing body failed to display an updated copy of patient’s rights including contact information for the state survey agency and End Stage Renal Disease Network in a visible and accessible area in the facility. This failure denied patients their right to be aware of external ways to file grievances. Findings Included: On 09/10/2024 at 10:50 a.m.,during the facility’s flash tour led by the Home Program Manager, the surveyor observed that the contact information for the State Agency and the facility staff members were outdated and were no longer accurate. Interviews with the Home Program Manager stated that the information will have to be updated.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 47759 Based on record review, observation and staff interviews, the facility’s governing body failed to ensure that the clinical staff members complied with the facility’s monitoring protocol put in place for monitoring of arteriovenous grafts and fistulas. This failure places patients at risk for late detection of access failure. Findings Included: On 09/13/2024 at 12:00 p.m., review of the facility’s policy titled “ Access Assessment and Cannulation “ (Reference Number: 45178) page 2 number 5 under Look, it stated, “ Skin discoloration / redness / bruising / lesion / hematomas / new or change in aneurysm or pseudoaneurysm, poor rotation of cannulation sites...any other unusual findings. Document in treatment record.” 1. On 09/12/2024 at 11:00 a.m., during staff interviews, Staff #1 indicated that Patient #1’s access site was enlarged and looked like a hematoma. a. On 09/13/2024 at 11:30 a.m., review of Patient A’s treatment flowsheet for 09/12/2024 stated “No unusual findings.” 2. On 09/13/2024 at 11:15 a.m., during staff interviews, the Clinical Manager indicated that Patient B’s access site has thinning that could possibly result from poor cannulation rotation. a. On 09/13/2024 at 11:40 a.m., review of Patient B’s treatment flowsheet for 09/12/2024 stated “No unusual findings.” 3. On 09/13/2024, interviews with Staff #4 stated that per policy, any unusual findings must be documented in the treatment record.”

“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: 47759 Based on record review and a staff interview, the facility’s governing body failed to ensure that the interdisciplinary team (IDT) members, including the patient or the patient’s designee met as a team and signs the plan of care; or if the patient chooses not to sign the plan of care, choice be documented on the plan of care, along with the reason the signature was not provided. This failure denied the affected patients their rights to a minimum standard of medical care. Findings Included: On 09/13/2024 at 12:00 p.m., review of the facility’s policies and procedure titled “Comprehensive Interdisciplinary Assessment and Plan of Care” (Reference Number: 45283) page 7 stated, “ 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 remote at the time of review, signature may be obtained at a later date.” On 09/11/2024 from 09:00 a.m. -11:00 a.m., during review of the selected patient’s medical record review, the surveyor observed that the following plan of care did not have a documented patient’s signature acknowledging that the patient agrees with the plan nor a patient signature refusing the meeting. 1. Patient E’s Plan of Care dated 11/2023, 02/2024 through 04/2024 did not have a documented patient plan of care meeting acknowledgement or refusal 2. Patient F’s Plan of Care dated 09/2022, 12/2022, 01/2024 through 04/2024 did not have a documented patient plan of care meeting acknowledgement or refusal 3. Patient G ‘s Plan of Care dated 09/2023 and 01/2024 did not have a documented patient plan of care meeting acknowledgement or refusal 4. Patient H’s Plan of Care dated 09/2023 and 01/2024 did not have a documented patient plan of care meeting acknowledgement or refusal 5. Patient I ‘s Plan of Care dated 08/2024 did not have a documented patient plan of care meeting acknowledgement or refusal 6. Patient J ’ s Plan of Care dated 04/2024 did not have a documented patient plan of care meeting acknowledgement or refusal At 11:30 a.m., interviews with the Clinical Manager stated that moving forward, the facility staff members will obtain a plan of care patient signature.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47759 Based on observations, staff interviews and review of the facility’s policies and procedures, the medical director and the facility’s governing body failed to ensure that the staff adhered to their own policies and procedures. This failure posed a potential risk of safety to the patients, and denied patients their rights to a minimum standard of medical care Findings Included: 1. On 09/12/2024, review of the facility’s emergency preparedness binder revealed failure to reassess the facility and community based all-hazards risk assessment. This finding failed to meet the facility’s policy titled “Guidelines for Emergency Preparedness “ (Reference Number: 25907) 2. On 09/12/2024, review of the facility’s emergency preparedness binder revealed failure to provide a community based emergency preparedness training. This finding failed to meet the facility’s policy titled “Guidelines for Emergency Preparedness “ (Reference Number: 25907) 3. On 09/10/2024, observations revealed incompliance with the facility based catheter care technique. This finding failed to meet the facility’s policy titled “Initiation of Treatment Using a Central Venous Catheter” (reference number: 45651) 4. From 09/12/2024- 09/13/2024, observations, interviews and record reviews revealed incompliance with the facility ’ s vascular access ’ monitoring protocol. This finding failed to meet the facility ’ s policy titled “Access Assessment and Cannulation” (Reference Number: 45178) 5. On 09/11/2024, record review of the selected patients ’ medical record revealed no signature page with patient ’ s acknowledgement of acceptance of the plan of care. This finding failed to meet the facility ’ s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” (Reference Number: 45283) 6. On 09/10/2024, observations and staff interviews revealed that direct patient care staff members were utilizing Cryodose Anesthetic Spray upon patient request and without a physician’s order. This finding failed to meet the facility’s policy titled “CryoDose TA Topical Anesthetic Spray.” (Reference Number: 69007)”