Lake Plains Dialysis at Batavia

“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: 40430 Based on observation, policy review and interview, the facility failed to ensure that staff followed standard infection control practices regarding the use of gloves and hand hygiene. Failure to follow standard infection control practices places patients and staff at risk for potential infection. Findings Include: Observation on the treatment floor on 01/23/24 revealed the following: - At 10:55 AM at Station #2, Staff (K), Patient Care Technician, removed the bloodlines for Patient #6 from the machine, exited the station, retrieved clean disinfectant wipes from the common supply area, returned to Station #2 and began wiping down the machine. Staff (K) did not remove gloves or preform hand hygiene prior to exiting the station to retrieve clean supplies. - At 11:50 AM, Staff (H), Registered Nurse, exited Station #8 and removed gloves. Staff (H) retrieved a clean glove from the clean supply cart, wrapped the glove around a finger, entered Station #10 and touched the machine for Patient #1. Staff (H) then discarded the glove in the garbage and retrieved another glove from the common supply wall shelf and proceeded to Station #12 to confirm/check machine settings with a gloved left hand and assess Patient #7. Staff (H) exited station #12 and discarded the glove. Staff (H) then went to Station #7 to assess Patient #5. Staff (H) touched Patient #5’s ankles and auscultated (listened to) breath sounds with the stethoscope. Staff (H) then applied clean gloves and touched the machine at Station #7. Staff (H) then exited Station #7, discarded the gloves in the garbage can and proceeded to the nurse’s station. Staff (H) proceeded to draw up heparin for Patient #5 inside the nurse’s station. Staff (H) returned to Station #7, applied clean gloves, and attached the heparin to the machine. Staff (H) exited the station, discarded the gloves, and then grabbed a sharpie from the common supply cart, and labelled an acid jug at Station #8. Staff (H) did not perform hand hygiene after each glove change. - At 11:40 AM, Staff (K) Patient Care Technician, strung lines (set up dialysis machine for a new patient) at Station #11 with gloved hands. Staff (K) exited the station and grabbed a clean glove from the common supply area and wrapped the new clean glove around their already gloved hand, entered Station #10, touched the machine for Patient #1, exited Station #10, discarded the glove in the garbage, and returned to Station #11 without changing gloves or performing hand hygiene. Observation on the treatment floor on 01/24/24 revealed the following: - At 12:00 PM, at Station #7, Staff (O), Registered Nurse, with gloved hands, was opening supplies, on the chairside tray table, to initiate treatment via fistula of Patient #30. Staff (O) cleansed the fistula site and primed the needles with normal saline. Staff (O) changed gloves but did not perform hand hygiene. After cannulating and initiating treatment Staff (O) removed their gloves and gown without performing hand hygiene and exited the unit. - At 12:20 PM at Station #11 Staff (K), with gloved hands, took Patient #32’s temperature and pulled out the footrest on the chair. Staff (K) removed their gloves but did not perform hand hygiene. Review of policy “Departmental Infection Control Practice Guidelines,” effective 11/15/19 indicated to wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station; remove gloves and wash a hands with medicated soap between each patient and station. Approved hand sanitizer may be used in lieu of hand washing as long as there is no visible blood on the equipment or machine. Interview on 01/25/24 at 11:15 AM with Staff (A) Nurse Manager and Staff (L) Facility Administrator confirmed this finding.”

“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: 40430 Based on observation, policy review, and interview, staff did not wear personal protective equipment, as required. Specifically, impervious gowns were not fastened/protective from the neck to the thigh area, and eye protection was not worn when performing procedures during which spurting or spattering of blood might occur. Findings Include: Observations on the treatment floor revealed the following staff did not fasten their gowns neck to thigh area while initiating and discontinuing dialysis, stripping the dialysis machines of bloodlines and dialyzers, while cleaning the machines and stations following patient treatments, and stringing/setting up the machines for patient treatments as follows: - On 01/23/24 from 10:20 AM to 12:25 PM Staff (H) Charge Registered Nurse, Staff (I) Registered Nurse, Staff (G) Registered Nurse, Staff (J) Licensed Practical Nurse, Staff (F) Patient Care Technician, and Staff (K) Patient Care Technician. - On 01/24/24 from 10:10 AM to 12:15 PM Staff (A) Nurse Manager, Staff (O) Registered Nurse, Staff (N) Licensed Practical Nurse, Staff (P) Licensed Practical Nurse, and Staff (K) Patient Care Technician. - On 01/25/24 from 11:30 AM to 12:30 PM Staff (A) Nurse Manager, Staff (G) Registered Nurse, Staff (J) Licensed Practical Nurse, Staff (P) Licensed Practical Nurse, Staff (F) Patient Care Technician, and Staff (K) Patient Care Technician. Observations on 01/24/24 the treatment floor revealed the following staff lacked eye protection while discontinuing dialysis as follows: at 10:10 AM, Staff (P) Licensed Practical Nurse, while discontinuing dialysis treatment for fistula Patient #6 at Station #2, at 10:35 AM, Staff (A) Nurse Manager, while removing arteriovenous access clamps for fistula Patient #34 at Station #16 and at 10:45 AM, Staff (A), Nurse Manager, while discontinuing dialysis treatment for fistula Patient #35 at Station #7. Review of policy “Departmental Infection Control Practice Guidelines,” effective 11/15/19, revealed all staff are to wear impervious lab coats while doing direct patient care when at risk of exposure to blood and blood products. Face and eye protection must be worn when performing tasks where the employee will be at risk of exposure to blood and blood products. Masks with attached face shields, masks and goggles, or face shield and mask are acceptable. The employee must cover eyes, nose, and mouth at all times when at risk for exposure. Personal eyeglasses are not considered personal protective equipment. Review of policy “Termination of Hemodialysis” effective 08/18/09 indicates required equipment for termination of treatment include impervious lab coat, mask and eye protection. Interview on 01/25/24 at 11:15 AM with Staff (A) Nurse Manager and Staff (L) Facility Administrator confirmed this finding.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 40430 Based on observations, policy review, and interview, staff do not disinfect items before taking them back to a common area or between each patient. This lapse in disinfection places staff and patients at risk for transmission of bloodborne pathogens and facility acquired infections. Findings Include: Observations on 01/23/24 from 10:20 AM to 12:25 PM, and 01/24/24 from 10:10 AM to 12:15 PM revealed staff did not disinfect the “black” and “green” order folders located on the mobile chairside tray tables in the dialysis station, prior to removing them from the dialysis station and placing them back at the nursing station after each patient treatment. Observations on the treatment floor 01/23/24 revealed the following: - At 11:50 AM, Staff (H) Registered Nurse, brought two pre-filled heparin syringes for Patient # 9 to Station #8 and placed both syringes on the chair side table. Staff (H) strung one of the syringes to the dialysis machine and initiated dialysis treatment. Staff (H) then exited Station #8 with the other pre-filled syringe and placed the syringe in the nursing station medication prep area. Staff (H) then retrieved the Phoenix meter from the wall shelf at the end of the pod (Pod 2), returned to Station #8 and tested the dialysate. Staff (H) exited Station #8 and returned the meter back to the wall shelf. Staff (H) did not disinfect the syringe or the Phoenix meter prior to exiting the station. - At 12:00 PM, Staff (H), Registered Nurse, retrieved a sharpie marker from the common supply cart, entered Station #8 and labelled an acid concentrate jug that was connected to the dialysis machine. Staff (H) exited the station and returned the sharpie marker to the common supply cart located in the center of the pod without cleaning and/or disinfecting the marker. Observations on 01/24/24 at 10:15 AM at Station #2 with Patient #20, at 10:30 AM at Station #4 with Patient #22, and at 12:15 PM at Station #1 with Patient # 26 revealed Staff (P), Licensed Practical Nurse, did not clean and disinfect the stethoscope as Staff (P) moved between patients. Review of policy “Departmental Infection Control Practice Guidelines,” effective 11/15/19, revealed items taken into the dialysis station should either be disposed of, dedicated for use only for a single patient, or cleaned and disinfected before being taken to the common area or used on another patient. Unused supplies (e.g., syringes, alcohol swabs) taken to the patient’s station should only be used for that patient and should not be returned to the common area or used on other patients. All folders shall remain at the dirty chairside until it has been wiped down with the rest of the items. They are not to be carried to the scale or the nurse’s station until this is completed. Hospital grade germicide is used to decontaminate surfaces of all equipment (i.e., chairs, side tables, TV’s, remotes, phones, BP cuffs, stethoscopes, garbage cans as well as biohazard cans). Interview on 01/25/24 at 11:15 AM with Staff (A) Nurse Manager and Staff (L) Facility Administrator confirmed this finding.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 40430 Based on observation and interview the facility did not ensure that clean supplies were stored in a manner to avoid contaminations with spurting or spattering of blood or fluids. This has the potential for cross-contaminating clean patient supplies. Findings include: Observations on the treatment floor on 01/23/24 from 10:20 AM to 12:25 PM and 01:00 PM to 03:00 PM, 01/24/24 from 10:10 AM to 12:15 PM and 01:00 PM to 03:00 PM, and 01/25/24 from 10:00 AM to 12:30 PM revealed clean supplies were stored in the splash zones of treatments chairs/stations as follows: At Station #3: Chux pads and clean wipes. At Station #4: 3 boxes of gloves. Behind Station # 6, Station #7, Station #12, and Station #13: Bleach jug/basin and clean wipes. At Station #9; Chux pads, wipes and three boxes of gloves. A Station #10: Chux pads and ten boxes of gloves. At Station #15: Ten boxes of gloves. At Station #16: Thirteen boxes of gloves. Review of policy “Departmental Infection Control Practice Guidelines,” effective 11/15/19 indicates, items taken into the dialysis station should be disposed of, or dedicated for use only on a single patient, or cleaned and disinfected before being taken to the common area or used on another patient. Interview on 01/25/24 at 11:15 AM with Staff (A) Nurse Manager and Staff (L) Facility Administrator confirmed this finding.”

“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: 40430 Based on observation, policy review, and interview, staff do not clean and disinfect all contaminated surfaces. This lapse in disinfection places staff and patients at risk for transmission of bloodborne pathogens and facility acquired infections. Findings Include: Observations on 01/23/24 from 10:20 AM-12:25 PM, and 01/24/24 from 10:10 AM-12:15 PM revealed staff did not disinfect the back counters, where patient belongings/items are stored, hand sanitizer bottles on machines stored in a basket affixed to each machine, wall boxes, red biohazard garbage bins, or portable sharps containers (on wheels) in stations #1-#12, #14-#16 and station #18 after each patient treatment. Review of policy “Departmental Infection Control Practice Guidelines,” effective 11/15/19 indicates to clean and disinfect the dialysis station, within the splash zone and other surfaces that are frequently touched and potentially contaminated with patients’ blood (chairs, shelves, tables, and machines), in between patients. Items taken into the dialysis station should be disposed of, or dedicated for use only on a single patient, or cleaned and disinfected before being taken to the common area or used on another patient. Hospital approved germicide is used to decontaminate surfaces of all equipment (chairs, side tables, phones, blood pressure cuffs, stethoscopes, garbage cans, as well as biohazard cans). The policy did not include direction for disinfection of the purified water connection, dialysate concentrate container (s), or connection (s). Interview on 01/25/24 at 11:15 AM with Staff (A) Nurse Manager and Staff (L) Facility Administrator confirmed this finding. THIS IS A REPEAT DEFICIENCY FROM THE 12/02/22 RECERTIFICATION SURVEY.”

“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: 40430 Based on observation, policy review, and interview, nursing staff did not follow facility policy while performing central venous catheter care. Failure to follow central venous care policy places patients at increased risk for infection. Findings Include: Observations on 01/23/24 at 11:35 AM on the treatment floor revealed at Station # 8 for Patient #9 and at 12:10 PM at Station #11 for Patient #12, Staff (H), Registered Nurse, initiated treatment, via central venous catheter. Staff (H) removed the old dressings covering the central venous catheter site, removed gloves and applied clean gloves. Staff (H) did not perform hand hygiene prior to applying clean gloves and continuing with catheter care. Review of policy “Subclavian, I.J., or Femoral Catheter Dressing Change” effective 11/15/19 indicated while not a sterile procedure in the outpatient dialysis setting, catheter dressing change procedures should be treated as sterile as possible, for the safety of the patient. The policy indicated to wash hands and don clean gloves. Remove old dressing and discard. Remove gloves, cleanse hands and don clean gloves. Interview on 01/25/24 at 11:15 AM with Staff (A) Nurse Manager and Staff (L) Facility Administrator confirmed this finding.”

“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: 25545 Based on observation and interview the facility did not maintain 4 of 16 patient treatment chairs free from rips and missing material to ensure that they are impervious to fluid. Findings Include: Based on observation and interview, the building is not maintained, free from defects and/or hazards to ensure safety and functionality for patients, staff, and visitors. Findings Include: Observations on 01/23/2024 on the treatment floor at 11:05 AM revealed chairs at Station #1 and #5 had a large tear in the seat of the chair and chairs at Stations #13 and #16 had missing material on the arms of the chair. At 01:30 PM revealed that there was damage to the lower area of the wall at stations #16- #18. The cove molding was missing, there were two holes-approximately three inches in diameter each. Drywall is exposed, which is not a fluid impermeable surface. Interview on 01/25/2024 at 02:30 PM with Staff (A) Nurse Manager verified these findings.”

“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: 34528 Based on observation and interview, the facility does not prominently display a copy of Patients’ Rights that contains all the rights required by CMS, including the contact information for the State Agency and the ESRD Network. Lack of posting may delay or inhibit a patients ability to make a complaint. Findings Include: Observation on 01/23/24 at 09:30 AM in the patient waiting room and treatment unit revealed no evidence that the CMS Patient’s Rights was posted prominently and included the addresses and phone numbers for the State agency and the ESRD Network. Interview on 01/25/24 at 01:00 PM with Staff (A), RN Nurse Manager verified these findings and that there is no policy pertaining to the posting of Patients’ Rights.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 34528 Based on policy review, document review, and interview, the facility Quality Assessment and Performance Indicators program does not ensure evaluation of all indicators or performance measures as specified in the Centers for Medicare and Medicade Services Measures Assessment Tool. Findings Include: Review of the Policy “Continuous Quality Improvement (CQI) Committee” last effective date 11/15/11 revealed the program must reflect the complexity of the dialysis facilities organization and services and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The team will review the indicators on each patient using the Centers for Medicare and Medicade Services Measures Assessment Tool. The policy does not list the following indicators or performance measures for review: Water and Dialysis Quality, Dialysis Equipment, Transplant Referral, Staffing, Fluid and Blood Pressure Management, and Physical Plant and Safety rounds Review of Continuous Quality ImprovementQuality Improvement meeting minutes dated 11/09/23 revealed no evidence of indicators for Physical and mental functioning using KDQOL-36, Patient Hospitalizations, Patient Survival, Hemodialysis Adequacy: KT/V, Nutritional Status: Albumin, Mineral metabolism/bone disease: Phosphorus, Medical Injuries and Medication Errors, Patient Satisfaction and Grievances, Vaccinations, Physical Plant and Safety Rounds. Interview on 01/25/24 at 01:00 PM with Staff (A), RN Nurse Manager verified these findings. THIS IS A REPEAT DEFICIENCY FROM THE RECERTIFICATION SURVEY COMPLETED 12/02/22.”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 34528 Based on policy review, document review and interview, the facility does not conduct monthly quality meetings for the analysis of quality indicators as evident for 11 of 11 months (January thru November 2023). Failure to implement ongoing monitoring of health outcomes may lead to missed opportunities toidentify issues to improve the safety and quality of patient care. Findings Include: Review of policy “Continuous Quality Improvement (CQI) Committee”, last effective date 11/15/11. revealed the dialysis facility must maintain and demonstrate evidence of a quality improvement program. The Continuous Quality Improvement team will meet monthly. The team will review the indicators on each patient using the Centers for Medicare and Medicade Services Measures Assessment Tool (MAT). Upon completion of monthly meetings, meeting minutes will indicate all discussions. Discussions will include but not be limited to measurable improvement in health outcomes. Review of the Administrative Quality Improvement meeting minutes revealed no monthly meetings were documented from January 2023 to 11/09/23. Quarterly quality improvement meetings were held for Quarter #1, (no date), Quarter #2 (no date). Third Quarter quality information was reviewed on 09/29/23 by Staff (B) Medical Director and the last Quality Improvement meeting was held 11/09/23. Interview on 01/25/24 at 11:00 AM with Staff (L) Facility Administrator, stated the facility does not have monthly quality meetings. Interview on 01/25/24 at 01:00 PM with Staff (A), RN Nurse Manager verified these findings. THIS IS A REPEAT DEFICIENCY FROM THE SURVEY COMPLETED 12/02/22.”

“PQ-H20 TREATMENT SYSTEM TECHS TRAINING CFR(s): 494.140(f) Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body. This Standard is not met as evidenced by: 34528 Based on policy review, document review, and interview the facility did not ensure staff had facility water training for 3 of 6 Staff (Staff (E), Bio Medical, (Q) Biomedical Technician, (R) Biomedical Technician). Findings Include: Review of policy, Water Treatment Training In Lake Plains Dialysis Units, last reviewed December 2019 revealed Lake Plains Dialysis Centers will ensure all technicians and designated nursing staff will understand all the components and testing of the water purification system. Review of Renal Dialysis Chief Dialysis Technician job description, last revised 07/2023, revealed the Chief Dialysis Technician is a member of the Dialysis team and assists with water systems and the quality monitoring of all water systems and other technical services. Review on 01/24/23 of Staff training files revealed Staff (E), Bio Medical, (Q) Biomedical Technician, (R) Biomedical Technician did not have facility water training. Interview on 01/25/24 at 01:00 PM with Staff (A), RN Nurse Manager verified these findings.”