Davita Downtown Dialysis Center

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedure, the facility’s governing body failed to ensure a sanitary environment at all times. This failure placed the patients and the staff at potential risk for exposure to infectious diseases through cross contamination. Findings Included: On 04/19/2024 at 12:00 p.m., during record review of the facility’s policy titled “Bleach Policy” (Policy 1-05-08) page 1 states “bleach solution needs to be covered with a secure lid ...without a secure lid, the bleach solution is open to air causing the solution to degrade overtime and become less effective. “Infection Control for Dialysis Facilities (Policy 01-05-01) page 3 number 12 states “Cleaning or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials ....cleaning of visible blood should be performed when first observed.” On 04/17/2024, during observation of the treatment floor, the surveyor observed the following: 1. At 10:20 a.m., the surveyor observed red splatter like residuals surrounding the top of the needle container located near stations #8, #20, #26 and #31. 2. At 12:19 p.m., the surveyor observed that the bleach located in station #9 was labeled 04/16/2024 and was left uncovered with 5 clamps located inside. On 04/18/2024, at 12:04 p.m. during observations of the water room, the surveyor observed the following: 1. Brown, yellow residuals surrounding the water room wall. 2. Uncovered and unlabelled blue bucket with unknown liquid substance located in the water room. 3. Gray brown residuals surrounding the sink in the water room”

“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: 47759 Based on observations and review of the facility’s policies and procedure, the facility’s governing body failed to ensure that personal protective equipment (PPE)s are worn in the treatment area and removed prior to leaving the treatment areas. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to other staff members, as well as patients. Findings included: On 04/19/2024 at 12:00 p.m., during record review of the facility’s policy titled “Infection Control for Dialysis Facilities” (1-05-01)Page 2 number 5 states, “Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient care areas. PPE is to be: a. Removed prior to leaving the treatment area..” Number 6 states “Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, physicians and non-physician (NPP) and visitors when in the treatment area.” On 04/17/2024, at 12:25 p.m. during observations of the clinical treatment floor, the surveyor observed holes in Staff #4 ‘s footwear exposing the employee’s feet to injury from dropped contaminated needles and sharps. On 04/18/2024, at 11:30 a.m. during observations of the clinical treatment floor, the surveyor observed holes in Staff #8’s footwear. In addition, the surveyor observed staff #6 and #7 without PPE’s on the treatment floor, solely wearing their lab coats which were also worn outside the treatment floor.”

“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: 47759 Based on observations on the clinical treatment floor, a review of the dialysis machine disinfection logs, and a review of the facility’s policies and procedures, the governing body failed to ensure that all clinical staff followed the standard protocol for cleaning and disinfection of equipment and supplies used in dialysis. This failure placed all patients and staff at potential risk for exposure to bloodborne pathogens and other infectious diseases. Findings included: Proper cleaning and disinfection of hemodialysis machines is crucial in preventing the transmission of blood-borne pathogens and other infectious diseases in hemodialysis units. Failure to perform adequate cleaning and disinfection can result in the accumulation of contaminants within the machine’s internal circuits which can lead to the transfer of infectious agents from one person to another. To prevent the transmission of infectious diseases, healthcare facilities must follow strict policies and procedures for cleaning and disinfecting of all equipment used in dialysis. These policies and procedures should be based on the guidelines set forth by regulatory agencies such as the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA). 1. According to the facility’s policy (7-05-16, page 1, #2), “All dialysis delivery systems, including backup dialysis delivery systems intended for patient use, are routinely required to be disinfected at no more than 48 hour interval.” Upon review of the facility’s dialysis machine disinfection logs on 4/17/2024, no documentation was found showing that the dialysis machines used for their patients were cleaned and disinfected at the end of the day on the following dates: a. On 3/19/2024 - Dialysis machines #2, #7, #10, #13, #14, #17, #22, and #29. b. On 3/20/2024 - Dialysis machines #2, #7, #10, #12, #13, #14, #16, #19, #20, #22, #24, #29, #30, and #34. c. On 3/22/2024 - Dialysis machines #2, #10, #15, and #35. d. On 3/23/2024 - Dialysis machines #1, #2, #3, #5, #6, #8, #10, #11. #12, #13, #14, #15, #16, #18, #19, #20, #22, #24, #25, #26, #27, #28, #29, #30, #32, #34, and #35. 2. During observations on the clinical treatment floor on 4/17/2024 at 11:30 a.m., it was noted that a 3-tier supply cart across station #11 was covered with white dry residue indicating that the cart was not being cleaned on a regular basis. On the 2nd level of this same cart, a black rectangular basin labeled to contain Reverse Osmosis (R/O) water was dated to have been prepared on 4/16/2024. The basin contained 3 acid wands, 2 blue clamps and 1 white clamp. One of the acid wands was not completely submerged in the R/O water. These findings were confirmed by the charge nurse on 4/17/2024 and again discussed with the administrative team during the exit conference on 4/19/2024.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 47759 Based on record review, the facility’s governing body failed to ensure that all patient’s hepatitis B virology (HBV) status were known before admission to the facility and failed to ensure routine testing was done for all patients. This failure placed patients and staff at risk of contracting infectious diseases. Patients: C, L, M, N, O and P Findings Included: On 04/19/2024 at 12:00 p.m., during record review of the facility’s policy, Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance (Policy 1-05-02) page 2 number 7 “All permanent patients including Acute Kidney Injury (AKI) patients will have HBV serologic testing drawn immediately upon admission to the facility and results known within 7 days of admission (I.e., HBsAg, HBcAb, and HBsAb). On page 4, it states “susceptible patients with X<10 HBsAb must have HBsAg testing done monthly.” According to the Centers for Disease Control and Prevention (CDC), although the incidence of Hepatitis B virus (HBV) infection is low among chronic hemodialysis patients, preventing transmission depends on timely detection of patients converting from HBsAg negative to HBsAg positive and rapid implementation of isolation procedures before cross-contamination can occur. On 04/19/2024 at 09:05 a.m., during record review of the facility’s Hepatitis B Audit Report, the surveyor observed the following: 1. Patient L was admitted to the facility on 08/18/2023. Patient L’s HBcAb and HBsAb were known to the facility on 09/13/2023, which was x> 7 days from the date of admission. Patient L did not have a documented HBsAg due 08/2023. 2. Patient M, a susceptible patient since 08/22/2023 had no documented HBsAg documented for the following months: 09/2023, 10/2023 and 03/2024 3. Patient C was admitted to the facility on 02/13/2024. Patient C does not have a documented HBcAb, HBsAb, HBsAg 4. Patient N, a susceptible patient since 03/17/2023 had no HBsAg documented for the months of 02/2024 and 03/2024. Patient N also does not have a documented annual Antibody result due 03/2024. 5. Patient O, a susceptible patient since 10/17/2023 had no HBsAg documented for the months of 10/2023 and 02/2024. 6. Patient P was admitted to the facility on 03/2024. Patient P does not have a documented HBcAb, HBsAb, HBsAg”

“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 policies and procedures, the facility’s governing body failed to ensure that staff utilized aseptic technique when accessing central venous catheters. This failure places the affected patients at an increased risk of infection(s). Findings Included: On 04/19/2024, at 12:00 p.m., during record review of the facility’s policies and procedure titled Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps (Procedure 1-04-02 B), page 2 states, “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason”; page 5 number 16 states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly...minimize the time it is open” Page 4 Number 8 states, “clean exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol swab for a minimum of 30 seconds...Then wait 60 seconds for air dry time.” On 04/17/2024, during observations of the clinical treatment floor, the surveyor observed Staff #3 disconnect the blood line from the patient [sitting in station #10]’s cvc line, troubleshoot the dialysis machine, and reconnect the bloodline back to the patient’s cvc line without re-scrubbing the cvc hub. On 04/18/2024, during observations of the clinical treatment floor, the surveyor observed Staff #8 (1) scrub the patient [sitting in station #3]’s exit site for 10 seconds and (2) remove the patient [sitting in station #3]’s cvc arterial and venous hubs at the same time leaving both hubs exposed at the same time.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. 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 an environment free from defects or hazards in order to maintain a safe, functional and comfortable treatment environment. This failure placed the patients, staff and visitors at potential risk of harm including injury or infection. Findings included: On 04/19/2024 at 12:00 p.m., during review of the facility’s policies and procedures titled “Physical Environment” (Policy: 08-04-01) page 1 number 1 states,”The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public safe, functional, and comfortable treatment environment.” Number 2 states “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public.” All equipment utilized in the dialysis facility, must be kept safe and fully operational.The facility must implement a preventive maintenance and repair program for all equipment following the manufacturer’s guidelines. On 04/17/2024 at 11:15 a.m., during inspection of the treatment floor, the surveyor observed tears on the dialysis chairs located in station #8, #22, #24 and #26. On 04/18/2024 at 12:04 p.m., during inspection of the water room and the treatment floor, the surveyors observed the following: 1. Missing ceiling tiles above the acid container and the water storage area. 2. Missing ceiling tiles above the toilet located in the patients’ restroom adjacent to dialysis station #1. 3. Multiple gray and brown floor stains at different areas of the the supply room where the dialysis acid concentrate containers, saline acid bags, and dextrose peritoneal dialysis solutions were stocked on a pallet. 4. A nonfunctional hand sanitizer dispenser located at the patients’ waiting area. 5. Tears and punctures on 7 out of the 10 waiting area chairs 6. Two empty portable oxygen tank [Lot #01013011824] mixed in the same area with the useful portable oxygen tanks.”

“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: 47759 Based on record review and staff interview, the facility’s governing body failed to document reasons why the prescribed orders were not followed.This failure to follow prescribed orders for target weight increased the risk for patient harm by delaying re-evaluation of the appropriateness of dialysis. Findings Included: On 04/19/2024 at 12:00 p.m., during review of the facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (Policy 1-03-08) Page 4 Number 11 states “Abnormal findings ...will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on the individual patient needs to determine if any clinical interventions are necessary.” Number 13 states “All findings, interventions, and patient response will be documented in the patient’s medical record.” Number 16 states “If an abnormal finding (s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge.” On 04/19/2024, at 08:40 a.m., during record review of the sampled patients’ treatment flowsheet, the surveyor noted the following: 1. On treatment date 04/16/2024, [Patient I] did not meet the ordered and calculated target weight post treatment. Review of [Patient I]’s flow sheet showed no supporting documentation explaining why the ordered prescription was not followed. 2. On treatment date 04/12/2024 and 04/15/2024, [Patient A] did not meet the ordered and calculated target weight post treatment. Review of [Patient A]’s flow sheet showed no supporting documentation explaining why the ordered prescription was not followed. 3. On treatment date 04/8/2024, 04/10/2024, and 04/12/2024 [Patient G] did not meet the ordered and calculated target weight post treatment. Review of [Patient G]’s flow sheet showed no supporting documentation explaining why the ordered prescription was not followed. 5. On treatment date 04/10/2024, 04/12/2024, and 04/15/2024 [Patient B] did not meet the ordered and calculated target weight post treatment. Review of [Patient B]’s flow sheet showed no supporting documentation explaining why the ordered prescription was not followed.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 47759 Based on observations, the facility’s governing body failed to ensure that the clinical staff complied with the appropriate procedures in assessing the patients’ vascular access prior to cannulation. This failure placed the safety and well being of the patients at potential risk of harm in maintaining their vascular access. Findings included: A tourniquet is used when cannulating an arteriovenous fistula (AVF) to aid in vein dilation and to make the vein more prominent and accessible. By applying pressure proximal to the site of cannulation, the tourniquet restricts venous outflow, causing the vein to distend or swell with blood. This distension makes the vein easier to locate and access for cannulation, which is crucial for successful hemodialysis treatments. Additionally, the use of a tourniquet can help minimize the risk of infiltration and ensure a more secure needle placement during the cannulation process. The facility’s policy on arteriovenous fistula (AVF) and arteriovenous graft (AVG) vascular access care (Policy 1-04-01, page 3) states: “10. Fistula requires a tourniquet for cannulation (some patients may prefer to manually simulate a “tourniquet” with their non-access hand)” During observations on the dialysis treatment floor on 4/17/2024, the following were noted: a. Staff #1 assigned at station #28, did not use a tourniquet prior to cannulating Patient J’s AVF. b. Staff #12 assigned at station #14, did not use a tourniquet prior to cannulating Patient K’s AVF.”

“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: 47759 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 in assessing the patients’ vascular access prior to cannulation, and practiced the correct infection control protocol. This failure placed the safety and well being of the patients at potential risk of harm in maintaining their vascular access. Findings included: The facility’s policy on Arteriovenous Fistula (AVF) or Graft (AVG) Cannulation (1-04-01E) states: “Do not palpate insertion site once the area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” During observations on the dialysis treatment floor on 4/17/2024 between 11:45 a.m. to 12:15 p.m., the following were noted: a. At station #28, Staff #1 touched the patient’s vascular access site immediately before needle insertion after it had already been prepped. b. At station #19, Staff #13 touched the patient’s vascular access immediately before needle insertion after it had already been prepped. These findings were discussed with the administrative team during the exit conference on 4/19/2024.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 47759 Based on the review of patients’ medical records and interviews with the facility’s administration, the facility’s 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 hemodialysis sessions beginning with the first outpatient dialysis session. This failure placed the affected patients at potential risk of harm and denied patients their rights. Findings included: On 04/19/2024 at 12:00 p.m., during review of the facility’s policy titled “Interdisciplinary team (IDT) Patient Assessment and Plan of Care” (Policy 01-14-01) page 4 number 10 states “An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” On 04/19/2024 at 08:50 a.m., during record review of the sampled patients’ medical records, the surveyor noted the following: 1. Patient B was admitted on 01/26/2024. Patient B’s 30 day plan of care was completed 03/13/2024, approximately 16 days late 2. Patient D was admitted on 08/29/2022. Patient D’s 30 day plan of care was completed on 11/01/2022, approximately 2 months late 3. Patient F was admitted on 02/23/2024. Patient F’s 30 day plan of care was completed on 04/05/2024, approximately 42 days late.”

“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: 47759 Based on review of the facility’s policies and procedure, review of Quality Assessment and Performance Improvement (QAPI) meeting minutes and interviews with staff, the facility’s governing body failed to (1) ensure that the facility incorporated mortality data and hospital data in QAPI meetings, (2) track mortality and hospitalization data in QAPI, and (3) analyzed each data trends to identify potential problems and opportunities for improving care. This failure placed patients at potential risk of harm by failing to utilize the data gathered to identify potential problems in the facility potentially resulting in delay in interventions aimed at improvement. Findings Included: On 04/19/2024 at 12:00 p.m., during record review of the facility’s Continuous Quality Improvement Program (Policy 12-16-06) page 1 number 7 states, “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: ...mortality (review of deaths); hospitalizations.” Number 8 states, “continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to ensure improvements are sustained.” On 04/19/2024 at 12:50 p.m., during record review of the facility’s Facility Health Record (FHR) meeting for 2023 and 2024, the surveyor observed that (1) the facility did not incorporate the mortality and hospital data provided to the surveyor on the FHR meeting (2) The facility did not perform a mortality review on 4 out of the 11 patients that died in 2023 and 2024. (3) The facility did not do an analysis on the hospital and mortality data thereby failing to identify potential problems in the facility On 04/19/2024 at 12:55 p.m., interviews with Staff #11 corroborated that moving forward, analysis and action plan will be documented on the FHR meeting.”

“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 review of the facility’s policies and procedures, the medical director and the facility’s administration 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. “Infection Control for Dialysis Facilities (Policy 01-05-01) page 3 number 12 states “Cleaning or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials ....cleaning of visible blood should be performed when first observed.” 2. “Bleach Policy” (Policy 1-05-08) page 1 states “bleach solution needs to be covered with a secure lid ...without a secure lid, the bleach solution is open to air causing the solution to degrade overtime and become less effective. 3. “Infection Control for Dialysis Facilities” (1-05-01) Page 2 number 5 states, “Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient care areas. PPE is to be: a. Removed prior to leaving the treatment area..” Number 6 states “Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, physicians and non-physician (NPP) and visitors when in the treatment area.” 4. “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” (Policy 1-05-02) page 2 number 7 “All permanent patients including Acute Kidney Injury (AKI) patients will have HBV serologic testing drawn immediately upon admission to the facility and results known within 7 days of admission (I.e., HBsAg, HBcAb, and HBsAb). On page 4, it states “susceptible patients with X<10 HBsAb must have HBsAg testing done monthly.” 5. “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps” (Procedure 1-04-02 B), page 2 states, “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason”; page 5 number 16 states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly...minimize the time it is open” Page 4 Number 8 states, “clean exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol swab for a minimum of 30 seconds...Then wait 60 seconds for air dry time.” 6. “Operation of Portable Myron L Conductivity Meter (D-1)” (Procedure 2-08-01B) page 1 “Manual pH testing must be performed prior to each patient treatment.” 7. “Physical Environment” (Policy: 08-04-01) page 1 number 1 states, “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public safe, functional, and comfortable treatment environment.” Number 2 states “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public.” 8. “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (Policy 1-03-08) Page 4 Number 11 states “Abnormal findings ...will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on the individual patient needs to determine if any clinical interventions are necessary.” Number 13 states “All findings, interventions, and patient response will be documented in the patient ’ s medical record.” Number 16 states “If an abnormal finding (s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge.” 9. “Interdisciplinary team (IDT) Patient Assessment and Plan of Care” (Policy 01-14-01) page 4 number 10 states “An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” 10. “Arteriovenous Fistula (AVF) or Graft (AVG) Cannulation” (1-04-01E) states: “Do not palpate insertion site once the area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.””

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to ensure an adequate number of qualified and trained staff to meet the needs of the patients. This failure placed the patients at potential risk and denied their rights to a minimum standard of medical care. Findings Include: The Code of Maryland Regulations 10.05.04.06C (Dialysis Monitoring for Freestanding Kidney Dialysis Centers) states: (a) In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be: (i) A minimum of one staff member to three participants; and (ii) Sufficient to meet the needs of patients. ... (c) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. (d) The charge nurse may not be included in the staffing ratio except: (i) When there are nine or fewer patients; or (ii) In the event of an emergency. On 04/18/2024 at 10:00 a.m., a review of the facility’s staffing exception report from February 2024 through April 2024 revealed that staffing ratios did not meet the requirements on the following dates: a. February 9, 10, 16, 17, 19, and 27 b. March 6, 7, 8, 9, 11, 13, 19, and 20 c. April 1, 2, 5, 6, 8, 11, and 13 In all instances, the charge nurse was either included in the staffing ratio or had to monitor patients.”