Fmc Fairfield (Steel City)

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 49894 Based on review of medical records, facility policies and procedures, and staff interviews, it was determined the facility failed to ensure: 1. Staff documented vital signs and safety checks in the required time. 2. Staff delivered patient treatments per the physician’s order. 3. Staff cleaned the patient access per facility policy. 4. Staff documented cleaning of the patient access in the patient chart. 5. The Interdisciplinary team signed the patient Plan of Care (POC) in the required timeframe. 6. The patient signed the POC or documentation of a refusal to sign was in the patient’s medical record. Refer to: V 543, V 544, V 550, and V 556”

“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: 49797 Based on observations, review of facility policies, and staff interview it was determined the facility failed to ensure: 1. Staff performed hand hygiene and glove changes per facility policy in two of three observations for initiation of dialysis with an Arteriovenous Fistula/Arteriovenous Graft (AVF/AVG), which included Patient Identifier (PI) # 8, and PI # 3 2. Staff performed hand hygiene and glove changes per facility policy in one of two observations of initiation of dialysis with a Central Venous Catheter (CVC), which included PI # 11. 3. Staff performed hand hygiene and glove changes per facility policy in two of two observations of discontinuation of dialysis with a CVC, which included PI # 7 and PI # 11. 4. Staff performed hand hygiene before accessing new gloves in one of two observations of intravenous (IV) medication preparation and administration, including PI # 9. This had the potential to negatively affect all patients dialyzing at the facility. Findings include: Facility Policy: Access Assessment and Cannulation Reference Number: 45178 Version: 3 Published: 7/5/22 Assessment of Vascular Access: Follow the steps below to assess the vascular access: ...2. Wash hands and don Personal Protective Equipment (PPE): gloves... ...5. Look... 6. Listen... 7. Feel... ...9. Remove gloves and perform hand hygiene. Don new gloves. Facility Policy: Hand Hygiene Reference Number: 47664 Version: 8 Published: 11/6/23 Purpose: The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content. ... Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water: Before and after direct patient contact with patients, entering and leaving treatments area, before performing any invasive procedure such as vascular access cannulation or administration of parental medications, immediately after removing gloves... ...After contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient... ...After Contact with other objects within the patient station or treatments space... 1. An observation of care was conducted on 4/2/24 at 11:09 AM with Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician (CCHT), at station 6 to initiate dialysis for PI # 8 with an AVF/AVG. With gloves on, EI # 6 cleaned the stethoscope with an alcohol pad, then evaluated PI # 8’s AVF/AVG sites with a stethoscope and palpation. EI # 6 applied alcohol pads to the cannulation sites and inserted the cannulation needles without first changing gloves and performing hand hygiene. An interview was conducted on 4/3/24 at 2:45 PM with EI # 1, Clinic Manager, and EI # 2, Director of Operations who confirmed staff failed to remove gloves and perform hand hygiene after access evaluation and before cannulation. 2. An observation was conducted on 4/2/24 at 11:44 AM of PI # 11 at station 5 to initiatie dialysis with a Central Venous Catheter (CVC). EI # 3, Registered Nurse (RN), performed CVC care, then walked out of the station to discard used supplies, and returned to the station to continue initiation of dialysis. EI # 3 failed to perform hand hygiene and a glove change when returning to the dialysis station before continuing initiation of dialysis. An interview was conducted in 4/3/24 at 2:45 PM with EI #1 and EI # 2, who confirmed staff failed to follow hand hygiene per facility policy. 3. An observation was conducted on 4/2/24 at 12:56 PM with EI # 6, CCHT, at station 10 initiating treatment with an AVF/AVG for PI # 3. After evaluating the access (look, listen, feel), EI # 6 failed to remove gloves, perform hand hygiene, and don new gloves before performing antisepsis of the cannulation sites. An interview was conducted in 4/3/24 at 2:45 PM with EI #1 and EI # 2, who confirmed staff failed to follow hand hygiene per facility policy. 4. An observation of care was conducted on 4/2/24 at 1:10 PM at station 7 with EI # 3, during discontinuation of dialysis with a CVC for PI # 7. Wearing gloves, EI # 3 discontinued dialysis and without performing hand hygiene or changing gloves, documented on the dialysis keyboard screen, then exited the station to retrieve a Hoyer lift and proceeded to transfer PI # 7 from the treatment chair to the Hoyer lift. EI # 3 failed to perform hand hygiene after treatment discontinuation, upon exiting the dialysis station and upon entering the station. An interview was conducted on 4/3/24 at 2:45 PM with EI # 1 and EI # 2, who confirmed staff failed to follow the facility procedure for hand hygiene. 5. An observation was conducted on 4/2/24 at 3:42 PM of PI #11 at station 5 discontinuation of dialysis with a CVC. EI # 3 performed patient care then walked out of the station to discard used supplies, and returned to the station to continue discontinuation of dialysis. EI # 3 failed to perform hand hygiene and a glove change when returning to the dialysis station before completing the discontinuation of treatment. An interview was conducted on 4/3/24 at 2:45 PM with EI #1 and EI #2, who confirmed that the staff did not follow the policy for Hand Hygiene, 6. An observation was conducted on 4/3/24 at 9:02 AM to observe EI # 4, RN, prepare medication for administration. EI # 4 prepared IV Venofer, obtained gloves from the clean glove supply, exited the medication preparation area, donned gloves on the way to station 4, entered the station, and administered the IV Venofer to PI # 9. EI # 4 failed to perform hand hygiene before accessing the clean glove supply, prior to donning gloves, and before administration of the IV Venofer. An interview was conducted on 4/3/24 at 2:45 PM with EI # 1 and EI # 2 who confirmed staff failed to follow the facility procedure for hand hygiene. 30952 49894”

“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: 49894 Based on observation, review of facility policies, and staff interviews, it was determined the facility failed to ensure staff maintained clean, dry transducer protectors per facility policy. This affected an unsampled patient and PI # 13 in two of five dialysis prescription verifications on the flash tour and had the potential to negatively affect all patients who dialyze at the facility. Findings Include: Facility Policy: Maintenance of the Transducer Protectors Procedure Reference Number: 45670 Version: 2 Published: 11/1/21 Purpose: The purpose of this policy is to ensure accurate measure of arterial and venous pressures by maintaining clean, dry transducer protectors and to prevent cross contamination of bloodborne pathogens due to a contaminated internal transducer protector. Policy: External transducer protectors must be changed immediately when they become wet with blood or other fluid. Manufacturer’s Directions for Use (DFU): Combiset Smartech Hemodialysis Blood Tubing Set Catalog Number: 03-2722-9C and 03-2742-9C Published: Not Documented Priming Precautions: Prime arterial chamber approximately 90% full and venous chamber to approximately 70% full. Dialysis Treatment Precautions: ... 2. During Treatment: ... c. Maintain fluid level in arterial chamber to approximately 90% full and venous chamber at approximately 70% full. Levels may rise and fall during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Facility Policy: Patient Assessment and Monitoring Published 9/29/18 Reference Number: Not documented Version: 3 Policy: Monitoring During Treatment: Machine Parameters and Extracorporeal Circuit: Observe and ensure that: Transducer protectors are not wet. 1. During observations of care on the treatment floor on 4/2/24 at 10:20 AM, the surveyor observed a transducer wet with blood at station 8 with an unsampled patient. At 10:23 AM, Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician (CCHT) entered the station to address an arterial pressure alarm. At 10:30 AM, EI # 5, CCHT entered the station to address an arterial pressure alarm. EI # 6 and EI # 5 failed to change the wet transducer. An interview was conducted on 4/2/24 at 10:40 AM with EI # 5 who confirmed the wet transducer. EI # 5 changed the transducer at 10:42 AM. An interview was conducted on 4/3/24 at 2:45 PM with EI # 1, Clinic Manager, and EI # 2, Director of Operations, who confirmed staff failed to monitor and change the wet transducer, per policy. 2. An observation was conducted on 4/2/24 at 10:50 AM at station 2 with EI # 3, Registered Nurse (RN), verifying the prescription for PI # 13. The surveryor observed the transducer protector was wet. The transducer remained wet until the treatment ended at 11:40 AM. An interview was conducted on 4/3/24 at 2:45 PM with EI # 1 and EI # 2, who confirmed the staff failed to maintain clean, dry transducer protectors per facility policy. 30952”

“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: 49797 Based on review of facility policy and procedures, observations, and interviews, it was determined the facility failed to ensure: 1. The dialysis station was cleaned and disinfected according to facility policy and procedure, which was observed during floor observations for cleaning and disinfection of the dialysis station. 2. Vinyl surfaces on the patient treatment chairs were not torn. 3. Tape residue was removed from the patient treatment chairs during station cleaning and disinfection. This had the potential to negatively affect all patients who dialyze at the facility. Findings include: Facility Policy and Procedure: Cleaning and Disinfecting of the Dialysis Station Published: 09/05/2023 Reference Number: 47806 Version: 14 Purpose ...of this policy is to provide guidelines to prevent the spread of infectious disease...maintain a clean. safe...environment for patients, staff, and visitors. ...Dialysis Station Area including the dialysis machine, chair/bed and other reusable equipment...include (but is not limited to) the following: Dialysis machine...and attachments, such as IV (intravenous) pole...hand sanitizer/holder... Dialysis Wall Box...located in the chase wall...routinely cleaned at the end of each treatment day... Cleaning of the Dialysis Machine Externally disinfect the dialysis machine with 1:100 (one part bleach to one hundred parts water) bleach solution after each dialysis treatment... During observations of care conducted on the dialysis treatment floor on 4/2/24 from 10:15 AM to 1:00 PM, the surveyor observed the following: 1. At station 12, after station cleaning and disinfection, there was a two-inch tear in the seat of the patient treatment chair and paper tape residue on the right armrest. 2. At station 8, after station cleaning and disinfection, there were three one half inch tears to the seat of the patient treatment chair and paper tape residue on the right armrest. 3. At station 10, after station cleaning and disinfection, there were three one half inch tears on the left armrest of the patient treatment chair and tape residue on the right armrest. 4. At the treatment floor entrance/exit was a patient treatment chair with two one-inch tears in the seat vinyl, six quarter inch tears on the right armrest, and tape residue on the left armrest. An interview was conducted on 4/3/24 at 1:55 PM with Employee Identifier (EI) # 7, Biomedical Technician II, who confirmed the patient treatment chairs have tears in the vinyl. In an interview conducted on 4/3/24 at 2:45 PM, EI # 1, Clinic Manager and EI # 2, Director of Operations, confirmed staff failed to remove all paper tape and tape residue during station cleaning and disinfection, and the facility failed to ensure treatment chairs were without tears in the vinyl. 30952”

“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: 30952 Based on review of medical records (MR), the facility Hepatitis B Summary Report, QAPI data, policy, and interview, it was determined the facility failed to ensure all susceptible patients were vaccinated or a declination form was obtained per policy. This affected one of one new patients including Patient Identifier (PI) # 1 and had the potential to negatively affect the 39 patients served by the facility. Findings include: Facility Policy: Patient Vaccination for Hepatitis B Published 2/7/22 Policy Number: 47676 Version 5 Purpose: Provide guidance for hepatitis B vaccination. Hepatitis B Vaccine: Guidelines The Hepatitis B vaccine (HBV) shall be offered to all susceptible patients... ...Patients shall sign a vaccination consent/declination form. ...A protective antibody response is 10 or more multigenerational units per milliliter... Declination: ...Each offering of the vaccine should be documented in the patient’s medical record. 1. PI # 1 was admitted to the facility on 2/7/24 with a diagnosis of End Stage Renal Disease. Review of the Hepatitis B Summary Report documentation revealed laboratory results dated 2/7/24 for the Anti-HBs (antibodies indicating immunity from hepatitis B) below 10 (patient not immune and is susceptible to hepatitis B virus). Review of the MR revealed no documentation PI # 1 received or declined the HBV vaccination. An interview was conducted on 4/4/24 at 9:40 AM with Employee Identifier (EI) # 1, Clinic Manager, who confirmed there was no documentation the HBV vaccination series was initiated, and no documentation PI # 1 was offered and refused the HBV vaccination. 2. Review of the facility’s QAPI data revealed three patient outliers who were susceptible to hepatitis B and had not received the hepatitis B vaccination. Further review of the data revealed all three patients had declined the vaccine. Review of the medical records for the three susceptible patients revealed they did not have a declination of the vaccine on file. An interview was conducted on 4/4/24 at 11:30 AM with EI # 1 and EI # 2, who confirmed the facility failed to obtain a vaccine declination from susceptible patients refusing the hepatitis b vaccination. 49894”

“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: 30952 Based on observation, review of facility policy and interview, it was determined the facility failed to ensure staff labeled all multi-dose vials (MDV) when opened per policy. This affected one of one observation for preparation and administration of an MDV medication including Patient Identifier (PI) # 7 and had the potential to negatively affect all 39 patients who dialyzed at this facility. Findings include: Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Version: 9 Purpose: To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. ...Labeling Vials When preparing medications if the vial is not used immediately in its entirety, the nurse ... must place the date and time the vial was opened on the medication label along with their initials. Note: To ensure all open vials are properly marked, the nurse must never walk away from an opened MDV (multi-dose vial) without writing the date and time the vial was opened. Label any open MDV that is not used immediately and store vial accordingly. An observation of care was conducted on 4/2/24 at 1:10 PM at the medication preparation area with Employee Identifier (EI) # 3, Registered Nurse (RN). EI # 3 retrieved an open MDV of heparin, prepared two syringes with heparin 2200 units, and administered the heparin to PI # 7. There was no open date and time documented on the heparin MDV label. An interview was conducted on 4/2/24 at 1:14 PM with EI # 3 who confirmed the MDV was not labeled with the date and time it was opened.”

“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: 30952 Based on observations, review of facility policy and procedure, and staff interview it was determined the facility failed to ensure: 1. Staff scrubbed the threads and end of the luer lock (hub) of the Central Venous Catheter (CVC) for 10-15 seconds per facility policy. 2. Staff cleaned the CVC exit site per facility policy. This affected Patient Identifier (PI) # 7, in one of two observations for discontinuation of dialysis with a CVC, and PI # 6, in one of two observations of CVC exit site care and one of two observations of initiation of dialysis with a CVC. Findings include: Facility Policy: Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer Published: 2/7/22 Reference Number: 45640 Version: 7 Purpose ...to provide direction to reinfuse blood in the extracorporeal system to the patient at completion of the hemodialysis treatment... Termination: Disinfection of Catheter and Disconnecting the Patient Follow the steps to disinfect the catheter and to disconnect the patient ... Threads and end of luer lock (hub) must be scrubbed with 70 % sterile alcohol pad ...for 10-15 seconds any time the caps are removed, or bloodlines are disconnected ...to reduce risk of contamination. ...Step 5: Disconnect the arterial bloodline from the catheter limb. 6. Using a sterile alcohol pad ...scrub the sides (threads) and the end of the hub thoroughly with friction, making sure to remove any residue ... This step should take 10-15 seconds ...9. Repeat ...for the venous end of the catheter limb ... Facility Procedure: Changing the Catheter Dressing Published: 2/5/24 Reference Number: 45664 Version: 8 Purpose: ...is to provide instruction for cleaning the hemodialysis catheter exit site, changing the catheter dressing... and maintaining a protective barrier in order to prevent infection. ...Cleaning the Site: Follow the steps below to clean the catheter exit site: ...2. Remove swabstick from package...2% (percent) Chlorhexidine (SP) and 70% alcohol (Chloraprep): Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward in the area of the size of the dressing to be applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds... 1. An observation of care was conducted on 4/2/24 at 1:10 PM at station 7 with Employee Identifier (EI) # 3, Registered Nurse (RN), during discontinuation of dialysis with a CVC for PI # 7. During the observation, EI # 3 scrubbed the venous limb threads and hub with an alcohol pad for eight seconds. EI # 3 failed to disinfect the threads and hub for 10-15 seconds per policy. An interview conducted on 4/3/24 at 2:45 PM with EI # 1, Clinic Manager and EI # 2, Director of Operations, confirmed staff failed to follow the facility procedure for disinfection of the CVC threads and hub. 2. An observation of care was conducted on 4/3/24 at 8:26 AM at station 3 with EI # 4, RN, during CVC exit site care and treatment initiation for PI # 6. EI # 4 removed the CVC exit site dressing and cleansed the CVC exit site with a Chloraprep swabstick for 20 seconds, and not for 30 seconds per facility procedure. EI # 4 removed the hub and disinfected the venous threads and hub with an alcohol pad for 5 (five) seconds and not 10-15 seconds. An interview was conducted on 4/3/24 at 2:45 PM with EI # 1, and EI # 2, who confirmed the staff failed to follow the facility procedure for CVC exit site care and CVC hub disinfection.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 30952 Based on review of facility procedure, observation, and interview, it was determined the staff failed to complete testing for total chlorine according to the facility procedure. This had the potential to negatively affect all patients who dialyze at this facility. Findings include: Facility Procedure: Total Chlorine Testing using RPC Ultra Low Total Chlorine Test Strips Published: 4/5/21 Version: 4 ...Procedure 3. Remove one test strip from its foil package and dip it in the sample for 60 seconds...While dipping the strip, move it back and forth at a constant gentle rate of approximately two, 1-2 wide strokes...per second. 4. Remove the strip and shake once, briskly, to remove excess water. 5. Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it provides a consistent viewing background. 6. After the 20 second wait period, immediately compare the strip color to the K100-0118F color chart to determine the Total Chlorine level in the sample. The color block that most closely resembles the color of the test strip is the total chlorine level of the sample... An observation of Total Chlorine testing was conducted on 4/2/24 at 2:44 PM with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician and EI # 1, Clinic Manager. EI # 5 obtained the 100 ml sample, swished the RPC test strip in the sample for 60 seconds, folded the white plastic handle of the test strip under the reagent area and immediately compared the test strip color to the K100-0118F color chart. The staff failed to wait 20 seconds and compare the test strip color to the color chart for the Total Chlorine level results. An interview was conducted on 4/2/24 at 2:49 PM with EI # 1, Clinic Manager, who confirmed staff failed to follow the facility procedure for total chlorine testing.”

“BICARB MIX SYS-STOR/USE TIME/MIN COMBINE CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: storage/use time limits/min combine Once mixed, bicarbonate concentrate should be used within the time specified by the manufacturer of the concentrate. 7 Strategies for bacterial control 7.1 General Storage times for bicarbonate concentrate should be minimized, as well as the mixing of fresh bicarbonate concentrate with unused portions of concentrate from a previous batch. The manufacturer’s instructions should be followed if they are available. This Standard is not met as evidenced by: 30952 Based on observation, review of facility policies, and interviews, it was determined the facility failed to ensure the bicarbonate (bicarb) solution was not expired and the bicarbonate Solution Delivery System was labeled per policy. This had the potential to negatively affect all 39 patients who dialyze at the facility. Findings include: Facility Policy: Concentrate Labeling Requirements Published: 9/5/23 Reference Number: 46300 Version: 6 ...Labeling strategies must allow for positive identification of the contents of the...mixing tanks...storage tanks... Policy Temporary Labeling (Incenter...) When a tank contains a solution, a label identifying the solution must be conspicuously displayed on the tank and must remain until the tank is emptied. Mix tank labeling must include: Contents identification ...Date and time of mixing Facility Policy: Bicarbonate Concentrate Mixing Published: 6/23/22 Reference Number: 45007 Version 7 Purpose state... policy regarding the mixing of bicarb concentrate from powder. ...Definitions SDS (Solution Delivery System): A multi-function piece of equipment...includes a bicarbonate mixer and a means of delivering the prepared concentrate solution to the dialysis machines... Labeling Bicarbonate...SDS system will be labeled... Quality Assurance... The facility must perform bicarb concentrate conductivity testing...prior to using. Expiration of Bicarb Concentrate Bicarbonate solution expires 24 hours after mixing and must be used within this time period... 1. A tour of the facility water treatment area was conducted on 4/2/24 at 12:30 PM with Employee Identifier (EI) # 8, Area Technical Operations Manager. The surveyor observed the facility bicarbonate mixing system. The documentation posted on the bicarb SDS revealed bicarb solution was prepared on 4/1/24, and the preparer’s initials. The time prepared and the conductivity result was not legible. An interview was conducted with EI # 8 during the tour. The surveyor asked how long mixed bicarb was kept. EI # 8 replied, “we don’t keep it overnight, we drain and rinse the tank at the end of the day”. The surveyor asked EI # 8 when the bicarb was last mixed? EI # 8 confirmed the bicarb mixing documentation did not reveal the bicarb was disposed of 4/1/24 and mixed on 4/2/24 per policy. EI # 8 confirmed the bicarb preparation time was 4/1/24 and the conductivity result was not legible. An interview was conducted on 4/2/24 at 1:20 PM with EI # 1, Clinic Manager. who confirmed he/she mixed the bicarb this morning and failed to label the SDS per policy.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 30952 Based on observations, facility policy, the Digital Dialysate Meter Operation Manual instructions for use (IFU), and interviews, the facility failed to ensure staff followed the facility procedure for potential of Hydrogen (pH) and conductivity testing of the final dialysate. This affected two of three observations of dialysis machine preparation, including Patient Identifier (PI) # 8, PI # 3, and had the potential to negatively affect all 39 patients who dialyze at the facility. Findings include: Facility Policy: Checking Conductivity and pH of Final Dialysate Reference Number: 25912 Published: 4/11/22 Version: 9 ...purpose...provide guidelines to verify final dialysate conductivity and pH prior to initiating hemodialysis treatments and during treatments... Policy The final dialysate conductivity and pH must be tested prior to each patient’s treatment. Test Verification Prior to Treatment Incenter setting: 2 (two) staff members will verify the...pH parameters prior to treatment. Digital Dialysate Meter Operation Manual Myron L Company Water Quality Instrumentation 18 February 16 ...VI. After using the Dialysate Meter A. Maintenance of the Conductivity Cell Rinse out the conductivity cell with clean water... 1. An observation was conducted on 4/2/24 at 11:00 AM with Employee Identifier (EI) # 1, Clinic Manager, to observe the preparation of the hemodialysis (HD) machine for PI # 8, at station six. During the observation, EI # 1 obtained a dialysis sample from the HD machine at the station, entered the Tri Station test counter, poured the samples into the Myron L D 6-meter, pressed the measurement key for conductivity, then for pH, and exited the Tri Station. EI # 1 failed to have another staff verify the pH and conductivity readings, per policy and failed to rinse the conductivity cell with clean water per IFU. An interview was conducted on 4/4/24 at 11:15 AM with EI # 2, Director of Operations, who confirmed staff failed to follow the facility policy and IFU for the Myron L D-6 meter. 49894 2. An observation of care was conducted on 4/2/24 at 12:56 PM at station 10 with EI # 6, CCHT, initiating treatment for PI # 3. EI # 6 obtained a sample of dialysate and tested the pH with the Myron-L D6 meter. EI # 6 failed to obtain verification of the results by a second staff member. An interview was conducted on 4/3/24 at 2:45 PM with EI # 1 and EI # 2, who confirmed the staff failed to verify pH results by two staff members per facility policy.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 30952 Based on review of direct patient care (DPC) staff technical practice audits for water and dialysate testing, facility policy, and interviews, it was determined the facility failed to ensure the Medical Director certified staff had demonstrated competency for water skills validation. This affected seven of ten direct DPC water skills validation record reviews and had the potential to affect all 39 patients who dialyze at the facility. Findings include: Facility Policy: Medical Director Compliance Guidelines Version 3 Effective Date: 1/1/2007 ...1. Specific Medical Director Responsibilities ...Assuring adequate training of nurses and technicians... An interview was conducted on 4/3/24 at 1:30 PM with Employee Identifier (EI) # 7. Biomedical Technician II. The surveyor asked EI # 7 what role he/she had in conducting staff technical practice audits for water and dialysate testing? EI # 7 reported annual skills checkoffs were conducted by the Biomedical Technician. The surveyor requested documentation of the staff technical practice audits for the last 12 months. EI # 7 provided 2023-2024 DPC water skills validation documentation for ten staff. There were seven DPC Water Skills Validation documents with no medical director signature and date certifying competency skills validations for 7 of 10 staff. An interview was conducted on 4/4/24 at 11:10 AM with EI # 2, Director of Operations, who confirmed certification of DPC water skills had not been conducted for all staff performing water testing.”

“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: 30952 Based on observations, review of the manufacturer’s directions for use (DFU), facility policies, and interviews, it was determined the facility failed to ensure: 1. Staff followed the facility policy and bloodline manufacturer’s DFU during dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing it through a filter) treatments by maintaining the arterial drip chamber (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at the required fill level. This affected five of eleven patients dialyzing and had the potential to negatively affect all 39 patients who dialyze at the facility. 2. Staff labeled Residual Bleach test strips with the date the bottle was opened and discarded within three months. This had the potential to negatively affect all 39 patients who dialyze at the facility. 3. Expired dialysis supplies were not available for patient use. This had the potential to negatively affect all 39 patients who dialyze at the facility. Findings include: Manufacturer’s Directions for Use: Combiset Smartech Hemodialysis Blood Tubing Set Catalog Number: 03-2722-9C and 03-2742-9C Published: None Documented Priming Precautions: Prime arterial chamber approximately 90% full and venous chamber to approximately 70% full. Dialysis Treatment Precautions: ... 2. During Treatment: ... c. Maintain fluid level in arterial chamber to approximately 90% full and venous chamber at approximately 70% full. Levels may rise and fall during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Facility Policy: Patient Assessment and Monitoring Published 9/29/18 Reference Number: Not documented Version: 3 Policy: Monitoring During Treatment: Machine Parameters and Extracorporeal Circuit: Observe and ensure that: The arterial chamber is 85-95% full and venous chamber is 65-75% full. Facility Policy: Testing for Residual Bleach Using WaterCheck RC Residual Chlorine Reagent Test Strips Published: 10/24/22 Reference Number: 45010 Version: 7 ...Policy ...The opened bottle of strips will expire three months after the date the bottle is opened or on the manufacturer’s expiration date, whichever comes first. ...Procedure: Residual Bleach Test ...Step 3. Inspect the bottle...of test strips to ensure: The bottle is dated, initialed, and not expired... 1. Observations of the hemodialysis treatment area on 4/2/24 revealed the following: At 10:32 AM, the arterial drip chamber fluid level was less than 25% full at station 12. At 10:35 AM, the arterial drip chamber was less than 50% full at station 10. At 10:35 AM, the arterial drip chamber was than 25% full at station 7. At 10:35 AM, the arterial drip chamber was than 25% full at station 8. An interview was conducted on 4/2/24 at 10:46 AM, with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician (CCHT), who confirmed the arterial fluid levels were not maintained at the correct level. 2. An observation was conducted on 4/2/24 at 10:55 AM at station 1. The surveyor observed the arterial chamber of the patient’s blood line was not filled to 90% per facility policy. An interview was conducted on 4/3/24 at 2:45 PM with EI # 1, Clinic Manager, and EI #2, Director of Operations, who confirmed the staff failed to follow the manufacturer’s DFU and facility policy for maintaining the level of the arterial chamber. 3. An observation was conducted on 4/2/24 at 10:56 AM on the dialysis treatment floor at the supply counter. There was one opened bottle of Residual Chlorine Watercheck RC test strips with an expiration date of 1/25 and no opened date documented on the bottle. An interview was conducted on 4/2/24 at 12:55 PM with EI # 8 who confirmed staff failed to follow the facility policy and document the opened date on the test strip bottle. 4. Observations were conducted in the water treatment area on 4/2/24 at 12:30 PM with EI # 8, Area Technical Operation Manager. The surveyor observed one bottle of Residual Chlorine Watercheck RC test strips with an expiration date of 1/26 and no opened date documented on the bottle. An interview was conducted on 4/2/24 at 12:55 PM with EI # 8 who confirmed staff failed to follow the facility policy and document the opened date on the test strip bottle. 5. An observation was conducted on 4/2/24 at 11:30 AM at the storage cabinet/desk located on the treatment floor. there were twenty-five 17 Gauge needles for Arteriovenous fistula/Arteriovenous Graft cannulation in the drawer and available for patient use. The cannulation needles had an expiration date of 12/11/23. An interview was conducted with EI # 1 on 4/2/24 at 12:03 with EI # 1, who confirmed the needles were expired and available for patient use. 49894”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 30952 Based on review of medical records (MR), facility policies, and interview with staff, it was determined the facility failed to ensure: 1. Tuberculin skin testing (TST) was performed. 2. Pneumococcal immunizations were completed, or a vaccine declination was obtained. This affected Patient Identifier (PI) # 1, one of one new patient record reviews, and had the potential to affect all patients who dialyzed at the facility. Findings include: Facility Policy: Patient Tuberculosis Testing Published: 2/5/24 Reference Number: 47628 Version: 5 ...Background: Patients with End Stage Renal Disease (ESRD) should have at least one test for Mycobacterium tuberculosis infection to screen for tuberculosis (TB). New Admission Screening: The Mantoux Tuberculin Skin Test (TST) or the Interferon-Gamma Release Assay (IGRA) blood tests, can be used to test for Mycobacterium tuberculosis... On admission, review the medical records of each patient to determine if they have received TB testing within the last year... Patients who have no documented TB test within the last year will be tested using the TST... Documentation: Document in the electronic TB Testing Assessment results of TB test... Facility Policy: Pneumococcal Vaccine for Adults Published: 2/5/24 Reference Number: 47714 Version: 6 Purpose The purpose of the policy is to reduce the incidence of Pneumococcal disease by providing immunization to eligible patients. ...Background Pneumococcal vaccination is recommended for adults diagnosed with chronic renal failure... Policy ...Obtain a declination statement for any patient who declines the pneumococcal vaccine. ...Documentation Document vaccine administration in the ...medical record and maintain the consent or declination in the patient’s medical record. If the pneumococcal vaccine is not administered, document the reason in the...record. 1. PI # 1 was admitted to the facility on 2/7/24 with a diagnosis of ESRD. Review of the MR revealed no documentation PI # 1 had received a TB test within the past year. There was no documentation a new patient screening for TB was completed. Further review of the MR revealed no documentation PI # 1 was offered or refused the pneumococcal vaccination per facility policy. An interview was conducted on 4/4/24 at 9:50 AM with Employee Identifier (EI) # 1, Clinic Manager, who confirmed there was no documentation PI # 1 was offered or refused the pneumococcal vaccination.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 49894 Based on Medical Record (MR) review, review of facility policy, and staff interview it was determinined the facility failed to ensure staff performed and documented blood pressure, pulse, and safety check every thirty minutes or more as needed but not to exceed forty-five minutes per facility policy. This affected three of five medical records reviewed, including Patient Identifier (PI) # 2, PI # 4, and PI # 1, and had the potential to negatively affect all patients who dialize at this facility. Findings include: Facility Policy: Patient Assessment and Monitoring Reference Number: 45284 Version: 4 Published: 5/1/23 ... During treatment: Obtain blood pressure and pulse rate every thirty minutes or more as needed but not to exceed forty-five minutes... 1. PI # 2 was admitted to the facility on 7/29/21 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Sheet (TS) dated 3/12/24 revealed no blood pressure, pulse, or safety checks documented from 8:35 AM to 9:33 AM, which is fifty-eight minutes, and not within the forty five minutes per facility policy. Review of the TS dated 3/19/24 revealed no blood pressure, pulse, or safety checks documented from 5:50 AM until 7:00 AM, which was one hour and ten minutes, and not within the forty-five minutes per policy. An interview was conducted on 4/4/24 at 9:35 AM with Employee Identifier (EI) # 1, Clinic Manager, who confirmed the staff failed to document blood pressure, pulse, and safety checks per facility policy. 2. PI # 4 was admitted to the facility on 6/19/23 with a primary diagnosis of ESRD. Review of the TS dated 3/25/24 revealed no blood pressure, pulse, or safety checks documented from 10:02 AM to 10:54 AM, which was fifty-two minutes, and not within forty-five minutes per policy. An interview was conducted on 4/4/24 at 9:45 AM with EI # 1, who confirmed staff failed to document blood pressure, pulse, and safety checks per facility policy. 30952 3. PI # 1 was admitted to the facility on 2/7/24 with a diagnoses of ESRD. Review of the TS dated 3/22/24 revealed no blood pressure and pulse were documented from 2:44 PM to 4:11 PM, which was eighty-seven minutes and greater than forty-five minutes. Review of the TS dated 3/29/24 revealed no blood pressure and pulse were documented from 1:03 PM to 2:06 PM, which was sixty-three minutes and greater than forty-five minutes. An interview was conducted on 4/4/24 at 9:50 AM with EI # 1, who confirmed staff failed to monitor and document the blood pressure and pulse at least every forty-five minutes per policy.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 49894 Based on medical record (MR) review, facility policy, and staff interview it was determined the facility failed to ensure: 1. Staff administered treatments per the physician’s order for Blood Flow Rate (BFR). 2. Staff administered treatment per the physician’s order for Dialysate Flow Rate (DFR). This affected five of five medical records reviewed including Patient Identifier (PI) # 1, PI # 2, PI # 3, PI # 4, and PI # 5 has the potential to negatively affect all patients who dialyze at the facility. Findings include: 1. PI # 1 was admitted to the facility on 2/7/24 with a diagnosis of End Stage Disease (ESRD). Review of the Order Summary Report (OSR) dated 3/11/24 revealed an ordered BFR 350, and DFR manual 800. Review of the Treatment Sheet (TS) dated 3/20/24 revealed the BFR was 400 from 1:03 PM to 4:31 PM. There was no documentation why the BFR was not 350 as ordered. Review of the TS dated 3/25/24 revealed the BFR was 300 from 1:35 PM to 4:07 PM, the entire treatment. There was no documentation why the BFR was not 350 as ordered. Review of the TS dated 3/27/24 revealed the BFR was 400 from 12:18 PM to 4:15 PM. There was no documentation why the BFR was not 350 as ordered. Review of the TS dated 3/29/24 revealed the BFR was 400 from 11:58 AM to 3:54 PM. There was no documentation why the BFR was not 350 as ordered. Review of the TS dated 4/1/24 revealed the BFR was 400 from 1:31 PM to 4:33 PM. There was no documentation why the BFR was not 350 as ordered. An interview was conducted on 4/4/24 at 9:50 AM with Employee Identifier (EI) # 1, Clinic Manager, who confirmed staff failed to maintain the physician ordered BFR for five of six treatments reviewed. 2. PI # 2 was admitted to the facility on 7/29/21 with the primary diagnosis of ESRD. Review of the OSR dated 4/3/24 revealed hemodialysis treatment orders dated 2/15/24 that included BFR of 400. Review of the TS dated 3/18/24 revealed the BFR was 300 from 12:05 PM to 3:53 PM with no reason documented why it was not 400 as ordered. An interview was conducted on 4/4/24 at 9:35 AM with EI # 1, who confirmed the staff failed to follow the physician’s order for BFR in one of six treatments reviewed in one of six treatments reviewed per facility policy. 3. PI # 3 was admitted to the facility on 12/19/23 with the primary diagnosis of ESRD. Review of the OSR revealed hemodialysis treatment orders dated 3/12/24 that included a BFR of 250 and DFR of 400. Review of the TS dated 3/19/24 revealed the BFR was 350 from 1:04 to 3:30 PM with no reason documented why it was not 250 as ordered. Review of the TS dated 3/21/24 revealed the BFR/DFR was 300/800 from 11:39 AM to 2:10 PM with no reason documented why it was not 250/400 as ordered by the physician. Further review of the TS dated 3/21/24 revealed the BFR was 300 from 2:10 to 3:26 PM with no reason documented why it was not 250 as ordered. Review of the TS dated 3/26/24 revealed the BFR was 400 from 12:12 to 2:59 PM with no reason documented why it was not 250 as ordered. Review of the TS dated 3/28/24 revealed the BFR/DFR was 400/800 from 11:22 AM to 2:36 PM with no reason documented why it was not 250/400 as ordered. An interview was conducted on 4/4/24 at 9:38 AM with EI # 1, who confirmed the staff failed to follow the physician’s order for BFR/DFR in four of six treatments reviewed. 4. PI # 4 was admitted to the facility on 6/19/23 with the primary diagnosis of ESRD. Review of the OSR revealed hemodialysis treatment orders dated 3/20/24 which included a BFR of 400. Review of the TS dated 3/20/24 revealed the BFR was at 300 from 5:58 AM to 7:40 AM with no reason documented why the BFR was not 400 as ordered. An interview was conducted on 4/4/24 at 9:45 AM with EI # 1, who confirmed the staff failed to follow the physician’s order for BFR in one of six treatments reviewed per facility policy. 5. PI # 5 was admitted to the facility on 8/2/21 with the primary diagnosis of ESRD. Review of the OSR revealed hemodialysis treatment orders dated 3/19/24 that included a BFR of 350. Review of the TS dated 4/2/24 revealed the BFR was 300 from 08:10 to 11:14 AM with no reason documented why it was not 350 as ordered. An interview was conducted on 4/4/24 at 9:40 AM with EI # 1, who confirmed the staff failed to follow the physician’s order for BFR in one of six treatments reviewed. 49797 30952”

“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: 49894 Based on observation, review of medical records (MR) and facility policy, and staff interview, it was determined the facility failed to ensure staff: 1. Performed ArteriovenousFistula/Arteriovenous Graft (AVF/AVG) site preparation per facility policy. 2. Documented assessment and cleaning of the vascular access on the treatment record prior to initiation of treatment per facility policy. This affected two of three observations of initiation of treatment with an AVF/AVG including Patient Identifier (PI) # 8 and PI # 3 and one of five medical records reviewed including PI # 4, and had the potential to negatively affect all patients who dialyze at this facility. Findings include: Facility Policy: Access Assessment and Cannulation Reference Number: 45178 Version: 3 Published: 7/5/22 Background: ...The access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin. Policy: Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session. Assessment of Vascular Access: Follow the steps below to assess the vascular access: 1. Prior to treatment, ask patient to wash access area with soap and water per hand hygiene procedure. Wash access (per above) if patients unable to clean their access. 2. Wash hands and don Personal Protective Equipment (PPE): gloves... ...5. Look... 6. Listen... 7. Feel... ...9. Remove gloves and perform hand hygiene. Don new gloves. Skin Disinfection: Step 1: Disinfect cannulation sites as follows using any of the disinfectants below: 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward two inches in a concentric circle for 30 seconds and allow to dry before cannulating. Step 2: Perform skin asepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection... Chevron Method: Follow the steps in the table below to secure the fistula needle using the chevron method: ... 4. Place the following directly over the venipuncture site to prevent the migration of bacteria down the needle into the sterile blood stream. Band-Aid or other adhesive dressing, 2x2 Gauze pad and tape. 1. An observation was conducted on 4/2/24 at 11:09 AM at station 6 with Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician (CCHT), to initiate dialysis with an AVF/AVG for PI # 8. EI # 6 cleaned the arterial cannulation site with an alcohol pad for six seconds and the venous cannulation site for five seconds. EI # 6 failed to apply the alcohol over the cannulation sites for thirty seconds. EI # 6 cannulated the access sites, and taped the needles. EI # 6 failed to apply Band-Aid or other adhesive dressing, 2x2 (two inch width and 2 inch length) gauze pad to the access sites per policy. An interview was conducted on 4/3/24 at 2:45 PM with EI # 1, Clinic Manager, and EI # 2, Director of Operations, who confirmed staff failed to follow the facility policy and clean each access cannulation site for thirty seconds, and apply Band-Aid or other adhesive dressing, 2x2 gauze to the cannulation sites. 2. An observation was conducted on 4/2/24 at 12:56 PM at station 10 with EI # 6 initiating treatment with an AVF/AVG for PI # 3. EI #6 did not verbally confirm with the patient that they had washed their access with soap and water or wash the access with soap and water themselves prior to initiating skin antisepsis. EI # 6 cleaned the venous access of the patient’s AVG for ten seconds and allowed to it dry for fifteen seconds. Before cannulating the venous access, EI # 6 touched the skin on the access and did not re-clean the access before inserting the needle. EI # 6 did not clean the arterial access with an alcohol pad before inserting the cannulation needle. An interview was conducted on 4/3/24 at 2:45 PM with EI #1 and EI # 2, who confirmed the staff failed to follow the facility policy for access site preparation. 3. PI # 4 was admitted to the facility on 6/19/23 with the primary diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Sheet dated 3/20/24 revealed the assessment and skin disinfection of the patient’s AVG was not documented prior to cannulation and initiation of treatment. An interview was conducted on 4/4/24 at 9:45 AM with EI # 1, who confirmed assessment and skin disinfection of the patient’s AVG was not performed per facility policy. 30952”

“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: 30952 Based on review of medical records (MR), facility policy, and interviews, it was determined the staff failed to ensure: 1. The interdisciplinary team (IDT) signed the Plan of Care within the required timeframe as directed per the facility policy. 2. The patient signed the POC, or refusal to sign was documented in the MR. This affected two of five MR’s reviewed, including Patient Identifier (PI) # 1 and PI # 4 and had the potential to negatively affect all patients who dialyze at this facility. Findings Include: Facility Policy: Comprehensive Interdisciplinary Assessment and Plan of Care Published: 7/3/22 Version: 6 Purpose: The purpose of this policy is to provide guidance on the requirements for the Comprehensive Interdisciplinary Assessment (CIA) and the patient Plan of Care (POC). ...General Policy for Patient Assessment and POC The CIA and POC must be developed and implemented by an... IDT consisting of at a minimum, the patient or patient’s designee, the registered nurse, the...attending physician... social worker (SW)...and registered dietician (RD)... The CIA and POC...must be completed electronically in the patient’s medical record. The POC must be signed at the time of the IDT meeting for those attending in person... Comprehensive Assessment Participation and POC Review ...The patient’s level of participation is determined by the patient. The patient must sign the POC meant to acknowledge the information in the POC. If the patient chooses not to sign their POC, the reason for refusal must be documented in the patient’s MR. 1. PI # 1 was admitted to the facility on 2/7/24 with a diagnosis of End Stage Renal Disease (ESRD). Review of the MR revealed an Initial Stable Plan of Care dated 3/6/24 with documentation all IDT members attended the POC meeting in person on 3/6/24. The Medical Director signature of approval was dated 3/20/24, which was 14 days after the POC meeting, the SW signed and approved the POC on 3/12/24, which was seven days after the meeting, and the RD signed and approved the POC on 3/8/24, which was two days after the POC meeting. The IDT failed to sign and approve the POC at the time of the IDT meeting. An interview was conducted on 4/4/24 at 9:50 AM with Employee Identifier (EI) # 1, Clinic Manager, who confirmed the IDT failed to follow the facility policy for CIA assessment and POC completion. 2. PI # 4 was admitted to the facility on 6/19/23 with a primary diagnosis of ESRD. Review of the MR revealed the POC dated 1/26/24 was not signed by the patient. There was no documentation of the patient’s refusal to sign the POC. An interview was conducted on 4/4/24 at 9:45 AM with EI # 1, who confirmed the patient had not signed the POC and there was no documentation of the patient’s refusal to sign the POC per facility policy. 49894”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 49894 Based on review of facility policy, facility Quality Assessment and Performance Improvement (QAPI) data, and staff interview, it was determined the facility failed to ensure the QAPI program tracked and trended complete patient data used for mortality. This had the potential to negatively affect all patients dialyzing at the facility. Findings include: Facility Policy: Quality Assessment and Performance Improvement Program Reference Number: 25799 Version: 5 Published: 5/2/22 Purpose: This policy outlines the purpose, structure, and required activities of the QAPI Program. Policy: ... QAPI requires the use of aggregate patient data to evaluate the facility patient outcomes...QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. QAPI Meeting Objectives: The QAPI team will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. An effective and successful review of the QAPI meeting and program activities will include: ... Performing a Root Cause Analysis on the identified opportunities to include: Identification of commonalities, circumstances, conditions or barriers that are impacting quality improvement and facility indicators. Review of the facility’s Mortality Analysis in eQUIP (Electronic Quality Improvement Program, the facility’s data tracking tool) on 4/4/24 at 11:20 AM revealed nine deaths in the last twelve months (one in February 2024, two in October 2023, two in August 2023, one in July 2023, one in June 2023, one in April 2023, and one in March 2023) Of those nine, only one had a cause of death listed. Further review of the eQUIP data revealed the facility did not have an action plan for Mortality tracking. Review of the facility’s QAPI meeting minutes for the past six months, October 2023-March 2024, revealed patient cause of death was discussed in the QAPI meetings. The January QAPI meeting minutes revealed identification of the need for the cause of death to be entered into the Mortality Workbook in eQUIP. Further review of QAPI meeting minutes revealed the QAPI team did not initiate an action plan for tracking Mortality data. An interview was conducted on 4/4/24 at 11:40 AM with EI # 1, Clinic Manager, who confirmed the facility failed to track and trend patient mortality information per facility policy.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 49797 Based on review of the facility policy, Patient Grievance log documentation and interviews, it was determined the facility failed to ensure: 1. Patient Grievance Log documentation was complete. 2. A meeting with the patient/representative was conducted within 5 days to discuss the grievance, resolve it as quickly as possible, and provide periodic updates to the patient per facility policy. This had the potential to negatively affect all patients with a grievance treated at the facility. Findings include: Facility Policy: Patient Grievance Version: 3 Published: 1/2/14 Purpose: To comply with the federal and state regulations and ,the Health Insurance Portability and Accountability Act (HIPAA). To provide guidance to FKC staff on handling patient grievances. To inform patients, or patient representative of the FMCNA Grievance Process. Policy: ... Responsibility of the Nurse in Charge or Team leader: Meeting with the patient /representative within 72 hours of being notified of the grievance. Assisting in assessing and resolving patient grievances as appropriate. Completing as many fields on the Patient Grievance Status Report. Responsibility of the Clinical Manager: Reviewing the Patient Grievance Status Report daily. Meeting with the patient /representative within 5 days to discuss the grievance, resolve it as quickly as possible, and provide periodic updates to the patient. Documenting actions taken on the patient Grievance Status Report and reporting this information to the QAI Committee. Escalating unresolved grievances to the attention of the Director of Operations / Area Manager. Ensuring the facility is adhering to the Patient Grievance Policy... A review of the facility Patient Grievance Log documentation for the past six months, October 2023- March 2023, conducted on 4/4/24, revealed three of five patient grievances without complete documentation and/or follow up. An unsampled patient # 1 grievance dated 11/17/23 revealed no documentation of patient education regarding the resolution of the grievance. A second grievance dated 2/12/24 revealed the patient was unaware of the resolution of the first grievance. An unsampled patient # 2 grievance dated 2/4/24 revealed the staff failed to document the date resolved, and the resolution. An interview was conducted on 4/4/24 at 12:55 with Employee Identifier # 1, Clinic Manager, who confirmed the grievances were not properly completed per facility policy.”

“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: 49894 Based on review of facility policies, facility Hepatitis B Vaccine Record, Quality Improvement Action (QIA) Plan, Quality Assessment and Performance Improvement (QAPI) data, and staff interview, it was determined the facility failed to develop a performance improvement action plan for Hepatitis B vaccinations per facility policy. This had the potential to negatively affect all patients who dialyze at the facility. Findings Include: Facility Policy: Patient Vaccination for Hepatitis B Published 2/7/22 Policy Number: 47676 Version 5 Purpose: Provide guidance for hepatitis B vaccination. Hepatitis B Vaccine: Guidelines The Hepatitis B vaccine (HBV) shall be offered to all susceptible patients... ...Patients shall sign a vaccination consent/declination form. ...A protective antibody response is 10 or more multigenerational units per milliliter... Declination: ...Each offering of the vaccine should be documented in the patient’s medical record. Facility Policy: Quality Assessment and Performance Improvement Program Reference Number: 25799 Version: 5 Published: 5/2/22 Purpose: This policy outlines the purpose, structure, and required activities of the QAPI Program. Policy: ... QAPI requires the use of aggregate patient data to evaluate the facility patient outcomes. QAPI Meeting Objectives: The QAPI team will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. An effective and successful review of the QAPI meeting and program activities will include: ... Performing a Root Cause Analysis on the identified opportunities to include: Identification of commonalities, circumstances, conditions or barriers that are impacting quality improvement and facility indicators. Following a root cause analysis, action plans will be determined and prioritized by the QAPI Committee. Review of the facility’s Hepaptits B Vaccination data in eQUIP (Electronic Quality Improvement Program, the facility’s data tracking tool) on 4/4/24 at 11:20 AM revealed a six month declining trend in Hepatitis B vaccinations being administered to patients who are susceptible and have not received or declined the vaccine from 94.1% in September 2023 to 81.6% in February 2024, with eight current patient outliers (patients who have not received the hepatitis b vaccination). Review of the facility’s QAPI meeting minutes from October 2023 to March 2024 revealed the QAPI team had discussed the declining trend in hepatitis B Vaccinations and identified the patient outliers but had not developed an action plan in regard to the declining trend. An interview was conducted on 4/4/24 at 11:30 AM with Employee Identifier # 1, Clinic Manager, who confirmed the facility failed to develop an action plan for Hepatitis B Vaccinations per facility policy.”