Dialysis Center of Western Massachusetts

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 44223 Based on observations, staff interview, and review of the Centers for Disease Control (CDC) Infection Control Requirements for Dialysis Facilities, the facility failed to ensure 1 of 2 staff members (Registered Nurse [RN] #3) observed, removed potentially contaminated personal protective equipment (PPE) before entering the medication preparation area and preparing patient intravenous medication. Findings Include: Review of the Centers for Disease Control (CDC) Infection Control Requirements for Dialysis Facilities and Clarification Regarding Guidance on Parenteral Medication Vials, dated 8/15/08, included the following: *CDC recommends that all parenteral medications should be prepared in a clean area separate from potentially contaminated items and surfaces. In hemodialysis settings where environmental surfaces and medical supplies are subjected to frequent blood contamination, medication preparation should occur in a clean area removed from the patient treatment area. Proper infection control practices must be followed during the preparation and administration of injected medications. This is consistent with official CDC recommendations for infection control precautions in hemodialysis. On 7/17/24 at 11:30 A.M., during observation of the medication preparation and administration task, the surveyor observed RN #3 enter the medication preparation area wearing a gown that had been worn in and out of patient dialysis stations to care for other patients. At no time did RN #3 remove the gown prior to entering the medication preparation area. He/she prepared the intravenous medication heparin (blood thinning agent) 3000 units, left the medication area with his/her gown still on, then entered station #4 wearing the same gown, to administer the medication. During an interview on 7/17/24 at 3:15 P.M., the Clinic Manager said staff should not be wearing PPE in the medication preparation area because that area is considered to be a clean area.”

“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: 37700 Based on observation, interview, and policy review, the facility failed to ensure 1.) 2 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #1 and #2) observed, adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the hemodialysis station, increasing the risk of cross contamination of blood borne pathogens; and 2.) 7 of 15 blood pressure (BP) cuffs were free of lint and debris to allow for proper disinfection, and to reduce the risk of the spread of infection. Findings include: Review of the facility policy, entitled, Cleaning & Disinfection of Equipment, Supplies & Treatment Area, dated 6/20/24, included the following: *All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure cracks/crevices come in contact with the bleach solution. This includes, but not limited to: * Dialysis machine * Chair, including the top and bottom of the chair-side table (s) * Bedside table * Television, phone * Counters and wall boxes 1 a. The facility failed to ensure that CCHT #2 adequately cleaned and disinfected all contaminated surfaces within the dialysis station, between patients, increasing the risk for cross contamination of blood borne pathogens. On 7/17/24 at 9:18 A.M., the surveyor observed CCHT #2 disinfect station #7 for the next patient. She was observed disinfecting the hemodialysis machine and hemodialysis chair using 1:100 bleached soaked pads. CCHT #2 failed to disinfect the back of the hemodialysis chair including the attached pad in the back of the chair. During an interview on 7/17/24 at 9:33 A.M., CCHT #2 said she missed cleaning the back of the chair including the pad, as required. 10249 1 b. The facility failed to ensure that CCHT #1 adequately cleaned and disinfected all contaminated surfaces within the dialysis station, between patients, increasing the risk for cross contamination of blood borne pathogens. On 7/17/24 at 9:30 A.M., the surveyor observed CCHT #1 cleaning the dialysis machine and equipment within station #13. CCHT #1 was observed to clean the machine with 1:100 bleach-soaked pads. CCHT #1 failed to clean the wall box, located behind the dialysis chair. During an interview on 7/17/24 at 9:35 A.M., CCHT #1 said she should have cleaned the wall box when cleaning the equipment in the station, but usually cleans all the wall boxes at the end of the day. 44223 2. On 7/17/24 at 9:15 A.M., during observation of the treatment area, the surveyor observed the blood pressure (BP) cuffs at 7 of the 15 stations (stations #5, 7, 9, 10, 11, 12, and 14) which were laden with lint embedded in the Velcro portion of the BP cuffs, making it difficult to adequately disinfect in between patients. During an interview on 7/17/24 at 10:30 A.M., Registered Nurse (RN) #2 said that all equipment is cleaned with bleach to the best of their ability.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 37700 Based on observation, policy review, and interview, the facility failed to ensure 1 of 2 staff (Certified Clinical Hemodialysis Technician [CCHT] #2) observed, provided adequate infection control measures during an arterio-venous fistula (AVF) cannulation, and failed to ensure the access site was cleansed and not touched after disinfection and prior to needle insertion for 1 of 2 patients (#8) observed, out of a total sample of 8 patients. Findings include: Review of the facility policy, entitled, AVF-AVG Cannulation, Treatment Initiation and Termination, dated 6/20/24, included the following: * If access is touched after being disinfected, it must be disinfected again before needle insertion. Patient #8 was admitted to the facility in May 2023 with a diagnosis of End Stage Renal Disease (ESRD), requiring dialysis. On 7/17/24 at 10:35 A.M., the surveyor observed CCHT #2 initiate treatment via an AVF for Patient #8. CCHT #2 palpated the access site and chose a cannulation site. She disinfected the access site, then let the site dry. She then palpated the access site with a gloved hand and cannulated the site (contaminating the area with a gloved hand). During an interview on 7/17/24 at 11:00 A.M., CCHT #2 said she should not have touched the site after disinfecting it, as required.”

“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: 31240 Based on record review, policy review and interview, the facility failed to ensure staff performed repeat testing for conductivity when there was more than a 0.4 milliSiemens/centimeter (mS/cm) variance between readings, for 1 of 5 applicable patients (#5), out of a total sample of 8 patients. Findings include: Review of the facility’s policy entitled, Checking Conductivity and pH of Dialysate-Using Phoenix Meter, dated 6/20/24, included the following: *Ensure that the upper and lower alarm limits for the conductivity are set 0.5 mS/cm above and below the conductivity reading on the dialysis machine. *If there is more than a 0.4 mS/cm variance in the conductivity reading, repeat testing following the manufacturer guidelines. Patient #5 was admitted to the facility in June 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis treatments 3 times a week. Review of 9 treatment sheets, dated 6/26/24 through 7/15/24, indicated that 2 of 9 treatments, including 6/26/24 and 7/8/24, had variances in conductivity readings that were greater than 0.4 mS/cm. Further review of the documentation indicated that no repeat testing of the dialysis machine’s conductivity was performed prior to initiation of treatment for the patient, as required. During an interview on 7/17/24 at 11:42 A.M., the Clinic Manager said the staff should have performed retesting of the machine’s conductivity when the readings had a variance greater than 0.4 mS/cm”

“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: 10249 Based on observation, review of facility preventative maintenance records, Manufacturer’s Directions For Use (MDFU) review, and staff interview, the facility failed to ensure 1.) 4 of 4 dialysis machines (#2, #9, #100 and #105) were maintained per the MDFU; and 2.) 1 of 2 staff (Certified Clinical Hemodialysis Technician [CCHT] #2) observed followed the Manufacturer’s Operation User Guide-Rinsing Recommendations for rinsing the pHoenix XL Meter (used to test the pH of dialysate solution before a treatment) prior to initiation of a treatment. Failure to rinse the meter between conductivity checks can give a false reading of conductivity. Findings include: 1. Review of the MDFU for the dialysis machines included the following: * Maintenance is performed in only two intervals: six (6) months, and annually or 4000 hours of operation. Perform the Annual Preventative Maintenance procedures every 12 months or 4000 hours of machine operation, whichever comes first. *Review of the Preventative Maintenance Checklist six (6) Months form indicated there are 11 items on the dialysis machine that are inspected and cleaned. *Review of the Preventative Maintenance Checklist Annual/4000 Hour form indicated there are 29 items that are inspected and cleaned, with the addition of replacement/rebuild of 4 parts including: replace Pre-UF Pump filter, replace UF Pump Check valves, rebuild UF, Concentrate (acid), Bicarbonate Pumps, and replace Deaeration Motor Brushes. Review of the Preventative Maintenance records for dialysis machine #2 included the following: *June 6, 2023-Semi Annual preventative maintenance checklist completed with machine hours 16,037. *February 10, 2024-Annual preventative checklist was completed with machine hours of 17,412. There was a two month delay by the Biomed technician to conduct the Annual preventative maintenance. Review of the Preventative Maintenance records for dialysis machine #9 included the following: *March 7, 2023-Annual preventative maintenance checklist completed with machine hours 17,696. *February 13, 2024-Annual preventative maintenance checklist completed with machine hours 18,660. The Semi annual preventative maintenance was not performed 6 months after the annual preventative maintenance in September 2023, per MDFU. Review of the Preventative Maintenance records for dialysis machine #100 included the following: *August 25, 2022-Semi Annual preventative maintenance checklist completed with machine hours 39,406. *June 27, 2023-Annual preventative maintenance checklist completed with machine hours 39,470. *January 25, 2024-Quarterly preventative maintenance checklist completed with machine hours 39,633. There was a 4 month delay in performing the Annual preventative checklist, and a 1 month delay in conducting the semi annual preventative maintenance. Review of the Preventative Maintenance records for dialysis machine #105 included the following: *July 11, 2023-Semi annual 6 months preventative maintenance checklist completed with machine hours 26,114. *February 13, 2024-Annual preventative maintenance check list completed with machine hours 27,097. There was a 1 month delay in conducting the Annual preventative maintenance checklist. During an interview on 7/16/24 at 2:05 P.M., the Clinic Manager (CM) said that 3 Biomed technicians have been covering 7 clinics in the past 9 months, but she was not aware how far behind they were in performing the preventative maintenance on the dialysis machines. During an interview on 7/16/24 at 2:15 P.M., Biomed #1 said that the preventative maintenance should be performed twice a year (annual and semi annual). Biomed #1 said that he started last year (October 2023) and was aware that the maintenance of the machines was getting behind, but he was trying to catch up. He said the Annual preventative maintenance is more comprehensive and that is why he did another Annual check on machine #9, instead of a semi annual maintenance check. 37700 2. The facility failed to ensure that staff followed the Manufacturer’s Operation User Guide, Rinsing Recommendations, for rinsing the pHoenix XL meter prior to initiation of a treatment. Review of the Manufacturer’s Operation User Guide indicated that treated water (RO-reverse osmosis-a water purification process, DI-demineralized water or distilled water) be the only choice for rinsing meters. On 7/17/24 at 11:10 A.M., the surveyor observed CCHT #2 obtain a water sample from a dialysis machine at Station #10. She brought the sample to the counter, withdrew the sample with a syringe into the pHoenix XL Meter, then read the results. She failed to flush the meter prior to use. During an interview on 7/17/24 at 11:44 A.M., the CM said the pHoenix meter should be rinsed 3 times with RO water prior to each use. During an interview on 7/17/24 at 12:10 P.M., CCHT #2 said she did not rinse the pHoenix meter prior to use, as required.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 31240 Based on record review, policy review and interview, the facility failed to ensure that the interdisciplinary team (IDT) completed an initial comprehensive assessment within 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session for 1 of 7 applicable patients (#5), out of a total sample of 8 patients. Findings include: Review of the facility policy entitled, Comprehensive Patient Assessments, revised 3/28/23, included the following: *When a new patient is admitted to the dialysis center, a comprehensive patient assessment will be completed on the patient within the latter of the 30 calendar days or 13 outpatient hemodialysis treatments. *All comprehensive patient assessments shall be documented using the electronic medical record system. Patient #5 was admitted to the facility in June 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis 3 times a week. Review of the clinical record indicated Patient #5 began his/her in-center hemodialysis treatments on 6/5/24. Review of the clinical record indicated that no comprehensive initial assessments had been completed by the IDT. During an interview on 7/17/24 at 10:00 A.M., the Regional Clinical Manager said an initial comprehensive assessment is required to be completed within 30 days of admission, or 13 hemodialysis treatments. During an interview on 7/17/24 at 11:48 A.M., the Clinic Manager said Patient #5’s initial comprehensive assessments had not been completed within the required timeframe.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; This Standard is not met as evidenced by: 44223 Based on record review, staff interview, and facility policy review, the facility failed to ensure the physician completed an annual comprehensive assessment for 1 of 7 applicable patients (#1), out of a total sample of 8 patients. Findings Include: Review of the facility policy, titled Comprehensive Patients Assessments, revised 3/28/23, indicted the following: * The comprehensive patient assessment is completed by the facility’s interdisciplinary team (IDT) that consists of, at minimum: * The patient or patient’s designee (if the patient chooses) * Registered Nurse (RN) * Physician treating the patient for ESRD (or Nurse Practitioner or Physician Assistant) * Social Worker * Dietitian * Care Coordinator (Center Manager) * Ongoing comprehensive patient reassessments will be completed at the following times: * Annually for patients deemed stable by the IDT * Monthly for patients deemed unstable by the IDT * The Center Medical Director shall: * Review the Assessment and Treatment Plan report monthly to confirm that all scheduled patients are current * Follow up with medical staff behind on the process or who decline to participate in the patient assessment/reassessment process and/or attend treatment plan meetings on a scheduled basis. For Patient #1, the facility failed to ensure the physician conducted an annual comprehensive assessment as required. Patient #1 was admitted to the facility in October 2021 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Review of the clinical record indicated the most recent annual comprehensive assessment was completed in January 2024. Review of the assessment indicated each interdisciplinary team member completed their annual comprehensive assessment except for the physician. During an interview on 7/16/24 at 1:00 P.M., the Clinic Manager said the physician did not complete his required section of the annual comprehensive assessment. She said they have had a change in physicians and they are hoping to have a better system to ensure the assessments are completed. She said she does not have an answer as to why the physician did not complete the assessment.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 10249 Based on record review, interview, and policy review, the facility failed to ensure an unstable comprehensive re-assessment and revision of the plan of care was conducted after an extended hospitalization stay greater than 15 days, for 1 of 7 applicable patients (#3), out of a total sample of 8 patients. Findings Include: Review of the facility policy entitled, Comprehensive Patient Assessment, revised 3/28/23, indicated the following: *The following criteria should be used by the IDT (interdisciplinary team) whenever a comprehensive patient assessment is done to determine if the patient is or has become unstable. *Extended hospitalization (longer than 15 days). *After a patient has been deemed unstable, there must be documentation that the patient has been re-assessed monthly (for at least 1 month) with the plan of care revised to address the issues related to the unstable status. If the IDT (including the patient) deems that the patient’s status has either returned to stable or is chronic and the active care plan adequately addresses the issue, then the patient may be deemed stable. Patient #3 was admitted to the facility in January 2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated that Patient #3 had a comprehensive assessment completed in May 2023, with a plan of care developed based on that assessment. Further review of the clinical record indicated that Patient #3 had been hospitalized from 5/1/24 through 5/24/24, then returned to the hospital from 5/25/24 through 5/28/24, for a total of 28 days, for chest pain and hyponatremia (low sodium level in the blood). During an interview on 7/17/24 at 2:55 P.M., the Clinic Manager said the team had developed an annual assessment and care plan in May 2024, during the patient’s hospitalization, however it should have not been done. The Clinic Manager said the patient should have be reassessed when he/she returned from the hospital.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 31240 Based on record review, and staff interview, the facility failed to ensure that the Interdisciplinary Team (IDT) developed and implemented a written, individualized plan of care (POC) for each patient that included services necessary to address patients’ needs, measurable and expected outcomes, and estimated timetables to achieve these outcomes, for 2 of 7 applicable patients (#4 and #5), out of a total sample of 8 patients. Findings include: 1. For Patient #5, the facility failed to ensure the IDT had developed an individual POC to meet care and service needs for hemodialysis, after the patient had been admitted. Patient #5 was admitted to the facility in June 2024 with a diagnosis of End Stage Renal Disease requiring hemodialysis 3 times a week. Review of the clinical record indicated that the IDT had not developed an individualized POC, nor completed comprehensive initial assessments of the patient. During an interview on 7/17/24 at 10:00 A.M., the Regional Clinical Manager said the POC is developed after an initial comprehensive assessment is completed. During an interview on 7/17/24 at 11:48 A.M., the Clinic Manager said Patient #5’s neither the initial comprehensive assessments nor the POC had been developed or completed, as required. 44223 2. For Patient #4, the facility failed to ensure the patient had a complete and individualized plan of care that included services necessary to address patient needs and changes in patient’s condition, measurable and expected outcomes, and estimated timetables to achieve these outcomes completed annually. Patient #4 was admitted to the facility in June 2022 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated that the facility completed an annual comprehensive assessment on 9/7/23. Further review of the clinical record indicated the facility failed to develop an individualized plan of care based on the annual comprehensive assessment for the patient. During an interview on 7/16/24 at 1:00 P.M., the Clinic Manager said there was no care plan developed for Patient #4.”

“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: 10249 Based on observation, interview, and record review, the facility failed to ensure the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate (BFR-speed (measured in milliliters per minute [ml/min]) in which the patient’s blood is pushed through the dialyzer and back into the body) and Dialysate Flow Rate (DFR-the measurement of how fast the dialysate solution flows in ml/min to draw toxins from the patient’s blood) during the process of dialysis, for 1 of 4 prescriptions (Patient #5) reconciled; and for 1 of 5 applicable patients (Patient #5) reviewed, out of total sample of 8 patients. Findings include: Patient #5 was admitted to the facility in June 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. a. For Patient #5, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the DFR. Review of the physician order, dated 7/15/24, indicated the dialysis order included a DFR to be delivered at a rate of 800. On 7/17/24 at 9:15 A.M., the surveyor observed Patient #5 receiving dialysis treatment and the machine was set to a DFR of 500, and not 800 as ordered. During an interview on 7/17/24 at 9:20 A.M., Certified Clinical Hemodialysis Technician (CCHT) #2 verified the patient’s prescription and said the DFR should be 800. CCHT #2 said that Registered Nurse (RN) #1 had started Patient #5 on his/her dialysis treatment that day. During an interview on 7/17/24 at 9:40 A.M., RN #1 said it was a mistake and she should have set the rate to 800 and not 500. 31240 b. For Patient #5, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the BFR and DFR. Review of the Physician’s orders, dated 6/21/24 and 7/1/24, indicated the BFR was to be delivered at a rate of 400 ml/min. Review of the Physician’s order, dated 7/5/24, indicated the DFR was to be delivered at a rate of 600 ml/min. Review of the 9 Hemodialysis Flowsheets, dated 6/26/24 through 7/15/24, indicated the BFR and/or DFR had not been delivered as prescribed for 3 of 9 treatments, including the following: *6/21/24 - the BFR was delivered at a rate of 350 ml/min, not 400 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. * 7/5/24 - the BFR was delivered at a rate of 300 to 350 ml/min, not 400 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *7/10/24 - the DFR was delivered at a rate of 500 ml/min, not 600 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 7/17/24 at 12:00 P.M., the Clinic Manager (CM) said the BFR and DFR should have been delivered as prescribed, or staff should have documented why a change was made.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 10249 Based on record review, policy review, and staff interview, the facility failed to complete necessary psychosocial status monitoring by failing to complete standardized mental and physical assessment tool (KDQOL-36) chosen by the Social Worker (SW) within four months of initiating treatment (or first reassessment) and at least annually, at regular intervals for 4 of 7 applicable Patients (#2, #3, #4, and #6), out of a total sample of 8 patients. Findings include: Review of the facility policy entitled, Comprehensive Patient Assessment, last revised 3/28/23, indicated the following: *The KDQOL-36 is the standardized mental and physical assessment tool designated by the facility for use by Social Workers to determine the patient’s perceived physical and mental functioning and incorporating findings in the patient’s comprehensive assessment and treatment plan. This survey should be administered within 4 months of initiating treatment at the facility. Subsequently, it should be administered annually at minimum with the patients comprehensive assessment to ensure that accurate patient data is incorporated into the comprehensive patient assessment and treatment plan. 1. For Patient #6, the facility failed to ensure the KDQOL-36 had been completed at least annually. Patient #6 was admitted to the facility in February 2023 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Review of the annual comprehensive assessments indicated that the Social Worker (SW) had completed a comprehensive psychosocial status assessment on 5/21/24, which indicated that the KDQOL-36 was not administered. Review of the clinical record indicated that there was no evidence that Patient #6 was given, and/or completed, the KDQOL-36 survey, or is he/she had refused to complete it. During an interview on 7/17/24 at 8:40 A.M., the Clinic Manager said that there was documentation from 9/11/23 that Patient #6 had refused to complete the survey the previous year, however Patient #6 was never offered a new KDQOL-36 to complete for the annual review. During an interview on 7/17/24 at 8:45 A.M., the SW said she is new to the facility and cannot speak to why the patient did not complete the KDQOL-36. She said the KDQOL-36 should coordinate with the annual comprehensive assessment. The SW said they are working on a new system to ensure the KDQOL-36 is completed timely. 2. For Patient #3, the facility failed to ensure the KDQOL-36 had been completed at least annually, or after an unstable care plan was developed. Patient #3 was admitted to the facility in January 2023 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Patient #3 had an extended hospitalization (28 days) in May 2024 which required him/her to have a comprehensive reassessment and new care plan developed. Review of the clinical record indicated that a KDQOL-36 survey was not offered to the patient to complete. During an interview on 7/17/24 at 8:45 A.M., the SW said Patient #3 had completed a survey last year, but was not offered a KDQOL-36 survey to be complete after his/her return from the hospital. 44223 3. For Patient #2, the facility failed to ensure the KDQOL-36 had been completed at least annually. Patient #2 was admitted to the facility in January 2020 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Review of the annual comprehensive assessment, dated 4/10/24, indicated that the SW had completed a comprehensive psychosocial status assessment on 4/16/24 which indicated that the KDQOL-36 was not administered. Review of the clinical record indicated that a depression screen was completed in June 2024, however there was no evidence that Patient #2 was given and/or completed the KDQOL-36 survey, or if he/she had refused to complete it. During an interview on 7/17/24 at 8:45 A.M., the SW said she is new to the facility and cannot speak to why the patient did not complete the KDQOL-36. She said the KDQOL-36 should coordinate with the annual comprehensive assessment. 4. For Patient #4, the facility failed to ensure the KDQOL-36 had been completed at least annually. Patient #4 was admitted to the facility in June 2022 with a diagnosis of End Stage Renal Disease (ESRD) requiring hemodialysis. Review of the comprehensive psychosocial status assessment, dated 9/12/23, indicated a copy of the KDQOL-36 was initiated for completion by the patient. Review of the clinical record indicated that the SW met with Patient #4 in November 2023 for a monthly review and completed a depression screen. The documentation indicated a KDQOL-36 was given to the patient to complete. Further review of the clinical record indicated a KDQOL-36 was given to be completed in December 2023. The documentation did not include any further information from the SW whether the patient was provided education on the completion of the KDQOL-36. The clinical record failed to indicate any documented evidence Patient #4 had completed the KDQOL-36 or if he/she had refused to complete it. During an interview on 7/17/24 at 8:45 A.M., the SW said she did not believe a KDQOL-36 was completed in 2023 for the patient and she couldn’t speak as to why it wasn’t done.”

“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: 44223 Based on record review, interview, and policy review, the facility failed to ensure the care plan was signed by 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, to ensure the patient had involvement with his/her plan of care for 2 of 7 applicable patients (#1 and #6), out of a total sample of 8 patients. Findings Include: Review of the facility policy entitled, Treatment Plans, last revision date 5/2022, indicated the following, but not limited to: * The treatment plan is developed by the centers interdisciplinary team (IDT) which included, but not limited to the: Physician, Registered Nurse with knowledge of the patient, Dietitian, Social Worker, patient and/or patient representative if desired by the patient. * The patient will be an integral part of the planning process and will be part of the interdisciplinary meeting whenever possible. If the patient is not able or chooses not to attend the meeting, the treatment plan will be discussed with him/her by a member of the healthcare team and the patient’s signature obtained on the treatment plan. * The IDT must make efforts to involve the patient and/or patient representative in the treatment plan process. The team must document efforts to include the patient in the process and the patient’s response to those efforts in the patient’s electronic medical record. * If the patient chooses not to sign the treatment plan, this choice must be documented on the treatment plan along with the reason the signature was not provided. 1. For Patient #1, the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the Comprehensive Assessment and Plan of Care review acknowledgement form; of if patient chose not to sign, there was no documentation as to why he/she did not provide a signature. Patient #1 was admitted to the facility in January 2021 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Patient #1 was receiving dialysis treatment through home hemodialysis. Review of the clinical record indicated the annual comprehensive assessment and plan of care was developed on 1/4/24. Review of the IDT signature section of the care plan included the electronic signatures of the nurse, dietitian, social worker, and physician. Patient #1’s signature was not on the document, nor was there any documented reason why Patient #1 did not provide a signature. During an interview on 7/16/24 at 1:00 P.M., the Clinic Manager said she did not know why the patient did not sign the care plan. 10249 2. For Patient #6, the facility failed to ensure that the patient’s involvement in his/her plan of care occurred by signing the annual care plan, or if the patient chose not to sign, there was documentation as to why he/she did not provide a signature. Patient #6 was admitted to the facility in February 2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the plan of care, dated 5/22/23, included a signature section which included the electronic signatures of the Interdisciplinary team (IDT). The signature section did not include Patient #6’s signature, and there was no documented evidence that the patient refused to sign, or that the plan of care was reviewed with the patient. During an interview on 7/16/24 at 2:00 P.M., the Clinic Manager said that Patient #6 wanted to change the date of the care plan meeting, so he/she did not attend on 5/22/24, however no staff ever reviewed the plan of care with the patient. The Clinic Manager said she was not aware that the patient had to sign the care plan during review, and had no system in place to ensure the care plan was reviewed with the patient, if he/she chose not to attend.”

“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: 31240 Based on interview, policy review, and Quality Assessment and Performance Improvement (QAPI) review, the facility failed to ensure the QAPI committee identified and put a plan in place relative to dialysis machine preventative maintenance. Findings include: Review of the facility policy entitled, Quality Assessment and Performance Improvement (QAPI), effective 1/2021, included the following: * When discussing data/issues related to their specific roles/job functions the following staff should be included in the QAPI meeting: Biomedical Technician. *The Interdisciplinary Team (IDT) must demonstrate effective communications and devote sufficient time and attention to producing effective QAPI activities that positively influence outcomes. * At minimum, the QAPI program must include, but not limited to, equipment maintenance. Review of the Preventative Maintenance records for dialysis machine #2 included the following: *June 6, 2023-Semi Annual preventative maintenance checklist completed with machine hours 16,037. *February 10, 2024-Annual preventative checklist was completed with machine hours of 17,412. There was a two month delay by the Biomed technician to conduct the Annual preventative maintenance. Review of the Preventative Maintenance records for dialysis machine #9 included the following: *March 7, 2023-Annual preventative maintenance checklist completed with machine hours 17,696. *February 13, 2024-Annual preventative maintenance checklist completed with machine hours 18,660. The Semi annual preventative maintenance was not performed 6 months after the annual preventative maintenance in September 2023, per MDFU. Review of the Preventative Maintenance records for dialysis machine #100 included the following: *August 25, 2022-Semi Annual preventative maintenance checklist completed with machine hours 39,406. *June 27, 2023-Annual preventative maintenance checklist completed with machine hours 39,470. *January 25, 2024-Quarterly preventative maintenance checklist completed with machine hours 39,633. There was a 4 month delay in performing the Annual preventative checklist, and a 1 month delay in conducting the semi annual preventative maintenance. Review of the Preventative Maintenance records for dialysis machine #105 included the following: *July 11, 2023-Semi annual 6 months preventative maintenance checklist completed with machine hours 26,114. *February 13, 2024-Annual preventative maintenance check list completed with machine hours 27,097. There was a 1 month delay in conducting the Annual preventative maintenance checklist. During an interview on 7/16/24 at 2:05 P.M., the Clinic Manager (CM) said that 3 Biomed technicians have been covering 7 clinics in the past 9 months, but she was not aware how far behind they were in performing the preventative maintenance on the dialysis machines. During an interview on 7/16/24 at 2:15 P.M., Biomed #1 said that the preventative maintenance should be performed twice a year (annual and semi annual). Biomed #1 said that he started last year (October 2023) and was aware that the maintenance of the machines was getting behind, but he was trying to catch up. He said the Annual preventative maintenance is more comprehensive and that is why he did another Annual check on machine #9, instead of a semi-annual maintenance check. During an interview on 7/17/24 at 1:45 P.M., the CM said she was not aware that semi annual/annual preventive maintenance had not been completed on 4 hemodialysis machines. She said the Biomed Technician should have reported these findings to the QAPI team so that a corrective plan could have been implemented by the QAPI team, to ensure all preventive maintenance was being completed.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 31240 Based on review of the Quality Assurance/Performance Improvement (QAPI) Program, staff interview, record review, and policy review, the facility failed to ensure that psychosocial assessments (KDQOL-36) were being tracked, trended and monitored accurately for completeness, including an action plan that resulted in performance improvement that were sustained overtime. Findings include: Review of the facility’s policy entitled, QAPI, dated January 2021, included the following: *The Interdisciplinary Team (IDT) must demonstrate effective communications and devote sufficient time and attention to producing effective QAPI activities that positively influence outcomes. *The QAPI program must: *Continually look at indicators for patients and associates as they are available. *Trend outcomes. *Develop an improvement plan when indicated by the data. *Implement an action plan. *Monitor the effectiveness of the plan. Review of clinical records indicated that for 4 of 7 applicable patients (#2, #3, #4, and #6), the facility failed to ensure that a standardized mental and physical assessment tool (KDQOL-36) was completed by the patient within four months of initiating treatment (or first reassessment) and at least annually, or after an unstable care plan was developed. During an interview on 7/17/24 at 9:00 A.M., the Social Worker (SW) said that she entered the dates of the KDQOL-36 assessments when they were completed and not coordinating with the annual assessments. The SW said she was new to the position and was not fully aware of the timing of KDQOL-36 assessment requirements. During an interview on 7/17/24 at 1:45 P.M., the Clinic Manager reviewed the recent QAPI data submitted by SW regarding KDQOL-36 completed assessments. She said the data submitted was incorrect, and it reflected more completed KDQOL-36 assessments than were completed, therefore an action plan had not been implemented to improve outcome and performance.”