Gary Dialysis Center

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure that emergency crash carts were checked by staff per policy, and emergency medications were not expired in 1 of 1 dialysis facility. Findings include: 1. A policy, dated 08/2017, titled “Crash Cart” indicated that the crash cart will be checked monthly, and that the person doing the checks should document and sign his/her name and title. 2. A revised policy, dated 06/11/2025, titled “G48 Medications: Handling, Administration, Storage, & Disposal”, indicated that expired medication should be immediately removed and disposed of. 3. A review of the crash cart during observation of the treatment floor on 12/17/2025, evidenced the following emergency medications had expired: A. Two vials of Solu-medrol (expiration date 11/2025) B. One vial of Epinephrine (expiration date 11/2025) 4. A document titled “Monthly Code Cart Checklist” evidenced that the last documented check was dated 11/01/2025 and did not evidence a monthly check for the month of December 2025. 5. During an interview on 12/17/2025 beginning at 3:20 PM, the FA indicated that crash cart check should be completed and documented monthly by the RN, and that the crash cart check should include checking medications for expiration dates.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure a sanitary environment in 3 of 3 observation periods of the HD treatment floor. Findings include: 1. A revised policy, dated 10/15/2025, titled “G45 Cleaning & Disinfection of Equipment, Supplies, and Treatment Area,” indicated that bleach solutions used for disinfection must be covered by a lid to prevent contamination. 2. During an observation of the HD treatment floor on 12/17/2025, beginning at 1:05 PM and ending at 3:09 PM, the following observations were made: A. Two vessels included a clear solution, labeled “1:100,” were located at the designated clean area between patient stations 6 through 10, were partially uncovered from 1:15 PM to 3:09 PM. During the observation, staff were able to enter and exit the vessel without moving the lid and failed to secure the lid upon exit of the vessel. B. A vessel with a clear solution, labeled “1:100” located at the designated clean area across from patient station 3, was partially uncovered from 1:15 PM to 2:40 PM. During the observation, staff were able to enter and exit the vessel without moving the lid and failed to secure the lid upon exit of the vessel. 3. During an observation of the HD treatment floor on 12/18/2025, beginning at 9:18 AM and ending at 10:30 AM, the following observations were made: A. A vessel with a solution, labeled “1:100”, located at the designated clean area between patient stations 18-20, was partially uncovered from 9:18 AM to 10:30 AM. During the observation, staff were able to enter and exit the vessel without moving the lid and failed to secure the lid upon exit of the vessel. B. A solution, labeled “1:100”, located in the designated clean area between patient stations 6-10, was partially uncovered from 9:18 AM to 10:30 AM. During the observation, staff were able to enter and exit the vessel without moving the lid and failed to secure the lid upon exit of the vessel. 4. During an observation of the HD treatment floor on 12/19/20205, beginning at 9:38 AM and ending at 10:25 AM, a solution, labeled “1:100”, located at the designated clean area between patient stations 18-20, was partially uncovered from 9:38 AM to 10:25 AM. During the observation, staff were able to enter and exit the vessel without moving the lid and failed to secure the lid upon exit of the vessel. 5. During an interview on 12/19/2025 beginning at 4:00 PM, the FA indicated that bleach solutions on the HD treatment floor should remain covered when not in use.”

“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: 51199 Based on observation, record review, and interview, the dialysis facility failed to perform hand hygiene and don clean gloves in 1 of 2 observations of discontinuation of dialysis with a central venous catheter [CVC] (large catheter used for dialysis) (Patient 15), 2 of 2 observations of access of and arteriovenous fistula [AVF] (dialysis access) for initiation of dialysis (Patient 14, Patient 18), and 2 of 2 observations of discontinuation of dialysis and post dialysis access care for an AVF. (Patient 12, Patient 10) Findings include: 1. A revised policy, dated 11/29/2022, titled “G40 Infection Control”, indicated that hand hygiene should be performed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions, and contaminated items. 2. During an observation on 12/18/2025 beginning at 9:37 AM, at station 18, PCT 3 was performing discontinuation of dialysis with a CVC to Patient 15. PCT 3 reinfused the extracorporeal circuit, removed gloves, and failed to perform hand hygiene before donning new gloves. 3. During an observation on 12/17/2025 beginning at 2:48 PM, at station 20, PCT 1 was performing access of an AVF to Patient 14. PCT 1 palpated the access site, removed gloves, and failed to perform hand hygiene prior to donning new gloves. 4. During an observation on 12/18/2025 beginning at 10:05 AM, at station 2, PCT 2 was performing access of an AVF to Patient 18. PCT 2 palpated the access site, removed gloves, and failed to perform hand hygiene prior to donning new gloves. 5. During an observation on 12/17/2025 beginning at 1:36 PM, at station 16, PCT 1 was performing discontinuation of dialysis and post dialysis access care for AVF on Patient 12. PCT 1 disconnected the bloodlines, removed gloves, and failed to perform hand hygiene prior to donning new gloves. 6. During an observation on 12/17/2025 beginning at 2:00 PM, at station 11, PCT 4 was performing discontinuation of dialysis and post dialysis access care for AVF on Patient 10. PCT 4 disconnected the bloodlines, removed gloves, and failed to perform hand hygiene prior to donning new gloves. PCT 4 then removed needles from Patient 10, removed gloves, and failed to perform hand hygiene prior to donning new gloves. 7. During an interview on 12/17/2025 beginning at 3:05 PM, PCT 4 indicated that hand hygiene should be performed after removing gloves.”

“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: 51199 Based on record review and interview, the dialysis facility failed to ensure they offered and or vaccinated susceptible patients against Hepatitis B in 3 of 3 patients identified as susceptible to Hepatitis B. (Patient 27, Patient 24, Patient 25) Findings include: 1. A revised policy, dated 10/15/2025, titled “G43 Hepatitis B: Control & Management”, indicated that patient that are considered susceptible to Hepatitis B will be offered the Hepatitis B vaccine series if they have not previously received two full vaccine series. 2. A review of the Hepatitis B program indicated the following: A. Patient 27 was identified as susceptible to Hepatitis B on 06/26/2025 and was not offered the Hepatitis B vaccination by the dialysis facility. B. Patient 24 was identified as susceptible to Hepatitis B on 11/18/22025, consented to administration of the Hepatitis B vaccine on 11/18/2025, and was not offered the Hepatitis B vaccine. C. Patient 25 was identified as susceptible to Hepatitis B on 07/03/2025 and was not offered the Hepatitis B vaccination by the dialysis facility. 3. During an interview, on 12/19/2025 beginning at 1:00 PM, the FA indicated the dialysis facility was unable to provide an accurate identified count of which patients were in which step of Hepatitis B vaccination. The FA relayed the clinic should have offered the Hepatitis B vaccine to susceptible patients and to those who had consented to receive the vaccine.”

“IC-HBV-TEST PTS/STAFF POST LAST DOSE CFR(s): 494.30(a)(1)(i) Hepatitis B Screening: Patients and Staff Test all vaccines [patients and staff] for anti-HBs 1-2 months after last primary vaccine dose. -- If anti-HBs is <10 mIU/mL, consider patient or staff member susceptible, revaccinate with an additional three doses, and retest for anti-HBs. -- If anti-HBs are =10 mIU/mL, consider immune, and retest patients annually. -- Give booster dose of vaccine to patients if anti-HBs declines to <10 mIU/mL and continue to retest patients annually. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to retest patients for Hepatitis B antibodies after they had received booster vaccinations for Hepatits B in 1 of 2 clinical record reviews of patients who were determined to be susceptible to Hepatitis B and received Hepatitis B booster vaccinations. ( Patient 26) Findings include: 1. A revised policy, dated 10/15/2025, titled “G43 Hepatitis B: Control & Management”, indicated that patients who receive a Hepatitis B booster vaccine should be retested 60 days post-booster to determine the patient’s antibody response to the booster dose. 2. A clinical record review for Patient 26, evidenced a Hepatitis B booster vaccination was administered on 07/03/2025. The record review failed to evidence a retest of Patient 26’s Hepatitis B antibodies since the booster administration. 3. During an interview on 12/19/2025, beginning at 1:00 PM, the FA indicated that patient should be retested for antibodies 2 months after administration of a Hepatitis B booster.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure patient safety by ensuring the hemodialysis [HD] (a process to filter the blood in a patient whose kidneys do not work normally) access sites were visible during HD treatment in 3 of 3 observation periods of in-center HD treatment. (Patient 12, Patient 10, Patient 2, Patient 11, Patient 13, Patient 17, Patient 7, Patient 21, Patient 20) Findings include: 1. A revised policy, dated 11/29/2022, titled “IC08 Monitoring & Documentation of Patient Care During Treatment”, indicated that patient vascular access should remain uncovered and readily visible throughout the course of treatment. 2. During an observation of the HD treatment floor on 12/17/2025, beginning at 1:05 PM and ending at 3:09PM, the following observations were made: A. Patient 12’s vascular access was covered by a blanket from 1:05 PM to 1:36 PM. B. Patient 10’s vascular access was covered by a blanket from 1:05 PM to 2:00 PM. C. Patient 2’s vascular access was covered by a blanket from 1:05 PM to 2:45 PM. D. Patient 11’s vascular access was covered by a blanket from 1:05 PM to 3:09 PM. E. Patient 13’s vascular access was covered by a blanket from 1:05 PM to 3:09 PM. 3. During an observation of the HD treatment floor on 12/18/20205, beginning at 9:18 AM and ending at 10:30 AM, the following observations were made: A. Patient 17’s vascular access was covered by a blanket from 9:18 AM to 9:55 AM. B. Patient 7’s vascular access was covered by a blanket from 9:18 AM to 9:55 AM. 4. During an observation period of the HD treatment floor on 12/19/2025, beginning at 9:38 AM and ending at 10:25 AM, the following observations were made: A. Patient 21’s vascular access was covered by a blanket from 9:38 AM to 9:57 AM. B. Patient 20’s vascular access was covered by a blanket from 9:38 AM to 10:03 AM. 5. During an interview on 12/19/2025, beginning at 4:00 PM, the FA indicated that access should be visible to staff throughout HD treatment.”

“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: 51199 Based on record review and interview, the dialysis facility failed to offer the pneumococcal vaccine to a patient who had consented in 1 of 1 clinical record reviews of patients who had consented to administration of the pneumococcal vaccination. ( Patient 24) Findings include: A revised policy, dated 04/08/2023, titled “G50 Vaccines”, indicated that pneumonia vaccines are routinely provided to facility patients. A clinical record review, for Patient 24 evidenced that Patient 24 consented to the administration of the pneumococcal vaccine on 11/18/2025. The record review failed to evidence that the pneumococcal vaccine had been administered to Patient 24. During an interview with the FA on 12/24/2025 beginning at 8:20 AM, the FA indicated that the facility did not administer the pneumonia vaccine to Patient 24.”

“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: 51199 Based on record review and interview, the dialysis facility failed to follow policy in regard to monitoring patient data while patients are receiving in-center hemodialysis [HD] (a process to filter the blood in a patient whose kidneys do not work normally) in 3 of 7 clinical record reviews of patients who received in-center hemodialysis. (Patient 3, Patient 4, Patient 6) Findings include: 1. A revised policy, dated 11/29/2022, titled “IC08 Monitoring & Documentation of Patient Care During Treatment”, indicated that to ensure safety during HD treatment, data (including patient blood pressure, heart rate, blood flow rate [BFR], dialysate flow rate [DFR], and ultrafiltration rate [UFR]) must be documented at least every 30 minutes. 2. A clinical record review for Patient 3, evidenced an HD Treatment Flow Sheet, dated 12/09/2025, that indicated there was no data collection of blood pressure, heart rate, BFR, DFR, and UFR between 11:02 AM and 12:00 PM, and between 1:32 PM and 2:30 PM. 3. A clinical record review for Patient 4, evidenced an HD Treatment Flow Sheet, dated 11/04/2025, that indicated there was no data collection of blood pressure, heart rate, BFR, DFR, and UFR between 10:02 AM and 11:00 AM. 4. A clinical record review for Patient 6, evidenced an HD Treatment Flow Sheet, dated 11/21/2025, that indicated there was no data collection of blood pressure, heart rate, BFR, DFR, and UFR between 6:01 AM and 6:59 AM. An HD Treatment Flow Sheet, dated 12/12/2025, indicated there was no data collection of blood pressure, heart rate, BFR, DFR, and UFR between 5:48 AM and 6:35, and 8:04 AM and 8:59 AM. 5. During an interview on 12/22/2025, beginning at 2:30 PM, the FA indicated they did not know what occurred to casue these lapses in monitoring and relayed monitoring of in-center HD patients should be documented every 30 minutes or more frequently if needed.”

“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: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure PCT’s (PCT1, PCT 2) performed aseptic technique when accessing the arteriovenous fistula [AVF] (dialysis access) for initiation of dialysis in 2 of 2 observations of access of an AVF for initiation of dialysis. (Patient 14, Patient 18) Findings include: 1. A revised policy, dated 06/20/2024, titled “IC04A AVF-AVG Cannulation, Treatment Initiation and Termination” indicated that if the access site is touched after being disinfected, it must be disinfected again before needle insertion. 2. During an observation on 12/17/2025 beginning at 2:28 PM, PCT 1, at station 20, was performing access of an AVF for initiation of dialysis on Patient 14. PCT 1 disinfected the access site, repalpated and touched the site, and failed to disinfect the access site again prior to inserting the needles. 3. During an observation on 12/18/2025 beginning at 10:05 AM, PCT 2 at station 2, was performing access of an AVF on Patient 18. PCT 2 disinfected the access site, repalpated and touched the site, and failed to disinfect the access site again prior to inserting the needles. 4. During an interview on 12/17/2025 beginning at 2:02 PN, PCT 1 indicated that if the access site is touched after disinfection, then the area should be disinfected again before the needles are inserted.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to implement an initial plan of care within 30 days after admission to the dialysis facility in 2 of 2 clinical record reviews of new admission patients. (Patient 3, Patient 7) Findings include: 1. A revised policy, dated 06/11/2025, titled “G35 Comprehensive assessment, Plan of Care CAPOC”, indicated that the initial plan of care will be initiated within 30 days of the patient admission. 2. A clinical record review for Patient 3, indicated an admission date of 11/01/2025, failed to evidence an initial plan of care at the time of record review, 12/22/2025. 3. A clinical record review for Patient 7, indicated an admission date of 11/04/2025, failed to evidence an initial plan of care at the time of record review, 12/23/2025. 4. During an interview on 12/24/2025 beginning at 8:20 AM, the FA indicated that the initial plan of care should be completed within 30 days of patient admission, and relayed there was no initial plan of care for Patient 3 nor Patient 7 at the conclusion of survey, 12/24/2025. 5. During an interview on 12/22/2025 beginning at 10:25 AM, the Medical Director indicated a plan of care for a new admission patient should be completed and initiated within 30 days of admission.”

“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: 51199 Based on record review and interview, the dialysis facility failed to analyze and track the quality indicators related to physical plant safety rounds in 1 of 1 dialysis facility. Findings include: A revised policy, dated 10/15/2025, titled “G09 Quality Assurance & Performance Improvement (QAPI)” indicated that the dialysis facility should regularly review data to identify areas for improvement and take appropriate action to improve outcomes and processes and that meeting minutes should be documented in the QAPI application. A review of data and meeting minutes of the facility Quality Assurance and Performance Improvement Program, on 12/23/2025, failed to evidence analysis or tracking of physical plant safety rounds from January 2025 to 12/24/2025. During an interview on 12/23/2025, beginning at 11:19 AM, the FA indicated the physical plant safety rounds should be uploaded into QAPI by the Technical department and reviewed monthly. The FA indicated that she did not know why it had not been uploaded for the months of 2025.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to set priorities for performance improvement affecting clinical outcomes relative to transplant referral in 1 of 1 dialysis facility. Findings include: A revised policy, dated 10/15/2025, titled “G09 Quality Assurance & Performance Improvement (QAPI)”, indicated that QAPI outcomes should be continually monitored, trends should be discussed, and action plans should be developed as necessary to improve outcomes. A review of the facility QAPI program evidenced trends in transplant referral below the facility goal of 33.9% for the following months: A. June 2025 = 9.26% B. July 2025 = 7.69% C. August 2025 = 7.69% D. September 2025 = 9.62% E. October 2025 = 10.2% The facility QAPI program failed to identify that transplant referral was routinely below goal or develop any action plan in an effort to improve patient outcomes related to transplant. During an interview on 12/23/2025 beginning at 11:19 AM, the FA indicated there were no interventions in place for transplant referral improvement and she would expect interventions if below goal.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to ensure their policies and procedures were followed as relative to dialysis prescription in 1 of 1 clinical record review of a patient not meeting mineral bone outliers (Patient 6) and relative to following the Initial RN assessment requirements in 1 of 2 clinical record reviews of new admissions (Patient 3). Findings include: 1. A revised policy, dated 11/29/2022, titled “IC08 Monitoring & Documentation of Patient Care During Treatment,” indicated that before starting a patient’s treatment, treatment prescription should be reviewed and verified for machine set-up. A clinical record review, for Patient 6, evidenced an HD Treatment Flow Sheet, dated 11/17/2025, that indicated a prescribed dialysis flow rate [DFR] of 600. The flow sheet indicated the actual DFR delivered to Patient 6 was 500 at 5:30 AM, 400 at 6:00AM, and 500 from 6:30 AM to the conclusion of dialysis at 9:53 AM. During an interview on 12/23/2025, beginning at 11:19 AM, the FA indicated that DFR administered should match the patient prescription, and any DFR that differs would require a new MD order. 2. A revised policy, dated 10/15/2025, titled “G04 Admission & Discharge of Patients”, indicated that prior to the initiation of any patient’s first HD treatment at the facility, an Initial Nursing Assessment will be completed in the patient’s electronic medical record. A clinical record review, for Patient 3, evidenced an admission date of 11/01/2025. An HD Treatment Flow Sheet indicated the first HD treatment was initiated on 11/01/2025 at 10:46 AM. A Nursing Initial Assessment Form indicated that the initial nursing assessment was not performed until 11/01/2025 at 11:15 AM. During an interview on 12/24/2025, the FA indicated the initial nursing assessment should be completed by the nurse prior to initiation of the first HD treatment.”

“MR-COMPLETE RECORDS PROMPTLY CFR(s): 494.170(b)(1) (1) Current medical records and those of discharged patients must be completed promptly. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to timely complete patient records relative to quarterly psychosocial assessments in 5 of 7 clinical record reviews of in-center hemodialysis [HD] (a process to filter the blood in a patient whose kidneys do not work normally) patients. (Patient 2, Patient 4, Patient 5, Patient 6, Patient 8) Findings include: 1. A revised policy, dated 01/01/2019, titled “Social Worker Progress Notes”, indicated that the social worker must meet with each patient quarterly and document their status in the social work progress notes. 2. A clinical record review, on 12/22/2025, for Patient 2, evidenced the most recent Social Worker Quarterly Review dated 04/17/2025. 3. A clinical record review, on 12/19/2025, for Patient 4, evidenced the most recent Social Worker Quarterly Review dated 04/17/2025. 4. A clinical record review, on 12/22/2025, for Patient 5, evidenced the most recent Social Worker Quarterly Review dated 08/06/2025. 5. A clinical record review, on 12/23/2025, for Patient 6, evidenced the most recent Social Worker Quarterly Review dated 08/22/2025. 6. A clinical record review, on 12/23/2025, for Patient 8, evidenced the most recent Social Worker Quarterly Review dated 08/06/2025. 7. During an interview on 12/22/2025 beginning at 12:05 PM, the Social Worker indicated the Social Worker Quarterly Reviews should be completed every 3 months and if not completed 3 months from the previous review, it would be due to error.”