Universal Dialysis Center

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to follow the recommended “Standard Precautions” set by the facility to maintain a sanitary environment. This failures placed the patients and the staff members at risk for exposure to infectious diseases. Findings Included: On 03/21/2024, at 01:35 p.m., during review of the facility’s policy titled “Cleaning & Disinfection of Equipment, Supplies & Treatment Area” (Policy G45) Page 1 number 2 states “Bleach solutions for this purpose must be made fresh each day and all containers are labeled per risk management policies for labeling of chemical containers and must be covered with a lid to prevent contamination.” Facility’s policy titled “Infection Control” (Policy G40) page 5 number 35 states “Sterile packaged items are considered sterile only if the package or container remains dry and intact (unopened). Sterile items in damaged or wet packaging are no longer sterile and will not be used.” According to the CDC, Wall box surfaces should be disinfected at least daily (e.g., at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (e.g., when visibly dirty). From 03/18/2024 through 03/21/2024, the surveyor observed the following: 1. On 03/18/2024 at 12:19 p.m.,during observations of the treatment floor, the surveyor observed bleach 1:100 containers without covers located near stations number 6, 13 and 14. 2. On 03/19/2024 at 11:20 a.m., during observations of the treatment floor, the surveyor observed wallboxes located in stations number 10 through 17 with yellow, orange and brown colored residual build up. 3. On 03/21/2024 at 01:34 p.m., during observations of the treatment floor the surveyor observed that the packaging for following items located in the crash cart were no longer intact: a. 1 Ambu Bag b. 1 Transducer protector 4. On 03/21/2024 at 02:18 p.m., during observations of the water room, the surveyor observed that the back corner of the facility’s water room floor had black, white and brown debris and orange tinge residual build up that did not match the rest of the floor.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 47759 Based on review of the facility’s policies and procedures and review of the facility’s hepatitis serology report, the facility’s governing body failed to ensure routine testing was done for all patients. This failure placed patients and staff at risk of contracting infectious diseases. Findings Included: On 03/21/2024 at 01:40 p.m., during review of the facility’s policy titled “Hepatitis B: Control & Management” (Policy G43) page 3 number 16 stated that patients who are vaccine non-responders or susceptible (patients who has a hepatitis B antibody[HBsAb of X<10) must have a Hepatitis Antigen (HBsAg) screening test on a monthly basis. On 03/21/2024 at 02:50 p.m., during record review of the facility’s hepatitis B report, the surveyor observed the following: 1. Patient J, a susceptible patient with a HBsAb <10 has missing HBsAg testing result for the months of 11/2023, 01/2024 and 02/2024. 2. Patient K, a susceptible patient with a HBsAb <10 has missing HBsAg testing result for the months of 01/2024 and 02/2024. 3. Patient L, a susceptible patient with a HBsAb <10 has missing HBsAg testing result for the month of 11/2023 4. Patient I, a susceptible patient with a HBsAb <10 has missing HBsAg testing result for the months of 01/2024 and 02/2024. 5. Patient E, a susceptible patient with a HBsAb <10 has missing HBsAg testing result for the months of 01/2024 and 02/2024. 6. Patient M, a susceptible patient with a HBsAb <10 has missing HBsAg testing result for the months of 01/2024 and 02/2024.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 47759 Based on staff interviews, observations, and reviews of policies and procedures, the facility’s governing body failed to ensure that a label (with the correct date and preparer) has been affixed to the mixing tank and/or container prior to batch preparation of any solution. This failure placed the patients and staff at potential risk of harm. Findings Included: On 03/20/2024 at 01:35 p.m., during record review of the facility’s policies and procedure titled “Bicarbonate Mixers and Distribution” page 79 under “Policy: Mixing Tank Labeling” letter a states “A label must be attached to the mixing tank at the time of the mixing ....with the: date of preparation, time of mixing, and initials of the trained staff member mixing the bicarbonate.” On 03/18/2024 at 01:19 p.m., during observations of the water room, the surveyor observed that the bicarbonate mixing tank did not have a label stating the date and time as well as the initials of who prepared the solution. This observation was verified by Staff #3 who was able to corroborate that a label should have been filled out stating the date, time, and the initials of the preparer.”

“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: 47759 Based on observations, review of policies and procedures, and staff interviews, the facility’s governing body failed to ensure that all patient supplies used for dialysis treatment were maintained in a manner that provided for patient safety. This failure placed affected patients at potential risk of harm. Findings Included: On 03/20/2024 at 01:45 p.m., during record review of the facility’s policies and procedure titled “Infection Control” (Policy G40) page 1 states “No dialysis supplies or medications may be used after the manufacturer expiration date printed on the package, label, or carton. “ On 03/18/2024 at 12:15 p.m., during observations on the treatment floor, the surveyor observed the following expired items located in the laboratory storage area: 1. 16 pieces of 6 millimeter (mL) blue lab tube with lot number B22083B8 -Expired 01/31/2024 2. 19 pieces of 3.5 mL red lab tube with lot number B220738V -Expired 10/03/2023 On 03/21/2024 at 01:34 p.m., during observations on the treatment floor, the surveyor observed the following expired items located inside the facility’s crash/emergency cart. 1. 2 normal chloride 1 Liter bag with lot number 23BU05024 -Expired 02/2024 2. 1 yankauer/suction connecting tube with lot number 48618110001 -Expired 11/01/2022 3. 4 pieces of yankowers with a lot number of 201903014 -Expired 02/28/2024 4. 3 pieces of diphenhydramine 50 mg/mL with a lot number of 6128028 -Expired 02/2024 On 03/21/2024 at 01:40 p.m., the Clinical Manager corroborated that the items found should have been disposed of.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47759 Based on review of the selected patient’s treatment flowsheets, review of facility’s policies and procedure, and staff interview, the facility’s governing body failed to ensure that the dialysis prescriptions were the same as what the patients received. The failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm or injury. Findings Included: On 03/20/2024 at 01:50 p.m. during review of the facility’s policy titled “Charge Nurse Notification Protocol” (Policy IC07A), the surveyor observed a list of events reportable to the charge nurse by direct patient care staff. Of which includes: Weight: 1.0 kg < or > estimated dry weight (EDW) post treatment. Review of the facility’s policy titled “Monitoring & Documentation of Patient Care During Treatment” (Policy IC08) number 15 listed a list of information that must be entered manually. This includes: interventions for unexpected situations, such as slowing blood flow for access problems, target weight change, etc ...” On 03/20/2024 at 12:00 p.m., during review of the selected patient’s treatment flowsheet, the surveyor observed the following: 1. On treatment date 03/18/2024, Patient E had an estimated dry weight (EDW) ordered as 74.0 kg. At the end of treatment, Patient E’s post weight was 77.4 kg, which was 3.4 kg over the EDW. No supporting documentation was found stating that the nurse had been notified by Staff #1 per facility policy. 2. On treatment date 03/15/2024, Patient D had an EDW ordered as 69.5 kg. At the end of treatment, Patient D’s post weight was 72.4 kg, which was 3.4 kg over the EDW. No supporting documentation was found stating that the nurse had been notified by Staff #1 per facility policy. 3. On treatment date 03/18/2024, Patient D had an EDW ordered as 69.5 kg. At the end of treatment, Patient D’s post weight was 72.3 kg, which was 3.3 kg over the EDW. No supporting documentation was found stating that the nurse had been notified by Staff #1 per facility policy. 4. On treatment date 03/15/2024, Patient D was prescribed with a DFR of 800 milliliter/minute (mL/min). The patient’s actual dialysis flow rate (DFR) recorded from 07:01 a.m. -09:50 a.m. as 700 mL/minute. No supporting documentation was found explaining why the DFR prescription was not followed. 5. On treatment date 03/15/2024, Patient B was prescribed with a DFR of 500 milliliter/minute (mL/min). The patient’s actual DFR recorded from 06:16 a.m.-08:31 a.m. as 600 mL/minute. No supporting documentation was found explaining why the DFR prescription was not followed. On 03/21/2024 at 03:40 p.m., the clinical manager corroborated that staff members should be documenting instances in which the patient’s prescription was not followed.”

“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: 47759 Based on review of facility’s policies and procedures, review of the selected patient’s medical chart, and interview of a patient, the facility’s governing body failed to ensure that the interdisciplinary team (IDT) members, including the patient or the patient’s designee met as a team in order to discuss the patients’ plans of care (PoC); or if the patient chooses not to sign the plan of care, choice must be documented on the plan of care, along with the reason the signature was not provided. This failure denied the affected patients their rights to a minimum standard of medical care. On 03/20/2024 at 01:05 p.m., during review of the facility’s policies and procedures titled “Comprehensive Patient Assessments” (Policy G35) Page 1 number 1 states, “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)...” Facility’s policy titled “Treatment Plans” (Policy G37) on page 2 number 4 states “The patient will be an integral part of the planning process and will be a 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.” Number 6 states “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.” On 03/19/2024 at 01:00 p.m., during review of the selected patient’s medical record review, the surveyor observed that the following plan of care did not have a documented patient’s signature acknowledging that the patient agrees with the plan nor a patient signature refusing the meeting. 1. Patient C’s annual assessment dated 08/30/2023 did not have a documented patient plan of care meeting acknowledgement or refusal 2. Patient D’s annual assessment dated 08/23/2023 did not have a documented patient plan of care meeting acknowledgement or refusal 3. Patient E’s 30 Day and 90 day plan of care meeting did not have a documented patient plan of care meeting acknowledgement or refusal a. On 03/18/2024, during an interview with Patient E. The surveyor asked Patient E if [s/he] has been invited to a plan of care meeting, the patient denied the information. 4. On 03/21/2024 at 03:26 p.m. the Clinical Manager corroborated that the plan of care should involve the patient and be invited to the meetings with the patient’s signature validating the occurrence.”

“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: 47759 Based on review of the facility’s policies and procedure, review of Quality Assessment and Performance Improvement (QAPI) meeting minutes, and interviews with staff, the facility’s governing body failed to ensure that the facility analyzed the (1) mortality data and (2) hospitalization data to identify potential problems and opportunities for improving care. This failure placed patients at potential risk of harm by failing to utilize the data gathered to identify potential problems in the facility resulting in delay in interventions aimed at improvement. Findings Included: On 03/20/2024 at 01:15 p.m., during review of the facility’s policies and procedure titled “Quality Assessment & Performance Improvement” (QAPI) (Policy G09) page 2 number 9 states “The QAPI meeting minutes and the IRC/ARA QAPI reporting tools will be used to: ...allow for identification, prevention, and reduction of medical errors, mortality, and morbidity.” Number 11 states “At a minimum, the QAPI must include: ... anemia management, equipment and maintenance.” Number 16 states “The medical director and Center Manager will perform a monthly review of Clinical Performance Measures (CPM) from data available ...Data will be tended to assure that indicators stay stable and within stated performance goals .... All QAPI action plans related to clinical outcomes will be reviewed to assure that progress is being made toward the defined goal. On 03/21/2024 at 03:00 p.m., during reviews of the facility’s QAPI and interviews with the Clinical Manager, the surveyor observed the following: 1. There was no documented hospitalization meeting data on QAPI for the month of January 2024. Hospitalization meeting data on QAPI for the months of November 2023 and December did not show discussion and analysis of the hospitalization data used to identify potential problems and opportunities for improving care. From November 2023-January 2024, the facility had approximately 15 hospitalizations. On 03/21/2024 at 03:10 p.m., the Clinical Manager corroborated that the facility’s Interdisciplinary team should have done analysis on the hospitalization data and trend gathered to identify problems and opportunities for improving care 2. There was no documented mortality meeting data on QAPI for the month of January 2024. Mortality meeting data on QAPI for the months of November 2023 and December 2023 did not show discussion and analysis of the mortality data used to identify potential problems and opportunities for improving care. From January 2023-March 2024, the facility’s overall mortality was 9. On 03/21/2024 at 03:07 p.m., the Clinical Manager corroborated that the facility should have filled out the mortality review for the patients that have died and analyzed the cause of death to identify problems and opportunities for improving care.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47759 Based on observations, staff interviews and review of the facility’s policies and procedures, the medical director and the governing body failed to ensure that the facility’s staff members adhered to their own policies and procedures. This failure posed a potential risk of safety to the patients, and denied patients their rights to a minimum standard of medical care. Findings included: 1. “Cleaning & Disinfection of Equipment, Supplies & Treatment Area” (Policy G45) Page 1 number 2 states “Bleach solutions for this purpose must be made fresh each day and all containers are labeled per Risk Management policies for labeling of chemical containers and must be covered with a lid to prevent contamination.” 2. “Infection Control” (Policy G40) page 5 number 35 states “Sterile packaged items are considered sterile only if the package or container remains dry and intact (unopened). Sterile items in damaged or wet packaging are no longer sterile and will not be used. 3. “Hepatitis B: Control & Management” (Policy G43) page 3 number 16 states “that patients who are vaccine non-responders or susceptible must have a HBsAg screening test on a monthly basis.” 4. “Bicarbonate Mixers and Distribution” page 79 under “Policy: Mixing Tank Labeling” letter a states “A label must be attached to the mixing tank at the time of the mixing ....with the: date of preparation, time of mixing, and initials of the trained staff member mixing the bicarbonate.” 5. “Infection Control” (Policy G40) page 1 states “No dialysis supplies or medications may be used after the manufacturer expiration date printed on the package, label, or carton. “ 6. “Charge Nurse Notification Protocol” (Policy IC07A), the surveyor observed a list of events reportable to the charge nurse by direct patient care staff. Of which includes: Weight: 1.0 kg < or >EDW post treatment. 7. “Monitoring & Documentation of Patient Care During Treatment” (Policy IC08) number 15 listed a list of information that must be entered manually. This includes: interventions for unexpected situations, such as slowing blood flow for access problems, target weight change, etc ...” 8. “Comprehensive Patient Assessments” (Policy G35) Page 1 number 1 states, “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)...” 9. “Treatment Plans” (Policy G37) on page 2 number 4 states “The patient will be an integral part of the planning process and will be a 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.” Number 6 states “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.” 10. “Quality Assessment & Performance Improvement” (QAPI) (Policy G09) page 2 number 9 states “The QAPI meeting minutes and the IRC/ARA QAPI reporting tools will be used to: ...allow for identification, prevention, and reduction of medical errors, mortality, and morbidity.” Number 11 states “At a minimum, the QAPI must include: ... anemia management, equipment and maintenance.” Number 16 states “The medical director and Center Manager will perform a monthly review of Clinical Performance Measures (CPM) from data available ...Data will be tended to assure that indicators stay stable and within stated performance goals .... All QAPI action plans related to clinical outcomes will be reviewed to assure that progress is being made toward the defined goal. 11. “Admission & Discharge of Patients” (Policy G04) page 2 number 8 states “Prior to the initiation of any patient ’ s first treatment at the facility, an initial nursing assessment will be completed and documented in the patient ’ s medical record. 12. “Fire Safety Preparedness” (RM715) Page 1 number 4 states “Fire drills will be conducted quarterly. All shifts will have a minimum of one fire drill annually.””

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to ensure an adequate number of qualified and trained staff to meet the needs of the patients. This failure placed the patients at potential risk and denied their rights to a minimum standard of medical care. Findings Include: The Code of Maryland Regulations 10.05.04.06C (Dialysis Monitoring for Freestanding Kidney Dialysis Centers) states: (a) In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be: (i) A minimum of one staff member to three participants; and (ii) Sufficient to meet the needs of patients. ... (c) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. (d) The charge nurse may not be included in the staffing ratio except: (i) When there are nine or fewer patients; or (ii) In the event of an emergency. On 03/21/2024 at 02:40 p.m., a review of the facility’s staffing exception report from February 1, 2024 - March 21, 2024 revealed that staffing ratios did not meet the requirements on the following dates: 1. February: 6, 8, 10, 15, 24, 27 and 29 2. March 7, 9, and 15. In most instances, the charge nurse was either included in the staffing ratio or had to monitor patients. On 03/21/2024 at 02:40 p.m., The Clinical Manager corroborated that the short staffing at times lead to delay in patient treatment.”

“POC-PT/FAMILY EDUCATION & TRAINING CFR(s): 494.90(d) The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types. This Standard is not met as evidenced by: 36839 Based on interview with the facility’s clinical manager, the governing body failed to ensure that the patient’s family member(s) or caregiver(s) or both, were educated in aspects of the dialysis experience, dialysis management, infection prevention and personal care, This failure placed the patient at potential risk of infection and denied the patient’s rights to receive the minimum standard of care. Findings included: Patients/designees/caregivers must be educated on vascular access, dialysis access hygiene, infection prevention, etc. The medical record should show proof of education across these areas, either in a dedicated section or dispersed within different parts, such as progress notes. During interview with the clinical manager in 1/24/2024, any proof of documentation that the patient’s designated caregiver was provided education regarding any dialysis-related management and care of the patient outside of the dialysis facility was requested by this surveyor. The clinical manager admitted that there was no documentation available.”

“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: 36839 Based on interview with the clinical manager, the Quality Assurance and Performance Improvement (QAPI) team and administrative staff failed to track, trend and analyze information on patients’ satisfaction, complaints and grievances. Findings include: QAPI aims to enhance care by using patient satisfaction surveys and grievance investigations. Surveys should be non-threatening and protect patient identity. QAPI discussions on survey results and grievances should emphasize data-driven insights into the care delivery system, with documented evidence of implementing necessary changes. During interview with the clinical manager on 1/24/2024, it was revealed that the QAPI team failed to create further documentation that would allow trending, tracking and provide additional information on the family members’ grievance from 10/25/2023.”