The Dialysis Center of Rhode Island Hospital

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 41729 47279 Based on record review and staff interview, it has been determined that the facility failed to conduct all required exercises to test the facility’s emergency plan. This deficient practice has the potential to impact 110 of 110 patients, as well as an indeterminable number of staff and visitors. Findings are as follows: Record review failed to reveal evidence that the facility conducted a full-scale emergency preparedness exercise that was facility based, or a tabletop exercise that includes a group discussion designed to challenge the emergency plan, during the 2023 and 2024 calendar years. During a surveyor interview on 1/15/2025 at 3:11 PM with the Director of Dialysis Services, she was unable to provide evidence of a full-scale emergency preparedness exercise or a tabletop exercise to challenge the emergency plan. Additionally, she acknowledged that a full-scale emergency preparedness exercise or a tabletop exercise were not completed during the 2023 and 2024 calendar years.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 41729 Based on surveyor observation and staff interview, it has been determined that the facility failed to ensure that the water purification and storage system is secure and only accessible to individuals responsible for monitoring and maintenance of the system for 1 of 1 water purification system and storage area observed. Findings are as follows: During a surveyor observation of the facility on 1/13/2025 at 9:10 AM, while conducting an environmental flash tour, in the presence of the Director of Dialysis Services, revealed the housekeeping supply closet was situated in the water purification and storage system room. Indicating the housekeeping staff would have to access the water purification and storage system room in order to access their equipment. During a surveyor interview immediately following this observation with the Director of Dialysis Services, she acknowledged that the housekeeping supply closet was situated in the water purification and storage system room and is accessible to the housekeeping staff. She indicated that the housekeeping staff are contracted staff that they enter the facility after hours. Additionally, she acknowledged that the contracted housekeeping staff have access to the water purification system and supply room. Lastly, she was unable to provide evidence that the water purification and storage system area were restricted only to those individuals responsible for monitoring and maintaining the system.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 46539 47279 Based on record review and staff interview, it has been determined that the facility failed to conduct periodic audits to assess the compliance of procedures for staff responsible for disinfection and quality mixing and testing of the water and dialysate (a solution used during dialysis to help maintain the body’s electrolyte balance) systems for 5 of 5 staff reviewed, Staff A, B, C, D, and E. Findings are as follows: Record review failed to reveal evidence of any audits completed during the 2023 and 2024 calendar years for Staff A, B, C, D, and E that includes, but is not limited to, conducting water and dialysate testing, dialysate mixing, dialysate pH (a measure of acidity), and conductivity testing at the point of use. During a surveyor interview on 1/16/2025 at approximately 12:00 PM with the Clinical Nurse Manager and the Director of Dialysis Services, they revealed that they do not conduct periodic audits of staff to assess compliance of procedures including the above-mentioned tasks.”

“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: 41729 Based on surveyor observation and staff interview, it has been determined that the facility failed to ensure that the water distribution equipment was properly maintained for 1 of 1 Reverse Osmosis system (RO, a water purification system that uses a semipermeable membrane to remove contaminants from water used in dialysis treatments) and 1 of 1 dialysis station observed with a leak, Station #13. Findings are as follows: 1. During a surveyor observation on 1/13/2025 at 10:36 AM of the water treatment area, in the presence of the Director of Dialysis Services, revealed clear fluid dripping from the 5 micron filter on the RO system (a filter that removes particles larger than 5 microns in diameter from the water, that acts as a protective barrier to prevent clogging of the the RO system). Further observation revealed a saturated blue pad on the floor under the RO system where the drippings were being absorbed. During a surveyor interview immediately following the above observation with the Director of Dialysis Services, she acknowledged the RO system was leaking. 2. During surveyor observations of Station #13, in patient care area, revealed an accumulation of crystallized substance built-up on the wall and on the floor on the following dates and times: - 1/13/2025 at 9:16 AM and 11:06 AM - 1/16/2025 at 9:31 AM During a surveyor interview immediately following the observation on 1/16/2025 with the Clinical Nurse Manager, she acknowledged the crystallized substance, and indicated it was caused by a leak of bicarbonate (a substance that is added to dialysis fluid to help maintain a patient’s blood acid-base balance) from the connection in the wall of Station #13. She further indicated that she would expect the staff to clean the area daily until the leak has been repaired.”

“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: 46539 41729 Based on staff interview and record review, it has been determined that the facility failed to ensure that staff follow the dialysis prescription when administering dialysis treatments for 9 of 9 sample patients, Patient ID #s 2, 3, 4, 5, 6, 7, 9, 10, and 11. Findings are as follows: 1. Review of the record for Patient ID #2 revealed that s/he was admitted to the facility in November of 2024 with a diagnosis of end stage renal disease (ESRD) and is receiving hemodialysis (HD, a procedure where a dialysis machine and a special filter called an artificial kidney, or a dialyzer, are used to clean the blood) three times per week. Further review of the record revealed the patient’s current dialysis prescription order is for a dialysate flow rate (DFR) of 800 milliliter/minute (mL/min) and a blood flow rate (BFR,the speed that the patient’s blood is moving through the dialysis tubing) of 500 mL/min and to notify the Medical Doctor (MD) if unable to maintain the ordered parameters. Review of the dialysis treatment flow sheets revealed that Patient ID #2 received his/her treatment with a BFR of 450 mL/min and not the ordered 500 mL/min on the following dates: - 1/4/2025 - 1/7/2025 Additional record review of the dialysis treatment flow sheets revealed that Patient ID #2 received his/her treatment with a DFR of 500 and not the ordered DFR of 800 mL/min on 1/7/2025. Further review of the record failed to reveal evidence that the MD was notified that Patient ID #2 did not receive their dialysis treatments as ordered. 2. Review of the record for Patient ID #3 revealed that s/he was admitted to the facility in March of 2024 with a diagnosis of ESRD three times per week and is receiving HD three times per week. Further review of the record revealed the patient’s current dialysis prescription order is for a DFR of 800 mL/min and BFR of 450 mL/min and to notify the MD if unable to maintain ordered parameters. Review of the dialysis treatment flow sheets revealed that s/he received his/her treatment with a BFR of 400 mL/min and not the ordered BFR of 450 mL/min on the following dates: -12/22/2024 -12/27/2024 -12/31/2024 -1/3/2025 -1/8/2025 -1/10/2025 -1/13/2025 Additional record review of the dialysis treatment flow sheets revealed that Patient ID #3 received his/her treatment with a DFR of 500 mL/min instead the ordered DFR of 800 mL on 1/10/2025. Further review of the record failed to reveal evidence that the MD was notified that Patient ID #3 did not receive their dialysis treatments as ordered. 3. Review of the record for Patient ID #4 revealed that s/he was admitted to the facility in October of 2024 with a diagnosis of ESRD and is receiving HD three times per week. Further review of the record revealed a current dialysis prescription order for a DFR of 800 mL/min and BFR of 500 mL/min and to notify the MD if unable to maintain ordered parameters. Review of the dialysis treatment flow sheets revealed that Patient ID #4 received his/her treatment with a BFR of 450 or 400 mL/min and not the ordered BFR of 500 mL/min on the following dates: - 12/23/2024 - 12/26/2024 - 12/28/2024 - 1/7/2025 - 1/9/2025 - 1/11/2025 Further review of the record failed to reveal evidence that the MD was notified that Patient ID #4 did not receive their dialysis treatments as ordered. 4. Review of the record for Patient ID #5 revealed that s/he was admitted to the facility in April of 2017 with a diagnosis of ESRD and is receiving HD three times per week. Further review of the record revealed a current dialysis prescription order for a DFR of 500 mL/min and a BFR of 450 mL/min and to notify the MD if unable to maintain ordered parameters. Review of the dialysis treatment flow sheets revealed that Patient ID #5 received his/her treatment with a BFR of 400 mL/min and not the ordered BFR of 450 mL/min on 12/30/2024. Further review of the record failed to reveal evidence that the MD was notified that Patient ID #5 did not receive their dialysis treatment as ordered. 5. Review of the record for Patient ID #6 revealed that s/he was admitted to the facility in December of 2021 with a diagnosis of ESRD and is receiving HD three times per week. Further review of the record revealed a current dialysis prescription order for a DFR of 500 mL/min and a BFR of 450 mL/min and to notify the MD if unable to maintain ordered parameters. Review of the dialysis treatment flow sheets revealed that Patient ID #6 received his/her treatment with a BFR of 400 mL/min ad not the ordered BFR of 450 mL/min on the following dates: -12/28/2024 -12/30/2024 -1/7/2025 -1/11/2025 -1/14/2025 Further review of the record failed to reveal evidence that the MD was notified that Patient ID #6 did not receive their dialysis treatments as ordered. 6. Review of the record for Patient ID #7 revealed that s/he was admitted to the facility in February of 2021 with a diagnosis of ESRD and is receiving HD three times per week. Further review of the record revealed a current dialysis prescription order for a DFR of 500 mL/min and a BFR of 400 mL/min and to notify the MD if unable to maintain ordered parameters. Review of the dialysis treatment flow sheets revealed that Patient ID #7 received his/her treatment with a BFR of 300 or 350 mL/min and not the ordered BFR of 400 mL/min on the following dates: - 8/20/2024 - 8/22/2024 - 8/24/2024 - 8/29/2024 Further review of the record failed to reveal evidence that the MD was notified that Patient ID #7 did not receive their dialysis treatments as ordered. 7. Review of the record for Patient ID #9 revealed that s/he was admitted to the facility in November of 2019 with a diagnosis of ESRD and is receiving HD three times per week. Further review of the record revealed a current dialysis prescription order for a DFR of 500 mL/min and BFR of 500 mL/min and to notify the MD if unable to maintain ordered parameters. Review of the dialysis treatment flow sheets revealed that Patient ID #9 received his/her treatment with a BFR of 300 or 350 mL/min and not the ordered BFR of 500 mL/min on the following dates: - 1/2/2025 - 1/11/2025 - 1/14/2025 Additional review of the dialysis treatment flow sheets revealed that Patient ID #9 received his/her treatment with a DFR of 800 or 600 mL/min and not the ordered DFR of 500 mL/min on the following dates: - 12/26/2024 - 1/2/2025 Further review of the record failed to reveal evidence that the MD was notified that Patient ID #9 did not receive their dialysis treatments as ordered. 8. Review of the record for Patient ID #10 revealed that s/he was admitted to the facility in April of 2021 with a diagnosis of ESRD and is receiving HD three times per week. Further review of the record revealed a current dialysis prescription order for a DFR of 500 mL/min and a BFR of 400 mL/min and to notify the MD if unable to maintain ordered parameters. Review of the dialysis treatment flow sheets revealed that Patient ID #10 received his/her treatment with a BFR of 450 or 350 mL/min and not the ordered BFR of 400 mL/min on the following dates: - 1/4/2025 - 1/11/2025 Further review of the record failed to reveal evidence that the MD was notified that Patient ID #10 did not receive their dialysis treatments as ordered. 9. Review of the record for Patient ID #11 revealed that s/he was admitted to the facility in February of 2021 with a diagnosis of ESRD and is receiving HD three times per week. Further review of the record revealed a dialysis prescription order for a DFR of 800 mL/min and BFR of 500 mL/min and to notify the MD if unable to maintain ordered parameters. Review of the dialysis treatment flow sheets revealed that Patient ID #11 received his/her treatment with a BFR of 450, 350 or 300 mL/min and not the ordered BFR of 500 mL/min on the following dates: - 12/20/2024 - 12/27/2024 - 12/29/2024 - 12/31/2024 - 1/3/2025 - 1/8/2025 Additional review of the dialysis treatment flow sheets revealed that Patient ID #11 received his/her treatment with a DFR of 500 mL/min and not the ordered DFR of 800 mL/min on 12/20/2024. Further review of the record failed to reveal evidence that the MD was notified that Patient ID #11 did not receive their dialysis treatments as ordered. During a surveyor interview with the Director of Dialysis services on 1/16/2025 at approximately 10:00 AM, she acknowledged that the dialysis prescription orders were not followed for the above-mentioned patients on the above-mentioned dates and would expect the MD to be notified. During a surveyor interview with the Medical Director for HD, she acknowledged that the facility does not notify her when the patients’ prescribed therapy is not followed related to their ordered BFR or DFR.”