Davita South Philadelphia Dialysis Center

“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: 41684 Based on a review of the facility emergency preparedness program, facility policy, and an interview with the facility administrator and regional director, the facility failed to conduct exercises to test the emergency plan at least annually. Findings include: A review of “Facility Emergency Management Plan [EMP] (ICHD, Home)” on January 24, 2024, at approximately 11:00 am states, “Emergency Drills: 2. EMP training exercises: e. Frequency: i. The facility will conduct and/or participate in one (1) exercise to test the facility EMP at least annually...” A review of the facility emergency preparedness program was conducted on January 24, 2024 at approximately 9:30 am, revealed no documentation of emergency plan training exercises for 2022. An interview with the facility administrator and regional director confirmed that there was no documentation of emergency plan exercises for 2022.”

“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: 41684 Based on observation of the clinical area, facility policy and an interview with the facility administrator, the facility did not follow its policy with regard to teammate fingernails. (Observations #2, 4, and 6). Findings include: Policy “Infection Control For Dialysis Facilities” was reviewed on January 24, 2023 at approximately 11:30 am. Policy states: “Hand Hygeine: 4. It is a requirement for all DaVita teammates whose primary location is working in a facility have only natural nails and fingernail length should not extend more than 1/4 inch. Traditional nail polish that is not chipped may be worn...” Observation of the clinical area was conducted on January 22, 2024 from approximately 9:30 am to 11:45 am. Observation #2. PCT #6 was noted to have artificial fingernails. Observation #4. RN #2 was noted to have artificial fingernails. Observation #6. PCT #2 was noted to have artificial fingernails. An interview with the facility administrator and regional director on January 24, 2024 at approximately 11:00 am confirmed the above findings.”

“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: 41684 Based on observation, review of policy and procedures, and an interview with the Facility Administrator, it was determined, the facility failed to ensure infection control procedures were followed for machine disinfection by cleaning and disinfecting the Hansen connectors and the counter surface behind the dialysis chair for three (3) of twenty (20) hemodialysis machines observed. (Dialysis machines at station #2, 5 and 7). Findings include: A review of policy number 1-05-01 titled, “Infection Control for Dialysis Facilities “ was conducted on January 24, 2024 at approximately 11:00 am states, “Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment...Disinfection: 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are no limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front, and sides of dialysis machine; touchscreens; countertops)...” Observation of the clinical area was conducted on January 22, 2024 from approximately 9:30 am through 11:45 am. Obervations #4. At approximately 10:15 am, it was observed that RN #2, did not disinfect the Hansen connectors of the dialysis machine and did not disinfect the counter surface behind the dialysis chair at Station #7, prior to the start of the next dialysis treatment. Observation #6. At approximately 10:30 am, it was observed that PCT #2, did not disinfect the Hansen connectors of the dialysis machine and did not disinfect the counter surface behind the dialysis chair at Station #5, prior to the start of the next dialysis treatment. Observation #10. At approximately 10:50 am, it was observed that PCT #1, did not disinfect the Hansen connectors of the dialysis machine and did not disinfect the counter surface behind the dialysis chair at Station #2, prior to the start of the next dialysis treatment. An interview with the facility administrator and regional director was conducted on January 24, 2024 at approximately 11:00 am confirmed the above findings.”

“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: 41684 Based on observation of the sterile supply storage area, facility policy, and an interview with the facility administrator and regional director, the facility did not follow its policy to ensure sterile supples are taken out of circulation by the expiration date for four (4) observations (Observations #14, 15, 16, and 17). Findings include: A review of policy number 1-05-01 titled, “Infection Control for Dialysis Facilities “ was conducted on January 24, 2024 at approximately 11:00 am states, “Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment...Supplies 8. Supplies will be stored in a manner that maintains their integrity...b. Expiration date and package integrity will be verified prior to use...” Observation of the sterile supply storage area was conducted on January 22, 2024 from approximately 11:30 am to 11:45 am. Observation #14. Ninety-seven (97) Monoject filter needles size 20 gauge by 1.5 inch were found with an expiration date of 3/15/2022. Observation #15. Twenty (20) BD microtainer contact activated lancets size 30 gauge by 1.5 millimeter were found with an expiration date of 5/2022. Observation #16. Seventy-one (71) BD 22 gauge by 1 inch needles were found with an expiration date of 1/31/2023. Observation #17. Thirty-four (34) VioNex single use antiseptic towelettes were found with an expiration date of 1/1/2023. An interview with the facility administrator and regional director was conducted on January 24, 2024 at approximately 11:00 am confirmed the above findings.”

“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: 41684 Based on review of facility policies/procedure, medical records (MR), and an interview with the facility administrator and regional director, the facility failed to ensure the blood flow rate (BFR) and/or the dialysate flow rate (DFR) was administered per physician order for three (3) of seven (7) incenter hemodialysis patient MR’s reviewed. (MR #1, 4, and 5); and the facility failed to provide documentation that a patient requested early treatment termination for three (3) of seven (7) incenter hemodialysis patient MR’s reviewed, (MR #1, 3, and 6). Findings include: A review of facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” on January 24, 2024 at approximately 11:25 am states, “Policy: 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment...Prescription components include but are not necessarily limited to: f. Blood flow rate (BFR) g. Dialysate flow rate (DFR)...Intradialytic Data Collection/ Assessment: 10. If the dialysis prescription is not being met (including DFR or change to/inability to obtain prescribed BFR, the reason will be documented and the licensed nurse informed...” A review of facility policy titled “Prescribed Treatment Time Not Met” on January 24, 2024 at approximately 11:20 am states, “Policy: A. Completion of the Early Termination of Treatment Against Medical Advice Form: 1. The RN will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time...3. The RN will obtain the patient’s signature on the Early Termination of Treatment Against Medical Advice form prior to the patient being rinsed back from their treatment. If unable to obtain the patient’s signature prior to rinse-back, the RN will obtain the patient’s signature on the form prior to the patient’s departure from the facility. 4. A RN must countersign all Early Termination of Treatment Against Medical Advice forms. A witness signature is required only if the patient refuses to sign the form. 5. If a patient refuses to sign the Early Termination of Treatment Against Medical Advice form, the RN will document the patient’s refusal with the words “patient refused” in the patient signature box along with the date. Under such circumstances, the RN will sign the form and will also obtain a witness’ signature on the form... B. Prescribed Treatment Time Not Met: 1. If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs...6. The facility’s administrator (FA) will verify that all shortened treatments are recorded and trended, and the FA shall verify that such records are reviewed and discussed at the facility health meetings, as appropriate...” A review of patient medical records (MR) was completed on January 23, 2024 from approximately 11:00 am to 2:30 pm. MR #1: Admission Date: 12/18/17. Dialysis order date: 1/18/2024. Frequency: Tuesday, Thursday, and Saturday; Target Weight: 75.5 Kg; Dialyzer: Revaclear 300; Dialysate: 3 K, 2.5 CA, 35 HCO3, 138 NA; Treatment Duration: 210 minutes; BFR: 400; DFR: 800 (Prior orders: BFR: 400; DFR: 500). Review of Dialysis Treatment Details Reports revealed the BFR/DFR was not administered at prescribed rates on the following dates: 1/11/2024, during entire treatment the BFR was administered at 350 ml/hr. 1/13/2024, during entire treatment the BFR was administered at 350 ml/hr. 1/16/2024, from 1:02 pm through 2:32 pm, the BFR as administered at 425 ml/min and the DFR was administered at 800 ml/min. 1/18/2024, from 2:02 pm through 3:03 pm, the DFR was administered at 500 ml/min. 1/20/2024, during entire treatment DFR was administered at 500 ml/min. There was no documentation in the medical record that the hemodialysis staff had obtained a physician order to allow the BFR/DFR to be administered at a rate different from the prescribed amount for any of the above dates and there was no documentation of a reason why the BFR/DFR was administered at a rate different from the prescribed amount for any of the above dates. Review of Dialysis Treatment Details Reports revealed the patient requested early termination of treatment on the following date: 1/11/2024. Treatment time 170 minutes, short 40 minutes. There is no documentation of an Early Termination of Treatment Against Medical Advice form in the MR for the above date. MR # 3: Admission Date: 9/8/2023. Dialysis order date: 1/9/2024. Frequency: Monday, Wednesday, and Saturday; Target Weight: 72.5 Kg; Dialyzer: Revaclear 300; Dialysate: 1 K, 2.5 CA, 35 HCO3, 136 NA; Treatment Duration: 210 minutes; BFR: 400; DFR: 800. Review of Dialysis Treatment Details Reports revealed the patient requested early termination of treatment on the following dates: 1/12/2024. Treatment time 155 minutes, short 55 minutes. 1/19/2024. Treatment time 119 minutes, short 91 minutes. There is no documentation of an Early Termination of Treatment Against Medical Advice form in the MR for the above dates. MR #4: Admission Date: 3/10/2021. Dialysis order date: 12/19/2023. Frequency: Tuesday, Thursday, and Saturday; Target Weight: 115 Kg; Dialyzer: Revaclear 400; Dialysate: 2 K, 2.5 CA, 35 HCO3, 136 NA; Treatment Duration: 255 minutes; BFR: 550; DFR: 800. Review of Dialysis Treatment Details Reports revealed the BFR/DFR was not administered at prescribed rates on the following dates: 1/6/2024, during entire treatment BFR was administered at 400 ml/min, and during entire treatment the DFR was administered at 500 ml/min. 1/16/2024, during entire treatment the DFR was administered at 500 ml/min. 1/18/2024, from 11:00 am through 11:53 am, the DFR was administered at 500 ml/min. There was no documentation in the medical record that the hemodialysis staff had obtained a physician order to allow the BFR/DFR to be administered at a rate different from the prescribed amount for any of the above dates and there was no documentation of a reason why the BFR/DFR was administered at a rate different from the prescribed amount for any of the above dates. MR #5: Admission Date: 8/6/14. Dialysis order date: 1/18/2024. Frequency: Tuesday, Thursday, and Saturday; Target Weight: 64 Kg; Dialyzer: Optiflux F180NR; Dialysate: 3 K, 2.5 CA, 35 HCO3, 136 NA; Treatment Duration: 180 minutes; BFR: 400; DFR: 600 (Prior order: BFR: 400, DFR: 500). Review of Dialysis Treatment Details Reports revealed the BFR was not administered at prescribed rates on the following dates: 1/6/2024, during the entire treatment, the BFR was administered at 300 ml/min There was no documentation in the medical record that the hemodialysis staff had obtained a physician order to allow the BFR to be administered at a rate different from the prescribed amount for the above date and there was no documentation of a reason why the BFR was administered at a rate different from the prescribed amount for the above date. MR # 6: Admission Date: 11/30/2021. Dialysis order date: 1/3/2024. Frequency: Tuesday, Thursday, and Saturday; Target Weight: 50.5 Kg; Dialyzer: Revaclear 300; Dialysate: 2 K, 2.5 CA, 35 HCO3, 136 NA; Treatment Duration: 210 minutes; BFR: 400; DFR: 500. Review of Dialysis Treatment Details Reports revealed the patient requested early termination of treatment on the following dates: 1/16/2024. Treatment time 177 minutes, short 33 minutes. 1/18/2024. Treatment time 180 minutes, short 30 minutes. There is no documentation of an Early Termination of Treatment Against Medical Advice form in the MR for the above date. An interview with the facility administrator and regional director was conducted on January 24, 2024 at approximately 11:00 am confirmed the above findings.”