Raceway Dialysis Center

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 40084 Based on the scope and severity of deficiencies related to Emergency Preparedness, the facility failed to substantially comply with this condition. The findings include: See Tag E-0006 Based on staff interview and document review, it was determined the facility failed to ensure its Emergency Preparedness Plan was based on a facility-based and community-based risk assessment. See Tag E-0032 Based on staff interview and document review, it was determined the facility failed to ensure its emergency preparedness communication plan identified a primary and alternate means for communicating with facility staff and federal, state, tribal, regional, and local emergency management services. See Tag E-0038 Based on staff interview and document review, it was determined the facility failed to ensure staff training on its emergency preparedness plan in one (1) of three (3) personnel files reviewed (Staff member #2). See Tag E-0039 Based on staff interview and document review, it was determined the facility failed to ensure it conducted annual exercises to test the emergency preparedness plan.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 36946 Based on the scope and severity of deficiencies related to infection control, the facility failed to substantially comply with this condition. The findings include: Tag V-0116 Based on observations and document review, it was determined the facility staff failed to clean and disinfect items taken into the dialysis station before being used on another patient during two (2) of two (2) observations. Specifically, the facility staff failed to ensure the conductivity meter was cleaned after each patient use. Tag V-0124 Based on staff interview and document review, it was determined the facility staff failed to ensure each patient’s HBV (hepatitis B virus) serological status was known before admission to the hemodialysis unit in one (1) of five (5) medical records reviewed in the survey sample (Medical record #8). Tag V-0128 Based on staff interview and document review, it was determined the facility failed to ensure a HBsAg (hepatitis B surface antigen) positive patient was isolated in a separate room for treatment in one (1) of one (1) medical record reviewed in the survey (Medical record #5).”

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure its Emergency Preparedness Plan was based on a facility-based and community-based risk assessment. Findings: The facility’s emergency preparedness plan was reviewed 01/23/24. The materials presented to the surveyor contained a blank hazard vulnerability analysis (HVA) form and no other documentation related to a risk assessment. Staff member #1 was asked on 01/23/24 for the facility’s risk assessment. On 01/24/24, staff member #1 provided the surveyors a document, “Hazard and Vulnerability Assessment Tool” that was documented as completed on 01/23/24 (the date of the request from the surveyors). The document was only partially completed and did not contain a total score for the risk of each event and/or hazard. There was no indication that the facility’s emergency preparedness plan was based off of an all-hazards risk assessment. The facility’s policy, Emergency Preparedness Overview was reviewed and reads in part: Annually, the facility will complete and HVA risk assessment.”

“Primary/Alternate Means for Communication CFR(s): §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure its emergency preparedness communication plan identified a primary and alternate means for communicating with facility staff and federal, state, tribal, regional, and local emergency management services. Findings: The facility’s emergency preparedness plan was reviewed 01/23/24. The plan did not contain information related to an alternate means of communication. Staff member #’s 1 and 6 were asked on 01/23/24 what the facility staff would use as an alternate form of communication. The staff members stated they believed there was a radio, but was unsure of its location or any other details. The surveyor then asked staff member #1 for the facility’s policy related to the communication plan and alternate means of communication. The staff member presented the surveyor with a document, Hazard Communication Program and identified it as the emergency communication plan. The document contained information related to labeling and storage of hazardous chemicals. It did not contain any information related to an alternate means of communication in the event of an emergency.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure staff training on its emergency preparedness plan in one (1) of three (3) personnel files reviewed (Staff member #2). Findings: An interview was conducted with staff member #2 via phone on 01/24/24. The staff member stated they had been covering a vacant position at the facility for approximately three weeks in addition to working at other facilities. Staff member #2 stated that they had been trained on emergency preparedness at their normal clinic (a separately certified facility) but had received no training related to emergency preparedness at this facility. Staff member #2 was asked for the location that staff and patients would evacuate to in the event of an emergency. The staff member stated she was unsure of the meeting point or where to evacuate in the event of an emergency. The personnel file for staff member #2 was reviewed and contained no documentation that the social worker had received emergency preparedness training at this facility. On 01/24/24 staff member #1 confirmed staff member #2 had not received emergency preparedness training and stated the staff member was only in an interim role.”

“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: 36946 Based on staff interview and document review, it was determined the facility failed to ensure it conducted annual exercises to test the emergency preparedness plan. Findings: Information related to the facility’s emergency preparedness plan was reviewed 01/23/23. The plan contained only one (1) testing exercise documented for 2023. Staff member #1 was asked to provide documentation for emergency exercises conducted for 2021 and 2022. No additional documentation was provided prior to the end of the survey.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 36946 Based on observations and document review, it was determined the facility staff failed to clean and disinfect items taken into the dialysis station before being used on another patient during two (2) of two (2) observations. Specifically, the facility staff failed to ensure the conductivity meter was cleaned after each patient use. Findings: On 01/24/2024 at 10:15 a.m. and again at 10:53 a.m., Staff Member (SM) 8 obtained a dialysate sample directly from the dialysis machine, read the conductivity and expelled the contents of the meter’s tubing down the sink. The meter was then returned to a rack on the countertop without being rinsed or sanitized. A review of the facility’s policy, entitled “IC24 Checking Conductivity & pH of Dialysate - Fresenius Machines,” last revision date 06/2022, states, in part: ... 10. The conductivity meter and any collection tubing or cup must be rinsed with reverse osmosis water after each test, prior to testing on another machine, and at the end of each shift. DO NOT allow dialysate, standard solution, and bleach or RO [reverse osmosis] water to remain in the cell overnight. ... 11. The external portion of the conductivity meter must be cleaned with a cloth soaked in 1:100 bleach solution after each use, prior to using at another station, and prior to storing in a clean designated area. A review of the manufacturer’s “User’s Guide” for the Phoenix Conductivity Meter reads, in part: I. Cleaning your Instrument General External Cleaning Recommendations ... 1. For meters in use, use a damp cloth to wipe the exterior of the instrument daily with a mild soap solution or the bleach solution described in the “Disinfecting Recommendations” section if disinfection is required. Do not submerge meter. ... Rinsing Recommendations It is recommended that treated water (RO, DI [deionized], or Distilled water) be the only choice for rinsing meters The above concern was discussed with SM 1, 4, 12 and 13 at the exit conference on 01/24/2024 at 4:45 p.m.”

“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: 36946 Based on staff interview and document review, it was determined the facility staff failed to ensure each patient’s HBV (hepatitis B virus) serological status was known before admission to the hemodialysis unit in one (1) of five (5) medical records reviewed in the survey sample (Medical record #8). Findings: The medical record for patient #8 was reviewed and contained documentation that prior to admission to the dialysis facility, the hospital conducted a hepatitis B surface antigen test (HBsAG, A protein on the surface of hepatitis B virus that can be detected in high levels in serum during acute or chronic hepatitis B virus infection. The presence of HBsAg indicates that the person is infectious, https://www.cdc.gov/hepatitis/hbv/interpretationOfHepBSerologicResults.htm) on 04/15/23. The test result indicated that the specimen was sent for confirmatory testing and no positive or negative result was reported. The patient received their first dialysis treatment in the facility on 04/19/23. On 4/20/23 the medical record contained documentation that the patient was hepatitis B positive. An interview was conducted with staff member #1 on 01/24/24. Staff member #1 stated that the facility’s admission personnel sent an erroneous email that the patient was negative for HBsAG, despite results attached to the email that did not indicate a negative test. The record contained no further documentation that the patient’s HBV serological status was known prior to admission to dialysis. The facility’s policy, Hepatitis B: Control and Management was reviewed and reads in part: It is strongly recommended that each patient’s hepatitis status be known upon admission to the center, based on labs drawn within the previous 30 days...If a patient is admitted for treatment before HBsAg results are known, they will be treated as if the HBsAg test result is potentially positive (until HBsAg result is known), except that the patient will not be treated in the isolation room/area or on the machine dedicated for use on the HBsAg patients: the delivery system will be disinfected internally and externally before use on another patient and the patient will be places at a station with as few adjacent stations as possible and in close proximity to a sink for handwashing.”

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure a HBsAg (hepatitis B surface antigen) positive patient was isolated in a separate room for treatment in one (1) of one (1) medical record reviewed in the survey (Medical record #5). Findings: An interview was conducted with staff member #12 on 01/24/24. Staff member #12 stated that a patient who was positive for hepatitis B received dialysis in April on the treatment floor next to a hepatitis B susceptible patient and not in the isolation room. Staff member #12 reported notifying the facility’s Medical Director and Clinic Manager that the patient was hepatitis B positive and not in isolation. Staff member #12 reported being asked by staff member #1 to sign a verbal order indicating that isolation for the patient was not required, despite being positive for hepatitis B. Staff member #12 reported declining to sign such an order. The medical record for patient #8 was reviewed and contained documentation that prior to admission to the dialysis facility, the hospital conducted a hepatitis B surface antigen test (HBsAG, A protein on the surface of hepatitis B virus that can be detected in high levels in serum during acute or chronic hepatitis B virus infection. The presence of HBsAg indicates that the person is infectious, https://www.cdc.gov/hepatitis/hbv/interpretationOfHepBSerologicResults.htm) on 04/15/23. The test result indicated that the specimen was sent for confirmatory testing and no positive or negative result was reported. The patient received their first dialysis treatment in the facility on 04/19/23. On 4/20/23 the medical record contained documentation that the patient was hepatitis B positive and a nursing note reads as follows, “Critical lab received on 04/20 at 7:54 PM. On call MD [name] called. Patient is to be on isolation and MD [name of medical director] to be called at 8:00 AM to be informed.” Despite the nursing note, the medical record contained no order for the patient to be on isolation. Each treatment sheet reviewed from 04/19/23 to 05/02/23 contained documentation from the nurse as follows: “no isolation.” An interview was conducted with staff member #1 on 01/24/24. Staff member #1 stated that the facility’s admission personnel sent an erroneous email that the patient was negative for HBsAG, despite results attached to the email that did not indicate a negative test. The patient received one (1) dialysis treatment on 04/17/23 on the dialysis floor, not in isolation. The patient was then placed in isolation beginning with the 04/19/23 treatment. Staff member #1 was asked why the documentation stated on all flowsheets that the patient was not in isolation. Staff member #1 stated the treatment records document that the patient received treatment initially at station #6 and all subsequent treatments were conducted at station #11, the isolation room. Staff member #1 confirmed the patient’s HBsAg status should be known prior to admission and any patient positive for hepatitis B should be on isolation and dialyzed in the isolation room. During observations on 01/23/24 and 01/24/24, it was confirmed that the facility had an isolation room and was capable of caring for HBsAg positive patients. The facility’s policy, Hepatitis B: Control and Management was reviewed and reads in part: It is strongly recommended that each patient’s hepatitis status be known upon admission to the center, based on labs drawn within the previous 30 days...If a patient is admitted for treatment before HBsAg results are known, they will be treated as if the HBsAg test result is potentially positive (until HBsAg result is known), except that the patient will not be treated in the isolation room/area or on the machine dedicated for use on the HBsAg patients: the delivery system will be disinfected internally and externally before use on another patient and the patient will be places at a station with as few adjacent stations as possible and in close proximity to a sink for handwashing.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 49355 Based on observations and document review, it was determined the facility staff failed to perform conductivity testing using the Phoenix Conductivity Meter as per the facility’s policy and the manufacturer’s instructions during two (2) of two (2) observations. Findings: On 01/24/2024 at 10:15 a.m. and again at 10:53 a.m., Staff Member (SM) 8 obtained a dialysate sample directly from the dialysis machine, read the conductivity and expelled the contents of the meter’s tubing down the sink. The meter was then returned to a rack. The staff member did not rinse the meter prior to and after testing. A review of the facility’s policy, entitled “IC24 Checking Conductivity & pH of Dialysate - Fresenius Machines,” last revision date 06/2022, states, in part: ... 10. The conductivity meter and any collection tubing or cup must be rinsed with reverse osmosis water after each test, prior to testing on another machine, and at the end of each shift. DO NOT allow dialysate, standard solution, and bleach or RO [reverse osmosis] water to remain in the cell overnight. ... 11. The external portion of the conductivity meter must be cleaned with a cloth soaked in 1:100 bleach solution after each use, prior to using at another station, and prior to storing in a clean designated area. The above concern was discussed with SM 1, 4, 12 and 13 at the exit conference on 01/24/2024 at 4:45 p.m.”

“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: 36946 Based on staff interview and document review, it was determined the facility failed to ensure personnel were trained on water room duties to include quality testing, the risks and hazards of improperly prepared concentrate and bacterial issues; and failed to conduct periodic audits of compliance with procedures in two (2) of two (2) personnel files reviewed (Personnel file #’s 1 and 2). Findings: The personnel files for a Registered Nurse and a Dialysis technician were reviewed. The personnel file for the Registered Nurse (RN) had conflicting dates of hire. The facility’s personnel worksheet indicated the RN was hired 06/07/21. However, the competencies in the file were conducted 04/05/12, nine (9) years prior to the date of hire. The only documented water room competencies were dated 01/24/24 (the second day of the survey). The personnel file for the dialysis technician indicated the employee was hired on 02/07/22. The first documented water room competencies were dated 05/22/22. There were no documented skills checks, audits, or competencies related to the water room for 2023. Another water room competency was dated 01/24/24 (the second day of the survey). The surveyor asked staff member #1 to confirm the RN’s date of hire on 01/24/24. Staff member #1 stated that the RN transferred from another clinic and staff member #1 would obtain the dates after checking her email. On 01/24/24, the surveyor asked the RN when they began employment with the facility. The RN stated they began employment in June of 2023, despite the personnel file indicating the RN was hired in June of 2021. The facility’s Technical Service Manual was reviewed and reads in part: Charge personnel will be trained prior to assuming charge responsibilities and semiannually thereafter. Other clinical staff will be trained prior to performing water testing and semiannually thereafter, unless more frequent testing is deemed necessary by management. Staff member #1 indicated that water room competencies were completed annually, despite the facility policy indicating they should be performed semi-annually. No additional documentation related to water room competencies, audits, or clarification related to dates of hire was provided to the surveyor prior to the exit conference on 01/24/24.”

“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: 40084 Based on observations, interviews, and document review, it was determined the facility staff failed ensure the access site was visible during dialysis treatment for two central venous catheter (CVC) patients (Patient #5 and Patient #6). Findings: At 9:40 a.m. on 01/24/2024, the surveyor observed Patient (P) 5’s accessed CVC site was completely covered up with a blanket at station #7, in Staff Member (SM) 8’s area. P 5’s site remained covered until her treatment ended, at approximately 10:45 a.m. At 9:50 a.m. on 01/24/2024, the surveyor observed P 6’s accessed CVC site was covered by the clean field towel that remained on P 6’s chest at station #12, in SM 9’s treatment area. A review of the facility’s policy, “IC08 Monitoring & Documentation Of Patient Care During Treatment,” last revision date 11/29/2022, states, in part: ... 12. The patient’s vascular access should remain uncovered and readily visible throughout the course of the patient’s treatment. The facility also has a sign posted on the treatment room wall which reads, “Access Must be Visible at all Times.””

“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: 36946 Based on staff interview and document review, it was determined the facility failed to provide the necessary services to manage the patient’s volume status. Specifically, facility staff failed to notify the Registered Nurse (RN) of abnormal vital signs, and administered fluids without a physician’s order in one (1) of five (5) medical records reviewed in the survey sample (Medical record #4). Additionally, the facility failed to follow established policies related to early termination of treatment in one (1) of five (5) medical records reviewed in the survey sample (Medical record #3). Findings: Six (6) treatment records for patient #2 were reviewed. The treatment record for patient #4 dated 01/12/24 was reviewed and contained documentation that the patient’s blood pressure was 81/38 at 10:31 AM. The technician documented: patient blood pressure low. Patient not feeling well. UF trend off. Recheck blood pressure. The blood pressure was rechecked at 10:33 AM and documented as 89/33. The technician documented a fluid bolus of 900 mL was given. The record contained no documentation of a physician order for the fluid bolus and no documentation that the RN was notified of the patient’s blood pressure. An interview was conducted with the Charge Nurse on 01/24/24. The Charge Nurse stated they advise the technicians to notify the charge nurse of any abnormal blood pressure. The treatment record for patient #2 dated 01/19/24 contained documentation that the patient’s blood pressure was 77/50 at 9:01 AM. The technician documented: Patient’s blood pressure low, blood pressure cuff readjusted and chair reclines UFR off normal saline given for low blood pressure. The record contained no documentation that the RN was made aware of the low blood pressure. The agency’s policy, Charge Nurse Notification Protocol reads in part: Events reportable to the charge nurse by direct patient care staff: Intradialytic - Blood pressure systolic greater than 200 or less than 90 or any significant change in blood pressure. An interview was conducted with staff member #1 on 01/24/24. Staff member #1 confirmed abnormal blood pressures should be reported to the RN. Staff member #1 confirmed there was no order for patient #2 to receive a 900 mL fluid bolus. The medical record for patient #3 was reviewed to include six (6) treatment records. The patient was ordered to receive dialysis treatments three (3) times a week for 180 minutes each treatment. The medical record indicated the patient requested to terminate treatment early in two (2) of the six (6) treatment records reviewed. On 01/10/24 the patient’s treatment was ended approximately 30 minutes early. The technician documented: Treatment terminated..Patient complaining of not feeling well and wanted off treatment. The medical record contained no documentation that the RN was notified of the early termination of treatment or that the risks of early termination were explained to the patient. On 01/17/24, the patient requested to terminate treatment 38 minutes early. The record contained no documentation that the risks of early termination were explained to the patient. The facility’s policy, Against Medical Advice (AMA) was reviewed and reads in part. 3. The AMA process should not be used to document patient non-adherence for matters that are not likely to cause serious or immediate harm to the patient or others, such as the patient insisting on regularly signing off treatment early. In these cases, there must be a detailed progress note entered in the patient’s medical record that explains the situation each time it occurs. Each note must provide details of patient counseling of the potential risks to the patient of not following medical orders/advice and the patient’s response, and notification of the patient’s physician as applicable. The medical record for patient #3 contained no documentation that the patient was ever counseled on potential risks of terminating treatment early.”

“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: 49355 Based on observations, interviews, and document review, it was determined the facility staff failed to properly assess and access an arteriovenous (AV) graft/fistula during one (1) patient observation. Findings: At 12:29 p.m. on 01/24/2024, the surveyor observed SM 8 accessing an AV graft on P 7 at station #8. SM 8 cleaned the area and then palpated the graft area. SM 8 then accessed the site without cleaning the area again. SM 8 did not assess the site via auscultation for the presence of a bruit. Interviews with SM 1 and 11 confirmed that SM 8 should have been recleaned the site after palpating and should have auscultated the site for a bruit. A review of the facility’s policy, “IC04A AVF-AVG Cannulation, Treatment Initiation and Termination,” last revision date 11/15/2023, states, in part: ... 3. The access is palpated for thrill and auscultated for bruit. ... 10. Each needle insertion site is then disinfected.... If the access is touched after being disinfected, it must be disinfected again before needle insertion. The above concerns were discussed with SM 1, 4, 12 and 13 at the exit conference on 01/24/2024 at 4:45 p.m.”

“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: 40084 Based on observation, interview and record review, it was determined the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to take action to ensure sustained improvement over time. Specifically, the QAPI program failed to correct known issues identified during the previous recertification survey. The findings include: Current recertification survey Based on observations and document review, it was determined the facility staff failed to clean and disinfect items taken into the dialysis station before being used on another patient during two (2) of two (2) observations. Specifically, the facility staff failed to ensure the conductivity meter was cleaned after each patient use. Recertification survey ending 02/10/2021 Based on one (1) infection control observation and facility document review, it was determined the facility staff failed to ensure non-disposable items taken into the dialysis station were disinfected prior to returning to the clean area. [conductivity meter]”

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must- (i) Be a full time employee of the facility; (ii) Be a registered nurse; and (iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure it had a nurse manager responsible for nursing services in the facility who was a full time employee of the facility. Findings: The facility’s nurse manager (staff member #1) stated to the surveyors on 01/23/23 that they were the regional clinic manager and had oversite responsibilities of four (4) dialysis facilities. Staff member #1 confirmed they were not a full time employee of only this facility. Staff member #1’s job description was reviewed and reads in part: Supervisory Responsibility - This position may have overall supervisory responsibility for a group of clinic manager, nurse managers, and/or Directors of Nursing, as well as administrative, patient care and technical and personnel of their facilities. Staff member #1 confirmed the clinic did not have a full time nurse manager dedicated to the facility on 01/23/23. At the time of the survey, the facility employed one full time RN (staff member #11). Staff member #11 was interviewed on 01/24/24 and confirmed they were not the nurse manager and not responsible for nursing services in the facility.”

“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: 36946 Based on staff interview and document review, it was determined the facility’s Medical Director failed to ensure that all policies and procedures relative to patient admissions, patient care, infection control, and safety were adhered to by all staff members. Findings: Based on interview and document review, it was determined the facility dialyzed a patient with HBV (hepatitis B virus) on the facility floor and not in isolation on at least one occasion (refer to V124 and V128); failed to follow other infection control policies and procedures (refer to V110) leading to a citation at the condition level related to infection control; and failed to ensure policies and procedures related to emergency preparedness were adhered to (refer to E0032, E0038, E0039) leading to a condition level deficiency. The facility’s medical director was interviewed on 01/24/24 and stated that he was unaware that a HBV positive patient was dialyzed not on isolation, despite communication from the on-call physician directing the Medical Director to be notified of the patient’s status at 8:00 AM the morning following notification of the positive result (refer to V0128).”