Rai - Thimble Shoals-Newport News

“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: 34452 Based on observations, document review and interview, it was determined that the facility failed to ensure staff perform: A, Hand hygiene after glove removal and after touching face mask for three (3) of eight (8) Staff Members (SM); SM # 3, # 6 and # 7, B, Use hand sanitizer correctly when performing hand hygiene for one (1) of eight (8) SM; SM # 3, C, Have fingernails 1/4 inch or less for one (1) of eight (8) SM; SM # 3; and D, Wear gloves during patient care for one (1) of eight (8) SM; SM # 3. The findings include: On July 14, 2025, between 10:30 AM and 1:00 PM, observations during initiation and termination of treatments revealed the following: At 10:30 AM, SM # 3 was observed administering medication at Station # 5. SM # 3 had on one (1) glove. SM # 3 was observed with fingernails greater than 1/4 inches with greenish bluish polish. SM # 3 used hand sanitizer and the waved hands in air to dry. At 10:50 AM, SM # 7 was observed at the counter in between stations. SM # 7 pulled the face mask down below nose and was resting chin on hand which was covering the face mask that was below the chin. SM # 7 then pulled to face mask up above nose and proceeded to Station # 19 and performed care. SM # 7 failed to perform hand hygiene after touching face mask and before donning clean gloves. At 11:15 AM, SM # 6 was observed in the treatment area, pulling mask below nose and scratching nose with gloved hand and then pulled mask back up above nose. SM # 6 proceeded to Station # 19 for setup. SM # 6 failed to change gloves and perform hand hygiene. At 11:20 AM, SM # 6 was observed pulling mask up above nose and not performing hand hygiene before donning clean gloves at Station # 24. SM # 6 then removed gloves and failed to perform hand hygiene. At 11:25 AM, SM # 7 was observed at Station # 20. SM # 7 removed gloves and failed to perform hand hygiene before clean gloves were donned. At approximately 1:00 PM, SM # 1 indicated the facility follows CDC (Center for Disease Control and Prevention) guidelines. CDC guidelines (www.cdc.gov) include “be sure to wash your hands or use sanitizer before putting on a face mask. Do not touch the face mask when wearing it. If you touch the face mask be sure to wash hands or use sanitizer”. On July 14, 2025 at approximately 2:00 PM, a review of the facility’s policy titled “Personal Protective Equipment “ found in part, “personal protective equipment (PPE) including gloves must be worn to protect employees from blood. Practice hand hygiene after mask removal to prevent cross contamination. Always perform hand hygiene after glove removal.” The facility’s policy titled “Hand Hygiene” reads in part “do not wear artificial fingernails, extenders or nail wraps when having direct contact with patients. Natural fingernail length shall be kept to 1/4 inch or less....Decontaminating hands with alcohol-based hand rubs: rub hands together covering all surfaces of the hands and fingers until hands are dry.””

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 34452 Based on observation, document review and interview, it was determined that the facility failed to ensure two (2) of eight (8) Staff Members (SM) observed wear PPE to protect from blood or other potentially infectious materials. SM # 3 and # 6. The findings include: On July 14, 2025, between 10:30 AM and 1:00 PM, observations during initiation and termination of treatments revealed the following: At 10:30 AM, SM # 3 was observed administering medication at Station # 5. SM # 3 failed to tie the gown around waist to secure it. The gown was left hanging off of the body and exposing SM # 3 to blood and other potentially infectious materials while at the treatment station. At 10:45 AM, SM # 3 was observed walking in the treatment with gown untied and SM # 3 pulled the ties off and threw them in the trash continuing to provide care with gown hanging off of body and exposing self to blood and other potentially infectious materials. At 10:50 AM, SM # 7 was observed entering the treatment area without a gown or face shield. SM # 7 went to Station # 19 with no gown or face shield. On July 14, 2025 at approximately 2:00 PM, a review of the facility’s policy titled “Personal Protective Equipment “ revealed in part, “personal protective equipment (PPE) including a full face shield or mask and protective eye wear with full side shield, fluid - resistant gowns, and gloves must be worn to protect employees from blood and other potentially infectious materials.” On July 15, 2025 at approximately 12:00 PM, SM # 1 explained that staff are expected to tie gowns around waist either in front or back to secure.”

“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: 34452 Based on document review and interview, it was determined that the facility failed to have hepatitis B virus (HBV) results prior to treatment for one (1) of two (1) Patients (P); P # 3 The findings include: On July 15, 2025 at 12:00 PM, review of P # 3’s clinical record revealed the first dialysis treatment was on April 29, 2025. There were no results of HBV testing prior to treatment. At 1:00 PM, an interview with SM # 1 revealed, there was no results of HBV testing prior to treatment for [P # 3 name]. At 1:30 PM, a review of the facility’s policy titled “Patient Hepatitis B Testing Requirements” reads in part, “HBV status should be known prior to admission for all new patients.””

“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: 34452 Based on document review and interview, it was determined that the facility failed to ensure: A, Six (6) of ten (10) In-center Hemodialysis (ICHD) Patients (P) included in the survey sample received a dialysis treatment at the prescribed blood flow rate (BFR); P # 1, # 2, # 3, # 8, # 9 and # 10, and B, The Registered Nurse (RN) and/or Physician were notified of the need to reverse central venous catheter (CVC) lines for three (3) of ten (10) ICHD P; P # 3, # 4 and # 6. The finding include: On July 15, 2025, the clinical record review revealed the following: P # 1 The flowsheet dated July 2, 2025, revealed the BFR was documented as 300 or 425 during the treatment (6:50 AM to 10:56 AM) The physician prescribed a dialysis treatment to be administered at BFR of 450. There was no documentation that the physician and/or RN were notified of the change in BFR. P # 2 The flowsheet dated July 3, 2025, revealed the BFR was documented as 400 during the treatment (5:05 AM to 8:46 AM) The physician prescribed a dialysis treatment to be administered at BFR of 450. There was no documentation that the physician and/or RN were notified of the change in BFR. P # 3 The flowsheet dated July 4, 2025, revealed the BFR was documented as 355 to 380 during the treatment (6:15 AM to 10:19 AM) The physician prescribed a dialysis treatment to be administered at BFR of 400. There was no documentation that the physician and/or RN were notified of the change in BFR. The flowsheet dated July 7, 2025, revealed “line reversed” at 8:30 AM. There was no documentation that the physician and/or RN were notified. P # 4 The flowsheet dated July 4, 2025, revealed “line reversed” at 6:33 AM. There was no documentation that the physician and/or RN were notified. P # 6 The flowsheet dated July 8, 2025, revealed “line reversed” at 5:52 AM. There was no documentation that the physician and/or RN were notified. P # 8 The flowsheet dated July 2, 2025, revealed the BFR was documented as 325 to 400 during the treatment (5:06 AM to 9:18 AM) The physician prescribed a dialysis treatment to be administered at BFR of 450. There was no documentation that the physician and/or RN were notified of the change in BFR. P # 9 The flowsheet dated July 2, 2025, revealed the BFR was documented as 350 during the treatment (11:20 AM to 2:51 PM) The physician prescribed a dialysis treatment to be administered at BFR of 400. There was no documentation that the physician and/or RN were notified of the change in BFR. P # 10 The flowsheet dated July 9, 2025, revealed the BFR was documented as 430 during the treatment (12:09 PM to 16:09 PM) The physician prescribed a dialysis treatment to be administered at BFR of 450. There was no documentation that the physician and/or RN were notified of the change in BFR. On July 15, 2025 at approximately 2:00 PM, a review of the facility’s policy titled “Unable to achieve prescribed blood flow rate” revealed in part, “achieving prescribed BFR is a critical parameter in achieving adequate treatment Kt/v. Staff, patient and care partner will recognize and report to the nurse in charge the inability to achieve prescribed blood flow rate.” The facility policy titled “reversal of Central Venous Catheter Lines” reads in part, “reversal of CVC lines may increase the risk of reticulation and decrease adequacy as the reversed catheter arterial limb now becomes the venous return. The RN is responsible for assessing and performing any trouble-shooting procedures including reversal of CVC lines. Reversal of CVC lines requires the following documentation in the patient’s medical record: Provide order with frequency. Reason for reversal. Action of line reversal. Evaluation of catheter function and future need for vascular referral.” At 2:15 AM, SM # 1 indicated staff are expected to follow the facility’s policies.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 34452 Based on document review and interview, it was determined that the facility failed to ensure: A, The RN performed and documented the nursing assessment within one (1) hour of the treatment initiation for two (2) of ten (10) ICHP, P # 3 and # 5, B, Staff obtained a standing blood pressure (BP) for three (3) of ten (10) ICHP, P # 2, # 3 and # 7, and C, Staff obtained machine parameters and vital signs to include BFR and BP at lease every 30 minutes for seven (7) of ten (10) ICHP, P # 2, # 3, # 4, # 5, # 6, # 7 and # 9. The findings include: On July 15, 2025, the clinical record review revealed the following: P # 2 The flowsheet dated July 3, 2025, documented the pre dialysis standing BP as “cannot assess”. The post dialysis standing BP was 226/129. The RN assessment documented “ambulates w/o assistance”, “BP elevated at start of treatment”. The flowsheet dated July 5, 2025, documented the pre dialysis standing BP as “cannot assess”. The post dialysis standing BP was “cannot assess”. The RN assessment documented “ambulates w/o assistance”. P # 3 The flowsheet dated July 4, 2025, revealed there were no documented machine parameters and vital signs to include BFR and BP between 8:01 AM and 9:01 AM (greater than 30 minutes). The flowsheet dated July 7, 2025, documented the pre dialysis standing BP as “cannot assess”. The post dialysis standing BP was 150/105. The RN assessment documented “ambulates w/o assistance”. The flowsheet dated July 14, 2025, revealed there were no documented machine parameters and vital signs to include BFR and BP between 7:02 AM and 8:10 AM (greater than 30 minutes). P # 4 The flowsheet dated July 7, 2025 revealed there were no documented machine parameters and vital signs to include BFR and BP between 6:02 AM and 7:03 AM (greater than 30 minutes). P # 5 The flowsheet dated July 9, 2025, revealed the treatment was initiated at 9:01 AM and ended at 1:02 PM. The RN assessment was documented at 10:50 AM (greater than one (1) hour). There were no documented machine parameters and vital signs to include BFR and BP between 11:35 AM and 12:20 PM (greater than 30 minutes). P # 6 The flowsheet dated July 3, 2025, revealed there were no documented machine parameters and vital signs to include BFR and BP between 7:30 AM and 8:41 AM (greater than 30 minutes). P # 7 The flowsheet dated July 1, 2025, revealed there were no documented machine parameters and vital signs to include BFR and BP between 6:06 AM and 7:06 AM (greater than 30 minutes). The flowsheet dated July 10, 2025, documented the pre dialysis standing BP as “cannot assess”. The post dialysis standing BP was as “cannot assess”. The RN assessment documented “ambulates w/o assistance”. P # 9 The flowsheet dated July 7, 2025, revealed there were no documented machine parameters and vital signs to include BFR and BP between 1:03 PM and 3:01 PM (greater than 30 minutes). On July 15, 2025 at approximately 2:00 PM, a review of the facility’s policy titled “Patient Assessment and Monitoring” revealed in part “blood pressure and pulse rate every 30 minutes or more as needed and documented machine parameters and safety checks every 30 minutes or more often as needed. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment. Standing BP and weight are obtained pre and post dialysis by the licensed nurse or PCT (Patient Care Technician).” At 2:00 PM, SM # 1 indicated in an interview that staff are expected to follow the facility’s policies.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 34452 Based on document review and interview, it was determined that the facility failed to ensure the patient’s care plan was signed by the interdisciplinary team members and patient for two (2) of two (2) Home Peritoneal Dialysis (PD) patients (P), P # 11 and # 12. The findings include: On July 14, 2025, the clinical record review revealed the following: P # 11 The initial care plan meeting was documented on March 25, 2025 and the 90-day care plan on June 30, 2025. There was no patient signature on either care plan to indicate participation in the care plan meeting. P # 12 The annual care plan meeting was documented on January 29, 2025. There was no patient signature on the care plan to indicate participation in the care plan meeting. On July 15, 2025 at approximately 2:00 PM, review of the facility’s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” revealed in part “The comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, the Patient, a registered nurse, the patient’s attending Physician, social worker and registered dietitian. The plan of care should be signed at the time of the interdisciplinary team meeting for those attending in person. If unable to sign at the time of the meeting or if attending remotely, the care plan must be signed by the IDT member within 30 days of the interdisciplinary team meeting”. At 2:10 PM, SM # 5 indicated the care plans were awaiting signatures by patients during their next office visit.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 34452 Based on document review and interview, it was determined that the facility failed to ensure the patient’s initial care plan was completed with 30 calendar days after admission to the dialysis facility for one (1) of twelve (12) patients (P) included in the survey sample. P # 11 The findings include: On July 14, 2025, the clinical record review revealed the following: P # 11 was admitted to the facility on February 10, 2025, as a home PD patient. The initial care plan meeting was documented as March 25, 2025 (greater than 30 days). Documentation read in part “reason overdue: MD clinic schedule”. On July 15, 2025, at approximately 2:00 PM, a review of the facility’s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” revealed in part, “An initial comprehensive interdisciplinary assessment and plan of care must conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session”. At 2:10 PM, SM # 5 indicated the initial care was late due to the MD schedule.”

“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: 42725 Based on facility document review and interviews, the facility staff failed to meet the requirement to participate in and/or conduct an emergency preparedness (EP) exercise annually or participate in a full scale community exercise or table-top drill every two years during calendar years 2021 and 2022. Findings: A surveyor conducted a review of the facility’s EP plan on 12/5/23 and 12/6/23. The review revealed that an EP drill was conducted in January 2023; however, the last table-top exercise was conducted on 7/17/2020. The surveyor requested any additional documentation to show a drill or table-top exercise had been conducted for 2021 or 2022. Staff Member (SM) #3 was unable to locate any additional drill or exercise conducted by the facility. In the afternoon of 12/5/23, the surveyors reviewed the finding with SMs #2, #3, #4, #23, #24, #25 and #29. During the exit conference on 12/6/23, the surveyors reviewed the finding with the following SMs: #1, #2, #3, #4, #20, #23, #24, #25, #26, #27, #28 and #29.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 42725 Based on record review and interview, the facility failed to ensure complete education and documentation of Emergency Preparedness (EP) training for seven (7) of ten (10) In-Center Hemodialysis (ICHD) patients. Findings: A surveyor conducted a review of ICHD patient medical records on 12/5/23. During the review, the surveyor identified the following: Patients #2, #3, #5, #6, #7, #8 and #9 had not received complete EP training and education. The documentation in each chart indicated the patients received education related to emergency evacuation but no training and education related to emergency disconnect from the machine. The surveyor discussed the findings with Staff Members (SMs) #3 and #29. SM #3 attempted to obtain additional documentation, but was unable to locate any. SM #3 was unable to verify who is responsible for completing EP patient education. On 12/6/23, an interview was conducted with SM #21. SM #21 could not verify who is responsible for completing EP patient education, but said “I don’t think it is the tech’s responsibility”. During the exit conference on 12/6/23, the surveyors reviewed the finding with the following SMs: #1, #2, #3, #4, #20, #23, #24, #25, #26, #27, #28 and #29.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 42725 Based on observations and facility policy review, it was determined the facility staff failed to place the access needles directly into the sharps container upon removal for two (2) of four (4) observations. Findings: On 12/5/23 at 9:44 a.m., a surveyor observed Staff Members (SMs) #12 and #32 working together to discontinue treatment for a patient at station #6. The surveyor observed SM #12 remove an access needle for the patient. Upon remove, SM #12 capped the needle and laid it down on the tray. SM #12 proceeded to apply gauze to the access site. Once completed, SM #12 picked up the capped needle and walked it over to the sharps container for disposal. SM #32 was observed removing the second access needle for the patient. SM #32 repeated the same process for the second access needle as SM #12. On 12/5/23 at 11:05 a.m., a surveyor observed SM #31 remove an access needle for a patient at station #12. Upon removal, SM #31 capped the needle and laid it down on the tray. SM #31 proceeded to apply gauze to the access site. Once completed, SM #31 picked up the capped needle and walked it over to the sharps container for disposal. SM #31 repeated the same process for the second access needle removal. In the afternoon of 12/5/23, the surveyors discussed the findings with the following SMs: #2, #3, #4, #23, #24, #25 and #29. A policy regarding discontinuing treatment for a patient with a fistula or graft was requested. The facility’s policy titled, Post Treatment Fistula Needle Removal, was reviewed on 12/6/23 and reads, in part: “...Procedure... 6. Carefully remove the needle... Engage the safe needle device per manufacturer’s instructions for use. Discard needle in sharps container...”. During the exit conference on 12/6/23, the surveyors reviewed the finding with the following SMs: #1, #2, #3, #4, #20, #23, #24, #25, #26, #27, #28 and #29.”

“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: 42725 Based on observations and facility policy review, it was determined the facility staff failed to follow facility policy for cleaning and disinfecting the dialysis station for two (2) of four (4) observations. Findings: On 12/5/23 at 9:30 a.m., the surveyor observed Staff Member (SM) #21 cleaning station #21. SM #21 did not wipe under the side trays of the chair. On 12/5/23 at 9:40 a.m., the surveyor observed SM #31 cleaning station #9. SM #31 did not wipe under the side trays of the chair. In the afternoon of 12/5/23, the surveyors discussed the findings with the following SMs: #2, #3, #4, #23, #24, #25 and #29. A policy regarding station cleaning was requested. The facility’s policy titled, Cleaning and Disinfection of the Dialysis Station, was reviewed and reads, in part: “... Procedure... 3. Use a cloth wetted with 1:100 bleach solution of EPA-approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, IV pole, B/P cuff, hand sanitizer dispenser and holder, chaise wall behind chair)... 4. Clean all surfaces...”. During the exit conference on 12/6/23, the surveyors reviewed the finding with the following SMs: #1, #2, #3, #4, #20, #23, #24, #25, #26, #27, #28 and #29.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 42725 Based on observations and facility policy review, it was determined that facility staff failed to label one (1) open medication with the date it was opened and initials of the staff member who opened it. Findings: During the flash tour on 12/4/23 at 11:35 a.m., a surveyor discovered an opened vial of Epogen 20,000 units in the refrigerator with no date or initials. In the afternoon of 12/4/23, the surveyors discussed the findings with the following Staff Members (SMs): #1, #2, #3, #4, #23, #25 and #29. A policy regarding medication preparation and handling was requested. A review of the facility’s policy titled, Medication Preparation and Administration, was conducted and reads, in part: “... Labeling Vials... When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT (if allowed by state regulations), must place the date and time the vial was opened on the medication label along with their initials. Note: To ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened...”. During the exit conference on 12/6/23, the surveyors reviewed the finding with the following SMs: #1, #2, #3, #4, #20, #23, #24, #25, #26, #27, #28 and #29.”

“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: 42725 Based on observations and facility policy review, the staff failed to ensure the access site for seven (7) patients were visible during the dialysis treatment. Findings: On 12/4/23, a surveyor conducted observations on the treatment floor from 11:50 a.m. until 2:30 p.m. During this time, the surveyor observed access sites covered at the following stations: #6, 17, #18 and #21. Prior to leaving the treatment floor, the surveyor observed the sites (at the four stations) remained covered. In the afternoon of 12/4/23, the surveyors discussed the findings with the following (Staff Members) SMs: #1, #2, #3, #4, #23, #25 and #29. A policy regarding patient assessment and monitoring was requested. On 12/5/23, a surveyor conducted observations on the treatment floor from 9:25 until 11:50 a.m. During this time, the surveyor observed access sites covered at the following stations: #7, #11 and #23. Prior to leaving the floor, the surveyor observed the site at station #23 had been uncovered; however, #7 and #11 remained covered. A review of the facility’s policy titled, Patient Assessment and Monitoring, was conducted on 12/5/23 and reads, in part: “... During Treatment... Access... Ensure access remains uncovered throughout the treatment...”. During the end of the day meeting on 12/5/23, the surveyors reviewed the observations of the day with SMs: #2, #3, #4, #23, #24, #25 and #29. During the exit conference on 12/6/23, the surveyors reviewed the finding with the following SMs: #1, #2, #3, #4, #20, #23, #24, #25, #26, #27, #28 and #29.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 42725 Based on record review and facility policy review, the interdisciplinary team failed to complete an initial comprehensive interdisciplinary assessment (CIA) and Plan of Care (POC) according to the facility’s policy and failed to complete a follow-up assessment according to the facility’s policy for one (1) of five (5) patients sampled that have been at the facility for less than one (1) year. Findings: On 12/5/23, a surveyor reviewed medical records for the patients sampled. Five (5) of the patients had been at the facility for a least one (1) year. Patient #4 was admitted on 2/24/23. The patient had a POC on 4/17/23 which was over 30 days or thirteen (13) treatments. There was no documentation indicating the patient had a CIA/POC within 90 days. The surveyor requested an updated POC for the patient; however, the staff were unable to locate one. In the afternoon of 12/5/23, the surveyors reviewed the finding with Staff Members (SMs) #2, #3, #4, #23, #24, #25 and #29. A policy related to the plan of care was requested. On 12/6/23, a review of the facility’s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” was conducted and reads, in part: “... CIA and POC for Patients New to Dialysis... An initial comprehensive interdisciplinary assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session... A follow up CIA must occur within 90 days. The POC should be adjusted as appropriate and implemented within 15 days of reassessment...”. During the exit conference on 12/6/23, the surveyors reviewed the finding with the following SMs: #1, #2, #3, #4, #20, #23, #24, #25, #26, #27, #28 and #29.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; This Standard is not met as evidenced by: 42725 Based on record review and facility policy review, the interdisciplinary team failed to complete a revised Plan of Care (POC) at least annually for one (1) of five (5) stable patients who have been at the facility for at least one (1) year. Findings: On 12/5/23, a surveyor reviewed medical records for the patients sampled. Five (5) of the patients had been at the facility for a least one (1) year. Patient #7’s last POC was dated 8/2/22. The surveyor requested an updated POC for the patient; however, the staff were unable to locate one. In the afternoon of 12/5/23, the surveyors discussed finding with Staff Members (SMs) #2, #3, #4, #23, #24, #25 and #29 and requested the facility’s policy related to the plan of care. On 12/6/23, a review of the facility’s policy titled “Comprehensive Interdisciplinary Assessment and Plan of Care” was conducted and reads, in part: “... CIA/POC for Stable Patients... Comprehensive interdisciplinary assessments and modifications to the Plan of Care must be conducted 12 months after the completion of the 3 month assessment and then reassessed annually thereafter on all stable patients. The Plan of Care must be implemented within 15 days of the reassessment...”. During the exit conference on 12/6/23, the surveyors reviewed the finding with the following SMs: #1, #2, #3, #4, #20, #23, #24, #25, #26, #27, #28 and #29.”

“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: 42725 Based on record review and facility policy, it was determined that the staff failed to follow the dialysis treatment prescription for one (1) of ten (10) patients sampled. Findings: On 12/5/23, the surveyor reviewed treatment flowsheets of ten sampled patients. The review revealed that patient #1 was prescribed the following: “Heparin Sodium (Porcine) 1,000 Units/mL Catheter Lock Arterial Red Port 2500 units Every Treatment... Start: 11/17/2023... Heparin Sodium (Porcine) 1,000 Units/mL Catheter Lock Venous Blue Port 2500 units Every Treatment... Start: 11/17/2023...”. On the 11/27/23 flowsheet, there was no documentation the medications were administered and no documentation to indicate why they were not given. On the 11/29/23 flowsheet, there was no documentation the medications were administered. There was a comment documented that read, “did not receive” but no additional documentation why they were not received. In the afternoon of 12/5/23, the surveyors discussed finding with Staff Members (SMs) #2, #3, #4, #23, #24, #25 and #29. The facility’s policy titled, Nursing Supervision an Delegation, reads, in part: “...The registered nurse must evaluate the patient preferably within an hour or according to state requirements to... Review patient treatment prescription and equipment parameter to verify correct settings, and if dialysis prescription is being followed ...”. During the exit conference on 12/6/23, the surveyors reviewed the finding with the following SMs: #1, #2, #3, #4, #20, #23, #24, #25, #26, #27, #28 and #29.”