Usrc Petersburg Dialysis

“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: 42042 Based on interview and document review, it was determined the facility failed to conduct an emergency preparedness exercise for the 2023 calendar year. The finding include: On July 8, 2024, at 2:46 PM, the surveyor initiated review of the facility’s Emergency Preparedness (EP) binder. Upon initial review, the surveyor observed there were no EP exercises documented for the 2023. On July 9, 2024, at 1:33 PM, the surveyor met with Staff Member #12 regarding the facility’s EP testing. The staff member speculated that a previous EP exercise may have been performed that year but that no documentation of the event could be located. In the afternoon of July 9, 2024, the surveyor was provided by Staff Member #12 both the facility’s Emergency Plan (#C-EM-0006A) and the “Conduction of Emergency Preparedness Exercises” policy (#C-EM-0007). On page nine of the former document, revealed that the facility is expected to conduct EP exercise annually along with corresponding documentation for each training exercise. The EP policy stated, in part, that EP exercises will be conducted “once every 12 months or per stricter state regulations”, and that documentation for each exercise will be appropriately maintained.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 49355 Based on observation and policy review, it was determined that the facility failed to ensure a sanitary environment by allowing staff to have fingernails longer than the length stated in the facility’s policy. The findings include: Based on numerous observations from 07/08/2024 to 07/09/2024, while this surveyor was on the facility’s treatment floor, Staff Member #8 has nails that are longer than what is allowed per the facility’s policy. The policy, entitled “Infection Control and Precautions for All Patients,” policy # C-IC-0010, revision date 07/2023, states, in part: ... “Procedure: ... 8. Staff performing dialysis access care will not wear artificial nails and will maintain nails at no longer than 1/4 inch beyond the fingertip.” The above observations were discussed at the exit conference on 07/09/2024 at 1:35 p.m. with Staff Members #12 and 13.”

“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: 49355 Based on two (2) infection control observations, interview and document review, it was determined that the facility failed to conduct hand hygiene to prevent the spread of infection among patients and staff. The findings include: On 07/08/2024 at 1:09 p.m., this surveyor observed Staff Members #5 and #8 fail to perform hand hygiene prior to donning gloves and assessing Patient #5 at station #11. At 1:10 p.m., Staff Member #5 donned a new pair of gloves without performing hand hygiene and returned to station #11. Once finished, Staff Member #5 returned to the nursing station, still wearing the gloves from station #11, and opened a drawer to retrieve an item. After closing the drawer, the Staff Member removed the gloves but did not perform hand hygiene. During interviews with Staff Members #8 and #10 on 07/09/2024, both staff members indicated that the proper protocol is to always perform hand hygiene whenever donning or doffing gloves and to never leave a patient’s area with gloves still on. The facility’s policy entitled, “Infection Control and Precautions for All Patients,” policy #C-IC-0010, revision date 07/2023, reads, in part: ...”Procedure: ... 10. Hand Hygiene: ... b. Staff will perform hand hygiene: ... i. Using soap and water or antibacterial hand sanitizer before/after all patient contact and before donning and after doffing PPE, including gloves. ... ii. After contact with integrated keyboard or chairside computer, regardless of whether contact occurred through gloved or ungloved hands.” In the policy entitled, “Personal Protective Equipment (PPE),” policy #C-IC-0025, revision date 07/2023, reads, in part: ... “Policy: ... 10. Hand Hygiene is performed before donning and doffing PPE. ... Additional Guidance ... 2. Hand hygiene is performed prior to donning and after doffing gloves. ... Proper Use of PPE ... 1. Avoid contamination: ... b. Do not touch environmental surfaces or other items with contaminated gloves.” The above observations were discussed at the exit conference on 07/09/2024 at 1:35 p.m. with Staff Members #12 and 13.”

“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: 49355 Based on observations and document review, it was determined the facility failed to ensure that dialysis stations and chairs were appropriately disinfected between patients in two (2) out of three (3) observations. The findings include: On 07/08/2024 at 2:43 p.m., the surveyor observed Staff Members #5 and #8 cleaning and disinfecting a vacated chair and equipment at station #11. Neither staff member wiped down the sides of the chair and under the chairside tables. Staff Member #5 cleaned the blood pressure cuff and hung it up on the clean machine. The cuff fell to the floor and Staff Member #8 picked it up and hung it back on the machine, without disinfecting it again. Staff Member #5 nor Staff Member #8 cleaned the outside or inside of the prime waste container after the contents were disposed of in the sink. At 2:53 p.m. on 07/08/2024, Staff Member #6 was cleaning and disinfecting a vacated chair at station #4. The Staff Member did not wipe down either side of the chair and under the chairside tables. The facility’s policy entitled, “Infection Control and Precautions for All Patients,” policy #C-IC-0010, revision date 07/2023, reads, in part: ... “Procedure: ... 15. Cleaning and disinfection: ... a. Clean and disinfect the dialysis station (e.g. chairs, ... ancillary equipment, .... ... iii. discard all fluid and clean and disinfect all surfaces and containers associated with the prime waste (including buckets attached to the machines).” The above observations were discussed at the exit conference on 07/09/2024 at 1:35 p.m. with Staff Members # 12 and 13.”

“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: 49355 Based on observations, interview and document review, it was determined the facility failed to remove expired medications from the treatment floor; and ensure aseptic technique when preparing intravenous (IV) medications in three (3) out of five (5) observations. The findings include: On 07/08/2024 at 10:32 a.m., this surveyor inspected the facility’s medication stock in the refrigerator and drawers. The following medications were found to be out-of-date: - #2 vials of Tobramycin Injection 80mg/2ml with an expiration date of 06/30/2024. - #1 opened multidose vial of Tuberculin Purified Protein Derivative (Mantoux) Tubersol. The box and vial were marked with the date and time the vial had been entered for the first time, 01/23/2024 at 3:10 p.m. During observations on 07/08/2024 and 07/09/2024, this surveyor witnessed the following staff members fail to wipe the vial septum with an alcohol pad prior to entering the multidose vial of heparin: - Staff Member #14 at 1:54 p.m. on 07/08/2024 - Staff Member #8 at 1:55 p.m. on 07/08/2024 - Staff Member #6 at 2:32 p.m. on 07/08/2024. Staff Member #10 confirmed in an interview on 07/09/2024 that it is the expectation the staff will wipe the septum of the vial with an alcohol pad prior to entering the vial. A review of the facility’s policy entitled, “Guidelines for Administration of Medication,” policy #C-MA-0010, revision date 04/2024, reads, in part: ... “Procedure: ... 17. Multi-dose vials (MDV): ... a. Multi-dose vials will be discarded within 28 days of opening unless otherwise specified by manufacturer’s instructions. Unopened vials will be discarded according to the manufacturer’s expiration date. ... c. Use aseptic techniques when entering a vial.” In the facility’s policy entitled, “Preparation and Administration of IV/SubQ/IM Medications,” policy #C-MA-0070, revision date 02/2023, reads, in part: ... “Policy: ... 2. Use alcohol pads to prep medication vials/bags. ... Preparation of Medications: Vial.... ... I. Preparation of Medication: Vial ... 6. Wipe rubber top of vial with alcohol pad and allow to dry.” A review of the package insert for the Tuberculin Purified Protein Derivative (Mantoux) Tubersol, production information as of October, 2021, states, in part: ... “A vial of Tubersol which has been entered and in use for 30 days should be discarded. Do not use after expiration date.” The above observations were discussed at the exit conference on 07/09/2024 at 1:35 p.m. with Staff Members # 12 and 13.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 49355 Based on observations, interview and document review, it was determined the facility failed to ensure a safe environment by failing to dispose of contaminated sharps at the point of use in four (4) out of four (4) observations when deaccessing patients with a Arteriovenous (AV) fistula or graft. The findings include: On 07/08/2024 at 10:18 a.m., this surveyor observed Staff Member #7 discontinue dialysis on Patient #8 at station #5 with an AV fistula/graft. The staff member removed the cannulation needles from the patient’s fistula/graft, placed the needles on the chairside table, and then later discarded them into the sharps container. At 10:56 a.m., Staff Member #6 was observed discontinuing dialysis on Patient #11 at station #4 with an AV fistula/graft. The staff member removed the cannulation needles from the patient’s fistula/graft, placed the needles on the chairside table, and then later discarded them into the sharps container. At 1:28 p.m., this surveyor observed Staff Member #6 discontinue dialysis on Patient #9 at station #3 with an AV fistula/graft. The staff member removed the cannulation needles from the patient’s fistula/graft, placed the needles on the chairside table, and then later discarded them into the sharps container. At 2:33 p.m. on 07/08/2024, Staff Member #8 discontinue dialysis on Patient #10 at station #12 with an AV fistula/graft. The staff member removed the cannulation needles from the patient’s fistula/graft, placed the needles on the chairside table, and then later discarded them into the sharps container. The surveyor observed sharps containers at each of the treatment stations. During an interview with Staff Member #10 on 07/09/2024, the Staff Member stated that the expectation is for the needles to be discarded directly into the sharps containers. While reviewing the facility’s policy entitled, “Termination of Dialysis Treatment,” policy #C-TP-0010, revision date 04/2023, it was noted that: ... “Procedure: ... 13. ... ... b. Engage safety device on the fistula needles as needle is removed and discard in the sharps container at point of use.” The facility’s policy entitled, “Infection Control and Precautions for All Patients,” policy #C-IC-0010, revision date 07/2023, reads, in part: ... “Procedure: ... 4. Discard used needles and sharps in appropriate containers.” The above observations were discussed at the exit conference on 07/09/2024 at 1:35 p.m. with Staff Members # 12 and 13.”

“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: 49355 Based on medical record reviews, interview and document review, it was determined the facility failed to: notify the registered nurse of pulse (P) readings outside of facility guidelines for three (3) out of six (6) patients, and; complete a pre-treatment and/or post-treatment nursing assessments by the time specified in the facility’s policy for six (6) out of six (6) patients. The findings include: The 6 most recent flowsheets for each of 6 sampled in-center hemodialysis patients were reviewed on 07/09/2024. Patient #1: On treatment date 07/04/2024, the patient’s treatment ended at 12:56 p.m. The post-treatment nursing assessment was completed at 3:37 p.m. On 07/06/2024, the patient’s treatment ended at 12:57 p.m. The post-treatment nursing assessment was completed at 2:15 p.m. Patient #2: On treatment date 06/26/2024, the patient’s treatment ended at 1:25 p.m. The post-treatment nursing assessment was completed at 3:41 p.m. On 06/28/2024, the patient’s treatment ended at 1:35 p.m. The post-treatment nursing assessment was completed at 3:47 p.m. On 07/01/2024, the patient’s treatment ended at 1:42 p.m. The post-treatment nursing assessment was completed at 3:04 p.m. On 07/03/2024, the patient’s treatment ended at 1:35 p.m. The post-treatment nursing assessment was completed at 6:29 p.m. On 07/05/2024, the patient’s treatment ended at 1:47 p.m. The post-treatment nursing assessment was completed at 4:51 p.m. Patient #3: On treatment date 06/29/2024, the there were three (3) intervals where the patient’s pulse (P) was higher than actionable levels with no note in the flowsheet from the technician or the charge nurse indicating acknowledgement. 9:02 a.m. P of 105 beats per minute (bpm) 10:02 a.m. P of 101 bpm 10:31 a.m. P of 101 bpm On 07/04/2024, the patient’s treatment ended at 10:28 a.m. The post-treatment nursing assessment was completed at 4:07 p.m. On 07/06/2024, the patient’s pulse during the final 45 minutes of a 4-hour treatment cycle ranged between 101 and 103 bpm, with no note in the flowsheet from the technician or the charge nurse indicating acknowledgement. Patient #4: On treatment day 07/01/2024, the patient’s treatment ended at 5:50 p.m. The post-treatment nursing assessment was completed at 7:04 p.m. On 07/03/2024, the patient’s treatment started at 2:07 p.m. The pre-treatment nursing assessment was completed at 5:43 p.m. Patient #5: On treatment date 06/26/2024, the patient’s treatment ended at 2:09 p.m. The post-treatment nursing assessment was completed at 3:49 p.m. On 07/03/2024, the patient’s treatment ended at 2:10 p.m. The post-treatment nursing assessment was completed at 6:34 p.m. On 07/05/2024, the patient’s treatment ended at 2:45 p.m. The post-treatment nursing assessment was completed at 4:59 p.m. Patient #6: On treatment day 06/27/2024, from 12:03 p.m. to 12:52 p.m., the patient’s pulse was greater than 100 bpm, ranging from 102 to 121 bpm during the three hour treatment cycle. The was no documentation on the flowsheet by the technician or the charge nurse acknowledging these readings. On 07/02/2024, the patient’s treatment started at 10:01 a.m. The pre-treatment nursing assessment was completed at 1:12 p.m. On 07/04/2024, the patient’s treatment ended at 12:34 p.m. The post-treatment nursing assessment was completed at 3:27 p.m. In interviews with Staff Members #8 and 10 on 07/09/2024, both indicated that any vital readings outside of the facility’s reportable parameters should be documented on the patient’s flowsheet and reported to the charge nurse. A review of the facility’s document entitled, “Pre-Treatment Assessment of Patient,” policy #C-PT-0010, revised 01/2020, reads, in part: ... “Policy: ... Pre dialysis nursing assessment will occur within the first hour of patient contact....” The facility’s document entitled, “Intradialytic Monitoring of Patient,” policy #C-ID-0010, revision date 09/2020, reads, in part: ... “Monitoring: ... 2. Vital signs: Obtained and documented at least every 30 minutes and reported to charge nurse if outside of standing orders and/or reportable parameters.... ... 10. Comment regarding patient status and staff observation at least every 30 minutes. ... Intervention: ... 2. Modify the treatment plan based on the patient’s response, which must be documented by the charge nurse.” A review of the facility’s document entitled, “Reportable Parameters to CN,” policy #C-FORMS-0081, revision date 01/2020, reads, in part: ... “PCT/CCHT/LPN: Report to Charge Nurse Intra-Dialysis ... Pulse <60 or >100 beats per minute” A policy entitled, “Post Dialysis Assessment of Patient,” policy #C-TP-0060, revision date 01/2020, reads, in part: ... “Intervention: ... 1. Compare data to pre dialysis assessment data and treatment goals.” The above concerns were discussed at the exit conference on 07/09/2024 at 1:35 p.m. with Staff Members #12 and 13.”

“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: 49355 Based on medical record reviews, interviews and document review, it was determined the facility failed to follow the physician’s orders for the prescribed blood flow rate (BFR) and dialysate flow rate (DFR) for five (5) of six (6) in-center hemodialysis patients included in the sample. The findings: The 6 most recent flowsheets for each of 6 sampled in-center hemodialysis patients were reviewed on 07/09/2024. Patient #1: 06/25/2024 - BFR was run at 400 ML/min for entire 3 hour treatment cycle when prescribed rate was 450 ML/min. No documentation was noted on flowsheet as to why. 06/27/2024 - BFR was run at 400 ML/min for entire 3 hour treatment cycle when prescribed rate was 450 ML/min. No documentation was noted on flowsheet as to why. 06/29/2024 - BFR was run at 400 ML/min for entire 3 hour treatment cycle when prescribed rate was 450 ML/min. No documentation was noted on flowsheet as to why. 07/02/2024 - BFR was run at 400 ML/min for entire 3 hour treatment cycle when prescribed rate was 450 ML/min. No documentation was noted on flowsheet as to why. 07/04/2024 - BFR was run at 400 ML/min for entire 3 hour treatment cycle when prescribed rate was 450 ML/min. DFR was run at 500 ML/min for the entire 3 hour cycle when prescribed rate was 600 ML/min. No documentation was noted on flowsheet as to why. 07/06/2024 - BFR was run at 400 ML/min for entire 3 hour treatment cycle when prescribed rate was 450 ML/min. DFR was run at 500 ML/min for the entire 3 hour cycle when prescribed rate was 600 ML/min. No documentation was noted on flowsheet as to why. Patient #2: 07/05/2024 - BFR was run at 400 ML/min throughout the 3 hour 45 minute treatment cycle when the prescribed rate was 450 ML/min. No documentation was noted on flowsheet as to why. Patient #3: 06/29/2024 - DFR was run at 500 ML/min throughout the 4 hour treatment cycle when the prescribed rate was 600 ML/min. No documentation was noted on flowsheet as to why. 07/02/2024 - BFR was run at prescribed rate of 450 ML/min when the treatment cycle started, but approximately 15 minutes later, the rate was decreased to 400 ML/min for the remainder of the cycle. No documentation was noted on flowsheet as to why. Patient #4: 06/24/2024 - DFR was run at 500 ML/min throughout the 4 hour treatment cycle when the prescribed rate was 600 ML/min. No documentation was noted on flowsheet as to why. 06/26/2024 - DFR was run at 500 ML/min throughout the 4 hour treatment cycle when the prescribed rate was 600 ML/min. No documentation was noted on flowsheet as to why. 07/01/2024 - DFR was run at 500 ML/min throughout the 4 hour treatment cycle when the prescribed rate was 600 ML/min. No documentation was noted on flowsheet as to why. 07/03/2024 - BFR was run at 500 ML/min for the first 2 hours of the 4 hour treatment cycle and then decreased to the prescribed rate of 400 ML/min for the remainder of the treatment. No documentation was noted on flowsheet as to why. Patient #5: 06/28/2024 - BFR was run at the prescribed rate of 400 ML/min for the first 30 minutes of a 3 hour 45 minute treatment cycle, then decreased to 350 ML/min for one hour and finally decreased to 300 ML/min for the remainder of the treatment cycle. No documentation was noted on flowsheet as to why. The DFR was run at 500 ML/min for the entire treatment cycle when the prescribed rate was 800 ML/min. No documentation was noted on flowsheet as to why. 07/01/2024 - DFR was run at 600 ML/min throughout the 3 hour 45 minute treatment cycle when the prescribed rate was 800 ML/min. No documentation was noted on flowsheet as to why. 07/05/2024 - DFR was run at 500 ML/min throughout the 3 hour 45 minute treatment cycle when the prescribed rate was 800 ML/min. No documentation was noted on flowsheet as to why. During interviews with Staff Members #10 and 8, both indicated that if the prescribed rates for BFR and DFR are not be run, then documentation should occur in the flowsheet and the charge nurse should be notified. A review of the facility’s document entitled, “Initiation of Dialysis Treatment,” policy #C-TI-0010, revision date 08/2020, states, in part: ...”Policy: ... 7. Two staff members must verify and document on the flow sheet indicating the following items are correct prior to initiation of treatment: ... d. Correct prescription (... DFR,...). ... 14. ... If unable to follow any part of the patient’s prescription...notify the charge nurse and document notification. ... Prescription orders....: ... a. Blood flow is at prescribed rate; ... c. Correct dialysate flow rate....” In the facility’s document entitled, “Intradialytic Monitoring of Patient,” policy #C-ID-0010, revision date 09/2020, reads, in part: ... “Monitoring: ... 8. Delivery of dialysis prescription. ... Delivery System: ... 3. Blood flow rate ... 4. Dialysate flow rate ... Intervention: ... 2. Modify the treatment plan based on the patient’s response, which must be documented by the charge nurse.” The above observations were discussed at the exit conference on 07/09/2024 at 1:35 p.m. with Staff Members #12 and 13.”

“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, interview, and document review, it was determined the facility failed to aseptically access an arteriovenous (AV) grafts/fistulas during two (2) out of 2 observations. The findings include: On 07/08/2024 at 1:15 p.m., the surveyor observed Staff Member #6 accessing an AV fistula on Patient #9 at station #3. The Staff Member cleaned the area and then palpated the site. Staff Member #6 then accessed the site with the cannulation needle without cleaning the area again. At 1:45 p.m., the surveyor observed Staff Member #14 accessing an AV fistula on Patient #12 at station #6. The Staff Member cleaned the area and then palpated the site. Staff Member #6 then accessed the site with the cannulation needle without cleaning the area again. During an interview with Staff Member #10 on 07/09/2024, the Staff Member confirmed that the sites should have been recleaned after palpating and before accessing. A review of the facility’s policy entitled, “Assessment and Cannulation for AV Fistula/Graft and Patient Self Cannulation,” policy #C-TI-0030, revision date 10/2023, reads, in part: ... “Procedure: ... Established AVF: ... 3. Access preparation: ... b. Locate and palpate the needle cannulation sites prior to skin disinfection.... ... 4. Locate the arterial site for puncture ... (DO NOT repalpate the vessel). ... 5. Locate the venous site for puncture ... (DO NOT repalpate vessel). ... Established AV Graft: ... 3. Follow procedure for Established AVF above for cannulation steps.” The above observations were discussed at the exit conference on 07/092024 at 1:35 p.m. with Staff Members #12 and 13.”

“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: 42042 Based on document review and interview, it was determined the facility failed to complete a Plan of Care with patient signatures for two (2) of six (6) medical records. The finding include: On July 9, 2024, at 12:22 PM, the surveyor initiated the medical record review of Patient # (1-6). During review of the most recent Plan of Care assessments for Patient #1 and Patient #4-performed on June 13, 2024, and May 30, 2024, respectively, the surveyor was unable to locate signatures by the patient or patient’s legal representative. On July 9, 2024, at 12:22 PM, the surveyor met with Staff Member #12 for interview. The staff member verbalized to surveyor that patients are offered POC invites as opportunity to participate and sign for care plans. The staff member confirmed signatures by both aforementioned patients (or designee) were not present within the medical records, and that there was no related documentation providing insight to the missing patient signatures. In the afternoon of July 9, 2024, the surveyor was provided the “Comprehensive Interdisciplinary Patient Assessment/Plan of Care (CIPA/POC)” policy (#C-AD-0480) (revision date of 04/2024) by Staff Member #12. The policy stated, in part, that the interdisciplinary team is responsible for completion of the care plan and will reflect participation with the patient (or patient’s legal representative). Under “Plan of Care (POC) completion” section of page four, the same policy continued to state that the POC will be signed by the patient (or legal representative) ...if signature cannot be obtained, appropriate documentation will be included in the medical record.”

“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: 42042 Based on document review and interview, it was determined the facility failed to ensure plans of care were completed within thirty (30) days of admission for three (3) of six (6) patients. The finding include: On July 9, 2024, at 12:22 PM, the surveyor initiated the review of the Plan of Care (POC) Assessments for Patient # (1-6). The surveyor identified the following POC documentation which was not completed within the required timeframe following admission: Patient #1: Date of Admission: May 9, 2024, Initial POC date: June 13, 2024 Patient #4: Date of Admission: April 15, 2024, Initial POC date: May 30, 2024 Patient #6: Date of Admission: March 7, 2024, Initial POC date: April 23, 2024 On July 9, 2024, at 12:22 PM, the surveyor met with Staff Member #12 for interview who confirmed all three aforementioned patients had initial POC assessments beyond the first thirteen (13) outpatient treatments and thirty (30) calendar days from admission. The staff member stated they were unable to locate any documentation explaining why the POCs were performed late. In the afternoon of July 9, 2024, the surveyor was provided the “Comprehensive Interdisciplinary Patient Assessment/Plan of Care (CIPA/POC)” policy (#C-AD-0480) (revision date of 04/2024) by Staff Member #12. Under “Frequency of CIPA/POC completion” section of page two, the policy stated, in part, that within thirteen (13) treatments or thirty (30) calendar days of patient admission, a plan of care will be completed.”