Davita Culpeper 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: 46466 Based on interview and facility documentation review, the facility failed to conduct annual exercises to test the emergency plan. The findings include: On 5/15/24 a review of the facility’s Emergency Preparedness binder was conducted. The binder did not include evidence that facility-based or community-based functional exercises were performed to test the facility’s emergency plan in 2024, 2023 or 2022. On 5/15/24 at approximately 1:45 p.m., the surveyor requested evidence of the facility’s annual emergency testing from Staff Member #12. Staff Member #12 was unable to provide any documentation to support that the facility conducted facility-based or community-based testing in the last two (2) years. A review of the facility’s policy “Facility Emergency Management Plan (ICHD, Home)”, revised October 2023 stated in part: “...Emergency Drills..2...e...Frequency: i. The facility will conduct and/or participate in one (1) exercises to test the facility EMP at least ANNUALLY, conducted on the OPPOSITE years (one year full-scale exercise, next year facility-based/exercise of choice)...”. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”

“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: 46466 Based on interview, medical record and facility documentation review, the facility failed to perform quarterly patient fire safety training for one (1) of six (6) patients included in the survey sample. The findings include: On 5/15/24, a review of six (6) sampled patient medical records was conducted. A review of Patient #2’s medical record was conducted on 5/15/24 at 8:45 a.m. The review revealed that Patient #2’s last quarterly Fire Safety Training was conducted on 6/17/23. There was no documented evidence to support that Patient #2 received any Fire Safety Training after 6/17/23. On 5/15/24 at approximately 3:30 p.m., Staff Member #12 verified that the documentation found in Patient #2’s medical record was the most current evidence of Fire Safety Training for Patient #2. A review of the facility’s policy “Facility Emergency Management Plan (ICHD, Home)”, revised October 2023 stated in part: “...Training and Education. Emergency Management Plan 1. The FA, or designee, is responsible to provide training of EMP: ...b. Training/In-service Documentation FormPatients {sic} ...ii. QUARTERLY: 1. Fire Safety Preparedness...v. Document training on applicable forms...”. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 46466 Based on observations and facility document review, the facility staff failed to properly label clean and dirty areas. The findings include: On 5/14/24 at 12:10 p.m., during the flash tour, the surveyor observed one (1) sink in the back of the treatment floor near Pod C that was not labeled as either clean or dirty. On 5/15/24 at 12:20 p.m., the surveyor observed several conductivity meters sitting on the counter next to the same unlabeled sink. A review of a facility policy “Infection Control for Dialysis Facilities”, Policy: 1-05-01, revised April 2023, stated in part, “...Facility Hygiene, 16. Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.” The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”

“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: 46466 Based on observations, interviews and document review, it was determined that the facility’s staff failed to properly clean and disinfect contaminated surfaces of the medical devices and equipment. The findings included: On 5/14/24 at 2:35 p.m., the surveyor observed Staff Member #7 use the facility’s hydraulic lift to transfer a patient to a wheelchair. After use, Staff Member #7 moved the lift back to its original location and did not disinfect the lift. On 5/14/24 at approximately 4:00 p.m., the surveyor observed Staff Member #7 place a citric acid jug onto the bottom shelf of patient station #3. Staff Member #7 had not disinfected patient station #3 prior to placing the clean citric acid jug onto the machine. On 5/15/24 at approximately 2:20 p.m., Staff Members #1 and #12 were asked about the proper procedure for using the citric acid jugs. Both staff members explained that the citric acid jugs should have been placed on the dialysis machine after the machine was disinfected or that the jugs should have been wiped with disinfectant after use. A review of the facility’s policy “Infection Control For Dialysis Facilities”, Policy: 1-05-01, revised April 2023, stated in part: “...DISINFECTION: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area...14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses...”. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 19883 Based on observation, facility policy review, and staff interview, the facility failed to ensure adequate cleansing of central venous catheter (CVC) hubs (end of a CVC that connects to blood lines or a cap) prior to the initiation of dialysis for one (1) of ten (10) patients, (Patient #9) included in the survey sample. The findings include: On 5/15/24 at approximately 11:10 AM, while preparing Patient #9’s CVC for dialysis, Staff Member #16 cleansed the two CVC hubs for less than 10 seconds before connecting syringes to the catheter ports. Review of the facility’s policy titled: “Central Venous Catheter” (Rev October 2023) reads in part: “Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason.” On 5/15/24, during an interview Staff Member #12 confirmed CVC hubs should be cleansed for 15 seconds before connecting or disconnecting from blood lines. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 46466 Based on interviews and facility document review, the facility failed to ensure a color blindness testing was performed per facility policy on two (2) out of three (3) employee included in the personnel records survey sample. The findings include: On 5/15/24 at 3:30 p.m., a review of three (3) personnel records was conducted with Staff Member #1. The documentation revealed that Staff Member #9 ‘s hire date was 2/12/24. There was no documented evidence that Staff Member #9 had received color blindness testing to date. Staff Member #14’s hire date was documented as 11/13/23. There was no documentation to support that Staff Member #14 received color blindness testing to date. On 5/15/24 at 3:45 p.m., an interview was conducted with Staff Member #1. Staff Member #1 confirmed that Staff Member’s #9 and #14 had not been tested for color blindness. Staff Member #1 stated that neither staff member had performed any water testing to date. This information was verified by a surveyor upon review of the facility’s water room chlorine testing logs. A review of the facility’s policy “Color Vision Evaluation”, Policy: 8-02-03, revised October 2017, stated in part: “...1...Color blindness testing is performed at time of hire...3. The Facility Administrator/Program Manager/designee is responsible for assuring that the appropriate teammates are evaluated for ability to see color...”. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 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: 46466 Based on interview and facility document review, the facility failed to provide evidence that two (2) of five (5) staff members’ (included in the sample) knowledge and skills were maintained according to facility policy. The findings include: On 5/15/24 at 2:55 p.m. a review of five (5) employee personnel records were reviewed with Staff Members #1 and #12. Staff Members #7 and #16’s personnel files did not include most recent documentation related to completion of annual water skills competency check. Staff Member #7’s last annual Water Skills Checklist was dated 3/4/23 and Staff Member #16’s last annual Water Skills Checklist was dated 3/8/23. An interview was conducted with Staff Members #1 and #12. Both staff confirmed that water skills testing was completed on an annual basis. Staff Member #1 stated that all of the facility’s staff members just conducted their annual Water Room Skills review on 3/19/24 with Staff Members #1 and #6. Staff Member #1 stated that the checklist paperwork was not completed by Staff Member #6. A review of the facility’s “Digital Teammate Files Document Guidance Checklist”, with no date, stated in part: “...Annual Documents...Water Skills Checklist...”. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”

“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: 19883 Based on observation, facility policy review and staff interview, the facility failed to have one of 10 patients, (Patient #8), in the survey sample wash their arterial/venous access site upon entry into the facility. The findings include: On 5/15/24 at approximately 10:45 AM, Staff Member #13 escorted Patient #8 to the dialysis station. Patient #8 was ambulatory and did not need assistance, and had full function of all extremities. Staff Member #13 did not instruct Patient #8 to wash their access site upon entering the facility, nor confirmed with Patient #8 that they had cleaned their access site upon entry to the facility. Prior to cannulation of Patient #8’s arterial and venous access site, Staff Member #13 cleansed Patient #8’s access site with a P.A.W.S. disposable towelette. (P.A.W.S. towelette is an antimicrobial premoistened towelette for professional use). Review of the facility’s policy titled “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (Rev. October 2022) reads in part: “Have patient wash access site with appropriate antibacterial soap, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry.” On 5/15/24, during an interview with Staff Member #12, Staff Member #12 confirmed that if a patient is able to wash their access site upon entry into the facility for dialysis, they should do so. Staff Member #12 confirmed that, prior to the initiation of dialysis, staff members are supposed to ask patients if they cleansed their access sites. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m. 46466 Based on observations, interview and facility document review, facility staff was observed utilizing two (2) clamps simultaneously to achieve hemostasis post cannulation in two (2) patients without physician’s order. The findings included: On 5/14/24 at 2:24 p.m., the surveyors observed a patient at station #4 with two (2) clamps over their arteriovascular (AV) fistula/graft site on their arm. On 5/14/24 at 3:45 p.m., a surveyor observed a patient at station #14 with two (2) clamps over their arteriovascular (AV) fistula/graft site on their arm. On 5/14/24 at 4:20 p.m., an interview was conducted with Staff Member #12. Staff Member #12 stated that patients needed to have a physician’s order in their chart to have two (2) clamps placed on their arm. On 5/15/24, Staff Member #12 provided two ancillary orders, for Patient #4 and #14 who were observed on 5/14/24 with two (2) clamps on their arms. The physician orders were written on 5/15/24 permitting the use of two (2) clamps to achieve hemostasis. Staff Member #12 confirmed that the orders for use of two (2) clamps were not in place when the above noted observations occurred. A review of the facility’s policy “Utilizing Vascular Access Clamps”, Policy: 1-04-08, revised April 2019, stated in part: “...2. A physician’s order is always required for utilization of vascular access clamps. 3. Vascular access clamps should not be used routinely. However, if a patient is unable to hold his/her own sites, it is recommended that only one (1) clamp is used at a time and should not be left on longer than 20 minutes...”. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 46466 Based on interviews, medical record review and facility document review, facility staff failed to report and document patient related safety events. The findings include: On 5/15/24 at 3:50 p.m., a review of Patient #4’s medical record was reviewed. The medical record documented on 4/22/24 that Patient #4 had an allergic reaction after receiving a dose of Mircera medication. Staff Member #1 navigated a review of the facility’s Risk Event Management (REM) log for the last six (6) weeks on 5/15/24 at 4:10 p.m. The REM log did not have documentation of Patient #4’s allergic reaction occurring on 4/22/24. A review of the facility’s policy “Risk Event Reporting Policy (Non-Teammate Related)”, Policy: 13-01-02, revised July 2023, stated in part: “A. Preparing a Risk Event Management Report (Event Report)...2...The teammate will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened...Exhibit A, Examples of Reportable Risk Events, Known or Suspected...Allergic Reaction or Adverse Drug Reaction, local...”. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 46466 Based on interview and facility document review, the facility staff failed to provide documented evidence that staff members annual competency skills were maintained according to facility policy. The findings include: On 5/15/24 at 2:55 p.m. a review of five (5) employee personnel records were reviewed with Staff Members #1 and #12. Staff Members #7’s last annual competency checklist was dated in 2021. Staff Member #15’s annual competency checklist was dated in March, 2023 and Staff Member #16’s annual competency checklist was dated in December, 2022. An interview was conducted with Staff Member #3 on 5/15/24 at 9:45 a.m. Staff Member #3 stated that Staff Member #3 was required to sign all staff member competency checklists on a yearly basis. Staff Member #3 stated that in the previous year, a previous employee had not provided Staff Member #3 with staff member annual checklists. The previous employee left the facility and Staff Member #1 discovered that competency checklists were not being done. Staff Member #3 stated that Staff Member #1 brought this to Staff Member #3’s attention and was now having the competency checklists completed for all staff members. An interview was conducted with Staff Members #1 and #12 on 5/15/24 at 4:25 p.m.. Staff Members #1 and #2 confirmed that the last documented evidence of annual competencies for the three (3) staff members were the dates listed above. A review of the facility’s “Digital Teammate Files Document Guidance Checklist”, with no date, stated in part: “...Annual Documents - Skills Checklist...”. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 46466 Based on interviews and facility document review, the facility staff failed to provide evidence that grievances were investigated and that appropriate action was taken towards a resolution. The findings include: On 5/14/24 at 3:45 p.m., a review of the facility’s “Complaint/Grievance Log” was reviewed. The last documented complaint/grievance was dated 8/16/23. There was no documentation on the form indicating the complaint/grievance was investigated or that there was a resolution. Complaint/grievance dated 7/19/23 also did not have documentation indicating the complaint/grievance was investigated or that there was a resolution. The log also included two (2) separate complaints that were made by staff members regarding patient interactions. On 5/14/24 at 4:20 p.m., an interview was conducted with Staff Member #11. Staff Member #11 stated that staff member complaints should not be documented in the “Complaint/Grievance Log”. The surveyor requested additional documentation from Staff Member #11 to support investigation and resolution on the two (2) patient complaints/grievances dated 8/16/23 and 7/19/23 . On 5/15/24, Staff Member #1 confirmed that no additional documentation to support investigation and/or resolution of these two (2) patient complaint/grievances were completed. A review of the facility’s policy “Patient Grievance”, Policy: 3-01-6, revised October 2021, stated in part: “...Internal Grievance Process...C. The FA (or her/his designee) is to discuss the grievance with the patient, investigate and take appropriate action towards a solution, if possible. This discussion should occur within 10 days of receipt of the grievance...”. The findings were discussed with Staff Members #1, #11 and #12 at the exit conference on 5/15/24 at 4:35 p.m.”