Davita Wyoming Street Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 27408 Based on observation, interview, and record review, the facility failed to maintain a sanitary environment to minimize the transmission of infectious agents which could result in an increased potential for infections for all 60 in-center patients currently being treated by the facility. Findings include: The facility failed to ensure all staff members performed hand hygiene between the change of gloves. (See Tag V-0113) The facility failed to ensure that staff disposed of infectious waste (bloodlines) in a safe manner. (See Tag V-0121) The facility failed to disinfect dialysis stations after treatments. (See Tag V-0122)”

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 22050 Based on interview and record review, the facility failed to provide current emergency contact information within the Emergency Preparedness Plan effecting 60 patients, resulting in the increased likelihood for delayed emergency response. Findings include: On 01/27/25 at 02:15 P.M., Record review of the facility “Emergency Preparedness Plan” revealed outdated disaster plan contact information for the following positions: (1) Facility Administrator, (2) Medical Director, (3) Regional Operations Director, and (4) Clinical Services Specialist. On 01/27/25 at 03:00 P.M., An interview was conducted with Manager Clinical Services “E” regarding securing a permanent full-time Facility Administrator. Manager Clinical Services “E” indicated the Facility Administrator position has been open since 09/2024.”

“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: 27408 Based on observation, interview, and record review, the facility failed to ensure staff performed hand hygiene per facility policy, resulting in the potential for spread of infectious agents to all 13 patients being served by this facility at the time of observations. Findings include: On 01/27/25 at 0958, Patient Care Technician (PCT) Staff M, was observed walking away from station #12, taking off her soiled gloves, and then grabbing some supplies from the clean supply cart. Staff M failed to perform any kind of hand hygiene after leaving Station #12. Staff M was queried as to what the process would be for hand hygiene. Staff M stated, “I guess I should’ve either washed my hands or used the hand gel”. On 01/27/25 at 1045, Patient Care Technician (PCT), Staff L, was observed taking her gloves off near station #7, discarding them in the trash can, then going to assist the patient at station #5, without performing hand hygiene first. Staff F then returned to station #7 and put on clean gloves to go assist the patient without performing hand hygiene. Staff F was queried as to what the process would be for hand hygiene. Staff L stated, “I guess I should’ve used hand gel in between patients”. On 01/27/25 at 1100, Patient Care Technician (PCT), Staff K, was observed initiating dialysis on the patient at station #9. During the procedure, Staff K was observed removing dirty gloves. She stepped away from the station for a minute, was observed putting on new gloves as she walked back to the station, without performing hand hygiene first. At 1110, Staff K removed her gloves, used the computer, and walked over to the nurse’s station and grabbed some clean supplies. She then returned to station #9 with clean gloves, without performing hand hygiene first. Staff K was queried as to what the process would be for hand hygiene. Staff K stated, “I know I should’ve changed my gloves and use hand gel”. On 01/27/25 at 1400 during review of the facility policy titled “Infection Control for Dialysis Facilities”, Policy: 1-05-01, last revised April 2023 it was noted on page 1 under “Hand Hygiene”, it stated: 1. All teammates... will perform hand hygiene... b. prior to gloving and immediately after removal of gloves”. On 01/29/25 at 0935, the Medical Director was interviewed, and stated that he expected “the staff to follow facility policies”.”

“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: 27408 Based on observation, interview, and record review. the facility failed to ensure biohazard waste was contained in a safe manner, resulting in the potential for the spread of infection amongst the 13 patients receiving dialysis at the time of observation. Findings include: On 01/27/25 at 1000, during an initial tour of the facility, one large biohazard bin was observed with the lid propped open. It was lined with a red biohazard bag containing biohazard waste, including used hemodialysis blood tubing. The biohazard bin was observed across from station # 8, near the exit door. At the time of observation Staff M, Patient Care Technician (PCT) was queried as to what the bin was used for, and if it should be left propped open or shut once waste products were placed in the bin. Staff M stated, “that bin is for biohazard waste, mainly our bloody tubing. That has been broken and propped open as long as I can remember”. On 01/27/25 at 1520, a policy was requested for use and handling of medical biohazard waste receptacles. During review of the policy “Segregation of Medical Waste”, policy #4-03-07. When using option c above, the following infection control practices need to be followed: *Lid should be tight fitting *Gloves should be always worn when removing the lid. *Lid should be put back on the container after medical waste is disposed of and contaminated gloves removed. Hand hygiene is to be performed after glove removal. On 01/29/25 at 0935, the Medical Director, Staff N, was interviewed, and he stated that he expected “the staff to follow facility policies”.”

“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: 27408 Based on observation, interview, and record review, the facility staff failed to disinfect the dialysis machine and surrounding surfaces, following a patient’s treatment for 5 of 5 station cleanings observed, resulting in the potential for the spread of infectious agents. Findings include: On 01/27/25 at 1015, Patient Care Technician (PCT), Staff M, was observed disinfecting station #12. Staff M failed to disinfect the back shelf at the station, and failed to clean the reusable patient blood pressure cuff when removing it from the contaminated chair. Staff M was queried about these observations, and she verified that she hadn’t cleaned the shelf, but thought she wiped the blood pressure cuff. On 01/27/25 at 1030, Patient Care Technician (PCT), Staff M, was observed disinfecting station #9. Staff M failed to disinfect the priming bucket and the footrest on the patient’s chair. Staff M was queried about these observations, and she verified that she did not clean the bucket or the footrest. Staff M stated “you got me again”. On 01/27/25 at 1045, Patient Care Technician (PCT), Staff L, was observed disinfecting station #7. Staff L failed to disinfect the back shelf at the station, and failed to fold down the side tables on the chair, and clean them. Staff L was queried about these observations, and she verified that she hadn’t cleaned the shelf nor fold the side tables and clean them. On 01/27/25 at 1100, Patient Care Technician (PCT), Staff K, was observed disinfecting station #5. Staff K failed to disinfect the back shelf at the station, and failed to leave the sides of the chair open to dry, once they were cleaned. Staff K was queried about these observations, and she verified that she hadn’t cleaned the shelf, but did not know that the sides of the chairs had to dry before closing them. On 01/27/25 at 1130, Patient Care Technician (PCT), Staff K was observed disinfecting station #6. Staff K failed to disinfect the back shelf at the station. Staff K also started to clean the station and 1130 (only wiping down the front of the dialysis machine) and returned at 1215 to finish the cleaning. Staff K wiped down only the chair. Staff K was queried as to how she knew what was clean and what was dirty. Staff K said she recalled that she knew she “cleaned the machine.” She stated that she “did not know that I had to wipe the back shelf and footrest down too”. On 01/27/25 at approximately 1100, review of the facility policy titled “Infection Control for Dialysis Facilities, #1-05-01, dated April 2023” documented, “46. Equipment including the dialysis delivery system, the interior and exterior of the prime (bucket) container, the dialysis chair and side tables... blood pressure equipment..., as well as all work surfaces will be wiped clean with a bleach solution of the appropriate strength after completion of procedures, before being used on another patient...” On 01/29/25 at 0935, during an interview with the Medical Director, Staff N, it was determined that he expected “staff to follow facility policies”.”

“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: 22050 Based on observations, interviews, and record reviews, the facility failed to clean and maintain the physical plant effecting 60 patients, resulting in the increased likelihood for cross-contamination, bacterial harborage, and decreased air quality. Findings include: On 01/27/25 at 09:50 A.M., An environmental flash tour was conducted with BioMed “F”. The following items were noted: The “Laboratory Specimen” refrigerator freezing compartment was observed partially occluded with ice dams. The refrigerator freezing compartment door was also observed to not close, due to accumulated ice dams within the freezing compartment. The return-air-exhaust ventilation grill was observed heavily soiled with accumulated dust and dirt deposits, adjacent to the “Unisex” patient restroom. The soiled return-air-exhaust ventilation grill measured approximately 24-inches-wide by 24-inches-long. Four full oxygen cylinders were observed unsecured and stationary, adjacent to the island drywall surface. BioMed “F” stated: “I will order a new storage rack today.” A black-watery substance was observed surrounding 1 of 4 dirty sink hot and cold-water valves and goose neck faucet assemblies. BioMed “F” indicated he would have the housekeeping contractual service thoroughly clean and sanitize the hot and cold-water valve perimeters and goose neck faucet assembly as soon as possible. 1 of 4 clean sink electronic faucet sensors was observed faulty, not allowing the water to flow upon activation. BioMed “F” indicated he would make necessary repairs as soon as possible. 5 of 5 elevated chair back exterior support ledges were observed with accumulated and encrusted dust/dirt deposits. BioMed “F” indicated he would have the housekeeping contractual service thoroughly clean and sanitize the chair surfaces as soon as possible. On 01/27/25 at 11:50 A.M., An interview was conducted with Facility Administrator “A” regarding the current housekeeping contractual service provider. Facility Administrator “A” stated: “We currently have Winters Cleaning Services, LLC.” On 01/27/25 at 03:30 P.M., Record review of the “Master Janitorial Services Agreement” dated 09/28/2018 revealed under Janitorial Statement of Work (Page 7): “(B) Weekly: (2) Clean and polish office furniture. (3) Dust and damp wipe light fixtures, ceiling vents.””

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 47415 Based on document review and interview, the facility failed to maintain monthly data records for 1 (P-4) of 2 home peritoneal dialysis (PD) patients reviewed, resulting in the potential failure to address any problems with dialysis adequacy or failure to determine if the patient is following the dialysis prescription. Findings include: On 1/27/25 at 1300, document review for P-4 revealed home treatment records were not available for review, last home treatment records available were from 8/2024. “PD Home Training Agreement and Training Release” document present in record, and signed by P-4 on 3/11/21, revealed under patient responsibilities that P-4 agreed to accurately keep home treatment records and bring them into each clinic visit. P-4 signed the agreement that it is her responsibility as part of participation in the home program. No documentation of discussion with the patient, or investigation of why the treatments sheets were not brought into clinic visits found in the record. On 1/27/25 at 1300 an interview was conducted with Home PD Nurse Staff O. Staff O confirmed P-4 did not bring home treatment records for review to facility during in center visits since last August. On 1/29/25 at 0935, an interview was conducted the medical director Staff N by phone revealed he expected staff to follow policy and procedures of the facility and home dialysis program. On 1/29/25 at 1100, policy 5-01-07, titled, “Failure to Comply with Home Dialysis Training Program Objectives”, dated April 23, revealed, “Home patients/care-partners are responsible for ...maintaining home treatment records; if home treatment records are on paper, bring to clinic visit for the nurse to review at least monthly .....The following steps may be taken for patient/care-partner who fails to comply with the treatment regimen ... Investigate causes of non-adherence ... Offer counseling, education, retraining as indicated ...Offer sources of additional support, referrals or alternate caregiver ...Involvement and support of interdisciplinary team as indicated ....Review alternative treatment options 4. Document in patient’s medical record non-adherence, interventions taken and patient/care-partner response ...”.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 15195 Based on record review and interview, the facility failed to have all professional members of the Interdisciplinary Team (IDT) participate in the Quality Assessment Performance Improvement (QAPI) meetings in six of six meetings held (08/2024 through 01/2025), resulting in the potential for less than optimal outcomes. Findings include: On 1/28/25 at approximately 1400, review of the facility designated QAPI Committee Meeting Minutes for six months (08/2024 through 01/2024) revealed the the following: QAPI Meeting 08/10/24 - Social Worker (MSW), Home Nurse, and Biomed did not attend. QAPI Meeting 09/10/24 - Social Worker (MSW) and Home Nurse did not attend. QAPI Meeting 10/18/24 - Home Nurse did not attend. QAPI Meeting 11/15/24 - In-center Nurse and Home Nurse did not attend. QAPI Meeting 12/20/24 - Home Nurse and Biomed did not attend. QAPI Meeting 01/24/25 - Home Nurse and Biomed did not attend. Interview with the Facility Administrator (FA, Staff A), on 01/29/25 at approximately 1030, verified that the Home Nurse did not attend the QAPI meetings, but rather shared information with the FA who spoke on her behalf. Staff A was not a registered nurse. Staff A also verified that the Social Worker did not attend or phone in to some of the meetings. The FA also stated that on 11/15/24 the Registered Nurse could not attend the meeting due to a call in, therefore, registered nurse representation was lacking. Further inquiry revealed that the FA did not utilize covering staff, phone call in, or video conference for those QAPI meetings. On 01/29/25 at approximately 1230, review of the policy provided titled “Continuous Quality Improvement Program, #5-15-06, revision date 4/2024 (home program) and #1-14-06 revision date 4/2021” (in-center program) both documented, “Each dialysis facility will have a Continuous Quality Improvement (CQI) Committee comprised of at least the following individuals from the interdisciplinary team: Facility Medical Director, Facility Administrator (FA) designee, Registered Nurse, Biomed Technician, Registered Dietitian, Social Worker.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47415 Based on observation, interview and record review, the medical director failed to ensure staff followed the facility policy and procedures for expired medications and proper storage of citrate liquid solution, resulting in the potential for less optimal outcomes for the 10 in-center patients being treated at time of finding. Findings include: During the initial tour of the facility, on 1/27/25 at approximately 1030, it was noted that there was one (1) open container of nitroglycerine sublingual 0.4 milligram (mg) tablets stored in the medication drawer that expired 11/2024. At 1100, one (1) container of Citra Pure, liquid concentrate - Citrate (1 potassium (K), 2.5 calcium (Ca)) was observed open and uncapped on the middle counter of treatment floor. Staff G interviewed at time of findings and confirmed nitroglycerine tablets were expired, and cap was off the Citra Pure container. Staff G stated the cap should have been on the container securing the contents. Record review of policy 1-06-01 titled, “Medication Policy”, dated 11/2023, revealed: “All open or unopened medication packages ...are stored according to manufacturer’s directions. Do not use any medication that has been stored improperly or has expired ...All medications are checked monthly for expiration dates ...Medications are ordered and replaced prior to expiration.” Record review of policy 1-20-06, Titled “Acid Concentrate System, Incoming Acid Concentrate, and Use of Acid Concentrate Containers”, revealed: “Open, unused acid concentrate solutions remain in the original container, are not to be combined and should be capped when not in use.” On 1/29/25 at 0935, interview with the Medical Director Staff N revealed that it is his expectation that all staff follow the policies and procedures of the facility.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 46476 Based on observation, record review, and interview the facility failed to 1. regularly monitor for a sanitary environment to minimize the transmission of infectious agents within the water purification room, failed to keep dirty and clean areas separated from one another, and failed to maintain a patient treatment chair, (see V0111); 2. ensure staff performed hand hygiene between each glove change, (see V0113); 3. ensure items taken into the dialysis station were cleaned or disinfected before being taken into a common area or used on another patient, (see V0116) 4. ensure staff disposed of infectious waste in a safe manner, (see V0121); 5. ensure aseptic technique was used while drawing up intravenous medications, (see V0143); 6. ensure staff maintained aseptic technique per facility policy when providing care to patients with intravascular catheters, (see V0147) all of which could potentially result in an increased potential for infections for all 52 incenter patients currently being treated by the facility. The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe environment for the condition of participation at 494.30 Condition: Infection control.”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 38304 Based on record review and interview, the facility failed to ensure the interdisciplinary team comprehensively assessed patient target weights in 2 of 2 records reviewed (P-6, P-8) for potential fluid overload, out of a total sample of 8 records reviewed, resulting in poor clinical outcomes and unmet patient needs (See V-0504). The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe environment for the condition of participation 494.80, Patient Assessment.”

“Arrangement with Other Facilities CFR(s): §403.748(b)(7), §418.113(b)(5), §441.184(b)(7), §460.84(b)(8), §482.15(b)(7), §483.73(b)(7), §483.475(b)(7), §485.625(b)(7), §485.920(b)(6), §494.62(b)(6). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] *[For Hospices at §418.113(b), PRFTs at §441.184,(b) Hospitals at §482.15(b), and LTC Facilities at §483.73(b):] Policies and procedures. (7) [or (5)] The development of arrangements with other [facilities] [and] other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients. *[For PACE at §460.84(b), ICF/IIDs at §483.475(b), CAHs at §486.625(b), CMHCs at §485.920(b) and ESRD Facilities at §494.62(b):] Policies and procedures. (7) [or (6), (8)] The development of arrangements with other [facilities] [or] other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients. *[For RNHCIs at §403.748(b):] Policies and procedures. (7) The development of arrangements with other RNHCIs and other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of non-medical services to RNHCI patients. This Standard is not met as evidenced by: 32000 Based upon interview and record review, the facility failed to develop arrangements with other facilities to receive patients in the event of an emergency, resulting in the potential for less than optimal outcomes for 52 patients receiving in-center hemodialysis treatment and its staff. Findings include: On 11/28/23 at 0955, the surveyor requested all policies and procedures regarding emergency preparedness from the Facility Administrator, staff B, to review. On 11/28/23 at 1019, record review of this binder revealed that the development of arrangements with other facilities to receive patients needing dialysis treatment in the event of an emergency was not present in the binder. On 11/28/23 at 1343, upon interview with staff B the surveyor asked if they could explain how the arrangements with other facilities would work to receive patients in the event of an emergency to which they replied, “We have a couple options, but after starting to work in this facility two weeks ago, I’ve realized a lot of things went undone”. At this time the surveyor asked staff B if they could clarify what they meant by things being, “undone” to which they replied, they are not in the binder because we don’t have approved agreements at the moment”.”

“Development of Communication Plan CFR(s): §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: 32000 Based upon interview and record review, the facility failed to develop a communication plan in the event of an emergency potentially effecting 52 patients receiving hemodialysis treatment and its staff resulting in an increased potential for harm. Findings include: On 11/28/23 at 0955, the surveyor requested all policies and procedures regarding emergency preparedness from the Facility Administrator, staff B, to review. On 11/28/23 at 1019, record review of this binder revealed that the development of a communication plan site specific to the dialysis suite was not present in the binder. However, at this time a blank document titled, “Communication checklist” dated May 2019 was present in the binder. On 11/28/23 at 1348, upon interview with staff D the surveyor asked if they could explain how information is communicated in the event of an emergency to which they replied, “We would coordinate with the other facilities and work with the Clinical Manager at each location”. The surveyor then asked if they had a written procedure to follow in the event of their absence during an emergency to which they responded, “no, not right now, but we will be working on that shortly. We have the templates to fill out and sign off on”.”

“Methods for Sharing Information CFR(s): §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility’s] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility’s] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI’s care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). This Standard is not met as evidenced by: 32000 Based upon interview and record review, the facility failed to develop a method to share information and medical documentation for all patients receiving in-center hemodialysis treatment in the event of an emergency potentially effecting 52 patients and its staff, resulting in an increased potential for harm. Findings include: On 11/28/23 at 0955, the surveyor requested all policies and procedures regarding emergency preparedness from the Facility Administrator, staff B, to review. On 11/28/23 at 1024, record review of this binder revealed that the development of a method to share information and medical documentation for patients receiving dialysis treatment in the event of an emergency was not present in the binder. On 11/28/23 at 1353, upon interview with staff B the surveyor asked if they could explain the methods used to share information and medical documentation for patients receiving dialysis treatment to which they replied, “we would use a variety of methods to suit our patient needs at the time”. The surveyor then asked if they had a written procedure to follow in the event of an emergency that they could review to which staff B responded, “we don’t have it clearly outlined in our binder, but we will”.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 32000 Based upon interview and record review, the facility failed to develop a written training and testing program including specific requirements for patient orientation, evacuation drills, and training in the event of an emergency potentially affecting 52 patients and its staff resulting in an increased potential for harm. Findings include: On 11/28/23 at 0955, the surveyor requested all policies and procedures regarding emergency preparedness from the Facility Administrator, staff B, to review.On 11/28/23 at 1027, record review of this binder revealed no written training or testing programs including requirements for patient orientation, evacuation drills, or any additional training deemed necessary by the facility were found present in this plan. No documentation of any emergency or safety drills were found conducted by the facility during this review. However, and undated blank document titled, “Facility Emergency Drill Exercise Evaluation” was present in the binder. On 11/28/23 at 1357, upon interview with staff B the surveyor asked if they could explain what emergency response staff training, or exercise drills had been conducted with staff over the last year to which they replied, “I don’t think any was done. I haven’t found any records of anything like that since I started here about two weeks ago”.”

“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: 32000 Based upon observation and interview, the facility failed to regularly monitor for a sanitary environment to minimize the transmission of infectious agents within the water purification room, failed to keep dirty and clean areas separated from one another, and failed to maintain a patient treatment chair, potentially effecting all 52 in-center hemodialysis patients, and all 3 home peritoneal dialysis patients currently receiving treatment, resulting in an increased potential for infections. Findings include: On 11/28/23 at 1049, stained ceiling tiles were observed over acid holding tank #1 and the acid mixing tank in the water purification room. Upon observation the surveyor inquired with Bio-Medical Technician, staff F, on the current state of the ceiling to which they stated, “I’m not sure if it’s an issue or not. I’ve never really noticed it”. On 11/28/23 at 1052, an accumulation of dust and debris was observed on the top and sides of the acid mixing tank, its supply lines and filter. At this time the surveyor inquired with staff F on the current state of the acid mixing tank and its plumbing to which they stated, “We identified this on our last audit towards the beginning of the month. Now we need to do training with staff to make sure we are doing a better job of cleaning it moving forward”. At this time the surveyor inquired with staff F on if the facility had any logs or checklists in place regarding cleaning related job duties to follow for equipment such as this which they stated, “not specifically.” 38304 On 11/28/23 at 1042, it was observed that 3 of 5 “clean sink” areas on the dialysis treatment floor had trash/garbage cans stored within 4 inches or less from the designed clean areas. On 11/29/23 at 1310, the lone “clean sink” area in 1 of 1 patient training rooms had trash/garbage stored within 2 inches from the designed clean area. In addition, a 9-inch gash/tear was observed on 11/28/23 at 1047 in the treatment chair (leg rest section) located at station ten, resulting in an uncleanable surface. The facility administrator (Staff B) acknowledged the findings (treatment floor) on 11/28/23 at 1147 and on 11/29/23 (home training room) at 1425. Staff B noted the above findings did not meet facility expectations or the facility policy referenced below. Facility Policy: “Physical Environment”, No. 8-04-01, Revised April 2018 stated, “The dialysis facility will be designed... and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. The dialysis facility will implement and maintain a program to verify all equipment... are maintained and operated in accordance with manufacturer’s recommendations.””

“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: 46476 Based on observation, interview, and record review, the facility failed to ensure staff performed hand hygiene between each glove change resulting in the potential for spread of infectious agents to all 52 incenter patients being served by the facility. Findings include: Facility policy titled “Infection Control for Dialysis Facilities”, Policy: 1-05-01, last revised April 2023 was reviewed on 11/30/23. On page 1 under “Hand Hygiene”, it stated: 1. All teammates... will perform hand hygiene... b. prior to gloving and immediately after removal of gloves”. On 11/28/23 during incenter hemodialysis treatment floor observation of staff, the following observations were noted: At 1050, Staff M, a patient care technician (PCT), was observed assisting the patient at Station #3 with discontinuation of hemodialysis. During the procedure, Staff M was observed removing dirty gloves without performing hand hygiene prior to donning a new pair for the next task. At 1110, Staff M, a PCT, was observed while performing the procedure of changing a Central Venous Catheter (CVC) dressing and then connecting the CVC to dialysis blood lines to begin dialysis at Station #2. During the procedure, Staff M was observed removing dirty gloves 4 separate times between tasks, without performing hand hygiene prior to donning new gloves for the next task. These findings were reviewed and acknowledged during interview on 12/5/23 at 1205 with the Facility Administrator (Staff B) and the Clinical Manager (Staff P). 47976 During dialysis floor observation on 11/28/23 and 11/29/23, the following observations were made: 1. On 11/28/23 at 1020, patient care technician (PCT, Staff M) was observed working with the patient at station #4. Staff M then removed her gloves and went to assist the patient at station #3 without performing hand hygiene in between glove exchanges. At 1035, Staff M was observed at station #4 disinfecting the patient’s arm with an alcohol pad before initiating dialysis. She then removed her gloves and put on new gloves to insert the needle without performing hand hygiene in between. At 1045, Staff M was observed removing her gloves, leaving station #4 and going to get supplies from the cart without performing hand hygiene first. 2. On 11/28/23 at 1100, registered nurse (Staff P) was observed removing one glove while at station #11, going to get tape from a drawer with that hand, then donning a new glove on that hand without performing hand hygiene in between. At 1120, Staff P was observed disconnecting a patient from the dialysis at station #11, removing her gloves and donning new gloves to assist another patient without performing hand hygiene. Staff P was also observed using gloved hands to pick up items that fell on the floor, removing her gloves, then touching the keyboard in the clean area before performing hand hygiene. 3. On 11/28/23 at 1200, PCT (Staff J) was observed removing her gloves before leaving station #5, going to the nurse’s station to consult a nurse, then returning to station #5 and donning new gloves without performing hand hygiene. Staff J was observed at 1203 removing her gloves after finishing a procedure at station #5, then touching the keyboard in the clean area before performing hand hygiene. 4. On 11/29/23 at 1025, PCT (Staff K) was observed working with a patient at Station #9. She was observed removing her gloves and getting supplies from the cart without performing hand hygiene. At 1043, Staff K was also observed removing 1 glove to touch the keyboard in the clean area before performing hand hygiene. She then proceeded to put on new gloves to finish the procedure on the patient without performing hand hygiene. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Manager of Operations (Staff R) during an interview on 12/5/23 at 1110.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 47976 Based on observation and record review, the facility failed to ensure items taken into the dialysis station were cleaned or disinfected before being taken into a common area or used on another patient, resulting in the potential to spread infectious diseases to all 52 patients receiving in-center dialysis at this facility. Findings include: **Policy 1-05-01 titled “Infection Control for Dialysis Facilities” (revised April 2023) stated on page 4, “Non-disposable items are to be disinfected after each patient use prior to the removal from the treatment area/station and if contaminated between uses” and “Stethoscopes will be disinfected with alcohol prep pad and/or 1:100 (one to one hundred) bleach solution ...” During dialysis floor observation on 11/28/23 at 1030, patient care technician (Staff M) was observed using a stethoscope to assess the patient’s access site at station #4 and then placing the stethoscope around her neck. At 1045, Staff M was observed removing the stethoscope from around her neck and placing it on a clean counter without disinfecting it first. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Manager of Operations (Staff R) during an interview on 12/5/23 at 1110. 46476 On 11/28/23 during incenter hemodialysis treatment floor observation of staff, the following was observed: At 1045, Staff M, a patient care technician (PCT) was observed using a thermometer retrieved from the computer between station #2 and #3 (clean area) and entered the treatment area of station #2 to check the patient’s temperature. When done, Staff M placed the thermometer back on the computer between station #2 and #3. At 1103, Staff M was observed taking the same thermometer, entering the treatment area at station #4, and checking the temperature of the patient. Staff M then placed the thermometer on the computer located between station #3 and #4 (clean area). Staff M did not disinfect the thermometer before or after using with each patient. This finding was reviewed and acknowledged by the Facility Administrator (Staff B) and the Clinical Manager (Staff P) during interview on 12/5/23 at 1230.”

“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: 46476 Based on observation and interview, the facility failed to ensure staff disposed of infectious waste in a safe manner resulting in the potential for the spread of infectious agents to the 12 patients being served by the facility at the time of observation. Findings include: On 11/28/23 during incenter hemodialysis treatment floor observation of staff, the following was observed: At 1110, Staff M, a patient care technician, was observed while preparing a patient at station #2 for a lab specimen collection and connection to blood lines to begin dialysis. After collecting the lab specimen and connection of the blood lines to the Central Venous Catheter to begin dialysis, Staff M had 4 syringes with varying amounts of aspirated blood from the patient, and one blood transfer device to dispose of in the sharps bin. Staff M tossed each of the 4 syringes containing patient blood 5 feet (actual measurement) to the sharps bin. Staff M also tossed the used (bloody) blood transfer device the same measured distance toward the sharps bin but missed. The blood transfer device landed on the floor and bounced 3 times depositing small splashes of the patient’s blood along its path. During interview on 12/5/23 at 1230 with the Facility Administrator (Staff B) and the Clinical Manager (Staff P), Staff P stated that tossing infectious waste 5 feet to the sharps bin was an unacceptable practice.”

“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: 47976 Based on observation, interview, and record review, the facility failed to ensure aseptic technique was used while drawing up intravenous medications (IV) resulting in the potential for transmission of infectious agents to all 52 patients receiving in-center dialysis at this facility. Findings include: **Policy 1-06-01 titled “Medication Policy” (revised October 2023) stated on page 2, “8. All teammates administering medications must utilize aseptic technique.” During dialysis floor observation on 11/29/23 at 1045, Nurse Manager (Staff C) was observed drawing up medication for a patient. During the procedure, it was noted Staff C failed to clean the top of the medication vial with an alcohol pad prior to puncturing it with the needle. Staff C was interviewed immediately following the procedure and was asked if she should have cleaned the top of the vial prior to puncturing it. Staff C reported she had gotten out an alcohol pad out in preparation to do that, but she forgot this time. She acknowledged the findings. Findings were further reviewed with and acknowledged by the Facility Administrator (Staff B) and Manager of Operations (Staff R) during an interview on 12/5/23 at 1110.”

“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: 46476 Based on observation, interview, and record review, the facility failed to ensure staff maintained aseptic technique per facility policy when providing care to patients with intravascular catheters during 1 (station #2) of 4 observations resulting in an increased risk for infection and potential for poor patient outcomes. Findings include: Facility policy titled “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure”; Procedure: 1-04-02B; Last revised October 2023 was reviewed on 11/30/23. On page 4., and under number 8., it stated “ ...using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds ...”. On page 5., under number 16., it stated “ ... One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds ...” On 11/28/23 during incenter hemodialysis treatment floor observation of staff, the following observations were noted: At 1110, Staff M, a patient care technician, was observed while cleansing and performing a dressing change to a Central Venous Catheter (CVC) insertion site and connecting the CVC to dialysis blood lines to begin dialysis at station #2. During the procedure, after removing the old dressing, Staff M began to cleanse the CVC insertion site with a 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab and cleansed the area for 10 seconds. After that, Staff M prepared the CVC for bloodline connection by removing one of the two caps from the CVC exposing the open end (CVC hub) and scrubbed the hub with an alcohol prep pad for 7 seconds before connecting a sterile syringe to the catheter hub. Staff M removed the second catheter cap to expose and cleanse the hub with an alcohol prep pad and was observed scrubbing the catheter hub for 7 seconds prior to connecting a syringe. These findings were reviewed during interview on 12/5/23 at 1205 with the Facility Administrator (Staff B) and the Clinical Manager (Staff P). Staff P confirmed the cleansing time per facility policy for CVC dressing change and hub cleansing and that Staff M did not perform the procedure per policy.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 47976 Based on observation, interview and record review, the facility failed to ensure the pH (acidity or basicity level) of the dialysate was properly tested prior to initiation of dialysis treatment per facility policy in 1 (station #9) of 2 observations on the dialysis floor, resulting in the potential for unsafe treatment conditions and poor patient outcomes. Findings include: During dialysis floor observation on 11/29/23 at 1015, patient care technician (Staff J) was asked to explain the process of testing the pH on the machines. Staff J reported the dialysate is collected in a medicine cup and the strip is dipped into it prior to comparing it to the colors on the bottle containing the test strips. At 1030, patient care technician (Staff K) was observed getting ready to test the pH at station #9. Another patient care technician (Staff H) was in training with her that day, so they were asked to explain the process together while it was being completed. Staff K was observed holding the test strip under the flow of dialysate coming directly from the machine. Staff H was asked if they use a medicine cup to collect the liquid prior to dipping the strip and she reported, “No, we don’t have those.” Staff K reported she is supposed to run the test strip under the flow of dialysate for “a few seconds” and then immediately compare the results to the color on the test strip bottle. Upon record review of facility policies on 11/30/23, the following policy was found regarding the testing of pH: **Policy 2-08-01P titled “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.808.5 Test Strips” (revised October 2020) stated, “ ...2. Obtain dialysate sample by using a disposable cup, then dip the strip into the solution for one (1) second. 3. Remove the strip from the fluid and shake off excess dialysate. 4. At 10 seconds, immediately compare the color reaction on strip to the color chart on the bottle to determine the closest match.” Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Manager of Operations (Staff R) during an interview on 12/5/23 at 1110.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 46476 Based on record review and interview, the facility failed to ensure the patient signed Against Medical Advice (AMA) documentation for early termination of hemodialysis treatments per facility policy in 5 (P #’s 1, 2, 3, 4, and 5) of 7 sample records reviewed resulting in the potential for these patient’s being uninformed of their right to participate in their treatment and the consequences of early termination of treatments. Findings include: Facility policy titled “Prescribed Treatment Time Not Met”, Policy: 1-01-09; Last revised October 2023 was reviewed on 12/5/23. On page 1., under “A. Completion of the Early Termination of Treatment Against Medical Advice Form”, it stated, “1. The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time.” P-3: This 31-year-old was admitted to the facility on 5/10/23 with end stage kidney disease; chronic high blood pressure; and Human Immunodeficiency Virus. The medical record was reviewed on 11/29/23 and included 6 hemodialysis treatment sheets between the dates of 9/11/23 and 11/24/23. The active physician orders for the period reviewed included a hemodialysis treatment duration of 210 minutes each treatment. On the treatment dated 11/24/23, the total treatment duration was noted to be 141 minutes (69 minutes less than prescribed). No signed AMA form was found which would have indicated that P-3 was informed of the health consequences associated with early termination or that doing so was against medical advice. P-4: This 63-year-old was admitted to the facility on 11/2/23 with end stage kidney disease, and high blood pressure. The medical record was reviewed on 11/29/23 and included 6 treatment sheets between the dates of 11/7/23 and 11/28/23. The active physician orders for the period reviewed included a hemodialysis treatment duration of 180 minutes each treatment. The following were noted during review: On the treatment dated 11/11/23, the total treatment duration was 121 minutes (59 minutes less than prescribed). On the treatment dated 11/16/23, the total treatment duration was 102 minutes (78 minutes less than prescribed). There were no signed AMA forms found for the dates above which would have indicated that P-4 was informed of the health consequences associated with early termination or that doing so was against medical advice. P-5: This 51-year-old was admitted to facility on 6/29/20 with end stage kidney disease; diabetes type 2; and high blood pressure. The medical record was reviewed on 11/30/23 and included 6 treatment sheets between the dates of 10/9/23 and 11/23/23. The active physician orders for the period reviewed included a hemodialysis treatment duration of 180 minutes each treatment. The following were noted during review: On the treatment dated 10/9/23, the total treatment duration was 120 minutes (60 minutes less than prescribed). On the treatment dated 10/16/23, the total treatment duration was 139 minutes (41 minutes less than prescribed). On the treatment dated 11/1/23, the total treatment duration was 130 minutes (50 minutes less than prescribed). On the treatment dated 11/23/23, the total treatment duration was 117 minutes (63 minutes less than prescribed). There were no signed AMA forms found for the dates above which would have indicated that P-5 was informed of the health consequences associated with early termination or that doing so was against medical advice. These findings were reviewed and acknowledged during interview on 12/5/23 at 1205 with the Facility Administrator (Staff B) and the Clinical Manager (Staff P). 47976 P-1: This 60-year-old patient was admitted to this dialysis facility on 9/21/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, the last 3 treatment sheets were reviewed. It was determined the visit on 9/23/23 was shortened by 75 minutes, the treatment on 9/28/23 was shortened by 33 minutes, and the treatment on 10/26/23 was shortened by 43 minutes. There were no AMA (Against Medical Advice) forms signed by the patient in the record stating the patient understands their rights and the risks of terminating treatment early. P-2: This 54-year-old patient was admitted to this dialysis facility on 2/28/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, the last 3 treatment sheets were reviewed. It was determined the visit on 9/21/23 was shortened by 42 minutes, the treatment on 10/8/23 was shortened by 63 minutes, and the visit on 10/16/23 was shortened by 78 minutes. There were no AMA (Against Medical Advice) forms signed by the patient in the record stating the patient understands their rights and the risks of terminating treatment early. The Facility Administrator (Staff B) was queried during an interview on 12/5/23 at 1110 on whether there was documentation of the patients signing the AMA forms in the record. Staff B reported there were no forms signed by the patients. She acknowledged the findings.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 46476 Based on record review and interview, the facility failed to provide medication services as outlined in the patients plan of care in 1 of 7 (P# 5) sampled records reviewed, resulting in a medication being administered outside of what was prescribed and potentially leading to a poor patient outcome. Findings include: Facility policy titled “Medication Policy”, Policy: 1-06-01; Last revised October 2023 was reviewed on 12/5/23. On page 2., it stated “9. Medications are administered as prescribed and then documented in the patient’s medical record ...” P-5: This 51-year-old was admitted to facility on 6/29/20 with end stage kidney disease; diabetes type 2; and high blood pressure. The medical record was reviewed on 11/30/2323 and included 6 treatment sheets between the dates of 10/9/23 and 11/23/23. The active physician orders in the plan of care included orders for Heparin 600 Units per hour intravenously every dialysis treatment. During record review, the following was noted: On the treatment sheet dated 10/9/23, the dialysis treatment ended in 120 minutes (2 hours). It was documented that 1800 Units of Heparin was given during this treatment (600 Units more than prescribed). On the treatment dated 10/16/23, the dialysis treatment ended in 139 minutes (2 hours and 19 minutes). It was documented that 1800 Units of Heparin was given during this treatment (410 Units more than prescribed). On the treatment dated 11/1/23, the dialysis treatment ended in 130 minutes (2 hours and 10 minutes). It was documented that the full dose of 1800 Units of Heparin was given during this treatment (500 Units more than prescribed). On the treatment dated 11/23/23, the dialysis treatment ended in 117 minutes (1 hour 57 minutes). It was documented that 1800 Units of Heparin was given during this treatment (630 Units more than prescribed). The above findings were reviewed and acknowledged during interview on 12/5/23 at 1205 with the Facility Administrator (Staff B) and the Clinical Manager (Staff P). Staff P stated that the staff probably just documented the total dose from the prescription which would have been 1800 Units if P-5 would have stayed for the entire prescribed treatment duration (180 minutes) but due to this type of documentation, the dose given was understood to be a medication error.”

“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: 38304 Based on record review and interview, the facility failed to assess actual vs. post- dialysis treatment target weight recordings in 2 (P-6, P-8) of 2 patients reviewed for potential fluid overload out of a total sample of 8 patients, resulting in hospitalization for both patients due to cardiovascular fluid overload. Findings include: Review of P-6’s medical record on 11/29/2023 revealed a 72-year-old female admitted to this dialysis facility on 9/15/2023 with a past medical history which included chronic kidney disease, anemia, hypertensive heart disease, congestive heart failure (CHF), and hypertension. P-6’s dialysis schedule was every Tuesday, Thursday, and Saturday. Review of physician orders on the following dates noted the prescribed target weights (TW) vs. actual post-dialysis weight recordings which are used to monitor fluid status and potential fluid overload: On 9/15/23; 92 kg. with a post-treatment weight of 117 kg. on 9/16/23. On 9/16/23; 118 kg. with a post-treatment weight of 138.1 kg. on 9/19/23, followed by a post-treatment weight of 92 kg. on 9/21/23. On 9/22/23; 93 kg. with a post-treatment weight of 92.9 kg. on 9/23/23; 107.6 kg. on 9/26/23; 103.3 kg. on 9/28/23; and 102.1 kg. on 9/30/23. On 9/30/23 (after that day’s treatment) order changed again to 102 kg. with a post-treatment weight of 106.9 kg. on 10/3/23. On 10/5/23; 107 kg. with a post-treatment weight of 105.1 kg. on 10/5/23. The following facility policy regarding fluid status results was reviewed on 11/30/23, to ascertain what deviation from ordered TW constitutes an abnormal finding with subsequent reporting procedures: Facility Policy: “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” No. 1-03-08 (Revised October 2023) stated under “Abnormal Findings” the following: “Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time... Fluid Status: Post-treatment: If patient is above or below 1 kg. from target weight.” Additional record review found P-6 was “hospitalized 10/12/23 through 10/15/23 for fluid overload.” Due to the significant fluctuations in P-6’s documented weight (e.g., 138.1 kg. on 9/19/23 to 92.0 kg. on 9/21/23 (difference of 46.1 kg. or 101.6 pounds in 2 days) put into question the validity of any weight measurements obtained by the facility. Due to the above poor outcome, another sample record (P-8) was specifically chosen and reviewed for facility adherence to the above policy to determine if any deviation of plus or minus 1 kg. from post-treatment target weight was reported to the nurse or physician. The following target weights were reviewed one week prior to a poor clinical outcome and documented as follow: On 8/25/23; 90.5 kg. TW ordered, with a post-treatment weight of 95.9 kg. (+5.4 kg. over). On 8/28/23; 90.5 kg. TW ordered, with a post-treatment weight of 97.6 kg. (+7.1 kg. over). On 8/30/23; 90.5 kg. TW ordered, with a post-treatment weight of 98.5 kg. (+8.0 kg. over) and was hospitalized the next day due to CHF/fluid overload. No documentation was found in the medical record among all patient care team members which alerted one another of the abnormal results for both P-6 and P-8, with subsequent hospitalizations due to fluid overload. During an interview on 12/5/23 at 0935, the facility’s Administrator (Staff B) reviewed the above findings and acknowledged that facility staff had failed to follow its policy noted above. In addition, the survey was extended to allow sufficient time to gather more documentation in other areas. The facility had already formulated a Plan of Correction (POC) on 12/5/23 concerning the above findings, which was reviewed and approved. An excerpt from the POC stated, “1. In-service all teammates on policy 1-03-08 Pre-Intra-Post Tx Data Collection and expectations going forward by 12/5/23 (42% completed 12/1/23. To resume in-services 12/4) 12/4 at 69%. Will review with 1 PCT by end-of-day 12/4, and 2 RN’s/1 PCT by 12/5 am) (12/5 am at 93%. just need PD RN who will be in today) 2. 100% treatment audit for BP/TW x 4 weeks, audit to determine compliance though 12/31/23 to verify policy being followed... Tracking process put in place to sustain compliance - CC (Clinic Coordinator) to review Fluid/BP report weekly during Core Team Meeting...””

“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: 46476 Based on record review and interview, the facility failed to ensure staff monitored and reported blood pressure values which were outside of parameters during hemodialysis treatments in 4 (P #1, 3, 4, and 5) of 7 sampled records reviewed, potentially resulting in undetected decline due to volume status and poor patient outcomes. Findings include: Facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, Policy: 1-03-08; Last revised October 2023 was reviewed on 12/5/23. On page 4., it stated: “12. The licensed nurse notifies the physician ... as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record “; On page 5., it stated: “Members of the patient care team should report ANY changes in patient conditions ... immediately to the licensed nurse ...”, and abnormal findings were stated as: “Blood pressure: Pre-dialysis: Systolic greater than 180 mm Hg or less than 90 mm Hg; Diastolic greater or equal to 100 mm Hg; Blood Pressure- Intradialytic: Difference of 20 mm Hg increase or decrease from patient’s last intradialytic treatment BP reading ...” P-3: This 31-year-old was admitted to the facility on 5/10/23 with end stage kidney disease; chronic high blood pressure; and Human Immunodeficiency Virus. The medical record was reviewed on 11/29/23 and included 6 hemodialysis treatment sheets between the dates of 9/11/23 and 11/24/23. During review of the treatment dated 11/24/23, the following was noted: At 0825 (pre-treatment), the registered nurse (RN) recorded the blood pressure (BP) as 169/126 millimeters of mercury (mm/Hg) in the Treatment Nursing Assessment note. At 0840 (beginning of treatment), the patient care technician (PCT) recorded the BP as 190/138 mm/Hg (an increase of 21/12 mm/Hg) and that the RN was aware. At 0901, the PCT recorded the BP as 159/125 mm/Hg (a decrease of 31/13 mm/Hg), and that the RN was aware. At 0931, the PCT recorded the BP as 184/132 mm/Hg (an increase of 25/7 mm/Hg), and that the RN was aware. At 1102, the RN recorded the BP as 190/144 mm/Hg followed by a recheck by the PCT at 1103 and the BP was 169/127 mm/Hg. At 1105, the PCT recorded the BP as 139/104 mm/Hg (a decrease of 51/40 mm/Hg). The post-dialysis BP was recorded as 169/126. Although the PCT reported the findings to the RN, the RN had no documentation related to the elevation in blood pressure, did not provide intervention such as administration of a facility standing order for high blood pressure, and did not document that the physician was made aware of the elevated pre, intra, and post dialysis blood pressure findings which could be a sign of fluid imbalance. P-4: This 63-year-old was admitted to the facility on 11/2/23 with end stage kidney disease, and high blood pressure. The medical record was reviewed on 11/29/23 and included 6 treatment sheets between the dates of 11/7/23 and 11/28/23. During review, the following was noted: On the treatment dated 11/14/23, at 1118, the PCT recorded the BP as 169/98 mm/Hg. At 1130, the PCT recorded the BP as 196/139 (an increase of 27/41 mm/Hg). The PCT did not document that the RN was notified of this change in BP. P-5: This 51-year-old was admitted to facility on 6/29/20 with end stage kidney disease; diabetes type 2; and high blood pressure. The medical record was reviewed on 11/30/23 and included 6 treatment sheets between the dates of 10/9/23 and 11/23/23. During review, the following was noted: On treatment dated 10/16/23, at 1146 the PCT recorded the BP as 172/117 mm/Hg. At 1203, the PCT recorded the BP as 187/70 (a change of +15/-47 mm/Hg). The PCT did not document that the RN was notified of this change in BP. On the treatment dated 11/1/23, at 1235 the PCT recorded the BP as 144/90 mm/Hg. At 1237, the PCT recorded the BP as 163/121 (an increase of 19/31 mm/Hg). The PCT did not document that the RN was notified of this change in BP. These findings were reviewed and acknowledged during interview on 12/5/23 at 1205 with the Facility Administrator (Staff B) and the Clinical Manager (Staff P). Staff P provided for review, a laminated sheet containing values regarding vital signs and other abnormal values to report per facility policy that are hung at all the dialysis stations for the PCTs and RNs to refer (so policy is always at their fingertips) and stated that all the staff should be following the policy and reporting parameters indicated within as directed. 47976 P-1: This 60-year-old patient was admitted to this dialysis facility on 9/21/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, it was determined that blood pressure changes outside the facility’s reportable parameter policy were recorded by the patient care technician (PCT) but not reported to the registered nurse (RN) as follows: On 11/14/23: From 0702 to 0732, blood pressure (BP) went from 183/95 to 177/73 = diastolic (bottom number) dropped 22 mm Hg (millimeters of mercury) From 0832 to 0902, BP went from 187/98 to 159/86 = systolic (top number) dropped 28 mm Hg On 11/18/23: From 0932 to 1002, BP went from 149/74 to 118/73 = systolic dropped 31 mm Hg On 11/23/23: From 0802 to 0833, BP went from 165/89 to 187/54 = systolic raised 22 mm Hg, diastolic dropped 35 mm Hg From 0833 to 0902, BP went from 187/54 to 181/90 = diastolic raised 36 mm Hg There was no documentation the nurse had been notified of these changes in blood pressure per facility policy. The Facility Administrator (Staff B) was queried regarding the expectations for reporting abnormal findings during an interview on 12/5/23 at 1110. Staff B stated numbers outside of the established parameters should be reported to the RN on duty and there should be documentation that occurred. Staff B was unable to find documentation that a RN had been notified in the instances above. She acknowledged the findings.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 38304 Based on observation, record review, and interview, the facility failed to deliver the prescribed dialysis prescription for 3 (P-4, 5, and 7) of 7 records reviewed, from a total sample of 7 records, resulting in the potential to impact the adequacy of dialysis and less than optimal outcomes for all 52 in-center patients currently receiving services at this facility. Findings include: During record review on 11/30/23, it was determined the treatment order for P-7 (effective 10/28/23) was written for a dialysis flow rate (DFR) of 500 milliliters per minute (mL/min). During review of the last 6 treatment sheets, it was noted the DFR was run at 800 mL/min for the entire treatment on 11/28/23. In 12 of 12 opportunities from 0649 through 1035, no documentation was evidenced in the medical record which explained why the DFR was delivered at a significantly higher rate than what was ordered. The overseeing RN (Staff P) signed off on 11/28/23 at 0740 “that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” In addition, the patient care technician (Staff M) failed to notify/document to an RN the DFR of 800 mL/min. in 9 of 9 opportunities. The above findings were reviewed and acknowledged by the Facility Administrator (Staff B) during an interview on 11/30/23 at 0950 and noted this failed to adhere to the facility’s policy referenced below. Facility Policy: “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” No. 1-03-08 stated, “Intradialytic Data Collection/Assessment: If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed.” 46476 P-4: This 63-year-old was admitted to the facility on 11/2/23 with end stage kidney disease, and high blood pressure. The medical record was reviewed on 11/29/23 and included 6 treatment sheets between the dates of 11/7/23 and 11/28/23. The active physician orders for the period reviewed included dialysis to be run with a blood flow rate (BFR) of 200 milliliters/minute (mL/min), and a dialysate flow rate (DFR) of 500 mL/min. During review of treatment sheets between 11/7/23 and 11/25/23, and during hemodialysis floor observation on 11/28/23, the following were noted: On the treatment dated 11/14/23, the BFR was ran at 350 mL/min (150 mL/min greater than prescribed) for 162 minutes of the 182-minute treatment. On the treatment dated 11/16/23, the BFR was ran at 250 mL/min (50 mL/min greater than prescribed) for the entire 102-minute treatment. On the treatment dated 11/21/23, the BFR was ran at 400 mL/min (200 mL/min greater than prescribed) for the entire 162-minute treatment. On 11/28/23 during hemodialysis floor observation at 1200, P-4 was receiving dialysis at station #6. The patient care technician (Staff J) was asked to show the dialysis prescription detail from the electronic medical record (EMR) system for comparison with the actual dialysis prescription that was being administered to P-4 in real time. It was noted that the physician prescription in the EMR ordered the BFR to be 200 mL/min. The actual real time BFR was running at 400 mL/min (200 mL/min greater than prescribed). The treatment had been running for 41 minutes prior to being discovered. There was no documentation on any of the above dates that indicated why dialysis was administered with different BFR than prescribed and no documentation that the physician was notified. P-5: This 51-year-old was admitted to facility on 6/29/20 with end stage kidney disease; diabetes type 2; and high blood pressure. The medical record was reviewed on 11/30/2323 and included 6 treatment sheets between the dates of 10/9/23 and 11/23/23. The active physician orders for the period reviewed included dialysis to be run with a BFR of 400 mL/min and a DFR of 600 mL/min. During review of the treatment record dated 10/16/23, it was noted that the DFR was ran at 500 mL/min for the entire 139-minute treatment. There was no documentation indicating why dialysis was administered with different DFR than prescribed and no documentation that the physician was notified. These findings were reviewed and acknowledged during interview on 12/5/23 at 1205 with the Facility Administrator (Staff B) and the Clinical Manager (Staff P).”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 47976 Based on record review and interview, the agency failed to ensure the necessary care and counseling services were provided to achieve and sustain an effective nutritional status in 2 (P-1, 2) of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-1: This 60-year-old patient was admitted to this dialysis facility on 9/21/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, it was determined the patient’s Albumin levels were marked as “low” per lab results as follows (*professionally-accepted clinical standards indicate values below 4.0 g/dL (grams per deciliter) are considered low): September 2023 = 3.7 g/dL October 2023 = 3.0 g/dL November 2023 = 3.4 g/dL Upon review of the patient’s plan of care dated 10/24/23 after a 0.7 g/dL drop in albumin levels from September to October, it was noted a 12 month goal was set for “Albumin level trends to move toward and remain within recommended and appropriate clinical ranges.” Lab values for November demonstrated a slight increase to 3.4 g/dL, however this is still considered low/abnormal. Upon further review of the patient’s record on 12/5/23, it was noted the plan of care dated 12/1/23 had a goal set to “Maintain albumin and potassium within goal,” however, the values are still not within normal range. During an interview on 12/5/23 at 1110, the Facility Administrator (Staff B) was queried regarding documentation of the interdisciplinary team acknowledging the values being below target for 3 months in a row or of any interventions documented to help improve the patient’s albumin levels. Staff B was unable to provide evidence the staff was aware of and monitoring the patient’s albumin status or providing interventions to help improve. Findings were also acknowledged by the Manager of Operations (Staff R) at the time of the interview. P-2: This 54-year-old patient was admitted to this dialysis facility on 2/28/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, it was noted the plan of care dated 11/22/23 also had a goal for nutrition that stated, “Albumin levels trend to move toward and remain within recommended and appropriate clinical ranges.” According to the lab records, the last recorded value for albumin revealed a drop from 4.3 g/dL on 8/29/23 to 3.7 g/dL on 9/26/23. The goal also stated, “Closed goals: Maintain albumin and potassium within goal,” even though albumin levels had not been met. The Facility Administrator (Staff B) was queried regarding what information was used to create this goal during an interview on 12/5/23 at 1110. Staff B reported according to the record, this patient has not had blood work done to determine albumin levels since 9/26/23 when it was recorded at 3.7 g/dL. Staff B reported the patient has been non-compliant with visits and often hospitalized, therefore that may be why no recent labs have been drawn. Staff B was unable to provide documentation of the reason for missed labs. She also acknowledged the plan of care cannot accurately assess and set appropriate goals without updated/current information. The Manager of Operations (Staff R) was also present during the interview and acknowledged the findings.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to ensure the interdisciplinary team provided necessary care and services to achieve and maintain a clinically appropriate hemoglobin level in 1 (P-2) of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-2: This 54-year-old patient was admitted to this dialysis facility on 2/28/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, it was noted the most recent plan of care was dated 11/22/23. This plan of care revealed a goal for anemia that stated, “Patient is not meeting goal, monitor Hgb (hemoglobin) weekly. Monitor patient iron and administer iron as needed according to protocol.” Upon further review of the data collected to create this plan of care, the section under most recent hemoglobin level stated, “No Data Available.” The Facility Administrator (Staff B) was queried regarding what information was used to create this goal during an interview on 12/5/23 at 1110. Staff B reported that according to the record, this patient has not had blood work done to determine hemoglobin levels since 10/21/23 which was recorded at 9.6 g/dL (grams per deciliter). Staff B reported the patient has been non-compliant with visits and often hospitalized, therefore that may be why no recent labs have been drawn. Staff B was unable to provide documentation of the reason for missed labs. She also acknowledged the plan of care cannot accurately set appropriate goals without updated information. The Manager of Operations (Staff R) was also present during the interview and acknowledged the findings.”

“H-HOME PT PLAN OF CARE DEV/UPDATED CFR(s): 494.100(b)(1)(iii) Services include, but are not limited to, the following: (iii) Development and periodic review of the patient’s individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs and meets the measurable and expected outcomes as specified in §494.90 of this part. This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to ensure a patient Plan of Care (POC) was reviewed and updated for 1 (P-7) of 1 home PD (peritoneal dialysis) patients, resulting in the potential for poor patient outcomes. Findings include: On 11/29/2023, during record review of P-7’s most recent annual home PD Plan of Care (POC) on 10/4/23, it was determined the evaluation of the patient’s needs were not reflected nor updated in the POC review. Under “Fluid/Blood Pressure”, the following was documented in its entirety: “Maintain post weight compared to target weight. Blood Pressure (BP) within range.” The safety range or parameters established for P-7’s BP readings were 150/90 (systolic/diastolic). However, further review of P-7’s bi-weekly BP readings (8/22/23 through 11/14/23) found 8 of 8 documented BP readings were significantly out of range, the readings are as follow: On 8/22/23, 200/123 On 8/24/23, 169/94 On 9/5/23, 187/124 On 9/19/23, 184/117 On 10/4/23 (date of POC), 195/114 On 10/17/23, 151/107 On 11/7/23, 172/112 On 11/14/23, 200/128 No documentation was found in the medical record in which staff attempted to ascertain if the high BPs above were associated with “white coat” phenomenon (when a patient’s BP is elevated due to stress/anxiety of being evaluated). In addition, the annual POC documented under Kt/V (value to quantify and determine the effectiveness of dialysis) the following: “No Kt/V data”. During an interview with the facility administrator (Staff B) on 11/30/23 at 1140, Staff B acknowledged the findings above and was noted the POC did not meet facility expectations. The POC failed to incorporate any interventions or detail the patient’s needs to have a safely controlled BP, failed to update the POC when P-7’s BP readings continued to run out of range, and failed to address the effectiveness of dialysis treatments (Kt/V) over the last year per facility policy referenced below. Facility Policy: “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” No. 1-14-01 (Revised October 2020) stated, “The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs... The plan of care will address, but not be limited to the following: 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.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47976 Based on record review and interview, the medical director failed to ensure the Initial Nursing Assessment was performed by a registered nurse prior to initiation of treatment per policy in 2 (P-1, 2) of 7 records reviewed; failed to ensure the physician was contacted when visits were shortened >30 minutes per policy in 5 (P-1, 2, 3, 4, and 5) of 7 records reviewed, and failed to maintain a current patient home medication record in 1 (P-7) 1 record reviewed in the home dialysis program, out of a total sample of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: **Policy 1-03-07 titled “CWOW-Initial Patient Nursing Assessment for New Patients” (revised October 2021) stated, “A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility.” P-1: This 60-year-old patient was admitted to this dialysis facility on 9/21/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, it was determined the Initial Nursing Assessment was not signed or dated, so it cannot be determined if it was completed before the initiation of her first treatment at the facility. P-2: This 54-year-old patient was admitted to this dialysis facility on 2/28/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, it was determined the Initial Nursing Assessment was signed and dated on 3/4/23 and the patient’s first treatment at this facility was on 2/28/23. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Manager of Operations (Staff R) during an interview on 12/5/23 at 1110. **Policy 1-01-09 titled “Prescribed Treatment Time Not Met” (revised October 2023) stated, “If shortened/early termination of treatment time exceeds 30 minutes or more, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs.” P-1: This 60-year-old patient was admitted to this dialysis facility on 9/21/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, the last 3 treatment sheets were reviewed. It was determined the visit on 9/23/23 was shortened by 75 minutes, the treatment on 9/28/23 was shortened by 33 minutes, and the treatment on 10/26/23 was shortened by 43 minutes. P-2: This 54-year-old patient was admitted to this dialysis facility on 2/28/23 with the diagnosis of End Stage Renal Disease and was receiving dialysis treatments 3 times per week. During record review on 11/29/23, the last 3 treatment sheets were reviewed. It was determined the visit on 9/21/23 was shortened by 42 minutes, the treatment on 10/8/23 was shortened by 63 minutes, and the visit on 10/16/23 was shortened by 78 minutes. The Facility Administrator (Staff B) was queried whether there was documentation regarding the physician being contacted on these dates during an interview on 12/5/23 at 1110. Staff B was unable to provide evidence the physician had been contacted. She acknowledged the findings. 46476 P-3: This 31-year-old was admitted to the facility on 5/10/23 with end stage kidney disease; chronic high blood pressure; and Human Immunodeficiency Virus. The medical record was reviewed on 11/29/23 and included 6 hemodialysis treatment sheets between the dates of 9/11/23 and 11/24/23. During review, it was noted that the treatment on 11/24/23 was terminated 69 minutes early. There was no documented evidence that the registered nurse (RN) informed the physician of the early termination of treatment. P-4: This 63-year-old was admitted to the facility on 11/2/23 with end stage kidney disease, and high blood pressure. The medical record was reviewed on 11/29/23 and included 6 treatment sheets between the dates of 11/7/23 and 11/28/23. During review it was noted that on 11/11/23, the treatment was terminated 59 minutes early. On 11/16/23, the treatment was terminated 78 minutes early. There was no documented evidence that the RN informed the physician of the early termination of treatments. P-5: This 51-year-old was admitted to facility on 6/29/20 with end stage kidney disease; diabetes type 2; and high blood pressure. The medical record was reviewed on 11/30/23 and included 6 treatment sheets between the dates of 10/9/23 and 11/23/23. During review it was noted that on 10/9/23, the treatment was terminated 60 minutes early. On 10/16/23, the treatment was terminated 41 minutes early. On 11/1/23, the treatment was terminated 50 minutes early. And on 11/23/23, the treatment was terminated 63 minutes early. There was no documented evidence that the RN informed the physician of the early termination of treatments. The above findings were reviewed and acknowledged during interview on 12/5/23 at 1205 with the Facility Administrator (Staff B) and the Clinical Manager (Staff P). 38304 P-7: On 11/29/2023, record review of P-7’s Plan of Care (POC) noted the following safety goals/parameters established for blood pressure effective 9/27/22 and renewed on 10/4/23: “To meet or trend toward goal of Blood Pressure of less than 150/90 (systolic/diastolic).” Further review of P-7’s most recent bi-weekly BP readings (8/22/23 through 11/14/23) noted 8 of 8 readings were significantly out of range (see below): On 8/22/23, 200/123 On 8/24/23, 169/94 On 9/5/23, 187/124 On 9/19/23, 184/117 On 10/4/23 (date of POC), 195/114 On 10/17/23, 151/107 On 11/7/23, 172/112 On 11/14/23, 200/128 Additional record review revealed the clinical note on 11/7/23 documented the patient was “wearing a Catapress patch (medication used for BP control)” with no dose noted. Review of the patient’s home medication list was performed to ascertain the dosage considering of the above elevated BP readings. However, no evidence was found in P-7’s list that the Catapress patch was added. No information was found in the medical record of the Catapress dosage, effective start date or how long the patch was to be continued. No details of how the Catapress patch (dosage unknown) would interact or effectiveness when combined with P-7’s active BP medications (Nifedipine ER 90 mg. daily and Metoprolol Tartrate twice a day, dosage unknown). During an interview with the Facility Administrator (Staff B) on 11/30/23 at 1350, the findings were reviewed and acknowledged. The Medical Director failed to ensure facility staff adhered to its policy referenced below. Facility Policy: “Home Medication Reconciliations” No. 1-06-07 (Revised January 2020) stated, “To establish for facility teammates to complete home medication reconciliations timely and effectively in order to maintain a current patient home medication record to help inform clinical decisions.””

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to document and maintain accurate records for 1 (P-6) of 7 patients, out of a total sample of 7 records reviewed, resulting in the potential for adverse patient outcomes for all 52 patients currently receiving services at this facility. Findings include: P-6: On 11/30/2023, review of the medical record revealed a 72-year-old female admitted to this dialysis facility on 9/15/2023 with a past medical history which included chronic kidney disease, anemia, hypertensive heart disease, congestive heart failure (CHF), and hypertension. Further review noted significant changes in the patient’s target weight; 92.0 kg. on 9/15/23 and changed to 118.0 kg. on 9/16/23 (57.3 pound increase). During exploration of this finding, it was noted the signed order was performed by a RN (registered nurse), not a physician. The Facility Administrator (Staff B) was queried on 11/30/23 at 1410, why an RN and not the physician was providing patient care orders. Staff B was unfamiliar with the RN who signed the order and could not offer an explanation at the time. On the day of survey exit (12/5/23), an internal audit had revealed the software used in utilizing its EMR (electronic medical records) had “glitched” producing the above error. The explanation in the audit documented the following: “When orders are created, edited, signed, coded, etc., the system inserts an access token in the orders command spanner service. This allows the system to link a specific user to the action and when the action was taken. Due to a defect, some of the orders are missing access token information. When this occurs, the system logs show that the UPDATE_SESSION_TOKEN_ID is updated incorrectly. As a result, the wrong user is displaying as having taken the action - in order history view (screen) as well as in reports. The Overview database holds the correct information on which provider signed the orders along with date/time stamps. The database is correct.” Further, the audit noted this was the lone occurrence to date but will continue to investigate and fix the software error. The facility failed to maintain an accurate medical record as stipulated by its facility policy referenced below. Facility Policy: “Medical Records Documentation Guidance” No. 3-02-02 (Revised October 2023) stated, “All entries must be accurate. Inaccurate can adversely affect patient care and false statements in a medical record can subject (company name) and the individuals making the false statement to serious administrative, civil and criminal sanctions.””