Dci James Island

“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: 30011 Based on observations, interviews, and review of facility policy and procedure, the dialysis facility failed to ensure the acid tank pipes were free of a crystal-like substance, the dialysis machine drain ports behind the dialysis machines were clean, and expired supplies were removed from the patient treatment area. The findings include: Observations on 01/29/24 at 12:43 PM in the acid storage room revealed the acid valves between the 2 Potassium (K) 2.5 Calcium (Ca) bath and 3 K 2.5 Ca baths had a white crystal-like coating substances. During an interview on 01/29/24 at 12:44 PM, Registered Nurse (RN) 1 verified the findings. Observations on 01/29/24 at 1:20 PM in the dialysis treatment room revealed a darkish brown substance inside the drain ports for the dialysis machines with a bubbly foaming substance during dialysis treatment at the following dialysis stations: B 6, B 7, C 8, C 9, C 10, C 12, D 13, D 14 and D 15. During an interview on 01/29/24 at 1:22 PM, Certified Clinical Hemodialysis Technician (CCHT) 4 stated, “I don’t know what that is.” Facility policy, entitled, “Routine Disinfection in the Hemodialysis Unit”, revealed, “12. Chase/water boxes will be cleaned at a scheduled interval per facility protocol...”. Observations on 01/29/24 at 1:32 PM in the dialysis treatment room revealed the following expired supplies: (25) Prevantics (Chlorhexidine Gluconate) 3.15 % (percent) and Isopropyl alcohol (70 %) swabs expired 11/23. During an interview on 01/29/23 at 1:33 PM, Registered Nurse (RN) 3 verified the findings. Observations on 01/30/24 at 9:10 AM in the dialysis treatment room revealed ceiling tiles by station A 4 had round brownish spots times 2. Review of roofing claim information on 01/31/24 at 11:23 AM revealed the facility roof repair was completed on 11/20/23. During an interview on 01/31/24 at 11:25 AM, Biomedical Technician (BMT) 1 stated, “I was waiting for the company to make repairs because we had roofing issues. The letter I gave you is when the repairs were completed.””

“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: 30011 Based on observations, interview, and review of facility policy and procedure, the dialysis facility failed to ensure hand hygiene was performed by patients post access holding for 2 of 2 random patients observed holding the access site. The findings include: Observations on 01/29/24 from 11:36 AM to 11:50 AM in the dialysis treatment room revealed the patient at station B7 post right upper access holding with left gloved hand, discarded the soiled glove, went to the scale for a post weight, and exited the dialysis treatment room without hand hygiene. Observations on 01/29/24 from 2:15 PM to 2:43 PM in the dialysis treatment room revealed the patient at station C 12 post left upper access holding with right hand, discarded the soiled glove, went to the scale for a post weight, and exited the dialysis treatment room without hand hygiene. During an interview on 02/01/24 at 12:14 PM, Patient Care Technician (PCT) 1 stated, “When patients take off their gloves after holding their access, they are supposed to use hand sanitizer.” Facility policy, entitled, “Use of Gloves Including Hand Hygiene”, revealed, “6. Hand hygiene will be performed:...Immediately after gloves are removed...Before entering and on exiting the patient treatment areas...”.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 30011 Observation from 01/29/24 at 3:01 PM to 3:06 PM in the dialysis treatment room revealed Biomedical Technician (BMT) 1 on the floor at the nurse desk using the computer without personal protective equipment (PPE) donned during the termination of the dialysis treatment for the patient at station C 10. During an interview on 01/31/24 at 9:22 AM, Biomedical Technician (BMT) 1 stated, “They don’t require us to put on a gown in the dialysis treatment room because we are only there for a few minutes. I put on a gown if there’s an issue with a machine.” 36779 Based on observation, interview and review of the facility’s policy, the facility failed to ensure staff were not in the treatment area without personal protective equipment (PPE) on during the termination and discontinuation of treatment. The findings include: On 1/29/24 at 3:03 PM the Biomed Technician (BMT) was observed to enter the treatment area without performing hand hygiene or donning any PPE. During an interview with the BMT on 1/31/24 at 9:22 AM, he/she confirmed he/she was in the treatment area on 1/29/24 without performing hand hygiene or donning PPE. The BMT stated he/she did not need to don PPE because he “wasn’t there all day.” When asked what period of time would require the donning of PPE, he/she did not answer. Review of the facility’s policy titled, “Universal Precautions” on 2/1/24 at 3:45 PM revealed, “...Staff members should wear gowns, face shields, eye wear, or masks to protect themselves...when performing procedures during which spurting or spattering of blood might occur...e.g. during initiation and termination of dialysis...”.”

“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: 30011 Based on observations and interview, the dialysis facility failed to ensure dialysis clamps were opened during the disinfection process. The findings include: Observations on 01/29/24 at 1:25 PM in the dialysis treatment room revealed bleach containers labeled as 1:100 (one to one hundred) without tops on them. Further observations revealed blue closed dirty dialysis clamps in a container labeled with 1:100 (one to one hundred) bleach solution. During an interview on 01/29/24 at 1:50 PM, Certified Clinical Hemodialysis Technician (CCHT) 2 stated, “The clamps are supposed to be open in the bleach water and the bleach containers are supposed to have tops on them.””

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 36779 Based on observations, record reviews, interview, and review of the facility’s policies, the facility failed to ensure the central line dressing was changed prior to the initiation of dialysis treatment for two of five patient records reviewed. (Patient #1 and #4) The Findings: On 1/29/24 from 11:57 AM to 12:12 PM, Patient #4 was observed in chair #8 of the dialysis treatment area. Patient #4 had a central line to the left chest. The central line dressing was not removed and site care was not performed before initiation of the patient’s dialysis treatment. After the termination of the patient’s dialysis treatment on 1/29/24 at 2:20 PM, Registered Nurse (RN) 2 was observed changing Patient #4’s central line dressing. On 1/31/24 at 1:00 PM, Patient #4’s dialysis treatment flow sheet dated 1/29/24 revealed Patient #4’s arrival was 11:05 AM and the dialysis treatment started at 11:09 AM. There was no documented evidence the central line dressing was changed prior to the initiation of the patient’s dialysis treatment. There was no documentation of any central line dressing change. During an interview with the Clinical Manager (CM) on 2/1/24 at 11:43 AM, the CM reviewed Patient #4’s dialysis treatment record dated 1/29/24 and confirmed there was no documented evidence the central line dressing was changed prior to the initiation of the patient’s dialysis treatment. The CM stated central line dressing changes are supposed to be done prior to the initiation of treatment. Review of Patient #4’s record on 1/31/24 at 1:00 PM revealed dialysis treatment flow sheets dated 1/1/24, 1/3/24, 1/5/24, 1/8/24, 1/10/24, 1/11/24, 1/15/24, 1/17/24, 1/19/24, and 1/29/24 revealed Patient #4 had a central venous access catheter (CVC). There was no documented evidence of central line dressing changes or site care on 1/1/24, 1/3/24, 1/10/24, 1/11/24, 1/15/24, 1/17/24, 1/19/24 or 1/29/24. There was no documented evidence central line dressing changes were done the weeks of 1/15/24 or 1/22/24. During an interview with the Clinical Manager (CM) on 2/1/24 at 11:43 AM, he/she confirmed the findings and stated central line dressing changes are supposed to be done weekly. Record review on 01/31/24 at 9:12 AM revealed Pt 1 was admitted on 12/12/23 with a diagnosis of Type 2 Diabetes Mellitus (DM). Review of the patient’s dialysis treatment sheet dated 01/02/24 revealed the patient’s dialysis treatment was initiated at 6:38 AM with documentation of a CVC dressing change not until 9:22 AM by the nurse. Review of the dialysis treatment sheet dated 01/06/24 revealed the patient’s dialysis treatment was initiated at 8:25 AM with documentation of a CVC change not until 8:44 AM by the nurse. Review of the dialysis treatment sheet dated 01/09/24 revealed the patient’s dialysis treatment was initiated at 6:35 AM with documentation of a CVC change not until 6:54 AM by the nurse. During an interview on 02/01/24 at 10:30 AM, the Clinic Manager (CM) verified the findings. Review of the facility’s policy, titled, “CENTRAL VENOUS CATHETER (CVC) EXIT SITE DISINFECTION AND DRESSING CHANGE...,” on 2/1/24 at 3:54 PM, revealed, “...Catheter exit-site care and dressing changes is required at least every seven days...Catheter care and dressing changes should be done prior to treatment initiation...”.”

“CHEMICAL INJECTION SYSTEMS CFR(s): 494.40(a) 5.2.6 Chemical injection systems Chemical injection systems consist of a reservoir that contains the chemical to be injected, a metering pump, and a mixing chamber located in the main water line. Chemical injection systems also include some means of regulating the metering pump to control the addition of a chemical. This system should be designed to tightly control the addition of the chemical. The control system should ensure that a chemical is added only when water is flowing through the pretreatment cascade and that it is added in fixed proportion to the water flow or based on some continuously monitored parameter, such as pH, using an automated control system. If an automated control system is used to inject the chemical, the controlling parameter should be independently monitored. There should also be a means of verifying that the concentrations of any residuals arising from the chemical added to the water are reduced to a safe level before the water reaches its point of use. When acid is added to adjust pH, a mineral acid should be used. 6.2.6 Chemical injection systems Systems for chemical injection should be monitored according to the manufacturer’s instructions. If a facility designs its own system, procedures should be developed to ensure proper preparation of the chemical, adequate mixing of the injected chemical with the water flowing through the pretreatment cascade, and reduction to a safe level of the concentration of any chemical residuals before the point of water use. The facility should also verify that the injected chemical does not degrade the performance of downstream devices, including the primary purification process. The adequacy of these procedures must be verified using an independent laboratory. Verification can be accomplished by testing samples from the chemical reservoir and the water line after the point of injection for at least three batches of chemical. When the chemical to be injected is prepared at a facility from powder or by dilution of a liquid concentrate, the chemical injection reservoir must be labeled with the name of the chemical and its concentration, the date the solution was prepared, and the name of the person who mixed the solution. Each batch of chemical should be tested for correct formulation before use. A batch of chemical must not be used or transferred to the injection system reservoir until all tests are completed. The test results-and verification that they meet all applicable criteria-should be recorded and signed by the individual performing the tests. Protective clothing and an appropriate environment, including ventilation adequate to meet applicable OSHA environmental exposure limits, should be provided when chemicals for injection are prepared in a dialysis facility. This Standard is not met as evidenced by: 36779 Based on observations, interview, and review of the “CWP (Continuous Water Processor) 100 INSERVICE UNIT OPERATION AND MONITORING” manual, the facility failed to ensure the system was monitored according to the manufacturer’s instructions when the chemical disinfectant (Minncare) was not monitored to ensure it was added in fixed proportion to the water. The findings include: On 1/31/24 at 11:10 AM, the CWP was observed with the Biomedical Technician (BMT). The disinfectant (Minncare) container had no date or markings on it to indicate what the level of solution was used. During a concurrent interview with the BMT, he/she stated, “They are supposed to” (mark the container with the date and the level of solution) “daily”, and “They are trained to do this.” The BMT stated Certified Hemodialysis Technician (CHT) 1 was the person responsible for doing this. On 1/31/24 at 12:30 PM, the CWP was observed with CHT 1. CHT 1 stated she/he is suposed to mark the level line when she/he puts on a new bottle of Minncare disinfectant and weekly before disinfection of the system. CHT 1 confirmed there was no date and/or marking on the bottle of Minncare disinfectant. Review of the, “CWP 100 INSERVICE UNIT OPERATION AND MONITORING”, manual on 1/31/24 at 11:25 AM, revealed, “...Disinfection..Mark the level and date on the disinfectant container with a permanent pen. (TIP: If the level does not change, chemical intake has failed.)...”.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 36779 Based on record reviews, interview, and review of the facility’s policies, the facility failed to ensure microbial samples were collected before sanitization/disinfection of the water treatment system. The findings include: On 1/31/24 at 9:22 AM, the facility’s water system documentation and logs were reviewed. Review of the facility’s CWP (Continuous Water Processor) Disinfection Log for August 2023 revealed the system was chemically disinfected on 8/1/23. Review of the culture and endotoxin report for August 2023 revealed the sample was collected on 8/3/23 (2 days after disinfection). Review of the CWP Disinfection Log for October 2023 revealed the system was chemically disinfected on 10/31/23. Review of the culture and endotoxin report for November 2023 revealed the sample was collected on 11/1/23 (the day after disinfection). During an interview with the Biomedical Technician (BMT) on 1/31/24 at 10:30 AM, he/she confirmed the findings and stated he/she collects samples “sometimes Monday, sometimes Thursday” because he/she is not always on-site at this location. The BMT confirmed the samples should be collected before weekly disinfection and not after. Review of the facility’s policy, titled, “Non-patient Lab Requirements,” revealed, “...Product water sample(s) will be collected in the worst case scenario within 72 hours before disinfection of the Reverse Osmosis (RO) unit and/or RO distribution system...”.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 36779 Based on observation, interview, and review of the facility’s policies, the facility failed to ensure the staff member responsible for the water system disinfection received training in the use of the equipment by the manufacturer or using materials provided by the manufacturer, failed to conduct observational audits to evaluate compliance at least annually, and failed to provide an ongoing training program designed to maintain the operator’s knowledge and skills. The findings include: On 1/31/24 at 11:10 AM the CWP was observed with the Biomedical Technician (BMT). The disinfectant (Minncare) container had no date or markings to indicate when the Minncare was placed or what the level of solution was used. During a concurrent interview with the BMT, he/she stated, “They are supposed to” mark the container with the date and the level of solution “daily” and “They are trained to do this.” The BMT stated Certified Hemodialysis Technician (CHT) 1 was the person responsible for doing this. On 1/31/24 at 12:30 PM, the CWP was observed with CHT 1. CHT 1 stated she/he is supposed to mark the level line when she/he puts on a new bottle of Minncare disinfectant and weekly before disinfection of the system. CHT 1 confirmed there was no date and no marking on the bottle of Minncare disinfectant. CHT 1 stated she has not received annual training on the procedure and the only training she received was when the previous BMT was here. CHT 1 stated she does not know how much disinfectant is supposed to be used. On 2/1/24 at 10:00 AM CHT 1’s employee file was reviewed. There was no documented evidence of any training on disinfection of the CWP by the manufacturer or using materials provided by the manufacturer, or any documented evidence of audits of compliance. During an interview with the Nurse Educator (NE) on 2/1/24 at 10:15 AM, she/he stated the previous BMT was last here at least five years ago, so the initial training CHT 1 received was at least five years ago. The NE reviewed CHT 1’s employee file and confirmed there was no documented evidence of any training including any training by the manufacturer or using materials provided by the manufacturer. She/he stated CHT 1 should have received training initially and annually. Review of the “CWP 100 INSERVICE UNIT OPERATION AND MONITORING” manual on 1/31/24 at 11:25 AM, revealed, “...Disinfection..Mark the level and date on the disinfectant container with a permanent pen. (TIP: If the level does not change, chemical intake has failed.)...”.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30011 Based on observations, interviews and review of facility policy and procedure, the dialysis facility failed to ensure preventative maintenance (PM) was performed on the facility centrifuge machine and intravenous (IV) pump. The findings include: Observations on 01/29/24 at 12:48 PM in the laboratory area revealed a combo centrifuge machine with a preventative maintenance sticker that showed completed 08/22 and next PM due on 08/23. Observations on 01/29/24 at 3:19 PM in the dialysis treatment room revealed one IV (Intravenous) pump with a preventative maintenance sticker that showed PM completed on 08/22 and next PM due on 08/23. During an interview on 01/29/24 at 3:21 PM, Biomedical Technician (BMT) 1 stated, “I will have to schedule a maintenance for the centrifuge and pump...”. Facility policy, entitled, “Maintenance of Equipment”, revealed, “4. Dialysis related ancillary equipment will be maintained following manufacture’s recommendation. Examples of this equipment include, but are not limited to, AED (automated externsl defibrillator), centrifuge, EKG (electrocardiogram), ECG (electrocardiography), pulse ox (oximeter) suction devices, IV pump, blood pressure monitor, Hoyer lift, glucose monitor, digital thermometer, Crit-Line, Transonic, or oxygen concentrators)...”. Review of the “Myron L D6 Meter Logs” on 01/30/24 at 3:48 PM revealed the facility has two meters used to check the pH and conductivity of the dialysis machines for conductivity and pH. Review of the logs further revealed the pH and conductivity for the dialysis machines was checked one time a day by the staff. During an interview on 02/01/24 at 2:38 PM, the Nurse Educator stated, “I think we teach them to calibrate it once a day along with pH and conductivity.” Review of Manufacturer Guidelines on 02/01/24 at 4:00 PM, revealed, “Suggested calibration intervals...Conductivity at the beginning and end of each workday and pH at the beginning and end of each workday,””

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 36779 Based on record reviews and interview, the facility failed to ensure tuberculosis screening was done for one of five patient records reviewed. (Patient #4) The findings include: On 1/31/24 at 1:00 PM, Patient #4’s record revealed Patient #4 was admitted on 9/28/23 with a diagnosis of Stage 5 Chronic Kidney Disease. There was no documented evidence of tuberculosis screening at the time of admission. The Immunization History indicated a tuberculin skin test was placed on 12/11/23 over two months after admission, however there was no result recorded. On 2/1/24 at 1:23 PM, during an interview with the Clinical Manager (CM), he/she reviewed Patient #4’s record and confirmed tuberculosis screening was not completed at admission stating, “It must have got missed.””

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 36779 Based on record review and interview, the facility failed to ensure a comprehensive assessment was completed for 1 of 5 patient records reviewed. (Patient #5) The findings include: On 1/31/24 at 2:47 PM, Patient #5’s record revealed Patient #5 was admitted on 4/13/23 with a diagnosis of Diabetes Mellitus Type I with Chronic Kidney Disease. The patient’s first interdisciplinary care plan was dated 7/27/23. There was no documented evidence a comprehensive assessment completed and an interdisciplinary plan of care developed within 30 days of admission. During an interview with the Clinical Manager (CM) on 2/1/24 at 1:07 PM, he/she reviewed Patient #5’s record and confirmed the findings, and stated Patient #5 was transferred from another facility and an admission comprehensive assessment and interdisciplinary plan of care were not done until 7/27/23. The CM confirmed the patient’s comprehensive assessment and IDT plan of care from the previous facility were not in Patient #5’s record at this facility. When asked how the staff at this facility knew what the plan of care was for the patient for the first 14.5 weeks at this facility, the CM did not answer. Review of the facility’s policy, titled, “Care Plans”, revealed, “...If a patient transfers into a new facility with a completed comprehensive patient assessment and plan of care, IDT must conduct a new reassessment and plan of care within three months of the patient’s new admission date to the facility.”

“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: 36779 Based on record reviews and interview, the Interdisciplinary Team (IDT) did not provide the necessary care and services when elevated blood pressures and pulse rates were not addressed and the physician was not notified for 3 of 5 patient records reviewed. (Patient #3, #4 and #5) The findings include: On 1/31/24 at 1:00 PM, Patient #4’s record revealed Patient #4 was admitted on 9/28/23 with a diagnosis of Stage 5 Chronic Kidney Disease. Review of Patient #4’s dialysis treatment flowsheet dated 1/11/24 revealed Patient #4’s blood pressure after dialysis was 203/105. There was no documented evidence the elevated blood pressure was addressed or the physician notified. Review of Patient #4’s dialysis treatment flowsheet for 1/15/24 revealed Patient #4’s blood pressure after dialysis was 200/97. There was no documented evidence the elevated blood pressure was addressed or the physician notified. Review of Patient #4’s dialysis treatment flowsheet dated 1/3/24 revealed Patient #4’s pulse rate was 136 sitting and 140 standing. There was no documented evidence the tachycardia was addressed or the physician notified. On 2/1/24 at 11:43 AM, the Clinical Manager (CM) reviewed Patient #4’s record, including the dialysis treatment flowsheets for 1/3/24, 1/11/24, and 1/15/24. The CM confirmed the findings and stated the nurses should have notified the physician of Patient #4’s elevated blood pressures and tachycardia. On 1/31/24 at 2:47 PM, Patient #5’s record revealed Patient #5 was admitted on 4/13/23 with a diagnosis of Diabetes Mellitus Type 1 with Chronic Kidney Disease. Review of Patient #5’s dialysis treatment flowsheet for 1/13/24 revealed Patient #5’s blood pressure after dialysis was 172/106. There was no documented evidence Patient #5’s elevated blood pressure was addressed or the physician notified. Review of Patient #5’s dialysis treatment flowsheet for 1/16/24 revealed Patient #5’s blood pressure after dialysis was 181/107. There was no documented evidence Patient #5’s elevated blood pressure was addressed or the physician notified. On 2/1/24 at 12:57 PM the CM was interviewed. The CM reviewed Patient #5’s treatment dialysis flowsheets dated 1/13/24 and 1/16/24. The CM confirmed the findings and stated the nurses should have notified the physician of the elevated blood pressures. On 01/31/24 at 1:49 PM, review of Patient 3’s record revealed Pt 3 was admitted with a diagnosis of end stage renal disease (ESRD). Review of Patient 3’s dialysis treatment sheet on 01/03/24 revealed Patient 3’s sitting blood pressure (BP) post treatment was 163/110. Further review revealed no documentation of physician notification and/or treatment provided. Review of Patient 3’s dialysis treatment sheet on 01/10/24 revealed Patient 3’s sitting BP post treatment was 142/115 with no documentation of physician notification and/or treatment provided. During an interview on 02/01/24 at 11:30 AM, the Clinic Manager (CM) stated, “We are in the process of changing our standing orders”. Review of the “Parameter Reporting Guidelines” on 02/01/24 at 4:03 PM, revealed, “Blood Pressure Post, staff reports to charge nurse, systolic > (greater than) 180, diastolic >95”. During an interview on 02/01/24 at 4:54 PM, the Nurse Educator stated, “We have a “Parameter Reporting Guidelines” sheet that is posted by the medication administration area for the nurses as a reminder”.”

“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: 30011 Based on record review and interview, the dialysis facility failed to ensure the Blood Flow Rate (BFR) was administered per physician prescription for 3 of 5 patient charts reviewed. (Patient 1, 2, and 3) The findings include: 1. Record review on 01/31/24 at 9:12 AM for Patient 1 revealed the patient was admitted to the dialysis facility with a diagnosis of Type II Diabetes Mellitus (DM) on 12/12/23. Review of Patient 1’s dialysis prescription dated 12/12/23 showed a BFR 400. Review of the patient’s dialysis treatment sheets revealed the following: 01/02/24: BFR 350 01/23/24: BFR 310-325 01/25/24: BFR 300 01/27/24: BFR 350 During an interview on 02/01/24 at 10:30 AM, the Clinic Manager (CM) verified the findings. 2. Record review on 01/31/24 at 11:36 AM for Patient 2 revealed the patient was admitted with a diagnosis of other cystic kidney disease on 08/30/21. Review of Patient 2’s dialysis prescription 07/03/23 showed a BFR of 450. Review of patient’s dialysis treatment sheets revealed the following: 01/03/24: BFR 400 01/12/24: BFR 400 01/15/24: BFR 400 01/17/24: BFR 400 01/22/24: BFR 440 01/29/24: BFR 400 During an interview on 02/01/24 at 11:09 AM, the CM verified the findings. 3. Record review on 01/31/24 at 1:49 PM for Patient 3 revealed the patient was admitted with a diagnosis of End Stage Renal Disease (ESRD) on 12/14/18. Review of Patient 3’s dialysis prescription dated 12/11/23 revealed a BFR of 450. Review of dialysis treatment sheets revealed the following: 12/04/23: BFR 400 12/08/23: BFR 400 12/13/23: BFR 350 12/15/23: BFR 325-400 01/05/24: BFR 380 01/08/24: BFR 350 01/17/24: BFR 400 01/29/24: BFR 400 During an interview on 02/01/24 at 11:30 AM, the CM verified the findings.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 30011 Based on record reviews and interview, the dialysis facility failed to ensure staff signed the plan of care the day of the Interdisciplinary (IDT) meeting for 3 of 5 dialysis patients. (Patient 1, 2, and 3) The findings include: Record review on 01/31/24 at 9:12 AM for Patient 1 revealed the patient was admitted on 12/12/23 with a diagnosis of Type 2 Diabetes Mellitus (DM). Review of the patient’s chart revealed the “Interdisciplinary Care Plan” IDT meeting was held on 12/19/23. Further review revealed the Physician (MD), Registered Nurse (RN), and Social Worker (SW) electronically signed the care plan on 12/19/23 and the Dietician (RD) electronically signed the care plan on 12/20/23. During an interview on 02/01/24 at 10:30 AM, the Clinic Manager (CM) stated, “Care plans are done on QAPI (Quality Assessment Performance Improvement) days. The staff is supposed to sign them the day of the meeting”. Record review on 01/31/24 at 11:36 AM for Patient 2 revealed the patient was admitted on 08/30/21 with a diagnosis of other cystic kidney disease. Review of the patient’s chart revealed an unstable “Interdisciplinary Care Plan” IDT meeting was held on 12/01/23. Further review revealed the MD electronically signed the care plan on 12/01/23, Registered Nurse (RN) did not electronically sign, the Social Worker (SW) signed the care plan on 12/04/23 and the Dietician (RD) signed the care plan on 12/01/23. Further review revealed a stable care plan meeting was held on 12/19/23. The MD electronically signed the care plan on 12/19/23, RN on 12/19/23, the SW signed the care plan on 12/19/23 and the Dietician (RD) signed the care plan on 12/20/23. During an interview on 02/01/24 at 10:30 AM, the Clinic Manager (CM) verified the findings. Record review on 01/31/24 at 1:49 PM for Patient 3 revealed the patient was admitted on 12/14/18 with a diagnosis of end stage renal disease (ESRD). Review of the patient’s chart revealed a stable “Interdisciplinary Care Plan” IDT meeting was held on 02/23/23. Further review revealed the MD, RN, and RD electronically signed the care plan on 02/23/23, but the SW did not electronically sign the care plan. During an interview on 02/01/24 at 11:30 AM, the Clinic Manager (CM) verified the findings.”

“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: 36779 Based on record review and interview, the facility failed to ensure the patient medical record was complete and accessible when there was no physician order and a comprehensive assessment and plan of care at the time of transfer were not included in the patient record for 1 of 5 patient records reviewed. (Patient #5) The findings include: On 1/31/24 at 2:47 PM Patient #5’s record was reviewed. Patient #5 was admitted to the facility on 4/13/23 with a diagnosis of Diabetes Mellitus Type I with Chronic Kidney Disease. The first interdisciplinary care plan was dated 7/27/23 (over three months after admission). During an interview with the Clinical Manager (CM) on 2/1/24 at 1:07 PM, he/she reviewed Patient #5’s record and stated Patient #5 was transferred from another facility. The Clinical Manager (CM) stated an admission comprehensive reassessment and interdisciplinary plan of care were not done until 7/27/23 because the patient had these at the previous facility. When asked to view them, the CM stated she/he was not able to access them because they were at the previous facility. The CM confirmed the comprehensive reassessment and IDT plan of care from the previous facility were not in Patient #5’s record at this facility. When asked how the staff at this facility knew what the plan of care was for the patient for the first 14.5 weeks at this facility, the CM did not answer. On 2/1/24 at 4:50 PM, the Nurse Educator (NE) confirmed she/he had reviewed Patient #5’s record and spoken with the Medical Social Worker and this facility does not have the transfer documentation and plan of care from the previous facility because “They were told not to transfer it.””