Premier Dialysis Service Lapeer LLC

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 36887 Based on interview and record review, the medical director failed to develop and implement a patient care policy and procedure resulting in the potential for unrecognized, unmet patient needs and poor patient outcomes for all patients cared for by the facility. Findings include: On 2/7/2024 at 1200, facility policy #8-002 titled “STAT LAB POLICY” effective 6/2020 states, “PURPOSE: To provide guidelines regarding the collection of non-routine laboratory samples considered emergent in nature. POLICY: 1. An order for non-routine emergent lab plus a valid ESRD (end-stage renal disease) related billing code must be obtained from the Nephrologist. 2. Stat lab draws shall be limited to only those tests associated with conditions related to ESRD and/or diagnoses that the attending Nephrologist is treating. 3. Stat lab draws are limited to only those that are critical to dialysis treatment and are time-sensitive (results needed back during or same day of treatment) or any tests that cannot be shipped due to sample degradation. Those tests are typically: Potassium, Hgb (hemoglobin), PTT (parathyroid hormone), Calcium.” The policy revealed a lack of direction on having an agreement with a local facility, method/procedure for obtaining the sample, the reporting of critical lab values including what constituted a critical value, and who bore responsibility to input the information into the facility’s electronic medical record. During an interview with Medical Director Staff E on 2/7/2024 at 1540, he stated the stat lab policy had just come to his attention with the previous CMS (Centers for Medicare and Medicaid Services) survey 11/29/2023 and he was “unaware of the technicalities behind it.” He further stated the process was that “the local lab is supposed to be doing labs by their critical results and the RN’s (registered nurses) are supposed to be checking those. He went on to say if any of the labs had critical values, the RN would call the physician who would issue an order for a repeat of that lab and “nine times out of ten I am already correcting the issue prior to getting stat lab results.” Staff E stated he understood the need for policy to dictate the process so it was done the same way for all patients by all of the providers. A revised “STAT LAB POLICY” effective 2/7/2024 states, “PURPOSE: To provide guidelines regarding the collection of non-routine laboratory samples considered emergent in nature. In instances where a STAT lab services agreement is in process, this policy dictates the procedure for STAT lab draws. Premier Dialysis will always get stat backup agreements (sic) per CMS regulations. POLICY: 1. An order for non-routine emergent lab plus a valid ESRD related billing code must be obtained from the Nephrologist and send order to nearest lab/hospital to the patient (sic) 2. Stat lab draws shall be limited to only those tests associated with conditions related to ESRD and/or diagnoses that the attending Nephrologist is treating. 3. Stat lab draws are limited to only those that are critical to dialysis treatment and are time-sensitive (results needed back during or same day of treatment) or any tests that cannot be shipped due to sample degradation. Those tests are typically: Potassium, Hgb, PTT, Calcium.” The policy again revealed a lack of direction on having an agreement with a local facility, method/procedure for obtaining the sample, the reporting of critical lab values including what constituted a critical value, and who bore responsibility to input the information into the facility’s electronic medical record.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 28042 Based on observation, interview, and record review the End Stage Renal Disease (ESRD) provider and its staff failed to take measures to prevent infections for all peritoneal dialysis patients treated by the ESRD provider and its staff, resulting in the risk for transmission of infectious agents among all patients who receive care by the provider. Findings include: See specific tags: V-111 Failure to maintain a sanitary environment to minimize the transmission of infectious agents. V-113 Failure to wear gloves while performing Peritoneal Dialysis (PD) exchange. V-115: Failure to ensure the patient wore a mask during PD exchange. V-117: Failure to keep clean areas separated from dirty areas. V-121: Failure to dispose of infectious waste in a safe manner.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 36887 Based on document review and interview the facility failed to establish a Quality Assessment Performance Improvement (QAPI) Program that covers the scope and complexity of all areas of the dialysis facility, failed to recognize major problems that threaten the health of patients, and failed to take action to address identified problems. Findings include: See Specific Tags: V-626 Failure to review all services provided V-628 Failure to develop an updated improvement plan V-634 Failure to take action to mitigate the potential for adverse safety events V-636 Failure to use patient satisfaction to identify opportunities for improvement V-639 Failure to set priorities for performance improvements”

“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: 28042 Based on observation and interview the End Stage Renal Disease (ESRD) provider failed to maintain a sanitary environment for 2 (#5, #6) of 2 peritoneal dialysis patients, resulting in an increased risk for exposure to infectious agents and poor outcomes for the 2 patients serviced by the facility. Findings include: On 11/27/2023 at 0925 during an observation of peritoneal dialysis (PD) treatment for P-6 in his room of the skilled nursing facility (SNF), Staff B was observed performing a connection of a drain bag to P-6’s PD catheter, completing a PD drain process, disconnecting the drain bag and tubing, placing a new mini cap on the PD catheter, and disposing of the fluid and supplies. During the process, A nursing staff of the SNF was observed opening the door of P-6’s room, walking in to get something off the counter, and walking back out of the room. During an interview on 11/28/2023 at 1205 in his patient room of the SNF, P-6 stated he had been performing his own PD (peritoneal dialysis) at home prior to coming to the SNF. He had been educated on the importance of infection control and keeping everything clean. P-6 said it bothered him that people and staff were allowed to open the door and walk in his room during his PD exchanges. P-6 stated staff walk in all the time and the dialysis tech doesn’t stop them. P-6 said the previous day a house keeping staff member came in during his exchange and swept his floor with a broom while Staff B was doing his PD exchange. Staff B did not stop the housekeeper or say anything. During an interview on 11/28/2023 at 1215 in her patient room of the SNF, P-5 stated people open the door of her room and come in all the time during her PD exchange. P-5 stated people will come in to deliver her food trays and take her vital signs during her PD exchange. P-5 said Staff B does not say anything to stop the people from coming in while he is completing her PD exchange.”

“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: 28042 Based on observation, interview, and record review, the End Stage Renal Disease (ESRD) provider staff failed to perform hand hygiene and/or utilize disposable gloves when providing patient care, resulting in the potential for the spread of infectious agents to the 2 (#5, #6) of 2 patients being served by the ESRD provider in the skilled nursing facility (SNF) during the observation periods. Findings include: On 11/27/2023 at 0925 during an observation of peritoneal dialysis (PD) treatment for P-6 in his room of the skilled nursing facility (SNF) Staff B was observed performing a connection of a drain bag to P-6’s PD catheter, completing a PD drain process, disconnecting the drain bag and tubing, placing a new mini cap on the PD catheter, and disposing of the fluid and supplies. During the process, Staff B did not wear gloves at any time. Staff B was observed using hand sanitizer one time during the exchange prior to disconnecting the drain bag. However, when the exchange was completed, Staff B left the room and did not perform hand hygiene, or wash his hands prior to leaving the room. In an interview on 11/27/2023 at 0930 in P-6’s room of the SNF, Staff B was queried as to whether he had access to disposable gloves. Staff B stated yes and pointed to a box of gloves on the counter next to the patient sink. Staff B stated he did not wear gloves during the PD exchange process. Staff B was asked if he knew where to locate his company policies and procedures if he had a question and Staff B stated no he did not. Review of ESRD Provider policy, “CAPD Ultra Set Disposable Disconnect Y-Set”, dated 06/2020 on 11/28/2023 at 1530 revealed, under “SUPPLIES: ...PPE-personal protective equipment (eye protection, gloves, fluid resistant/fluid impervious barrier garment). PROCEDURE: 1. Prepare room/area for procedure; Don PPE and perform hand hygiene. 7. Nurse will perform hand hygiene and don gloves.””

“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: 28042 Based on observation and interview, the End Stage Renal Disease (ESRD) provider failed to ensure that staff properly don personal protective equipment (PPE), a mask, when performing a patient care procedure for 1 (P-6) of 1 patients, resulting in the potential for exposure to infectious agents. Findings include: On 11/27/2023 at 0925 during an observation of peritoneal dialysis (PD) treatment for P-6 in his room of the skilled nursing facility (SNF), Staff B was observed performing a connection of a drain bag to P-6’s PD catheter, completing a PD drain process, disconnecting the drain bag and tubing, placing a new mini cap on the PD catheter, and disposing of the fluid and supplies. During the process, P-6 had a disposable surgical mask looped around his ears, and covering his chin only. P-6’s mouth and nose were not covered during the PD exchange. In an interview on 11/27/2023 at 0930 in P-6’s room of the SNF, Staff B was queried about masking during PD exchange. Staff B stated everyone in the room must wear a mask. Staff B was asked if he knew where to locate his company policies and procedures if he had a question and Staff B stated no he did not. Review of ESRD Provider policy, “Performing Dialysis in the SNF Procedure”, dated 09/2022 on 11/28/2023 at 1550 revealed, “...anyone in the room must wear an ear loop mask for patient safety. There are no exceptions to this rule.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 28042 Based on observation, interview, and record review, the End Stage Renal Disease (ESRD) provider failed to separate clean items and areas from dirty items and areas, resulting in the potential to spread infectious agents to 2 (#5, #6) of 2 patients that were currently dialyzing in the SNF (Skilled Nursing Facility). Findings include: On 11/27/2023 at 0925 during an observation of peritoneal dialysis (PD) treatment for P-6 in his room of the skilled nursing facility (SNF), Staff B was observed performing a connection of a drain bag to P-6’s PD catheter, completing a PD drain process, disconnecting the drain bag and tubing, placing a new mini cap on the PD catheter, and disposing of the fluid and supplies. During the process, Staff B was observed placing a new, open PD catheter mini cap on the bedside table next to a breakfast tray with half eaten food. Staff B was observed placing open, clean dressings, still on the dressing package, on P-6’s bed on his linens next to his leg. An open bottle of Alcavis (bleach solution used to clean the end of the PD catheter set during connection and disconnections) was observed on the counter next to the patient sink. Staff B was observed taking the mini cap from the bedside table and placing it on P-6’s PD catheter. Staff B used the dressings on P-6’s bed linens to clean P-6’s PD catheter before applying the mini cap. When the process was completed Staff B emptied the PD drain fluid bag into P-6’s sink. It was observed that the bottle of Alcavis was still next to the patient sink at that time. In an interview on 11/27/2023 at 0930 in P-6’s room of the SNF, Staff B was asked if the patient sink was a clean sink or a dirty sink. Staff B stated he did not know. Staff B stated he could empty the fluid in the bathroom but sink in the bathroom wasn’t as easy to access. Staff B was asked if he knew where to locate his company policies and procedures if he had a question and Staff B stated no he did not. Review of ESRD Provider policy, “Performing Dialysis in the SNF Procedure”, dated 09/2022 on 11/29/2023 at 1100 revealed there was no indication of how to dispose of effluent (peritoneal dialysis drain fluid).”

“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: 28042 Based on observation, interview, and policy review the End Stage Renal Disease (ESRD) provider failed to ensure infectious waste was disposed of and contained in closed biohazard waste bins, resulting in the potential for the spread of infectious disease to all patients receiving dialysis services at the facility. Findings include: On 11/27/2023 at 0925 during an observation of peritoneal dialysis (PD) treatment for P-6 in his room of the skilled nursing facility (SNF), Staff B was observed performing a connection of a drain bag to P-6’s PD catheter, completing a PD drain process, disconnecting the drain bag and tubing, placing a new mini cap on the PD catheter, and disposing of the fluid and supplies. When the process was completed Staff B emptied the PD drain fluid (effluent) bag into P-6’s sink. Staff B was then observed disposing of the effluent drain bag, which was observed to have a small amount of yellow fluid remaining in the bag, into the regular trash can under the counter/sink area of the P-6’s room. The trash can was observed to have a clear bag/liner. In an interview on 11/27/2023 at 0930 in P-6’s room of the SNF, Staff B was asked if he always disposed of effluent drain bags after being used for drain, in the regular trash in a regular trash bag. Staff B stated yes, that is the way he had always done it. Staff B was asked if he knew where to locate his company policies and procedures if he had a question and Staff B stated no he did not. Review of ESRD Provider policy, “Performing Dialysis in the SNF Procedure”, dated 09/2022 on 11/29/2023 at 1100 revealed there was no indication of how to dispose of effluent (peritoneal dialysis drain fluid) or infectious/biohazard waste.”

“PR-INFORMED OF EXTERNAL GRIEVANCE PROCESSES CFR(s): 494.70(a)(15) The patient has the right to- (15) Be informed of external grievance mechanisms and processes, including how to contact the ESRD Network and the State survey agency; This Standard is not met as evidenced by: 15195 Based on interview and record review, the facility failed to ensure that the external grievance information included the state agency, resulting in lack of patient rights for this grievance process for all 82 current patients. Findings include: On 11/27/23 at approximately 1200, the Administrator (Staff A) was queried about patient information regarding filing an external complaint/grievance. The Administrator stated that the information was included in the Admission Packet with consents and signatures. On 11/27/23 at approximately 1210, review of the Admission Packet information revealed that the State Agency contact information was not made available to the patients.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 15195 Based on electronic record review and interview, the facility failed to ensure a comprehensive reassessment and revision to the plan of care (POC) was completed monthly for 2 (#8, #10) of 2 unstable home peritoneal dialysis patients, resulting in the potential for unmet patient needs and less than optimal patient outcomes. Findings include: On 11/28/23 at approximately 1000 - 1100, electronic record review with Staff A revealed the following: Patient #8 was a 72-year-old female admitted for peritoneal dialysis on 1/19/23 and had developed peritonitis on 10/2/23. It was noted that the patient had previous peritonitis on 6/7/23 and 7/20/23, and was made unstable for recurrent peritonitis by the interdisciplinary team (IDT) plan of care (POC) on 8/18/23. No additional monthly comprehensive ITD POC had been documented since 8/18/23. This was verified by Staff A. Interview with Patient #8, on 11/28/23 at approximately 1500, revealed that nursing staff reviewed the dialysis procedure with her, she washes her hands, but does not use gloves during the procedure. Patient #10 was a 57-year-old female admitted for peritoneal dialysis on 2/22/23 and was made unstable by the IDT POC on 8/17/23 for severe anemia, need for blood transfusions, and non-compliance. There was no monthly IDT assessment POC for this patient after 8/17/23. This was verified with Staff A. On 11/28/23 at approximately 1530, interview with Staff F revealed that she coordinated the IDT POCs but that some had been missed. Review of the facility policy titled “Comprehensive Interdisciplinary Patient Assessment (CIPA), #2-032, effective 6/2020” documented, “A CIPA needs to be completed... At least monthly for unstable patients.” This had not been done.”

“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: 36887 Based on record review and interview, the facility failed to include key outcome data for all patient services separated into modalities for the provided 5 of 5 months (June 2023-October 2023) reviewed resulting in the potential for unidentified concerns and the potential for poor patient outcomes. Findings include: On 11/29/2023 at 1003, review of quality assessment performance improvement (QAPI) data June 2023-October 2023 revealed the data did not appear to have any information present for the one home hemodialysis (HHD) patient in the facility. Additionally, it did not include any data metrics or discussion for “transient” patients that were cared for by the facility for less than one month. During an interview with Administrator Staff A on 11/29/2023 at 1337, Staff A was queried as to if there was separate information from what had been provided for home hemodialysis (HHD) or for the transient patients. Staff A stated since there was only one HHD patient, the information was “rolled in” with the PD information. Staff A also stated there was “not enough data to collect” for the transient patients; however, the Interdisciplinary Team (IDT), who was also the Quality Committee, did discuss these patients weekly.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 36887 Based on record review and interview, the facility failed to analyze and re-evaluate the effectiveness of an action plan for late comprehensive assessments in 5 of 5 (June 2023-October 2023) months reviewed, resulting in the potential for unrecognized, unsafe patient outcomes. Findings include: Review of quality assessment performance improvement (QAPI) documents on 11/29/2023 at 1003, revealed the facility identified in June 2023, under the section titled “Comprehensive Patient Assessment”, that 2 plans of care were completed late. The action plan was to “Continue with monthly CIPA (comprehensive interdisciplinary patient assessment) tracker, and email reminders to IDT (interdisciplinary team) members to complete CIPAs timely. Follow up with physician office staff to remind MDs (physicians) when CIPAs are due.” Continued review of the QAPI documents revealed for July 2023, 1 care plan was late due to no nursing assessment. The action plan was to: “Continue monthly with CIPA tracker, and email reminders to IDT members to complete CIPAs timely. Follow up with physician office staff to remind MDs when CIPAs are due.” Continued review of QAPI documents revealed for August 2023, 2 care plans were late due to incomplete assessments by the physician and nurse. The action plan was to continue to email and text reminders to staff. Continued review of QAPI documents revealed for September 2023, 6 CIPAs had “incomplete or missing data.” The action plan stated, “RD (dietician) to continue with CIPA Tracking Tool monthly to track CIPA. Reminders via email and text to the IDT members to ensure timely completion of CIPAs.” Review of QAPI documents for October 2023 revealed 6 CIPAs that had “incomplete or missing data.” Again, the action plan stated, “RD (dietician) to continue with CIPA Tracking Tool monthly to track CIPA. Reminders via email and text to the IDT members to ensure timely completion of CIPAs.” Administrator Staff A was queried on 11/29/2023 at 1205 as to if the Quality Committee had identified any other plans of action to assist in timely comprehensive assessments to which he stated, “No.””

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 36887 Based on record review and interview, the facility failed to identify and address in the quality assessment performance improvement (QAPI) program, for 5 of 5 months (June 2023-October 2023) reviewed, why 8 (#7, 8, 9, 10, 12, 13, 14, 15) of 80 patients developed peritonitis, resulting in the potential for infections and/or peritonitis for the remaining 71 patients. Findings include: On 11/29/2023 at 1003, review of QAPI documents from June 2023-October 2023 revealed the only data present for infection control were the number of peritonitis infections, the antibiotic used to treat the infection, and the 12-month rolling infection rate each month. No documentation was present in the monthly summary for infections as to the cause of the infections. The action plan was to “Continue to retrain staff and nurses to achieve outcomes” and “Review protocol and perscribe [sic] Vanco to patients to prevent future infections.” Nothing was present about the use of gloves or for re-education of the patients. On 11/29/2023 at 1145, review of the Infection Tracking Log revealed from 6/2/2023-10/22/2023 there were 14 incidents of peritonitis in the facility. Patients #8, 10, 12, 13, and 14 were found to have more than one incident each. The log revealed the following information: P-7 had peritonitis 10/22/2023 and was hospitalized. The responsible organism was not identified. P-8 had peritonitis 6/7/2023, 7/20/2023, and 10/2/2023. The responsible organism was listed as Staphylococcus epidermidis (bacteria considered normal microbiota of the human skin) for the June and October infections. Enterococcus faecalis (bacteria found in the digestive tract) was listed as the cause for the July infection. P-9 had peritonitis 10/8/2023. The responsible organism was listed as Staphylococcus epidermidis. P-10 had peritonitis 6/2/2023 and 10/10/2023. The responsible organism was Staphylococcus epidermidis for both infections. P-12 had peritonitis 6/22/2020 and 7/11/2023. The responsible organism was listed as Gram-variable bacillus (older culture which may have lost the peptidoglycan cell wall and therefore gram stain is not useful) for the June infection and Stenotrophomonas maltophilia (a bacteria that comes from aqueous environments, soil, and plants) for the July infection. P-13 had peritonitis 7/17/2023 and 8/2/2023. The responsible organism was listed as Staphylococcus epidermidis for both infections. P-14 had peritonitis 7/11/2023 and 8/3/2023. The responsible organism was listed as Staphylococcus epidermidis for both infections. P-15 had peritonitis 7/11/2023. The responsible organism was listed as Staphylococcus epidermidis. During an interview with Administrator Staff A on 11/29/2023 at 1208, Staff A stated they do not educate patients to use gloves when initiating or discontinuing their PD treatment as it gives a false sense of security to the patient that they are protected. Staff A stated the patients are taught to wash their hands with anti-bacterial soap and to use hand sanitizer prior to initiation and discontinuation of dialysis. Staff A further stated the facility used the International Society for Peritoneal Dialysis (ISPD) and the Center for Disease Control (CDC) to form a basis for their policies and practices.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 36887 Based on record review and interview, the facility failed to monitor and track patient satisfaction for 5 of 5 months (June 2023-October 2023) reviewed, resulting in the inability to identify and address issues related to patient dissatisfaction and improve patient care. Findings include: On 11/29/2023 at 1003, during review of the quality assessment performance improvement (QAPI) data from June 2023-October 2023, it was noticed there was no documentation or discussion present regarding patient satisfaction. On 11/29/2023 at 1337, Administrator Staff A was queried as to if they gathered any patient satisfaction information. He stated that had been identified as an issue during their recent accreditation organization (AO) survey three weeks ago. He stated he had “reached out” to a company that specializes in obtaining patient satisfaction data. Staff A was asked to produce documentation that he was in the process of coming to an agreement with that satisfaction data company or documentation of any other means of collecting patient satisfaction. Staff A did not provide the documentation prior to the end of survey.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 36887 Based on record review and interview, the facility failed to prioritize their performance improvement activities for 5 of 5 months (June 2023-October 2023) reviewed, resulting in the potential for ineffective performance improvements and unsatisfactory patient outcomes. Findings include: On 11/29/2023 at 1003, review of the quality assessment performance improvement (QAPI) documentation from June 2023-October 2023 revealed there were no priorities assigned to any area reviewed. On 11/29/2023 at 1337, Administrator Staff A was queried as to what his priorities were in the quality program. He stated their “big indicators” for priority were to prevent hospitalizations and peritonitis. Staff A confirmed that currently each area reviewed in QAPI was not assigned a priority level.”

“LAB-CLIA LABS/MEET NEEDS OF PTS CFR(s): 494.130 The dialysis facility must provide or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter. This Standard is not met as evidenced by: 36887 Based on record review and interview, the facility failed to have a laboratory contract that provided details on the testing, collection, handling, resulting, and reporting specimens resulting in the potential for missed or inaccurate data and poor patient outcomes for all patients served by the facility. Findings include: On 11/29/2023 at 1422, Administrator Staff A was asked to provide any contracts the facility had with laboratory services. Staff A stated he would have to get those sent to him. Review of the laboratory contract and unattached addendums provided on 11/29/2023 at 1645, revealed a lack of specific information on how to collect and handle specimens, how test results would be calculated and/or obtained, how results would be provided, and how critical labs would be reported. The addendums did not include any laboratory policies and procedures or laboratory reference manuals that were mentioned in the body of the contract that the dialysis facility was to follow or reference.”

“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: 28042 Based on interview and record review, the medical director failed to ensure compliance with the End Stage Renal Disease (ESRD) provider policies and procedures for Registered Nurse (RN) Assessment and Admission for 4 (#1, #3, #5, #11) of 4 patient medical records reviewed for initial assessment, resulting in the potential for adverse patient outcomes. Findings include: Review of P-5’s medical record on 11/29/2023 at 1000, revealed she was a 76-year-old female admitted to the skilled nursing facility (SNF) on 11/17/2023 with diagnoses to include breakdown of vascular dialysis catheter, end stage renal disease, and type two diabetes. There was no assessment by a registered nurse employed by the End Stage Renal Disease (ESRD) provider. The surveyor requested an assessment by a registered nurse from the manager of the provider during the survey. No assessment was provided. During an interview on 11/28/2023 at 1215 in her patient room of the SNF, P-5 stated she had met with the nurse from the dialysis company. However, the nurse did not assess her, take her vital signs or look at her at all. P-5 said the nurse was very nice and talked about how their company did peritoneal dialysis and how the process worked. Review of ESRD Provider policy titled, “RN Assessment and Admission, revision date of 10/2023” on 11/29/2023 at 1200 revealed, “On the first day of admission a registered nurse will meet with patient, get all provider consents signed, and do a head-to-toe assessment.” 48030 Review of P-1’s medical record on 11/29/2023 at 1000, revealed she was a 38 year-old female admitted initially to the skilled nursing facility on 3/9/2023 with diagnoses to include end stage renal disease, hypertension, and DVT (deep vein thrombosis). There was no assessment by a registered nurse employed by the End Stage Renal Disease (ESRD) provider. Review of P-1’s nursing assessment dated 7/29/2022 revealed the registered nurse did not include a physical assessment. A box that said “Skip physical exam info” had a checkmark in it. Review of P-3’s medical record on 11/29/2023 at 1350, revealed he was a 70 year-old male admitted to the skilled nursing facility on 9/11/2023 with diagnoses to include end stage renal disease, anemia, and hypertension . There was no assessment by a registered nurse employed by the End Stage Renal Disease (ESRD) provider. Review of P-3’s nursing assessment dated 9/12/2023 revealed the registered nurse did not include a physical assessment. A box that said “Skip physical exam info” had a checkmark in it. Review of ESRD Provider policy titled, “RN Assessment and Admission, revision date of 10/2023” on 11/29/2023 at 1200 revealed, “On the first day of admission a registered nurse will meet with patient, get all provider consents signed, and do a head-to-toe assessment.” 15195 Additionally, on 11/29/23 at approximately 1630, record review revealed that P-11 was a 49-year-old female with end stage renal disease admitted on 4/14/23 and seen by the registered nurse. Review of the Admission Nursing Assessment revealed that it was incomplete and lacked a head-to-toe physical assessment. On 11/29/23 at approximately 1635, interview with the Administrator Staff A revealed that the patient came from Indiana and was seen by two nurses upon admission. Neither of the nurses completed the documentation of the initial nursing assessment prior to the patient going to the hospital on 4/17/23. On 11/28/23 at approximately 1000, interview with the medical director revealed that he reviewed and approved policies and procedures at the governing body meetings. He verified that staff were to follow policies and procedures.”