Rrc - West Flint

“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: 47976 Based on interview and record review, the facility failed to maintain updated patient census and patient emergency contacts in the emergency preparedness program, resulting in the potential for inadequate facility response during an emergency event, endangering the health and safety of all patients. Findings include: During dialysis floor observation on 11/15/23 at 0930, the contents of the emergency cart were inspected. Upon reviewing the list of active patients in the emergency binder, it was noted that it was last updated on 6/1/23. At 0945, a patient care technician (Staff L) was asked to identify a patient on the schedule who was recently admitted. Staff L identified a patient and it was determined the patient’s information was not included in the emergency binder. *Policy title, “Guidelines for Emergency Preparedness” (published 7/3/23) stated on page 1 stated, “Quarterly, the CM (Clinical Manager) will review and update:......The Emergency and Disaster Patient Contact Information Sheet.” During an interview on 11/15/23 at 1230, the Director of Operations (Staff B) reported the list in the binder is supposed to be updated quarterly or with new admissions. Findings were further reviewed with and acknowledged by Staff B, the Facility Administrator, and the Clinical Manager during the exit interview on 11/17/23 at 1200.”

“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: 47976 Based on observation, record review and interview, the facility failed to provide and monitor a sanitary environment for the patients, resulting in the potential for transmission of infectious agents to all 80 patients receiving in-center hemodialysis at this facility. Findings include: During dialysis floor observation on 11/15/23 between 0930 and 1430, the following observations were made: 1. On 11/15/23 at 1140, 3 used test strips, a gauze wrapper and a plastic cap were laying on the ground near stations #21 and #22. These items were still present upon observation >45 minutes later. 2. On 11/15/23 at 1230, 3 gloves and a gauze wrapper were laying on the ground around the trash can near stations #8-11. These items were still present upon observation >45 minutes later. 3. On 11/15/23 at 1330, 3 used test strips, a used alcohol swab and a gauze wrapper were laying on the floor near station #8. There was also 2 gloves on the floor and 2 inside out gloves on top of the cart near Pod #1 where medications are prepared (clean area). These items were still present upon observation >1 hour later. The registered nurse (Staff O) was interviewed on 11/16/23 at 1430 regarding the expectation of keeping the floor clear of trash. Staff O reported that it is unacceptable to have any trash or clutter on the treatment floor and that it should be picked up immediately. **Policy titled, “Cleaning the Dialysis Treatment Area and Isolation Area Procedure” (published 11/1/21) stated on page 1, “Pick up loose trash” under the General Cleaning section. Policy titled, “General Cleanliness and Infection Control Guidelines” (published 2/7/22) stated on page 1, “All areas must be kept clean and organized, including but not limited to the treatment areas.....”. Findings were further reviewed with and acknowledged by the Director of Operations, the Facility Administrator, and the Clinical Manager during the exit interview on 11/17/23 at 1200.”

“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: 47976 Based on observation and record review, the facility failed to properly dispose of infectious waste at 4 of 24 stations (#6, 14, 15, 22), resulting in the risk for exposure to bloodborne pathogens from over full sharps containers for all patients and staff. Findings include: During dialysis floor observation on 11/16/23 at 1020, it was noted the Sharps containers at Stations # 6, 14, 15 and 22 were filled beyond the fill line that indicates when the containers are full and need to be discarded. **Policy titled, “General Cleanliness and Infection Control Guidelines (pulblished 2/7/22) stated on page 3, “All containers for storage or disposal of needles/sharps shall be replaced on a regular basis or when no more than 2/3 to 3/4 full. The containers must be closed prior to being full and prior to being disposed.” Findings were reviewed with and acknowledged by the Director of Operations, Facility Administrator, and Clinical Manager during an interview on 11/17/23 at 1200.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 38304 Based on observation and interview, the facility failed to maintain the building in a safe manner, resulting in the potential for the transmission of infectious agents to the 22 patients receiving treatment in the home program at the time of observation. Findings include: On 11/15/2023 at 1020, it was observed during the inspection of the home program’s training rooms that 2 (#1 and #2) of 3 patient training rooms contained dust and construction debris underneath the cabinetry countertop with sink/faucet. The Clinical Manager (Staff D) and Home Therapy Manager (Staff H) were interviewed on 11/15/23 at 1050 and 1120 respectively concerning the finding. Both acknowledged the findings and stated it would be cleaned up that day. Request was also made as to the timeframe when the construction project was completed but no date(s) concerning the construction have been submitted to date (11/22/23). Both Staff D and H were noted to agree that materials from any construction remodeling should be cleaned upon completion. The facility failed to adhere to its policy referenced below. Facility Policy: “General Cleanliness and Infection Control Guidelines” Pub. 2/7/2022, Version 6 stated, “All areas must be kept clean and organized, including but not limited to the treatment area, water/supply room and offices. Facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff. Such cleaning should be done regularly using a schedule developed by the facility.” 39083 On 11/15/23 at 10:49 AM, a working spray bottle, located at the clean sink across from station 18, was observed to not be labeled to identify the contents. At this time, a staff member stated that the spray bottle contained vinegar and proceeded to label the bottle. A record review of the facility’s policy titled “General Cleanliness and Infection Control Guidelines,” published 02/07/2022, it notes under heading, “Detergents Germicides and Cleaning Supplies,” that, “Approved cleaning solutions shall be prepared daily or more frequently as per policy or manufacturer’s instructions for use. Solutions will be stored and labeled per policy.” On 11/15/23 at 10:50 AM, the bottom edge of the wall box chase system, at station 24, was observed to have sagging trim, exposing the particle board that appears to have water damage. At this time, Area Technical Operations Manager Staff “G” stated that they recently have repaired some wall chase systems in the facility. On 11/15/23 at 10:52 AM, the bottom edge of the chase system, at station 16, was observed to have exposed particle board that appeared to have water damage. On 11/15/23 at 1:36 PM, the bottom edges of the wall chase systems at stations 15, 18, and 20, were observed to have similar water damage, with exposed particle board, making the wall chase systems not easily cleanable.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 47976 Based on record review, observation, and interview, the facility failed to ensure patient access sites were in view of staff during dialysis treatment, resulting in the potential for needle dislodgement or line disconnection to go undetected and for significant bleeding to occur. Findings include: **Policy titled, “Patient Assessment and Monitoring” (published 5/1/23) stated on page 5, “Ensure access remains uncovered throughout the treatment.” During observation of of the dialysis floor on 11/15/23 and 11/16/23, the following observations were noted: 1. On 11/15/23 at 0925, it was noted the access site for the patient at station #19 could not be seen. At 0933, the patient care technician (Staff R) checked on the patient, however, she did not ask the patient to uncover her access site. At 0940, Staff R was asked if she could see the access site for the patient at station #19. She reported that she could not see it and that, “We have to constantly remind them.” Staff R returned to station #19 to uncover the patient’s access. 2. On 11/15/23 at 1350, it was noted the access sites for the patients at stations #4, 15, 17 and 22 were completely covered. Multiple staff were observed in and out of these stations during this time interacting with the patients, but access sites were not uncovered. At 1430, registered nurse (Staff Q) was asked if he could see their access sites. He stated, “Oh, no, you can’t.” He was observed returning to each station to ensure the access sites were visible. 3. On 11/16/23 at 0925, it was noted the patient at station #9 was fully covered with a red fleece blanket and the access site could not be seen. The patient care technician (Staff P) was observed assisting this patient at 0930, but the access site remained covered. Staff P was alerted at 0940 that the patient’s access site was not visible and immediately corrected the problem. The Medical Director (Staff A) was interviewed on 11/17/23 at 1030 regarding his expecations for how long is acceptable for an access site to be covered. Staff A reported no time was acceptatble and, at minimum, staff should be ensuring the sites are visible everytime they interact with the patient. Findings were reviewed with and acknowledged by the Director of Operations, the Facility Administrator, and the Clinical Manager during an interview on 11/17/23 at 1200.”

“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: 38304 Based on record review and interview, the facility failed to have Against Medical Advice (AMA) documentation per their policy concerning early termination of dialysis treatment for 3 (P-3 , P-5, and P-10) of 8 in-center records reviewed, out of a total sample of 10 records, resulting in the potential for the patient to not understand their right to refuse or the possible consequences of early termination. Findings include: P-10: This 51-year-old patient was admitted to the dialysis facility on 8/9/2021, with diagnosis which included end stage renal disease and diabetes-type 2. P-10 was receiving treatments 3 times per week (Mon-Wed-Fri) for a duration of 4 hours each treatment. On 11/16/23, record review of P-10’s six most recent dialysis treatment sheets found 2 of 6 treatments were terminated early by 16 minutes on 11/1/23 and 28 minutes early on 11/6/23. Additional review found no documentation (2 of 2) which explained why P-10’s treatments were not furnished as ordered and no physician notification was evidenced. The Clinical Manager (Staff D) was queried on 11/16/23 at 1040 as to the timeframe an AMA form would be generated when a patient’s treatment was cut short. Staff D replied, “Any time, even a minute.” A request was then made to Staff D at 1042 to review the AMA forms concerning the two shortened treatments noted above. Later that day at 1415, Staff D confirmed no documentation was found regarding the requested AMA forms. The facility failed to adhere to its policy referenced below. Facility Policy: “Early Termination or Arriving Late for Treatment” (Pub. 11/7/22), Version 3 stated, “If a patient requests to leave treatment early: The RN (registered nurse) is responsible to notify the physician, and document on the “AMA”, or Against Medical Advice form. Against Medical Advice forms are... signed with each early termination event and filed in the patient’s medical record.” 47976 P-3: This 63-year-old patient was admitted to dialysis on 6/23/22 with the diagnosis of end stage renal disease and was receiving dialysis treatment at this facility 3 times per week. During record review on 11/16/23, the last 6 treatment sheets were reviewed. It was noted the treatment on 11/3/23 was shortened by 56 minutes and the treatment on 11/7/23 was shortened by 27 minutes. Upon further review of the record, it was noted there was no documentation stating why the treatment had been shortened on those days. There was also no “AMA” (Against Medical Advice) form filled out according to the facility policy. The Clincal Manager (Staff D) was interviewed on 11/17/23 at 0930 regarding documenation of why those treatments were shortened. Staff D stated she thought one of the treatments was shorted due to the patient cramping, but agreed that there should have been documentation of this and an AMA form filled out. Findings were further reviewed with and acknowleged by the Director of Opeations, the Facility Administrator, and Clinical Manager during the exit interiew on 11/17/23 at 1200. 46476 P-5: This 40-year-old patient was admitted to the facility on 11/1/17 with diagnoses which included end stage kidney disease and heart disease. The medical record was reviewed on 11/16/23 and included the last 6 dialysis treatment record sheets between the dates of 11/2/23 and 11/13/23. Active orders for incenter hemodialysis at the time of review included a dialysis treatment run time of 4 hours and 30 minutes, three times per week. During review, it was noted that the dialysis treatment dated 11/4/23 was ran for a total of 2 hours and 48 minutes (102 minutes less than prescribed). There was no documented evidence on the treatment record sheet that the physician had been notified of the shortened treatment. There was no Against Medical Advice (AMA) form signed by P-5 on the date 11/4/23 in the medical record. During interview on 11/17/23 at 1313, the Clinical Manager (Staff D) confirmed that no signed AMA documentation for P-5 on the above date could be found and that all patients with early termination of dialysis should sign an AMA prior to leaving the facility.”

“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: 47976 Based on record review and interview, the facility failed to ensure each patient new to dialysis had a comprehensive assessment completed within 30 days or 13 treatments of admission in 1 (P-3) of 10 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-3: This 63-year-old patient was admitted to dialysis on 6/23/22 with the diagnosis of end stage renal disease and was receiving treatments at this facility 3 times per week. During record review on 11/16/23, it was noted the initial comprehensive assessment/plan of care was completed on 12/8/22 - 169 days after the patient’s first dialysis treatment at this facility. The Clinical Manager (Staff D) was queried on 11/17/23 at 0930 on the reason for the delay. Staff D reported the patient had been hospitalized during part of that time, but was only able to confirm a hospitalization from 7/2/22 to 8/31/22. She acknowledged that the initial comprehensive assessment should have been completed much sooner and that it was an oversight on their part. Findings were further reviewed with and acknowledged by the Director of Operations, the Facility Administrator, and the Clinical Manager during the exit interview on 11/17/23 at 1200.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to ensure a follow up comprehensive reassessment occurred within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care in 1 (P-3) of 10 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-3: This 63-year-old patient was admitted to dialysis on 6/23/22 with the diagnosis of end stage renal disease and was receiving treatments at this facility 3 times per week. During record review on 11/16/23, it was noted the first comprehensive assessment/plan of care was completed on 12/8/22 - 169 days after the patient’s first dialysis treatment at this facility. There was a subsequent assessment done on 3/23/23 (approximately 90 days from the initial comprehensive assessment done on 12/8/22), however this is way beyond the required 3 month timeline. The Clinical Manager (Staff D) was interviewed on 11/17/23 at 0930 about the reason for the delay. Staff D reported the patient had been hospitalized during part of that time, causing a delay in the 30 day assessment, however, she acknowledged both assessments should have been completed much sooner and that it was an oversight on their part. Findings were further reviewed with and acknowledged by the Director of Operations, the Facility Administrator, and the Clinical Manager during the exit interview on 11/17/23 at 1200.”

“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: 38304 Based on record review and interview, the facility failed to ensure patient blood pressure (BP) monitoring and assessment was performed per facility policy in 2 (P-10 and P-5) of 8 in-center records reviewed, and failed to notify the registered nurse (RN) of elevated BP readings per facility policy in 1 (P-10) of 8 in-center records reviewed, out of a total sample of 10 records, resulting in the potential for poor patient outcomes for all 85 in-center hemodialysis patients currently receiving treatment at the facility. Findings include: P-10: This 51-year-old patient was admitted to the dialysis facility on 8/9/2021, with diagnosis which included end stage renal disease and diabetes-type 2. P-10 was receiving treatments 3 times per week (Mon-Wed-Fri) for a duration of 4 hours each treatment. On 11/16/23, record review of P-10’s six most recent dialysis treatment sheets found 4 of 6 treatments failed to document P-10’s BP at least every 30 minutes and failed to notify the registered nurse (RN) of multiple runs with BP readings greater than 180 mm/Hg. (11/3/23) as stipulated by facility policy referenced below. The four treatment sheets are as follow: 1) On 11/15/2023, no BP documentation was found between 0549 through 0806 (2 hours and 17 minutes). 2) On 11/6/2023, no BP documentation was found between 0638 through 0721 (43 minutes) and 0835 through 0932 (57 minutes). 3) On 11/3/2023, no BP documentation was found between 0613 through 0702 (49 minutes) and 0804 through 0855 (51 minutes). BP readings greater than 180 mm/Hg. with no RN notification documentation found, all by Staff L (patient care technician), were noted during the following times: 0855-181/92; 0904-184/93; 0937-189/92; 0946-184/97; and 0952 (post-treatment)-189/95. 4) On 11/1/2023, no BP documentation was found between 0735 through 0833 (58 minutes). Additional record review found no documentation which explained why P-10’s BP’s (noted above) were no monitored according to facility policy. The Clinical Manager (Staff D) was queried on 11/16/23 at 1500, if the facility was expected to follow and document patient BP monitoring. Staff D replied, “Yes, they should.” Facility Policy: “Patient Assessment and Monitoring” Pub. 5/1/2023, Version 4 stated, “During Treatment: Obtain blood pressures and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations... Report to the nurse: Systolic blood pressures greater than 180 mm/Hg, Diastolic blood pressure greater than 100 mm/Hg.” 46476 P-5: This 40-year-old patient was admitted to the facility on 11/1/17 with diagnoses which included end stage kidney disease and heart disease. The medical record was reviewed on 11/16/23 and included the last 6 dialysis treatment record sheets between the dates of 11/2/23 and 11/13/23. Active orders included an order for Clonidine HCl., 1 milligram to be given as needed for hypertension. During review of the treatment record sheet dated 11/2/23, the following blood pressure (BP) readings were documented by a patient care technician (PCT): At 0732, BP was 159/106 millimeters of mercury (mm/Hg) At 0935, BP was 148/118 mm/Hg At 0939 (post treatment), BP was 181/105 mm/Hg There was no documentation on the above treatment record sheet dated 11/2/23 that the PCT notified the registered nurse (RN) of the elevated BP readings. There was no documentation by the RN indicating awareness of the elevated BP readings during treatment. No medication intervention for the elevated BP was noted during treatment. During interview with the Clinical Manager (Staff D) on 11/17/23 at 1015, Staff D was queried to what was meant by “hypertension” regarding the order for Clonidine HCl. and Staff D stated that it is the protocol of the facility that unless otherwise indicated in the medical record, hypertension is a systolic BP (top number) of over 180 mm/Hg or a diastolic BP (bottom number) of over 100 mm/Hg. Staff D stated that the PCT should have notified the RN of the findings and the RN should have documented awareness of the BP findings and document why medication intervention was not given as ordered.”

“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: 47976 Based on record review and interview, the facility failed to deliver the prescribed blood flow rate (BFR) and dialysate flow rate (DFR) for 1 (P-3) of 8 records reviewed of patients receiving in-center hemodialysis, resulting in the potential to impact the adequacy of dialysis for all 80 patients receiving treatment at this facility. Findings include: P-3: This 63-year-old patient was admitted to dialysis on 6/23/22 with the diagnosis of end stage renal disease and was receiving treatment at this facility 3 times per week. During record review on 11/16/23, it was determined the BFR was ordered at 400 milliliters per minute (mL/min) and the DFR was ordered at 600 mL/min (order dated 11/4/23). During review of the last 6 treatment sheets, it was determined the BFR and DFR were run incorrectly as follows: BFR 300 mL/min, DFR 500 mL/min on 11/4/23 at 1303 BFR 275 mL/min, DFR 500 mL/min on 11/4/23 at 1402, 1443 and 1534 DFR at 800 mL/min on 11/7/23 at 1229, 1304, 1330 BFR 300 mL/min, DFR 500 mL/min on 11/11/23 at 1403 BFR 250 mL/min, DFR 500 mL/min on 11/11/23 at 1430, 1501 and 1532 - The Clinical Manager (Staff D) was interviewed on 11/7/23 at 0930 regarding documentation of the reason for the change in flow rates or communication with the physician. Staff D reported the change was likely due to issues with the patient’s access/catheter, but she acknowledged there was no documentation for new orders or any communication with the physician to approve this change. Staff D acknowledged there should be new orders written if the flow rates are different than what is prescribed. Findings were further reviewed with and acknowledged by the Director of Operations, the Facility Administrator, and the Clinical Manager during the exit interview on 11/17/23 at 1200.”

“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: 38304 Based on interview and record review, the facility failed to accurately monitor, track, and trend the facility’s performance resulting in the potential to negatively impact all 102 incenter patients receiving treatment at this facility. Findings include: During an interview on 11/17/23 at 1010, the facility’s QAPI (quality assurance performance improvement) program was reviewed with the Clinical Manager (Staff D), who is tasked with the oversight of clinical applications generated from QAPI data collected. Review was completed of multiple facility concerns, including but not limited to hospitalizations, infections, water and dialysate quality, complaints and grievances, dialysis treatment adherence to facility policy and procedures, as well as discussion of performance improvement projects (PIP’s). During QAPI review, the statistical details of a sampled Performance Improvement Plan (PIP) was chosen to ascertain the overall insight and application of the data collected. The data which was based off the “Clinical Audit Checklist” which comprised of dialysis treatment adherence, (e.g., duration of treatment, prescribed blood flow and dialysate rates, vital signs performed every 30 minutes, medications administered as ordered, ...). A total of 10 “Yes” or “No” questions were noted within the audit tool which pertained to the above measures. Staff D stated that only one “No” would generate a “0%” achieved for the selected patient audit. A sample of 5 patient audits were reviewed, with none reaching the desired 10 of 10 “Yes” responses. Staff D was then asked the following concerning the PIP: Benchmark goal(s), and current percent achieved towards goal(s). Staff D brought up the cumulative data for the PIP which showed no benchmark goal(s) to be achieved, and the current audit percentage being 72%. When queried at 1045 for an explanation of how 72% would be generated when the sampled audit data (5 of 5 at 0%) strongly suggested a much lower “achieved” percentage vs. the 72% shown, Staff D offered no explanation. When asked for the decision rationale concerning the makeup of the clinical audit, Staff D stated that it came from corporate with no further explanation received. No additional information was submitted as to why the sampled PIP contained data which no one in the facility or corporate could satisfactorily answer by the time of exit on 11/17/23 at 12:10 PM. The facility failed to adhere to its policy referenced below concerning the insight and management of QAPI data collected to improve patient care. Facility Policy: “Quality Assessment & Performance Improvement Program” Pub. 5/2/022, Version 5, stated, “The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. A developed appropriate action plan will include monitoring progress and effectiveness of the action plan... Reassessment of plan if portions are unsuccessful.””

“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 observation, record review, and interview, the agency failed to follow policy to ensure patient vitals outside of reportable parameters were reported to the nurse by the patient care technician in 2 (P-1, 3) of 8 records reviewed of patients receiving in-center hemodialysis; and failed to follow policy to ensure expired medications were discarded at the appropriate time, resulting in the potential for poor patient outcomes. Findings include: **Policy titled “Patient Assessment and Monitoring” (published 5/1/23) stated on page 4 under the “During Treatment” section, “Report to the nurse patients whose heart rates have dropped below 60, risen above 100 or become irregular.” P-1: This 76-year-old patient was admitted to dialysis on 8/1/23 with the diagnosis of Stage IV Chronic Kidney Disease and was receiving dialysis treatment at this facility 3 times per week. During record review on 11/15/23, it was noted the patient’s heart rate was recorded by the patient care technician (PCT) at values outside of reportable parameters according to facility policy as follows: 11/7/23 = 52 at 0931, 57 at 1030, 56 at 1104 and 52 at 1234 11/9/23 = 59 at 1104, 57 at 1202, 49 at 1300 11/11/23 = 53 at 1257 11/14/23 = 55 at 0941, 57 at 1004, 56 at 1141 There was no documentation of these values being reported to the registered nurse. P-3: This 63-year-old patient was admitted to dialysis on 6/23/22 with the diagnosis of end stage renal disease and was receiving dialysis treatments at this facility 3 times per week. During record review on 11/16/23, it was noted the patient heart rate was recorded by the PCT at values outside of reportable parameters according to facility policy as follows: 11/2/23 = 54 at 1238, 54 at 1309, 55 at 1439, 58 at 1533 11/3/23 = 59 at 0815, 56 at 0830, 56 at 0900, 31 at 0935 There was no documentation of these values being reported to the registered nurse. P-4: This 66 year-old patient was admitted to dialysis on 11/15/19 with the diagnosis of end stage renal disease and was receiving dialysis treatment at this facility 3 times per week. During record review on 11/16/23, it was noted the patient heart rate was recorded by the PCT at values outside of reportable parameters according to facility policy as follows: 11/10/23 = 59 at 0533, 59 at 0601, 57 at 0535, 57 at 0702, 59 at 0733 11/13/23 = 58 at 0535, 56 at 0608, 58 at 0634, 57 at 0714, 57 at 0732, 55 at 0802, 57 at 0842, 57 at 0903, 59 at 0935 11/15/23 = 59 at 0641, 58 at 0902 11/17/23 = 59 at 0802, 58 at 0902, 58 at 0934 There was no documentation of these values being reported to the registered nurse. The Clinical Manager (Staff D) was interviewed on 11/17/23 at 09:30 regarding her expectations of patient care technicians reporting values to the nurse on duty. Staff D states she expects the PCT to report any and all values that fall outside the ranges outlined in the policy and that a nurse should be documenting that they are aware of the values. Staff D also reported these values can be found hanging from the dialysis machines to serve as a reminder to the PCT. These finding were reviewed with and acknowledged by the Director of Operations, the Facility Administrator, and Staff D during the exit interview on 11/17/23 at 1200. _________ **Policy titled “Medication Preparation and Administration” (published 2/6/23) stated on page 3, “Expiration dates for all stored medications are to be monitored on a monthly basis” and “ Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law.” During dialysis floor observation on 11/15/23 at 0930, the contents of the emergency cart were inspected. Upon opening the drawers to asses the contents, it was determined the following medications were expired: 1) Sodium Bicarbonate 50 mEq/50 mL (single dose bottle); expiration date 6/1/23 2) Naloxone Hydrochloride 0.4 mg/mL (1 box containing 10 vials); expiration date 5/2023 3) Atropine Sulfate 1 mg/10 mL injectable medication (10 pack); expiration date 9/2023 The registered nurse (Staff O) was made aware upon discovery and she promptly removed the expired items from the cart. The Facility Administrator (Staff C) and Clinical Manager (Staff D) were interviewed on 11/17/23 at 1025 regarding how to ensure medication expiration dates are monitored. Staff C and Staff D reported they facility uses a Total Maintenance System (TMS) with monthly tasks set as reminders to check dates on all supplies. The computer task system had the correct expiration dates logged, but nobody had removed them from the treatment floor. Findings were further reviewed with and acknowledged by the Director of Operations (Staff B), Staff C, and Staff D during the exit interview on 11/17/23 at 1200.”