Davita Yuma Dialysis

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. 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 at 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. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 45999 Based on review of policy and procedure, observation, and staff interview, it was determined that the facility failed to ensure staff appropriately cleansed (3) of (3) patients’ (Patients #12, #13, and #14’s) vascular access prior to cannulation with fistula needles. Failure to practice safe aseptic technique when cleansing and disinfecting a patient’s vascular access increases the risk for vascular access and blood stream infection if bacteria are not sufficiently reduced at the cannulation sites prior to needle insertion. Findings include: The policy titled “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” requires: “...Check for patient sensitivity to preferred skin antiseptic/skin disinfectant listed in table below (povidone iodine, hypochlorite ExSept Plus Isopropyl Alcohol 70%). If using Hypochlorite (ExSept Plus) ...if using sterile 2x2 gauze saturate with 3-5ml...Effective Contact Time...60 seconds with effective dry time ...2 minutes....” Observation on December 18, 2023, revealed Employee #18 preparing to cannulate Patient #12’s vascular access with fistula needles. Employee #18 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the arterial site for 46 seconds then allowed site to dry for three minutes and proceed to cannulate the site with a fistula needle. Employee # 18 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the venous site for 46 seconds, then allowed the site to dry for three minutes and then cannulate with a fistula needle. Observation also revealed on December 18, 2023, Employee #17 preparing to cannulate Patient #13’s vascular access with fistula needles. Employee #17 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the arterial site for 30 seconds then allowed site to dry for one minute and proceed to cannulate the site with a fistula needle. Employee #17 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the venous site for 30 seconds, then allowed the site to dry for one minute and then cannulate with a fistula needle. Observation on December 18, 2023, revealed Employee #4 preparing to cannulate Patient #14’s vascular access with fistula needles. Employee #4 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the arterial site for 12 seconds then allowed site to dry for two minute and proceed to cannulate the site with a fistula needle. Employee #4 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the venous site for12 seconds, then allowed the site to dry for one minute and then cannulate with a fistula needle. Employees # 1 and # 2 confirmed on December 19, 2023 that Employees #18, #17, and # 4 did not apply the Hypochlorite ExSept Plus for the required 60 seconds prior to cannulation of Patient #12, # 13 and #14’s vascular access with fistula needles as required by facility policy.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 45999 Based on a review of facility logs, policies and procedures, and staff interview, it was determined the facility failed to require staff to test and document total water hardness at the end of each treatment day, as it has the potential to harm the Reverse Osmosis and water delivered to the patient. Findings include: A review of facility policy and procedure October 2023 “DAILY WATER TREATMENT SYSTEM MONITORING” revealed: “...Except for hardness testing, done at the end of the day, all observations and test results listed on the Daily Water Treatment Log and in snappy are entered each facility operation day before the start of dialysis treatments...The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the Daily Water Log. A separate entry of time and initials is provided for the teammate performing end-of-day hardness testing...A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits. Upon satisfactory completion of this review, the licensed nurse initials and signs the log form where indicated....” A review of the facility’s “CWP DAILY WATER LOG” revealed the following missed entries and initials of the person to perform the test: October 6, 7, 10, 11,12,16, 31. November 22, 2023 The facility administrator verified in an interview on December 19, 2023, the above missing entries, and that staff had not completed the logs as per policy and procedures.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 45999 Based on a review of policy and procedures, facility documents, and staff interview, it was determined the facility failed to ensure clinical staff accurately documented the time that chlorine/chloramine testing was performed according to facility policy, which poses a high potential risk of patient safety if the water contained unsafe levels of chloramine and was not detected before patients dialyze. Findings include: A review of facility policy “DAILY WATER SYSTEM TOTAL CHLORINE MONITORING” revealed: “...Total Chlorine testing is done on a daily basis prior to the first patient treatment and every four (4) hours until all activities that require the use of dialysis quality water are completed, the water sample for testing should only be drawn after the water system has been operating after for 15 minutes, then the results will be entered into the Routine Total Chlorine Testing Log which contains entries for the day, date, test number and test time ....” The Routine Total Chlorine Testing Log 2-05-02A” requires staff to document the time that the Total Chlorine Test was performed. A review of the facility document titled, “ROUTINE TOTAL CHLORINE TESTING LOG” revealed that staff documented that the test was performed when the reminder alarm sounded rather than when the chlorine/chloramine test was actually performed. Chloramine/chloramine testing was not accurately documented at the time the tests were performed on the following dates. October 2023 10/2/23 10/3/23 10/4/23 10/5/23 10/6/23 10/7/23 10/10/23 10/11/23 10/12/23 10/13/23 10/14/23 10/16/23 10/17/23 10/18/23 10/19/23 10/20/23 10/21/23 10/23/23 10/24/23 10/25/23 10/26/23 10/27/23 10/28/23 10/30/23 10/31/23 The chlorine/chloramine test was checked at the time of the alarm sounding rather than at the time of the actual check. November 2023 11/1/23 11/2/23 11/3/23 11/4/23 11/6/23 11/8/23 11/9/23 11/10/23 11/11/23 11/13/23 11/15/23 11/16/23 11/17/23 11/19/23 11/20/23 11/21/23 11/22/23 11/24/23 11/25/23 11/27/23 11/28/23 11/29/23 11/30/23 The chlorine/chloramine test was checked at the time of the alarm sounding rather than at the time of the actual check. December 2023 12/1/23 12/2/23 12/5/23 12/6/23 12/7/23 12/8/23 12/9/23 Employee # 10 verified, during an interview conducted on December 19, 2023, that multiple entries showed chlorine/chloramine test performed/documented that the staff was not documenting the actual time that they were performing the test, they were documenting the time that the alarm is set to alarm to tell them the test is due.”

“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: 37489 Based on document review and interview, it was determined that the facility failed to ensure dialysis delivery systems were cleaned and disinfected daily which poses a potential risk of cross contamination and infection to patients receiving dialysis treatment if machines are not disinfected as required. Findings include: The facility policy titled “NIPRO SURDIAL DX DIALYSIS DELIVERY SYSTEM CLEANING AND DISINFECTION POLICY” requires: “...PROCEDURE..50% Citric Acid/Thermal Disinfection...EACH TREATMENT DAY...after patient use, end of day...Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log...Cleaning and disinfection of dialysis delivery systems will be documented on this log...At a minimum the facility specific log must include the following elements...Identification number...Date procedure provided...Type of procedure provided...Post chemical rinse residual test...Verification of negative chemical residual test just prior to next use...Status of equipment...Teammate initials...Signature/initial legend...Completed logs will be filed...and maintained for the entire time the equipment is owned by DaVita....” Review of the “Nipro SDX Dialysis Delivery System Clean and Disinfect Log” revealed the following days machines were not disinfected as required. August 2023 08/01/2023 No documentation of cleaning and disinfection for (21) of (35) dialysis machines. 08/08/2023 No documentation of cleaning and disinfection for (26) of (35) dialysis machines. 08/12/2023 No documentation of cleaning and disinfection for (35) of (35) dialysis machines. 08/14/2023 No documentation of cleaning and disinfection for (18) of (35) dialysis machines. 08/21/2023 No documentation of cleaning and disinfection for (19) of (35) dialysis machines. 08/22/2023 No documentation of cleaning and disinfection for (16) of (35) dialysis machines. 08/23/2023 No documentation of cleaning and disinfection for (22) of (35) dialysis machines. 08/25/2023 No documentation of cleaning and disinfection, verification of negative chemical residual testing, type of procedure provided, status of equipment, or teammate initials for (30) of (35) dialysis machines. September 2023 09/09/2023 No teammate initials for cleaning and disinfection of (9) of (35) dialysis machines. 09/11/2023 No documentation of cleaning and disinfection, verification of negative chemical residual testing, type of procedure provided, status of equipment, or teammate initials for (20) of (35) dialysis machines. 09/13/2023 No documentation of cleaning and disinfection for (20) of (35) dialysis machines. 09/15/2023 No documentation of cleaning and disinfection, verification of negative chemical residual testing, type of procedure provided, status of equipment, or teammate initials for (27) of (35) dialysis machines. 09/18/2023 No documentation of cleaning and disinfection for (17) of (35) dialysis machines. 09/19/2023 No documentation of cleaning and disinfection for (21) of (35) dialysis machines. 09/23/2023 No documentation of cleaning and disinfection for (20) of (35) dialysis machines. 09/25/2023 No documentation of cleaning and disinfection for (27) of (35) dialysis machines. 09/26/2023 No documentation of cleaning and disinfection for (15) of (35) dialysis machines. 09/29/2023 No documentation of cleaning and disinfection, verification of negative chemical residual testing, type of procedure provided, status of equipment, or teammate initials for (29) of (35) dialysis machines 09/30/2023 No documentation of cleaning and disinfection for (23) of (35) dialysis machines. October 2023 10/02/2023 No documentation of cleaning and disinfection for (23) of (35) dialysis machines. 10/04/2023 No documentation of cleaning and disinfection for (14) of (35) dialysis machines. 10/06/2023 No documentation of cleaning and disinfection, verification of negative chemical residual testing, type of procedure provided, status of equipment, or teammate initials for (2) of (35) dialysis machines 10/07/2023 No documentation of cleaning and disinfection for (27) of (35) dialysis machines. 10/09/2023 No documentation of cleaning and disinfection for (7) of (35) dialysis machines. 10/11/2023 No documentation of cleaning and disinfection for (31) of (35) dialysis machines. 10/13/2023 No documentation of cleaning and disinfection, verification of negative chemical residual testing, type of procedure provided, status of equipment, or teammate initials for (19) of (35) dialysis machines 10/14/2023 No documentation of cleaning and disinfection for (21) of (35) dialysis machines. 10/18/2023 No documentation of cleaning and disinfection for (23) of (35) dialysis machines. 10/20/2023 No documentation of cleaning and disinfection, verification of negative chemical residual testing, type of procedure provided, status of equipment, or teammate initials for (26) of (35) dialysis machines. 10/27/2023 No documentation of cleaning and disinfection, verification of negative chemical residual testing, type of procedure provided, status of equipment, or teammate initials for (22) of (35) dialysis machines. 10/30/2023 No documentation of cleaning and disinfection for (18) of (35) dialysis machines. November 2023 11/06/2023 No documentation of cleaning and disinfection for (15) of (35) dialysis machines. 11/07/2023 No documentation of cleaning and disinfection for (10) of (35) dialysis machines. 11/08/2023 No documentation of cleaning and disinfection for (20) of (35) dialysis machines. 11/20/2023 No documentation of cleaning and disinfection for (19) of (35) dialysis machines. 11/28/2023 No teammate initials for cleaning and disinfection of (17) of (35) dialysis machines. 12/01/2023 No teammate initials for testing of residual bleach for (3) of (35) dialysis machines. 12/15/2023 No documentation of cleaning and disinfection, verification of negative chemical residual testing, type of procedure provided, status of equipment, or teammate initials for (9) of (35) dialysis machines. Employee #10 confirmed on 12/19/2023 that staff did not document completion of cleaning and disinfection of dialysis machines as required by facility policy which is based upon the dialysis delivery system manufacturer’s guidelines.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 49430 Based on document review and interview, it was determined that the facility failed to ensure that staff followed the attending physicians prescribed hemodialysis (HD) order for blood flow rate for patients #2, 4, 5, and 7. Failure to follow physician orders poses the potential risk of inadequate dialysis, decreased clearances and hospitalizations. Findings Include: Patient #2 Treatment Sheet 12/6/23: Blood Flow Rate (BFR) ordered 350 ml/min. BFR during entire treatment charted 400 ml/min without any charted reason for deveation from physician order. Patient #4 Treatment Sheet 12/6/23: BFR ordered 450 ml/min. BFR charted 300 ml/min at 15:01 without any charted reason for deveation from physician order. BFR charted 350 ml/min at 15:31 without any charted reason for deveation from physician order. BFR charted 300 ml/min at 16:01 through 18:42 without any charted reason for deveation from physician order. Treatment Sheet 12/11/23: BFR ordered 450 ml/min. BFR charted 200 ml/min at 13:49 through 14:31 without any charted reason for deveation from physician order. BFR charted 400 ml/min at 15:01 through 17:01 without any charted reason for deveation from physician order. Treatment Sheet 12/13/23: BFR ordered 450 ml/min. BFR during entire treatment charted 300 ml/min without any charted reason for deveation from physician order. Treatment Sheet 12/15/23: BFR ordered 450 ml/min. BFR charted 350 ml/min at 15:31 without any charted reason for deveation from physician order. BFR charted 400 ml/min at 16:09 without any charted reason for deveation from physician order. Patient #5 Treatment Sheet 12/4/23: BFR ordered 450 ml/min. BFR charted 350 ml/min at 16:31 without any charted reason for deveation from physician order. Treatment Sheet 12/6/23: BFR ordered 450 ml/min. BFR charted 350 ml/min at 14:43 without any charted reason for deveation from physician order. BFR charted 420 ml/min at 15:01 without any charted reason for deveation from physician order. Treatment Sheet 12/13/23: BFR ordered 450 ml/min. BFR charted 400 during entire treatment without any charted reason for deveation from physician order. Patient #7 Treatment Sheet 11/25/23: BFR ordered 450 ml/min. BFR charted 400 ml/min at 14:31 without any charted reason for deveation from physician order. Treatment Sheet 11/30/23: BFR ordered 450 ml/min. BFR charted 300 ml/min at 14:32 without any charted reason for deveation from physician order. BFR charted 400 ml/min at 16:03 without any charted reason for deveation from physician order. Treatment Sheet 12/5/23: BFR ordered 450 ml/min. BFR charted 400 ml/min at 16:34 without any charted reason for deveation from physician order. Treatment Sheet 12/7/23: BFR ordered 450 ml/min. BFR charted 415 ml/min at 15:31 without any charted reason for deveation from physician order. Treatment Sheet 12/16/23: BFR ordered 450 ml/min. BFR charted 350 ml/min at 14:03 without any charted reason for deveation from physician order. Employee #1 confirmed on 12/19/2023 that staff failed to ensure prescribed blood flow rates were followed.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 49430 Based on review of facility policy and procedure, medical records, and interview it was determined that the facility failed to ensure RNs and PCTs monitored, assessed, and documented abnormal findings for (4) of (4) patients during treatment (Patients #2, 4, 5 and 7). This deficient practice limits the interdisciplinary team (IDT) in addressing blood pressure, heart rate, and fluid management issues in the patient’s plan of care if treatment data is not documented, assessed, and addressed in the patient’s medical record. Findings include: The facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” requires: “...Patient data will be obtained and documented...Data collection includes...Measurement of Blood Pressure...Intradialytic Data Collection/Assessment...Vital signs and treatment monitoring...At a minimum, obtain and document...Blood pressure...Abnormal findings...will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician...as needed of changes in patient status...Abnormal Findings...Blood pressure: Pre-dialysis ...Systolic greater than 180 mm Hg ...Diastolic greater than or equal to 100 mm Hg ...Blood Pressure-Intradialytic...Difference of 20 mm/Hg increase or decrease from patient’s last intradialytic treatment BP reading ...Post Treatment ...Standing systolic BP greater than 140 mm Hg ...Standing diastolic BP greater than 90 mm Hg ...Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute....” Review of Patient Treatment Sheets reveals: Patient #2 Treatment Sheet 12/6/23: 15:32 - Blood Pressure (BP) 184/100. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 16:01-16:32 Vital Signs greater than 30 min apart. Treatment Sheet 12/8/23: 11:31 - BP 174/104. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 12:02 - BP 182/106. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 12:31 - BP 175/103. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 13:46 - BP 163/102. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 11:31-12:02 Vital Signs greater than 30 min apart. 13:01-13:32 Vital Signs greater than 30 min apart. Treatment Sheet 12/11/23: 15:00-15:32 Vital Signs greater than 30 min apart. Treatment Sheet 12/13/23: 12:58 - BP 185/103. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 15:31 - BP 182/102. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 15:54 - BP 182/101. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 13:31-14:02 Vital Signs greater than 30 min apart. Treatment Sheet 12/15/23: 13:31 - BP 181/104. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 14:01 - BP 182/100. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 13:00-13:31 Vital Signs greater than 30 min apart. Patient #4 Treatment Sheet 12/4/23: 13:37 - BP 190/87. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 17:32 - BP 186/91. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 13:37-14:02 - BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 17:32-18:02 - BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 12/6/23: 16:01-16:32 Vital Signs greater than 30 min apart. 17:31-18:02 Vital Signs greater than 30 min apart. 14:01-14:31 - BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 12/8/23: 16:11 - BP 184/70. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 13:01-13:31 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 14:30-15:01 Vital Signs greater than 30 min apart. Treatment Sheet 12/11/23: 14:01-14:31 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 12/13/23: 13:00-13:31 Vital Signs greater than 30 min apart. Patient #5 Treatment Sheet 12/4/23: 14:50-15:01 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 15:31-16:01 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 17:01-17:31 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 12/6/23: 16:45 - BP 193/90. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 12/8/23: 14:45 - BP 190/89. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 12/11/23: 14:45 - BP 183/91. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 15:01 - BP 199/104. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 15:31 - BP 186/92. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 16:01-16:31 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Patient #7 Treament Sheet 11/25/23: 13:20 - Heart Rate (HR) 46. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 13:31 - HR 46. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 17:06-17:31 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 11/30/23: 15:32 - HR 52. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 16:03 - HR 44. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 16:24 - HR 53. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 16:44 - HR 45. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 16:03-16:24 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 12/5/23: 13:19 - HR 52. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 17:28 - HR 46. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 14:01-14:31 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 14:51-15:01 BP increased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 17:01-17:28 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 12/7/23: 14:54 - HR 43. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 17:13 - HR 57. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 17:01-17:13 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. Treatment Sheet 12/14/23: 13:01 - HR 45. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 13:32 - HR 52. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 15:04 - HR 58. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 13:01-13:32 Vital Signs greater than 30 min apart. 14:30-15:04 Vital Signs greater than 30 min apart. Treatement Sheet 12/16/23: 13:17 - HR 47. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 14:03 - HR 57. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 13:33-14:03 BP decreased more than 20 MM/Hg. No Registered Nurse (RN) notified by PCT or RN note/assessment charted. 14:03-14:40 Vital Signs greater than 30 min apart. Employee #1 confirmed on 12/19/2023 that staff failed to ensure RNs and PCTs monitored, assessed, and documented abnormal findings for the aforementioned patients and medical records.”

“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: 37489 Based on review of facility policy, medical records and interview, it was determined that the facility failed to ensure AMAs (against medical advice) forms were completed for treatment times not met for (4) of (5) patients (Patients #2, 3, 4, 5 and 7) with early termination of treatment which has the potential risk of adverse events related to inadequate dialysis. Findings include: The facility policy titled “Prescribed Treatment Time Not Met” requires: “...1. The Registered Nurse (RN) will verify that a patient signs the Early termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time....4. A copy of the Early termination of Treatment Against Medical Advice form signed by the patient, if shortened voluntarily by the patient, will be kept in the patient’s health record....” Patient #2 Treatment records dated 11/17/2023 through 12/15/2023 revealed (7) of (13) treatments were terminated early. The medical record did not contain AMA documentation for (7) of the (13) early terminated treatments. Patient #3 Treatment records dated 11/18/2023 through 12/16/2023 revealed (6) of (11) treatments were terminated early. The medical record did not contain AMA documentation for (6) of the (6) early terminated treatments. Patient #4 Treatment records dated 11/24/2023 through 12/15/2023 revealed (8) of (10) treatments were terminated early. The medical record did not contain AMA documentation for (7) of the (10) early terminated treatments. Patient #5 Treatment records dated 11/17/2023 through 12/15/2023 revealed (7) of (9) treatments were terminated early. The medical record did not contain AMA documentation for (6) of the (9) early terminated treatments. Patient #7 Treatment records dated 11/18/2023 through 12/16/2023 revealed (5) of (7) treatments were terminated early. The medical record did not contain AMA documentation for (4) of the (7) early terminated treatments. Employees #1 and 2 confirmed on 12/18/2023 that AMA forms were not completed for the aforementioned patients as required by facility policy.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 37489 Based on document review, observation, and staff interview, it was determined that the facility failed to ensure staff stored patient medical records in a secure manner. Failure to store patient medical records per facility policy poses the potential risk of unauthorized use. Findings include: The facility policy titled “Medical Records Custodian and Maintenance” requires: “...A purged medical record will be created for each patient and maintained in the same order as the active record. The information that is removed from the permanent medical record is placed in the patient’s purged record. The purged records are kept in a secure medical records storage site in the facility....” Observation on 12/18/2023 revealed multiple thinned and discharged patients’ medical records in unlocked cabinets in the conference room. The conference room door was propped open and the cabinets that were fitted with combination locks were all in the unlocked an open position. Employee #1 and 2 confirmed on 12/18/2023 that the medical records for discharged patients and thinned charts were not secured.”