Fmc Meadowlake Dialysis

“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: 28883 Based on observation, interview, and review of the facility policy “Hand Hygiene”, the dialysis facility failed to ensure Patient Care Technician (PCT) #2, one of four PCT’s observed providing care, failed to change gloves/perform hand hygiene prior to inserting vascular access needles. The findings include: Observation on 7/16/24 at 10:45 AM revealed Patient Care Technician (PCT) #2, at machine #2, station #19, starting a dialysis treatment for a patient. PCT #2 with gloved hands took a stethoscope and listened to the fistula; placing the stethoscope bell over the skin on the patient’s arm. PCT #2 opened an alcohol pad and wiped the bell, disinfecting it and placed a tourniquet on the arm, cleaned the skin with alcohol pads, and stuck 2 dialysis needles into the fistula. During an interview on 7/16/24 at 11:17 AM, the surveyor reviewed the observation with PCT #2 and informed him/her of the concern related to the lack of hand hygiene before sticking needles into the vascular access. PCT #2 verified the observation. Review on 7/18/24 at 8:24 AM of the facility policy, entitled “Hand Hygiene” revealed information that hands will be washed or decontaminated with alcohol based hand rub before performing any invasive procedures such as vascular access cannulation or after contact with inanimate objects near the patient.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 28883 Based on record review, interview, and review of the facility policy “Patient Vaccination for Hepatitis B”, the dialysis clinic nursing staff failed to ensure consent or declination for the Hepatitis B vaccine had been obtained for Patient #5, one of one patients reviewed who was susceptible to the Hepatitis B virus. The findings include: Record review on 7/17/24 at 12:35 PM of Patient #5 revealed Patient #5 was admitted to the dialysis clinic on 5/9/24. Review on 7/17/24 at 12:40 PM of lab results revealed a Hepatitis B antigen result that was negative on 4/24/24 and a Hepatitis B surface antibody result less than 10 mIU/ml (milliinternational units/milliliter) on 5/9/24. This indicated that the patient was susceptible to the Hepatitis B virus. Review of the medical record revealed no consent or declination had been documented for the Hepatitis B vaccine. During an interview on 7/17/24 at 2:15 PM, the Clinic Manager stated the nursing staff had not obtained a consent or declination from the patient for the Hepatitis B vaccine. Review on 7/18/24 at 8:27 AM of the facility policy, entitled “Patient Vaccination for Hepatitis B” revealed “...The Hepatitis B vaccine shall be offered to all susceptible patients...”. Review on 7/18/24 at 8:35 AM of the patient’s Plan of Care, dated 6/11/24, revealed a goal to have the patient vaccinated; with interventions that included to evaluate the patient for the need of the flu vaccine and evaluate the need for the Hepatitis B vaccine.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 28883 Based on observation and interview, the dialysis clinic staff, Patient Care Technician (PCT) #2, one of two PCT’s observed initiating a dialysis treatment for a patient with a graft/fistula, failed to ensure aseptic technique by contaminating the syringe tips used to push/pull blood through the dialysis needles. The findings include: Observation on 7/16/24 at 10:45 AM revealed Patient Care Technician (PCT) #2, at machine #2, station #19 starting a dialysis treatment for a patient. PCT #2 opened two 10 milliliter syringes, dropping them on the chux where one of the uncapped sterile syringe tips fell touching the chux and the other sterile syringe tip fell touching a dialysis needle. This caused the syringe tips to be contaminated (no longer sterile). After sticking the dialysis needles into the patient’s fistula, PCT #2 attached the syringes to the dialysis needles where the technician checked placement of the needles by pushing and pulling the blood from the vascular access back and forth using the syringes. During an interview on 7/16/24 at 11:17 AM, the surveyor reviewed the observation and concerns related to using the contaminated syringes for contact with the patient’s blood and verified the observation.”

“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: 22313 Based on record review, interview, and facility policy review, the dialysis facility nursing staff failed to ensure total chlorine tests were documented timely for May and June 2024. Findings include: Review of the total chlorine test log on 07/17/24 at 12:04 PM revealed the total chlorine test was performed on 05/14/24 at 8:09 AM. The next test was documented at 1:57 PM, after a period of 5 hours 48 minutes. The chlorine test was documented on 05/21/24 at 8:15 AM. The next test was documented at 2:01 PM, a period of 5 hours 46 minutes. The chlorine test was documented on 05/25/24 at 7:58 AM. The next test was documented at 12:40 PM, a period of 4 hours 42 minutes. The chlorine test was documented on 06/01/24 at 7:26 AM. The next test was documented at 11:58 AM, a period of 4 hours 32 minutes. The chlorine test was documented on 06/10/24 at 4:05 AM. The next test was documented at 9:15 AM, a period of 5 hours 10 minutes. In an interview on 07/18/24 at 1:15 PM with RN #2 and RN #3, verified the information. RN#3 stated, “The second bay didn’t pick up like they are supposed to (staff from the 2nd bay should have done the check) when the 1st bay went on break.” Facility policy, entitled “Carbon Filtration Monitoring For Incenter Central Water Systems policy” reads, “When to test: Worker Carbon Filter...Prior to the initiation of the first patient treatment of the day and at a minimum of every four hours”.”

“CARBON ADSORP-ACTION IF FIRST TEST + CFR(s): 494.40(a) 5.2.5 Carbon adsorption: action if first test positive When samples from the first sampling port are positive for chlorine or chloramine, operation may be continued for a short time (up to 72 hours) until a replacement bed is installed, provided that samples from the second sampling port remain negative. The replacement bed should be placed in the second position, and the existing second bed should be moved to the first position to replace the exhausted bed. If it is not possible to rotate the position of the beds, both beds should be replaced. This Standard is not met as evidenced by: 22313 Based on observation, interview and policy review, the dialysis clinic Patient Care Technician (PCT) #1, one of two nursing staff observed for the total chlorine test of dialysis water was unable to state what action to take if the chlorine tested over the allowable limit in the secondary carbon polisher tank/port. Findings include: On 07/16/24 at 11:00 AM, PCT#1 and Registered Nurse (RN) #2 performed the chlorine test in the water room. When PCT#1 was asked “What would you do if the 1st port water test was over the limit, over 0.1 parts per million?” PCT#1 responded, “Go into bypass and give the patient’s blood back.” RN #2 corrected PCT#1 saying, “No, no bleed back, keep the dialysis machines in bypass and do not return the patient blood.” Review on 07/16/24 at 12:20 PM, the facility policy entitled, “Chloride Breakthrough Action Plan,” reads “If test results are greater than 0.10 parts per million total chlorine, keep dialysis machines in bypass. Do not return the patient’s blood.””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 22313 Based on observation and interview, the dialysis clinic nursing staff failed to ensure that the Minncare used to disinfect the water system was not expired, expired Minncare had not been removed from staff access, and bottles of Reverse Osmosis (RO) water was not labeled/dated appropriately. Findings include: During a tour of the water room on 07/16/24 at 11:04 AM, it was observed that the Minncare disinfectant container connected to the RO unit, was marked with a chemical consumption check date of 07/15/24; which indicated the Minncare had been used after the expiration date of 07/09/24 listed on the label. Seven additional bottles of Minncare (expired 7/9/24) were observed on a nearby shelf. One unlabeled bottle of clear liquid was dated 07/09/24 and another bottle of clear liquid (not dated or labeled) was observed on the table. In an interview on 07/16/24 at 11:15 AM, the Biomedical Technician acknowledged that the Minncare was expired and that the bottles containing RO water should be labeled/dated properly. The Biomedical Technician verified that the RO water was out of date.”

“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: 22313 Based on Reverse Osmosis (RO) disinfection logs, Chemical Disinfection Residual Check logs, interview, and manufacturer’s directions for use, the dialysis clinic nursing staff failed to ensure residual checks were performed and documented after the weekly Minncare Chemical disinfections in May, June, and July of 2024. Findings include: Record review for RO disinfection and Chemical Disinfection Residual Check logs on 07/16/24 at 3:30 PM revealed that residual checks after Minncare chemical disinfections had not been documented timely before the patients’ next treatments. Minncare disinfection completed on 05/13/24 received a residual check on 05/15/24. Patients were dialyzed on 5/14/24 without documentation of a residual check. Minncare chemical disinfection on 05/27/24 received a residual check on 05/30/24. Patients were dialyzed on 05/28/24 without documentation of a residual check. Minncare chemical disinfection was performed on 06/03/24 with a residual check on 06/05/24. Patients were dialyzed on 06/04/24 without documentation of a residual check. Minncare chemical disinfection on 07/15/24 had no residual check documented on 07/16/24. Patients were dialyzed on 07/16/24 without documentation of a residual check. The directions for use for the water purifying system, CWP 100 Model WRO H/S, used by the facility specifies, “WARNING! Do not connect patients until a test for residual disinfectants has been performed!” In an interview with the Biomedical Technician on 07/16/24 at 1:00 PM, s/he confirmed the late/missing documentation.”

“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: 22313 Based on record review, interview and facility policy review, the dialysis clinic nursing staff failed to ensure care plans had been completed for the months of May and June 2024 for Patient #2, one of one patients reviewed who had been determined unstable. Findings include: Record review on 7/16/24 at 10:20 AM for Patient #2, revealed an unstable patient plan of care dated 04/24/24. There were no plans of care documented for the months of May and June 2024. In an interview with Registered Nurse (RN) #2 on 07/18/24 at 2:50 PM, it was confirmed that the patient’s plan of care had not been completed for May and June 2024. RN #2 stated, “They are not there”, after looking at the chart/record. Facility policy entitled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” reads “unstable patients must be reassessed by the Interdisciplinary Team (IDT) monthly related to the reason the patient is considered unstable.””

“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: 22313 28883 Based on record review, interview, and review of facility policy “Patient Monitoring and Safety Checks during Hemodialysis Treatment”, the dialysis clinic staff failed to ensure vital signs had been documented timely for 4 of 6 patients reviewed for monitoring during treatment. (Patients #2, #3, #6, and #7). The findings include: Record review on 07/16/24 at 11:34 AM of Patient #2’s treatment sheets revealed the following: A treatment sheet dated 07/02/24 revealed 76 minutes, from 2:07 PM to 3:23 PM, between vital signs. Treatment sheet dated 07/04/24 revealed 57 minutes, from 12:09 PM to 1:06 PM, between vital signs. Treatment sheet dated 07/04/24 revealed 80 minutes, from 1:34 PM to 2:54 PM, between vital signs.Treatment sheet dated 07/09/24 revealed 58 minutes, from 12:39 PM to 1:37 PM, between vital signs. Record review on 07/16/24 at 11:40 AM of Patient #3’s treatment sheets revealed the following: A treatment sheet dated 07/06/24 revealed 52 minutes, from 10:39 AM to 11:31 AM, between vital signs. Treatment sheet dated 06/29/24 revealed 54 minutes, from 1:34 PM to 2:33 PM, between vital signs. In an interview on 07/18/24 at 2:00 PM, the Clinic Manager confirmed the late assessments and safety checks. The dialysis clinic admitted Patient #6 on 4/14/17. Review on 7/17/24 at 1:02 PM revealed treatment sheets that documented blood pressure and pulse checks (vital signs) greater than 45 minutes apart during the patient’s dialysis treatment. A treatment sheet dated 7/12/24 revealed vital signs (vs) had been documented at 12:05 PM and again at 1:04 PM, 59 minutes apart. A treatment sheet dated 7/8/24 revealed vs documented at 10:14 AM and again at 11:36 AM, 1 hour 26 minutes apart. On 7/3/24 at 10:32 AM and again at 11:31 AM, 59 minutes apart. On 7/1/24 at 11:30 AM and again at 12:30 PM, 1 hour apart. On 6/24/24 at 10:31 AM and again at 11:39 AM, 1 hour and 8 minutes apart. The dialysis clinic admitted Patient #7 on 12/30/20. Review on 7/18/24 at 1:37 PM revealed treatment sheets where vital signs had been documented greater than 45 minutes apart during the patient’s dialysis treatment. A treatment sheet dated 7/13/24 documented vs at 8:33 AM and then again at 9:25 AM, 55 minutes apart and on 7/8/24 at 2:02 PM and again at 3:05 PM, 1 hour and 3 minutes apart. During an interview on 7/19/24 at 3:15 PM, the Clinic Manager reviewed the treatment sheets and verified the findings. Review on 7/18/24 at 2:30 PM of facility policy, entitled, “Patient Monitoring and Safety Checks during Hemodialysis Treatment,” reads “monitor and document every 30 minutes or more frequently as needed but not to exceed 45 minutes in the treatment record.””

“POC-MANAGE MINERAL METABOLISM CFR(s): 494.90(a)(3) Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease. This Standard is not met as evidenced by: 28883 Based on record review and interview, the dialysis clinic Registered Dietitian failed to ensure a medication used for the management of Parathyroid Hormone, Calcitriol, had been started for Patient #5, one of five patients reviewed for management of bone-mineral disease. The findings include: The dialysis clinic admitted Patient #5 on 5/9/24. Review of “Medical Provider” notes on 7/17/24 at 9:24 AM revealed notes dated 7/2/24 and 7/9/24 that indicated the patient was to start the medication Calcitriol (helps to regulate Parathyroid Hormone levels) at 0.25 micrograms (mcg) three times a week. A note by the Registered Dietitian (RD) dated 6/11/24 documented the patient was starting Calcitriol 0.25 mcg three times weekly due to an elevated Intact Parathyroid Hormone (iPTH) level of 751 and an elevated phosphorous level of 7.0. Review of the patient’s Plan of Care revealed a goal for the iPTH of 160-720 picograms/milliliter and a Phosphorous goal of 3.0-5.5 milligrams/deciliter. Review of physician orders revealed no order to start the medication Calcitriol. During an interview on 7/18/24 at 10:45 AM, the RD stated that there had been an interdisciplinary team meeting on 6/11/24 where the physician, RD, and SW had attended and agreed on starting the patient on Calcitriol. The RD stated that the Calcitriol should have been ordered and started but hadn’t.”