Fmc South Suburban Dialysis Facility

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 37700 Based on observations, staff interviews and policy reviews, the facility failed to ensure 5 out of 9 direct care staff observed (Registered Nurse [RN] #5) and (Certified Clinical Hemodialysis Technician [CCHT] #1, #6, #7, and #8) consistently implemented infection control standards to prevent risk of cross contamination and spread of infection within the dialysis unit. Findings include: 1. The facility failed to ensure that 1 staff member, Certified Clinical Hemodialysis Technician [CCHT] #1, changed his gloves and performed hand hygiene to reduce the risk of infection and cross contamination when providing care to a patient. Please refer to V113. 2. The facility failed to ensure 1.) Personal Protective Equipment (PPE) was worn correctly by 1 staff member (CCHT #6) during times when potential for spurting or splattering of blood, or potentially contaminated substances or chemicals may occur; and 2.) 2 of 3 staff members (CCHT #1 and CCHT #7) observed, removed their mask prior to exiting the isolation room after caring for a patient known to be Hepatitis B positive (HBsAg positive). Please refer to V115. 3. The facility failed to ensure that clean areas were clearly separated from contaminated areas as required, relative to staff personal protective equipment (PPE) being stored in an area containing and coming in contact with patient personal items and biohazard containers. Please refer to V117. 4. The facility failed to ensure 2 of 3 staff observed (CCHT #1 and CCHT #8) adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, on the treatment floor and in the isolation room, therefore increasing the risk for cross contamination of blood borne pathogens. Please refer to V122. 5. The facility failed to ensure proper infection control practices in the isolation room for 1 of 2 patients (#4) observed with positive Hepatitis B virus infection. Please refer to V130. 6. The facility failed to ensure one of two staff members observed (RN #5) prepared intravenous (IV) medication using aseptic technique to prevent cross contamination of the contents of the IV vial. Please refer to V143. 7. The facility failed to ensure that 1 of 2 staff observed (CCHT #6) performed adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 applicable patients (#11), with a Central Venous Catheter (CVC). Please refer to V147.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 37349 Based on record review, policy review, and staff interview, the facility failed to ensure that 2 staff members (Registered Nurse [RN] #5 and Certified Clinical Hemodialysis Technician [CCHT] #6) received Emergency Preparedness Training at least every 2 years, as required, out of a total sample of 6 staff member records reviewed. Findings include: Review of the facility policy titled, Guidelines for Emergency Preparedness, dated 7/3/23, included the following: *Staff will be trained on emergency disaster preparedness such as fire drills, emergency disconnection, and emergency evacuation. Review of RN #5’s education records on 3/28/24, indicated that the last time she completed Emergency Preparedness Training was 1/21/22, greater than 2 years, as required. Review of CCHT #6’s education records on 3/28/24, indicated that the last time she completed Emergency Preparedness Training was 3/1/22, greater than 2 years, as required. During an interview on 3/28/24 at 10:30 A.M., the Facility Administrator said that Emergency Preparedness Training for RN #5 and CCHT #6 was overdue.”

“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: 44223 Based on observation, interview, and policy review, the facility failed to ensure that 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #1), changed his gloves and performed hand hygiene to reduce the risk of infection and cross contamination when providing care for 1 Patient (#13), out of a total sample of 16 patients. Findings include: Review of the facility policy titled, Hand Hygiene, dated 11/6/23, included the following, but is not limited to: *Responsibility: All staff, patients, patient care givers, including physicians and non-physician practitioners, social workers, dietitians, and any other indirect patient care staff must follow the same requirements for hand hygiene. Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based hand rub with 60-90% alcohol content. *Hands will be decontaminated using alcohol-based hand rub or by washing with antimicrobial soap and water. *Before and after direct contact with patients. *Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications. *When moving from a contaminated body site to a clean body site of the same patient. On 3/26/24 at 11:00 A.M., the surveyor observed CCHT #1 perform Arteriovenous fistula (AVF) site care and initiate dialysis treatment for Patient #13. CCHT #1 started by evaluating the AVF site. He palpated (touched) and auscultated (listened) at the AVF site for a bruit and thrill (swooshing sound heard with the stethoscope placed over the access site). He then proceeded to disinfect the AVF site. CCHT #1 failed to remove his gloves and perform hand hygiene after evaluating the AVF site and prior to disinfecting. During an interview on 3/26/24 at 11:30 A.M., CCHT #1 said he should have removed his gloves and performed hand hygiene, before proceeding to disinfect the AVF site.”

“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: 37349 Based on observation, policy review, and interview, the facility failed to ensure 1.) that Personal Protective Equipment (PPE) was worn correctly by 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #6) during times when potential for spurting or splattering of blood, or potentially contaminated substances or chemicals may occur; and 2.) that 2 of 3 staff members (CCHT #1 and CCHT #7) observed, removed their mask prior to exiting the isolation room after caring for a patient known to be Hepatitis B positive (HBsAg positive). Findings include: 1. The facility failed to ensure that PPE was worn correctly by CCHT #6. Review of the facility’s policy titled, Personal Protective Equipment, dated 11/6/23, included: *Employees who may have occupational exposure shall be provided, without cost, appropriate PPE including gloves, fluid resistant gowns, face shields, masks, eye protection with full side shields. *Employees shall use personal protective equipment in accordance with the type of patient contact expected and anticipated exposure. On 3/26/24 at 8:40 A.M., the surveyor observed CCHT #6 discontinuing the dialysis treatment for a patient at station #2. The surveyor observed that while removing the needles from the patient’s Arteriovenous fistula/graft (AVF/AVG), the sleeves of PCT #6’s gown were pushed up her arms, exposing both of her wrists, including a blue wrist band and watch, which increases the risk of contamination from blood splatter, which would then increase the risk of spread of infection. On 3/26/24 at 9:00 A.M., the surveyor observed CCHT #6 using 1:100 bleach soaked pads to disinfect station #2. The sleeves of her gown were pushed up her arms, exposing both of her wrists, including a blue wrist band and watch, which increases the risk of contamination from contaminated surfaces and chemicals, which would then increase the risk of spread of infection and injury. During an interview on 3/27/24 at 11:45 A.M., the Facility Administrator said that staff wrists should not be exposed during initiation of dialysis treatment, termination of dialysis treatment, and disinfection of the station. 44223 2. The facility failed to ensure 2 of 3 staff members (CCHT #1 and CCHT #7) observed, removed their mask and or baseball cap prior to exiting the isolation room after caring for a patient known to be Hepatitis B positive (HBsAg positive). Review of the facility’s policy titled, Dialyzing Patients with Positive Hepatitis B (infection of the liver caused by a virus) Antigen (HBsAg+), dated 11/6/23, indicated the following: *Caring for HBsAg positive patients requires adherence to strict guidelines. The Hepatitis B virus is highly infectious because the concentration of the virus particles in the blood is very high and the Hepatitis B virus can live outside the body on surfaces for at least 7 days. Outbreaks of Hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for Hepatitis B. *All patients who are HBsAg positive must dialyze under isolation precautions. *PPE must be removed and discarded or left in the isolation room/area if not soiled. Review of the Centers for Disease Control and Prevention (CDC) Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007), indicated the following: *Wear PPE when the nature of the anticipated patient interaction indicates that contact with blood or body fluids may occur. *Before leaving the patient’s room or cubicle, remove and discard PPE. a. Review of the daily staff/patient assignment sheet, dated 3/26/24, indicated the patient receiving his/her dialysis in the isolation room between 8:00 A.M. and 12:45 P.M., was Hepatitis B positive. During an observation on 3/26/24 at 8:55 A.M., the surveyor observed CCHT #1 enter the isolation room wearing a face mask and a baseball cap. He put a faceshield, gown, and gloves on, then adjusted the hemodialysis machine. He then removed his gown and faceshield, and then took off his gloves and applied hand gel before exiting the room. He was observed exiting the isolation room without changing his face mask or removing his baseball cap. The baseball cap was not covered by PPE which could increase the risk of cross contamination. He then proceeded to care for another patient being dialyzed. During an observation on 3/26/24 at 12:12 P.M., the surveyor observed CCHT #1 enter the isolation room wearing a face mask. He put a faceshield, gown, and gloves on, and proceeded to adjust the hemodialysis machine and care for the patient. He then removed his faceshield, gown, and then took off his gloves. CCHT #1 applied hand gel before exiting the room. He was observed exiting the isolation room without changing his mask or removing his baseball cap. The baseball cap was not covered by PPE which could increase the risk of cross contamination. He then proceeded to care for another patient being dialyzed. During an observation on 3/26/24 at 12:45 P.M., CCHT #1 was observed entering the isolation room wearing a mask and baseball cap. He proceeded to put on a gown, gloves, and faceshield. CCHT #1 then proceeded to terminate the dialysis treatment. CCHT #1 then exited the isolation room with the patient. He was observed exiting the isolation room without changing his mask or removing his baseball cap. The baseball cap was not covered by PPE which could increase the risk of cross contamination. He then proceeded to care for another patient being dialyzed. During an interview on 3/26/24 at 2:30 P.M., CCHT #1 said he should of changed his mask when exiting the isolation room and he should not have been wearing his hat in the isolation room. During an interview on 3/26/24 at 3:15 P.M., the Facility Administrator said that masks should always be changed when leaving the isolation room and staff should not be wearing any type of hat in the isolation room. b. Review of the daily staff/patient assignment sheet, dated 3/27/24, indicated the patient receiving his/her dialysis in the isolation room between 11:05 A.M. and 2:35 P.M., was Hepatitis B positive. During an observation on 3/27/24 at 11:18 A.M., the surveyor observed CCHT #7 enter the isolation room wearing a face mask. She put on a faceshield, gown, and gloves, and proceeded to complete a safety check of the hemodialysis machine. She then removed her faceshield, gown, and then took off her gloves. CCHT #7 applied hand gel before exiting the room. She was observed exiting the isolation room without changing her face mask. During an interview on 3/27/24 at 11:25 A.M., CCHT #7 said she should have changed her mask when exiting the isolation room.”

“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: 37349 Based on observation and interview, the facility failed to ensure that clean areas were clearly separated from contaminated areas, as required, relative to staff personal protective equipment (PPE) being stored in an area containing and coming in contact with patient personal items and biohazard containers. Findings include: During observations of the treatment floor on 3/26/24 at 8:30 A.M., the surveyor observed an intravenous (IV) pole in the center of the treatment floor, across from station #10. There was a biohazard bin to the left and a patient wheelchair to the right. Two (2) PPE gowns were hanging from the pole, one touching the biohazard bin and the other touching the patient wheelchair. At 9:15 A.M., the surveyor observed Registered Nurse #2 remove the gown that she was wearing and place it on the IV pole, draped over the patient wheelchair. During an interview on 3/27/24 at 12:05 P.M., the Clinic Manager said that clean and dirty items should be separated and PPE should not be in contact with biohazard or patient belongings.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 44223 Based on observation, staff interview, and policy review, the facility failed to ensure 2 of 3 staff observed (Certified Clinical Hemodialysis Technician [CCHT] #1 and CCHT #8) adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, on the treatment floor and in the isolation room, therefore increasing the risk for cross contamination of blood borne pathogens. Findings Include: 1. The facility failed to ensure that CCHT #1 adequately cleaned and disinfected contaminated surfaces within the isolation dialysis room, between patients, increasing the risk for cross contamination of blood borne pathogens. Review of the facility policy titled, Dialyzing Patients with Positive Hepatitis B (infection of the liver caused by a virus) Antigen (HBsAg+), dated 11/6/23, indicated the following. but is not limited to: *Caring for HBsAg positive patients requires adherence to strict guidelines. The Hepatitis B virus is highly infectious because the concentration of virus particles in the blood is very high and the Hepatitis B virus can live outside the body on surfaces for at least 7 (seven) days. Outbreaks of Hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for Hepatitis B. Review of the daily staff/patient assignment sheet, dated 3/26/24, indicated the patient receiving his/her dialysis in the isolation room, between 8:00 A.M. and 12:45 P.M., was Hepatitis B positive. During an observation on 3/26/24 at 1:15 P.M., the surveyor observed CCHT #1 clean and disinfect the station in the isolation room, following the dialysis treatment for a Hepatitis B patient. CCHT #1 failed to: *clean and disinfect the prongs on the intravenous (IV) pole connected to the dialysis machine. *clean and disinfect the prime waste bucket. *clean and disinfect the basket connected to the right side of the dialysis machine. *clean and disinfect the three standing IV poles in the isolation room. *clean and disinfect the cabinets and the counter tops. *clean and disinfect the windowsill. *clean and disinfect the gray cart and the items located on top of the gray cart. During an interview on 3/26/24 at 1:35 P.M., CCHT #1 said he had thought he had cleaned all the required items in the isolation room. During an interview on 3/26/24 at 3:15 P.M. the Facility Administrator said the expectation is all areas/items within the isolation room should be cleaned and disinfected after treatment is completed. 37700 2. The facility failed to ensure that CCHT #8 adequately cleaned and disinfected the dialysis machine at station #13 after the patient previously occupying that station had left, increasing the risk of cross contamination of blood borne pathogens. Review of the facility policy titled, Cleaning and Disinfection the Dialysis Station, published 9/5/23, indicated, but not limited to: *Use a cloth wetted with 1:100 bleach solution or Environmental Environmental Agency (EPA)-approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, intravenous (IV) pole, blood pressure (B/P) cuff, hand sanitizer dispenser and holder, chaise wall behind chair.) On 3/26/24 at 10:15 A.M., the surveyor observed CCHT #8 cleaning the dialysis machine at station #13. CCHT #8 was observed to clean the machine with 1:100 bleach-soaked pads. CCHT #8 failed to thoroughly clean the storage basket that was located on the right upper side of the machine. CCHT #8 placed the bleach-soaked pad in the basket and quickly removed the pad. He did not clean the exterior of the basket. He did not clean the area above the basket to the top of the machine. He did not clean the IV pole that was attached to the machine or the stethoscope that was hanging on the pole. During an interview on 3/26/24 at 10:40 A.M., CCHT #8 said he did not clean the top upper right side of the machine to the hanging storage basket. He said he did not thoroughly clean the exterior and interior of the hanging storage basket. He further said he did not clean the stethoscope or the IV pole, as required.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 44223 Based on observation, staff interview, and policy review, the facility failed to ensure proper infection control practices in the isolation room for 1 of 2 patients (#4) observed with positive Hepatitis B virus infection. Findings Include: Review of the facility policy titled, Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+), dated 11/6/23, indicated the following, but is not limited to: *Caring for HBsAg positive patients require adherence to strict guidelines. The Hepatitis B virus is highly infectious because the concentration of virus particles in the blood is very high and the Hepatitis B virus can live outside the body on surfaces for at least 7 (seven) days. Outbreaks of Hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for Hepatitis B. *Patients that are HBsAg positive must dialyze in the separate room. The separate room is required to have a door to contain any spurting of blood, body fluids, and other contaminates to prevent cross transmission. The door must be closed during times when blood spurting or spattering is possible. On 3/26/24 at 12:45 P.M., the surveyor observed Certified Clinical Hemodialysis Technician (CCHT) #1 enter the isolation room. He put on a faceshield, gown, and gloves, along with his face mask. CCHT #1 initiated the discontinuation process of the dialysis treatment including removing the catheters from the patient’s arm. CCHT #1 failed to ensure the door was closed before discontinuing the dialysis treatment. During an interview on 3/26/24 at 3:15 P.M., the Clinical Manager and Facility Administrator both said the door should remain closed during the discontinuation of treatment in the isolation room.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 37700 Based on observation, staff interview, and record review, the facility failed to ensure 1 of 2 staff members observed (Registered Nurse [RN] #5) prepared intravenous (IV) medication using aseptic technique to prevent cross contamination of the contents of the IV vial. Findings include: Review of the facility policy, titled, Medication Preparation and Administration Procedure, published 9/5/23, included the following but is not limited to: *Draw up the dose of medication as ordered by the physician. *Wipe injection port of piggyback IV solution with an alcohol pad. Inject reconstituted medication into piggyback IV solution. Label IV piggyback solution per policy and administer per procedure. On 3/26/24 at 11:15 A.M., the surveyor observed RN #5 reconstitute Vancomycin (an antibiotic) 1 Gram powder with 20 milliliters (mls) of Sterile Water. RN #5 cleansed the stopper of the Sterile Water vial with an alcohol pad and withdrew 10 ml. She cleansed the stopper of the Vancomycin vial with an alcohol pad and injected the 10 ml of the Sterile Water into the Vancomycin vial. She cleansed the stopper of another Sterile Water vial and withdrew 10 ml. She cleansed the stopper of the Vancomycin vial with an alcohol pad and injected the 10 ml of Sterile Water into the Vancomycin vial. She mixed the medication by rotating the vial between her hands. She cleansed the stopper of the Vancomycin vial with an alcohol pad, withdrew 10 ml of the reconstituted Vancomycin and injected it into the injection port of the 200 ml Normal Saline piggyback IV bag. She did not cleanse the injection port of the piggyback IV bag prior to injecting the medication. She cleansed the stopper of the Vancomycin vial with an alcohol pad and withdrew another 10 ml of the reconstituted Vancomycin and injected it into the injection port of the piggyback IV bag. She did not cleanse the injection port of the piggyback IV bag prior to injecting the medication. During an interview on 3/26/24 at 11:26 A.M., RN #5 said she did not cleanse the injection port of the piggyback IV bag the two times she injected the reconstituted Vancomycin medication, as required.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 38141 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff observed (Certified Clinical Hemodialysis Technician [CCHT] #6) performed adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 applicable patients (#11), with a Central Venous Catheter (CVC). Findings include: Review of the facility policy titled, Changing the Catheter Dressing Procedure, published 2/5/2024, indicated the following: *Perform hand hygiene. *Remove swab stick from the package by stick end without touching foam applicator. Using a gentle back and forth friction, clean exit site beginning in the center and continuing outward the area of the size of the dressing to be applied (2 inches) in a concentric for 30 seconds and allow to dry a minimum of 30 seconds. *Using aseptic technique, apply the catheter dressing over dry exit site, being careful not to touch the patient’s side of the dressing with gloved hands or to any surface. During an observation on 3/26/24 at 10:15 A.M., the surveyor observed CCHT #6 as she prepared Patient #11 for initiation of his/her dialysis treatment. CCHT #6 obtained supplies which included a swab stick and sterile bordered dressing. CCHT #6 placed a clean barrier under the CVC limbs, moved Patient #11’s sweater away from the dressing, then she removed the old dressing, which she discarded into the trash. She then removed her gloves, performed hand hygiene, and donned new gloves and disinfected the exit site. As she applied the dressing, Patient #11’s sweater moved onto the exit site and touched the area where the catheter tunneled under the skin, which recontaminated the area. CCHT #6 moved Patient #11’s sweater back, touching the site with her gloved hand, and applied the new dressing to the exit site. CCHT #6 failed to repeat the disinfection process after the area was recontaminated. During an interview on 3/26/24 at 10:25 A.M., CCHT #6 said she should have secured Patient #11’s sweater prior to the dressing change, and that she should have repeated the disinfection process.”

“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: 38141 Based on observation, interview, and Manufacturer’s Recommendations for Use, the facility failed to ensure that 1 of 2 staff observed (Certified Clinical Hemodialysis Technician [CCHT] #8) waited 20 seconds before reading the results of chlorine testing to ensure an accurate result was obtained. Findings include: Review of the Manufacturer’s Total Chlorine Test Strips Instruction for Use indicated the following: *Collect a fresh 100 milliliter (ml) sample of water in a clean plastic sample cup. *Remove one test strip from its foil package and swish it in the sample for the amount of time indicated according to the temperature range. *Remove the strip and shake once, briskly, to remove the excess water. *Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it provides a consistent viewing background. *After 20 seconds wait period, immediately compare the color strip color to the color chart to determine the total chlorine level in the sample. During an observation on 3/26/24 at 9:15 A.M., the surveyor observed CCHT #8 obtain a fresh 100 ml sample of water in a clean sample cup. He moved the test strip in a back-and-forth motion in the sample for 60 seconds, he removed the excess water, and immediately read the results without waiting for 20 seconds for the test to develop. During an interview on 3/27/24 at 2:10 P.M., the Technical Manager said that CCHT #8 should have waited 20 seconds before reading the result.”

“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: 10249 Based on record review and interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate (BFR-speed (measured in milliliters per minute [ml/min]) in which the patient’s blood pushed through the dialyzer and back into the body) and Dialysis Flow Rate (DFR-the measurement of how fast the dialysate solution flows in ml/min) to draw toxins from the patient’s blood during the process of dialysis, for 3 of 8 applicable patients (#10, #8, and #4), out of a total sample of 16 patients. Findings include: 1. For Patient #10, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the BFR and DFR. Patient #10 was admitted to the facility in October 2023 with a diagnosis of End Stage Renal Disease (ESRD), requiring dialysis. Review of the Physician’s order, dated 2/7/24, indicated the BFR was to be delivered at a rate of 450 ml/min, and DFR was to be delivered at the rate of 600 ml/min. Review of the 9 Hemodialysis Flowsheets, dated 2/8/24 through 3/23/24, indicated the BFR and/or DFR had not been delivered as prescribed for 5 of 9 treatments, including the following: *2/8/24 - the DFR was delivered at a rate of 800 ml/min, not 600 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. * 2/20/24 - the BFR was delivered at a rate of 350 ml/min, not 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/16/24 - the DFR was delivered at a rate of 800 ml/min, not 600 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/19/24 - the DFR was delivered at a rate of 800 ml/min, not 600 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/21/24 - the DFR was delivered at a rate of 800 ml/min, not 600 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 3/28/24 at 10:15 A.M., the Clinic Manager (CM) said the BFR/DFR should be run as prescribed, or document why the change had to be made. 44223 2. For Patient #8, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the BFR. Patient #8 was admitted to the facility in May 2017 with a diagnosis of ESRD, requiring dialysis. Review of the current dialysis treatment orders, dated 2/15/24, indicated the BFR was to be delivered at a rate of 450. Review of treatment sheets, dated 3/5/24-3/23/24, indicated the BFR was not delivered as prescribed for 7 of 9 treatments, including the following: *3/5/24 - the BFR ran at a rate of 320, not the 450 as prescribed, with no documented reason as to why. *3/9/24 - the BFR ran at a rate of 350, not the 450 as prescribed, with no documented reason as to why. *3/12/24 - the BFR ran at a rate of 400, not the 450 as prescribed, with no documented reason as to why. *3/16/24 - the BFR ran at a rate of 400, not the 450 as prescribed, with no documented reason as to why. *3/19/24 - the BFR ran at a rate of 400, not the 450 as prescribed, with no documented reason as to why. *3/21/24 - the BFR ran at a rate of 350-400, not the 450 as prescribed, with no documented reason as to why. *3/23/24 - the BFR ran at a rate of 350, not the 450 as prescribed, with no documented reason as to why. During an interview on 3/27/24 at 1:40 P.M., the CM, after reviewing the 7 treatment sheets, said she could not find any documentation as to why the BFR was not delivered as prescribed, during the identified treatments. 37700 3. For Patient #4, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to BFR. Patient #4 was admitted to the facility in September 2021 with a diagnosis of ESRD, requiring dialysis. Review of the current dialysis treatment orders, dated 3/2/24, indicated the BFR was to be delivered at a rate of 400. Review of 9 treatment records, dated 3/7/24 through 3/26/24, indicated the BFR was not delivered as prescribed for 2 of 9 treatments, including the following: *3/16/24 - the BFR was delivered at a rate of 375, not the prescribed 400, with no documentation as to why the order was not followed. *3/21/24 - the BFR was delivered at a rate of 450, not the prescribed 400, with no documentation as to why the order was not followed. During an interview on 3/27/24 at 1:40 P.M., the CM, after reviewing the 2 treatment sheets, said she could not find any documentation as to why the BFR was not delivered as prescribed, during the identified treatments.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 37349 Based on clinical record review and interview, the facility failed to develop and implement a plan of care to monitor, adjust, and administer doses of Mircera (a medication used to treat anemia in dialysis patients) to meet their anemia management needs for 1 of 10 applicable patients (Patient #9), from a total sample of 16 patients. Findings include: Patient #9 was admitted to the facility in January 2018 with diagnoses including anemia and End Stage Renal Disease (ESRD), requiring hemodialysis. Review of Patient #9’s Plan of Care, dated 5/2023, indicated the following: -Patient does not meet goal of 10-11 for hemoglobin. Administer oral iron if home patient or allergic to intravenous (IV) iron and start or change IV iron administration per MD order/algorithm. Review of Patient #9’s hemoglobin test results indicated the following: * 3/19/24 - 8.4 * 3/12/24 - 9.9 * 3/5/24 - 9.8 * 2/27/24 - 10.3 * 2/20/24 - 9.7 Review of the Physician Treatment Medication orders, dated 2/3/24, indicated an order for Mircera 75 micrograms (mcg) intravenously, every 2 weeks, during dialysis. Review of the clinical record indicated that this dose of Mircera was administered on 2/3/24 and 2/20/24. Review of the Physician Treatment Medication orders, dated 3/8/24, indicated an order for Mircera 100 mcg intravenously every 2 weeks during dialysis. Hemoglobin results from 10.3 on 2/27/24 to 9.8 on 3/5/24 and 9.9 on 3/12/24. Review of the clinical record indicated that this dose of Mircera was not administered. Review of the Physician Treatment Medication orders, dated 3/23/24, indicated an order for Mircera 150 mcg intravenously every 2 weeks during dialysis. Further decrease of hemoglobin results from 9.9 on 3/12/24 to 8.4 on 3/19/24. Review of the medical record indicated that this dose of Mircera was not administered. During interview on 3/27/24 at 10:15 A.M., the Clinic Manager (CM) said that Patient #9 missed a dose of Mircera on 2/17/24, so it was rescheduled and administered on 2/20/24, the next treatment day. She said based on Patient #9’s hemoglobin of 9.8 on 3/5/24, the dose of Mircera was increased to 100 mcg and should have been administered on 3/9/24, but the patient did not come to his/her treatment. She said the patient should have received Mircera at the next treatment, but did not. She said based on Patient #9’s hemoglobin of 8.4 on 3/19/24, the dose of Mircera was increased to 150 mcg and should have been administered on 3/23/24, but the patient did not come to his/her treatment. She said the patient should have received Mircera at the next treatment, but did not.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 44223 Based on observation and interview, the facility failed to ensure 2 of 9 staff (Certified Clinical Hemodialysis Technician [CCHT] #1 and CCHT #8) observed did not use excessive force on the Normal Saline bag during the rinse back phase of dialysis (returning of blood back to the patient) for 2 patients (#4, #12) observed out of a total sample of 16 patients, which can cause damage to the patient access site. Findings Include: Review of the facility policy titled, Termination of Treatment Using an Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer, dated 2/7/22, indicated the following, but is not limited to: *Purpose: The purpose of this policy is to provide direction to re-infuse blood in the extracorporeal system to the patient at completion of the hemodialysis treatment using an arteriovenous fistula (AVF) or graft and an Optiflux Single Use electron beam (Ebeam) Dialyzer. *Termination: Returning the Blood from Arterial Segment *While closely monitoring the access site, return blood through the arterial line either by gravity, or by applying gentle pressure to the saline bag. *Do not apply excessive pressure on the saline bag; this may cause damage to the access. 1. On 3/26/24 at 9:15 A.M., the surveyor observed CCHT #8 at station #11, terminating dialysis for Patient #12. CCHT #8 twisted the upper portion of the Normal Saline bag used to flush back the blood and then used excessive force squeezing the solution back through the dialysis circuit to forcibly push the saline back through the dialysis system to the patient’s AVF access. 2. On 3/26/24 at 12:45 P.M., the surveyor observed CCHT #1 in the isolation room, terminating dialysis for Patient #4. CCHT #1 twisted the upper portion of the Normal Saline bag to flush back the blood and then used excessive force squeezing and twisting the bag to forcibly push the saline back through the dialysis system to the patient’s AVF access. During an interview on 3/26/24 at 3:15 P.M., the Facility Administrator said that squeezing and twisting the saline bag is not part of the dialysis practice, and should not have been done.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 37700 Based on record review and staff interview, the interdisciplinary team failed to provide the necessary monitoring and social work interventions to assist patients in achieving and sustaining an appropriate psychosocial status, as measured by a standardized mental and physical assessment tool chosen by the Social Worker, (Kidney Disease Quality of Life survey [KDQOL-36]), at regular intervals, or more frequently on an as-needed basis for 1 of 16 sampled patient records reviewed (#4). Findings include: Review of the facility policy titled, Measuring Patient Physical and Mental Function, published 4/4/12, indicated the following, but is not limited to: *At a minimum, the KDQOL-36 will be administered annually with each patient as part of the annual assessment and plan of care. The KDQOL-36 may be administered at more frequent times as determined by the Social Worker or Interdisciplinary (IDT) team to assist with the patient’s plan of care. *Any exception to completing the KDQOL-36 must be documented in the medical record. At a minimum, the patient should be assessed annually to determine if a change in the patient’s ability to complete a survey has changed. Patient #4 was admitted to the facility in September 2021 with a diagnosis of End Stage Renal Disease (ESRD) and had a language barrier. Review of the clinical record indicated a KDQOL-36 Exclusion/Refusal Report, dated 10/18/23. The form indicated the reason the form was not completed was due to a language barrier. The form was not dated or signed by the Social Worker. During an interview on 3/27/24 at 12:45 P.M., the Social Worker said she did not do an annual KDQOL-36 Assessment for 2023 due to Patient #4 having a language barrier. She said she did have a KDQOL-36 Assessment in the language the Patient #4 would understand, but she did not utilize it. She said she did not document in Patient #4 medical record the reason the assessment was not completed nor did she sign and date the Exclusion/Refusal Report, as required. Please refer to V628.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 37700 Based on record review, staff interview, and policy review, the facility failed to ensure the plan of care was reviewed by the patient/designee, or if the the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided, to ensure the patient involvement with his/her plan of care for 1 of 10 applicable patients (#4), from a total sample of 16 patients. Findings include: Patient #4 was admitted to the facility in September 2021 with a diagnosis of End Stage Renal Disease (ESRD). Review of the facility policy titled, Comprehensive Interdisciplinary Assessment and Plan of Care, published 7/2/23, indicated the following, but is not limited to: *If a patient and/or designee is unable or unwilling to attend the Plan of Care meeting or if the patient attends via telehealth/virtual: *The registered nurse may review the Plan of Care as developed by the Interdisciplinary Team (IDT) at the meeting with the patient and obtain the patient’s signature and any comments. *If the patient is not physically present at the meeting, or is remote at the time of review, signature may be obtained at a later date. *The patient’s level of participation is determined by the patient. The patient must sign the plan of care meant to acknowledge the information in the plan. If the patient chooses not to sign their plan of care, the reason for refusal must be documented in the patient’s medical record. Review of the clinical record indicated a Plan of Care meeting was held on 10/27/23. Review of the the Plan of Care Patient Approval Signature form was blank and did not indicate if patient/designee reviewed or participated in the plan of care or if the patient chose not to sign the plan of care. During an interview on 3/27/24 at 1:00 P.M., the Clinical Manager said she could not find any documentation to indicate the patient/designee reviewed or participated in the the Plan of Care meeting or chose not to sign the Plan of Care, as required.”

“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: 10249 Based on Quality Assurance Performance Improvement (QAPI) meeting minutes/program review, Kidney Disease Quality of Life survey (KDQOL-36 [rating of symptoms, problems and burdens of kidney disease]) reports, No Show missed treatment data, staff interviews, and policy review, the facility QAPI Committee failed to 1.) analyze data related to KDQOL-36 to identify potential problems and identify opportunities for improving care; and 2.) analyze data related to No Show missed treatments to identify opportunities for improving care. Findings include: Review of the facility policy titled, Quality Assessment and Performance Improvement, published 5/2/2022, indicated the following, but not limited to: *The QAPI program is a collaborative among the interdisciplinary team that must develop, implement, maintain, and evaluate an effective, data driven, quality assessment and performance improvement program. QAPI requires the use of aggregate patient data to evaluate the facility patient outcome. *QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. *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. *Elements to be reviewed will include: (but not limited to) -Infection surveillance. -Patient safety. -Patient care outcomes. -Staff training and education. *Following a root cause analysis, action plans will be determined and prioritized by the QAPI Committee, considering the prevalence and severity of identified problems and by ranking those which have potential to effect patient health and safety as a higher priority than those that do not have such potential. The facility must take immediate and appropriate actions to address any serious threats and ensure patient safety. 1. The facility QAPI Committee failed to analyze data related to KDQOL-36 to identify potential problems, and identify opportunities for improving care. Review of the QAPI data in regards to KDQOL-36 refusal rate (September 2023 to March 2024) indicated the following: *September 2023-facility refusal rate: 0% *October 2023-facility refusal rate: 50% *November 2023-facility refusal rate: 75% *December 2023-facility refusal rate: 0% *January 2024-facility refusal rate: 33% *February 2024 -facility refusal rate: 0% *March 2024- facility refusal rate: 40% The current year to date refusal average was 32.0%, and the corporate refusal rate was 8.6%. There was no indication that the refusal rates were analyzed, or an action plan developed to decrease the refusal rates. During an interview on 3/28/24 at 11:15 A.M., the Social Worker said she knew the refusal rate was high, because she reviews the data monthly, but did not analyze the data to identify why. She said she did not bring it forward to the QAPI team, and/or develop an action plan. 2. The facility QAPI Committee failed to analyze data related to No show/missed treatments to identify problems, and opportunities for improving care. Review of the QAPI data in regards to No Show Missed Treatments (September 2023 to January 2024) indicated the following: *September 2023-no show missed treatment rate: 15.7% *October 2023-no show missed treatment rate: 20% *November 2023-no show missed treatment rate: 28.7% *December 2023-no show missed treatment rate: 20.5% *January 2024-no show missed treatment rate: 27.6% *Data not available for February and March 2024. There was no indication that the No Show Missed Treatment rates were analyzed, or an action plan developed to decrease the rates of no show missed treatments. During an interview on 3/28/24 at 11:20 A.M., the Social Worker said she was aware the no show missed treatment data was high, however she never brought it forward to a QAPI meeting to discuss with the team. She also said there is no action plan created to address the no show missed treatments at the center.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 10249 Based on observation, Quality Assessment and Performance Improvement (QAPI) minutes review, Clinic Audit Checklist review, staff interview, and policy review, the facility failed to conduct 5 of 6 monthly clinic audits for infection control and despite conducting monthly audits in 1 of 6 months reviewed, the facility failed to sustain an effective performance improvement program in regards to the facility’s infection control program and procedures. Findings include: Review of the facility policy titled, Quality Assessment and Performance Improvement Program, published 5/2/22, included the following: * 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. * Elements to be reviewed will include: Infection Surveillance. * An effective and successful review of the QAPI meeting and program activities will include: review of the results of required self-audits. Review of 6 months of infection control clinic audits, dated September 2023 through February 2024, indicated clinic audits were not completed for 5 of 6 months, including September 2023, October 2023, November 2023, December 2023, and January 2024. Review of the infection control audit completed February 19, 2024, included 1 staff member, for Central Venous Catheter (CVC) exit site care and initiation of dialysis with a CVC with 90-100% accuracy. During this survey conducted from 3/26/24 through 3/28/24, the surveyors observed the following breaches in infection control: *Certified Clinical Hemodialysis Technician (CCHT) #1 failed to change his gloves and performed hand hygiene to reduce the risk of infection and cross contamination when providing care for Patient (#13). *CCHT #6 failed to correctly wear Personal Protective Equipment (PPE) during times when potential for spurting or splattering of blood, or potentially contaminated substances or chemicals may occur. *CCHT #1 and CCHT #7 failed to remove their mask prior to exiting the isolation room after caring for a patient known to have a Hepatitis B infection (HBsAg positive). *The facility failed to ensure that clean areas were clearly separated from contaminated areas as required, relative to staff PPE being stored in an area containing and coming in contact with patient personal items and biohazard containers. *CCHT #1 and CCHT #8 failed to adequately clean and disinfect contaminated surfaces, medical devices, and equipment within the dialysis station, on the treatment floor and in the isolation room, therefore increasing the risk for cross contamination of blood borne pathogens. *CCHT #1 failed to ensure the door to the isolation room was closed before discontinuing the dialysis treatment for Patient #4, with a known Hepatitis B infection, increasing the risk of spread of infection. *Registered Nurse (RN) #5 failed to prepared intravenous (IV) medication using aseptic technique to prevent cross contamination of the contents of the IV vial. *CCHT #6 failed to perform adequate infection control practices to minimize the risk of infection during exit site care for Patient (#11). During an interview on 3/28/24 at 11:00 A.M., the Facility Administrator said he had started at the facility in February 2024, and could not find any other infection control audits prior to February 2024.”

“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: 10249 Based on record review, staff interview, and policy review, the Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration to initiate treatment for 2 of 8 applicable patients (#10 and #6) records reviewed, out of a total sample of 16 patients. Findings Include: Review of the facility policy titled, Heparinization, published 8/3/2020, indicated the following, but not limited to: *Attach heparin syringe to the catheter port or access needle line. Gently push and pull syringe plunger back and forth 3 or more times to infuse ordered heparin. Following infusion, prior to treatment initiation, wait 3-5 minutes to allow systemic anticoagulation to occur. 1. For Patient #10, the Medical Director failed to ensure that staff adhered to the facility policy for administering IV heparin. Review of the clinical record for Patient #10 indicated a physician’s order for a 5000 unit bolus of heparin to be administered prior to every dialysis treatment. Review of 9 treatment flow sheets, dated 2/8/24 through 3/23/24, indicated that staff administered heparin and did not wait 3-5 minutes prior to initiation of dialysis for 4 of 9 treatments, including: *2/8/24 - Heparin was documented as administered at 11:24 A.M., treatment started at 11:04 A.M., staff failed to administer the heparin bolus 3-5 minutes prior to starting the treatment. *2/10/24 - Heparin was documented as administered at 11:21 A.M., treatment started at 10:56 A.M., staff failed to administer the heparin bolus 3-5 minutes prior to starting the treatment. *2/20/24 - Heparin was documented as administered at 11:19 A.M., treatment started 11:11 A.M., staff failed to administer the heparin bolus 3-5 minutes prior to the start of treatment. *3/21/24 - Heparin was administered at 11:10 A.M., treatment started at 11:10 A.M., staff did not wait 3-5 minutes. During an interview on 3/28/24 at 10:10 A.M., the Clinic Manager said after heparin administration, staff should wait 3-5 minutes before starting the patient’s dialysis treatment. 37349 2. For Patient #6, the Medical Director failed to ensure that staff adhered to the facility policy for administering IV heparin. Review of the clinical record for Patient #6 indicated a physician order for a 1000 unit bolus of heparin, prior to every dialysis treatment. Review of 9 treatment flow sheets, dated 1/31/24 through 3/22/24, indicated that staff administered heparin and did not wait 3-5 minutes prior to initiation of dialysis for 6 of 9 treatments, including: *2/5/24 - Heparin was documented as administered at 9:40 A.M., after treatment ended at 9:15 A.M., treatment started at 5:40 A.M., staff did not wait 3-5 minutes. *3/11/24 - Heparin was administered at 5:30 A.M., treatment started at 5:30 A.M., staff did not wait 3-5 minutes. *3/13/24 - Heparin was administered at 6:05 A.M., treatment started at 6:05 A.M., staff did not wait 3-5 minutes. *3/15/24 - Heparin was administered at 8:00 A.M., treatment started at 8:01 A.M., staff did not wait 3-5 minutes. *3/20/24 - Heparin was administered at 5:25 A.M., treatment started at 5:25 A.M., staff did not wait 3-5 minutes. *3/22/24 - Heparin was administered at 5:25 A.M., treatment started at 5:27 A.M., staff did not wait 3-5 minutes. During an interview on 3/28/24 at 10:10 A.M., the Clinic Manager said after heparin administration, staff should wait 3-5 minutes before starting the patient’s dialysis treatment.”