Davita Greystone 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: 30952 Based on observations, review of the facility policy, and interviews, it was determined the facility failed to ensure: 1. Patients performed hand hygiene after holding access sites and prior to leaving the treatment area in one of three observations for discontinuation of dialysis and post dialysis access care for AVF/AVG (arteriovenous fistula/graft), including PI (Patient Identifier) # 3, and two random observations on unsampled patients. 2. Staff performed hand hygiene after conductivity and pH (potential of hydrogen) testing of the final dialysate, before entering the dialysis station and touching the dialysis delivery system in one of five observations for preparation of the hemodialysis machine including PI # 14. This had the potential to negatively affect all forty-one patients who dialyze at the facility, staff, and visitors. Findings include: Facility In-center Hemodialysis Policy: 1-05-01 Title: Infection Control for Dialysis Facilities Revision Date: April 2023 Hand Hygiene 1. All teammates...will perform hand hygiene ...b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, ...g. before touching clean areas such as supplies... 2. Patients...will be encouraged to... b. Perform hand hygiene after treatment before leaving treatment area. ...7. Gloves should be changed when: i....soiled with...dialysate or other...fluids ii. When going from a “dirty” area or task to a “clean” area or task ...iv. After touching...their dialysis delivery system... Findings include: 1. An observation of care was conducted on survey day one, 12/12/23 at 9:05 AM with EI (Employee Identifier) # 4, Patient Care Technician, to discontinue dialysis of an AVF/AVG at station one on PI # 3. After holding pressure to both cannulation sites with a gloved hand, PI # 3 removed his/her glove and proceeded to exit the treatment floor at approximately 9:25 AM without performing hand hygiene per facility policy. An interview was conducted on 12/14/23 at 11:00 AM with EI # 2, Facility Administrator who confirmed staff failed to ensure PI # 3 performed hand hygiene after removing gloves per facility policy. 2. Observations of care were performed on survey day two, 12/13/23 from 9:30 AM to 10:45 AM. a. At 9:55 AM, the surveyor observed EI # 6, Certified Clinical Hemodialysis Technician, with gloved hands, working with PI # 14 at station eleven, collect the final dialysate, exit the station to the pH/conductivity test station, test the pH/conductivity, return to station eleven with same gloves on, then document on the dialysis delivery system keyboard. EI # 6 failed to remove gloves and perform hand hygiene after contact with dialysate during pH/conductivity testing. b. At 10:00 AM, the surveyor observed an unsampled patient, with a gloved hand, at station four holding his/her access site. The unsampled patient had a bleeding access and required staff attention with additional gauze/tape application. At approximately 10:15 AM, the unsampled patient exited the treatment floor without first performing hand hygiene. c. At 10:05 AM, the surveyor observed an unsampled patient, with a gloved hand, at station ten holding his/her access site. At approximately 10:25 AM the unsampled patient exited the treatment floor without first performing hand hygiene. Staff failed to remind/encourage patient compliance with hand hygiene after holding access sites, after glove removal, and prior to leaving the treatment floor. An interview was conducted on 12/14/23 at 11:00 AM with EI # 2 who confirmed staff failed to perform hand hygiene after testing dialysate and ensure patients performed hand hygiene after removing gloves and leaving the treatment floor per facility policy.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 30952 Based on observations, review of facility policy, and interview, it was determined the facility failed to ensure the staff cleaned and disinfected equipment before returning it to a common clean area or being used on another patient. This affected two unsampled patients on survey day two during observations of care and had the potential to affect all patients served by this facility. Findings Include: Facility Policy Number: 1-05-01 Policy Title: Infection Control for Dialysis Facilities Revision Date: October 2020 Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ...Teammate/Patient Safety ...25. Non-disposable items are to be disinfected between patients. ...34. If electronic thermometers ...are used, measures will be taken to prevent cross contamination between patients... If the potential for contamination exists, the device outercasing is wiped with an appropriate disinfectant before being returned to clean area or using on another patient. ...Dialysis Station Management ...65. Items taken into the dialysis station will be... cleaned and disinfected before taken to a common area or used on another patient... 66. Teammates will thoroughly wipe down all non-disposable items and equipment...with an appropriate disinfectant... 1. During observations of care on 12/13/23 at 9:35 AM, the surveyor observed EI (Employee Identifier) # 7, Registered Nurse, retrieve the electronic thermometer from the clean counter, check an unsampled patient’s temperature at station 1, then return the thermometer to the clean counter, next to clean supplies, without first cleaning the thermometer, per policy. 2. During observations of care on 12/13/23 at 9:50 AM, the surveyor observed EI # 6, Certified Clinical Hemodialysis Technician, retrieve the electronic thermometer from the clean counter, test an unsampled patient’s temperature at station 11, returned the thermometer to the clean counter, next to clean supplies, without first cleaning the thermometer, per policy. An interview was conducted on 12/14/23 at 11:00 AM with EI # 1, Director of Clinical Services, who confirmed the thermometer should be cleaned before being returned to the clean counter.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 41623 Based on observations, facility policy, and interview it was determined the facility failed to ensure staff did not store patient care supplies in the uniform pockets. This affected two of two observations of Central Venous Catheter (CVC) exit site care and did affect Patient Identifier (PI) # 8, PI # 5, and had the potential to affect all patients with CVC catheters at this facility. Findings include: Facility Policy Number: 1-05-01 Title: Infection Control for Dialysis Facilities Revision Date: April 2023 ...Supplies 8. Supplies will be stored in a manner that maintains their integrity... 11. Measures will be taken to prevent cross contamination between patients. a. Medication vials...or other supplies will not be carried in pockets... 1. An observation of CVC exit site care was conducted on 12/12/23 at 8:40 AM at station seven. After applying the dressing to PI # 8’s CVC site, Employee Identifier (EI) # 3, Registered Nurse (RN)/Preceptor, reached into his/her uniform pocket, removed a permanent marker, dated the CVC dressing on PI # 8, then replaced the marker in his/her uniform pocket. 2. An observation of CVC exit site care was conducted on 12/12/23 at 10:40 AM at station nine. After applying the dressing to PI # 5’s CVC site, EI # 3 reached into his/her uniform pocket, removed a permanent marker, dated the CVC dressing on PI # 5, then replaced the marker in his/her uniform pocket. An interview was conducted on 12/14/23 at 10:15 AM with EI # 2, Facility Administrator, who confirmed the staff failed to follow the facility policy for storage of patient care supplies.”

“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: 30952 Based on observation, facility policy, and interviews, it was determined the facility failed to ensure staff followed the facility policy for cleaning and disinfection of the dialysis station between patients in one of three observations of dialysis station disinfection. This did affect PI (Patient Identifier) # 6 and had the potential to affect all forty-one patients who dialyze at this facility. Findings include: Facility Policy Number: 1-05-01 Title: Infection Control for Dialysis Facilities Revision Date: April 2023 Purpose: To minimize the spread of infections or blood borne pathogens in the dialysis facility environment. Disinfection ...12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or potentially infectious materials (i.e.,used or brought into the station) ...b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. ...ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g...countertops). ...i. The Wall box...considered part of the dialysis delivery system... ii. Priming containers are to be emptied prior to disinfection... Facility Hygiene 16. Clean areas should be clearly designated for the...handling, and storage of...unused supplies...Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. 1. An observation was conducted on 12/12/23 at 9:30 AM at station one with Employee Identifier (EI) # 4, PCT (Patient Care Technician), during cleaning and disinfection of the dialysis station. EI # 4 first cleaned the dialysis machine, but failed to remove the prime container, empty the solution contents, disinfect the container, and the surface area under the prime container. EI # 4 failed to disinfect the Hansen connector and Hansen hoses. EI # 4 failed to disinfect the plastic bag on the intravenous pole, and the surrounding countertops. EI # 4 failed to open the chair arms, disinfect the inside of the arms of the treatment chair, and fully recline the treatment chair during cleaning/disinfection. EI # 4 exited station one, retrieved new supplies, a dialyzer, the bloodlines, the saline solution bag, and set up the dialysis machine for the next patient. An interview was conducted on 12/12/23 at 9:40 AM with EI # 4. The surveyor asked EI # 4 where solution in the prime container came from? EI # 4 reported the solution inside the prime container was from the saline solution hanging on the dialysis machine. The surveyor informed EI # 4 he/she had not yet primed the saline solution. EI # 4 confirmed the solution in the prime container was from the last patient treatment and that he/she failed to remove the prime container, empty the solution, and disinfect the prime container before beginning disinfection of the dialysis machine. EI # 4 then removed the prime container, emptied the solution into the dirty sink, wiped the inside/outside of the prime container, and replaced the prime container onto the dialysis machine. EI # 4 failed to remove the newly set up dialyzer, bloodlines, and saline solution from the dialysis machine set up before the prime container was disinfected. EI # 4 failed to ensure the dialysis station was completely disinfected between patient’s dialysis treatment before PI # 6 entered station one at 10:55 AM. An interview was conducted on 12/14/23 at 11:00 AM with EI # 2, Facility Administrator, who confirmed the dialysis station was not cleaned and disinfected between patients per facility policy.”

“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: 30952 Based on the facility policy, observation, and interview, it was determined the facility failed to ensure staff followed aseptic technique during IV (intravenous) medication preparation (med prep) in one of one observation for multi-dose vial (MDV) preparation. The failure to follow aseptic technique during medication preparation had the potential for cross contamination. This affected PI (Patient Identifier) # 5 and had the potential to negatively affect all forty-one incenter patients who dialyze at the facility. Findings include: Facility Incenter Hemodialysis Policy Number: 1-06-01 Title: Medication Policy Revision Date: November 2023 PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. POLICY: 1. ...multi-dose vials used for IV administration must be entered each time with a new sterile syringe and needle due to Centers for Disease Control (CDC) guidance that states residual amounts of medication from multi-dose vial (either in vial or syringe) must never be pooled with medication from another vial or syringe... 1. An observation was conducted on 12/14/23 at 8:40 AM with EI (Employee Identifier) # 3, RN (Registered Nurse)/Preceptor during MDV IV Heparin med prep at the nurse’s counter. EI # 3 wiped the rubber septum of opened vial of Heparin, withdrew medication, opened a new MDV of Heparin, wiped the rubber septum with alcohol, and with the same syringe/needle used to withdraw from previous bottle, withdrew Heparin from the new MDV vial. EI # 3 failed to use a sterile syringe and sterile needle to enter the Heparin MDV. On 12/14/23 at 10:50 AM, EI # 3 entered station two and administered PI # 5’s IV Heparin. An interview was conducted on 12/14/23 at 11:00 AM with EI # 1, Director of Clinical Services, and EI # 2, Facility Administrator, who confirmed the medication vial must always be entered with a new needle to prevent cross contamination of the medication vial.”

“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: 30952 Based on facility procedure, record review, and interview, it was determined the facility failed to ensure staff performed Central Venous Catheter (CVC) care per facility procedure. This affected two of three records reviewed with a CVC, including Patient Identifier (PI) # 5 and PI # 1 and had the potential to negatively affect all patients with CVC’s who dialyze at the facility. Findings include: Facility Procedure Number: 1-04-02 B Title: CVC With ClearGuard HD (Hemodialysis) Antimicrobial End Caps Procedure Revision Date: October 2023 ...CVC with ClearGuard HD Antimicrobial End Caps... Notes ... DaVita’s first choice for CVC care is 2% Chlorhexidine/70% Alcohol swab. If these agents are contraindicated for a patient, the physician will prescribe an agent for the individual patient and individual supplies will be used in place of the CVC kit... Procedure. ...8...Holding catheter with non-dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab... ...Upon completion of Dialysis... 34... While holding the shield and catheter hub in one hand, remove the single ClearGuard HD cap (red or blue)...Carefully insert the ClearGuard HD rod into the catheter hub and using a simultaneous push and twist motion, tighten by rotating clockwise. Repeat with the other ClearGuard HD cap and dispose of the shield and foil pouch... 37...Document findings and procedure in patient’s electronic health record... 1. PI # 5 was admitted to the facility on 8/26/23 with diagnosis including ESRD (End Stage Renal Disease). Review of the Comprehensive Assessment Report Dated 10/24/23 revealed PI # 5 had no known allergies. Review of the Treatment Details Reports (TDR) dated 11/28/23 and 12/09/23 revealed the nurse documented alcohol and ExSept was used to clean CVC. Staff failed to follow facility preferred choice for CVC 2% Chlorhexidine/ 70% Alcohol. PI # 5 had no documented allergies and there was no documentation the preferred agents were contraindicated for PI # 5. Review of the TDR dated 11/30/23 revealed the nurse documented the CVC site was prepped “...using chlorhexidine topical antiseptic; Access site prepped using Iodine topical antiseptic...”. Staff failed to follow the facility preferred choice for CVC 2% Chlorhexidine/ 70% Alcohol. PI # 5 had no documented allergies and there was no documentation the preferred agents were contraindicated for PI # 5. Review of the TDR dated 12/02/23 revealed the nurse documented status Not Fulfilled (Not Changed) for CVC Cap-ClearGuard. Staff failed to follow facility procedure and change the CVC caps upon dialysis completion. An interview was conducted on 12/14/23 at 10:23 AM with EI (Employee Identifier) #1, Director of Clinical Services who confirmed staff failed to follow and document CVC care per the facility procedure. 2. PI #1 was admitted to the facility on 9/19/23 with diagnosis including ESRD. Review of the Comprehensive Assessment Report dated 10/14/23 revealed PI # 1 had no known allergies. Review of the TDR dated 11/28/23 and 11/30/23 revealed the nurse documented the CVC site was prepped using ExSept topical antiseptic. Staff failed to follow facility preferred choice for CVC site care with CVC 2% Chlorhexidine/ 70% Alcohol. PI # 1 had no documented allergies and there was no documentation the preferred agents were contraindicated for PI # 1. Review of the TDR dated 12/09/23 revealed the nurse documented alcohol and ExSept was used to clean CVC exit site. Staff failed to follow facility preferred choice for CVC site care with CVC 2% Chlorhexidine/ 70% Alcohol swab. PI # 1 had no documented allergies and there was no documentation the preferred agents were contraindicated for PI # 1. Review of the TDR’s dated 12/02/23 and 12/07/23 revealed the nurse documented status Not Fulfilled (Not Changed) for CVC Cap-ClearGuard. Staff failed to follow facility policy for CVC cap change upon dialysis completion. An interview was conducted on 12/14/23 at 10:37 AM with EI # 2, Facility Administrator who confirmed staff failed to follow the facility procedure for CVC care.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 30952 Based on observations, medical record (MR) review, facility policy and procedures, and interviews, it was determined the facility failed to ensure: 1. Staff followed facility procedures for final dialysate conductivity testing. 2. Staff correctly interpreted the conductivity results and documented accurate results in the patient medical record. 3. Staff completed pH (potential of hydrogen) testing of the final dialysate and documented accurate pH test results in the patient medical record. This affected four of five observations for preparation of the hemodialysis machine prior to treatment initiation including Patient Identifier (PI) # 6, PI # 17, PI # 5, and PI # 7. This had the potential to negatively affect the forty-one patients who dialyze at the facility. Findings include: Facility Policy: Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate Policy: 1-03-02 Revision Date: April 2020 Purpose: To provide guidance for testing and documenting pH, conductivity, and temperature of proportioned dialysate. POLICY: 1. Trained teammates will test pH and conductivity of final dialysate utilizing appropriate test strips and meters prior to each patient treatment. ...3. Document results in the electronic treatment record or dialysis delivery system... 4. The acceptable range for machine displayed and final conductivity is 13-15.5 mS (millisiemens)... 7. The acceptable range for final dialysate pH is 6.9-7.6. Check independent pH...for final dialysate. ...9. If using a non-central acid delivery system...verify dialysate and conductivity and pH when changing acid concentration formulation during the course of a treatment... Facility Procedure: 2-08-01K Title: Testing of pH (pH is a measure of acidity or alkalinity) for Acetate Based Dialysate Using RPC E-Z CHEK K100-0117 6.8-8.5 Test Strips Revision Date: October 2023 Materials required: RPC E-Z CHEK K100-0117 6.8-8.5 Test Strips Disposable collection cup... ...Procedure 1....Remove strip from the vial...recap the vial. 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. After 10 seconds, compare the strip to the color chart on the bottle. 4. Match the strip as closely as possible to one of color scales...and read the pH range listed above the matched color. 5. pH test results should be between 6.9-7.6. 6. If results are outside the limit...repeat test on another dialysate sample. 7. If repeat test is outside limit...the dialysis delivery system is unsafe to use for patient treatments... 8. If results are within range of 6.9-7.6 document results and proceed with dialysis set up. The dialysis delivery system is within acceptable pH limits for use. Facility Procedure: 2-08-01B Title: Operation of Portable Myron L Conductivity Meter (D-1) Revision Date: October 2021 Material required: Myron L dialysate meter... D1 meter plunger/clean sample collection container or disposable collection cup Dialysis delivery system in conductivity and without conductivity alarms Dialysis quality water... NOTES: Manual pH testing must be performed prior to each patient treatment. ...The plunger enclosed with the dialysate meter has been calibrated specifically for this instrument... ...Procedure 2. Obtain proportioned dialysate sample per manufacturer’s recommendations using the D-1 dipper side of the plunger or a clean disposable collection cup. 3. Fill meter cell cup with sample so upper electrode is immersed. Insert plunger. 4. Agitate sample with plunger by moving up and down 3 or 4 times and then discard sample. 5. Repeat Steps # (number) 3 and # 4-at least 3 times. 6. Obtain another proportioned dialysate sample and fill the meter, drop plunger in the solution and press the black button. When the pointer stops, immediately read, and release the button. 7. Repeat step # 6 twice and press Read/Check button and record conductivity reading. 8. If result is not within acceptable range, recalibrate meter and retest. If results are still outside acceptable range, do not use. Notify Biomed Service Specialist teammate. 9. Document acceptable results in electronic treatment system... 10. When you are finished with the DI meter, RINSE thoroughly with dialysis quality water. Clean the exterior of the meter wit 1:100 bleach solution... The following observations of care were conducted on survey day one on 12/12/23 at the facility for final dialysate conductivity and pH testing: 1. At 9:40 AM, EI (Employee Identifier) # 4, Patient Care Technician (PCT), exited station one with two collection cups of dialysate solution, to the testing station, retrieved the Myron L meter, poured dialysate sample one into the meter cell cup, then discarded the sample. EI # 4 failed to insert the plunger, agitate the sample with plunger by moving up and down 3 or 4 times, then discard the dialysate sample. EI # 4 repeated the above steps with two additional samples, and with the fourth dialysate sample inserted the plunger into the cell cup, read the conductivity results as 12.4, which was incorrect, the correct conductivity reading was 12.8, which was below the acceptable parameter 13-15.5. EI # 4 discarded the sample and replaced the Myron L meter without rinsing with RO water and cleaning the meter with 1:100 bleach. EI # 4 failed to perform pH testing of the final dialysate sample for PI # 6’s treatment. EI # 4 failed to ensure the conductivity results were within acceptable parameters before treatment initiation for PI # 6. EI # 4 failed to rinse and clean the Myron L meter after use. 2. PI # 6 was admitted to the facility on 9/26/23 with a diagnosis of ESRD (End Stage Renal Disease). Review of the Treatment Details Report (TDR) dated 12/12/23 revealed dialysis machine setup documentation for the manual conductivity was 13.3 mS, and not 12.4 mS as reported by EI # 4 (the accurate conductivity was 12.8 observed by the surveyor). The manual pH documented was pH 7.0, however EI # 4 failed to perform pH testing for PI # 6 at station one on 12/12/23. An interview was conducted on 12/14/23 at 11:00 AM with EI # 1, Director of Clinical Services, and EI # 2, Facility Administrator, who confirmed the staff failed to follow the facility policy and procedure for testing, interpreting test results, and accurate documentation of the final dialysate conductivity and pH. 3. An observation of conductivity and pH testing was conducted on 12/12/23 at 10:05 AM for PI # 17 at station two. EI # 4 obtained a dialysate sample from the dialysis machine at station two. EI # 4 poured the sample in the Myron L meter, agitated the plunger, and discarded the sample three times. On the fourth sample, EI # 4 read the display and verbalized the reading as 13.6 mS. EI # 4 returned to station two and entered the data into PI # 17’s record. EI # 4 failed to rinse the Myron L meter with RO water after use. EI # 4 failed to perform a pH test on the final dialysate sample at station two. 4. PI # 17 was admitted on 12/9/21 with a diagnosis of ESRD. Review of the TDR dated 12/12/23 revealed the staff documented a Manual Conductivity of 13.6 mS and a pH of 7.0. In an interview conducted on 12/14/23 at 11:00 AM, EI # 1 confirmed the staff failed to follow facility policy for use of the Myron L meter and pH testing. 5. At 10:20 AM at station nine, EI # 5, CCHT (Certified Clinical Hemodialysis Technician) exited the station with two sample cups from the HD machine sample port. EI # 5 poured the dialysate sample in the Myron L meter, agitated the plunger, and discarded the sample three times. On the fourth sample, EI # 5 verbalized the conductivity was 12.6 mS, which was below the acceptable range of 13.0 mS. EI # 5 then rinsed the meter and recalibrated the Myron L meter with the standard solution. After recalibration, EI # 5 repeated the test with the sample from station nine. The conductivity as observed by the surveyor was 12.6 mS. EI # 5 returned to station nine and entered the data from the testing for PI # 5. 6. PI # 5 was admitted to the facility on 8/26/23 with a diagnosis of ESRD. Review of the TDR dated 12/12/23 revealed the staff documented the Manual Conductivity was 13.0 mS, not the 12.6 mS verified during the manual conductivity performed by EI # 5. In an interview conducted on 12/14/23 at 11:00 AM, EI # 1 confirmed the staff failed to follow facility policy for conductivity testing and documentation. 7. At 10:55 AM, EI # 5 entered the test station with two syringes of final dialysate from station six. EI # 5 completed the conductivity test for PI # 7’s treatment using the Myron L meter, interpreted the conduct results as 12.8. The surveyor observed the meter results, and asked EI # 5 what the conductivity results were? EI # 5 again responded 12.8. After final dialysate pH testing EI # 5 exited the test station. EI # 5 failed to ensure the final dialysate conductivity results were within the acceptable range 13.0-15.5 before dialysis treatment initiation for PI # 7. 8. PI # 7 was admitted to the facility on 6/11/2020 with a diagnosis of ESRD. Review of the TDR dated 12/12/23 revealed dialysis machine setup documentation for the manual conductivity 13.0 mS, and not 12.8 mS as reported by EI # 5 and observed by the surveyor. An interview was conducted on 12/14/23 at 11:00 AM with EI # 1, and EI # 2 who confirmed staff failed to follow the facility procedure for final dialysate conductivity and document accurate test results. 41623”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 30952 Based on review of facility policy, personnel file documentation, and interview, it was determined the facility failed to ensure staff responsible for testing of pH (potential of hydrogen) on the hemodialysis (HD) machines prior to treatment initiation had a verified competency documented. This affected one of one direct care staff personnel file reviews for staff performing final dialysate pH testing and had the potential to negatively affect all forty-one patients who dialyze at this facility. Findings Include: Facility Policy: Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate Policy: 1-03-02 Revision Date: April 2020 Purpose: To provide guidance for testing and documenting pH, conductivity, and temperature of proportioned dialysate. POLICY: 1. Trained teammates will test pH...of final dialysate utilizing appropriate test strips and meters prior to each patient treatment. 1. An observation of care was conducted on 12/12/23 at 10:05 AM at station two to observe Employee Identifier (EI) # 4, PCT (Patient Care Technician), perform pH and conductivity testing of the final dialysate for preparation of the dialysis machine. EI # 4 performed the conductivity test using the Myron L meter. However, EI # 4 failed to perform pH testing of the final dialysate for station two. Review of EI # 4’s personnel file included no documentation of competency validation for use of RPC Brand 6.8-8.5 pH Test Strips in use at the facility for final dialysate pH testing. An interview was conducted on 12/14/23 at 9:35 AM with EI # 1, Director of Clinical Services, who confirmed there was no documentation PI # 4 had competency validation for testing of the final dialysate pH using RPC pH test strips.”

“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: 30952 Based on observations, review of the manufacturer’s directions for use (DFU), facility policy and procedure, and interview, the facility failed to ensure staff followed the bloodline manufacturer’s DFU during dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing it through a filter) treatments by maintaining the arterial drip chamber (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at 75 % full during two of two survey observation days. The failure to follow the manufacturer’s DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the forty-one patients receiving in-center hemodialysis treatments at this facility. Findings include: Nipro Instructions for use...Nipro Set Blood Tubing Set ...General Warnings and Precautions ...10. Maintain drip chamber at 3/4/ full to help prevent drip chamber evacuation, causing possible air embolus... Facility Policy Number: 1-03-08 Title: Pre-Intra-Post Treatment Data Revision Date: October 2023 ...Intradialytic Data Collection Assessment ...e. The arterial and venous drip chamber levels should be observed and adjusted as needed. ... Facility Procedure: 1-03-06W Title: Priming a Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Nipro or Combiset Blood Lines for Subsequent Treatment Shifts Revision Date: October 2022 Procedure: ...13. Open the IV (intravenous) administration set clamp and allow saline to prime the arterial line. When air is purged from the patient end of arterial line, immediately close the large clamp. To fill arterial drip chamber, open short infusion line clamp, loosen the cap, and allow chamber to fill. When the arterial drip chamber is approximately 3/4 full (at least 75 %) or at the manufacturer’s fill line indicator, tighten the cap and re-clamp line... 1. Observations conducted on the treatment floor on 12/12/23, survey day one, revealed the following: a. At 8:14 AM at station 2, the arterial drip chamber level was less than approximately 50 % full. At 8:35 AM, EI (Employee Identifier) # 4, PCT (Patient Care Technician) and the surveyor observed the arterial chamber level. 2. The surveyor asked EI # 4 what was the required level of fill for the arterial chamber? EI # 4 reported the arterial chamber should be over 1/2 full, at least to the fill line (which is 75 % full). EI # 4 adjusted the arterial drip chamber to the required fill line. b. At 8:15 AM at station 9, the arterial drip chamber level was less than approximately 50 % full. At 8:45 AM, EI # 5, Certified Clinical Hemodialysis Technician (CCHT), and the surveyor observed the arterial drip chamber level. EI # 5 adjusted the drip chamber to approximately 75 % full. c. At 8:15 AM at station 10, the surveyor observed the arterial drip chamber was less than approximately 50 % full. At 8:46 AM, EI # 5 and the surveyor observed the drip chamber level. EI # 5 adjusted the drip chamber to approximately 75 % full. 2. Observations conducted on the treatment floor 12/13/23, survey day two, revealed the following: a. At 9:35 AM at station 10, the arterial drip chamber level was less than 50% full. At 9:40 AM, the surveyor and EI # 5, CCHT observed the arterial drip chamber. The surveyor asked EI # 5 what was the required level of fill for the arterial chamber? EI # 5 reported the arterial chamber “should be half way full, I’ll get it up.” EI # 5 adjusted the arterial drip chamber to the required fill line. In an interview conducted on 12/13/23 at 11:01 AM, EI # 1, Director of Clinical Service, reported staff must maintain the arterial drip chamber to the fill line, which would be 75 %. EI # 1 confirmed staff failed to follow the facility procedure and manufacturer’s DFU for arterial drip chamber levels. 41623”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 30952 Based on medical record (MR) review, the DaVita Greystone Standing Orders 2023 and interviews, it was determined the facility staff failed to ensure all patients received pneumococcal immunizations or completed a vaccine declination in three of five MR’s reviewed. This affected Patient Identifier (PI) # 1, PI #5, PI # 4, and had the potential to affect all forty-one patients served by this facility. Findings include: DaVita Greystone Standing Orders 2023 ...Pneumovax: All newly diagnosed ESRD (End Stage Renal Disease) patients should have (the) Pneumonia (vaccine) within the 1st 7 days of dialysis unless otherwise directed by MD or if there is a documented history of prior vaccination. Vaccination is good for 5 years. Pneumococcal 20 (Prevnar-20)... 1. PI # 1 was admitted to the facility on 9/19/23 with diagnoses including ESRD. MR review revealed a Comprehensive Assessment Report (CAR) dated 10/14/23 which included documentation that PI # 1’s pneumococcal vaccination status was unknown. Further review of the MR revealed no documentation PI # 1 was offered, received or declined the pneumococcal vaccination. An interview was conducted on 12/14/23 at 10:37 AM with Employee Identifier (EI) # 2, Facility Administrator, who verified the MR did not contain documentation for a vaccination declination and no pneumococcal vaccination was administered. 2. PI # 5 was admitted to the facility on 8/26/23 with diagnoses including ESRD. MR review revealed a CAR dated 10/24/23 which included documentation that PI # 5’s pneumococcal vaccination status was unknown. Further review of the MR revealed no documentation PI # 5 was offered, received or declined the pneumococcal vaccination. An interview was conducted on 12/14/23 at 10:23 AM with EI # 1, Director of Clinical Services who verified the MR did not contain documentation of a declination and no pneumococcal vaccination was administered. 41623 3. PI # 4 was admitted on 11/22/23 with a diagnosis of ESRD. Review of the MR revealed no documentation the pneumonia vaccine was offered, administered, or declined by PI # 4. In an interview conducted on 12/14/23 at 9:55 AM, EI # 2 confirmed there was no documentation PI # 4 had been offered,received, or declined the vaccine. EI # 2 further stated the patient had been in the hospital multiple times since admission on 11/22/23. 49797”

“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: 41623 Based on medical record (MR) review, facility Standing Orders, and interviews, it was determined the facility failed to ensure staff: 1. Followed physician orders for Hypertension management. 2. Followed physician orders for Normal Saline (NS) administration. This had the potential to affect all forty-one patients receiving dialysis at this facility and did affect Patient Identifier (PI) # 4 and PI # 2. Findings include: DaVita Greystone Standing Orders 2023 Dialysis Treatment Prescription ...Treatment of Hypertension: ...Hypertension is considered if systolic BP (Blood Pressure) is > 200 and diastolic > 100. If hypertension persist after 30 minutes of initiating treatment (initiate the) following steps: 1. Readjust BP cuff...(If BP is only taken on alternate extremity notify MD (Medical Doctor) or CRNP (Certified Registered Nurse Practitioner). 2. During treatment follow protocol if systolic is > 200 administer 0.1 (mg) of clonidine: if diastolic BP is > 100 administer 0.1 mg (milligrams) may repeat after 1 hour. ...4. Call CRNP or MD for further orders if patient remains symptomatic. 5. Evaluate for transfer to ER (Emergency Room)... 1. PI # 4 was admitted on 8/24/23 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Details Report (TDR) dated 12/5/23 revealed the treatment was started at 12:13 PM with a BP of 197/103 mm/Hg (millimeters of mercury). Review of the Medication Order dated 12/5/23 revealed an order for Clonidine 0.1 mg, oral, every four hours as needed. If no blood pressure response, notify provider. Further review of the TDR dated 12/5/23 revealed at 12:32 PM the nurse documented the BP was 221/129 mm/Hg, will give Clonidine. At 1:03 PM the nurse documented the BP was 256/145 mm/Hg, patient repositioned and will retake BP. At 1:08 PM the nurse documented the BP was 256/121 mm/Hg, Clonidine 0.1 mg given. Review of the TDR post treatment vital signs revealed the BP was 227/137 mm/Hg at 4:06 PM. There was no documentation the Clonidine was repeated as per standing orders and no documentation the physician or CRNP were notified of the continued high BP. In an interview conducted on 12/14/23 at 9:55 AM with Employee Identifier (EI) # 2, Facility Administrator, confirmed the staff failed to follow the standing orders for hypertension and failed to notify the provider of the high blood pressure. 2. PI # 2 was admitted on 8/16/22 with a diagnosis of ESRD. Review of the IDT (Interdisciplinary Team) Rounding Worksheet revealed physicians’ orders dated 6/21/23 for Normal Saline Solution 0.9 % NaCl (Sodium Chloride) 1,000 Milliliter (ml) intravenous as needed. May have a total of 2000 ml NS during treatment if needed for treatment of hypotension/volume depletion due to high ostomy output. Review of the TDR dated 11/24/23 revealed a total amount of 4000 ml NS was given. Further review of the TDR dated 11/24 revealed 200 ml NS was given as a prime at 5:42 AM and 300 ml NS was given as rinse back at 9:01 AM. There was no documentation of when the additional 3500 ml of NS was given, no documentation of the reason for total of 4000 ml of NS, and no documentation of a physician’s order for the additional 1500 ml of NS. In an interview conducted on 12/14/23 at 10:08 AM, EI # 2 confirmed a total of 4000 ml of NS was given during the treatment and there was no documentation of a physician’s order to increase the amount of NS. Review of the TDR dated 11/29/23 revealed at 6:00 AM the PCT (Patient Care Technician) documented 3000 ml NS bolus given for dehydration, RN (Registered Nurse) advised. Further review of the TDR dated 11/29/23 revealed at 6:04 AM the PCT documented 3500 ml NS bolus given for dehydration, RN advised. There was no documentation of a physician’s order for the additional NS. In an interview conducted on 12/14/23 at 10:08 AM, EI # 2 stated a total of 3500 ml of NS was given and confirmed there was no documentation of an order for additional NS. Review of the TDR dated 12/1/23 revealed a total of 3000 ml of NS was given. There was no documentation of a physician’s order for the additional 1000 ml to be given. In an interview conducted on 12/14/23 at 10:08 AM, EI # 2 confirmed a total of 3000 ml of NS was given and there was no documentation of a physician’s order for the additional NS. Review of the TDR dated 12/8/23 revealed a total of 3800 ml of NS was given. There was no documentation of a physician’s order for the additional 1800 ml of NS given. In an interview conducted on 12/14/23 at 10:08 AM, EI # 2 confirmed at total of 3800 ml of NS was given and there was no documentation of a physician’s order for the additional NS. Review of the TDR dated 12/11/23 revealed a total of 3000 ml of NS was given. There was no documentation of a physician’s order for the additional 1000 ml of NS. In an interview conducted on 12/14/23 at 10:08 AM, EI # 2 confirmed a total of 3000 ml of NS was given and there was no documentation of a physician’s order for the additional NS. EI # 2 further stated PI # 2 was to have a total of 2000 ml of NS during treatment as needed.”

“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: 41623 Based on medical record (MR) review, and interviews with staff it was determined the facility failed to ensure treatments were administered per physician prescription for Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR). This affected one of five MR’s reviewed including Patient Identifier (PI) # 4 and had the potential to affect all forty-one patients receiving dialysis at this facility. Findings include: 1. PI # 4 was admitted to the facility on 8/24/23 with a diagnosis of End Stage Renal Disease. Review of the Treatment Details Report (TDR) dated 11/16/23 revealed orders for BFR of 450 ml/min (milliliters/minute) and DFR of 800 ml/min. Further review of the TDR dated 11/16/23 revealed the treatment was started at 10:58 AM with a BFR of 350 ml/min and a DFR of 500 ml/min and continued at that rate until the end of treatment at 2:30 PM. There was no documentation of a physician’s order to change the BFR and DFR rates. Review of the TDR dated 11/18/23 revealed orders for a BFR of 450 ml/min and DFR of 800 ml/min. Further review of the TDR dated 11/18/23 revealed the treatment was started at 1:38 PM with a BFR of 400 ml/min and a DFR of 500 ml/min and continued at that rate until the end of treatment at 3:10 PM. There was no documentation of a physician’s order to change the BFR and DFR rates. An interview conducted on 12/14/23 at 9:55 AM with Employee Identifier # 2, Facility Administrator, who confirmed the dialysis was not administered per physician orders and there was no documentation of a physician’s order to change the BFR and DFR rates.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 30952 Based on observation, review of the facility procedure, medical record (MR), and interview, it was determined the facility failed to ensure staff: 1. Performed AVF/AVG (arteriovenous fistula/graft) site preparation per facility procedure in one of three observations conducted for AVF/AVG access and initiation of dialysis, including PI (Patient Identifier) # 6. 2. Followed the facility procedure for AVF/AVG site preparation in one of two MR reviews with an AVF/AVG access, including PI # 3. This had the potential to negatively affect all patients who dialyze with an AVF/AVG at the facility. Findings include: Facility Procedure Number: 1-04-01E Facility Procedure: AV (Arteriovenous) Fistula or Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose. Revision Date: October 2022 ...Materials required: Liquid soap or other skin cleansing agent 70 % alcohol preps Clean, moisture proof barrier Skin antiseptic... Notes: Check for patient sensitivity to preferred antiseptic/skin disinfectant listed in table below. Use Isopropyl Alcohol 70 % as the single skin antiseptic ONLY when the patient has documented allergies to other skin antiseptics. ...Skin Antiseptic Povidone Iodine... Hypochlorite (ExSept Plus)... Isopropyl Alcohol 70 %... Procedure ...Procedure: 1. ...wash access site with appropriate antibacterial soap...If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent... 5. Perform inspection, auscultation, and palpation on entire length of access... 10. While maintain aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site... 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic... 12. For patients who have a documented allergy to iodine or ExSept...necessitating alcohol alone... ...13. Do not palpate insertion site once area has been prepped...Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. ...19. Document findings and interventions in the patient’s medical record... 1. During an observation of care on 12/12/23 at 11:10 AM at station one, the surveyor observed EI (Employee Identifier) # 3, Registered Nurse/Preceptor perform access site antisepsis for PI # 6’s AVF/AVG site with ExSept, and alcohol. EI # 3 palpated/touched both access sites with his/her finger after site antisepsis, then cannulated the access sites. EI # 3 failed to repeat skin antisepsis after palpation/touching the access sites before cannulation, thus leading to potential contamination of the access sites and infection. EI # 3 failed to follow the facility procedure for access site preparation and clean each needle site first with 70 % alcohol, then with the approved skin antiseptic, ExSept. An interview was conducted on 12/14/23 at 11:00 AM with EI # 2, Facility Administrator, who verified staff failed to follow the facility procedure for preparation and cannulation of an AVF/AVG. 2. PI # 3 was admitted to the facility on 3/15/22 with a diagnosis of End Stage Renal Disease. Review of the Interdisciplinary Rounding Worksheet documentation revealed PI # 3 had no known allergies. Review of the Treatment Details Report dated 11/30/23 revealed documentation the AVF site was cleaned with alcohol prior to cannulation. There was no documentation the access site was cleaned with an antiseptic per facility procedure. An interview was conducted on 12/14/23 at 10:58 AM with EI # 2 who confirmed the staff failed to follow the policy for access site preparation for the AVF.”

“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: 30952 Based on the review of medical records (MR), facility procedure and interviews, it was determined the facility failed to ensure all MR entries were accurate concerning vascular access in one of three MR’s reviewed with Central Vascular Catheter (CVC). This affected Patient Identifier (PI) # 5, and had the potential to affect all patients with a CVC. Findings include: Incenter Hemodialysis Procedure: 1-04-02 B Title: Central Vascular Catheter (CVC) With ClearGuard HD (Hemodialysis) Antimicrobial End Caps Procedure Revised Date: October 2023 NOTE: The scope of practice...that impact the practice of the RN (Registered Nurse), LPN (licensed practical nurse) and PCT (Patient Care Technician)...vary among states. ...Upon Completion of Dialysis ...37. Document findings and procedure in patient’s electronic health record. 1. PI # 5 was admitted to the facility on 8/26/23 with diagnosis including ESRD (End Stage Renal Disease). Review of the Treatment Details Reports (TDR) dated 12/5/23 revealed the access in use was a CVC. Further review of the 12/5/23 TDR revealed documentation completed by the CCHT (Certified Clinical Hemodialysis Technician) at 10:08 AM, the “treatment was started without complications, access cleaned with alcohol and except (ExSept) 200 ns (normal saline) given”. The CVC care and treatment initiation documentation was completed by a CCHT and not a RN. Review of the TDR dated 12/7/23 revealed the access in use was a CVC. Further review of the 12/7/23 TDR revealed documentation completed by the PCT at 10:19 AM, the “treatment was started without complications, access cleaned with alcohol and except (ExSept) 200 ns (normal saline) given”. The CVC care and treatment initiation documentation was completed by a PCT and not a RN. An interview was conducted on 12/14/23 at 10:23 AM with Employee Identifier # 1, Director of Clinical Service who confirmed the PCT/CCHT is not trained or qualified to provide CVC care with treatment initiation. EI # 2 confirmed the electronic MR documentation was an error and was not accurate.”