Davita Northeast Cambridge 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: 44223 Based on observation, interview, and policy review, the facility failed to ensure that 1 staff member (Personal Care Technician [PCT] #4) observed, implemented adequate infection control practices, related to glove use and hand hygiene, to reduce the risk of spread of infection while caring for patients. Findings include: Review of the facility’s policy titled, Infection Control for Dialysis Facilities, revised April 2023, included the following: *Hand Hygiene: All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene prior to gloving and immediately after removal of gloves. *Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station, this will include patients and visitors assisting with procedures such as self-cannulation or holding access sites. a. Gloves should be changed when: i. When soiled with blood, dialysate or other bodily fluids. ii. When going from a “dirty” area or task to a “clean” area or task. iii. When moving from a contaminated body site to a clean body site of the same patient; and iiii. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system. Review of the facility’s policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance”, revised in April 2024, included the following: *Gloves are to be worn when touching the chair side cart, monitor, and keyboard. During an observation of the treatment floor on 5/5/25 between 10:10 A.M. and 10:55 A.M., the surveyor observed PCT #4 on three separate occasions, with clean ungloved hands, readjust her goggles and her facemask (which are considered dirty) on her face. Each time PCT #4 did not perform hand hygiene after touching her goggles and facemask. During an observation of the isolation room on 5/5/25 at 3:15 P.M., the surveyor observed PCT #4 discontinue dialysis treatment and conduct a post dialysis assessment. PCT #4 was observed removing her dirty gloves, sanitizing her hands, then with ungloved hands touch the computer keyboard to document. During an interview on 5/5/25 at 3:50 P.M., PCT #4 said she did not wear gloves when she used the computer in the isolation room because she thought it was considered a clean piece of equipment. She said she should have performed hand hygiene after touching her goggles and facemask. During an interview on 5/6/25 at 2:40 A.M., the Director of Clinical Operations said that equipment in the isolation room is considered dirty and the PCT should have worn gloves.”

“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 that 2 of 3 staff members (Patient Care Technician [PCT] #4 and Registered Nurse [RN] #1) observed, 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: Review of the facility’s policy titled, “Infection Control for Dialysis Facilities”, revised in April 2023, included the following: Disinfection: *At the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but 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., control panel, top, front and sides of dialysis machine, touchscreens, countertops). Review of the facility’s policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance”, revised in April 2024, included the following: *Dedicated ancillary supplies such as blood pressure cuffs, clamps, tourniquets, stethoscope, blood glucose meter, bicarb/dialysate jugs, bleach buckets, sharps container, thermometer, pens, centrifuge, and non-disposable items will be used. *Such supplies will be labeled “isolation” will remain in the isolation room/area or station and be disinfected after every patient use with a 1:100 bleach solution. *Trash and waste will be doubled bagged. *Trash is placed in an appropriate red biohazard leak proof bag by the teammate caring for the patient with known or suspected hepatitis B infection. *A second teammate holds a second red biohazard leak proof bag outside of the isolation room/area while the trash is placed inside. 1. During an observation on 5/5/25 at 3:15 P.M., the surveyor observed PCT #4 clean and disinfect the isolation room following the dialysis treatment for a patient with Hepatitis B. PCT #4 failed to disinfect the arm of the television, the outside of the chair on both sides, the oxygen tank, the 3 drawer cart, and the sharps container. She also failed to disinfect the computer on wheels, and the stool. Further observation of the disinfection process revealed that PCT #4 failed to disinfect the centrifuge sitting on top of the dirty sink area. She also was observed to leave the isolation room and proceed to bring in a new biohazard bucket before the isolation room was completely cleaned. She then took the contaminated biohazard bucket and placed it outside the room, with no assistance from a second staff member. PCT #4 transferred the biohazard bucket off the treatment floor. She then returned to the isolation room to continue the disinfection process. During an interview on 5/5/25 at 3:50 P.M., PCT #4 said she did not clean the oxygen tank or the stool because she did not use them and considered them clean. PCT #4 said that she did not clean the computer because that is considered clean equipment. She said that she didn’t clean the outside of the chair under the tray tables, but should have. During an interview on 5/6/25 at 2:40 P.M., the Director of Clinical Operations said that all items in the isolation room are considered dirty and should be disinfected after the completion of treatment. She also said that there should have been a second person to assist with the removal of the biohazard container. 10249 2. During an observation on 5/5/25 at 10:15 A.M., the surveyor observed RN #1 clean and disinfect station 5. She was observed disinfecting the hemodialysis machine and hemodialysis chair with 1:100 bleach soaked pads. RN #1 was observed to disinfect the left side of the dialysis machine, but failed to disinfect the interior and exterior of the prime waste bucket, which was attached to the left side of the machine. During an interview on 5/5/25 at 10:25 A.M., RN #1 said she had missed the prime waste bucket during the cleaning process.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 10249 Based on observation, interview, and policy review, the facility failed to ensure that 2 of 3 staff (Registered Nurse [RN] #7, and Patient Care Technician (PCT] #3) observed, followed proper infection control practices during the initiation of dialysis for 2 of 3 applicable patients (#10 and #9) with an Arteriovenous Fistula/Graft (AVF/AVG), from a total sample of 12 patients. Findings include: Review of the facility’s policy titled, AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose, last revised April 2025, included the following: *While maintaining aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site using circular motion, center out. *For patients who have a documented allergy to povidone iodine or ExSept Plus, necessitating alcohol alone, apply alcohol using circular rubbing motion, center out for 60 seconds and allow to dry for 15 seconds prior to cannulation. *Teammates will need to use a minimum of 4 prep pads per site for at least 60 seconds total contact time to adequately prep cannulation site. *Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. *While maintaining aseptic technique, grasp the wings of the appropriate fistula needle and remove cap. *Without contaminating the fistula needle, pull skin taut with non dominant thumb below anticipated insertion site in opposite direction of needle insertion. *Pulling the skin taut anchors the vessel and eases the cannulation process. 1. During an observation on 5/5/25 at 10:45 A.M., the surveyor observed RN #7 initiate dialysis treatment for Patient #10, who received dialysis via an AVG. RN #7 was observed to disinfect the access site with an alcohol prep pads for 10 seconds, she then opened a second prep pad and disinfected the area for 5 seconds, then opened a third prep pad and disinfected the area for an additional 5 seconds, for a total of 20 seconds. RN #7 failed to disinfect the access area for a total of 60 seconds, per the facility policy. During an interview on 5/5/25 at 11:10 A.M., RN #7 said she did not know how long she disinfected the area, or that she should have used 4 alcohol prep pads during the disinfection process. 27189 2. During an observation on 5/5/25 at 10:45 A.M., the surveyor observed PCT #3 initiate dialysis treatment for Patient #9, via an AVF. PCT #3 palpated the AVF access area with her fingertips for the presence of the thrill, disinfected the fistula site, and applied the tourniquet. She then used her thumb to pull the skin taut, anchoring the vessel, and contaminated the site with her thumb. She inserted the needle into the lower access site. PCT #3 did not disinfect the access site again after contamination with her thumb. During an interview on 5/5/25 at 11:05 A.M., PCT #3 said the access site should have been disinfected again, prior to cannulation, when the area had been touched with her thumb.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 44223 Based on observation, record review, and interview, the facility failed to follow its policies and procedures to control the transfer of acid concentrate, from the large drums of acid concentrate to the storage tanks, to prevent the inadvertent mixing of different concentrate formulas. Findings include: Review of the facility’s policy titled, Incoming Acid Concentrate Supply Procedure, revised 9/2013, included the following: *Under the column labeled “date”, indicated the date the acid concentrate was accepted by facility. *Under the column labeled “type of concentrate” indicated catalog number and ratio of the concentrate delivered. In receiving multiple shipments of different potassium or calcium acid concentrates, the catalog number indicates each item received separately on the form. *Under the “number of drums” column indicated- the number of drums received of that particular catalog number and ration of 45X. *Document the date the acid concentrate was transferred in the appropriate storage tank. *The signatures placed under the appropriate signature column by the delivery person or a teammate verifying the appropriate concentrate has been pumped into the appropriate concentrate storage tank. During the flash tour of the water treatment room conducted on 5/5/25 at 9:05 A.M., the surveyor observed the facility used two large storage tanks for 2K (Potassium) and 3K acid concentrates that facility staff transferred from large drums of acid concentrate. Review of the log titled, “Acid Concentrate (Liquid) Supply Log incoming and transfer”, the log indicated the following “Do not pump acid concentrate to storage tank until the appropriate acid concentrate and storage tank has been verified by a second teammate.” Review of the transfer logs indicated that multiple acid transfers from 1/20/24-1/6/25 (27 drums to the 2K storage tank, 14 drums to the 3K storage tank, and 2 entries did not indicate which dialysate was transferred), were not verified by a second teammate to ensure the transfers were correct, per the facility policy. During an interview on 5/7/25 at 10:00 A.M., the Biomed Technician said there should be two signatures to verify the correct acid transfer. During an interview on 5/7/25 at 12:00 P.M., the Director of Clinical Operations said it is the expectation of the facility to have two signatures for verification of the acid transfer. Failure to follow procedure leads to the potential that the wrong acid could be transferred to the wrong storage tank and patients could receive too much or too little potassium in their treatment, leading to serious and potentially life-threatening irregular heart rhythms.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 44223 Based on record review, policy review, and staff interview, the facility failed to ensure the Interdisciplinary Team (IDT) developed and implemented a written, individualized plan of care (POC) for each patient that included services necessary to address patients’ needs and changes in patients’ condition, measurable and expected outcomes, and estimated timetables to achieve these outcomes in regard to dialysis access for 2 of 7 applicable Patients (#5, #3) with a Central Venous Catheter (CVC), out of a total sample of 12 patients. Review of the facility’s policy titled, Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, revised October 2024, indicated the following: *The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and will include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care will be consistent with evidence based professionally accepted clinical practice standards. 1. For Patient #5, the facility failed to ensure the patient had a complete and individualized plan of care that included estimated timetables and measurable goals regarding preventing dialysis access infections. Patient #5 was admitted to the facility in November 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis, and received dialysis through a CVC. Review of the Patient Care Activities report, dated 3/15/25, indicated that during the exit site care of the CVC, the RN noticed purulent drainage coming from the site. Blood cultures were drawn and the MD was notified. Review of the physician “Limited Note”, dated 3/15/25, indicated the patient was sent to the hospital with a goal of the patient receiving a dose of antibiotics. Review of the Comprehensive Assessment Report, dated 3/15/25, under the section titled “Access”, there was no documentation provided. Review of the current Plan of Care, dated 4/1/25, under the section titled “Access”, indicated to support maintenance and functioning of permanent dialysis access. The Plan of Care failed to include a goal or interventions to remain infection free while utilizing the CVC. During an interview on 5/7/25 at 9:00 A.M., the Clinical Director of Services said there should be a care plan for the care and treatment of a CVC. 10249 2. For Patient #3, the facility failed to ensure the patient had a complete and individualized plan of care that included estimated timetables and measurable goals regarding preventing dialysis access infections. Patient #3 was admitted to the facility in August 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis, and received dialysis through a CVC. Review of the Comprehensive Assessment and current Plan of Care (90 day), dated 12/20/24, included a section titled “Access”. The section indicated to support maintenance and functioning of permanent dialysis access. The Plan of Care failed to include a goal or interventions to remain infection free while utilizing the CVC. During an interview on 5/7/25 at 9:00 A.M., the Clinical Director of Services said there should be a care plan for the care and treatment of a CVC.”

“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: 27189 Based on observation, interview, and policy review, the facility failed to ensure that 3 staff members (Patient Care Technician [PCT] #3, PCT #2, and Registered Nurse [RN] #7) observed, evaluated a vascular access to ensure functionality by the way of listening for a bruit the length of the access (swooshing sound heard with a stethoscope place over the access) for 3 of 3 applicable patients (#9, #8, and #10) with arteriovenous fistula/graft (AVF/AVG) access sites, out of a total sample of 12. Findings include: Review of the facility’s policy titled, AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose, revised April 2025, included but was not limited to the following: * Perform inspection, auscultation and palpation on the entire length of access. Determine presence of bruit and thrill (palpable vibration/buzzing sensation on the skin over the area of turbulent blood flow). The presence of a bruit and thrill indicates flow through the access. Absence of a bruit or thrill could indicate a clotted access. 1. During an observation on 5/5/25 at 10:45 A.M., the surveyor observed PCT #3 initiate dialysis treatment for Patient #9, via an AVF. PCT #3 palpated the AVF with her fingertips for the presence of the thrill, disinfected the fistula sites, applied the tourniquet, and inserted the needles into the lower access, and then upper access. PCT #3 failed to assess for the presence of a bruit with the use of a stethoscope. During an interview on 5/5/25 at 11:05 A.M., PCT #3 said she knows the patient very well and that because Patient #9 had a very strong thrill she didn’t listen for the bruit prior to cannulation. 44223 2. During an observation on 5/5/25 at 10:50 A.M., the surveyor observed PCT #2 as she prepared Patient #8 for his/her dialysis treatment via an AVF. PCT #2 palpated the vascular access with her fingertips, disinfected the site, applied the tourniquet, and then inserted the needle into the lower access. She then proceeded to repeat this and insert the second needle into the upper access. PCT #2 failed to assess for the presence of a bruit with use of the stethoscope. During an interview on 5/5/25 at 11:45 A.M., PCT #2 said she had realized that she didn’t use the stethoscope after she had already disinfected the access site. She said she should have listened for a bruit before disinfecting the site. 10249 3. During an observation on 5/5/25 at 10:45 A.M., the surveyor observed RN #7 as she prepared Patient #10 for his/her dialysis treatment via an AVG. RN #7 palpated the vascular access with her fingertips, disinfected the site, and then inserted the needle into the lower access. She then proceeded to repeat this and insert the second needle into the upper access. RN #7 failed to assess for the presence of a bruit with use of the stethoscope. During an interview on 5/5/25 at 11:10 A.M., RN #7 said I could feel it when I palpated the area. During an interview on 5/6/25 at 3:00 P.M., the Director of Clinical Operations said the staff should look, listen (with a stethoscope), and feel the AVF before cannulation, as per the facility policy.”

“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: 27189 Based on observation, policy review, record review, and interview, the Medical Director failed to ensure that staff followed the policy related to reversal of Central Venous Catheter (CVC) lines for 1 Patient (#11), in a total sample of 12. Findings include: Review of the facility’s policy titled, Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure, revised April 2025, indicated but was not limited to the following: *If unable to aspirate from either arterial or venous limb, close the clamp and attach a 10 ml saline filled syringe to affected limb and open clamp then gently instill saline. Re-attempt to aspirate. *If able to infuse saline into arterial limb but unable to aspirate, check venous limb for potency. *If venous limb is patent, use venous limb for arterial source for this one (1) treatment only. *Notify the physician of access insufficiency. *Document findings and procedure in the patient’s electronic health record. For Patient #11, the staff failed to follow the facility policy for the reversal of the CVC lines. Patient #11 was admitted to the facility in March 2025 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Patient #11 was receiving dialysis treatment via a CVC. During an observation on 5/6/2025 at 10:30 A.M., RN #8 was observed to aspirate the indwelling solution from the arterial and venous limb without incidence. RN #8 then attached syringes filled with 10 ml of saline and easily flushed both the arterial and venous limb. RN #8 then administered a loading dose of heparin and flushed back and forth and then waited the required amount of time for heparin administration (3-5 minutes), before starting the dialysis treatment. Prior to RN #8 initiating dialysis, the surveyor observed the patient point to the lines and tell the nurse that the lines needed to be switched. RN #8 reversed the lines and initiated dialysis. Surveyor observation indicated that RN #8 did not have any difficulty aspirating the indwelling solution from the arterial and venous limbs. RN #8 initiated the dialysis treatment without incidence. Review of the physician orders, dated 5/6/25, did not indicate a order for line reversal. Review of the dialysis flow sheets, dated 5/3/25 and 5/6/25, did not indicate that lines were reversed during treatment. During an interview on 5/6/24 at 2:15 P.M. RN #8 said she reversed the lines per the patient’s direction and did not know if the patient had an order to do so, and she had not contacted the physician.”