Fmc of Newburyport

“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: 27189 Based on observation, interview, and policy review, the facility failed to ensure that one staff member (Certified Clinical Hemodialysis Technician [CCHT] #2) wore eye protection (faceshield or goggles) in the event of the occurrence of spurting or spattering of blood when administering an infusion of heparin (blood thinner) during a dialysis treatment; and 2.) ensure that one staff member (Certified Clinical Hemodialysis Technician [CCHT] #2) removed protective eye goggles prior to leaving the treatment area. Findings include: Review of the facility policy, titled Personal Protective Equipment, revised 11/6/23, indicated the following: Purpose: The purpose of this policy is to identify Personal Protective Equipment (PPE) and potential areas for use. *Per OSHA’s bloodborne pathogen Standard, the employee must evaluate the task and the type of exposure expected and, based on the determination, select the “appropriate” personal protective equipment needed, based on the task and risk exposure to blood and other potentially infectious materials (OPIM). *Personal protective equipment including face shield or mask and protective eyewear with full side shield, fluid resistant gowns and gloves, must be worn to protect employees from blood or other potentially infectious materials (OPIM). PPE is used to protect employees who are occupationally exposed to blood or OPIM when performing procedures during which spurting or splattering of blood might occur (e.g. during initiation and termination of dialysis, cleaning of Dialyzer and centrifugation of blood). *All personal protective equipment shall be removed prior to leaving the treatment area. *Eyewear: Protective eyewear is provided by the facility and must be eye protection designed under normal conditions of use to prevent blood and OPIM from reaching the eyes. 1. During an observation of the treatment floor on 2/19/25 at 9:24 A.M., the surveyor observed CCHT #2 administer an infusion of Heparin via a port in the dialysis line during the patient’s dialysis treatment. She was observed to have her protective eye goggles on top of her head, not in place protecting her eyes in the event of the occurrence of spurting or spattering of blood. During an interview on 2/20/25 at 10:30 A.M., CCHT #2 said she should have had the goggles in place to protect her eyes, and not on top of her head. 44223 2. During an observation on 2/20/25 at 9:40 A.M., the surveyor observed CCHT #2 exit the dialysis treatment floor, to the clinic lobby, wearing protective eye goggles on top of her head. CCHT #2 did not disinfect the protective eye goggles before exiting the dialysis treatment floor, causing concern for potential risk of cross contamination. During an interview on 2/20/25 at 1:00 P.M., the Clinic Manager said CCHT #2 should not have left the floor with her goggles on.”

“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: 44223 Based on observation, staff interview, and policy review, the facility failed to ensure that there was separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to 1.) ensure storage containers with dirt and dust were not stored in a designated clean areas; and 2.) ensure contaminated personal protective equipment (PPE) did not come into contact with clean and dirty items. Findings Include: Review of the facility policy, titled Medication Preparation and Administration, revised 2/6/23, indicated the following: *Mediations shall be prepared in a clean work area away from dialysis patient stations and delivered separately to each patient. 1. During an observation of the dialysis treatment floor on 2/19/25 at 9:30 A.M., the surveyor observed the heparin preparation station. The preparation area was observed to have 2 plastic milk crates sitting on the counter filled with dialysis supplies. The milk crates were laden with dust and debris, causing concern for potential cross contamination. Further observation of the heparin preparation station identified 3 pieces of paper tape stuck to the counter top. The tape was observed to have dark residue on it causing concern for cross contamination. The tape cannot be disinfected when cleaned with 1:100 bleach. During an interview on 2/20/25 at 1:00 P.M., the Charge Nurse said the tape cannot be properly disinfected on the counters. The Charge Nurse also said she didn’t realize that the milk crates were dusty, but that she would make sure they were cleaned. 27189 2. During an observation on 2/19/2025 at 9:25 A.M., the surveyor observed gowns, which were worn by staff on the treatment floor, hung on 2 coat racks located at each end of the nursing station (clean area). One coat rack was observed to have 3 gowns overlapping each other, and the other coat rack was observed to have 2 gowns touching each other, with the ties of the gowns touching the floor. During a subsequent observation on 2/19/2025 at 1:02 P.M., 2 gowns were observed to be hung on each coat rack. The gowns were observed to be overlapping each other, and the ties of the gowns were touching the floor. During an observation on 2/20/25 at 10:30 A.M., the 2 coat racks were observed to have 2 gowns each and were overlapping/touching each other. During an interview on 2/20/25 at 11:00 A.M., Registered Nurse #1 said the gowns should not be like that.”

“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: 10249 Based on observation, interview, and policy review, the facility failed to 1.) ensure that 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #2) observed, implemented adequate infection control practices to minimize the risk of infection during exit site care and 2.) ensure that 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #2) observed, implemented adequate infection control practices to minimize the risk of infection during during initiation of treatment for 1 of 2 patients (#9) observed with a Central Venous Catheter (CVC), out of a total sample of 9 patients. Findings Include: -Review of the facility policy, titled Central Venous Catheter (CVC) Dressing Change, revised 5/6/2024, indicated the following: *Cleaning the catheter site: *Perform hand hygiene and done clean gloves. *Remove swabstick/applicator from the package by stick/wand end without touching the applicator. Handle only the stick/wand portion. *If using 2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean exit site beginning in the center and continuing outward the area the side of the dressing to be applied (2 inches) in a concentric circle for 30 seconds ad allow to dry for 30 seconds. If exudate or crusting is noted, an additional swabstick/applicator may be necessary to clean the exit site. Allow the area to air dry for approximately 30 seconds. *Remove the backing of the adhesive dressing using aseptic technique. Apply the catheter dressing over the dry site, being careful not to touch the patient-side of the dressing. -Review of the facility policy, titled Initiation of Treatment Using Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer, revised 5/6/24, indicated the following: *Preparing the Catheter: Disinfection of the Catheter Connections, heparin removal, flushing the catheter and heparin administration: *1. Check to make sure catheter clamps are closed. *2. Remove cap from clamped arterial limb. *3. Using a sterile alcohol pad scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue. *4. Using the same sterile alcohol pad applying friction to remove any blood or residue, move from the hub at least several centimeters towards the body of the catheter. (Steps 3 and 4 should take 10-15 seconds.) 1. The facility failed to ensure that CCHT #2 implemented adequate infection control practices to minimize the risk of infection during exit site care for Patient #9. On 2/19/25 at 9:12 A.M., the surveyor observed CCHT #2 as she prepared to initiate treatment for Patient #9 in station 10. The surveyor observed CCHT #2 prepare Patient #9 for treatment initiation by providing him/her with a face mask, and placed all the supplies on the tray table. CCHT #2 removed the patient’s dressing and performed hand hygiene and donned clean gloves. CCHT #2 then opened a package of Chlorhexidine and removed a swab from the package. She swabbed the area for 15 seconds. CCHT #2 allowed the area to dry and applied a new dressing. CCHT #2 failed to disinfect the exit site for 30 seconds per facility policy. During an interview on 2/19/25 at 9:30 A.M., CCHT #2 said she thought she had swabbed the exit site for 30 seconds with Chlorhexidine as she should have. She said that she did not look at the clock while cleaning the areas. 2. The facility failed to ensure that CCHT #2 implemented adequate infection control practices to minimize the risk of infection during during initiation of treatment for Patient #9. On 2/19/25 at 9:12 A.M., the surveyor observed CCHT #2 as she prepared to initiate treatment for Patient #9 in station 10. The surveyor observed CCHT #2 prepare Patient #9 for treatment initiation by providing him/her with a face mask, and placed all the supplies on the tray table. CCHT #2 disinfected the CVC hubs. She opened an alcohol prep pad and disinfected the arterial hub of the CVC for 7 seconds. CCHT # 2 then opened another alcohol prep pad and disinfected the venous hub for 7 seconds. CCHT #2 failed to disinfect the hubs for 10-15 seconds each, per facility policy. During an interview on 2/19/25 at 9:30 A.M., CCHT #2 said she thought she had scrubbed each hub for 15 seconds as she should have. She said that she did not look at the clock while cleaning the areas.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 44223 Based on observation and staff interviews, the facility failed to provide dialysis patients and staff a safe, functional, and comfortable treatment environment. Findings Include: During an observation of the dialysis treatment floor area on 2/19/25 at 11:30 A.M. the surveyor observed the following: *cracked tiles in the entry way to the isolation room *cracked tiles in station #3 that extended across the treatment floor to in front of the medication clean sink area *cracked tiles in front of the medication refrigerator *cracked tiles in front of entrance to reception area from treatment floor *cracked tiles in station #9 *cracked tiles around the floor scale *missing black stripping around the floor scale, leaving the area open and exposed to debris During an interview on 2/20/25 at 1:00 P.M., the Facility Administrator and the Charge Nurse said that it is difficult to effectively disinfect areas where there is cracked tiles.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 10249 Based on record review, interview, and policy review, the facility failed to ensure an unstable comprehensive re-assessment and revision of the plan of care was conducted after an extended hospitalization stay greater than 15 days, for 1 of 7 applicable patients (#1), out of a total sample of 9 patients. Findings Include: Review of the facility policy, entitled Comprehensive Interdisciplinary Assessment and Plan of Care, revised 7/3/23, indicated the following: *Unstable patients must be reassessed by the IDT (Interdisciplinary Team) monthly. Monthly reassessment and any POC updated related to the reason the patient is considered unstable must be documented until the issues have been resolved or the IDT (including the patient if possible) determines that the conditions is chronic. *The following are unstable criteria: a. Hospitalization of more that 15 days with discharge occurring within the last 30 days, or b. More than 3 admissions in the past 30 days Patient #1 was admitted in May 2023 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of the clinical record indicated that Patient #1 had a 90 day comprehensive assessment completed in August 2024, with a plan of care developed based on that assessment. Further review of the clinical record indicated that Patient #1 had been hospitalized from 10/8/24 through 11/23/24, for a total of 46 days, for unplanned revision of his/her access. During an interview on 2/20/25 at 2:00 P.M., the Charge Nurse said when Patient #1 returned to the clinic after the hospitalization, she discussed with the physician and determined they were not going to conduct an unstable assessment and care plan. She further said that the patient should have been made unstable and reassessed by the team.”

“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: 27189 Based on clinical record review, interview, and policy review, the facility failed to develop and implement a plan of care to monitor, adjust, and administer doses of Mircera (a medicine used to treat the symptoms of anemia - low levels of red blood cells) in adults with chronic kidney disease (CKD-long-term, progressive decrease in the ability of the kidneys to work properly) to meet their anemia management needs for 1 patient (#5), from a total sample of 9 patients. Specifically, the facility failed to follow their Algorithm and contact the physician when the patient’s hemoglobin dropped below 11.1 g/dl to obtain an order to restart the administration of Mircera. Findings include: Review of the facility policy, titled Mircera Algorithm Incenter, Quick Reference Guide, dated 1/1/23, indicated the following: *If no open Mircera order in the last 3 months, when the Hemoglobin (Hgb) </= 11.1 g/dl, contact the Provider to obtain a re-start dose. Patient #5 was admitted to the facility in August 2024 with diagnoses including anemia and End Stage Renal Disease (ESRD), requiring hemodialysis. Review of Patient #5’s Plan of Care, dated 9/2024, identified a problem with anemia management. Most recent hemoglobin 9.1 g/dl. Approaches included: Will continue to monitor Hgb weekly. Refer to prescribed algorithm and/or Physician for dose adjustments. Review of Patient #5’s Hgb test results indicated the following: *2/11/25 - 8.6 *2/4/25 - 9.8 *1/21/25 - 10.1 *1/18/25- 10.3 *12/30/24-11.0 Review of the clinical record indicated between 12/30/24 and 2/11/25 the hemoglobin was less than 11.1 g/dl, however there was no documented evidence that the physician was notified when the hemoglobin was less than 11.1g/dl. There was no documented evidence that there was a physician’s order for Mircera based on the facility algorithm policy. During an interview on 2/20/2025 at 12:05 P.M., the Charge Nurse (CN) said that Patient #5 had no current/open orders for Mircera. She said that when the Hgb goes below 11.1 the Provider/MD should be contacted per the Algorithm. The CN said that the Patient’s current Hgb was 8.6 and that the Provider/MD had not been contacted and that the Patient should have received Mircera, 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: 10249 Based on observation, staff interview, and policy review, the facility failed to ensure that 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #5) observed, evaluated a vascular access to ensure functionality by listening for the bruit the length of the access (swooshing sound heard with the stethoscope placed over the access) for 1 of 2 applicable patients (#8) with a Arteriovenous Fistula/Graft (AVF/G) access site, out of a total sample of 9 patients. Findings include: Review of the facility policy, entitled Assessment and Cannulation, published 5/6/24, included the following; *Before each treatment, the internal access must be assessed for patency, signs of infection and any abnormal findings. *Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session. *Look. *Listen: Staff should listen to the entire length of the access for changes in the sound of the bruit- a normal low-pitched bruit should be present. If no sound present, assume the access is thrombosed and do not attempt cannulation. *Feel: Thrill should have one of two sensations - a purring like a cat, or a vibration like a cell phone. It should not pulsate. Strong pulsation suggests that there is a flow issue due to a stenosis and needs to be referred immediately for further evaluation and possible intervention. During an observation on 2/19/25 at 9:48 A.M., the surveyor observed CCHT #5 as she prepared Patient #8 for his/her dialysis treatment via an AVF. CCHT #5 looked at the AVF and felt 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. CCHT #5 failed to listen to the length of the access with a stethoscope for the presence of a bruit prior to using the access. During an interview on 2/19/25 at 9:55 A.M., CCHT #5 said she should have used a stethoscope.”

“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: 37349 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 of heparin (blood thinning medication) bolus to initiate dialysis treatment for 2 patients (#2 and #3), out of a total sample of 9 patients. Findings Include: Review of the facility’s policy titled, Heparin Bolus Administration, published 11/1/21, indicated the following: * Allow heparin to circulate within the bloodstream for a minimum of 3-5 minutes before initiating treatment to prevent blood from clotting in the dialysis circuit. 1. Patient #2 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 1/30/25 to 2/18/25, indicated for 4 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 2/1/25 treatment started at 11:04 A.M., heparin was documented as administered at 11:09 A.M., 5 minute after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 2/5/25 treatment started at 11:02 A.M., heparin was documented as administered at 11:11 A.M., 9 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 2/6/25 treatment started at 11:12 A.M., heparin was documented as administered at 11:11 A.M., 1 minute prior, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 2/8/25 treatment started at 11:02 A.M., heparin was documented as administered at 11:03 A.M., 1 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. During an interview on 2/20/25 at 10:20 A.M., the Charge Nurse said that when heparin is administered, staff should wait 3-5 minutes before starting treatment, and it should be documented as such in the medical record. 44223 2. Patient #3 was admitted to the facility in May 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis three times a week. Patient #3 had a physician’s order to administer heparin bolus 3000 units intravenously (IV), every dialysis treatment. Review of 9 treatment sheets, dated 1/24/25 through 2/19/25 indicated for 5 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 1/24/25 treatment started at 7:11 A.M., heparin was documented as administered at 7:11 A.M., 0 minutes prior to initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 1/27/25 treatment started at 7:35 A.M., heparin was documented as administered at 7:36 A.M., 1 minute after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 2/12/25 treatment started at 8:01 A.M., heparin was documented as administered at 8:01 A.M., 0 minutes prior to initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 2/14/25 treatment started at 7:46 A.M., heparin was documented as administered at 7:46 A.M., 0 minutes prior to initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 2/19/25 treatment started at 7:36 A.M., heparin was documented as administered at 7:51 A.M., 15 minutes after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. During an interview on 2/20/25 at 10:20 A.M., the Charge Nurse said that when heparin is administered, staff should wait 3-5 minutes before starting treatment and it should be documented as such in the medical record.”