Unity Hospital of Rochester - St. Mary’s

“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: 40430 Based on policy review, observation, and interview, the facility does not ensure staff wear personal protective equipment (PPE-equipment worn for protection from workplace hazards such as blood) when cleaning/disinfecting patient care supplies/equipment and performing procedures which spurting or splattering of blood may occur. Findings include: Review of policy “Cleaning Reusable Equipment and Management of Multi-use Supplies Policy,” effective April 2024, indicated staff must wear PPE at all times while cleaning any reusable equipment. Review of the policy “Fresenius 2008 Dialysis Machine: Preparation and Setup Policy,” effective October 2024, indicated PPE equipment including clean gloves, gown and eye protection is required. If staff member has left machine during prime mode, they must wash hands and don (put on) clean gloves before returning to the machine. Review of the policy “Dialysis Infection Prevention Protocols (Supplemental) Policy,” effective March 2025, indicated personnel must wear disposable gloves for all patient and machine contact. Face protection (fluid barrier mask, goggles, shield, etc.) and an impervious (fluid resistant) gown must be worn by personnel while handling blood access, initiating or discontinuing treatment and dismantling equipment or whenever risk of blood contamination is evident. PPE is to be worn while performing procedures during which spurting or spattering of blood might occur. All personnel must scrupulously practice hand washing. Hand hygiene must be performed upon entering and exiting patient station, after all patient contact, when removing gloves and whenever hands are soiled. Observation on 08/04/25 at 10:20 AM at Station #22 revealed Staff (V), Patient Care Technician, was setting up/preparing a hemodialysis machine for the next scheduled patient. Staff (V) was wearing a short sleeve blue PPE gown, that did not cover their arms to their wrists, exposing their personal scrub jacket and was not wearing gloves while touching the machine and dialysis lines/set up with their bare hands. When the hemodialysis machine was priming, Staff (V) exited the station. At 10:30 AM Staff (V) returned to Station #19, did not don gloves, and used their bare hands to connect the dialysis lines together and touch the dialysis machine screen/buttons. At 12:20 PM at Station #15 for Patient #6, revealed Staff (O), Licensed Practical Nurse, initiating hemodialysis treatment via a central venous catheter (CVC-tube inserted into a large vein in the body to provide access for dialysis) wearing a short sleeve blue PPE gown, that did not cover their arms to their wrists, exposing their bare arms. At 03:40 PM at Station #22 for Patient #21, Staff (V) rinsed/returned blood to Patient #21 at the end of their hemodialysis treatment wearing a short sleeve blue PPE gown. At 03:50 PM at Station #13 for Patient 22, Staff (O) cannulated (put needles in) and initiated treatment wearing a short sleeve blue PPE gown. Observation on 08/05/25 at 09:30 AM revealed Staff (V), Patient Care Technician, wore gloves while typing on the computer keyboard (computer workstation on wheels) in front of Station #5. Staff (V) entered Station #5, wearing the same gloves and not wearing a PPE gown, to “tear down” and/or to remove the dirty/used dialysis blood lines from the hemodialysis machine. Staff (V) removed their gloves but did not perform hand hygiene prior to exiting the station. At 10:05 AM at Station #13, revealed Staff (Y), Registered Nurse, did not wear eye protection/goggles while “tearing down” and/or removing the dirty/used dialysis blood lines from the hemodialysis machine. Interview on 08/06/25 at 01:45 PM with Staff (F), Facility Administration, verified these findings.”

“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: 40430 Based on policy review, observation, and interview, the facility did not ensure patient care supplies were stored in a manner to avoid contamination. Specifically, gloves are being placed in staff uniform pockets. Findings include: Review of the policy “Cleaning Reusable Equipment and Management of Multi-use Supplies Policy,” effective April 2024, indicated any supplies brought into the patient station that cannot be disinfected must be discarded. The policy did not include direction on storing patient care supplies in uniform pockets. Review of the policy “Dialysis Infection Prevention Protocols (Supplemental) Policy,” effective March 2025, indicated all personnel must scrupulously practice hand washing. Hand hygiene must be performed upon entering and exiting patient station, after all patient contact, when removing gloves and whenever hands are soiled. Observation on 08/04/25 at 10:40 AM at Station #21 revealed Staff (Q), Registered Nurse, was initiating treatment for Patient #20 via their central venous catheter (CVC-tube inserted into a large vein in the body to provide access for dialysis). After connecting the dialysis tubing to the catheter ports, Staff (Q) removed their gloves and without performing hand hygiene and exited the station to the retrieve several clean gloves from the box on the common supply cart, placing the gloves in their uniform pocket. Staff (Q) entered Station #21 and without performing hand hygiene, donned (put on) gloves that they took out of their uniform pocket, and touched the hemodialysis machine. Interview on 08/06/25 at 01:45 PM with Staff (F), Facility Administration, verified these findings.”

“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: 40430 Based on policy review, observation, and interview, the facility did not ensure nursing staff maintained aseptic (steps taken to prevent the spread of infection) technique when performing central venous catheter care (CVC-tube inserted into a large vein above the heart to provide access for dialysis). Findings include: Review of the policy “Initiation and Termination of Dialysis with a Hemodialysis Catheter Policy,” effective April 2024, indicated to make sure the patient is masked. After treatment is complete and blood is returned to the patient, check blood pressure and ask them how they feel. Once post-treatment vital signs are stable and assessment is complete, perform hand hygiene, and don (put on) clean gloves. Review of “Hemodialysis Catheter Dressing Change Policy,” effective August 2024, indicated to place a mask on patient. Remove the old dressing and discard. Remove gloves, perform hand hygiene, and don clean gloves. Review of the policy “Dialysis Infection Prevention Protocols (Supplemental) Policy,” effective March 2025, indicated all personnel must scrupulously practice hand washing. Hand hygiene must be performed upon entering and exiting patient station, after all patient contact, when removing gloves and whenever hands are soiled. Observation on 08/04/25 at 10:20 AM at Station #9 for Patient #19, revealed Staff (U), Licensed Practical Nurse, initiated treatment via a central venous catheter (CVC- tube inserted into a large vein in the body to provide access for dialysis). Patient #19’s face mask was below their nose with their nostrils exposed. At 10:40 AM at Station #21 Staff (Q), Registered Nurse, was setting up to initiate treatment for Patient #20 via a CVC access. Staff (Q) removed their gloves, did not perform hand hygiene, and exited the station to the common supply cart to retrieve a mask for the patient. Staff (Q) re-entered the station and donned clean gloves without performing hand hygiene. After connecting the dialysis tubing to the CVC ports, Staff (Q) removed the old CVC dressing, removed their gloves, but did not perform hand hygiene prior to donning a new clean pair of gloves to cleanse the CVC exit site (site where the catheter enters the body). Staff (Q) removed their gloves, did not perform hand hygiene, reached down the neck hole of their PPE gown to retrieve their pen from the breast pocket of their uniform to label the new CVC dressing. Staff (Q) put the pen back in their breast pocket. Staff (Q) donned a new pair of gloves without performing hand hygiene and proceeded to apply a new dressing to the CVC exit site. Observation on 08/05/25 at 10:00 AM at Station #13 revealed Staff (O), Licensed Practical Nurse, discontinued treatment for Patient #12. After checking the sitting and standing blood pressure, Staff (O) removed their gloves, but did not perform hand hygiene prior to donning clean gloves to cleansing the CVC ports and disconnecting the dialysis tubing/blood lines. Interview on 08/06/25 at 01:45 PM with Staff (F), Facility Administrator, and 02:15 PM with Staff (I), Facility Administrator, verified these findings.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 42572 Based on policy review, observation, and interview, the facility does not ensure the reverse osmosis system (RO-a water purification system to make the water safe for patient treatment) is running for 15 minutes before obtaining a water sample for chlorine and chloramines testing (used to disinfect water, harmful to patients). Findings include: Review of the policy “Dialysis - Chloramine Testing of Pre-Treated Water ... Dialysis Locations Procedure,” revised June 2025, indicated the water is to be tested every four hours and the RO must run for 15 minutes before every test. Observation on 08/05/25 at 02:10 PM in the water room, revealed that the RO system only runs when the water holding tank is being filled. Interview on 08/05/25 at 02:05 PM with Staff (P), Patient Care Technician, revealed they performed a total chlorine test on the RO system but did not know how to verify if the RO system was continuously running for at least 15 minutes prior to the testing. Interview on 08/05/25 at 02:10 PM with Staff (E), Biomedical Technician, verified that Staff (P), Patient Care Technician, did not know how to determine if the RO was running for 15 minutes prior to performing water testing for Chlorine/Chloramines. Staff (E) verified the RO system does not run for at least 15 minutes prior to each water test and only runs when the water holding tank is being filled.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 42572 Based on observation and interview, the building is not maintained, free from defects and/or hazards to ensure safety and functionality for patients, staff, and visitors. Findings include: Observation on 08/04/25 at 10:45 AM in the treatment area adjacent to the double doors, revealed a four-tier, steel wire shelf, used for the storage of gallon acid solution jugs used during the hemodialysis treatment. There were two areas at the front of the bottom two shelves, approximately four-inches square, that were rusty with a brown rusty colored precipitate (possible spill) spanning between the wires of the shelves. The rust has the potential to prevent proper disinfection when cleaning the surface. Observation on 08/04/25 at 11:45 AM in the water room, revealed two holes in the vinyl flooring. The first hole was approximately a six-inch long tear in the flooring behind the acid mixing tank where the flooring meets/extends up the wall. The second hole was an approximately three-inch by nine-inch hole in the flooring next to the floor drain in the middle of the room. Water under the flooring in these areas creates the potential for mold growth. Interview on 08/04/25 at 12:00 PM with Staff (E), Biomedical Technician, verified these findings.”