Erie County Medical Center

“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: 22484 Based on policy review, observation, and interview, nursing staff do not follow standard infection control practices regarding the use of gloves and hand hygiene. Specifically, staff do not change gloves and/or perform hand hygiene when performing access care, initiating the dialysis treatment, when entering/exiting the dialysis station, and while preparing the dialysis machine for the next patient use. Findings include: Review of the policy “Hemodialysis Infection Control Guidelines,” revised 03/2024 indicated all personnel will adhere to proper hand hygiene (refer to the Hand Hygiene Infection Control policy). All personnel must perform hand hygiene before and after each patient contact and between different procedures on the same patient. Review of the policy “Hand Hygiene,” Revised 05/2024 indicated staff are to perform hand hygiene before/after touching a patient, before clean/aseptic procedures, after body fluid exposure risk, and after touching patient surroundings. Hand hygiene must be performed immediately after glove removal. Observation on 07/07/25 at 10:55 AM at Station A2 revealed Staff (Y), Registered Nurse, completed central venous catheter (CVC- flexible tube inserted into a large vein to deliver medications, fluids and/or an access for hemodialysis treatment) exit site (site where the catheter enters the body) care for Patient #32. Staff (Y) removed their gloves but did not perform hand hygiene prior to putting on new clean pair of gloves to touch the dialysis machine. Observation on 07/07/25 at 11:05 AM at Station A8 for Patient #40 revealed Staff (EE), Licensed Practical Nurse, entered the patient station but did not perform hand hygiene before putting gloves on to discontinue treatment for Patient #40. Observation on 07/07/25 at 12:00 PM at Station B6 revealed Staff (Q), Licensed Practical Nurse, grabbed and placed supplies on the table ungloved. Staff (Q) donned (put on) clean gloves but did not perform hand hygiene prior to performing CVC exit site care. Observation on 07/09/25 at 10:15 AM at Station A6 revealed Staff (DD), Registered Nurse, terminated treatment for Patient # 43 via CVC access. Staff (DD) removed their gloves after disconnecting the blood lines from the CVC, but did not perform hand hygiene before re-donning gloves to continue care. Interview on 07/09/25 at 11:05 AM with Staff (F), Vice President of End Stage Renal Disease (ESRD) Services, verified these findings.”

“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: 22484 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 the policy “Hemodialysis Infection Control Guidelines,” revised 03/2024 indicated all patients should be considered as infectious at all times and appropriate barrier precautions must be used whenever exposure to blood or bodily fluids is anticipated. Protection can be achieved through the use of PPE (i.e. gloves, masks, eye/face protection, and protective clothing). All hemodialysis employees are required to use appropriate PPE whenever potential contact with blood or body fluids/material is anticipated. Observation on 07/07/25 at 11:10 AM at Station A3 revealed Staff (Z), Licensed Practical Nurse, removed the clamps from Patient #39’s left lower arm needle insertion sites wearing eye protection, but no mask or face covering. Observation on 07/07/25 at 11:42 AM at Station B4 revealed Staff (O), Registered Nurse, cleaned/disinfected the hemodialysis machine, blood pressure cuff, machine lines behind the machine, TV clicker, and chair without wearing a gown, mask, or eye protection. Observation on 07/08/25 at 10:20 AM at Station A6 revealed Staff (P), Registered Nurse, cleaned/disinfected the hemodialysis machine, blood pressure cuff, machine lines behind the machine, back counter, TV clicker, and chair without wearing mask, eye and/or face protection. At 10:50 AM at Station A8, Staff (P) touched the clean lines/dialyzer on the machine, set up for the next patient, not wearing gloves. Observation on 07/09/25 at 10:36 AM at Station A3 revealed Staff (AA), Licensed Practical Nurse, discontinued treatment for Patient # 39. Staff (AA) rinsed back Patient # 39 ‘s blood, disconnected the blood lines from the arterial and venous needles, striped the used bloodlines and dialyzer from the hemodialysis machine, and removed both the arterial and venous needles from Patient # 39’s fistula (access made from an artery and vein used to provide hemodialysis) wearing eye protection, but no mask or face covering. Interview on 07/09/25 at 11:05 AM with Staff (F), Vice President of End Stage Renal Disease (ESRD) Services, verified these findings.”

“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: 40430 Based on policy review, observation, and interview, staff do not ensure items taken into the hemodialysis station are cleaned/disinfected between each patient and/or station. Specifically, pens are not being cleaned/disinfected after use and/or between stations. Findings include: Review of the policy “Hemodialysis Infection Control Guidelines,” revised 03/2024 indicated that any item taken to the dialysis station should be discarded or cleaned/disinfected before being returned to a common area or being used on another patient. Observation on 07/07/25 at 11:05 AM at Station #A2 revealed Staff (Y), Registered Nurse, initiated treatment for Patient # 32. Staff (Y) was wearing gloves, holding their pen, documenting on the paper flowsheet, and tapping the dialysis machine with their pen to retrieve patient data/machine readings from the machine. When finished, Staff (Y) placed the pen into their pocket and exited the station without cleaning/disinfecting the pen. Observation on 07/07/25 at 11:35 AM at Station #C2 revealed Staff (FF), Registered Nurse, initiated treatment for Patient #15. Wearing the same gloves worn to cannulate (put needles into access) and initiate treatment, Staff (FF) used their pen to document on the paper flowsheet. When finished, Staff (FF) placed the pen into their pocket and exited the station without cleaning/disinfecting the pen. Observation on 07/07/25 at 12:00 PM at Station #A6 revealed Staff (EE), License Practical Nurse, initiated treatment for Patient # 41. Wearing the same gloves, Staff (EE), used their pen to document on the paper flowsheet. When finished, without cleaning/disinfecting the pen, Staff (EE) placed the pen into their pocket and exited the station without cleaning/disinfecting the pen. Observation on 07/08/25 at 11:15 AM at Station #A8 revealed Staff (CC), License Practical Nurse, wore gloves when completing treatment initiation for Patient #45. Wearing the same gloves, Staff (CC) used their pen to document on the paper flowsheet. When finished, Staff (CC) left the pen in Station #A8 on the bedside tray table and exited the station without cleaning/disinfecting the pen. At 11:20 AM at Station #A7, Staff (CC) entered the station to prepare for the treatment termination for Patient #38. Staff (CC) went back to Station #A8, retrieved their pen, returned to Station #A7, but did not clean/disinfect the pen. Staff (CC) performed hand hygiene and used the pen without gloves, to document on Patient #38’s flowsheet. Staff (CC) put on gloves and proceeded to discontinue Patient #38 treatment. Wearing the same gloves, Staff (CC) used their pen to document on the paper flowsheet. Interview on 07/09/25 at 11:05 AM with Staff (F), Vice President of End Stage Renal Disease (ESRD) Services, verified these findings.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 22484 Based on policy review, observation, and interview, staff do not properly handle and/or dispose of potentially infectious waste. Specifically, staff do not immediately dispose of arterial and venous needles when removed. Findings include: Review of policy “Removal of Internal Vascular Access Needles- Arteriovenous Fistula/Graft Needles,” revised 03/2022 indicated to safely discontinue a hemodialysis treatment, ensure the sharp’s container (puncture/leak resistant container that holds contaminated needles and sharps) is within range to immediately dispose of needles. Observation on 07/07/25 at 10:55 AM at Station B4 revealed Staff (M), Licensed Practical Nurse, discontinued treatment for Patient #1. Staff (M) removed both the venous and arterial needles from Patient #1’s fistula (access made from an artery and vein used to provide hemodialysis) and placed the needles on a table while they applied a pressure to the sites before clamping each site. Staff (M) walked both needles over to the sharp’s container located within the station for disposal. Observation on 07/08/25 at 11:20 AM at Station A7 revealed Staff (CC), Licensed Practical Nurse, discontinued treatment for Patient #38. Staff (CC) removed both the venous and arterial needles from Patient #38’s fistula and placed the needles on a table while they applied a pressure to the sites before clamping each site. Staff (CC) walked both needles over to the sharp’s container located within the station for disposal. Observation on 07/09/25 at 10:23 AM at Station A7 revealed Staff (CC), Licensed Practical Nurse, discontinued treatment for Patient # 44. Staff (CC) removed both the venous and arterial needles from Patient #44’s fistula and placed the needles on a table while they applied a pressure to the sites before clamping each site. Staff (CC) walked both needles over to the sharp’s container located within the station for disposal. Observation on 07/09/25 at 10:45 AM at Station C8 revealed Staff (HH), Registered Nurse, discontinued treatment for Patient #42. Staff (HH) removed both the venous and arterial needles from Patient #42’s fistula and placed the needles on a table while they applied a pressure to the sites before clamping each site. Staff (HH) walked both needles over to the sharp’s container located within the station for disposal. Interview on 07/09/25 at 11:05 AM with Staff (F), Vice President of End Stage Renal Disease (ESRD) Services, verified these findings.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 34528 Based on policy review, observation, and interview, staff do not ensure all hemodialysis access sites are visible throughout the hemodialysis treatment. Findings include: Review of the policy “Assessment and Reassessment of the Hemodialysis Patient,” approved 02/2025 indicated staff are to document access visibility during treatment. Observation on 07/07/25 from 02:40 PM to 03:20 PM at Station C4 for Patient #6 with a central venous catheter access (CVC- flexible tube inserted into a large vein to deliver medications, fluids and/or an access for hemodialysis treatment) and at Station C6 for Patient #7 with a fistula access (access made from an artery and vein used to provide hemodialysis) revealed their access sites were covered by a blanket and not visible. Interviews on 07/07/25 at 03:25 PM with Staff (B), Nurse Manager, and on 07/09/25 at 11:05 AM with Staff (F), Vice President of End Stage Renal Disease (ESRD) Services, verified these findings.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 25545 Based on document review and interview, the facility does not ensure all staff have participated in fire drills during 2024 and 2025. Findings include: Review of the “Fire Safety Reports,” revealed on10/09/24 and 10/15/24, only two staff members were listed as participants during the fire drill. On 03/13/25, only one staff member was listed as a participant during the fire drill. The National Fire Protection Agency (NFPA) 101-2012 edition, Chapter 21 requires fire drills to be performed once per quarter per shift to ensure all staff are knowledgeable in the event of an actual fire. Interview on 07/08/25 at 03:00 PM, with Staff (H), Chief Quality Officer, verified this finding and stated all staff do participate in drills, but it has not been documented.”