Olean General Dialysis

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 16136 Based on observation and interview, the facility does not ensure that the sprinkler lines do not support non-sprinkler components. Findings include: Observation on 07/25/25 between 10:15 AM and 10:30 AM in the water room, above the ceiling tiles, there was a half inch conduit supported by the sprinkler line. The domestic hot water line was being supported by the sprinkler piping. Sprinkler piping cannot support items such as ductwork, wiring or the resting of any objects on the sprinkler piping. Interview on 07/25/25 at 10:45 AM with Staff (E), Facility Administration, verified these findings.”

“Subdivision of Building Spaces - Smoke Barrie CFR(s): NFPA 101 Subdivision of Building Spaces - Smoke Barrier Construction 2012 EXISTING Smoke barriers shall be constructed to a 1/2-hour fire resistance rating per 8.5. Smoke barriers shall be permitted to terminate at an atrium wall. Smoke dampers are not required in duct penetrations in fully ducted HVAC systems where an approved sprinkler system is installed for smoke compartments adjacent to the smoke barrier. 19.3.7.3, 8.6.7.1(1) Describe any mechanical smoke control system in REMARKS. This Standard is not met as evidenced by: 16136 Based on observation, document review, and interview, the facility does not ensure that the one-hour and two-hour fire rated walls (walls constructed to restrict the spread of fire) are maintained. Findings include: Observation on 07/25/25 between 10:15 AM and 01:00 PM, revealed penetrations were noted in the following fire rated walls: -In the water room: five unprotected 3/4-inch conduit lines passed through the two-hour fire wall. -In the soiled utility room: 12 unprotected various-size conduit lines passed through the one-hour fire-rated on the east wall. Conduits passed through the one-hour fire rated walls on the north wall (nurse call), the west wall (fire protection) and the south wall (fire, green and gray cables). Additionally, there was a 1½ inch black pipe that passed though the one-hour fire rated wall on the south wall. -In the clean utility room: five unprotected copper pipes passed through the ceiling; the south wall had unprotected exhaust ductwork that passed through the one-hour fire-rated wall; the north wall had a pipe containing red, gray, white and blue cables that passed through the one-hour fire-rated wall, and a 2x2 inch square penetration with rock wool insulation on the one-hour fire rated wall. -The one-hour and two-hour fire rated walls were verified by viewing a printed document provided by Staff (E), Facility Administration. Interview on 07/25/25 at 01:00 PM with Staff (E), Facility Administration, verified the rated fire wall penetrations.”

“Maintenance, Inspection & Testing - Doors CFR(s): Maintenance, Inspection & Testing - Doors Fire doors assemblies are inspected and tested annually in accordance with NFPA 80, Standard for Fire Doors and Other Opening Protectives. Non-rated doors, including corridor doors to patient rooms and smoke barrier doors, are routinely inspected as part of the facility maintenance program. Individuals performing the door inspections and testing possess knowledge, training or experience that demonstrates ability. Written records of inspection and testing are maintained and are available for review. 19.7.6, 8.3.3.1 (LSC) 5.2, 5.2.3 (2010 NFPA 80) This Standard is not met as evidenced by: 16136 Based on observation, document review, and interview, the facility does not ensure staff performing the fire door inspections are qualified. Findings include: Observation on 07/22/25 at 11:40 AM, revealed fire door #113 did not have a rated label on the frame as required. The fire door adjacent to the sink in the soiled utility room did not close proper, did not latch, and was rusty. Review of the document “Fire Door Inventory Log,” revealed an inspection was performed on 04/21/25 by Staff (O), Maintenance. The log indicated there was only one fire door for the soiled utility room and that corrective action was not required. The inspection failed to identified multiple fire doors within the facility and did not address the lack of a fire rated label on fire door #113, or that the fire door adjacent to the soiled utility room did not close, latch, and was rusty. Interview on 07/23/25 at 02:10 PM with Staff (E), Facility Administration, verified Staff (O) performed the fire door inspections but could not provide documentation to verify Staff (O) had received any training, qualifications, or experience that would demonstrate the ability to perform fire door inspections.”

“Electrical Systems - Other CFR(s): NFPA 101 Electrical Systems - Other List in the REMARKS section any NFPA 99 Chapter 6 Electrical Systems requirements that are not addressed by the provided K-Tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. Chapter 6 (NFPA 99) This Standard is not met as evidenced by: 16136 Based on observation and interview, the facility does not ensure that electrical junction boxes (electrical enclosure that houses one or more wiring connections) are covered and secured. Findings include: Observation on 07/25/25 at 10:00 AM, revealed the junction boxes located in the mechanical room on the 2nd floor and the soiled utility room (above the ceiling tiles on the north wall) did not have covers. Junction boxes are required to have a cover that is accessible, non-combustible and securely fastened to protect the connections inside the box, to prevent accidental contact with live wires and to protect the box against dust and moisture. Interview on 07/25/25 at 10:07 AM with Staff (O), Maintenance, 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 “Infection Control Guidelines in Dialysis,” last revised 05/11/17, indicated items taken into a dialysis station should either be disposed of, dedicated for use only on a single patient or cleaned and disinfected before being taken to a clean area or used on another patient. Observation on 07/22/25 from 12:05 PM until 12:15 PM at Station #1 with Patient #13 revealed Staff (G), Registered Nurse, used their pen to touch the dialysis machine to retrieve data from the machine, transferred the pen from one hand to the other, then used the computer mouse and/or keyboard to enter information into the electronic medical record (EMR) flowsheet. Without cleaning/disinfecting the pen or performing hand hygiene, Staff (G) proceeded to Station #2 with Patient #11 and used the same pen to touch the dialysis machine for data, transferred the pen from one hand to the other, then used the computer mouse and/or keyboard to enter information into the EMR flowsheet. Without cleaning/disinfecting the pen or performing hand hygiene, Staff (G) proceeded to Station #4 with Patient #4, to Station #5 with Patient #7, and Station #12 with Patient #20. Without cleaning/disinfecting the pen or performing hand hygiene, Staff (G) exited Station #12, entered Station #7 for Patient #5 and used their pen to reset a machine alarm then placed their pen into their pocket. Staff (G) proceeded to Station #9 and took a sharpie marker out of their pocket to touch the dialysis machine for data then use the computer mouse and/or keyboard to enter information into the EMR flowsheet. When they were finished, without cleaning/disinfecting the marker, Staff (G) put the marker in their pocket and performed hand hygiene. Interview on 07/24/25 at 10:45 AM with Staff (B), Nurse Administrator, verified findings.”

“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: 16136 Based on observation and interview, the facility does not ensure that adequate separation is provided between clean and dirty supplies and equipment. Findings include: Observation on 07/22/25 at 11:40 AM in the soiled utility room revealed the following “clean” equipment was stored: five intravenous pumps (a machine used to deliver in vein fluids and medications), one Total Parenteral Nutrition (TPN- used to deliver in vein nutrition) machine, and one blood pressure machine. A gray cart held the following “clean” supplies: two - one-gallon acid concentrate jugs, one package of 1000 ml (milliliter) normal saline (in vein fluid used for hydration and the flushing of lines), one package of dialysis tubing, and two dialyzers (used to filter toxins and excess fluids- one Opti flux 200 and one Opti flux180). Interview on 07/22/25 at 12:05 PM with Staff (B), Nurse Manager, and Staff (F), Biomedical Technician, 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: 34528 Based on policy review, observation, and interview, nursing staff do not ensure that a common supply cart/basket is not moved between stations to distribute supplies. Findings include: Review of the policy “Infection Control Guidelines in Dialysis,” last revised 05/11/17, indicated items taken into a dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a clean area or used on another patient. Observation on 07/22/25 from 12:40 PM to 12:42 PM revealed Staff (I), Patient Care Technician, carried a small basket of washcloths, entered multiple stations (Station #1, Station #2, Station #4, Station #5, and Station #7), and placed the washcloths on top of the hemodialysis machine in each dialysis station while patients were receiving their treatment. Interview on 07/24/25 at 11:00 AM with Staff (B), Nurse Administrator, 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: 34528 Based on policy review, medical record review, and interview, in four of four medical records reviewed, the facility does not ensure pre-treatment central venous catheter (CVC-tube inserted into a large vein of the body to provide an access for dialysis) assessments are documented and/or completed by a registered nurse (Patient #6, Patient #15, Patient #5, and Patient #17). Findings include: Review of the policy “Care of the Patient with the Dual Lumen Dialysis Catheter (CVC),” last reviewed July 2021, indicated staff are to inspect the insertion site. If there are any signs of inflammation, fluid leakage around the catheter, abnormal drainage, tissue edema or soreness noted, staff are to notify the physician or the nurse practitioner. Review of the medical record treatment flowsheets from 06/19/25 to 07/21/25 for Patient #6 revealed no evidence a catheter insertion site assessment was performed on 06/23/25, 06/30/25, 07/10/25, and 07/14/25. Review of the medical record treatment flowsheets from 06/30/25 to 07/21/25 for Patient #15 revealed no evidence a catheter insertion site assessment was performed on 06/30/25, 07/02/25, 07/04/25, 07/11/25, 07/16/25, and 07/18/25. Review of the medical treatment flowsheets from 07/01/25 to 07/22/25 for catheter Patient #5 revealed no evidence a catheter insertion site assessment was performed on 07/01/25 and 07/17/25. Review of the medical record treatment flowsheets from 06/16/25 to 07/19/25 for catheter Patient #17 revealed no evidence a catheter insertion site assessment was performed on 06/25/25, 06/28/25, 07/05/25, and 07/12/25. Interview on 07/24/25 at 12:00 PM with Staff (B), Nurse Administrator, verified these findings.”

“CARBON ADSORPTION-10 MINUTES EBCT CFR(s): 494.40(a) 5.2.5 Carbon adsorption: 10 min EBCT Refer to RD62:2001, 4.3.9 Carbon adsorption media: When granulated activated carbon is used as the adsorption medium ... each adsorption bed shall have an [empty bed contact time] EBCT of at least 5 minutes at the maximum product water flow rate (a total EBCT of at least 10 minutes). This Standard is not met as evidenced by: 16136 Based on observation and interview, the facility does not ensure that the empty bed contact time (EBCT- the amount of time water spends in contact with the carbon within the tank) on the carbon tank (tanks that contain carbon to filter water removing chlorine, chloramines, and other organic contaminants) is at least 10 minutes. Findings include: Observation on 07/23/25 at 03:00 PM of the water room revealed there were two carbon tanks, one primary, one secondary. Each tank is four cubic feet. The product water flow rate was 6.7 gallons per minute. Based on Centers for Medicare and Medicaid Services guidelines, this would require a EBCT of 10 minutes for each carbon tank. However, the EBCT was only 9.0 minutes. The facility would need to add two cubic feet of carbon to each carbon tank to meet the 10-minute EBCT required time. Interview 07/24/25 at 10:30 AM, with Staff (E), verified the size of the carbon tanks as four cubic feet and acknowledged the EBCT was inadequate.”

“UV LIGHTS-FILTERS POST CFR(s): 494.40(a) 5.3.4.1 Ultraviolet irradiators: filters post UV irradiators [shall] be followed by a means of reducing endotoxin concentrations, such as an ultrafilter in the purified water distribution system or reverse osmosis in the pretreatment cascade. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that the ultraviolet (UV) light (used to purify dialysis water) is changed every 8000 hours of continuous use (10-11 months) or that the quartz sleeve (protective cover from water, air and contaminants) is cleaned or replaced annually. Findings include: Review of the manufacturer recommendations for “Maintenance Requirements (UV and quartz sleeve),” revealed that the ultraviolet lamps (lights) are rated for 8,000 hours of continuous use. After 8,000 hours of use, the lamp glass will no longer effectively kill bacteria. The quartz sleeve should be cleaned annually. Review of the policy “Changing Ultraviolet Light,” last reviewed on 05/22/18, indicated that the UV light and sleeve are to be changed at or before 8,000 hours of use (10-11 months). Review of the maintenance log for the UV light and the quartz sleeve indicated that the light and sleeve were last changed on 01/25/24. Interview on 07/24/25 at 01:30 PM with Staff (E), Facility Administration, verified these findings.”

“H20 TEST-DEVIATIONS REQUIRE RESPONSE CFR(s): 494.40(c) Water testing results including, but not limited to, chemical, microbial, and endotoxin levels which meet AAMI action levels or deviate from the AAMI standards must be addressed with a corrective action plan that ensures patient safety. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that the daily water room readings are within facility established parameters. Findings include: Review of the policy “Startup Procedure for RO (reverse osmosis- water purification system) System,” reviewed 05/25/17, indicated daily testing/readings are required before any daily dialysis treatments can begin and that biomedical engineering/technician will be notified if any readings are out of parameters. Review of the “Daily Water Room Readings Log,” dated from 06/23/25 to 07/22/25, revealed the following readings: -Pressure gauge #6 (pre-carbon tank) was out of established parameters of 40-60 psi (pounds per square inch) for 17 of 26 days: on 06/23/25, 06/24/25, 06/25/25, 06/26/25, 06/27/25, 06/28/25, 06/30/25, 07/01/25, 07/02/25, 07/03/25, 07/24/25, 07/05/25, 07/07/25, 07/08/25, 07/09/25 and 07/16/25. -Pressure gauge #14 (water loop pressure) was out of established parameter of 17-32 psi for eight of 26 days: 06/23/25, 06/24/25, 06/25/25, 06/30/25, 07/02/25, 07/04/25, 07/08/25 and 07/21/25. -Temperature gauge #23 (water processed through the reverse osmosis water purifying device) was out of established parameters of 20-26 degrees Celsius for 25 of 26 days; the only day the reading was within established parameters was on 06/24/25. -Staff performing the daily readings notified the Biomedical Technician multiple times but there was no evidence of follow-up or corrective actions. Interview on 07/23/25 at 03:10 PM with Staff (E), Facility Administration, verified these findings.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 34528 Based on policy review, medical record review, and interview, in two of seven medical records reviewed, nursing staff did not ensure blood flow rates (BFR-the rate blood is being processed through the artificial kidney) and dialysate flow rates (DFR-the rate dialysate fluid flows through the dialyzer to remove waste from the blood) were maintained per physician order (Patient #5 and Patient # 15). Findings include: Review of the policy “Documentation on Hemodialysis Patients in Electronic Medical Record (EMR),” last revised December 2018, indicated if the ordered blood flow rate was not achieved, the medical doctor or nurse practitioner is to be notified. No guidance was found related to what documentation should be included in the EMR if the BFR and/or DFR are not implemented/maintained as prescribed. Review of the medical record treatment flowsheets for Patient #5, dated 07/01/25 to 07/22/25, revealed an ordered/prescribed BFR of 400 milliliters/minutes (ml/min) was not maintained on 07/03/25, 07/05/25, 07/08/25, 07/12/25, or 07/17/25. There was no documentation in the medical record indicating why the blood flow was not maintained. Review of the medical record treatment flowsheets for Patient #15, dated 06/30/25 to 07/21/25, revealed an ordered/prescribed DFR of 800 ml/min was not maintained on 06/30/25, 07/02/25, or 07/16/25. There was no documentation in the medical record indicating why the dialysate flow was not maintained. Interview on 07/24/25 at 12:00 PM with Staff (B), Nurse Administrator, verified these findings.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 40430 Based on policy review, document review, and interview, the Quality Assessment and Performance Improvement (QAPI) program does not conduct patient satisfaction surveys to identify opportunities to improve patient care. Findings include: Review of the policy “QAPI Plan for Dialysis,” last reviewed 08/15/21, indicated the dialysis facility must measure, analyze and track quality indicators. To identify opportunities for improvement and track progress of the patients the program will include, but not be limited to, patient satisfaction and grievances. Any information on patient satisfaction surveys will be reviewed. Review of the facility quality assurance documents from 12/20/24 to 06/2025 revealed no evidence patient satisfaction surveys that were conducted. Interview on 07/24/25 at 10:45 AM with Staff (B), Nurse Administrator, and on 07/25/25 at 11:00 AM with Staff (D), Social Worker, revealed patient satisfaction surveys had not been conducted by the hospital or dialysis unit.”