Fms-Kenmore Artificial Kidney Center

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 40430 Based on policy review, document review, and interview, in two of five personnel files, the facility does not ensure direct patient care staff have cardiopulmonary resuscitation (CPR) certification (Staff N and Staff O). Findings include: Review of the policy “Cardiac and Pulmonary Arrest,” published on 05/06/24 revealed all registered nurses (RN), licensed practical nurses (LPN), and patient care technicians (PCT) will be certified to perform basic CPR. Review on 01/10/25 of employee personnel records revealed the CPR certification for Staff (N), PCT expired in September 2024. The CPR certification for Staff (O), LPN expired in June 2024. Interview on 01/10/25 at 10:00 AM, with Staff (B), Clinical Manager, verified this finding.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 40430 Based on policy review, document review, and interview, the facility did not conduct fire drills on each shift quarterly. Findings include: Review of the policy “Fire Drill,” published 08/02/17, revealed the facility shall perform a fire drill for each shift of patients and staff quarterly. Review on 01/10/25 of the “Emergency Preparedness (EP) Manual,” revealed in 2024, only two fire drills were completed (04/19/24 and 11/15/24). No documentation was found to indicate fire drills were performed for the other two quarters of 2024 and that all shifts were covered. Interview on 01/10/25 at 09:30 AM with Staff (B), Clinical Manager, and Staff (K), Director of Operations, verified these findings.”

“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: 34528 Based on policy review, observation, and interview, nursing staff failed to follow infection control practices regarding the use of gloves and hand hygiene. Findings include. Review of the policy “Hand Hygiene,” published 11/06/23, revealed hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water after contact with inanimate objects near the patient. Review of the policy “Personal Protective Equipment,” published 11/06/23, revealed staff must remove gloves and wash hands after patient care, exposure to blood and body fluids, and touching surfaces within the patient station. If hands are not visibly soiled, alcohol-based hand sanitizer may be used. Always perform hand hygiene after glove removal. Observation on 01/08/25 at 10:45 AM at Station #6 for Patient #1 revealed Staff (H), Licensed Practical Nurse (LPN) removed fistula (surgically created access used to deliver dialysis treatment to patients) needles and applied clamps (used to apply pressure to needle sites to stop bleeding, post dialysis) to both the arterial (removes blood from patient to get “cleaned” through dialyzer [artificial kidney]) and venous (returns clean blood back to patient) needle sites. Staff (H) exited the station, removed their gloves, did not perform hand hygiene, and proceeded to the lobby to retrieve Patient #2. At 10:55 AM Staff (H) entered Station #7 with Patient #2. Staff (H) applied clean gloves but did not perform hand hygiene first. Staff (H) proceeded to apply the blood pressure cuff, touched the dialysis machine, and cannulate (insert needles) Patient #2 fistula. Staff (H) exited the station, removed their gloves, but did not perform hand hygiene. Staff (H) went to the nursing station to retrieve a vacutainer (used to hold needle to draw blood into lab tubes) and re-entered Station #7. Staff (H) applied clean gloves but did not perform hand hygiene first. Staff (H) obtained lab specimens, and initiated Patient #7 treatment. Staff (H) removed their gloves without performing hand hygiene and exited the station. Staff (H) re-entered Station #6, applied a clean pair of gloves without performing hand hygiene, removed the clamps, and taped up Patient #1’s needle insertion sites. Observation on 01/08/25 at 01:45 PM revealed Staff (H), LPN, wheeled the “sharp smart” container (contains medical waste) to Station #8 with gloved hands and proceeded to disconnect both blood lines from arterial and venous needles for Patient #12 without changing gloves and performing hand hygiene. Observation on 01/08/25 at 02:15 PM revealed Staff (H) LPN, wheeled the “sharp smart” container to Station #7 with gloved hands and proceeded to disconnect both blood lines from the arterial and venous needles for Patient #2 without changing gloves and performing hand hygiene. Interview on 01/10/25 at 02:00 PM with Staff (B), Clinical Manager, 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: 34528 Based on policy review, observation, and interview, nursing staff do not wear personal protective equipment (PPE) appropriately while performing procedures during which the spurting or spattering of blood might occur Findings include: Review of the policy “Exposure Categories and Determination,” published 07/01/24 revealed when emptying blood lines and stripping the machine, staff will wear a full-face shield/mask and goggles. Observation on 01/08/25 at 02:30 PM at Station #13 revealed Staff (J), Registered Nurse, did not have eye protection on when removing/stripping used blood lines off the hemodialysis machine. At 02:35 PM at Station #7, Staff (H),Licensed Practical Nurse did not have eye protection on when removing/stripping the used blood lines off the hemodialysis machine. Interview on 01/10/25 at 02:00 PM with Staff (B), Clinical Manager, verified these findings.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 40430 Based on policy review, document review, policy review, observation, and interview, the facility does not ensure expired medications and supplies/biologicals are not available for use. Findings include: Review of the policy “Storage of Supplies,” published 04/05/21 revealed staff will appropriately dispose of items that have reached the expiration date. Review of the package insert for the “Waterchek Chlorine/Peroxide Test Strips,” revealed the test strips expire three months after opening. Review of the policy “Medication Preparation and Administration,” published 02/06/23 revealed expiration dates for all stored medication are to be monitored monthly. Expired medications are to be discarded per facility off-site return program or in accordance with local and/or state law. Label any open multidose vial that is not used immediately. Any open multidose vial must be discarded 28 days after opening or per manufacturer’s expiration date. Review of the package insert for “Epogen,” (medication used to help produce more red blood cells) revealed unused portions of Epogen in multiple dose vials are to be discarded 21 days after the initial entry (with a needle). Observation on 01/08/25 at 10:00 AM in the nursing station/lab supplies revealed the following: -One bottle of “Glucose Meter Test Strips (used to test diabetic patient blood sugar levels)” were not labeled with “opened on” date. The “notice” printed on the side of the bottle indicated the test strips expire four months after opening. -One case (100 tubes) of light blue top blood tubes (used for laboratory tests) expired on 11/30/23. -60 red top blood tubes (used for laboratory tests) expired on 07/31/24. -One bottle of the “Waterchek Chlorine/Peroxide” test strips expired 02/2023. -Five packages of recirculating adapters (used for connecting the dialysis blood lines together to recirculate blood/fluid on the machine) expired on 11/24/24. Observation on 01/08/25 at 10:20 AM in the medication room revealed the following: -One 30,000 units/milliliter (ml) multi dose vial of Heparin (used to prevent blood clotting during dialysis) was opened but not labeled with an “opened on date.” -Two cartons of LiquaCel (oral protein supplement) with no “opened on” date. Instructions printed on side of carton indicated to “use within three months of opening.” -Three 250 ml bags of 0.9 % Normal Saline (intravenous solution used during dialysis to administer intravenous medication) expired on 07/2024. -One 20,000 units/ml multi dose vial of Epogen (medication to treat anemia (low red blood cells) was opened but not labeled with an “opened date.” -Two boxes (60 vials) of Aranesp (medication to treat anemia) expired 02/2024; three vials of Aranesp expired 02/2024; and one box of Aranesp expired 07/2024. Interview on 01/08/25 at 10:30 AM with Staff (G), Registered Nurse, verified these findings. Observation on 01/09/25 at 09:45 AM in the soiled utility room revealed five unopened bottles of “Waterchek Chlorine/Peroxide Test Strips,” that expired 02/2023. Staff (M), Registered Nurse verified this finding. Interview on 01/10/25 at 10:00 AM with Staff (B), Clinical Manager, verified these findings.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 16136 Based on policy review, observation, and interview, the facility does not ensure that the salt in the brine tank (part of the water system used to form sodium chloride solution (brine) used for the regeneration of ion exchange systems, such as water softeners) is half full of salt pellets and hardness testing is performed correctly. Findings include: Review of the policy “Water Softener,” published 05/03/23 indicated that staff will monitor and document the water softener each operational day and check the brine tank daily to be sure the tank is at least half filled with salt. Salt levels inside the brine tank will be maintained at a minimum of half full.” Observation on 01/10/25 at 12:00 PM, in the water room revealed the brine tank was approximately one quarter full of salt pellets. The salt pellets were put inside the tank at an angle. The water level was approximately six inches above the salt pellets. Interview on 01/10/25 at 12:15 PM with Staff (N), Patient Care Technician and at 12:45 PM with Staff (P), Area Technical Operations Manager, verified this finding. Review of the policy “Total Hardness Testing with Sterichek Sensitive Low Range Water Hardness Test Strip Procedure,” published 09/03/24 indicated when staff perform an “in-stream” hardness test they are to compare the test pad (end of the test strip that changes colors based on the water sample) to the color chart (located on the side of the test strip bottle) 15 seconds after removing from the water stream. Observation on 01/10/25 at 12:00 PM revealed Staff (N), Patient Care Technician conducted a hardness test putting the test strip under the post softener tank water stream and immediately read the result, not waiting 15 seconds. Interview on 01/10/25 at 12:45 PM With Staff (N), Patient Care Technician and Staff (P), Area Technical Operations Manager, verified this finding. Interview on 01/10/25 at 12:45 PM With Staff (N) and Staff (P), verified this finding.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 16136 Based on policy review, observation, and interview, the facility does not ensure separation between different acid concentrations (used to make dialysate for the removal of waste and correct electrolyte imbalance during hemodialysis). Findings Include: Review of the policy “Storage of Supplies,” last reviewed 04/05/21, indicated all supplies must be stored in a manner that does not present a safety hazard. Observation on 01/09/25 at 10:00 AM revealed two containers of 2.0 K (potassium), 3.0 Ca (calcium), five containers of 2.0 K 2.0 Ca and two containers of 1.0 K 2.5 Ca were stored together on a grey shelf adjacent to Station #1. Interview on 01/09/25 at 10:15 AM with Staff (M), Registered Nurse, and Staff (N), Patient Care Technician, verified these findings. Observation on 01/10/25 at 12:00 PM in the supply room revealed one gallon acid concentrates were stored together: eight cases (one case equals four one-gallon jugs) of 1.0 K 2.5 Ca; five cases of 2.0 K 2.0 Ca; nine and a half cases of 2 K 2.5 Ca; eight cases of 3 K 2.5 Ca; and three cases of 2 K 3.0 Ca. Interview on 01/10/25 at 12:30 PM with Staff (B), Clinical Manager and Staff (N), Patient Care Technician, verified this finding acknowledging that the separation of the acid concentrations was inadequate.”

“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: 16136 Based on document review and interview, the facility does not ensure that the sprinkler system is maintained, fire doors are inspected annually, documentation is maintained for the generator, and documentation of for ground fault circuit interrupters (GFCI) is complete. Findings include: Review on 01/09/25 of the “2024 Sprinkler Inspection Reports,” indicated that the hydraulic placard was not present on the system. Without this placard, it is not possible to determine crucial information about the system’s design, including its water flow capacity and pressure per National Fire Protection Association - NFPA-25, 2012 edition. Review on 01/09/25 of the “2024 Fire Inspection Reports,” revealed no evidence facility fire doors were inspected annually per NFPA 80, 2010 edition. Review on 01/09/25 of the “Life Safety-Generator Log for 2024,” revealed testing was conducted monthly, however, the documentation did not include the date of the test, the generator identification number, the person performing the test, the generator’s nameplate rating, the load applied during the test, the duration of the test, any observed issues or corrective actions taken, the transfer switch used, transfer time, and a cool-down period per NFPA 110, 2010 edition. Review on 01/09/25 of the two “2024 GFCI’s testing reports,” dated 06/10/24 and 12/17/24, did not indicate the level of milliamperes (mA) the outlets become inactivated per NFPA 99, 2012 edition that indicates ground fault circuits need to “inactivate quickly” because their primary function is to rapidly cut off power to a circuit when they detect a ground fault, which could potentially cause a dangerous electrical shock to someone if not interrupted immediately. Interview on 01/10/25 at 01:00 PM with Staff (P), Area Technical Operations Manager, verified these findings.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 16136 Based on observation, document review, and interview, the facility does not ensure that CitruClean (acid cleaning solution used for daily decalcification and cleaning of the hemodialysis machine) is labeled with the date and time when mixed. Findings include: Observation on 01/08/25 at 10:18 AM, revealed two 2.5-gallon containers of CitruClean located on a black common supply cart across from Station #4, were not dated when the solution was prepared. Review on 01/08/25, of the “CitruClean Manufacturer Recommendations,” indicated that the CitruClean mixing container was to be labeled with “batch information” and the solution should be used within 30 days of mixing. Interview on 01/08/25 at 10:22 PM with Staff (F), Registered Nurse revealed that the CitruClean containers should be dated and initialed when the solution is prepared. Interview on 01/08/25 at 02:30 PM with Staff (E), Biomed Technician verified this finding.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 34528 Based on policy review, medical record review, and interview, in two of four medical records reviewed, catheter assessments were not completed timely by a registered nurse (Patient #15 and Patient #16). Findings include: Review of the policy “Nursing Supervision and Delegation,” published 11/06/23, revealed the registered nurse (RN) must perform an assessment of each patient, including their vascular access (surgically created access used to deliver hemodialysis treatment), to review the patient’s condition, preferably within an hour or according to state requirements (New York requires an evaluation within 45 minutes of treatment initiation). Review on 01/10/25 of the medical record hemodialysis treatment flowsheets for Patient #16, dated 12/17/24 to 01/07/25, revealed a central venous catheter (CVC) was used to deliver hemodialysis treatments. On 12/19/24 at 11:24 AM, treatment was initiated by a licensed practical nurse (LPN), but there is no RN assessment of the CVC documented. Review on 01/10/25 of the medical record hemodialysis treatment flowsheets for Patient #15, dated 12/17/24 to 01/07/25, revealed a CVC was used to deliver hemodialysis treatments. On 12/21/24 at 10:45 AM, treatment was initiated by an LPN, but the RN assessment of the CVC was not documented until 02:42 PM. On 12/30/24 at 10:42 AM, treatment was initiated by an LPN, but the RN assessment of the CVC was not documented until 02:46 PM. On 12/26/24 at 10:48 AM, treatment was initiated by an LPN, but the RN assessment of the CVC was not documented until 02:25 PM. Interview on 01/10/25 at 02:00 PM with Staff (B), Clinical Manager, 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, document review, medical record review, and interview, in four of seven patients, nursing staff did not ensure blood flow rate (the rate blood is being processed through the artificial dialyzer) and dialysate flow rates (the rate dialysate fluid flows through the dialyzer to remove waste from the blood) were maintained per physician order (Patient #15, Patient # 16, Patient #19, and Patient #20). Findings include: Review of the policy “Patient Assessment and Monitoring,” published 05/01/23, revealed staff are to check to see if the prescribed blood flow is being achieved or document the reason in medical record if unable to meet prescribed blood flow. Review of the document “Dialysate Flow Rate Guidance,” (no date) revealed if an adjustment in the dialysate flow rate is made, it should be reflected in the patient’s hemodialysis order. Review on 01/10/25 of the medical record hemodialysis treatment flowsheets for Patient #15, dated 12/17/24 to 01/07/25, revealed the ordered dialysate flow rate of 800 milliliters per minute (ml/min) was not maintained on 12/23/24, 01/02/25, 01/07/25. There was no documentation in the medical record indicating why the dialysate flow rate was not maintained. Review on 01/10/25 of the medical record hemodialysis treatment flowsheets for Patient #16, dated 12/17/24 to 01/07/25, revealed the ordered dialysate flow rate of 800 ml/min was not maintained on 12/21/24 and the ordered blood flow rate of 450 ml/min was not maintained on 01/02/25. There was no documentation in the medical record indicating why the blood flow rate and dialysate flow rate were not maintained. Review on 01/10/25 of the medical record hemodialysis treatment flowsheets for Patient #19, dated 12/12/24 to 01/07/25, revealed the ordered blood flow rate of 500 ml/min was not maintained on 12/21/24 or 01/02/25. There was no documentation in the medical record indicating why the blood flow was not maintained. Review on 01/10/25 of the medical record hemodialysis treatment flowsheets for Patient #20, dated 12/17/24 to 01/07/25, revealed the ordered blood flow rate of 400 ml/min was not maintained on 12/26/24. There was no documentation in the medical record indicating why the blood flow was not maintained. Interview on 01/10/25 at 02:00 PM with Staff (K), Director of Operations, verified these findings.”