Davita Pdi Middlesex Dialysis Center

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 32738 The facility did not ensure that Policies & Procedures including Evacuation were developed, delivered to staff and reviewed at least annually , as required by the Emergency Preparedness Codes as referenced in §494.62, Condition for Coverage for End-Stage Renal Disease (ESRD) Facilities. On 09/24/24 during document review, surveyor was not provided with documentation from the facility to indicate that the facility has developed, delivered to staff and reviewed at least annually, policies & procedures including evacuation, as required by the Emergency Preparedness Codes, §494.62(b)(2), Condition for Coverage for End-Stage Renal Disease.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 32738 The facility did not ensure that a training and testing program was developed, maintained and reviewed at least annually; based on the emergency plan, risk assessments, policies and procedures and the communication plan as required by the Emergency Preparedness Codes as referenced in §494.62, Condition for Coverage for End-Stage Renal Disease (ESRD) Facilities. On 09/24/24 during document review, the surveyor was not provided with documentation by the facility to indicate that the required testing and training program had been developed; i.e., no information in the emergency plan and facility could not produce it.”

“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: 32738 The facility did not ensure that Emergency Preparedness Testing was being conducted as required by the Emergency Preparedness Codes as referenced in §494.62, Condition for Coverage for End-Stage Renal Disease (ESRD) Facilities. On 09/24/24 during document review, the surveyor was not provided with documentation from the facility to indicate that any drills or exercises on the facility ’ s Emergency Plan have been conducted as required by the Emergency Preparedness Codes, §494.62(c)(4)-(6), Condition for Coverage for End-Stage Renal Disease (ESRD) Facilities; i.e.no exercises have been conducted of the Emergency Plan.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 44675 Based on observations, facility documentation, facility policy and interviews, the facility failed to provide a clean and sanitary environment. The findings include: 1. Observations conducted in the lobby of the facility on 9/23/24 identified the following: a. Staff Person #3 entered the lobby wearing his/her dialysis gown to carry a patient’s bag into the treatment area. Interview Staff Person #3 on 9/23/24 at 11:52 AM identified he/she should have removed his/her dialysis gown prior to entering the lobby. b. Staff Person #2 entered the lobby wearing his/her dialysis gown while greeting a patient and holding the door open for him/her. Interview with Staff Person #2 at 12:17 PM on 9/23/24 identified he/she was suppose to remove his/her dialysis gown prior to entering the front lobby. Review of the Infection Control for Dialysis Facilities policy directed staff to remove personal protective equipment (gowns, gloves, eye protection, face shield) prior to leaving the treatment area. 2. Observations conducted of the facility treatment floor on 9/24/24 at 10:30 AM identified the following: a. Station #5’s wallbox (contains connections for the dialysis machine to receive acid and base concentrations, treated water and dispose of waste products) was cracked. b. Station #11 and 18’s wallbox was cracked. c. Station #20 and 22’s wallbox had a black substance around the drain pipe. d Station #23’s wallbox had a black/purple splatter around the wall box. Interview with the Clinical Services Specialist on 9/24/24 at 11:00 AM identified she identified the wall box concerns on her previous internal audit. She identified the facility is in negotiations for new wall box prices but had yet to repair them. Review of the infection control for dialysis facilities policy directed that the policy’s purpose is to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. It further directed at the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include the wallbox, brain and water supply lines. It further directed teammates will monitor and address wallbox residue/build up. 47491”

“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: 47491 Based on observations and review of facility policy, the facility failed to clean and disinfect the hemodialysis station after patient treatment thoroughly per facility policy. The findings included: a) Observations conducted on 9/24/24 at 9:55 AM of Station #18 identified Staff Person #2 cleaning and disinfecting the station after a patient’s treatment. Staff Person #2 failed to clean and disinfect the tubing in front of the machine, the primer bucket, and the tubing on the side of the machine. b) Observation on 9/24/24 at 10:05 AM identified Staff Person #3 cleaning and disinfecting Station #15 after a patient’s treatment. Staff Person #3 failed to clean the tubing on the side of the machine and only partially cleaned the tubing on the front of the machine. Review of the infection control policy directed at the end of each treatment, the dialysis station will be clean and disinfected. Surfaces to disinfect include but are not necessarily limited to all surfaces in contact with the patient or their belongings and frequently contacted by healthcare personnel (control panel, top, front, sides of dialysis machine). It further directed to clean and disinfect the prime bucket, drain and water supply lines.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 32738 Based on clinical record review, facility documentation, and interviews, for one (1) of three (3) patients reviewed for Central Venous Catheters (CVCs), the facility failed to address possible signs and symptoms of infection in a CVC exit site timely. Patient # 3 had a diagnosis of end stage renal disease and received hemodialysis through a CVC in the right chest three (3) times weekly. Review of treatment detail report dated 6/29/24 identified that the CVC exit site dressing was not clean and dry and the exit site had non-purulent drainage. Review of a treatment detail report dated 7/1/24 identified that the old dressing was not clean and dry and the exit site was noted with non-purulent drainage and redness, bacitracin was applied. Review of a treatment detail sheet dated 7/4/24 identified that the exit site had redness and purulent drainage, a wound culture was ordered. A progress note dated 7/8/24 identified that the catheter site culture was positive for Methicillin- Resistant Staphylococcus Aureus (MRSA, a drug resistant bacteria), an appointment was made to replace the catheter and the patient was started on Vancomycin 500 milligrams (mg) (an intravenous antibiotic) three (3) times a week for two (2) weeks. Interview with staff person #10 on 9/23/24 at 2:30 PM identified that she was assigned to Patient #3 on 6/29/24 and cannot recall any drainage to the CVC exit site, she would normally inform the charge nurse of any concerns related to the CVC, however she could not recall if she had on that day. Interview with staff person #11 on 9/23/24 identified that he had the patient on 7/1/24, however, could not recall the redness and drainage to the CVC, he would normally inform the charge nurse and a culture probably would have been ordered. Interview with the Facility Administrator on 9/23/24 at 3:00 PM identified that once any type of abnormality is noted to the CVC site the charge nurse should be notified and if the assessment deems appropriate, the physician should be notified.. Review of the pre-intra-post assessment policy identified that any abnormal findings found on a pre-treatment assessment should immediately be reported to the charge nurse. Review of the CVC policy identified that exit site infections can be characterized by erythema.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 32738 44675 Based on observation, interview and policy review, the facility failed to ensure the hemodialysis water treatment room was secured from unauthorized personal in accordance with facility policy, resulting in a finding of Immediate Jeopardy. The finding included: Observations conducted on 9/24/24 at 12:45 PM identified the loading dock garage door was open to the outside, this door leads into supply room, and then to the the water treatment room (a secure dedicated space that houses the water treatment system for the facility). The water treatment room door was propped open with a bucket, leaving the water room accessible from the outside of the facility. Simultaneous observations with the Clinical Services Specialist (CSS) identified and a vendor passing through the water treatment room was unaccompanied by staff. Interview at the time of the observation with the CSS identified that she was unaware that the door to the water room was not functioning, no vendors should be left unsupervised with access to the water treatment room, and the water room should not be accessible to the outside of the facility and unauthorized personnel. Interview with the Facility Administrator (FA) on 9/24/24 at 12:50 PM identified that the access to the water room from the supply room was restricted to facility staff only. The FA was not aware the secured door between the supply room and water treatment room was not functioning as designed and was propped open with a bucket. Once brought to her attention by the surveyor it was determined that the battery to the key pad needed to be replaced to enable the door to be secured. The battery was replaced, and the key pad was functional, however, it was then determined that the door was not latching unless it was pulled shut, once the door was pulled shut the door was secure. The staff were educated to ensure the door is pulled shut, until the vendor comes on 9/25/24 to fix the door. The FA further identified that when a vendor rings the back door bell by the loading dock the secretary or an available staff member lets the vendor in and should supervise the vendor while having access to the water treatment room. Interview with the Secretary on 9/24/24 at 1:08 PM identified a facility contracted vendor rang the back doorbell to be let in for delivery, she opened the back door for him to enter the facility and walked away, leaving the unauthorized personnel unsupervised. She further identified she was not aware she was to remain with the vendor while he was passing through the water treatment room, where unauthorized personal are prohibited. The state agency requested a removal plan on 9/24/24. The facility removal plan dated 9/24/24 included clinical teammate in-service on the physical environment policy, education to never leave unauthorized personnel such as vendors alone with access to the water treatment room, a sign in log will be utilized whenever a vendor is allowed access to the building and the teammate allowing access must accompany the vendor, and audits to ensure the security of the loading dock door, supply area and water treatment room. It further identified the lock (keypad) on the water treatment room door was repaired and the facility maintenance contractor was scheduled to be in the facility on 9/25/24 to repair the latch on water treatment room door. An onsite visit was conducted on 9/30/24 to remove the immediate jeopardy, however, observation of the water treatment area identified the supply room door (to the outside) was propped open with a garbage can, the door to the water treatment area could be opened without a code leaving the water treatment room accessible from the outside of the facility. Furthermore, there was a heating and air conditioning vendor working on the roof (access to the roof was through the ceiling of the supply room) and at the time of the observation had access to the unsecured water room. Interview with the dietician on 9/30/24 at 9:15 AM identified that she had given the vendor access to the supply room that morning and had closed the water room door behind her, leaving the vendor access to only the supply room, assuming that the water treatment door was locked. Interview with the vendor on 9/30/24 at 9:30 AM identified that after they were let into the supply room they had propped the back door open with a garbage can. Interview and observation with the FA on 9/30/24 at 9:00 AM identified that although the keypad battery was replaced and functioning, there was dead bolt on the door that was left in the unlocked position, therefore the door was not locked and could be accessed without restriction, leaving the water treatment room accessible to the outside of the facility and the vendor. The FA further identified that although the door vendor had come to the facility on 9/25/24, he did not have the correct part and would be returning 9/30/24. An second action plan was requested by the state agency and provided on 9/30/24 that included constant staff member supervision of the water treatment room until the door vendor arrived to ensure the security of the water treatment door. The action plan also included educating all vendors no to prop any doors open at the facility. Review of the physical environment policy directed, in part, that access to patient treatment areas and water treatment systems is restricted to authorized personnel only. Access limitation does not preclude visitors or tours by individuals authorized and supervised by facility personnel.”

“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: 32738 On 09/24/24 at 12:30 PM and during a tour of the facility while accompanied by the clinical specialist, regional bio med, and the bio med the facility failed to maintain a safe environment. The findings include the following: 1. On 09/24/24 during a tour of the facility with the clinical specialist, regional bio med, and the bio med, the surveyor, observed that the floor throughout the treatment floor was dirty, soiled and otherwise not being maintained as cleanable or sanitary; 2. On 09/24/24 during a tour of the facility with the clinical specialist, regional bio med, and the bio med, the surveyor observed that the counter by the dirty sinks were not being maintained as cleanable or sanitary.”

“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: 32738 On 09/24/24 at approximately 9:30 AM and during document review, the facility failed to maintain a building that was constructed and maintained to ensure the safety of the patients, the staff and the public. The findings include the following: a. Documentation was not provided to indicate that the FDC was hydrostatically tested within the past 5 years, as required by table 5.1.1.2 of NFPA 25, 2011 edition. b. Documentation was not provided on day or survey that fire alarm is being inspected as required by # 14.3.1 of NFPA 72,”National Fire Alarm Code “and by the facility ’ s procedures & policies; i.e. last report provided was a report on 05/23, around 16 months. c. Documentation was not provided that the smoke detector sensitivity testing at the facility was not being performed as required by “National Fire Alarm Code”, section #14.4.5.3 and as part of the facility’s preventive maintenance program; i.e. no record of sensitivity testing available. d. Documentation was not provided on the day of survey that the battery powered emergency lights throughout the facility are being tested annually for 90 minutes, as required by section # 7.9 of the “Life Safety Code”; e. Documentation was not provided to indicate that all staff have been annually in-serviced on the facility fire plan and kept informed with respect to their duties under the plan, as required by section # 21.7.1.2 of the “Life Safety Code”;i.e. documentation was not provided. f. Documentation was not provided to indicate that the fire drills are being conducted , as required by section # 21.7.1.6 of the “Life Safety Code”; i.e. there is no indication that Tuesday, Thursday, Saturday shift had drills 1st and 2nd quarter of 2023. g. Documentation was not provided to indicate that the sprinkler system was being maintained per NFPA 25 chapter 5. Ie. No documentation was provided for first and second quarter of 2024 and fourth quarter of 2023.”

“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: 44675 Based on a review of clinical records, interview, and policy review for one (1) of two (2) hemodialysis patients reviewed for hemodialysis treatment, (Patients #9), the facility failed to address an abnormal finding post treatment per facility policy. The findings include the following: Patient #8 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s order directed hemodialysis three (3) times weekly for four (4) hours with a left upper arteriovenous fistula (AVF) and an estimated dry weight (EDW) of 97.5 kg. An annual care plan dated 7/25/24 identified Patient #8’s fluid/blood pressure goal was to maintain post weight compared to target weight and blood pressures within range. Review of Patient #8’s hemodialysis treatment calendar identified Patient #8 missed his/her prescribed hemodialysis treatments on 8/27/24, 8/29/24 and 8/31/24, 9/3/24 (11 days without hemodialysis treatment). A Social Work note dated 9/3/34 at 7:00 AM identified Patient #8 missed multiple treatments due to transportation issues. Patient #8 reported he/she miscalculated his/her money and did not have money for the bus. The SW encouraged Patient #8 to find a ride through his/her friends and if not feeling well should call 911. Patient #8 called the clinic on 9/3/24 to report he/she was not coming in but would have money for the bus for his/her next treatment. Patient #8 reported swelling in his/her ankles/legs which was painful. SW encouraged Patient #8 to go to the emergency department but Patient #8 declined and the CN was made aware. Review of Patient #8’s hemodialysis treatment calendar identified Patient #8 received hemodialysis treatment on 9/5/24. Review of Patient #8’s progress notes failed to identify documentation the CN was aware of Patient #8’s transportation concerns and painful swelling. The progress notes failed to identify if the physician was notified of Patient #8 having 11 days without hemodialysis treatment, and if it was appropriate for hemodialysis treatment to have been conducted in-center on 9/5/24. Interview with the FA on 9/24/24 at 12:00 PM identified the facility does not have missed treatment policy. She identified the facility practice standard of care is for patients to go to the hospital if they miss a week of hemodialysis treatments.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 32738 Based on clinical record review, facility documentation and interviews for one (2) of nine (9) hemodialysis patients (Patients #1 and #9), the facility failed to address an abnormal finding post treatment per facility policy. The findings included: 1) Patient #9 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s order directed hemodialysis three (3) times weekly for four (4) hours with a right upper arteriovenous fistula (AVF) and an estimated dry weight (EDW) of 114 kilograms (kg). A annual care plan dated 7/16/24 identified Patient #9’s fluid/blood pressure goal was to maintain post weight compared to target weight and blood pressures within range. Review of Patient #9’s treatment flowsheet dated 8/28/24 identified Patient #9’s pretreatment sitting blood pressure was 153/70. Treatment was initiated at 7:48 AM. Patient #9’s blood pressure decreased to a low of 72/42 during treatment and Midodrine (a medication used to increase blood pressure) was given to Patient #9 at 9:02 AM. Patient #9’s post treatment sitting blood pressure at 11:47 AM was 87/64 (decrease of 66 points systolic compared to pre-treatment) with no documentation of a nursing assessment prior to discharge and if Patient #9’s blood pressure was safe for discharge. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “abnormal findings” section in this policy). If an abnormal finding is identified post treatment, it needs to be reported to the licensed nurse and the licensed nurse will assess the patient prior to discharge. The policy directed an abnormal blood pressure finding would be a systolic less than 90mm/HG. 2) Patient # 3 had a diagnosis of end stage renal disease and received hemodialysis through a CVC in the right chest three (3) times weekly. A physician’s order dated 7/1/24 directed for the patient to receive a 2 K (potassium) 2.5 Ca (calcium) bath with a dialysis flow rate of 500 and an EDW of 86 kg. Review of a treatment detail report dated 7/15/24 identified that the patient arrived to treatment weighing 92.2 kg, the post hemodialysis weight was 88.4 kg ( 2.4 kg over EDW). Review of a treatment detail report dated 7/18/24 identified that the patient arrived to treatment weighing 94 kg, the post hemodialysis weight was 91 kg (5 kg over EDW). Interview with the Facility Administrator on 9/26/24 at 2:00 PM identified that the charge nurse should be notified to do an assessment or offer an extra treatment if the patient is 1 kg above EDW. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy identified that if the patient’s post treatment weight is one (1) kg above the EDW the charge nurse should be notified.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 32738 Based on clinical record review, interviews, and review of facility documentation for one (1) of nine (9) patients (Patient #4), reviewed for vaccinations, the facility failed to properly assess a patient for tuberculosis in accordance with facility policy. The findings included: Patient #4 was admitted to the facility on 3/5/24, had diagnoses which included end stage renal disease, a physician’s order for daily peritoneal dialysis treatments for nine (9) hours and thirty (30) minutes, utilizing an abdominal catheter in the upper left abdomen and varied strengths of dialysate solution. Review of Patient #4’s Vaccination and Surveillance Report identified the following: a. A TST (Tuberculin Skin Test) was refused on 3/26/24. b. A TB RAQ (Tuberculosis Risk Assessment) was completed on 4/16/24 c. A chest x-ray was completed on 5/3/24. Interview with the Facility Administrator on 9/24/24 at 2:45 PM identified the facility utilized TST results dated 12/26/23 for admission to the facility, however failed to identify a second TST and/or chest x-ray were completed in accordance with facility policy. Further review of the patient’s chart failed to identify documentation noting the 12/26/23 TST result, the completed TB RAQ (that was charted as complete on 4/16/24), and a chest x-ray that specifically ruled out tuberculosis. The Facility Administrator further identified Patient #4 had not been outside of the country. Interview with Patient #4’s Nephrologist (MD #1) on 9/24/24 at 2:48 PM identified he/she was aware a TST was performed and resulted during the patient’s extended hospitalization (dated 12/26/24), that Patient #4 refused the second TST, and expected the facility to follow their guidelines related to tuberculosis testing. MD #1 further identified the expectation that tuberculosis testing/screening, which could have included an x-ray or QuantiFERON testing (a blood test to rule out tuberculosis infection), should have been done within a week of starting dialysis treatment. Review of the facility’s Tuberculosis Infection Control Policy directed to administer a second TST as soon as possible after admission, to complete the TB RAQ upon admission to the facility, and that chest x-rays interpreted as clear, negative, normal or unremarkable were acceptable.”

“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: 44675 Based on a review of clinical records, interviews, and policy reviews for one (1) of four (4) patients reviewed for treatment records (Patient #7), the facility failed to complete Against Medical Advice (AMA) forms and contact the physician for a patient that prematurely terminated treatment. 1. Patient #7 was admitted to the clinic with diagnoses that included end stage renal disease. Review of the physician’s order directed hemodialysis treatment three times weekly for four (4) hours with a right upper arteriovenous fistula (AVF) and an estimated dry weight of 88.0 kg. Review of Patient #7’s treatment flowsheet dated 6/5/24 and 9/9/24 identified the patient terminated treatment 2.5 hours early. Review of the AMA binder failed to identify AMA’s were completed for Patient #7 on 6/5/24 and 9/9/24. Interview with the Facility Administrator on 9/24/24 at 3:43 PM identified the AMA forms for Patient #7 were not completed for treatments dated 6/5/24 and 9/9/24 and further indicated the facility failed to notify the physician of the 6/5/24 treatment which was terminated 2.5 hours early. Review of the CWOW - Prescribed Treatment Not Met policy directed the registered nurse will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed time and that if the early termination of treatment time exceeds 30 minutes of more, the registered nurse will notify the patient’s attending nephrologist to discuss the appropriate intervention.”