Davita Callowhill Dialysis Center

“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: 45377 Based on a review of facility policy, infection control audits, observations (OBS) of the patient bathroom, in-center treatment (ICTX) area, the facility storage room, and interviews with the clinical coordinator and facility administrator, the facility failed to maintain a sanitary environment for two (2) of three (3) observations: OBS#2 and OBS#3 and failed to remove expired supplies for one (1) of three (3) observations: OBS#3. Findings include: Facility Policy Infection Control For Dialysis Facilities, Policy: 1-05-01 with a revision date of April 2023 reviewed on September 16, 2025 at approximately 10:15 AM reads in part, “Supplies will be stored in a manner that maintains their integrity. “ Infection Control (IC) Audits conducted by facility personnel encompassing September 2024, October 2024, November 2024, January 2025, February 2025, March 2025, April 2025, and June 2025 reviewed on September 16, 2025 starting at approximately 10:20 AM revealed the following: The November 6, 2024 IC Audit which was to include observations of station disinfection and supply management conducted by facility personnel, noted that bleach solution was placed in the appropriate area, and all medications, medical treatment supplies, and lab supplies were not expired as denoted by a “yes” on the audit tool. The February 5, 2025 IC Audit, which was to include observations of station disinfection and supply management conducted by facility personnel, noted that bleach solution was placed in the appropriate area, and all medications, medical treatment supplies, and lab supplies were not expired, as denoted by a “yes” on the audit tool. OBS #2 of the ICTX area conducted September 16, 2025 starting at approximately 9:35 AM found the following: The isolation room used for treatment of Hepatitis B Positive patients contained an isolation cart. The top of the cart had white debris in various places. A container of bleach (that had been opened) was sitting on top of the cart. There was no date on the bleach container as to when it was opened. A bottle of vinegar was sitting directly on the floor next to the isolation cart. OBS#3 of the Facility Storage Room conducted on September 16, 2025 starting at approximately 10:05 AM found the following: Two opened cardboard boxes, one containing souffle cups (used for medication administration) and one containing intravenous tubing were sitting on the floor next to the storage rack located near the entrance of the room. One unopened box of disposable under pads was sitting on the floor between cart racks #5 and #6 located on the right side of the storage room. A large bag of water softener pellets was sitting on the floor in front of the second cart located on the left side of the storage room. An unopened canister of Oxivir TB Wipes (used for high-level disinfection), found on the bottom shelf of the second cart located on the left side of the storage room, was expired: lot #041818VX03, expired 04/18/2020. The top of the canister was dusty and dirty. One cardboard box, located on the top shelf of the storage rack located near the entrance of the room, was found to be less than eighteen (18) inches from the ceiling. An interview conducted with the facility administrator on September 16, 2025 starting at 12:40 PM confirmed the above findings.”

“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: 45377 Based on observations of patient and facility activity, document review and interviews with the administrator (SINT1) and another staff member (SINT2), the agency did not consistently provide patients with a safe, functional and comfortable environment. Findings include: Observation #1 took place on March 27, 2024 from 4:38 AM to 6:00 AM. The surveyor observed activity from the car with a clear line of sight to the facility entrance. The following observations were noted for patients arriving for the first shift of the day: 4:38 AM: The surveyor arrived at the facility parking lot. Lights were on in the facility. There was a clear line of sight into the facility via large windows with shades pulled up. The surveyor was able to see at least two (2) people inside the facility appearing to prepare the hemodialysis (HD) machines, moving from chair location to chair location. A callbox with a camera was visible next to a large window (the window was between the main entrance door and the call box). A small awning was over the main entrance door. 5:22 AM: Patient (Pt)#1 arrived via commercial transportation (van). The patient was using a walker. Pt#1 approached the main entrance door, but did not use (ring) the callbox, nor did the patient attempt to open the main entrance door. 5:24 AM: A staff member arrived and used the call box. The staff member also walked over to the window to get the attention of a staff member inside the building to let him/her in. 5:25 AM: The staff member was provided entry to the building. Pt#1 who was waiting outside continued to wait outside. 5:29 AM: Pt#2 arrived via private vehicle. Pt#2 did not ring the call box nor attempt to open the door. 5:29 AM: Pt#3 arrived via private vehicle. Pt#3 did not ring the call box nor attempt to open the door. 5:32 AM: Pt#4 arrived via commercial transportation (wheelchair van). The patient was in a wheelchair and was transported to the main entrance door by the van driver. Pt#4 did not ring the call box nor attempt to open the door. 5:33 AM: Pt#5 arrived via private vehicle. Pt#5 did not ring the call box nor attempt to open the door. 5:34 AM: Pt#6 arrived and waited in his/her car. 5:39 AM: Pt.#7 arrived via private vehicle. Pt#7 did not ring the call box nor attempt to open the door. 5:42 AM: One of the patients pushed the call box button which lit up when the button was pressed. The main entrance door opened remotely, and the group of seven (7) patients entered the facility. 5:43 AM: Pt#6 left his vehicle. Upon reaching the main entrance, the patient pushed the call button and was permitted entrance (remotely) immediately. 5:45 AM: Pt#8 arrived via commercial vehicle (van). Upon reaching the main entrance, the patient pushed the call button and was permitted entrance (remotely) immediately. 5:47 AM: Patients were visible through the window and noted to be sitting in the lobby. A Staff member was visible in lobby. 5:47 AM: Pt#9 arrived via commercial vehicle (van). Upon reaching the main entrance, the patient pushed the call button. A staff member came out and physically opened the door to let the patient into the facility. 5:50 AM: Pt#10 arrived via private vehicle. Upon reaching the main entrance, the patient pushed the call button and was permitted entrance (remotely) immediately. 5:56 AM: It appeared that all patients were out of the lobby/waiting area and moved to the treatment area. 6:00 AM: Surveyor left the parking lot. The observations revealed that, from the time of the first patient arrival at 5:22 AM, a patient did not press the call box button until 5:42 AM for entry into the building’s vestibule. Observation #2 took place on March 27, 2024 from 8:45 AM to 10:45 AM. Observations were made of the physical building to include entrances, security processes, signage, audible notification of patient arrival procedures, and observation of video monitors located in the administrative assistant and treatment areas. Upon arrival of the Surveyor at 8:45 AM, the surveyor noted that there was no outward signage on the door, or the window to the left of the door, to explain the process for entry into the building’s vestibule. The call box, located to the left of the window, contained three (3), 1/2 inch sized labels: Label 1 stated “Callowhill” at the top of the call box; Label 2 stated “In-Center Dialysis” below the call box speaker; and Label 3 stated “Press Here” located next to the call button. The surveyor also observed that there was another call box to the far left of Callowhill’s call box, separated by a portion of a brick wall and another door. This call box contained two (2) 1/2 inch labels: a “Do Not Use” label at the top of the call box, and an “Out of Order” label over the call button. The main entrance door was unlocked. The Surveyor was able to freely enter the building’s vestibule. The surveyor noted that within the vestibule, there was a sign lying sideways on the windowsill stating, “Callowhill Patient & Visitor Entry Here - (Press Callowhill call button on left wall inside vestibule for entry).” The vestibule contained two (2) doors leading to separate/different entrances. One set of doors (secured) provided access to the Callowhill Dialysis Center patient waiting area. The other set of doors (also secured) provided access to Franklin At Home Dialysis. From the vestibule, the surveyor was provided remote access to enter Callowhill Dialysis Center’s lobby/waiting area. An interview was conducted with SINT1 on March 27, 2024 at approximately 8:50 AM. SINT1 was aware of a complaint alleging that a second shift patient, who arrived at approximately 11:00 AM on a rainy Saturday, was unable to gain access to the building’s vestibule and waited outside in the rain for ten (10) minutes. SINT1 stated that it was determined that there was confusion on the part of the patient as to which call box to press to gain entry into the building as evidenced by: 1) no audible notification occurring within the facility for the patient requiring entrance; and 2) the external call box that was no longer functional had not been labeled as “do not use” and “out of order” at the time of the event. SINT1 stated that the labels were placed on the non-functioning call box after the event. SINT1 also relayed that the other building tenant would typically unlock the main entrance door leading to the vestibule upon their arrival, which was 9:00 AM Monday through Friday. Likewise, the other building tenant had no operating hours on the weekend. There was no clear process or procedure as to who within Callowhill Dialysis Center was responsible for unlocking the main entrance door to permit entry into the building’s vestibule on the weekend. An interview with SINT2 on March 27, 2024 at approximately 11:15 AM confirmed that confusion on the part of the above-referenced patient led to a delay in the patient gaining access to the building’s vestibule. SINT2 also stated that the facility had security services for approximately six (6) months, from September 2023 to February 2024, due to problems with the call box system. Once the call box system was functional, security services were terminated as the staff were able to provide remote access to the main entrance door and the door leading to the waiting area. However, the time of day/day of week procedures, and responsibilities therein, related to unlocking the main entrance door for Callowhill Dialysis patients was unresolved. SINT2 also stated that it is the policy of DaVita to not permit patients into the facility’s lobby/waiting area until a registered nurse (RN) is on site, and that the RN’s generally arrive between 5:30 AM and 5:45 AM. SINT2 stated that patients are aware of this policy. A distinction between the the building’s vestibule area and Callowhill Dialysis Center’s lobby/waiting area, which are two distinct areas within the building, was not provided. Policy 8-02-01 Teammate Qualifications, Licensure and Adequate Teammate Staffing, reviewed on March 28, 2024 at 8:30 AM reads in part, “A registered nurse (RN), who is responsible for the nursing care provided, is present in the facility at all times that patients are being treated.” This policy that was provided by SINT2 intended to support that patients are not permitted in the lobby/waiting area until an RN is on site. Several confounding factors contributed to the delay associated with the patient complaint including adequate patient communication, lack of signage at the main entrance door, and unanticipated system issues given the interplay and differences between Callowhill Dialysis Center and the other building tenant’s operating hours and patient entry processes. An interview conducted with the administrator on March 27, 2024 starting at 11:15 AM confirmed the above findings.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 45377 Based on review of facility policies/procedure, medical records (MR), hemodialysis (HD) treatment records, and interviews with the facility administrator (FA) and Director of Clinical Services (DCS), the facility failed to follow its policy for monitoring vital signs, reporting and/or documenting abnormal findings pre, during and/or post HD, and documenting shortened HD treatments for one (1) of one (1) MR reviewed: MR#1. Findings include: A review of the facility’s policy Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment (Policy: 1-03-08) on November 27, 2023 at approximately 10:00 AM reads in part, “Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. Data collection includes ... measurement of BP (blood pressure), Heart or pulse rate;” “The nursing assessment will be performed and documented by a licensed nurse. The assessment includes the following components: review of patient reports, data collection, response to treatment.” “Pre-Treatment Data Collection/Assessment: any abnormal findings during pre-treatment data collection will be documented and immediately reported to the licensed nurse. If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis ...the licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner if applicable) will be notified of any concerns that may preclude the initiation of dialysis. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated.” “Intradialytic Data Collection/Assessment: the licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation .... Vital signs and treatment monitoring - for non-nocturnal treatments is completed at least every thirty (30) minutes ....Abnormal findings will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician (or non physician practitioner if applicable) as needed of changes in patient status.” “Post Treatment Data Collection/Assessment: the PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings. If an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician is necessary prior to discharge of the patient from the facility.” “Abnormal Findings - any weight loss from last post weight .... Blood Pressure Pre-Dialysis: Systolic greater than 180 mm Hg or less than 90 mm Hg; Diastolic greater than or equal to 100 mmHg; Blood Pressure - Intradialytic: Difference of 20 mmHg increase or decrease from patient ’ s last intradialytic treatment BP reading; Blood Pressure Post Treatment: Standing systolic BP greater than 140 mmHg or less than 90 mmHg; Standing diastolic BP greater than 90 mmHg or less than 50 mmHg; Sitting BP for patient ’ s that cannot stand: Sitting systolic BP greater than 140 mmHg or less than 90 mmHg; Sitting diastolic BP greater than 90 mmHg or less than 50 mmHg; Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minutes or greater than 100 beats per minutes and/or an irregular heart beat.” A review of the facility’s policy Prescribed Treatment Time Not Met (Policy 1-01-09) on November 27, 2023 at 2:30 PM reads in part,”The Registered Nurse (RN) 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 run time .....If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs. Shortened/early termination of the dialysis treatment includes all reasons the prescribed dialysis time is not met by 30 or more minutes. This includes but is not limited to: the late initiation of treatment with termination at scheduled time, early termination at the end of treatment and interruptions of dialysis during treatment, i.e., machine or access problems or use of the bathroom by the patient; A copy of the Early Termination of Treatment form signed by the patient, if shortened voluntarily by patient, will be kept in the patient’s health record. Additionally, if the patient’s dialysis treatment is terminated 30 or more minutes prior to the ordered treatment length, the reason must be documented in the patient electronic health record at the time the treatment was terminated while reconciling/late reconciling the treatment times.” A review of twenty (20) hemodialysis (HD) treatment records (treatment detail reports) encompassing September 1, 2023 to November 2, 2023 took place on site November 27, 2023 from 10:00 AM to 3:00 PM, off site on November 28, 2023 from 9:00 AM to 11:00 AM, and November 29, 2023 from 8 AM to 9 AM. The start of care (SOC) is indicated below. MR #1 SOC 08/24/2017: 09/01/2023: Hemodialysis (HD) Treatment was initiated at 6:24 AM. Vital sign check by the PCT (patient care technician) recorded a heart rate (HR) of 58. Vital sign check did not occur again until 7:36 AM (37 minutes after the last check) at which time HR was 59. Vital signs recorded by the PCT at 8:06 AM and 8:32 AM documented a HR 58 on both occasions. There was no documentation as to the reason why the vital sign check after 6:24 AM was not obtained at least every 30 minutes per facility policy, nor was there documentation that the RN (registered nurse) was notified of a HR less than <60 per facility policy nor that the physician was notified at the time of the occurrence. At discharge, the HR was 70 standing and 72 sitting. 09/04/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 41 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR). 09/06/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 10 minutes. The HD treatment record states that the treatment was terminated for patient choice but there was no Early Termination of Treatment Against Medical Advice Form present in the MR nor was there evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy. 09/18/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 2 hours, 50 minutes. The HD treatment record states that the treatment was terminated for patient choice and there was an Early Termination of Treatment Form in the medical record, but there was no evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy. 09/22/2023: HD Treatment was initiated at 11:24 AM by the PCT at which time the BP was noted to be 202/91. There was no documentation that the RN was notified. At 1:02 PM, the PCT documented a BP of 192/80. BP was not checked again by the PCT until 1:47 PM (45 minutes after prior BP check) and found to be 202/80. There was no documentation as to the reason why the vital sign check after 1:02 PM was not obtained at least every 30 minutes per facility policy nor that the RN and/or physician were notified of the abnormal findings at the time. There was no documentation of any interventions concerning the elevated BP at the time of the occurrence. Treatment ended at 3:10 PM. The post HD treatment vital signs and the nursing assessment did not contain documentation of a standing blood pressure or heart rate even though the patient was noted to be ambulatory. Sitting BP was 175/83. There was no evidence that that the RN was notified at the time of the occurrence that the sitting systolic BP was > 140 mmHg per facility policy. 09/27/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 2 hours, 32 minutes. The HD treatment record states that the treatment was terminated for patient choice. There was an Early Termination of Treatment Form in the medical record, but there was no evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy. HD treatment was initiated at 11:58 AM. The HD pre-treatment, post-treatment vital sign section of the treatment record, and the pre or post HD nursing assessment did not contain documentation of a standing blood pressure or heart rate. The patient was noted to be ambulatory upon arrival to the facility. During the HD treatment at 1:03 PM, the PCT documented a HR of 41. There was no documentation that the RN was notified of a HR <60 per facility policy. At 1:25 PM (22 minutes later), the RN documented a manual HR of 70. HD treatment was terminated at 2:32 PM at which time the PCT documented a HR 51 on the intradialytic treatment record. There was no documentation that the RN was notified of the post treatment HR < 60 per facility policy, and/or the physician was notified at the time of the occurrence. Post treatment vital signs were not documented until 6:29 PM and the post HD nursing assessment was not completed until 6:31 PM. 09/29/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 41 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR). 10/02/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 2 hours, 50 minutes. The HD treatment record states that the treatment was terminated for patient choice and there was an Early Termination of Treatment Form in the medical record, but there was no evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy. Treatment was initiated at 11:40 AM. During the HD treatment, HR was 56 and 59 at 1:32 PM and 2:05 PM, respectively as documented by the PCT. There was no indication that the RN was notified of a HR < 60 per facility policy and/or the physician was notified at the time of the occurrence. 10/04/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 2 hours, 6 minutes. Documentation on the treatment record noted that the shortened treatment was due to patient choice, but there was no Early Termination of Treatment Against Medical Advice Form present in the medical record (MR) nor was there evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy. Treatment was initiated at 11:57 AM. At 12:02 PM, the PCT documented a: BP of 199/86; at 12:23 PM, a HR 59; at 1:19 PM, a HR 55. There was no evidence that the RN was notified of a HR < 60, an intradialytic systolic blood pressure increase of 20 mmHg from the patient’s last intradialytic BP reading occurred, nor that any interventions were took place. 10/09/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 38 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR). 10/11/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 36 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR). 10/13/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 32 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR). 10/16/2023: HD treatment was initiated at 11:25 AM. At 1:03 PM, the PCT recorded a HR 39 with a notation to ‘recheck.’ A recheck at 1:12 PM (9 minutes later) found HR to be 69. There was no documentation that the RN was notified at 1:03 PM of a HR < 60 as per facility policy nor that any other interventions occurred. 10/23/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 31 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR). HD Treatment was initiated at 11:23 AM at which time HR was 56 per PCT documentation. Repeat HR at 11:32 PM was 57. There was no documentation that the RN was notified of a HR < 60 as per facility policy nor that any other interventions occurred. 10/26/2023: HD Treatment was initiated at 6:16 AM. At 8:31 AM, the PCT recorded a HR 46. RN was notified at 9:01 AM (30 minutes later) at which time HR was 49. RN turned off ultrafiltration sometime after 9:01 AM. There was no documentation that the RN was notified at 8:31 AM of a HR < 60 as per facility policy. 10/28/2023: HD Treatment was terminated at 10:39 AM. Post Treatment standing BP at 10:30 AM was 210/54; sitting BP was 154/50. The standing BP was also noted in the post HD nursing assessment. There was no comment or documentation addressing the BP of 210/54, no indication that it was retaken prior to discharge, nor that any other interventions took place. 10/31/2023: HD Treatment was terminated at 10:31 AM. Post treatment vital signs contained a documented standing HR 54, and a sitting HR 73. The post HD nursing assessment noted the same findings, along with a comment of regular (heart) rate and rhythm. There was no indication that the HR 54 was addressed. 11/02/2023: HD Treatment was initiated at 6:31 AM. The PCT documented a BP 194/61. There was no evidence that the RN was notified of a SBP > 180 at the start of treatment per facility policy. Treatment was terminated at 10:31 AM. A HR of 54 was recorded on the intradialytic record by the PCT. There is no documentation on the intradialytic record/at the end of treatment that the RN was informed of a HR < 60 at the end of treatment. A late entry by the RN at 2:28 PM retrospectively addresses the interventions for the low heart rate. An interview conducted with the Director of Clinical Services on November 27, 2023 at approximately 2:45 PM, and again with the Director of Clinical Services and Facility Administrator via conference call on November 28, 2023 confirmed the above findings.”