Initial Comments:
Based on the findings of an onsite unannounced complaint investigation conducted on March 27, 2024, Callowhill Dialysis Center was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT
Name - Component - 00
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.
Observations:
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.
Plan of Correction:V401
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 04/05/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment" and Policy 8-02-01 ""Teammate Qualifications, Licensure and Adequate Teammate Staffing" with emphasis on but not limited to: A. Physical environment: 1) The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. B. Teammate qualifications... 1) 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. Verification of attendance is evidenced by teammate's signature on the in-service sheet.
Immediately after the surveyor's departure on 03/27/24, the Facility Administrator or designee conducted an in-service with all clinical teammates to reinforced instructions on how activate the functionality of the main entry door. This will facilitate patient entry into building's vestibule only, upon teammates' arrival at 5:15AM on treatment days.
[Patient Communication]: This permits patient entry into the building's vestibule, however, prohibits/restricts patient entry into the dialysis facility's lobby, until which time the Charge Nurse has arrived for duty @ 5:45AM. The Facility Administrator will conduct patient education regarding building vestibule access for MWF patients starting on 04/05/24, and for TTS patients starting on 04/06/24. Documentation of the education will be filed and maintained in patient medical record.
[Main Door Signage]: 1) To further improve easy access into the building, outward signage was hung on the main entry door stating, "This building contains "2" DaVita Dialysis Programs. Use this main entry door for access to both clinics, Franklin At Home (right side) and Callowhill In-Center dialysis (left side). Enter vestibule and follow instructions for lobby entry on left hand wall." 2) Four (4) additional signs were hung outward on glass windows/door, adjacent to the main entry door sign. a. Sign #1: DaVita Franklin At Home (right side of building), 301 Callowhill Street, Phila, PA 19123, Phone - 215.873.0711; Hours of operation Monday thru Friday 9:00A-5:00P.
b. Sign #2: DaVita Callowhill (left side of building), 401 N. 3rd Street, Phila., PA 19123, Phone 445.269.2403; Hours of Operation Monday thru Saturday 5:45A-4:00P (Signs #1 and #2 were placed approximately five-inches apart adjacent to the main entry outward signage.
c. Sign #3: DaVita Callowhill In-Center Dialysis, Patient Entry Guidelines: "The Building's main entry door will be open for vestibule entry only at 5:15A; (If main entry door is locked, please call the nurses station @ 445.269.2402); Entry to DaVita's patient lobby begins at 5:45A. Please ring callbox in the vestibule (left wall) for lobby entry." (Sign #3 placed directly beneath Sign #2).
d. Sign #4: "DAVITA CALLOWHILL DO NOT ENTER AUTHORIZED PERSONNEL ONLY" was placed on mirrored glass door externally.
[Vestibule signage]: 1) Two (2) additional signs were mounted on the lobby doors of each program. Sign #1 DaVita Callowhill Lobby Entrance, In-Center Dialysis and Sign #2 DaVita Franklin at Home Lobby Entrance, Peritoneal Dialysis (PD) and Home-Hemo Dialysis (HHD).
2) Instructions for all callboxes and paddle buttons located on the left wall in the vestibule were updated to provide clear directions for lobby access to each program. All instructions were framed in 5x7 acrylic frames and mounted above each callbox/paddle buttons. For the exit paddle button, signage was mounted beneath the paddle button for easy access for any patient seated in a wheelchair. Franklin At Home signage was highlighted in yellow and Callowhill was highlighted in blue.
3) One exterior callbox to the left of the mirrored door labeled for Callowhill personnel only, is inactive. This callbox is pending removal by the construction company who completed the buildout project for the Callowhill relocation-side. This callbox has been securely covered in red-duct tape, with no visibility, exposure or access to activate this callbox.
The Facility Administrator or designee will conduct audits to verify communication with patients is clarified regarding instructions for timely building and facility access.
1) Patient education: Two (2) weeks after patient education is completed, the Facility Administrator or designee will audit one hundred percent (100%) medical records for documentation of patient education regarding instructions for timely building and facility access. Expected compliance rate is one hundred percent (100%). Any missing education documentation will be completed immediately.
2) Signage: The Facility Administrator or designee will conduct physical plant audits to verify signage on main door and in the vestibule remain posted to clarify specific facility demographics and instructions for specific facility access: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored monthly. Instances of missing signage will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. Governing Body will maintain oversight until the inactive exterior callbox is removed. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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