Initial Comments:
Based on the findings of an onsite unannounced complaint investigation conducted on September 7, 2023, Buttonwood Dialysis 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:
494.30(b)(3) STANDARD
IC-STAFF REPORT IC ISSUES
Name - Component - 00
[The facility must-]
(3) Require all clinical staff to report infection control issues to the dialysis facility ' s medical director (see § 494.150 of this part) and the quality improvement committee.
Observations:
Based on a review of the facility's complaint log, facility policies, QAPI (quality assurance performance Improvement) meeting minutes, social work notes, and interviews with the facility administrator and biomedical technician, the facility failed to ensure that infection control issues are reported to the dialysis facility's medical director and the quality improvement committee.
Findings include:
Interview #1 (INT1) and Interview #2 (INT#2) conducted with the facility administrator (FA) and biomedical technician respectively, on September 7, 2023 at approximately 10:30 AM, 12:00 PM, and again at 1:30 PM, confirmed that the facility was aware of an ongoing gnat problem as voiced by a patient complaint that began in January 2023.
A review of the Continuous Quality Improvement Program Policy (Policy 1-14-06) conducted on September 7, 2023 at 1:00 PM reads in part, " Facility Administrators (FAs) conduct periodic Facility Health Meetings (FHM) (also known as QAPI in the CMS Conditions for Coverage) with the CQI (Continuous Quality Improvement) committee to review issues and indicators regarding facility's management and performance" and "Written documentation and plans of action will be documented within the FHM application known as Facility Health Record and will be maintained in a confidential manner. Copies of the QI meeting minutes will be provided upon request to CMS)" and "The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following ....Patient Satisfaction and Grievances ..."
QAPI meeting minutes were reviewed on September 7, 2023 starting at 11:45 AM. Meetings occurred on 02/28/2023, 03/21/2023, 04/18/2023, 05/23/2023, 06/13/2023, 07/25/2023. There is no evidence that the QAPI Committee was made aware of the gnat issue at the time, nor that the QAPI Committee was informed of the ongoing persistent gnat problem seven (7) months later. There was no discussion in any of the above QAPI minutes pertaining to the gnat problem, including the meeting minute sections associated with infection prevention and control, technical and facility operations, and physical plant issues. There was also no documentation or discussion pertaining to the initial or ongoing grievances voiced by MR#3.
A review of the 2023 complaint log was conducted on September 7, 2023 starting at 10:15 AM. The complaint log contained a patient complaint dated 01/09/2023. The form did not contain any evidence of follow-up to the patient, nor that the complaint was discussed at or referred to the QAPI committee for review.
An interview conducted with the facility administrator on September 7, 2023 starting at 1:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates including the Continuous Quality Improvement (CQI) Committee starting on 09/08/23. Surveyor observations were reviewed. Education included but was not limited to a review of A. Policy 1-14-06 "Continuous Quality Improvement (CQI) Program", B. Policy # 3-01-06A "Addressing Patient Grievances..." with emphasis on but not limited to:
A. CQI: 1) The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following... Infection control... Patient... grievances... Other indicators as reflected in the Facility Health Record application: physical plant – ongoing gnat problem... 2) Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.
B. Patient Grievances: 1) All complaints/grievances should be documented on the facility Patient Grievance Log. 2) All details of patient grievances and discussions will be documented. This documentation will be maintained in a separate file and kept in a secure and locked location. The Grievance Investigation Document may be used for this purpose.
Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The next Quality Assessment and Performance Improvement (QAPI) meeting known as Facility Health Meeting (FHM) meeting is scheduled for 09/27/23. The Facility Administrator will discuss the physical plant issue of persistent gnats, findings of the patient complaints and the plan for resolution, along with the proper documentation of the steps being taken.
The Facility Administrator or designee will conduct an audit of the Complaint and Grievance log and the Invesitagtion Document: weekly for four (4) weeks, monthly for two (2) months, then ongoing compliance will be monitored monthly for QAPI review.
Monthly pest control services for gnat elimination in the clinic will be documented in the FHM. Instances of non-compliance will be addressed immediately.
The Manager of Clinical Services (MCS) and/or Regional Operations Director (ROD) or designee will attend FHM and /or review meeting minutes for three (3) months to provide coaching on proper FHM documentation and effective FHM management, and to review all documentation prior to submission, including but not limited to grievance trending review and physical plant issues. The Facility Administrator or designee will review audit results and the MCS/ROD feedback with the CQI Committee, and with the Medical Director during monthly Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this 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 (OBS) of the in-center hemodialysis area, private treatment area and home training rooms, and interviews with the facility administrator and biomedical technician, the facility failed to ensure a safe and comfortable treatment environment as evidenced via OBS#1, OBS#2, and OBS#3.
Findings include:
Observations of the In-Center Hemodialysis Unit (ICHD), Private Treatment Area and Home Training Rooms was conducted on September 7, 2023 between 9:00 AM and 10:00 AM.
Observation #1 of the ICHD Unit found the following:
(1) dead gnat on the shelf behind patient/station #1
(1) live gnat on the wall behind the patients and between stations #3 and 4
(1) dead gnat on the horizontal surface/room divider behind the patients between stations #17 and #18
(1) dead gnat on the shelf behind the patients between stations #12 and #13
(1) dead gnat on the shelf behind the patients between stations #6 and #7
Observation #2 of the Private Treatment Area (which was unoccupied at the time of the observation) found the following:
(1) dead gnat on the shelf behind station #10
(1) dead gnat on the shelf behind and between stations #9 and #10
(1) dead gnat on the shelf behind station #9
(1) dead gnat on the shelf next to station #9
Observation #3 of the Home Training Rooms found the following:
Training Room #1 (not in use at the time of the observation)
oFour (4) dead gnats in the sink labeled 'dirty'
Training Room #2 (not in use at the time of the observation)
oOne (1) dead gnat on the top of a clear plastic container with green handles, next to the sink labeled 'dirty,' which appeared to contain some type of dressing or gauze.
Interview #1 (INT1) and Interview #2 (INT#2) conducted with the facility administrator (FA) and biomedical technician respectively, on September 7, 2023 at approximately 10:30 AM, 12:00 PM, and again at 1:30 PM, confirmed that the facility was aware of a gnat problem as initially voiced by a patient complaint in January 2023 and that the gnat problem was an ongoing issue despite the use of an exterminator.
An interview conducted with the facility administrator on September 7, 2023 starting at 1:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/08/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment" and Policy 1-05-01 "Infection Control for Dialysis Facilities" with the 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. Infection control: 1) At the end of each treatment, the dialysis station will be cleaned and disinfected. 2) Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system. Verification of attendance is evidenced by teammate's signature on the in-service sheet.
These actions steps were initiated to address the gnat problem:
1) The Facility Administrator shared surveyor observations with the cleaning crew on 09/15/23, and outlined cleaning crew responsibilities after treatment hours for in-center treatment area, private treatment area and home training rooms. 2) Exterminators are scheduled for gnat fogging every three (3) weeks. 3) Weekly drain cleaning is performed by end of day staff. 4) Additional drain jetting scheduled for 10/03/23. 5) Meeting is scheduled with cleaning crew on 09/22/23 to reset expectations.
The FA or designee will conduct observational inspection for live and dead gnats in the facility daily until problem resolved. Then ongoing compliance will be monitored with the Monthly OSHA and Safety Checklist. Deficiencies not corrected immediately will be documented on the Monthly OSHA and Safety Plan of Correction [last page of the checklist] outlining the: deficiency, cause of the deficiency and corrective action: expected date of correction and actual date of correction.
The Facility Administrator will review the audit results, including Monthly OSHA and Safety Checklist, with teammates during weekly homeroom meetings and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.110(a)(2)(viii) STANDARD
QAPI-INDICATOR-PT SATIS & GRIEVANCES
Name - Component - 00
The program must include, but not be limited to, the following:
(viii) Patient satisfaction and grievances.
Observations:
Based on a review of the facility complaint log, social work notes, interviews with the facility administrator and biomedical technician, facility policy, and quality assurance performance improvement (QAPI) meeting minutes, the facility failed to ensure that the QAPI program included documentation of a patient grievance related to the presence of gnats.
Findings include:
A review of the 2023 complaint log was conducted on September 7, 2023 starting at 10:15 AM. The complaint log contained a patient complaint (MR#3) dated 01/09/2023. There was no evidence that the complaint was referred to the QAPI committee.
A review of social work notes conducted on September 7, 2023 starting at 1:10 PM, dated 06/16/2023, 06/21/2023, and 07/24/2023 found evidence that MR#3 was continuing to voice grievances five months after his/her initial complaint about the presence of gnats. There was no evidence that the ongoing grievances were forwarded to the QAPI committee.
A review of the Continuous Quality Improvement Program Policy (Policy 1-14-06) conducted on September 7, 2023 at 1:00 PM reads in part, " Facility Administrators (FAs) conduct periodic Facility Health Meetings (FHM) (also known as QAPI in the CMS Conditions for Coverage) with the CQI committee to review issues and indicator regarding facility ' s management and performance " and " Written documentation and plans of action will be documented with the FHM application known as Facility Health Record and will be maintained in a confidential manner. Copies of the QI meeting minutes will be provided upon request to CMS) " and " The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following ....Patient Satisfaction and Grievances ... "
QAPI meeting minutes were reviewed on September 7, 2023 starting at 11:45 AM. Meetings occurred on 02/28/2023, 03/21/2023, 04/18/2023, 05/23/2023, 06/13/2023, 07/25/2023. There is no evidence that the QAPI Committee was made aware of the gnat issue at the time, nor that the QAPI Committee was informed of the ongoing persistent gnat problem seven (7) months later. There was no discussion in any of the above QAPI meeting minutes pertaining to the gnat problem, including the meeting minute sections associated with infection prevention and control, technical and facility operations, and physical plant issues. There was also no documentation or discussion pertaining to the initial or ongoing grievance associated with gnats.
An interview conducted with the facility administrator on September 7, 2023 starting at 1:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates including Continuous Quality Improvement (CQI) Committee starting on 09/08/23. Surveyor observations were reviewed. Education included but was not limited to a review of A. Policy 1-14-06 "Continuous Quality Improvement (CQI) Program", B. Policy 3-01-06A "Addressing Patient Grievances..." with emphasis on but not limited to:
A. CQI: 1) The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following... Patient... grievances... 2) Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.
B. Patient Grievances: 1) All complaints/grievances should be documented on the facility Patient Grievance Log. 2) All details of patient grievances and discussions will be documented. This documentation will be maintained in a separate file and kept in a secure and locked location. The Grievance Investigation Document may be used for this purpose. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The next Quality Assessment and Performance Improvement (QAPI) meeting known as Facility Health Meeting (FHM) meeting is scheduled for 09/27/23. The Facility Administrator will discuss the physical plant issue of persistent gnats, findings of the patient complaints and the plan for resolution, along with the proper documentation of the steps being taken.
Manager of Clinical Services (MCS) will provide coaching and guidance for Facility Administrator and Social Worker on proper documentation in the Facility Health Meeting, and in the Patient Grievance Log and Investigation Document.
The Facility Administrator or designee will conduct an audit of the Patient Grievance log and the Investigation Document: weekly for four (4) weeks, monthly for two (2) months, then ongoing compliance will be monitored monthly for QAPI. Instances of non-compliance will be addressed immediately.
The Manager of Clinical Services (MCS) and/or Regional Operations Director (ROD) or designee will attend FHM and /or review meeting minutes for three (3) months to provide coaching on proper FHM documentation and effective FHM management, and to review all documentation prior to submission, including but not limited to grievance trending review. The Facility Administrator or designee will review all audit results and MCS/ROD/designee feedback with the CQI Committee, and with the Medical Director during monthly Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.180(e) STANDARD
GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED
Name - Component - 00
The facility's internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services.
The grievance process must include-
(1) A clearly explained procedure for the submission of grievances.
(2) Timeframes for reviewing the grievance.
(3) A description of how the patient or the patient's designated representative will be informed of steps taken to resolve the grievance.
Observations:
Based on a review of medical records (MR), facility policies, facility complaint log, and interviews with the facility administrator and biomedical technician, the facility failed to follow-through on the patient internal grievance process for one (1) of one (1) medical record: MR#3
Findings include:
MR#3 SOC 05/02/2022 contained a document in the medical record titled, "Grievance Procedure." The document was signed by the patient on 05/02/2022.
A review of the 2023 complaint log was conducted on September 7, 2023 starting at 10:15 AM. The complaint and grievance log contained a patient complaint (MR#3) dated 01/09/2023. There was no evidence of resolution to the 01/09/2023 complaint, nor that ongoing complaints regarding the same issue were documented in the complaint log. There was also no documentation in the complaint log that the grievance was escalated beyond the local facility level, per the facility's grievance procedure, due to the lack of a resolution.
Interview #1 (INT1) and Interview #2 (INT#2) conducted with the facility administrator (FA) and biomedical technician respectively, on September 7, 2023 at approximately 10:30 AM, 12:00 PM, and again at 1:30 PM, confirmed that the facility was aware of an ongoing gnat problem as initially voiced by a patient complaint that began in January 2023 and continued to persist over the next seven (7) months.
A review of social work notes conducted on September 7, 2023 starting at 1:10 PM, dated 06/16/2023, 06/21/2023, and 07/24/2023 found evidence that MR#3 was continuing to voice grievances five months after his/her initial complaint about the presence of gnats. The note dated 06/21/2023 states that the social worker has "forwarded all emails and reports that came from the patient to corporate."
A review of the Patient Grievance Policy 3-01-6, conducted on September 7, 2023 starting at 10:15 AM reads in part, "Grievances may be reported to a DaVita teammate either verbally or in writing. Grievances should be submitted to a DaVita teammate within 30 days of the date of the incident or when the person filing the grievance on behalf of the patient became aware of the issue. The DaVita teammate should report the grievance to the charge nurse. If a solution to the grievance is not reached through this discussion, the charge nurse is to notify the FA and the Regional Operations Director (ROD) within one business day for follow-up. The FA/designee is to discuss the grievance with the patient, investigate and take appropriate action towards a solution, if possible, This discussion should occur within 10 days of receipt of the grievance. If the patient's grievance cannot be resolved by the FA, the ROD and Medical Director will be notified and a formal grievance conference will be coordinated. This grievance conference should occur within 10 days of receipt of the grievance. If the patient grievance cannot be resolved by the ROD and/or Medical Director, the Divisional Vice President will be notified. The Divisional Vice President will discuss the grievance with the patient and take appropriate action towards a solution, if possible, The Divisional Vice President along with the Group General counsel will take the necessary steps to review and if necessary, investigate the grievance. The Divisional Vice President will issue a written, final decision to the patient within 10 days of the grievance conference."
There was no evidence or documentation of involvement by the Regional Operations Director or Divisional Vice President, nor a response from the Divisional Vice President to the patient given the lack of a resolution at the facility level.
An interview conducted with the facility administrator on September 7, 2023 starting at 1:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/08/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy # 3-01-06A "Addressing Patient Grievances..." with emphasis on but not limited to: : 1) All complaints/grievances should be documented on the facility Patient Grievance Log. 2) All details of patient grievances and discussions will be documented. This documentation will be maintained in a separate file and kept in a secure and locked location. The Grievance Investigation Document may be used for this purpose. This form is not for patient use. Grievance documentation is not part of the patient medical record and should not be provided to the patient. 3) The DaVita teammate receiving the grievance should report the grievance to the charge nurse, Facility Administrator, or Social Worker. 4) Based on the nature of the complaint, the appropriate member of the interdisciplinary team (IDT) will discuss the grievance with the patient and take appropriate action towards a solution, if possible. 5) If the patient grievance cannot be resolved, the Facility Administrator will be notified. The Facility Administrator will meet with the patient to discuss the grievance and take appropriate action towards a solution, if possible. If the grievance is not resolved, the patient should be invited to a grievance conference. The grievance conference should be coordinated to occur within 10 days of receipt of the complaint. 6) If the patient grievance cannot be resolved by the Regional Operations Director and/or Medical Director during the grievance conference the Divisional Vice President will be notified. The Divisional Vice President will discuss the grievance with the patient and take appropriate action towards a solution, if possible. 7) The Divisional Vice President along with Group General Counsel will take the necessary steps to review and, if necessary, investigate the grievance. 8) The Divisional Vice President issues a written, final decision to the patient within 10 days of the grievance conference. Verification of attendance at in-service will be evidenced by teammate's signature on the in-serve sheet.
Manager of Clinical Services (MCS) will provide coaching and guidance for Facility Administrator and Social Worker on proper documentation in the Patient Grievance Log and Investigation Document from Policy 3-01-06A "Addressing Patient Grievances..."monthly for three (3) months. The MCS or ROD or designee will conduct an audit of the Patient Grievance log and the Investigation Document: weekly for four (4) weeks, monthly for two (2) months, then ongoing compliance will be monitored monthly for QAPI. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review all audit results and MCS/ROD/designee feedback with the CQI Committee, and with the Medical Director during monthly Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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