Initial Comments:
Based on the findings of an onsite unannounced complaint investigation conducted on November 30, 2022, Renal Care Group Mount Airy 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, and interviews (INT1, INT2, and INT3), the facility failed to ensure that clinical staff report infection control issues to the dialysis facility's medical director and the quality improvement committee.
Findings include:
Interview #1 (INT1) with a patient took place on November 30, 2022 in the Self Care Dialysis Unit at approximately 11:05 AM. The patient, who was receiving a dialysis treatment at Station #3, recognized that the surveyor was observing for gnats and offered that on the wall between Station #3 and Station #4, there are frequently dozens of gnats on the wall and that the problem has been ongoing for several months. INT1 stated that s/he had voiced concerns to management regarding the presence of gnats.
Interview #2 (INT2) and interview #3 (INT3) conducted with the biomedical manager and biomedical technician respectively, on November 30, 2022 from 12:10 PM to 12:30 PM confirmed that pest control treatments for the presence of gnats was started on September 13, 2022.
A review of the complaint log for 2022 was conducted on November 30, 2022 starting at approximately 2:00 PM. The complaint from CR#1 was received from CR#1 via an email message to the social worker on October 26, 2022. The complaint stated that the dialysis unit has a gnat problem. The documentation further stated that CR#1 had reached out to the clinical manager in the past, prior to 10/26/2022, to voice the same concerns as noted in the complaint of 10/26/2022. There was no documentation in the complaint log or via any other documentation of the gnat complaint that was voiced by CR#1 prior to 10/26/2022 nor was there any documentation in the complaint log of a complaint voiced by INT1 regarding the presence of gnats, nor were any complaints regarding gnats reported to the medical director and quality improvement committee at any time.
Quality Assurance Performance Improvement (QAPI) Meeting Minutes were reviewed on November 30, 2022 starting at 12:30 PM. Minutes of meetings held 10/20/2022, 09/20/2022, 08/31/2022, 07/27/2022 and 06/21/2022 found no documentation or discussion related to the concern regarding the gnats voiced by CR#1, nor the steps undertaken to mitigate the problem.
An interview conducted with the area manager and charge nurse on November 30, 2022 starting at 3:55 PM confirmed the above findings.
Plan of Correction:To ensure compliance, the Director of Operations (DO) and Facility Administrator (FA) or designee will educate all the staff on the following policy:
- Quality Assessment and Performance Improvement (QAPI)
- General Cleanliness and Infection Control Guidelines
The meeting will emphasize the importance of ensuring that any concerns that patients have are reported to the charge nurse, FA, Master of Social Work (MSW) or DO. These concerns include issues with infection control (IC) such as the presence of gnats in the facility. The meeting informed the staff that the process for QAPI includes that the Medical Director and the QAPI members are informed of the issue and updated on the progress of the resolution at the monthly QAPI meetings. A unit tracker for issues/grievances will be instituted and the tracker will be located at the nursing stations. Staff will be informed at the meeting to write the concern in the tracker after a verbal report has been made. Staff were also informed of the action plan that is in place with the exterminator for the abatement of the gnats.
The in-servicing will be completed by December 16, 2022, with documentation of the training on file at the facility.
The DO or charge nurse will review the tracker weekly for three (3) months to ensure updates/resolutions are being added to the tracker. The unit tracker will be addressed at the QAPI meeting along with review of the grievances, If after 3 months compliance is noted, the audits will be completed monthly.
The QAPI committee will be responsible for further guidance and ongoing oversight.
Completion date: January 12. 2022
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 in-center and self-care hemodialysis areas, and interviews with a patient, the charge nurse, biomedical manager, biomedical technician and area manager, the facility failed to ensure a safe and comfortable treatment environment as evidenced via OBS#1, OBS#2, OBS#3, and INT#1, INT#2, INT#3, INT#4, and INT#5.
Findings include:
Observation #1 in the Self Care Dialysis Unit, conducted on November 30, 2022 from 10:50 AM until approximately 11:20 AM found the following:
(1) Flowtron Diplomat Bug Zapper located on the shelf behind Station #6.
(8) dead gnats on the shelf behind Station #6 around the Bug Zapper.
(10) live gnats on the wall located between Stations #3 and #4.
Observation #2 in the In-Center Hemodialysis Unit, conducted on November 30, 2022 from 11:20 AM until approximately 12:10 PM found the following:
(3) Flowtron Diplomat Bug Zappers located on the shelves behind Stations 3, 6, and 9.
(5) dead gnats located on the shelf behind Station #11.
(7) live gnats located on the shelf behind Station #10.
(4) live gnats located on the shelf behind Station #2.
(1) dead fly located on the windowsill across from Station #26 (window between Station #26 and the Crash Cart).
(4) dead gnats and five (5) live gnats located on windowsill across from Station #26 (window between Station #26 and Crash Cart).
(7) dead gnats behind/between Stations #14 and #15 on windowsill.
Observation #3 in the Conference Room on November 30, 2022 at approximately 10:30 AM found one (1) live gnat, and at 11:50 AM, one (1) live gnat), and at 3:30 PM one (1) live gnat.
Interview #1 (INT1) with a patient took place on November 30, 2022 in the Self Care Dialysis Unit at approximately 11:05 AM. The patient, who was receiving a dialysis treatment at Station #3, recognized that the surveyor was observing for gnats and offered that on the wall between Station #3 and Station #4, there are frequently dozens of gnats on the wall and that the problem has been ongoing for several months. INT 1 stated that s/he had voiced concerns to management regarding the presence of gnats.
An interview with the Biomedical Manager (INT2) was conducted on November 30, 2022 from approximately 11:20 AM to 11:25 AM in the In-Center Hemodialysis Unit, and with the Biomedical Manager (INT 2) and Biomedical Technician (INT 3) from 12:10 PM to 12:30 PM in the conference room whereby a review of documents took place. INT2 and INT3 confirmed that the dialysis center has been plagued with gnats and that they have been actively working to resolve the issue since September 13, 2022 via a pest control company, use of a plumber and facility protocols to abate the gnats. Both INT1 and INT2 stated that the gnat problem seems to be seasonal, as colder weather approaches and that the same problem, to a lesser degree, occurred in 2021 around the same time frame.
An interview (INT4) was conducted with the Charge Nurse (CN) on November 30, 2022 at approximately 2:20 PM. INT4 confirmed that there are gnats in the dialysis center and that patients have complained about gnats.
An interview (INT 5) was conducted with the Area Manager on November 30, 2022 at approximately 3:50 PM. INT 5 stated that s/he is aware of the patient concerns regarding the gnats, and that the facility is continuing to address the issue.
An interview conducted with the area manager and charge nurse on November 30, 2022 starting at 3:55 PM confirmed the above findings.
Plan of Correction:To ensure compliance, the DO and FA or designee will educate all the staff on the following policy:
- General Cleanliness and Infection Control Guidelines
The meeting will emphasize the importance of ensuring that the unit is maintained in a clean and orderly manner. This includes cleaning up any dead gnats that may be found in windowsills, shelves, chase walls or other surfaces in the units. The meeting also reviewed that the direct patient care (DPC) staff are to add drain gel on Monday, Wednesdays and Fridays after the patient treatments.
The in-servicing will be completed by December 16, 2022, with documentation of the training on file at the facility.
The FA or designee will complete daily audits for gnat infestation for four (4) weeks. At that time if the unit is free of gnats, the audits will be decreased to twice a week for 4 weeks. A that time if continued absence of gnats is noted, the units will be completed monthly following the QAPI calendar.
The FA will review the audits and report the findings to the QAPI Committee at the monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
Completion date: January 12. 2022
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 complaint log, interviews (INT2 and INT3), agency policy, and quality assurance performance improvement (QAPI) meeting minutes, the facility failed to ensure that the QAPI program included the documentation of a patient grievance related to the presence of gnats.
Findings include:
A review of the 2022 complaint log was conducted on November 30, 2022 starting at approximately 2:00 PM. The complaint from CR#1 was received via an email message by the social worker on October 26, 2022 and entered into the complaint log by the social worker. The complaint stated that the dialysis unit has a gnat problem, and that CR#1 had reached out to the clinical manager in the past, prior to 10/26/2022, to voice the same concerns as noted in the complaint of 10/26/2022. There was no documentation of CR#1's grievance prior to 10/26/2022 in the complaint log nor via any other means.
An interview with the biomedical manager (INT 2) and biomedical technician (INT 3) confirmed that pest control treatments, in an attempt to abate the gnats, were begun on 09/13/2022.
A review of the following agency policy was conducted on November 30, 2022 starting at 1:30 pm: "Flying Insects Assessment (Gnats/Drain Flies)" states,"Document all actions taken with specifics in your QAI Committee and share this information to your Governing Body...."
Quality Assurance Performance Improvement (QAPI) Meeting Minutes were reviewed on November 30, 2022 starting at 12:30 PM. Minutes of meetings held 10/20/2022, 09/20/2022, 08/31/2022, 07/27/2022 and 06/21/2022 found no documentation or discussion related to the grievance voiced by CR#1 prior to 10/26/2022, nor any discussion concerning the presence of gnats in the dialysis unit nor the steps undertaken to mitigate the problem.
An interview conducted with the area manager and charge nurse on November 30, 2022 starting at 3:55 PM confirmed the above findings.
Plan of Correction:To ensure compliance, the DO or designee will educate all the QAPI staff on the following policy:
- Patient Grievance
- Patient grievance Procedure
- Quality Assessment and Performance Improvement (QAPI)
The meeting will emphasize the importance of ensuring that all patient complaints are entered into the complaint log by the MSW. The meeting will also review that all specific actions taken to address a grievance are reviewed and documented in the QAPI meeting and the information shared with the Governing Body (GB).
The in-servicing will be completed by December 16, 2022, with documentation of the training on file at the facility.
The FA or designee will complete monthly audits, following the QAPI calendar, of the QAPI meeting minutes to ensure that grievances are being discussed in QAPI with notification of the GB.
The FA will review the audits and report the findings to the QAPI Committee at the monthly meeting. The QAPI and GB committee will be responsible for further guidance and ongoing oversight.
Completion date: January 12. 2023
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, interviews (INT1, INT2 and INT 3), and governing body meeting minutes, the facility failed to implement the patient internal grievance process for one (1) of one (1) clinical record reviewed: CR#1.
Findings include:
CR#1 SOC 09/30/2020 contained a document in the medical record titled, "Acknowledgement of FMCNA Patient Grievance Procedure," acknowledging that the patient received a copy of the FMCNA Patient handout titled, "What To Do If You Have a Concern and Important Numbers." The document was signed on 09/30/2020.
A review of two (2) facility policies was conducted on November 30, 2022 starting at 1:30 PM. Policy "FMCNA Patient Grievance" states, " Step 1 - Talk about the problem with the Clinical Manager or Social Worker. You may ask for a private meeting. Efforts will be made to resolve your problem. You will be contacted verbally on in writing about any progress or solution within 10 business days; Step 2 - If you feel the problem is not resolved to your satisfaction, you may speak, write to, or meet with the Area Manager. The Area Manager will acknowledge your concerns within 20 business days. The Area Manager gathers information and tries to resolve the problem as quickly as possible (usually within 30 days). Step 3 -..... " Policy "Flying Insects Assessment (Gnats/Drain Flies)" states, "Document all actions taken with specifics in your QAI Committee and share this information to your Governing Body..."
A review of the complaint log for 2022 was conducted on November 30, 2022 starting at approximately 2:00 PM. The complaint from CR#1 was received via an email message by the social worker on October 26, 2022. The complaint stated that the dialysis unit has a gnat problem, and that CR#1 had reached out to the clinical manager in the past, prior to 10/26/2022, to voice the same concerns as noted in the complaint of 10/26/2022. There was no documentation of CR#1's grievance prior to 10/26/2022 in the complaint log nor via any other means, nor were compliants voiced by any other patients regarding the presence of gnats recorded in the complaint log or via any other documentation.
An interview with the biomedical manager (INT2) and biomedical technician (INT3) conducted on November 30, 2022 from 12:10 PM to 12:30 PM confirmed that pest control treatment treatments, in an attempt to abate the gnats, were begun on 09/13/2022.
Interview #1 (INT1) with a patient took place on November 30, 2022 in the Self Care Dialysis Unit at approximately 11:05 AM. The patient, who was receiving a dialysis treatment at Station #3, recognized that the surveyor was observing for gnats and offered that on the wall between Station #3 and Station #4, there are frequently dozens of gnats on the wall and that the problem has been ongoing for several months. INT1 stated that s/he had voiced concerns to management regarding the presence of gnats.
Governing Body (GB) Meeting Minutes were reviewed on November 30, 2022 starting at 1:00 PM. Minutes of GB meetings (ad hoc and scheduled) held 10/20/2022, 09/21/2022, 09/20/2022, and 06/13/2022 found no documentation or discussion related to the presence of gnats in the dialysis unit nor the steps undertaken to mitigate the problem.
An interview conducted with the area manager and charge nurse on November 30, 2022 starting at 3:55 PM confirmed the above findings.
Plan of Correction:To ensure compliance, the DO or designee will educate all the QAPI staff on the following policy:
- Patient Grievance
- Patient Grievance Procedure
- Quality Assessment and Performance Improvement (QAPI)
The meeting will emphasize the importance of ensuring that all patient complaints are entered into the complaint log by the social worker as soon as they are made. This includes verbal complaints made to staff members. The meeting will also reviewed that all specific actions taken to address a grievance are reviewed and documented in the QAPI meeting minutes. The meeting reinforced that the grievance information is shared with the GB along with a=the action plan to mitigate the issue.
The in-servicing will be completed by December 16, 2022, with documentation of the training on file at the facility.
The FA or designee will complete monthly audits, following the QAPI calendar, of the QAPI meeting minutes to ensure that grievances are being discussed in QAPI with notification of the GB.
The FA will review the audits and report the findings to the QAPI Committee at the monthly meeting. The QAPI and GB committee will be responsible for further guidance and ongoing oversight.
Completion date: January 12. 2023
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