Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey conducted onsite September 19, 2023 through September 21, 2023 and completed offsite September 25, 2023, Homestead Dialysis was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey conducted onsite September 19, 2023 through September 21, 2023 and completed offsite September 25, 2023, Homestead 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(a)(1)(i) STANDARD
IC-IF TO STATION=DISP/DEDICATE OR DISINFECT
Name - Component - 00
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.
Observations:
Based on review of facility policy, observation and an interview with the facility Administrator the facility failed to ensure items taken to the dialysis station were disinfected before being taken to a common clean area for one (1) of one (1) observations made. OBS #1.
Findings include:
Review of Policy: 1-05-01 completed on 9/21/23 at approximately 1030 a.m. revealed:
" TITLE: Infection control for Dialysis Facilities, PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment., POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients.... section: DISINFECTION: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into station) and prior to returning to clean/designated area or removal from treatment area."
Observations of dialysis treatment and care completed on 9/19/23 between approximately 10:00 a.m. and 1:00 p.m. revealed the following:
OBS#1 at 10:30 a.m., survey witnessed employee #1 taking a sharps container and a garbage bin from a common clean area to a patient dialysis station. Following use, the sharps container and garbage bin were returned to the common clean area without being cleaned and/or disinfected.
An interview with the facility administrator and the manager of clinical services conducted on 9/19/23 at approximately 2:30 p.m. the above findings were reviewed. Facility administrator and manager of clinical services confirmed the above policy as current.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 9/22/2023. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with emphasis on but not limited to: 1) Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to ... designated area... 2) Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct audits to verify sharps containers and biohazard waste containers are cleaned prior to removing from patient station after each treatment: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audit.
The Facility Administrator or designee will review the audit results with teammates during 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.
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
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;
Observations:
Based on a review of policies, medical records (MR), and employee interviews, the agency failed to provide the necessary care and services to manage a patient's volume status for one (1) of seven (7) medical records reviewed (MR5).
Findings include:
Review of facility policy "1-03-08 CWOW- Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment on 9/21/23 at approximately 2:00 p.m. PURPOSE: To obtain and document baseline and ongoing information about the patient before, during and after dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient's dialysis treatment, monitoring during treatment and for reviewing the patient's response to the treatment and status prior to discharge...POST TREATMENT DATA COLLECTION/ASSESSMENT...
15. The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre dialysis findings.
16. If an abnormal finding(s) 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.
17. Licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility."
Review of medical records on 9/21/23 at approximately 11:30 a.m. to 12:00 p.m. and 12:30 p.m. to 2:00 p.m. revealed the following:
MR5 admission date 8/3/2021. Treatment Details Report for 9/18/2023, which was obtained onsite September 20, 2023, at approximately 3:00 pm, revealed undocumented post dialytic treatment vital signs and post dialysis weight.
The above information was reviewed with the Facility Administrator and Regional Compliance Manager during an onsite interview on 9/21/23.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/22/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre- Intra- Post treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient's dialysis treatment, monitoring during treatment and for reviewing the patient's response to the treatment and status prior to discharge. 2) The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings. 3) If an abnormal finding(s) 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. 4) Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator or designee will conduct audits to verify documentation is complete and accurate for patient vital signs and weight, including for post treatment data: on twenty five percent (25%) of the treatment records daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during 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.
494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE
Name - Component - 00
Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.
Observations:
Based on a review of facility policies, medical records (MRs), and staff (EMP) interviews, the facility failed to ensure treatments were delivered in accordance with the dialysis prescriptions ordered by the physician for five (5) of seven (7) hemodialysis patient records reviewed (MR1, MR2, MR4, MR5, and MR6).
Findings included:
Review of facility policy "1-03-08 CWOW- Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment on 9/21/23 at approximately 2:00 p.m. PURPOSE: To obtain and document baseline and ongoing information about the patient before, during and after dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient's dialysis treatment, monitoring during treatment and for reviewing the patient's response to the treatment and status prior to discharge...3. Patient identity, prescription and machine settings re verified by teammate prior to initiation of treatment with exception of blood flow rate which is verified and documented when the order is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with nursing assessment...INTRADIALYTIC DATA COLLECTION ASSESSMENT...9. Intradialytic monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. vital signs and treatment monitoring...b. At a minimum, obtain and document the following:..iii. Blood and dialysate flows, arterial and venous pressures...10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtained prescribed blood flow rate) the reason will be documented and the licensed nurse informed...
12. The licensed nurse notifies the physician as needed of changes in patient status. 13. All findings, interventions and patient response will be documented int the patient's medical record.
16. If an abnormal finding(s) 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.
17. Licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility.
Review of medical records (MRs 1, 2, 4, and 5) on 9/21/23 at approximately 11:30 a.m. to 12:00 p.m. and 12:30 p.m. to 2:00 p.m. revealed the following:
MR1, admission date 5/21/19. Treatment sheets reviewed dated between 8/26/23 and 9/9/23. Physician orders verified 9/2/23- blood flow rate (BFR) 450, dialysate flow rate (DFR) 700.
-9/2/23 Start time 10:50 a.m. BFR at 200 from 10:50 a.m. to 12:44 p.m DFR at 600 from 11:35 a.m. to end of treatment-14:11 p.m.
Medical record did not contain documentation regarding the changes in the BFR or DFR.
MR2, admission date 7/26/07. Treatment sheets reviewed dated between 8/22/23 and 9/19/23. Physician orders verified 8/29/23- BFR 450, DFR 700.
-8/29/23 Start time 11:02 a.m. BFR at 400 from 13:11 p.m. until the end of treatment-14:35 p.m.
Medical record did not contain documentation regarding the changes in the BFR.
MR4, admission date 10/27/22. Treatment sheets reviewed dated between 9/4/23 and 9/19/23. Physician orders verified 9/7/23- BFR 450, DFR 700.
-9/7/23 Start time 12:21 p.m.. BFR at 400 from 13:33 p.m. until 14:02 p.m.
-9/16/23 Physician order verified 9/16/23- BFR 450, DFR 700. Start time 16:11 p.m. Treatment end 19:39 p.m. DFR at 500 from 18:41 p.m. to 19:11 p.m.
Medical record did not contain documentation regarding the changes in the BFR or DFR.
MR5, admission date 8/3/2021. Patient Summary Report and Treatment Details Reports which were obtained onsite September 20, 2023, at approximately 3:00 pm revealed a prescribed treatment duration time of 210 minutes and a dialysate filtration rate (DFR) of 800 ml/min.
A review of eight (8) treatment flow sheets from 8/28/23 to 9/18/23 noted documentation that treatment time was not achieved on the following dates:
On 8/28/2023, total treatment of 121 minutes completed.
On 9/1/2023, total treatment of 166 minutes completed.
On 9/4/2023, treatment start time: 11:40, treatment end time 14:27, 167 minutes.
On 9/6/2023, Treatment Details Report listed a treatment duration of 112 minutes.
On 9/8/2023, Treatment Details Report listed a treatment duration of 175 minutes.
On 9/11/2023, Treatment Details Report listed a treatment duration of 104 minutes.
On 9/13/2023, Treatment Details Report listed a treatment duration of 98 minutes.
On 9/18/2023, Treatment Details Report listed a treatment start time of 16:56 and a treatment end time of 18:31, a total treatment time of 95 minutes and a DFR of 500 ml/min.
MR6, first treatment at facility 2/22/2019 . Patient Summary Report and Treatment Details Reports which were obtained onsite September 20, 2023, at approximately 3:00 pm revealed the prescribed treatment duration time ordered by the physician and specified on the plan of care was 240 minutes. A review of eight (8) treatment flowsheets from 8/12/23 to 9/19/23 noted documentation that the prescribed treatment time was not achieved on the following dates:
On 9/19/2023, treatment start time: 16:20, treatment end time 19:17, completed 177 minutes.
On 9/16/2023, treatment start time: 16:14, treatment end time 19:02, completed 168 minutes.
On 9/12/2023, treatment start time: 11:45, treatment end time 15:18, completed 213 minutes.
On 9/7/2023, treatment start time: 12:07, treatment end time 15:20, completed 193 minutes.
On 9/2/2023, treatment start time: 11:54, treatment end time 14:51, completed 177 minutes.
On 8/12/2023, treatment start time: 12:01, treatment end time 15:30, completed 209 minutes.
The above information for MRs 1, 2, 4, and 5 was reviewed during an onsite interview with the facility administrator and regional compliance manager on 9/21/23. MR6's information was reviewed offsite via telephone on 9/25/23 with the facility administrator at approximately 9:00am.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/22/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre- Intra- Post treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient's dialysis treatment, monitoring during treatment and for reviewing the patient's response to the treatment and status prior to discharge. 2) Patient identity, prescription and machine settings are verified by teammates prior to initiation of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. 3) Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring...completed at least every thirty (30) minutes. b. At a minimum, obtain and document the following ... Blood and dialysate flows, arterial and venous pressures... 4) If the dialysis prescription is not being met [including dialysis flow rate or change to/inability to obtain prescribed blood flow rate] the reason will be documented and the licensed nurse informed. 5) Abnormal findings or findings outside of any patient specific physician ordered parameters 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. 6) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 7) The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre dialysis findings. 8) If an abnormal finding(s) 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. 9) All findings, interventions and patient response will be documented in the patient's medical record.
Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct audits to verify teammate documentation of abnormal findings, notification given to the licensed nurse, and the appropriate response by the nurse to the findings: on twenty five percent (25%) of the treatment records daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during 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.
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