Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on September 10, 2021, Fresenius Medical Care Latrobe, 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 onsite unannounced Medicare recertification survey completed on September 10, 2021, Fresenius Medical Care Latrobe, 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) STANDARD
IC-WEAR GLOVES/HAND HYGIENE
Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
Observations:
Based on reviews of observations, facility policy, and staff (EMP) interview, the facility failed to ensure the staff followed infection control protocols by failing to instruct patients to perform hand hygiene after holding sites for four (4) of four (4) observations (OBS#1-4.)
Findings included:
Review of facility policy conducted on September 8, 2021 at approximately 1:00pm. revealed: "Post Treatment Fistula Needle Removal...Procedure...9. Remove the second needle following steps 4-8 above...12. Remove and discard gloves. Perform hand hygiene per policy. Instruct patient holding sites to perform hand hygiene..."
Observations of 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' conducted in patient treatment area on September 8 and 9, 2021 between revealed the following:
Observation#1: conducted 9/8/2021 at approximately 9:40am by surveyor 2 at station #9: EMP 7 failed to ensure patient performed hand hygiene after holding sites.
Observation#2: conducted 9/9/2021 at approximately 10:20am by surveyor 2 at station #2: EMP 13 failed to ensure patient performed hand hygiene after holding sites.
Observation#3: conducted 9/8/2021 at approximately 9:40am by surveyor 1 at station #6: EMP 5 failed to ensure patient performed hand hygiene after holding sites.
Observation#4: conducted 9/9/2021 at approximately 10:30am by surveyor 1 at station #12: EMP 13 failed to ensure patient performed hand hygiene after holding sites.
An interview with the Clinic Manager and Director of Operations on September 10, 2021 at approximately 12:30 p.m. confirmed the above findings.
Plan of Correction:
The Clinic Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Post Treatment Fistula Needle Removal
Special emphasis was placed on ensuring that patients are reminded to perform hand hygiene after they hold their cannulation sites after the needles are pulled. Staff were also informed that the patients would also be re-instructed on the importance of hand hygiene after holding their sites.
The in-servicing of staff and patients will be completed by September 28, 2021, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if one hundred percent (100%) compliance is observed, the audits will then be completed two (2) times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment Improvement (QAI) schedule. A Plan of Correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling. Patients found to be non-complaint will be referred to the CM or designee for re-education.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: October 8, 2021
494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.
Observations:
Based on reviews of observations, facility policy, and staff (EMP) interview, the facility failed to ensure the the crash cart was secured/locked while not in use for one (1) of two (2) Supply Management observations (OBS#1.)
Findings included:
Review of facility policy conducted on September 8, 2021 at approximately 1:00pm. revealed: "Emergency Medications, Equipment, and Supplies...Emergency Cart...The emergency cart must be: Locked when not in use..."
Observation of 'Supply Management' conducted in patient treatment area on September 8, 2021 at approximately 8:40am by surveyor 1 and 2 identified crash cart not in use and without a lock.
An interview with the Clinic Manager and Director of Operations on September 10, 2021 at approximately 12:30 p.m. confirmed the above findings.
Plan of Correction:The CM or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Emergency Mediations, Equipment, and Supplies
The meeting will emphasize the importance of ensuring that the crash cart with the emergency medications, equipment and supplies is always locked when not in use.
The in-servicing of staff will be completed by September 24, 2021, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: October 8, 2021
494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based on reviews of observations, facility policy, and staff (EMP) interview, the facility failed to follow facility policy for post dialysis access care for AV Fistula or graft for four (4) of four (4) observations (OBS#1-4.)
Findings included:
Review of facility policy conducted on September 8, 2021 at approximately 1:00pm. revealed: "Post Treatment Fistula Needle Removal...Procedure...6. Carefully remove the needle...7...Apply pressure for 5-10 minutes before checking for hemostasis. 8. Once hemostasis is achieved: Remove the gauze...Place Band-Aid, adhesive dressing, or gauze dressing secured with clean tape...9. Remove the second needle following steps 4-8 above..."
Observations of 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' conducted in patient treatment area on September 8 and 9, 2021 between revealed the following:
Observation#1: conducted 9/8/2021 at approximately 9:40am by surveyor 2 at station #9: EMP 7 removed needles and taped folded gauze over site and patient applied pressure. Without observing site to confirm hemostasis applied 2 additional pieces of tape over site and repeated same process for site 2. EMP did not observe either site to confirm hemostasis or change the gauze after patient held site.
Observation#2: conducted 9/9/2021 at approximately 10:20am by surveyor 2 at station #2: EMP 13 removed needles and taped folded gauze over site and patient applied pressure. Without observing site to confirm hemostasis applied 2 additional pieces of tape over site and repeated same process for site 2. EMP did not observe either site to confirm hemostasis or change the gauze after patient held site.
Observation#3: conducted 9/8/2021 at approximately 9:40am by surveyor 1 at station #6: EMP 5 removed needles and taped folded gauze over site and patient applied pressure. Without observing site to confirm hemostasis applied 2 additional pieces of tape over site and repeated same process for site 2. EMP did not observe either site to confirm hemostasis or change the gauze after patient held site.
Observation#4: conducted 9/9/2021 at approximately 10:30am by surveyor 1 at station #12: EMP 13 removed needles and taped folded gauze over site and patient applied pressure. Without observing site to confirm hemostasis applied 2 additional pieces of tape over site and repeated same process for site 2. EMP did not observe either site to confirm hemostasis or change the gauze after patient held site.
An interview with the Clinic Manager and Director of Operations on September 10, 2021 at approximately 12:30 p.m. confirmed the above findings.
Plan of Correction:The CM or designee re-educated all the DPC staff on the following policy:
- Post Treatment Fistula Needle Removal
The meeting reinforced the importance of ensuring that the patient's access sites are observed for hemostasis by removing the gauze used to hold the sites. New dressing must then be applied to the sites.
The in-servicing of staff will be completed by September 24, 2021, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: October 8, 2021
494.180(f)(4) STANDARD
GOV-INVOL DISCHARGE PROCESS REQUIREMENTS
Name - Component - 00
The medical director ensures that no patient is discharged or transferred from the facility unless -
(4) The facility has reassessed the patient and determined that the patient's behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient's interdisciplinary team-
(i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient's medical record;
(ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge;
(iii) Obtains a written physician's order that must be signed by both the medical director and the patient's attending physician concurring with the patient's discharge or transfer from the facility;
(iv) Contacts another facility, attempts to place the patient there, and documents that effort; and
(v) Notifies the State survey agency of the involuntary transfer or discharge.
(5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure.
Observations:
Based on a review of the medical record (MR), facility policy/procedure, as well as staff (EMP) and patient interviews the facility failed to document evidence that the facility reassessed the patient/ongoing problems and made efforts to resolve the problem. The facility also failed to provide the patient and the local ESRD Network with a 30-day notice of the planned involuntary discharge (IVD) for one (1) of one (1) MR. MR#3.
Findings included:
Review of facility policy conducted on September 8, 2021 at approximately 1:00pm. revealed: "...Routine and Involuntary Patient Discharge Procedure...Documentation-In cases of non-immediate transfer or discharge, there shall be evidence in the patient's medical record of: Assessments, ongoing problem(s), and efforts made to resolve the problem(s)..."
A review of MR#3 was conducted on September 9, 2021 at 1:30pm.
The patient was admitted to the facility and consent for treatment and the receipt of patient rights and responsibilities was signed on 12/30/2020.
The patient was given the discharge letter on July 6, 2021 with the last date of treatment as August 1, 2021, a 25 day notice. This is 5 days short of the 30 day requirement. The patient was given provided a letter from the physician on June 23, 2021 stating discontinuation of care from physician annd associated doctors/practitioners in associated group stating the patient has "consistently failed to follow our advice and recommendations, and there are also philosophical differences in our views of medical care and treatment..."
Social worker note dated 7/6/21 documented that Message was left for ESRD Network to call back.
An interview was conducted with patient on 9/9/2021 at aproximately 10:10am. During interview patient described events as documented to have occured on 6/10/2021 when "incident" occured with physician. Patient reports a "personality conflict" and confirms request to not be visited by physican on noted date. Expressed concerns of distance to new clinic as he provides his own transportation and it will add"4 plus hours a week" and the weather can be bad in the winter. Also reports concern with reliability of car and change in days and time treatment will be received at new clinic.
An interview was conducted with the facility Medical Director/patient physician on 9/10/2021 @ approximately 8:25am. During interview Medical Director (MD) confirmed plan for IVD of patient related to incident documented to have occurred on 6/10/2021. Medical Director described incident where patient was sleeping when MD approched for routine rounding and patient refused the visit that day. MD reports difference in goals for treatment and confirms that the verbal altercation was a disruption to the clinic, but does not feel the patient is a threat or danger to any staff or patients at the clinic.
Plan of Correction:The Director of Operations (DO) or designee will in-service the Interdisciplinary Team (IDT) on:
- Routine and Involuntary Patient Discharge Procedure
The in-service will reinforce that importance of ensuring that the potential involuntary discharged (IVD) patient has evidence of assessments and clinical notes documented in the medical records which indicate that efforts were being made to resolve the issue. The IDT will also be reminded that any patient who has a possible IVD must be given 30 days' notice before the facility can discharge the patient except for a serious physical threat or discharge from the attending nephrologist practice.
The in-servicing of the IDT staff will be completed by September 30, 2021, with documentation of the training on file at the facility.
Moving forward, the CM or designee will perform audits weekly for any patient who has a potential for an IVD. The auditing will continue through to the resolution of the problem or discharge of the patient to ensure that compliance is maintained.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: October 8, 2021
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