Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed July 12, 2023, K.T.C. of Slatebelt was identified to be in compliance with the following requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed July 12, 2023, K.T.C. of Slatebelt 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)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure the staff followed infection control protocols, included but not limited to, cleaning and disinfecting surfaces and equipment, for two (2) of two (2) treatment area observations (Observation #1, Observation #2).
Findings include:
A review was conducted of facility policy/procedure on July 12, 2023 at approximately 11:30 a.m.. 'Priming Bucket Disinfection' ''Purpose' "To disinfect the priming bucket post patient treatment." 'Cleaning and Disinfection of the Dialysis Station' 'Purpose' "The purpose of this policy is to provide guidance to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients,, staff, and visitors." 'background' "The Centers for Medicare and Medicaid Services(CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients."
('CMS ESRD (End Stage Renal Disease) Core Survey Version 1.6' 'Cleaning and disinfection of the Dialysis Station' 'Action' "Remove all bloodlines and disposable equipment, ...." "Empty prime waste receptacle, if present on the machine." Remove gloves, hand hygiene, don clean gloves." "Use disinfectant-soaked cloth/wipe to visibly wet all machine top, front, and side surfaces ...." Wipe wet all internal and external surfaces of the prime waste container ...")
('Centers for Disease Control and Prevention (CDC) Checklist: Dialysis Station Routine Disinfection' 'Part A: Before beginning routine disinfection of the dialysis station:' "..... Ensure that the priming bucket has been emptied. ....." 'Part B: Routine Disinfection of the Dialysis Station-After patient has left station:' ",.... Apply disinfectant to all surfaces ........ Disinfect all surfaces of the priming bucket. ...... ")
Observations conducted in the patient treatment area on July 10, 2023 between approximately 9:25 a.m. and 12:55 p.m. revealed the following:
Observation #1: The observation on 07/10/23 at approximately 9:35 a.m. of 'Cleaning and Disinfection of the Dialysis Station' for station #1, employee #5 did not empty the prime waste receptacle (bucket/container) prior to the disinfection of the dialysis machine/chair. Employee #5 emptied the prime waste receptacle after the disinfection of the dialysis machine/chair.
Observation #2: The observation on 07/10/23 at approximately 9:38 a.m. of 'Cleaning and Disinfection of the Dialysis Station' for station #11, employee #3 did not empty the prime waste receptacle (bucket/container) prior to the disinfection of the dialysis machine. Employee #3 emptied the prime waste receptacle after the disinfection of the dialysis machine.
An interview with the facility Clinical Nurse Manager on July 12, 2023 at approximately 11:45 a.m. confirmed the above findings.
Plan of Correction:To ensure compliance the Clinic Manager (CM) or designee will in-service all the direct patient care (DPC) staff on the following policies:
- Cleaning and Disinfection of the Dialysis Station
- Priming Bucket Disinfection
The meeting will focus on ensuring that the prime waste bucket is emptied prior to the cleaning and disinfection of the dialysis machine and station. The meeting reinforced that all internal and external surfaces of the prime waste bucket must be cleaned and disinfected.
Inservicing will be completed by July 21, 2023. All training documentation is on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan of correction (POC) specific 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
494.80(d)(2) STANDARD
PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO
Name - Component - 00
In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted-
At least monthly for unstable patients including, but not limited to, patients with the following:
(i) Extended or frequent hospitalizations;
(ii) Marked deterioration in health status;
(iii) Significant change in psychosocial needs; or
(iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.
Observations:
Based on a review of facility policy/procedure, review of medical records, and an interview with the Clinical Nurse Manager, the facility failed to ensure a monthly re-assessment and plan of care revision was established for one (1) of five (5) in-center hemodialysis patient medical records (MR) reviewed (MR#5).
Findings include:
A review was conducted of facility policy/procedure on July 12, 2023 at approximately 11:30 a.m. 'Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC)' 'CIA and POC for unstable patients' "Unstable patients must be reassessed by the Interdisciplinary Team (IDT) monthly. Monthly reassessment and and POC updates related to the reason the patient is considered "unstable" must be documented until the issue have been resolved or the IDT (including the patient if possible) determines that the condition is chronic." The following are unstable criteria: Extended or frequent hospitalizations: ...(b) More than 3 admissions in the last 30 days."
A review of medical records conducted on July 12, 2023 between approximately 9:00 a.m.- 11:30 a.m. revealed the following:
MR#5 Date of admit 10/21/20: Documentation provided of the patient being admitted to the hospital four (4) times in March of 2023 (3/1/23-3/2/23, 3/13/23-3/16/23, 3/17/23-3/21/23, 3/27/23-3/29/23). No documentation provided of a comprehensive reassessment of the patient and a revision of the plan of care being conducted at least monthly due to frequent hospitalizations. (Note: The patient was not designated as unstable).
An interview with the facility Clinical Nurse Manager on July 12, 2023 at approximately 11:45 a.m. confirmed the above findings.
Plan of Correction:To ensure compliance, the CM or designee re-educated all the Interdisciplinary Team members on the following policy:
- Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC)
Special emphasis will be placed on ensuring that any patient deemed unstable is reassessed monthly. The reassessment and updates to the POC must be documented along with the reason the patient is considered unstable. The monthly reassessment must be completed until the issue is resolved or it is determined by the IDT members that the condition is chronic. The meeting will also review the unstable criteria.
The in-servicing will be completed by July 21, 2023, with documentation of the training on file at the facility.
The CM or designee will perform monthly audits of the CIA/POCs for 3 months. At that time if compliance is observed, the audits will then follow the monthly QAPI 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
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 facility policy/procedure, a review of medical records, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure the staff followed facility procedure for early termination of treatment for three (3) of five (5) medical records (MR) reviewed (MR#3, MR#4, MR#5).
Findings include:
A review was conducted of facility policy/procedure on July 12, 2023 at approximately 11:30 a.m. Policy 'Early Termination or Arriving Late for Treatment' 'Policy: Early Termination: "If a patient requests to leave treatment early: *The RN who evaluates the patient must document the rationale for early termination.....*The RN is responsible to notify the physician and document on the 'AMA' (Against medical advice) form.' 'Requirement Documentation- AMA Forms: AMA Forms are "Signed by the patient" and "Signed with each early termination event and filed in the patients medical record". 'Arriving Late' states "There may be times when a patients transportation is delayed and arrives late for their scheduled time. If patient arrives after their scheduled time for dialysis treatment start the patients treatment as soon as possible. Staff should do their best to accomodate the patients prescribed treatment time. If this is not possible ....the physician must be notified to review the time delay and determine the appropriate intervention. ......"
A review of medical records conducted on July 12, 2023 between approximately 9:00 a.m.- 11:30 a.m. revealed the following:
MR#3 Date of admission 03/07/16: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 3:00 hours".
Patient treatment flow sheet date 06/26/23 reviewed. Flow sheet stated "Hours On: "02:47". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
MR#4 Date of admission 07/04/23: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 4:00 hours".
Patient treatment flow sheet date 07/06/23 reviewed. Flow sheet stated "Hours On: "03:03". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
Patient treatment flow sheet date 07/08/23 reviewed. Flow sheet stated "Hours On: "03:39". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
MR#5 Date of admission 10/21/20: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 4:00 hours".
Patient treatment flow sheet date 06/30/23 reviewed. Flow sheet stated "Hours On: "03:43". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
Patient treatment flow sheet date 07/03/23 reviewed. Flow sheet stated "Hours On: "03:49". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
An interview with the facility Clinical Nurse Manager on July 12, 2023 at approximately 11:45 a.m. confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will in-service all the DPC staff on the following policies:
- Early Termination or Arriving Late for Treatment
- Against Medical Advise (AMA) Form
The meeting will focus on ensuring that the registered nurse (RN) is notified when a patient is requesting to discontinue treatment early with documentation of the RN notification. The meeting will review that the RN must evaluate the patient and document the reason for the early termination of treatment. The staff meeting will also reinforce that the patient must sign an AMA form and the physician notified with documentation of the notification.
Inservicing will be completed by July 21, 2023. All training documentation is 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/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific 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 QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on a review of facility policy/procedure, a review of medical records, and an interview with the facility Clinical Nurse Manager, it was determined the facility failed to ensure an initial registered nurse evaluation was conducted, prior to the initiation of first treatment, for two (2) of four (4) initial registered nurse (RN) evaluation patient medical records (MR) reviewed (MR #1, MR#4), failed to ensure physicians medication orders were administered as ordered for one (1) of five (5) medical records reviewed (MR#1), and failed to ensure the nurse in charge was made aware of patient hypotension/change in patients condition during treatment for one (1) of five (5) in-center patient medical records (MR) reviewed (MR#2).
Findings include:
A review was conducted of facility policy/procedure on July 12, 2023 at approximately 11:30 a.m. 'Clinical Services' policy 'Comprehensive Interdisciplinary Assessment and Plan of Care' 'Prior to Initiation of the patients first treatment for Patients New to Dialysis' states "A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs. The RN must document the assessment. The assessment may be documented on the CIA in eCC, evaluation cascade in Chairside or multidisciplinary notes and should include at a minimum: *Neurologic: level of alertness/mental status, orientation, identification of sensory deficits. *Subjective complaints. *Rest and comfort: pain status. *Activity: ambulation status, support needs, fall risk. *Access: assessment. *Respiratory: respirations description, lung sounds. *Cardiovascular: heart rate and rhythm; presence and location of edema. *Fluid gains, blood pressure and temperature pre-treatment. *Integumentary: skin color, temperature and as needed, type/location of wounds."
(Note: The facility policy states "New to dialysis". The regulation states "New to the facility.")
A review of medical records conducted on July 12, 2023 between approximately 9:00 a.m.- 11:30 a.m. revealed the following:
MR#1 Date of Admission 07/03/21: Patient's first treatment flowsheet dated 07/03/21 was reviewed. Treatment initiated at 6:04 a.m. Documentation provided of the initial RN evaluation being completed at 8:27 a.m.
MR#4 Date of Admission 07/04/23: Patient's first treatment flowsheet dated 07/04/23 was reviewed. Treatment initiated at 12:14 p.m. Documentation provided of the initial RN evaluation being completed at 12:30 p.m.
Facility policy/procedure related to adhering to physicians orders was requested on 04/13/23 at approximately 11:30 a.m. No policy/procedure provided.
MR#1, Date of admission 07/03/21: 'Orders Summary Report' 'Treatment Medications' includes "4% Sodium Citrate Catheter Lock Arterial Red Port 2.1 mL Post Dialysis Every Treatment." 'Start Date: 06/05/23.' 'End Date: 06/03/24.'
"4% Sodium Citrate Catheter Lock Venous Blue Port 2.2 mL Post Dialysis Every Treatment." 'Start Date: 06/05/23.' 'End Date: 06/03/24.'
Patient treatment flowsheet dated 07/05/23 'Medications' 'Description' '4% Sodium Citrate Catheter Lock Arterial' 'Administered prescribed:' "No; Unable to administer as prescribed."
'Description' '% Sodium Citrate Catheter Lock Venous' 'Administered prescribed:' "No; Unable to administer as prescribed."
Patient treatment flowsheet dated 07/07/23 'Medications' 'Description' '4% Sodium Citrate Catheter Lock Arterial' 'Administered prescribed:' "No; Unable to administer as prescribed."
'Description' '% Sodium Citrate Catheter Lock Venous' 'Administered prescribed:' "No; Unable to administer as prescribed."
Patient treatment flowsheet dated 07/10/23 'Medications' section blank with no entries. No documentation provided of 4% Sodium Citrate Catheter Lock Arterial nor 4% Sodium Citrate Catheter Lock Venous administered as prescribed.
Policy 'Patient Assessment and Monitoring' 'During treatment' 'Follow the steps below for monitoring patient and machine parameters during treatment:' Step (1) Blood pressure. Record blood pressure. 'Report to the nurse:' ....... Blood pressure less than or equal to 100 mm/hg systolic.
Policy 'Hypotension' 'Treating Hypotension' 'Note:' "LPN/LVN, PCT must immediately report signs and symptoms of hypotension to the FKC RN/Supervising RN."
Policy 'Patient Assessment and Monitoring' 'Data Collection' "..... if the PCT/LPN note any changes or abnormal findings in the patients condition or vascular access are observed or reported by the patient, ......., the registered nurse must assess the patient."
MR#2, Date of admission 05/02/23: Treatment flowsheet dated 07/06/23 reviewed. Treatment initiated at 9:51 a.m. At 1:02 p.m. blood pressure (BP) was "89/45" (entered by Employee #5, patient care technician). At 1:02 BP recheck was "53/21" (entered by Employee #5, patient care technician). At 1:19 p.m. BP "87/44" (entered by Employee #5, patient care technician). At 1:19 p.m. BP recheck "79/37" (entered by Employee #5, patient care technician). At 1:37 p.m. BP "75/44" (entered by Employee #7, registered nurse).
No documentation provided of the personal care technician notifying the registered nurse of the patients lowered blood pressure readings during treatment.
Treatment flowsheet dated 06/27/23 reviewed. Treatment initiated at 10:03 a.m. At 1:31 p.m. 'Comments' (entered by employee #5, patient care technician) include "..... Lines reversed......" At 2:09 p.m. 'Comments' (entered by employee #5, patient care technician) include "..... Lines reversed......"
No documentation provided of the patient care technician notifying the registered nurse of a change in the patients condition which would warrant reversing the patients central venous catheter blood lines.
An interview with the facility Clinical Nurse Manager on July 12, 2023 at approximately 11:45 a.m. confirmed the above findings.
Plan of Correction:By July 18, 2023, the Director of Operations (DO) and the CM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policy:
- Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC)
- Medication Preparation and Administration
- Patient Assessment and Monitoring
- Unable to Achieve Prescribed Blood Flow Rate
The meeting will focus on the importance of the staff adhering to all Fresenius Medical Care (FMC) policies and ensuring that an initial RN assessment is completed prior to the initiation of treatment for any patient new to the facility. The meeting will also review that all medications ordered by the physician are administered as prescribed. The importance of ensuring that the RN is made aware of any out-of-range vital signs (VS), including blood pressures (BP) will be reinforced. The meeting will review that blood flow rates (BFR) must be set per the physician order. If the BFR cannot be achieved at the prescribed rate, the RN must be notified and any intervention taken to achieve the BFR , including switching the blood lines, is reported to the physician and documented.
Minutes of the meeting with the Medical Director will be on file at the facility for review.
The Medical Director was informed at the meeting that the CM or designee will hold a DPC staff inservice and will receive education on the above policies by July 21, 2023.
All training documentation will be on file at the facility.
The Medical Director was informed that the CM or designee will perform audits for 2 weeks for VS, BFR and medication administration. If compliance is noted at that time, the audits will be completed 2 times/week for 2 weeks. If 100% compliance is sustained at that time, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits. The CM or designee will also monitor all newly admitted patients monthly to ensure completion of an assessment prior to the start of treatment and report findings at the monthly QAPI meetings.
The Medical Director will be informed that staff found to be non-compliant will be re-educated and counseled.
To ensure ongoing compliance the CM will review the audit findings with the Medical Director weekly. The results and progress of the POC will be reviewed at the QAPI Committee monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
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