Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on September 15, 2023, Liberty Dialysis - Hopewell Llc 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 15, 2023, Liberty Dialysis - Hopewell Llc was found 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-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK
Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.
Observations:
Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure staff members wore face shields and eye wear to protect themselves when performing procedures during which spurting and spattering of blood might occur for two (2) of two (2) staff members observed wearing personnel prescription corrective eyewear during discontinuation of dialysis (EMP8, & EMP10).
Findings included:
Review of facility policy on September 15, 2023, at 11 a.m. showed, "Personal Protective Equipment ... Policy Employees who have potential occupational exposure shall be provided ... appropriate equipment including ... face shields ... eye protection with full side shields as appropriate. ... Personal protective equipment such as full face shield or mask and protective eyewear with full side shield ... will be worn to protect and prevent employees from blood or other potentially infections materials to pass through to or reach the employee's skin, eyes ... Protective eyewear is provided by the facility and must be eye protection intended to shield the wearer's eyes from certain hazards. Prescription corrective eyewear is not considered appropriate eye protection. For blood and body fluid hazards, this would be face shield or any other form of eye protection designed to prevent blood and OPIM to reach eyes under normal conditions of use and for the duration the PPE will be used."
Observation of discontinuation of dialysis with a patient who had an arteriovenous fistula on September 15, 2023, at 10:35 a.m. at station 14 revealed EMP8 remove needles from patient's arm and apply gauze dressings. EMP10 was also present at the station. Both employees wore their personal prescription corrective eyewear while caring for the patient. EMP8's glasses were observed to be slid down on his/her nose while providing care.
Interviews with EMP8, and EMP10 on September 15, 2023, at 10:50 a.m. confirmed above findings.
Plan of Correction:V 115
The clinic manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Personal Protective Equipment
Special emphasis will be placed on ensuring that all personal protective equipment (PPE) is always worn per policy. This includes the PPE eyewear and ensuring that it covers the eyes.
The in-servicing of staff will be completed by September 25, 2023, 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 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 Quality Assessment and Performance Improvement (QAPI) schedule. A plan od correction (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.
Completion Date: October 20, 2023
494.30(a)(1)(i) STANDARD
IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS
Name - Component - 00
Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled.
When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station.
Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients.
Observations:
Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure a clean area was clearly separated from where used contaminated supplies were handled and stored for one (1) of four (4) dirty supply container locations.
Findings included:
Review of facility policy on September 14, 2023, at 11 a.m. showed, "Dialysis Precautions ... General Approach ... All used dialyzers [are] contaminated ... All supplies and equipment used for a patient's treatment [are] contaminated ... Clean area: An area designated for clean and unused equipment, supplies and medications. Dirty area: An area where [there] is a potential for contamination with blood body fluids and areas where contaminated or used supplies, equipment, blood supplies or biohazard containers are stored or handled. Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled and stored."
Observation of the treatment area on September 13, 2023, at 10:30 a.m. revealed a large waste receptacle (garbage can) for trash such as used gloves and another square receptacle labeled "regulated medical waste" located up against a half wall. The half wall was a partition between the treatment area and a space where staff could document and make business related phone calls-- a clean area. When patient treatments were completed, staff would discard used supplies into these containers such as blood sets/dialyzers. Located approximately 8 inches above the tops of the waste receptacles, and on the same half wall, were unused and staged patient care supplies to be used for second shift patients. The area of the half wall partition from where the tops of the receptacles were located to where clean supplies were located was discolored and soiled.
Further observation with EMP1 (clinic manager) and EMP5 (administrator) on September 13, 2023, at 11 a.m. confirmed above findings.
Plan of Correction:V 117
For ongoing compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Dialysis Precautions
Special emphasis will be placed on ensuring that all equipment and supplies are stored in a designated clean area. This includes that clean supplies being stored on countertops in the treatment area are clearly separated and not located close to the to the dirty area where the trash is disposed of. Clean versus dirty areas are to be clearly labeled to prevent any risk of contamination. The staff meeting will reinforce that the area where the clean supplies are stored above the wall partition must be kept clean and free of any stains.
The in-servicing of staff will be completed by September 25, 2023, 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 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.
Completion Date: October 20, 2023
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 review of facility policy, a clinical record (CR), and staff (EMP) interview, the facility failed to ensure one (1) of one (1) record reviewed with concurrent poor lab values in nutrition, anemia, and adequacy had monthly comprehensive assessments and plans of care (CR1).
Findings:
Review of facility policy on September 14, 2023, at 11:30 a.m. showed, "Comprehensive Interdisciplinary Assessment [CIA] and Plan of Care [POC] ... General Policy for Patient Assessment and Plan of Care ... Patient stability must be reviewed monthly. ... CIA/POC for Unstable Patients ... Unstable patients must be reassessed by the IDT monthly. Monthly re-assessment and any POC updates related to the reason the patient is considered 'unstable' must be documented until the issues have been resolved or the IDT (including the patient if possible) determines that the condition is chronic. The following are unstable criteria: ... Concurrent poor nutritional status, unmanaged anemia, and inadequate dialysis ... a. Albumin [protein level] <4.0 for any modality ... b. Hgb [red blood cells] <10 for any modality plus c. Kt/V meeting the following criteria for 3 months ... ii. SpKt/V <1.2 for Incenter HD."
Review of CR1 on September 14, 2023, at 10:30 a.m. showed patient was admitted to facility on 8/3/2017. The patient's last plan of care was completed on 3/6/2023 as "Stable" with the next POC meeting scheduled for 2/29/2024. Review of CR1's labs showed he/she had concurrent poor nutritional status, unmanaged anemia, and inadequate dialysis from 6/2/2023 to 9/8/2023. On 6/7/2023, the patient's hgb was 7.9, spKt/V was 0.91, and albumin was 3.2. On 7/5/2023, the patient's hgb was 7.2, spKt/V was 1.05, and albumin was 2.9. On 8/4/2023, the patient's hgb was 8.6, spKt/V was 1.14, and albumin was 3.3. On 9/6/2023, the patient's hgb was 8.8, an albumin was 3.1. On 9/8/2023, the patient's spKt/V was 0.88.
Interview with EMP1 (clinic manager) on September 14, 2023, at approximately 12 p.m. confirmed findings. The patient had no monthly CIA/POC because he was "chronic."
Plan of Correction:V 520
To ensure compliance, the CM or designee will in-service all members of the Interdisciplinary Team (IDT) on the following policy:
- Comprehensive Interdisciplinary Assessment and Plan of Care
The in-service will provide re-education on ensuring that all patients are reviewed monthly for a possible status change which would meet the criteria for designating the patient unstable. The meeting will review the concurrent conditions that deem a patient unstable, such as poor nutrition, anemia and inadequate dialysis.
The IDT training will be completed by September 25, 2023, with documentation on file at the facility.
The CM or designee will perform audits for all patients for the next four (4) months to ensure all unstable patients are identified with a completed care plan monthly. At that time, if compliance is sustained, 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.
Completion Date: October 20, 2023
494.110(a)(2)(ix) STANDARD
QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT
Name - Component - 00
The program must include, but not be limited to, the following:
(ix) Infection control; with respect to this component the facility must-
(A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence;
(B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and
(C) Take actions to reduce future incidents.
Observations:
Based on review of a clinical record (CR), policy, facility documentation and staff (EMP) interview, the facility failed to record and follow-up on all patient infections and failed to record such information in a centralized log book or other tracking mechanism with documentation of action taken for one (1) of two (2) clinical records reviewed for infections (CR1).
Findings:
Review of facility policy on September 15, 2023, at 11 a.m. showed, "Quality Assessment and Performance Improvement Program [QAPI] ... QAPI meetings will be held monthly. ... QAPI Meeting Objectives The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. Elements to be reviewed will include: ... Infection surveillance.
Review of CR1 on September 14, 2023, at 10:15 a.m. showed patient was admitted to the hospital on 3/11/2023 and discharged on 3/17/2023. According to CR1's hospital discharge summary, "Patient was also diagnosed with C diff colitis [gut infection] and patient was started on p.o. [by mouth] vancomycin [antibiotic] which is completed for a 10 day course." A provider rounding note completed while patient was on dialysis at the facility status post hospital discharge showed, "Observation Time: 3/29/2023 ... Provider Rounding Note ... Service Date: 3/29/2023 ... I met face to face with the patient today. ... Comments: out of hospital again. Back on oral Vanco and has follow up with GI. Missed treatment last week due to diarrhea and came off several times today to use BR [bathroom] until he adventually [sic] called it quits. Says he is not eating much because when he does he is incontinent of stool LAST HOSPITALIZATION ... Discharge Date 3/17/2023."
Review of "INFECTION SURVEILLANCE PLATFORM" on September 14, 2023, at 1 p.m., from May of 2022 to present, did not show CR1's C diff colitis infection had been logged or tracked.
Interview with EMP1 on September 14, 2023, at 1:12 p.m. confirmed CR1's infection was not tracked and no documentation to show what action was taken.
Plan of Correction:V 637
The Director of Operations (DO) or designee will re-educate the QAPI committee on policy:
- Quality Assessment and Performance Improvement Program (QAPI) Policy
Emphasis will be placed on the importance of recognizing a focus area, including infections, and ensuring that the infection is recorded and tracked, and a root cause completed if indicated. The meeting will also reinforce the importance of oversight of infections with the implementation and follow up of an action plan to decrease the risk of transmission. Education also included monitoring and sustaining improvements, as well as what actions the committee will take if improvements with the action plans are not noted.
The in-services were completed by September 25, 2023. Documentation of the in-servicing will be on file at the facility.
To maintain compliance, the DO will monitor the monthly QAI minutes to ensure that BSI are being completed and tracked on the QAPI schedule. The DO will ensure the development, implementation and monthly review of action plans if indicated. The DO review of the QAPI minutes will be performed monthly over the next three (3) months to ensure 100% compliance is achieved. The auditing will then be completed bimonthly for another 3 months. The DO will report the findings of the QAPI meeting review to the CM who will report the results at the monthly QAPI Meeting. The QAPI committee will provide ongoing monitoring for sustained compliance.
Non-adherence will result in re-education and counseling.
Completion Date: October 20, 2023
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