Initial Comments:
Based on the findings of an onsite unannounced complaint investigation completed February 27, 2024, Fresenius Medical Services of Cranberry 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-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, manufacturer directions for use, and staff (EMP) interview, the facility failed to ensure two (2) of two (2) registered nurses disinfected items taken into the dialysis station (EMP1, & EMP3).
Findings included:
Review of facility policy on February 26, 2024, at 11:35 a.m. showed, "Cleaning and Disinfecting the Dialysis Station ... The purpose of this policy is to provide guidelines to prevent the spread of infectious disease ... After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station."
Observation of EMP3 on February 26, 2024, at 10:50 a.m. revealed him/her assess a patient at station 7. Once finished with the assessment, EMP3 hung his/her stethoscope around his/her neck and left the station. EMP3 walked to clean supply area and wiped his/her stethoscope with a small 4.5cm x 9cm (centimeter) alcohol (70% isopropyl) pad and hung it on the wall with other stethoscopes.
Observation of EMP1 on February 26, 2024, at 10:56 a.m. revealed him/her assess a patient at station 3 while patient was dialyzing. Once finished with the assessment, EMP1 left the station with his/her stethoscope. EMP1 walked to clean supply area and wiped his/her stethoscope with a small 4.5cm x 9cm alcohol pad and hung it on the wall with other stethoscopes.
Interviews with EMP1 and EMP3, and review of the alcohol wipe wrapper and its directions for use on February 26, 2024, at 11 a.m. confirmed findings. Per the directions for use, "ALCOHOL PREP PAD ... Directions ... apply topically as need to cleanse intended area."
Interview with EMP4 (administrator) on February 26, 2024, at 12:05 p.m. confirmed the alcohol prep pad used by EMP1 and EMP3 was not bleach or an EPA registered disinfectant as outlined in facility policy.
Plan of Correction:To ensure compliance the covering Clinic manager (CM) or designee will in-service all direct patient care (DPC) staff on:
- Cleaning and Disinfecting the Dialysis Station
The in-service will focus on the staff ensuring that all non-disposal items and/or equipment is cleaned and disinfected after each use before being returned to the clean storage area. These items and/or supplies must be cleaned and disinfected with 1:100 bleach per policy. This cleaning and disinfection includes stethoscopes.
Inservicing will be completed by March 7, 2024. 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 one-hundred percent (100 %) 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.
Completion Date: March 29, 2024
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 clean areas were separated from contaminated areas, and that unused supplies and patient care items were stored in a clean area.
Findings included:
Review of facility policy on February 26, 2024, at 12:05 p.m. showed, "General Cleanliness and Infection Control Guidelines Purpose The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, aesthetically pleasant environment for patients, staffs, and visitors. ... All areas must be kept clean and organized, including but not limited to the treatment area, ... Walkways must be kept clear of debris and free of clutter."
Review of facility policy on February 27, 2024, at 11 a.m. showed, "Storage of Supplies ... Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged. ... All supplies must be stored in a clean ... environment."
Observation on February 26, 2024, at 9:30 a.m. revealed the facility stored a large pallet of supplies, and two (2) wheelchairs in the corridor leading into the patient treatment area.
Observation on February 26, 2024, at 9:35 a.m. revealed the facility was storing an unused 55-gallon drum of acid (intended to be clean and used in water room to make dialysate) in the patient's bathroom (not a clean area).
Observation on the treatment floor on February 26, 2024, at 9:45 a.m. revealed that the "biohazard" sharps container (used to store used needles etc.) attached to the hemodialysis machine at station 4, while a patient was dialyzing, was situated adjacent to the facility's medication storage fridge.
Observation of the staff bathroom on February 26, 2024, at 12 p.m. revealed it contained an unused 55-gallon drum of acid, and patient care items such as a Hoyer lift (used in treatment area to transfer patients from their wheelchairs to their treatment chairs), and a patient privacy partition. The cord for charging the Hoyer lift was fashioned over the sink and plugged into the wall.
Interviews with EMP1 (clinic manager) and EMP4 (administrator) on February 26, 2024, at 12 p.m. confirmed above findings.
Plan of Correction:For immediate compliance, on February 26, 2024, the bio-medical technician (BMT) removed the acid drum from the patient's and staff bathrooms as well as the Hoyer lift. On the same date, the pallet of recently delivered supplies were placed in their appropriate storage location. The wheelchairs were also relocated to an area where they were not blocking the hallway. The biohazard sharps container at station four (4) was removed.
For ongoing compliance, the CM or designee will in-service all the DPC and the BMT staff on the following policy:
- General Cleanliness and Infection Control Guidelines
- Storage of Supplies
Emphasis will be placed on ensuring that the facility is maintained in a clean and organized manner, this includes the treatment area and the patient and staff bathrooms. The meeting will also reinforce that the hallways must always be kept clear and free of any obstructions. The staff will be re-educated that all supplies must be stored in a clean environment, this means that no items and/or supplies can be stored in bathrooms
The inservice will be completed by March 7, 2024, and the education records will be on file in the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if 100% compliance is observed, the audits will then be completed 2 times/week for 2 weeks. At that time, if compliance is maintained, 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: March 29, 2024
494.60(c)(1) STANDARD
PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE
Name - Component - 00
The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff.
Observations:
Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure sufficient space was available to provide care and services in a manner that allowed for emergency exit corridors to remain clear; that allowed clean items to be stored in a clean area; and that allowed a contaminated item to be separated from clean supplies.
Findings included:
Review of facility policy on February 26, 2024, at 12:05 p.m. showed, "General Cleanliness and Infection Control Guidelines ... The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, aesthetically pleasant environment for patients, staffs, and visitors. ... All areas must be kept clean and organized, including but not limited to the treatment area, ... Walkways must be kept clear of debris and free of clutter."
Review of facility policy on February 27, 2024, at 11 a.m. showed, "Storage of Supplies ... Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged. ... All supplies must be stored in a clean ... environment."
Observation of corridor leading into the facility on February 26, 2024, at 9:30 a.m. revealed a large pallet full of supplies on one side of the corridor. The facility also stored two (2) wheelchairs in this corridor due to limited space inside the clinic. This arrangement reduced the corridor width to 24 inches (not large enough for a wheelchair or stretcher to pass).
Observation on February 26, 2024, at 9:35 a.m. revealed the facility was storing an unused 55-gallon drum of acid (intended to be clean and used in water room to make dialysate) in the patient's bathroom (not a clean area).
Observation on the treatment floor on February 26, 2024, at 9:45 a.m. revealed that the "biohazard" sharps container (used to store used needles etc.) attached to the hemodialysis machine at station 4, while a patient was dialyzing, was situated adjacent to the facility's medication storage fridge so that it was slightly in front of the fridge's front facing panel.
Observation of the staff bathroom on February 26, 2024, at 12 p.m. revealed it contained an unused 55-gallon drum of acid, and patient care items such as a Hoyer lift (used in treatment area to transfer patients from their wheelchairs to their treatment chairs), and a patient privacy partition. The cord for charging the Hoyer lift was fashioned over the sink and plugged into the wall. In order to was hands in the sink, staff would have to unplug the cord or duck underneath it (the cord has some elasticity).
Interviews with EMP1 (clinic manager) and EMP4 (administrator) on February 26, 2024, at 12 p.m. confirmed above findings.
Plan of Correction:For immediate compliance, on February 26, 2024, the BMT removed the acid drum from the patient's and staff bathrooms as well as the Hoyer lift. On the same date, the pallet of recently delivered supplies were placed in their appropriate storage location. The wheelchairs were also relocated to an area where they were not blocking the hallway. The biohazard sharps container at station 4 was removed.
For ongoing compliance, the CM or designee will in-service all the DPC and the BMT staff on the following policy:
- General Cleanliness and Infection Control Guidelines
- Storage of Supplies
Emphasis will be placed on ensuring that the facility is maintained in a clean and organized manner, this includes the treatment area and the patient and staff bathrooms. The meeting will also reinforce that the hallways must always be kept clear and free of any obstructions. The staff will be re-educated that all supplies must be stored in a clean environment, this means that no items and/or supplies can be stored in bathrooms
The inservice will be completed by March 7, 2024, and the education records will be on file in the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if 100% compliance is observed, the audits will then be completed 2 times/week for 2 weeks. At that time, if compliance is maintained, 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: March 29, 2024
494.60(f) STANDARD
PE-INCORPORATION BY REFERENCE
Name - Component - 00
(f) Incorporation by reference. The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material from the sources listed below. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov, or go to: www.archives.gov/federal__register/cfr/ibr-locations.html. If any changes in the editions of the Codes are incorporated by reference, CMS will publish a document in the Federal Register to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1-617-770-3000.
(i) NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11 2011.
(ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) [Reserved]
Observations:
Based on review of 2012 NFPA (National Fire Protection Agency) 101 standards, observation, posted facility evacuation route, and staff (EMP) interview, the facility failed to ensure one of two exit routes were kept clear (EXIT1).
Findings included:
Review of 2012 NFPA 101 on February 27, 2024, at 9 a.m. showed, "Chapter 19 Existing Health Care Occupancies ... 19.1 General Requirements ... 19.2.3.5 The aisle, corridor, or ramp shall be arranged to avoid any obstructions to the convenient removal of nonambulatory persons carried on stretchers or on mattresses serving as stretchers."
Observation of corridor leading into the facility (EXIT1) revealed a large pallet full of supplies on one side of the corridor and two (2) wheelchairs located on the other side of the corridor. This arrangement reduced the corridor's width to 24 inches.
Interview with EMP1 (clinic manager) on February 26, 2024, at 10 a.m. confirmed findings.
Plan of Correction:For immediate compliance, on February 26, 2024, the BMT unpacked the pallet of supplies in the hallway that had been delivered that morning. They were placed in their designated storage areas.
For ongoing compliance, the CM or designee will in-service all the DPC and the BMT staff on the following policy:
- General Cleanliness and Infection Control Guidelines
- Storage of Supplies
Emphasis of the meeting will be placed on ensuring that the corridors of the facility are always free of any obstructions.
The inservice will be completed by March 7, 2024, and the education records will be on file in the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if 100% compliance is observed, the audits will then be completed 2 times/week for 2 weeks. At that time, if compliance is maintained, 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: March 29, 2024
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